AJP Spring 2012

Spring 2012 Vol. 4, No. 1

Arizona Journal of Pharmacy

THE OFFICIAL PUBLICATION OF THE ARIZONA PHARMACY ALLIANCE

The Voice of Pharmacy in Arizona

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Arizona Journal of Pharmacy

THE OFFICIAL PUBLICATION OF THE ARIZONA PHARMACY ALLIANCE

Vol. 4, No. 1

Spring 2012

In This Issue Columns

President’s Message CEO’s Message Academy News • Community Pharmacy Academy • Geriatric Care Academy

• Health-System Academy

• Managed Care Academy

• Student Pharmacist Academy • Technician Academy

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Featured Articles

Features of Electronic Prescribing Software: A Pilot Study to Evaluate Importance & Satisfaction PACT: Medical Home the VA Way

A Look Back - Suppository Molds Time Capsule Service to Country

Departments

New Members Association News PAPA Legislative Update Arizona State Board of Pharmacy Drug Information Question Student Perspective • Pharmacy Day at the State Capital: Promoting the Pharmacy Profession Feature Pharmacist • The Lady and the Law Continuing Education

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Editor

Janet Weigel Marketing and Communications Manager

www.azpharmacy.org

Editorial Board

Leslie Rodriguez, Pharm.D. Whitney Rice, Pharm.D. Julie Hernandez, Pharm.D.

Tina Smith, Pharm.D., BCPS Nicholas Muscolino, Pharm.D.

Spring 2012 • Arizona Journal of Pharmacy • 1

President’s Message

Find Your Voice

Kevin Boesen, Pharm.D. AzPA President

Do you have a favorite voice? Is it a favorite singer like Adele, Taylor Swift, or Jason Aldean? Or maybe it’s a classic voice like Patsy Cline, Johnny Cash, or Justin Beiber. Maybe it’s not someone famous at all. Maybe it’s your spouse or your kids or your best friend. A voice can be very influential. A voice can be comforting, exciting, or even inspiring. Do you ever think about what kind of voice you have?

One of my favorite voices belong to long-time Chicago Cub baseball player and broadcaster, Ron Santo.

Ron Santo played for the Cubs from 1960 to 1973. He was a 9-time all star and fan favorite. He had a love for the game that fans were drawn to. In 1990, Santo became a radio broadcaster for the Cubs. I never saw Santo play the game, but I listened to him almost everyday during baseball season from 1990 until he passed away in 2010.

Ron Santo was not a typical radio broadcaster. He didn’t have a particularly smooth voice or anywhere near a polished delivery. He would constantly fumble over words, forget to describe the action, and even yell into the microphone while, as a listener, I would struggle to figure out what was happening in the game.

So, how could someone so bad at broadcasting stay on the air for 20 years and become one of my favorite voices? It is because nobody loved the game or the Cubs more than Santo (not even me).

What he lacked in broadcasting ability, he more than made up for with his passion. I loved listening to Santo because it was like I was in the booth with him. When the Cubs won, it was the greatest of days. When they lost, it was tough to get over the disappointment. You didn’t always know what was happening, but the emotion was undeniable. He also told great stories about his playing days and compared it with the game today.

I loved listening to someone talk about what they loved.

The theme for this journal is AzPA: the Voice of Pharmacy in Arizona.

We talk a lot about pharmacy needing a strong voice to influence policy makers so that we can have a greater impact on patient care. Maybe, all we really need is just more passion.

Do you ever talk about pharmacy the way Ron Santo talked about baseball?

Do you talk with anyone who will listen about what you do on a daily basis and why you love it so much? A couple of years ago, my brother and I started making short videos about different pharmacy settings. The idea was to get middle school kids excited about a career in pharmacy. We call the segments, “PharmTalk” and post them on the University of Arizona College of Pharmacy webpage (www. pharmacy.arizona.edu/pharmtalk).

I start most videos by stating (maybe yelling) that pharmacy is one of the most exciting professions. I truly believe that. Pharmacy offers a number of career options and opportunities to positively impact people’s lives. I talk about pharmacy as much as I can to friends, neighbors, and even sometimes to perfect strangers. I don’t always use the same level of enthusiasm that I do in the

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videos, but maybe I should. Maybe if I talked about pharmacy with as much passion that Ron Santo talked about baseball and the Cubs, then mine would be a voice that inspires, that people are drawn to. My guess is we could all be more passionate when we talk about pharmacy with those outside the profession and even with our patients.

There is one other thing that made Ron Santo somewhat unique. He was diagnosed with Type I diabetes when he was 18. He concealed that from his teammates during most of his playing days, but while in the broadcast booth it was tough to conceal. He had both of his legs amputated (one in 2001 and the other in 2002) and in 2004, Santo and his fight against diabetes were the subject of the documentary This Old Cub. I am sure somewhere along the way, Santo had help from amazing pharmacists and pharmacy technicians.

Since he lived in Scottsdale, they may have even been AzPA members.

However, in all the years I listened to Ron Santo on the radio, I never heard him mention pharmacists or pharmacy.

I wonder if a passionate pharmacist could have provided comfort or inspiration for Ron Santo like he did for me for so many years.

AzPA is here to be your voice the voice of pharmacy in Arizona. I challenge you to find your voice and make sure it is heard as a member of the pharmacy profession.

CEO’s Message

Recognizing Pharmacists as Providers We have made huge strides in advancing pharmacists’ scope of practice in the state of Arizona. In fact in just six short years we have expanded our immunization rules beyond what we thought possible and modified our Collaborative Practice rules to be one of the most expansive packages in the U.S. and a model for other states. Pharmacists and student pharmacists can now administer flu vaccines to children without a prescription and pharmacists can enter into a collaborative practice agreement with a physician to help manage diabetic drug treatment plans or collaborate with a physician to initiate the proper tobacco cessation treatment. I am very excited to be a part of our changing profession, but one big elephant still remains in the room: recognition of pharmacists as health care providers. To date our profession has minimal opportunities to be paid for services outside of dispensing despite the overwhelming evidence that we positively impact patient outcomes and reduce overall health care costs.

In December the Chief Pharmacist at the U.S. Surgeon General’s Office released Improving Patient and Health System Outcomes through Advanced Pharmacy Practice. This report makes the case for the “recognition of pharmacists as health care providers, clinicians, and an essential part of the health care team is appropriate given the level of care they provide in many health care settings” and “for pharmacists to continue to improve patient and health system outcomes as well as sustain various roles in the delivery of care, they must be recognized as health care providers by statute via legislation and policy, and be compensated through additional mechanisms commensurate with the level of services provided (and with other practitioners providing comparable services).”

I invite all of you to join our efforts in lobbying at both the state and national level to get pharmacists recognized as providers under the Social Security Act. Sandra Leal, Pharm.D., CDE and Kelly Green Boesen, Pharm.D., BCPS, both longtime AzPA members, started a petition on the change.org website (www.change.org) that I encourage all of you to sign and share with your colleagues and patients. It is time to fight for our position on the health care team and to solidify our futures as health care providers. This is a grassroots effort and it will take all of us to move this elephant in the right direction.

Kelly Ridgway, R.Ph. AzPA CEO

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On page 4 of this journal we are including talking points for your use in your lobbying efforts. This document is also available to download from the AzPA website.

AzPA introduced the following new policy statement regarding the issue of pharmacists needing to be recognized as providers during APhA’s House of Delegates and we hope to do the same this summer at the ASHP Meeting.

Current Policy Statement: • APhA supports changes to the Social Security Act to allow pharmacists to be recognized and paid as providers of patient care services, including, but not limited to, medication therapy management.

Proposed New Policy Statement Amendments: • APhA supports changes to the Social Security Act to allow pharmacists to be recognized and paid as providers of patient care services, including but not limited to medication therapy management.

• APhA’s Board of Trustees shall direct Association resources to

actively advocate nationally for the necessary changes to the Social Security Act. APhA shall assume a leadership role, in cooperation with other national and state pharmacy organizations as well as the appropriate public health advocates to develop a strategy to accomplish this task.

AzPA is working to secure the support of other State Associations so that we can put pressure on our national pharmacy associations to pursue this effort. AzPA is also considering future state legislation that would recognize pharmacists acting under collaborative practice agreements as mid-level practitioners.

Last, but not least, once pharmacists have the ability to bill for cognitive services it will lead the way for us to expand the technician’s scope of practice so that they can adequately support our new roles. Technicians are critical to profession and they need to be utilized to their fullest abilities in order to free up the pharmacists for clinical services.

I am blessed and honored to be your CEO and look forward to serving you in 2012. I am excited to see what this year has to offer and look forward to seeing you all at the AzPA 8th Annual Meeting June 28 to July 1 at the historic Wigwam Resort.

Spring 2012 • Arizona Journal of Pharmacy • 3

Recognizing Pharmacists in the Social Security Act as health care providers is the appropriate evolution of legislation that will expand the utility and eligibility of pharmacists to better address the nation’s health care demands, and improve patient and health system outcomes.

Studies have shown that when a pharmacist is directly involved in patient care, patients have fewer adverse drug reactions, experience improved outcomes, and health care costs are reduced.

The Social Security Act currently recognizes other health care professionals such as dieticians, nurse practitioners, physician assistants, nurse midwives, and clinical social workers.

Despite overwhelming evidence of the positive impact pharmacists can have on patient health, pharmacists are not recognized as health care providers under the Social Security Act.

WHY PHARMACISTS?

Arizona Pharmacy Alliance www.azpharmacy.org 480.838.3385

PHARMACISTS ARE QUALIFIED. Compared to physician assistants and nurse practitioners, the educational preparation of pharmacists emphasizes patient assessment and therapeutic monitoring, which establishes pharmacists’ expertise in the comprehensive management of disease through medication use. The emphasis on drug therapy in the pharmacy curriculum is inextricably linked to providing quality care subsequent to a diagnosis. Pharmacy school curricula also include diagnostic and physical assessment coursework.

Once a diagnosis is made, especially in the case of chronic disease, most of patient care (up to 80 percent) is geared to management of disease through drug therapy. Considering these patient care needs, the pharmacist is uniquely qualified to compliment the diagnosticians, such as physicians, to provide comprehensive care.

Pharmacists’ formal education appropriately prepares them to successfully perform clinical services related to the prevention and control of disease through medications. Pharmacists are also well-positioned (through accessibility, expertise and experience) to play a much larger primary care role in the U.S. health care system to meet these demands and improve health care delivery (and the health) of the nation.

Much like pharmacists in the IHS and VA, a growing number of states (such as New Mexico, North Carolina, and Massachusetts) already allow for prescriptive authority to pharmacists through collaborative practice. In February 2011, the Drug Enforcement Administration (DEA) granted prescriber numbers to pharmacists in Massachusetts (1 of 7 states). This important recognition of pharmacists as mid-level practitioners allows pharmacists working under collaborative practice agreements to prescribe controlled substances. For over forty years, federal pharmacists in the IHS, VA, and DOD have collaboratively managed disease through medication use, and other cognitive and clinical pharmacy services. The enduring history of physician-supported collaborative PHARMACISTS ARE ACCESSIBLE. As a profession, pharmacists are underutilized in addressing the health care needs of the nation. Pharmacists are the most accessible health care professionals in the United States and have always been one of the most trusted professions. A 2000 estimate of pharmacy patronage showed that the equivalent of the entire U.S. population (approximately 275 million people at the time of publication) visited pharmacies each week. In underserved rural areas, pharmacists are especially valued and serve many public health needs.

Physicians are currently overburdened, and the problem is only going to worsen as the first of the baby-boomer generation turns 65 in 2011. The U.S. population as a whole is aging; it is projected by 2030, one in five Americans will be over the age of 65. Older Americans require more health care, including office visits, hospital visits, and prescriptions. Existing pharmacy practice models can rapidly relieve some of the projected burden of access to quality care, reduce health disparities, and improve overall health care delivery.

In recent years, many reports have identified an imminent shortage of primary care physicians. Some studies projected a physician shortage anywhere from 85,000 to 200,000 by 2020, and a 38 percent increase in demand for general internists is projected by the year 2020. At least 12 states have already reported current or projected physician shortages (AZ, CA, FL, GA, KY, MA, MI, MS, NC, TX, OR, and WI).

pharmacy practice models clearly validates and confirms these models’ provision of positive patient-focused quality care.

• By 1974, over 90 percent of the IHS sites had one or more pharmacist-run disease management programs in place.

• Since 1996, IHS has recognized Clinical Pharmacy Specialists as primary providers with prescriptive authority.

RECOGNIZING PHARMACISTS AS HEALTH CARE PROVIDERS

Rev. 02-2012

PHARMACISTS IMPROVE TREATMENT OUTCOMES. Pharmacists deliver patient care services in a variety of practice settings through collaborative practice with physicians or as part of a health care team. After an initial diagnosis is made, pharmacists deliver many patient care services - and function as health care providers - in a variety of practice settings through collaborative practice agreements (CPAs), to manage disease in patients where medications are the primary mode of treatment. Through the delivery of patient care services, pharmacists improve outcomes, increase access to services for medically underserved and vulnerable populations, improve patient safety, shift time for physicians to focus on diagnosis and more critically ill patients, improve patient and provider satisfaction, enhance cost-effectiveness, and demonstrably improve the overall quality of health care through evidence-based practice.

Nearly 100,000 hospitalizations and emergency department visits annually are attributed to 4 classes of medication in patients over 65 years of age. There are numerous articles published where pharmacists have made positive health outcomes related to each of these classes of medications.1 An opportunity exists for health leadership and policy makers to support and implement additional, existing and evidence-based models of cost-effective pharmacist-delivered patient care as the following demands within our health system escalate: • Chronic Care. Chronic diseases are the leading causes of death and disability in the United States.

Chronic diseases currently affect 45% of the population (133 million Americans), account for 81% of all hospital admissions, 91% of all prescriptions filled, 76% of physician visits, and continues to grow at dramatic rates. Additionally, of all Medicare spending, 99% goes to beneficiaries with chronic disease.

• Access to care. Medically underserved patients seeking a health care home and the growth of primary care visits are two components that lead to insufficient time for focused or comprehensive disease or medication management and other related health care issues.

• Provider workforce. The primary care workforce may not be able

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Perform patient assessments including physical assessments; Through the use of CPAs, have prescriptive authority to initiate, adjust, modify, or discontinue medication therapy to manage disease; Order, interpret, and monitor laboratory tests; Administer medications, including immunizations; Formulate clinical assessments and develop therapeutic plans; Provide care coordination and other health services for wellness and prevention of disease; Develop partnerships with patients and providers for ongoing follow-up care.

PHARMACISTS CAN:

1. New England Journal of Medicine: 2011:365:2001-2012

Primary Source Document: Giberson S, Yoder S, Lee MP. Improving Patient and Health System Outcomes through Advanced Pharmacy Practice. A Report to the U.S. Surgeon General. Office of the Chief Pharmacist. U.S. Public Health Service. Dec 2011.

PHARMACISTS SAVE HEALTH CARE DOLLARS. Pharmacists have been shown to produce annual health care savings of: • $3.5 billion in hospital costs by coordinating medications from multiple providers.

• More than $1,600 in direct health care costs per patient at a pharmacistrun anticoagulation clinic, compared with usual medical costs.

• $1,200 to $1,872 per patient in direct health care costs for patients with diabetes enrolled in the Asheville Project for up to five years.

• $918 per patient in direct health care costs for patients with diabetes enrolled in the Patient Self-Management Program for Diabetes for one year.

• $1,230 per patient in indirect costs for those with asthma and direct cost savings of $725 average per patient.

• $1,123 per patient on medication claims and $472 per patient on medical, hospital, and emergency department expenses at five primary care sites in Connecticut. (The pharmacists in this study provided comprehensive evaluation of multiple medical conditions.)

to meet the demands of increased access to care. Physician shortages and maldistribution of health care providers impact how we address this issue. The proportion of newly graduated U.S. medical students who choose primary care as a career has declined by 50% since 1997.

Currently, it is estimated that over 56 million Americans lack adequate access (not coverage) to primary health care because of shortages of primary care physicians in their communities.

As millions of new beneficiaries enter the health care system, the situation will most likely worsen.

New Members

WELCOME NEW MEMBERS PHARMACISTS Jordan Davis Linh Huynh Cody R Plaisted Chad Harrison Branden Deaton Janna Merritt Mary Allen Ying Baker Scott Beci Nickalaus D Bryce Jaimi Bylsma Andy L Do David L Gorneau Shelagh R Grosch Ha Hua Andy Kizer Ranjita J Kokje David V Larson Julie M Lehn Reddy Srinivasa Male Donyaila McClendon James Moser Joseph N Muise Sarah W Randolph Garry L Roberts Haissam Shiblak Habibatu Turay-Samura Matthew Varacallo Helen H Wang

Andrew Kolp Sharon Moore Roberson Eric Bauer David W Buck Joseph W Coyne Christina Creech Anna L Naff Linda Woods Donald Bryce Megan M Burchardi Dawn Durham Karen Z. Bakst Alan W Bakst Steve Roberts Clinton Anderson Shar Dool Patel ASSOCIATES Robert Host TECHNICIANS Joy Buelow Efrain Sanchez Henry J Kosciuk Norma Allegrezza Sara Alvarez Barbara T Downs Jacqueline A Hall Myra James

STUDENT PHARMACISTS Natasha Naheed Aslam Shawn Birdsall Albert Cheng Emalee Craft Benjamin Voth Joseph Bong Jonathan Booker Luis Caragan Michael Carlile Ricky Cheukleung Chan Mei Chen Chauv Jeremy J Clarke Leann Cody Deryl Cooley Irene D Coon Kyle DeWitt Kevin Dey Gina Fox Sheldon Frost Gerardo Garcia Ramzi Hout Tai Long Huynh Dustin Ingraham Kimberly Irby Saira Abid Khokhar Benjamin Lai Vincent Le Beman Li

Vivian Loo Aldwin Lopez-Dee Nhung Hong Luong Manuel Maksumov Natasha Masters Kasidy McKay Trung Ngo Dominic Khoi Nguyen Lisa Nguyen Ronald Obrique Ellen Ong Stacy Minji Park Richard Pearson Preston Rhoades Thomas Shaw Hyon Wook Song Katherine Stein John Thomas Albert Vo Tiffany Sze Mane Wong Francis Djorgee Dustin Herring David Ray

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.

Annual dues for a pharmacist are just $225 per year. This equates to: • Approximately 2/10 of 1% of the annual wage for a new practitioner pharmacist • Less than 5 hours of work per year, after taxes • Less than 62 cents per day Visit the AzPA website at www.azpharmacy.org to join online or to download a printable Membership Investment Statement.

AzPA values its members and recognizes that your time is valuable. Monthly payment plans are available for pharmacist membership categories, as well as an automatic annual renewal option, when you provide your credit card information.

Spring 2012 • Arizona Journal of Pharmacy • 5

Association News

WANTED

PHARMACY PIONEERS PAST, PRESENT, AND FUTURE Join us June 28 to July 1, 2012, at the historic Wigwam Resort in Litchfield Park, Arizona. This year’s conference theme, Pharmacy Pioneers: Past, Present, and Future celebrates our state’s centennial and recognizes the accomplishments of Arizona pharmacy pioneers. This is the largest annual pharmacy meeting in Arizona and offers an impressive selection of continuing education programs, networking sessions, opportunities for personal and professional growth, entertainment, and fun!

On Thursday, June 28, 2012, three optional preconference continuing education activities will be offered You may choose between two certificate training programs - Pharmacy-Based Immunization Delivery or Pharmacist and Patient-Centered Diabetes Care - or attend a threehour workshop on Collaborative Practice Agreements.

The conference officially begins on Friday, June 29, 2012, with the Opening General Session at 8:00 AM with the AzPA Town Hall and Law CE. Saturday’s Keynote Speaker is Joe Rannazzisi, R.Ph., Deputy Director of the Drug Enforcement Agency.

On Saturday morning, June 30, 2012, all PharmPAC members are invited to attend the annual PharmPAC breakfast for an oppportunity to meet with state legislators and decision makers. Be sure to buy a PharmPAC ticket and become a member of the PharmPAC to secure your invitation.

Over the course of this three-day meeting, more than 22 continuing education programs will be offered with attendees having the opportunity to earn up to 12 hours of CPE (0.12 CEUs).

This meeting marks the transition of our organization’s leadership. A highlight of the event is the AzPA Awards Banquet on Saturday, June 30, 2012, when we recognize the contributions and accomplishments of our members.

The PharmPAC drawdown winners will be announced during the banquet and we may even have a good oldfashioned duel or two!

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Don’t miss this year’s Arizona Western-themed Exhibit Hall. More than 50 exhibitors will be showcasing their companies and organizations in the Wigwam Ballroom.

Come try your hand at the shooting gallery and pose for a photo with your old west hero. As always, we will have great food, fun, and prizes.

The annual Arizona Pharmacy Foundation (APF) Golf Tournament is moving to Sunday, July 1, 2012 and includes a Law CE luncheon open to all attendees. A portion of the proceeds from the APF tournament benefit the Llyn Lloyd Service to Pharmacy Scholarship Fund.

See you in June at The Wigwam to celebrate Arizona’s Centennial and more than 100 years of Arizona state pharmacy associations’ history.

CONFERENCE REGISTRATION IS NOW AVAILABLE ONLINE AT THE AzPA website at www.azpharmacy.org.

Cheers for Volunteers!

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

Regi Roy Josh Kramer Jean Moffitt Jon Glover Whitney Rice Nick Muscolino Julie Hernandez Ann Sears Dawn Knudsen Gerber Teresa Stickler Kristin Calabro

Association News Mark Boesen Ken Fletcher Steve LeMahieu Terry Daane Ken Mahan Laura Hanson Dean Wright Hal Wand Stacy Haber Joe Rowan Tina Smith Lorri Caum Eric Perry Chris Meilinger Kim Cauthon Grace Akoh-Arrey Betty Louton Nicole Romney Sandra Leal Kelly Green Boesen Ken Baker Mindy Throm Burnworth

Nicole Scovis Judi Day Linda Peralta Terri Warholak Bao Nguyen Laura Tsu Christina Creech Clinton Anderson Shardool Patel Lindsay Davis Jon Merchen Kristin Allison Joy Davis Mike Severn Chris Lesaca Kevin Boesen Roger Morris Mitch Buckley Carol Rollins Martie Fankhauser

CALL FOR NOMINATIONS!

2012-2013 azPA board of directors nominations A membership privilege of the Arizona Pharmacy Alliance is the ability to participate in the election of the Board of Directors and Officers. Your voice is important to the future of our profession and AzPA! Please consider running for a position on the 2012-2013 AzPA Board of Directors. Nominations are now being accepted for President-elect, Treasurer, all six Academy Chair-Elect positions, and Industry Representative at: www.azpharmacy.org/2012.2013.BOD.Nominations

awards nominations Honor your peers and colleagues by nominating them to receive an award. If you know someone who is worthy of receiving one or more of our annual awards, please submit your nominations at: www.azpharmacy.org/2012.Awards.Nominations

DEADLINE FOR ALL NOMINATIONS EXTENDED TO APRIL 9, 2012.

Spring 2012 • Arizona Journal of Pharmacy • 7

Association News APF News In 2009 the Arizona Pharmacy Foundation (APF) established the Llyn Lloyd Service to Pharmacy Scholarship Fund. Llyn Lloyd served as executive director of the Arizona State Board of Pharmacy for more than 20 years. He dedicated his life to protecting and advancing the pharmacy profession. The scholarship award honors his personal and professional commitment.

Each year this scholarship recognizes a pharmacy student at each of the colleges of pharmacy in Arizona - Midwestern University Glendale and The University of Arizona - for their service to the profession of pharmacy. The students each receive a $500 award from APF. The Class of 2013 recipients of the Llyn Lloyd Service to Pharmacy Scholarship are Phillip Le from Midwestern University College of Pharmacy Glendale and Ashley Sweaney, The University of Arizona College of Pharmacy. Congratulations, Phillip and Ashley.

Annual APF Golf Tournament You can support the Arizona Pharmacy Foundation and the Llyn Lloyd Service to Pharmacy Scholarship Fund by playing in or becoming a sponsor of the APF annual golf tournament. Mark your calendars for Sunday, July 1, 2012. This year’s event will be held at the The Wigwam Golf Course, Litchfield Park, Arizona. Shotgun start is at 6:30 AM for the the best-ball format competition. Prizes will be awarded for longest drive, closest to the pin, hole-in-one, and winning team. Proceeds from the tournament benefit the Llyn Lloyd Service to Pharmacy Scholarship. To register go to: www.azpharmacy.org/APFGolfTourney The Arizona Pharmacy Foundation is a 501(c)3 non-profit, charitable foundation. In addition to playing in or becoming a sponsor of the APF Annual Golf Tournament, you can support APF by participating in the APF Legacy Endowment program, designating APF in your workplace United Way or other charitable fundraising campaign, or making a donation in cash or kind. All donations are 100% tax-deductible.

8 • Arizona Journal of Pharmacy • Spring 2012

AzPA Calendar of Events April 14, 2012 Health-System Academy Conference Banner Desert Medical Center Mesa, Arizona April 28, 2012 Student Pharmacist Leadership Conference Westin La Paloma Tucson, Arizona May 4, 2012 Geriatric Care Academy Conference Crowne Plaza Phoenix Airport Hotel Phoenix, Arizona May 5, 2012 Delivering MTM Services in the Community Crowne Plaza Phoenix Airport Hotel Phoenix, Arizona June 28 to July 1, 2012 AzPA 8th Annual Meeting The Wigwam Litchfield Park, Arizona Visit www.azpharmacy.org for all upcoming events.

The voice of pharmacy in Arizona.

PAPA Buprenorphine – is it all we are hoping for?

by Mel Pohl, M.D. Medical Director, Las Vegas Recovery Center and Logan Smith, Program Development Coordinator, Las Vegas Recovery Center

Introduction: Setting the stage – the era of medicationassisted treatment More than 50 million Americans currently are living with chronic pain unrelated to cancer. The costs associated with chronic pain are approximately 90 billion annually (Carter, Goldfarb et al., 2006). During the last two decades of the 20th century, vast amounts of literature were published in support of fundamental changes to how physicians treat chronic pain conditions (Khouzam, 2000; Koo, 2003; Pletcher, Kertesz, Kohn, & Gonzales, 2008). Pressure from national agencies and worldwide organizations has led to increased attention to untreated and undertreated pain symptoms. (Claudill-Slosberg, Schwartz, & Woloshin, 2004). At the same time pharmaceutical companies were marketing new products that were anticipated to be safer and to have lower dependence potential (Ballantyne, 2010). In response, many physicians were enticed to prescribe opioids for patients with chronic noncancer pain (CNCP). By 2002 prescriptions for OxyContin alone had reached 6.2 million per year (Zee, 2009).

Today, opioid analgesic painkillers are the most prescribed medication in the United States (Kuehn, 2007) and a clear reliance on prescribing these medications rather than getting to the underlying causes is now part of the standard for “pain management” medical practices (Caudill-Slosberg et al., 2004).

Not surprisingly, as rates of prescription opioids increase, so have the negative effects including addiction and unintentional drug poisoning deaths (Paulozzi, Budnitz, & Xi, 2006). There is a close correlation between death and the amount of opioid medication sold. (Brown, Auelsdorff and Fleming, 2006) A recent study of the Treatment Episode Data Set (TEDS) revealed that admissions to substance abuse treatment programs for abuse of prescription pain relievers increased over 400 percent (TEDS, 2010). Prescription opioid abuse in the US has overtaken illicit opioid (heroin) abuse and has grown to epidemic proportions. In spite of rising rates of non-medical use of opioids, the medical field maintains that the potential for addiction is not sufficient to prohibit the use of narcotic medications (Paulozzi et al., 2006; Portenoy and Foley, 1986).

In February 2009, the American Pain Society and the American Academy of Pain Medicine published Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain (Chou et al., 2009). The guideline offers clinical suggestions for appropriately managing pain while accounting for dependence risk potential (Kuehn, 2009). In addition to current prevention and awareness initiatives, national agencies such as the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have also started to investigate the effectiveness of previous measures to curb misuse and abuse of opioid medication (Kuehn, 2009). Despite these efforts, rates of nonmedical use of prescription pain relievers involve 5.2 million Americans (NSDUH Report, 2009).

Behavioral abuse and dependence patterns often develop during the course of prescribed treatment. Few treatment options are available for those who misuse such medications for secondary gains or nonmedical reasons. Currently, an

abundant number of rehabilitation centers offer variable durations for detoxification, individual and group therapy, and recommendations for continuing care through such programs as Alcoholics Anonymous (AA) and Narcotics Anonymous (NA); (Montgomery, Miller, & Tonigan, 1995). However, with relapse rates so high, many clients have turn to medication assisted treatment (formerly called maintenance) programs that provide long lasting opioids such as Methadone (Dolophine) or Buprenorphine (Suboxone and Subutex). Today, there are currently over 1,000 clinics authorized to dispense Methadone (SAMHSA, 2010a) and over 1,800 treatment centers authorized to dispense Buprenorphine in the U.S. (SAMHSA, 2010b). This review will focus on the clinical uses, potential problems, and implications for treatment using Buprenorphine.

Basic science and pharmacology of buprenorphine The U.S. Food and Drug Administration (FDA) approved Buprenorphine in 2002 for the treatment of opioid dependence (Jaffe & O’Keefe, 2003). Under the Drug Addiction Treatment Act of 2000 Buprenorphine is available for use through physicians registered with the Substance Abuse and Mental Health Administration (SAMSHA); (Sullivan, Chawarski, O’Connor, Schottenfeld, & Fiellin, 2005). There are currently more than 12,000 physicians waivered by the FDA. to prescribe buprenorphine in a clinical office setting (SAMHSA, 2010a).

Buprenorphine’s unique pharmacology causes less of the same negative side effects commonly seen with morphine and methadone (e.g., respiratory depression, cognitive impairment and euphoria more likely to be associated with craving and abuse) and has opened the way for treatment of opioid dependence in new settings. This allows treatment options to reach those who may not have previously had access or don’t feel comfortable with other treatment settings, such as a methadone clinic (Sullivan et al., 2005).

Classified as a Schedule III narcotic, Buprenorphine is a semisynthetic opioid which is an antagonist at kappa opioid receptor sites (Walsh, Preston, Bigelow, & Stitzer, 1995) and a partial agonist of mu opioid receptors (Jones, 2004). Activation of mu receptors produces some of the most common effects associated with opioids (i.e. pleasure and pain relief; Jones, 2004). By not fully stimulating mu receptors, the cognitive and euphoriogenic effects of Buprenorphine are consequently not as intense as full agonist opioids such as morphine. Buprenorphine does not provide the same levels of pleasure and positive mood elevation, nor does it cause cravings as strong as commonly abused opioids such as heroin, oxycodone, hydrocodone, morphine and others.

Due to its high affinity for mu receptors, Buprenorphine is not easily displaced and theoretically prevents the intense effects of other subsequently used opioids (Walsh et al., 1995). It will also dislodge a previously or presently used opioid from receptor sites (Jones, 2004).

Buprenorphine also has high affinity with Kappa receptors as an antagonist (Induru & Mellar, 2009). Kappa receptors have been shown to play a role in opposing the rewarding effects of drugs of abuse (Spanagel & Shippenberg, 1993). By preventing the dysphoric effects of Kappa receptor stimulation, Buprenorphine is able to elevate mood (Emrich, Vogt, & Herz, 1982) and show antipsychotic properties (Nutt & Groves, 1991).

Blocking kappa receptors may also contribute to Buprenorphine’s analgesic properties (Induru & Mellar, 2009).

Spring 2012 • Arizona Journal of Pharmacy • 9

PAPA Buprenorphine has been touted as a safe, low risk option for treatment of opioid dependence (Jones, 2004) because of its mild effects and a ceiling effect at high doses (Walsh, Preston, Stitzer, Cone, & Bigelow, 1994). Yet despite the apparent advantages of Buprenorphine over other opioid maintenance medications, an abuse potential remains. Use of Buprenorphine for diversion has been reported internationally (Stoller, Bigelow, Walsh, & Strain, 2001). Also, using buprenorphine illicitly to avoid withdrawal symptoms (called “bridging”) until the drug(s) of choice become available is an alarming trend. (Monte, Mandell, Wilford, Tennyson, & Boyer, 2009). Furthermore, when combined with benzodiazepines, there is an increased incidence of adverse effects including overdose and death (McCance-Katz & Mandell, 2009). One new and dangerous trend is the rise of “user-how to” websites touting the effects of “bupe” combined with promethazine, temgesic, hydroxyzine, and benzodiazepines as the “new heroin substitute”.

Early development of Buprenorphine has transferred from liquid injections (because of abuse potential), to sublingual solutions (because of practical limitations and limited oral bioavailability), and is now available in two forms of sublingual tablets (Stoller et al., 2001; Jones, 2004). Tablets that contain only Buprenorphine are marketed as Subutex. The risk potential for diversion remains with Subutex because tablets can easily be broken down, dissolved and the solution injected. The second tablet form, Suboxone, was developed to incorporate Naloxone (Narcan), a mu opioid receptor competitive antagonist. Naloxone has low bioavalability when taken sublingually. However, when injected it produces a precipitated opioid withdrawal syndrome.

The negative effects of the withdrawal syndrome are meant to deter IV abuse and have shown to be effective when compared to Subutex (Stoller et al., 2001).

Clinical efficacy studies – detox and maintenance Medication assisted treatment programs that use methadone have been shown to reduce the spread of HIV, decreasing use of illicit opioids, criminal activity, and prolonging average time until next relapse (Springer, Chen, & Altice, 2010). One of the most cited outcomes of buprenorphine maintenance is rates of treatment retention (Lobmaier, Gossop, Waal, & Bramness, 2010). Among combination treatment options, detoxification using buprenorphine and psychosocial treatments are more effective than use of pharmacological treatments alone (Amato et al., 2009) and reflects established research indicating that the use or abuse of a substance implicates changes to more than just physiological processes.

Buprenorphine for pain - does it cause hyperalgesia?

Drug use has been positively correlated with pain tolerance and has been shown to vary depending on the type of drug used (Compton, 1994). Pain intolerance due to substance use may even appear to cause hyperalgesia in certain patients (Compton, Charuvastra, & Ling, 200; Alford, Compton, & Samet, 2006).

Recovering drug addicts have shown higher levels of pain tolerance than their currently using peers, demonstrating that the hyperalgesic effects of opioids are drug and dose specific (Compton, 1994). In other words, opioids may cause more pain. Once the hyperalgesic effects begin to offset the analgesic properties of the prescribed opioid pain treatment becomes more difficult (Alford et al., 2006). This inadvertent increase in pain 10 • Arizona Journal of Pharmacy • Spring 2012

tolerance hinders adequate pain management in patients with comorbid chronic pain conditions. This effect may not be as pronounced with patients receiving buprenorphine maintenance treatment versus treatment with full opioid agonists (Cowen, Lewis, & Macfarlane, 1977).

Acute pain treatment can be hindered by the use of buprenorphine as well. Due to its pharmacological properties, emergency care centers will find it difficult to control acute pain by administering full agonist opioids because their effects will be blunted by the adherent buprenorphine molecule (Harrington & Zaydfudim, 2010). Opioid tolerance will also contribute to diminished pain relief as a result of the chronic use of a long lasting opioid. Special consideration needs to be given to potential circumstances that buprenorphine maintenance treatment patients may encounter during the course of their treatment.

Where does that leave the addiction professional with respect to clients on Buprenorphine in your practice setting? Here are several key questions which will challenge each of us as we attempt to assess and treat opioid-dependent clients.

1. Is the brain of the opioid addict more normal with buprenorphine than without, as many medication assistance proponents assert? At least with methadone dependent addicts, it has been shown that brain dopamine transport system is impaired compared to abstinent opioid addicts (Shi et al., 2008).

2. Is there a reasonable hope of achieving a buprenorphine-free state once it has been started? If so, when is the logical time to attempt withdrawal? After six weeks, six months, two years? If withdrawal fails, is that because of dependence on buprenorphine which is extremely difficult to discontinue, or is relapse inevitable in the absence of some opioid? We all know that discontinuing maintenance doses of opioids is extremely difficult – but is that because of withdrawal (protracted with buprenorphine) or is it because the brain requires a medication like buprenorphine to function and feel normal.

3. There are clinics that have sprung up in some cities that include buprenorphine treatment among a vast “service line” menu including Botox, Restalyne, liposuction and teeth whitening. Do we, for one minute, expect an addict to find recovery in such a setting?

4. How are you to manage these clients as an addiction professional? It is your task to help clients find quality in their lives. Can you steer them to buprenorphine-friendly meetings?

Should the maintained addict go to mainstream meetings and hide the fact that they are on buprenorphine? It is not uncommon for addicts who disclose their status to be ostracized or encouraged to discontinue medications by nonprofessional peers. Can you help clients navigate these difficult waters and develop a supportive community to help them as they live life on life’s terms?

5. Some feel that opioid-free is simply not an achievable state – the data appear to suggest low percentages of successful abstinence. Where are all the addicts who are successful? There are thousands of opioid addicts in recovery who have abstained through the help of the twelve step fellowships for decades. We know it can be done – but how can we tell who is likely to be successful?

6. Do we commit everyone to maintenance for life? Is this “harm reduction” or are we actually doing harm by using mediations for all without attempting to help clients achieve a drug-free state? Do we try abstinence a time or two – or ten?

PAPA Do we eventually accept buprenorphine maintained recovery as a reasonable alternative? Do we try again for abstinence after a time? If so, when?

These and other questions need to be studied in order for us to develop a rational policy for buprenorphine of opioid dependence and provide the best care for all.

References Alford, D., Compton, P., & Samet, J. (2006). Acute pain management for patients receiving maintenance methadone or buprenorphine therapy. Annals of Internal Medicine, 144, 127-134.

Amato, L., Minozzi, S., Davoli, M., Vecchi, S., Ferri, M., & Mayet, S. (2009).

Psychosocial and pharmacological treatments versus pharmacological treatments for opioid detoxification (Review). Cochrane Database of Systematic Reviews, 4, CD005031.

Ballantyne, J. (2010). Opioid controls: Regulate to educate. Pain Medicine, 11, 480-481.

Brown , R., Zuelsdorff, M., Fleming, M. Adverse effects and cognitive function among primary care patients taking opioids for chronic nonmalignant pain. J Opioid Manag 2006;2:137-140 Carter, D., Goldfarb, N. et al. Chronic pain management in managed care organizations: a national survey of medical directors. Pharmacol Ther 2003;28:170-215.

Chou, R., Fanciullo, G., Fine, P., Adler, J., Ballantyne, J., Davies, P., et al.

(2009). Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. The Journal of Pain, 10, 113-130.

Claudill-Slosberg, M., Schwartz, L., & Woloshin, S. (2004). Office visits and analgesic prescriptions for musculoskeletal pain in US: 1980 vs. 2000. Pain, 109, 514-519.

Compton, M. (1994). Cold-pressor pain tolerance in opiate and cocaine abusers: correlates of drug type and use status. Journal of Pain and Symptom Management, 9, 462-473.

Compton, P., Charuvastra, V., & Ling, W. (2001). Pain intolerance in opioidmaintained former opiate addicts: effect of long-acting maintenance agent. Drug and Alcohol Dependence, 63, 139-146.

Cowen, A., Lewis, J., & Macfarlane, I. (1977). Agonist and antagonist properties of buprenorphine, a new antinociceptive agent. British Journal of Pharmacology, 60, 537-545.

Emrich, H., Vogt, P., & Herz, A. (1982) Possible antidepressive effects of opioids: action of buprenorphine. Annals of the New York Academy of Science, 398, 108-112.

Harrington, C., & Zaydfudim, V. (2010). Buprenorphine maintenance therapy hinders acute pain management in trauma. The American Surgeon, 76, 397-399.

Induru, R., & Mellar, D. (2009). Buprenorphine for neuropathic pain – targeting hyperalgesia. American Journal of Hospice and Palliative Medicine, 26, 470-473.

Jaffe, J., & O’Keefe, C. (2003). From morphine clinics to buprenorphine: regulating opioid agonist treatment of addiction in the United States. Drug and Alcohol Dependence, 70, S3-S11.

Jones, H. (2004). Practical considerations for the clinical use of buprenorphine.

Science and Practice Perspectives, 2, 4-23.

Khouzam, H. (2000). Chronic pain and it’s management in primary care.

Southern Medical Journal, 93, 946-952.

Koo, P. (2003). Acute Pain Management. Journal of Pharmacy Practice, 16, 231-248.

Kuehn, B. (2007). Opioid prescriptions soar: Increase in legitimate use as well as abuse. JAMA, 297, 249-251.

Kuehn, B. (2009). Efforts aim to curb opioid deaths, injuries. JAMA, 301, 1213-1215.

Lobmaier, P., Gossop, M., Waal, H., & Bramness, J. (2010). The pharmacological treatment of opioid addiction – a clinical perspective. European Journal of Clinical Pharmacology, 66, 537-545.

McCance-Katz, E., & Mandell, T. (2009). Drug interactions of clinical importance with methadone and buprenorphine. The American Journal on Addictions, 19, 2-3.

Monte, A., Mandell, T., Wilford, B., Tennyson, J., & Boyer, E. (2009). Diversion of buprenorphine/naloxone coformulated tablets in a region with high prescribing prevelance. Journal of Addictive Diseases, 28, 226-231.

Montgomery, H., Miller, W., & Tonigan, S. (1995). Does Alcoholics Anonymous involvement predict treatment outcome? Journal of Substance Abuse Treatment, 12, 241-246.

NSDUH Report (2009). Trends in nonmedical use of prescription pain relievers.

SAMHSA, http://oas.samhsa.gov/2k9/painRelievers/nonmedicalTrends.pdf (Retrieved 7/13/10).

Nutt, D., & Groves, S. (1991). Buprenorphine and Schizophrenia. Human Psychopharmacology, 6, 71-73.

Paulozzi, L., Budnitz, D., & Xi, Y. (2006). Increasing deaths from opioid analgesics in the United States. Pharmacoepidemiology and Drug Safety, 15, 618-627.

Pletcher, M., Kertesz, S., Kohn, M., & Gonzales, R. (2008). Trends in opioid prescribing by race/ethnicity for patients seeking care in U.S. emergency departments. JAMA, 299, 70-78.

Portenoy, R., & Foley, K. (1986). Chronic use of opioid analgesics in nonmalignant pain: Report of 38 cases. Pain, 25, 171-186.

SAMHSA (2010a). Buprenorphine physician and treatment locator. SAMHSA, http://buprenorphine.samhsa.gov/bwns_locator/aboutphysician.htm (Retrieved 8/30/10).

SAMHSA (2010b). Substance Abuse Treatment Facility Locator. SAMHSA, http://www.findtreatment.samhsa.gov/ (Retrieved 8/30/10).

Shi, J., Zhao, L.-Y., Copersino, M., Fang, Y.-X., Chen, Y., Tian, J., et al. (2008).

PET imaging of dopamine transporter and drug craving during methadone maintenance treatment and after prolonged abstinence in heroin users. European Journal of Pharmacology, 579, 160-166.

Spanagel, R., & Shippenberg, T. (1993). Modulation of morphine-induced sensitization by endogenous K opioid systems in the rat. Neuroscience Letters, 153, 232-236.

Springer, S., Chen, S., & Altice, F. (2010). Improved HIV and substance abuse treatment outcomes for released HIV prisoners: the impact of Buprenorphine treatment. Journal of Urban Health: Bulletin of the New York Academy of Medicine, 87, 592-602.

Stoller, K., Bigelow, G., Walsh, S., & Strain, E. (2001). Effects of buprenorphine/ naloxone in opioid dependent humans. Psychopharmacology, 154, 230-242.

Sullivan, L., Chawarski, M., O’Connor, P., Schottenfeld, R., & Fiellin, D. (2005).

The practive of office-based buprenorphine treatment of opioid dependence: is it associated with new patients entering into treatment? Drug and Alcohol Dependence, 79, 113-116.

TEDS Report (2010). Substance abuse treatment admissions involving abuse of pain relievers: 1998 and 2008. SAMHSA, http://oas.samhsa. gov/2k10/230/230PainRel. vr2k10Web.pdf (Retrieved 7/16/10).

Walsh, S., Preston, K., Bigelow, G., & Stitzer, M. (1995). Acute administration of Buprenorphine in humans: partial agonist and blockade effects. The Journal of Pharmacology and Experimental Therapeutics, 274, 361-372.

Walsh, S., Preston, K., Stitzer, M., Cone, E., & Bigelow, G. (1994). Clinical pharmacology of buprenorphine: ceiling effects at high doses. Clinical Pharmacology & Therapeutics, 55, 569-580.

Zee, A. (2009). The promotion and marketing of OxyContin: Commercial triumph, public health tragedy. American Journal of Public Health, 9

Reprinted with permission from the authors.

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Legislative Update submitted by Mark Boesen, Legislative Affairs Committee Chair and Jeff Gray, R & R Partners, AzPA Lobbyist The Arizona State Legislature continues to work on a number of bills and is gearing up for a wrap up hoping to adjourn on time, which is scheduled for April 17, 2012 (their 100th day). So far, 1395 bills have been introduced. As of Friday, March 9th at 10:00 A.M., twenty four bills have been passed by the Legislature, and five have been signed into law by Governor Brewer.

Specific Actions Related to Our Profession • HB2646 (Authorizes the Arizona State Board of Pharmacy to Transfer up to $1M Annually to the University of Arizona’s Poison and Drug Information Center). This bill passed out of the Senate Health Committee without issue. AzPA supported the bill and there was not a need to testify, as there was in the House. AzPA participated in a pre-meeting with Senator Barto, scheduled by the UofA, to answer questions prior to committee. The bill was heard in Senate Appropriations on March 13, 2012, and passed with a vote of 10-1. AzPA supports this legislation • HB 2369 (Electronic Medical Records) is the clean-up bill to last year’s electronic medical records bill and includes the electronic prescription of controlled substances language. It was held in the Senate Healthcare and Medical Reform Liability Committee this week due to concerns raised by Senator Nancy Barto and discussion of a possible amendment. The bill is on the Senate Health agenda for Wednesday, March 14th. AzPA Supports this legislation.

• HB2263 (Meth Precursors) was heard in Senate Public Safety & Human Services, where it passed without issue. AzPA supported in committee.

• SB1073 (Board of Pharmacy; Drug Schedules; Rules; Allows the Board of Pharmacy to Define New Chemical Derivatives as Controlled Substances if Appropriate). Awaits a hearing before Senate Judiciary. AzPA supports this legislation.

• HB 2534 (AHCCCS; methodology payments) is a proposal supported by AHCCCS that beginning on October 1, 2013 would require AHCCCS to adopt a hospital reimbursement methodology consistent with CMS. It was heard in the Senate Healthcare and Medical Liability Reform Committee on Wednesday, March 7th and held due to numerous concerns raised by committee members. It is on the agenda again for Wednesday, March 14th , but it is unclear whether concerns will be addressed for the bill to pass out of committee.

PharmPAC

Pharmacists Political Action Committee of Arizona

SUPPORT PHARMACY POLITICAL ACTION IN ARIZONA! Make a contribution to the PharmPAC! The Pharmacist Political Action Committee of Arizona (PharmPAC) is a voluntary political action committee that allows AzPA members to pool our financial resources to support state candidates who understand and appreciate the value of our profession and its importance to improving health care.

Although associations like AzPA are prohibited from making direct contributions to candidates, we can form a PAC, pay its administrative costs, and solicit voluntary contributions from members. The PharmPAC is a legal, ethical, and effective way to involve the association in the political process. PharmPAC plays an important role in enhancing the legislative action mission of the profession of pharmacy in Arizona. Our ability to interact with key legislators plays a major role in keeping our visibility at the necessary high level.

The Arizona Pharmacy Alliance PharmPAC uses its political action funds carefully and wisely to provide support to legislators and candidates who are supportive of pharmacy’s role in delivering patient care. Our goal in 2012, especially with the elections on the horizon, is that PharmPAC be able to continue to nurture the profession’s involvement in the political process by providing support to allow pharmacy to attend or host as many important political fundraising events as possible.

PHARMACY’S FUTURE IS UP TO ALL OF US! GET INVOLVED! STAY INVOLVED! MAKE YOUR FUTURE! To make a contribution go to www.azpharmacy.org/PharmPAC 12 • Arizona Journal of Pharmacy • Spring 2012

Featured Article

A Look Back - Suppository Molds

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

Anyone interested in pharmacy collectibles and memorabilia may contact Dr. Kravetz at bob@brownies.com .

Suppositories have been used for several centuries to administer medications via the rectum, vagina, and urethra. The first known suppositories were made by hand in the 18th century and some were molded in paper cones.

Metal suppository molds were made from pewter and tin and were introduced in 1860. The tin mold pictured here dates from that time. The oval tray held ice to chill and harden the suppository; the lid contained holes which supported individual molds for each suppository.

Later models were composed of a two-piece metal mold which simplified the process. By 1875, there were over 20 different molds in use. Suppository machines were widely used by 1895. Unlike the molds which were filled with melted material, they compressed the suppository from a solid mass of cocoa butter.

Two-hundred and fifty years after their introduction, suppositories are still a basic part of the gastroenterologists’ therapeutic armamentarium.

Pharmacy Time Capsules First Quarter 2012

1987—Twenty-five Years ago: • Nova Southeastern University’s College of Pharmacy admitted its first class thus becoming the first college of Pharmacy in south Florida.

• Fluoxetine (Prozac) approved for marketing as treatment for depression.

1962—Fifty Years Ago: • Kefauver-Harris bill passed in response to thalidomide tragedy. Bill required manufacturers to prove effectiveness as a condition of FDA approval.

• Hospital Pharmacy Residency accreditation standards leading to a rapid expansion of clinical training programs were first approved by American Society of Hospital Pharmacists.

1937—Seventy-five Years Ago: • American Journal of Pharmaceutical Education (Lyman’s Journal) was launched by American Association of Colleges of Pharmacy with Dean Lyman of Nebraska serving as the founding editor.

• Cannabis sativa remains listed in the USP XI (official from 1936). The Marijuana Tax Act passed levying a fee on “every person who imports, manufactures, produces, compounds, sells, deals in, dispenses, prescribes, administers, or gives away marihuana.”

1912—One hundred Years Ago: • Journal of the American Pharmaceutical Association launched in January 1912 with James Hartley Beal serving as the editor.

• Zada Mary Cooper (University of Iowa) was the first woman faculty member to attend an annual meeting of the American Association of Colleges of Pharmacy, (then American Conference of Pharmaceutical Faculties).

1887—One hundred twenty-five Years ago: • Florida Pharmacy Association formed in the Board of Trade Rooms in Jacksonville on June 8, 1887. Henry Robinson of Jacksonville was elected the first president.

One of a series contributed by the American Institute of the History of Pharmacy, a unique non-profit society dedicated to assuring that the contributions of your profession endure as a part of America’s history.

Membership offers the satisfaction of helping continue this work on behalf of pharmacy, and brings five or more historical publications to your door each year. To learn more, check out: www.aihp.org.

Spring 2012 • Arizona Journal of Pharmacy • 13

Featured Article Service to Country

by Joe Rowan, R.Ph. .

Following completion of my licensing exams in January 1950, I returned to El Paso, Texas and began my career with Gunning Casteel Drug Stores to assume duties as an Assistant Store Manager and Pharmacist in the newly-completed Store No. 10 in an affluent El Paso neighborhood. Pay was $300 per month and a yearly bonus could be paid if your store enjoyed a successful year. For this unbelievable salary, we toiled 7 days a week, averaging 9 to 10 hours each day. Celebrating my newfound prosperity, I purchased my first new car, a 1950 Chevrolet Deluxe, for $1900. It had a standard transmission, heater, and radio. No air conditioning back then. I had to wait six weeks for delivery, and even then the car I accepted was not exactly what I ordered. In those days, there wasn’t a lot of choice, so you had to take what was available.

News clipping spotlighting Joe Rowan, R.Ph, Manager of Gunning-Casteel Store #10.

The good fortune of my career did not last long as trouble was brewing in Korea and it became evident that the United States would soon become involved in an armed conflict to prevent the North Koreans from overrunning South Korea. In September 1950 I received a letter from President Harry S. Truman saying, “Greetings, Joe, You have been selected for service to your country. Please report for duty in the United States Army.”

This was not a convenient time for me to go into the Army.

Army pay was $21.00 per month including room & board. I had just committed to a $60 per month car payment for that new Chevy, and I was also paying on a loan from Gunning Casteel for some college expenses. Thankfully, both my employer and the auto loan company suspended my loan payments until after I fulfilled my patriotic duty. Such extraordinarily generous individuals and companies are few and far between today.

I reported for duty at Fort Sam Houston in San Antonio, Texas and was sent to Camp Carson in Colorado Springs, Colorado for basic training. I was assigned to the South Dakota National Guard Regimental Combat Team as an infantry rifleman. I had never fired a loaded gun in my life and the thought of using one to kill someone – be they enemy or friend – did not appeal to me. About a week after arriving in Camp Carson, our company reported to the dispensary for our bevy of shots. The line was 14 • Arizona Journal of Pharmacy • Spring 2012

extremely long and there was only one person administering the injections. After receiving my shots, I approached Major Gilbert, the Commanding Officer of the Medical Company, introduced myself and offered my assistance in the shot-giving business as I was a pharmacist and interested in performing such duty. By mid-afternoon my transfer orders were complete and I traded my automatic rifle for a syringe and needle.

In addition to new recruit shots, I dispensed an abundance of elixir of terpin hydrate and codeine for coughs, APC tables for pain or fever, and penicillin shots. I was later transferred to the Camp Carson hospital for duty as a hospital pharmacist, treating soldiers stationed at the Camp and injured G.I.’s returning from Korea, as well as wives and children of military personnel. I also volunteered to escort patients being discharged to veterans hospitals who required full medical attention on their journey, always by train. On one of these assignments, I crossed the great Mississippi River for the first time while accompanying a patient to Augusta, Georgia. Other trips took me back to Texas where I was able to renew acquaintances with old University of Texas college chums.

I never did complete my basic training and within three months of my first day in the Army, I was promoted to the rank of Staff Sergeant. I spent my entire army stint at Camp Carson. Finally, in November 1952, President Truman determined that the country could do without my services and I was able to return to my job with Gunning Casteel. I am very proud of the fact that during my time in the service of our country, not one North Korean reach the top of Pike’s Peak!

This is the fifth installment in a series of reflections from Joe Rowan, R.Ph., longtime Arizona pharmacist and AzPA member.

Follow Joe’s memoirs in future issues of the Arizona Journal of Pharmacy or catch up on past installments by visiting the Arizona Journal of Pharmacy archives on the AzPA website.

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Featured Article Features of Electronic Prescribing Software: A Pilot Study to Evaluate Importance and Satisfaction

by Terri L. Warholak, Ph.D., R.Ph. Karen Smith, Ph.D., R.Ph. Debra Legner, Pharm.D., M.S., M.BA. Michael T. Rupp, Ph.D., R.Ph. Jeannie K. Lee, Pharm.D. BCPS NOTE: Tables and figures for this article appear on pages 19 and 20.

ABSTRACT OBJECTIVE: To meet meaningful use criteria and qualify for electronic health record (EHR) incentives, eligible practitioners must e-prescribe. Software systems must be practicable to be incorporated into workflow. The objective of this pilot study was to measure Arizona e-prescribing practitioners’ views of: (1) importance and (2) satisfaction with features implemented in their current e-prescribing systems. These data may inform future e-prescribers, information technology designers, and receiving pharmacies of best practices that may contribute to maximum use.

METHODS: This study was a descriptive survey of ambulatory care e-prescribers in Arizona.

Respondents evaluated the importance (‘Not At All’-‘Extremely’) and satisfaction (‘Very Dissatisfied’ - ‘Very Satisfied’) with 37 e-prescribing features. Demographic data included practice size, practice type, e-prescribing software vendor, and system used. Data were collected via survey.

Surveys were faxed weekly to 1,885 officebased e-prescribers in Arizona until either a response was received or three fax cycles were completed.

RESULTS: A total of 114 practices representing up to 1280 e-prescribers completed and returned surveys for this pilot. Overall means for feature importance and satisfaction were 4.22 (of 5 possible) and 4.92 (of 6 possible) respectively. Of 37 items, 14 features were categorized as high importance with high satisfaction.

Practitioners rated nine features as high importance but low satisfaction including: vendor support, system cost, lack of e-prescribing features, and unrealized benefits.

CONCLUSION: Respondents indicated perception of importance and satisfaction with their e-prescribing system. Three features in both top ten lists of importance and satisfaction included ease of: sending to pharmacy, patient look-up, and of processing renewals. These findings may inform providers considering e-prescribing solutions, and pharmacies that must be able to receive data from practitioners. Items with high satisfaction and high importance ratings could contribute to selecting systems that consider both practitioner and pharmacies.

INTRODUCTION The value of health information technology (HIT) as it contributes to safety, quality, and efficiency of health care is generally agreed upon by healthcare professionals; however, its adoption has not been rapid. To encourage use of HIT, Congress passed the Health Information Technology for Economic and Clinical Health Act (HITECH) in 2009. HITECH provides incentive payments that will be administered through Medicare and Medicaid to eligible providers who utilize certified electronic health records (EHRs) to improve health care. The incentives may reach a total of $27 billion, with $44,000 for Medicare eligible providers and $63,750 for Medicaid eligible providers.1 This support will provide a foundation that is essential to achieve nationwide use of EHRs which is intended to improve the efficiency and effectiveness of health care and its delivery. To receive incentive payments, practitioners must be eligible providers according to Medicare or Medicaid criteria and demonstrate implementation of certified EHRs as well as demonstrate meaningful use of their system.1-4 Eligible providers according to Medicare are “physicians,” while Medicaid includes physicians in addition to nurse practitioners, physician assistants, and certified nurse midwives if a specified proportion of patient encounters are with Medicaid clients. This is especially relevant to family practitioners as many of their patient visits are attributable to Medicaid and/or Medicare.

Meaningful use criteria will be measured in three stages that begin in 2011, 2013, and 2015, respectively. Each stage has escalating requirements that must be met by eligible providers and hospitals to qualify for incentives. These requirements are important to pharmacy and e-prescribing because several of the required core measures are directly related to medication use and patient safety. For example, date

of birth, drug-drug and drug-allergy checks, active medication list, active medication allergy list, and e-prescribing are just a few of the measures necessary to receive incentive payments. More specifically, the e-prescribing objective requires that 40% of prescriptions written be transmitted electronically if permissible by law in stage 1 with higher percentages anticipated in subsequent stages.1 Because successful e-prescribing is necessary to meet meaningful use requirements, it is vital that evaluation of prescribers’ perceptions and satisfaction associated with current e-prescribing systems be conducted to identify features that may contribute to effective adoption.

CMS defined e-prescribing as “the transmission, using electronic media, of prescription or prescription-related information between a prescriber, dispenser, pharmacy benefit manager, or health plan, either directly or through an intermediary, including an e-prescribing network.

E-prescribing includes, but is not limited to, two-way transmissions between the point of care and the dispenser.”5 There are many of software systems with a plethora of features available for both prescribers and pharmacies that allow electronic transmission of prescriptions. Prescribers who will be utilizing software systems are in need of evaluation results in order to make informed software choices.

BACKGROUND E-prescribing has been a priority since the 2006 Institute of Medicine (IOM) report estimated 1.5 million preventable adverse medication events annually.6 One source of error is poor communication between prescribers, pharmacists, and consumers. The report recommended that better communication occur, and to prevent medication errors, all prescriptions in the U.S. should be electronically generated by prescribers and electronically received by patients’ pharmacies by year 2010.6 Although this has not been attained, the HITECH Act brings the goal of complete e-prescribing closer to reality.

Despite the potential benefits of e-prescribing and recent incentives, the rate of provider adoption of HIT including e-prescribing and complete use of electronic health records (EHR) remains low. Only six percent of primary care physicians use a fully functioning EHR.7 In a 2009 report, Surescripts stated only 25 percent of all office-based physicians, nurse practitioners and physician assistants in the U.S. were e-prescribing, representing approximately

Spring 2012 • Arizona Journal of Pharmacy • 15

Featured Article 18% of eligible prescriptions.8 Overcoming both real and perceived barriers to e-prescribing is essential to increasing the rate of adoption.9, 10 Therefore, the authors surveyed e-prescribing Arizona practitioners to identify the importance of and satisfaction with key features implemented within their current e-prescribing system. Survey items were selected by members, stakeholders, and the Steering committee of Arizona Health-e Connection (AzHeC) based upon information they requested to inform their policies and from Surescripts guide to implementing e-prescribing. AzHeC is a not-for-profit organization with the mission to increase statewide adoption of HIT. At first glance these items may appear similar to existing research on physician computerized order entry (CPOE), however, the majority of CPOE research has been conducted in hospital settings. CPOE describes electronic prescribing software systems that integrate patient specific data from electronic sources such as inpatient records or ambulatory electronic health records (EHR) with medication, laboratory, imaging, and other individual data. Much research has been conducted on CPOE in in-patient settings, but characteristics, safety, and efficiency of ambulatory systems (e.g. e-prescribing) are not as clearly elucidated.

Sources such as the Leapfrog Group, a voluntary program aimed at improving safety and efficiency of health care, and KLAS, a research firm specializing in health information technology report on CPOE, but as previously stated, the majority of their work is within hospitals.11, 12 The purpose of this study was to determine office-based ambulatory care e-prescribers’ perceived importance and satisfaction regarding features of marketed e-prescribing applications.

METHODS This study describes a survey of practitioners who e-prescribe in Arizona.

Practitioners were eligible to participate if they were office-based e-prescribers in the State of Arizona. Survey data were collected from e-prescribing practitioners over three weekly fax cycles. One week prior to the first fax cycle, participants received a faxed letter informing them that they would be receiving the questionnaire via fax. The faxed questionnaire asked participants about their perception of importance regarding e-prescribing system features and their satisfaction with the same features. Surveys were faxed weekly to 1,885 practitioners until either a response was received or three fax cycles were completed. Steps taken to

promote response rate included contacting potential respondents via fax and asking them to participate prior to the study, using three fax cycles, and assuring respondents of confidentiality.13, 14 Instrument: The survey requested demographic data including practice size, practice type, and e-prescribing software vendor and system used. E-prescribing features to evaluate were derived from the eHealth Initiative Foundation’s publication, “A Clinician’s Guide to Electronic Prescribing” and supplemented by recommendations by the Arizona Health e Connection’s (AzHeC) and its e-prescribing initiative’s (EAzRx) Steering Committee.15 AzHeC is a not-for-profit organization that exists to foster adoption of health information technology in Arizona. A total of 37 features were selected for evaluation.

Respondents were asked to rate their perception of importance and satisfaction with the 37 e-prescribing features.

Importance was measured using a five-point summative rating scale that included anchors of ‘Not at all,’ ‘Slightly,’ ‘Moderately,’ ‘Very,’ and ‘Extremely.’ The answers were scored from 1 to 5 with 2.5 as the implied midpoint. Satisfaction was measured on a six-point bipolar scale that included anchors of ‘Very Dissatisfied,’ ‘Moderately Dissatisfied,’ ‘Slightly Dissatisfied,’ ‘Slightly Satisfied,’ ‘Moderately Satisfied,’ ‘Very Satisfied,’ and ‘Not Applicable.’ These answers were scored from 1 to 6 for analysis with ‘Not Applicable’ scored as 0. The implied midpoint for satisfaction was 3.5.

The survey may be found in Appendix A. Data analysis: E-prescribing applications’ features were summarized using means and standard deviations, with a grand mean for importance and a grand mean for satisfaction used to determine significant features. That is, if the mean importance of a feature was greater than the grand mean then it was considered ‘relatively important.’

Frequencies and percentages were used for count data. The a-priori alpha selected was 0.05. Impact of non-response bias was estimated by comparing early versus late respondents (cycle 1 to cycle 3 respondents).

The University of Arizona Institutional Review Board approved the study.

RESULTS A total of 1,885 e-prescribers were identified and included in the first fax cycle.

The second and third fax cycles comprised 1,782 and 1,601 practitioners, respectively.

Questionnaires were completed and returned by 114 practitioners over the three cycles for a total response rate of 6%. A comparison of early respondents’ demographics as well

16 • Arizona Journal of Pharmacy • Spring 2012

as importance and satisfaction outcomes (fax cycle one) to late respondents (fax cycles two and three) showed no statistical difference between the two groups. This may be important because late responders are thought to be similar to non-responders and the absence of difference between the early and late responders may suggest little difference between responders and nonresponders overall.

Office and e-prescribing characteristics are displayed in Table 1. Respondents represented a wide range of practice settings and sizes with an average of 11.3 employees per practice (maximum = 300, minimum = 1) and 52% in single specialty clinics. Of practicing e-prescribers (n=93), 75.2% were using e-prescribing with an EHR and the remaining 24.7% were using a stand-alone system. Over half (59%) of respondents indicated using one of three vendors for their e-prescribing services: AllScripts™, SAGE, and NextGen Healthcare. The majority of respondents (over 63%) indicated that someone other than the prescriber entered prescriptions using the e-prescribing system at least “frequently.” Medical assistants were most likely to complete the prescription entry process (37%) other than the prescriber of record.

Results of study participants’ assessment of 37 e-prescribing system features with respect to importance and satisfaction are shown in Tables 2 and 3, respectively.

Across all 37 features, the grand mean for importance was 4.22 (SD=0.38) out of 5 possible. All features with a mean greater than 4.22 were considered to have relatively higher importance.

Similarly, the grand mean for respondents’ satisfaction with the features of their current e-prescribing application was 4.92 (SD=0.31) out of 6 possible. All features with a mean satisfaction rating above 4.92 were considered to be those with relatively higher satisfaction.

Figure 1 illustrates the relationship between importance and satisfaction. High to low importance is displayed from right to left on the horizontal axis, and high to low satisfaction from top to bottom on the vertical axis. This matrix is modeled after the needs assessment matrix developed by Rupp, et al.16 Items rated by participants that ranked in the top ten of both higher importance and satisfaction include ease of: sending prescription to pharmacy; patient look-up, and processing renewal requests. Other items that were both important and with which users were satisfied included: import of patient demographics from practice management system, easy access to patient

Featured Article medication history, and easy patient lookup, review screens and useful drug-allergy alerts, the ability to easily process renewal requests, allowing multiple prescription renewal, easy signing processes, fast and easy medication searches, and ease of transmission to the pharmacy, and complying with CMS Part D e-prescribing standards.

Respondents had a relatively low level of satisfaction with their current e-prescribing application for 9 of the 23 criteria they rated important. These items were: initial training, ongoing support, customer service, system updates, initial costs and ongoing system costs, support of two-way electronic communication, and the ability to decrease pharmacy phone calls. E-prescription delivery failure notification (Item 23) ranked the lowest in satisfaction of important items (Figure 1).

Items rated by participants as having relatively lower importance with concurrent higher satisfaction included: allows incorporation of over the counter medications in the medication list, makes good use of default fields, supports mobile devices, provides a favorite medication list, and provides access to prescriber when out of the office, and allows diagnosis or reason for prescribing to be transmitted with the prescription.

The items with relatively lower importance and lower satisfaction ratings were: allows incorporation of herbals into the medication list, provides easy access to patient medication history, provides useful drug problem and drug lab alerts, allows for complex sigs (dosing instructions) through templates, provides e-prescription delivery confirmation from pharmacy, displays patient-specific drug benefits information to help manage costs, and provides the ability to order supplies like syringes.

DISCUSSION This descriptive study compared individual item means to the grand mean to establish a classification system of ‘relatively important’ and ‘relatively satisfied’ e-prescribing system functions. It should be noted that this relative classification does not suggest that some e-prescribing functions are not important, but rather that they are relatively less important when viewed within the context of the other features.

This may assist with establishing priorities and focusing action on selected features of e-prescribing systems or applications.

Features with Relatively High Importance Practitioners reported being relatively satisfied with 14 of the 23 features they considered to be relatively important. This

finding suggests that users believe vendors have done an adequate job of developing and implementing these features in their systems. Because these functionalities include basic, essential activities for successful e-prescribing, results may reflect the extent to which a clinician believes his/her e-prescribing system fulfills the basic operational functions. The degree of satisfaction suggests that most e-prescribing applications are reasonably easy to use.

In contrast, respondents maintained a relatively low level of satisfaction with 9 of the 23 criteria they deemed to be relatively important. Respondents indicated being relatively dissatisfied with vendor e-prescribing system training and support.

Seventy five percent of these respondents were from practices of 10 employees or less which may reflect insufficient employee resources because some vendors recommend smaller practices have a local expert or super user. Alternatively, the systems may be less intuitive to use than providers expect thus requiring additional training and support for meaningful use.

Of note for pharmacies, providers expressed relatively low satisfaction with their e-prescribing systems’ support for bi-directional electronic communication with pharmacies, ability to decrease pharmacy phone calls, and ability to provide notification of e-prescription delivery failures. Respondents generally indicate they are not realizing promised e-prescribing benefits such as decreased contacts from pharmacies related to e-prescription orders.

Reported dissatisfaction by current survey respondents regarding the inability of e-prescribing to reduce telephone calls from pharmacies may indicate larger system problems. For example, although pharmacists may be experiencing fewer problems with legibility, they may continue to experience therapeutic conflicts, or coverage problems, or unintended electronic errors that need to be resolved via phone conversations with the providers.17 The results may suggest that providers expect pharmacy call-related problems to be eliminated or mitigated by the implementation of e-prescribing.

In summary, the 23 features considered to be relatively important by respondents can be categorized as vendor support and basic system functionality. Thus, it may be beneficial for potential e-prescribing system users to focus on evaluating these functions when selecting an e-prescribing application to implement, while e-prescribing system vendors might focus on improving these features to enhance the functionality of their product to users.

Features with Relatively Low Importance Of the 37 features assessed, respondents considered 14 features to be of relatively low importance. Some patient information, safety, and formulary management features that may result in important benefits were rated as relatively unimportant, including incorporation of over-the-counter medications and herbal medications into the medication list, useful drug problem and drug lab interaction alerts, and patientspecific drug benefit information to help manage costs (Table 2). This is in contrast to HIT literature that suggests improved medication safety through drug-drug, drug-allergy, drug-lab, drug-disease interaction alerts and having a more complete medication history are features that contribute to e-prescribing benefits.18 It is notable that prescribing practitioners perceive that transmitting the diagnosis or reason for medication with the prescription order was rated as having relatively lower importance. Pharmacists who receive and process the prescription order, however, may not share this perception. Moreover, it is in direct conflict with research that suggests that having more information increases the pharmacists’ ability to identify potential problems with medication therapy and The Joint Commission’s National Safety Goal that encourages practitioners to include the purpose of the medication on the prescription order.19, 20 Limitations An important limitation of this study is the response rate. The researchers intended the unit of analysis to be practitioner, yet most practices indicated they were responding for multiple personnel. If this were to have occurred for each survey returned, the total number of contributing respondents could have represented as many as 1280 e-prescribers. However, the researchers must consider potential reasons for low response. Physicians are well known to have low participation rates, and response rates have been decreasing for both household and physician surveys over the previous several years.21-26 Yet there is empiric evidence that suggests that response rates may be poorly linked to response bias.27 This is not to say that non-response is without bias, but valuable data may be gathered in situations of low response. To examine potential bias due to low response rate in this study, survey responses of early responders were compared to late responders. There was no difference in demographics or importance and satisfaction outcomes. Because it is often assumed that non-responders are

Spring 2012 • Arizona Journal of Pharmacy • 17

Featured Article similar to late responders, this analysis provides some evidence that the low response rate may not be a significant threat to external validity.13, 28, 29 Another factor that may have contributed to response rate may have been the fate of the survey at the practice site. The fax was intended for prescribers, but it is unknown if faxes were delivered to each practitioner in clinics with multiple practitioners.

From a practicability perspective, if significant bias is present due to limited responders this study may still be helpful for prescribers considering implementation of electronic systems. The range of features presented here may provide more information and items to consider than they had previously.

Although the quantity of features addressed brings to light the potential for alert fatigue, this study was not intended to address alert fatigue. There is evidence that supports the use of alerts such as “drugdrug” and “drug-allergy”, but practitioners may perceive the method of presentation as a burdensome or unsatisfactory.30-32 The alert-related items administered in this study were not intended to elicit practitioners’ preferences for alerts, nor to determine methods to overcome alert fatigue, but to determine general satisfaction and importance of these alerts. Other research addresses how to make alerts most useful and avoid “alert fatigue.”

CONCLUSIONS Practitioners must meet meaningful use measures and objectives defined by CMS’ final rule to receive reimbursement for implementing EHR systems. The reimbursement is sizeable which creates substantial incentive to implement within CMS’ timeframe. In addition to improving the general quality, safety, and efficiency of health care delivery, EHRs are expected to improve medication safety. E-prescribing is a required component of meaningful use of EHRs, therefore examining the process of e-prescribing is necessary in order to facilitate implementation.

This study described the results of a survey to evaluate key features of e-prescribing from the perspective of the end-user. Respondents indicated their perception of satisfaction and functionality importance regarding 37 e-prescribing system features. Functionalities in the relatively important/low satisfaction category should be improved by system vendors to provide an enhanced product that will better fulfill users’ needs and expectations. Providers considering e-prescribing adoption may also use these

functionalities to evaluate and compare available systems.

Transparency Declaration of funding: This article was not developed or written with financial support by a commercial entity including the e-prescribing software companies. The authors have not received writing assistance from a commercially sponsored third party.

Declaration of financial/other: There are no conflicts of interest affiliations or financial arrangements with any of the e-prescribing companies whose product appears in the manuscript or with any company making a competing product.

Acknowledgments: The authors would like to thank Brad Tritle and Melissa Rutala, M.P.H. for their help and support during data collection.

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9. Bell DS, Cretin S, Marken RS, Landman AB. A conceptual framework for evaluating outpatient electronic prescribing systems based on their functional capabilities. J Am Med Inform Assoc. 2004;11(1):60-70.

10. Grossman JM, Gerland A, Reed MC, Fahlman C. Physicians’ experiences using commercial e-prescribing systems. Health Aff (Millwood). 2007;26(3):w393-404.

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to Meaningful Use. Orem, UT2010.

13. Fink A. How to Conduct Surveys: A Step-byStep Guide. 4th ed. Thousand Oaks, CA: Sage Publications; 2008.

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Featured Article

Figure 1. Relative Priority Matrix *Item numbers found in Tables 2, 3, and Appendix A.

Table 1. Characteristics of e-Prescribing Clinician Practice Sites Characteristic

Download this article, including full-size tables, figures and Appendix A from the Arizona Journal of Pharmacy Archives on the Arizona Pharmacy Alliance website at www.azpharmacy.org.

n (%)1

Practice Type (n=104) Single Specialty

54 (52)

Primary Care

33 (32)

Multiple Specialty

11 (11)

Medical/Surgical

4 (4)

Combination

2 (2)

Someone Other than Prescriber Enters e-Prescriptions (n=102) Never

38 (37.3)

Sometimes

18 (17.6)

Frequently

28 (27.5)

Usually

14 (13.7)

Always

4 ( 3.9)

Role of Person Entering e-Prescription (n=70) Medical Assistant

26 (37.1)

Other

16 (22.9)

Multiple Staff

11 (15.7)

Clinician

8 (11.4)

Nurse

6 (8.6)

Not Applicable

2 (2.9)

Nurse Practitioner

1 (1.4)

Vendor of e-Prescribing System (n=91) AllScripts™

27 (29.7)

SAGE

14 (15.4)

NextGen Healthcare

13 (14.3)

Instant Dx

6 (5.3)

Misys

3 (2.6)

SOAPware

3 (2.6)

Bizmatics

2 (1.8)

Cerner

2 (1.8)

Dr First

2 (1.8)

eMD

2 (1.8)

GE

2 (1.8)

iScribe

2 (1.8)

RxNT

2 (1.8)

Other

34 (29.8)

Spring 2012 • Arizona Journal of Pharmacy • 19

20 • Arizona Journal of Pharmacy • Spring 2012

Provides e-prescribing delivery failure notification from the pharmacy

Provides useful drug-drug interaction alerts

Provides timely routine system updates by vendor

Has reasonable on-going system costs

Provides review screen before sending

Allows multiple prescriptions to be renewed at once for the same patient

Has a reasonable initial cost

Complies with all CMS Part-D e-prescribing standards

Provides easy import of patient demographic information into the e-

23

15

34

37

21

6

36

35

4

Allows incorporation of over-the-counter medications in the medication list

14

Supports mobile devices such as PDAs 2

Rating scale: 1, Not at all; 2, Slightly; 3, Moderately; 4, Very; 5, Extremely; Standard Deviation

94

99

98

97

100

98

98

99

102

100

96

99

101

100

99

99

101

89

95

103

102

93

100

101

102

103

101

101

102

103

101

103

103

103

103

101

103

N

3.16

3.41

3.55

3.56

3.62

3.82

3.85

3.89

3.95

4.12

4.13

4.14

4.19

4.21

4.22

4.24

4.24

4.29

4.31

4.33

4.33

4.34

4.37

4.37

4.40

4.43

4.46

4.47

4.48

4.48

4.50

4.56

4.58

4.60

4.63

4.64

4.65

4.75

Mean

1

1.47

1.25

1.28

1.28

1.25

1.16

1.30

1.10

1.21

1.17

.89

1.06

.94

1.05

0.38

.97

1.03

.89

1.12

.97

.94

.94

.94

.85

.83

.86

.78

.83

.77

.74

.90

.74

.76

.77

.73

.62

.71

.59

2

S.D.

items with lower mean are considered relatively not important.

The shaded row represents the grand mean of all importance items (4.22). Items with higher mean are considered relatively important and

1

29

to diagnosis or problem list)

Allows for inclusion of the reason for prescribing the medication (matched

Provides useful drug-lab interaction alerts

17

Allows incorporation of herbal medications in the medication list

Allows for complex sigs through templates (sliding scales, tapers, etc.)

11

19

Provides a favorite medications list feature

7

13

Provides access to prescribers when they are out of the office

30

Displays patient-specific drug benefits information to help manage cost

Makes good use of pre-filled default fields

10

Has the ability to order supplies like syringes

Provides useful drug-problem interaction alerts

18

12

Provides reporting capability about medication history

27

28

Provides e-prescription delivery confirmation from the pharmacy

22

Relatively Unimportant

Provides adequate initial training for users by vendor

31

Relatively Important

Supports two-way electronic communications with pharmacies

26

prescribing application from current patient management system

Provides an easy e-prescription signing process

20

Provides easy access to the patient’s complete medication history

5

Provides good ongoing customer service by vendor

Has a fast (including trade names) medication search

8

Provides good on-going support by vendor

Has an easy (including trade names) medication search

9

32

Has the ability to decrease phone calls from the pharmacy

24

33

Provides easy refill/renewal authorization

Has the ability to handle Rx renewal requests

Provides an easy patient lookup process

3

25

Provides useful drug-allergy alerts

16

1

Sends a prescription to the pharmacy easily

How important is this feature to users like yourself?

2

No.

Item

Table 2. Relative importance ratings of survey items (highest to lowest)

Complies with all CMS Part-D e-prescribing standards Provides review screen before sending Provides an easy patient lookup process Sends a prescription to the pharmacy easily Provides an easy e-prescription signing process Provides a favorite medications list feature Has a fast (including trade names) medication search Provides access to prescribers when they are out of the office Provides easy refill/renewal authorization Has the ability to handle Rx renewal requests Has an easy (including trade names) medication search Provides easy import of patient demographic information into the

35 21 3 2 20 7 8 30 1 25 9 4

Allows for inclusion of the reason for prescribing the medication (matched to

19

Has the ability to decrease phone calls from the pharmacy Provides good on-going support by vendor Provides useful drug-lab interaction alerts Allows for complex sigs through templates (sliding scales, tapers, etc.)

24 32 17 11

102

100

100

99

101

100

102

101

100

101

102

102

102

99

99

100

99

99

102

99

100

101

102

100

101

102

101

102

100

102

102

101

102

102

101

95

100

N

4.14

4.30

4.43

4.47

4.52

4.67

4.69

4.70

4.71

4.72

4.75

4.75

4.75

4.79

4.82

4.86

4.91

4.92

4.93

4.93

4.94

4.95

4.97

5.06

5.07

5.08

5.11

5.11

5.16

5.16

5.20

5.23

5.27

5.27

5.29

5.34

5.43

5.46

Mean

Standard Deviation considered relatively satisfied and items with lower mean are considered relatively not satisfied.

*The shaded row represents the grand mean of all satisfaction items (4.92). Items with higher mean are

2

Rating scale: 1, Very Dissatisfied; 2, Moderately Dissatisfied; 3, Slightly Dissatisfied; 4, Slightly Satisfied; 5, Moderately Satisfied; 6, Very Satisfied; 0, Not Applicable

1

Provides e-prescription delivery failure notification from the pharmacy

Provides useful drug-problem interaction alerts

18

Provides e-prescription delivery confirmation from the pharmacy

Has the ability to order supplies like syringes

12

23

Provides good ongoing customer service by vendor

33

22

Provides adequate initial training for users by vendor

31

Supports two-way electronic communications with pharmacies

Provides timely routine system updates by vendor

34

Displays patient-specific drug benefits information to help manage cost

Allows incorporation of herbal medications in the medication list

13

28

Has a reasonable Initial cost

36

26

Provides reporting capability about medication history

Has reasonable on-going system costs

27

37

Relatively Dissatisfied

10

Relatively Satisfied

Provides easy access to the patient’s complete medication history Makes good use of pre-filled default fields

5

diagnosis or problem list)

Provides useful drug-allergy alerts Allows incorporation of over-the-counter medications in the medication list

14

Allows multiple prescriptions to be renewed at once for the same patient

6 16

Provides useful drug-drug interaction alerts

15

E-prescribing application from current patient management system

Supports mobile devices such as PDAs

29

No.

How satisfied are you with this e-prescribing feature?

Table 3. Relative satisfaction ratings of survey items (highest to lowest) Item 1

1.95

2.00

2.12

1.93

1.83

2.08

1.71

1.63

1.78

1.85

1.75

1.78

1.62

1.85

1.53

1.51

1.53

0.31

1.43

1.56

1.77

1.66

1.52

1.53

1.30

1.57

1.38

1.36

1.26

1.72

1.39

1.48

1.23

1.27

1.22

1.31

1.59

2.01

2

S.D.

Featured Article

Featured Article “PACT: Medical Home the VA Way”

by Kelsey Bohling, Pharm.D. and Michael T. Rupp, Ph.D., R.Ph. Midwestern University College of Pharmacy Glendale Eric Weber, Pharm.D., FASHP, Carl T. Hayden, VAMC In keeping with the goal to position itself at the vanguard of health care, the Veterans Health Administration (VHA) recognized the need to reorganize the delivery of care around the patient.

Although the incorporation of primary care within VHA had demonstrated significant improvements in Veteran satisfaction and key quality indicators, it was determined that the VHA health care system remained largely organized around the provider and health care team rather than the patient1. The solution to this problem came in the form of a patientcentered medical home (PCMH) model referred to as Patient Aligned Care Teams (PACT).

The objective of the PACT was to improve patient satisfaction, clinical quality, safety and efficiency through the integration of seven basic principles into the delivery of care1: • Patient-driven: Patient preferences guide the care provided to the patient.

• Team-based: The primary care team consists of the patient along with all the staff, clinical and administrative, necessary to promote the wellbeing of the patient.

• Efficient: Technology is utilized to support optimal patient care.

• Comprehensive: Every member of the health care team optimizes their clinical contributions.

• Continuous: The cycle of care is uninterrupted.

• Communication: Open and honest communication allows for informed decisions and health care recommendations.

• Coordination: Tasks are delegated among members of the health care team to accomplish the ultimate goal of patient-centered care.

The vision of PACT implementation was to transform primary care; to establish an interdisciplinary group of healthcare personnel functioning at their highest level of competency to most efficiently meet the Veteran patient’s goals and needs, and

clinical pharmacy was part of this vision.

In the fall of 2010 a PACT pilot program was launched at the Phoenix VA Health Care System with the creation of a multidisciplinary PACT work-group to aid in program planning, transition and conflict-resolution. At the direction of the PACT work-group and National VA directive, PACT team were formed around the patient that included four individuals: the primary care provider (PCP), a registered nurse care manager, a nursing assistant (NA) or licensed nurse practitioner (LPN), and an administrative support representative. The recognized need for pharmacy services within the team led to the incorporation of a fifth member: the PACT pharmacist. Based on work-load of primary care pharmacists prior to PACT implementation, it was hypothesized that one pharmacist could serve as the “the PACT pharmacist” to four teams, accounting for approximately 4,800 patients per PACT pharmacist.

Importantly, the members of each patient’s PACT team remain constant throughout the patient’s course of care within the VHA, thereby enhancing coordination and continuity of care.

To ensure the veteran is kept at the center of their care, healthcare information must be accessible to all members of the PACT, including the patient. In addition to a comprehensive electronic medical record (EMR) that is available to all members of the PACT, every patient is given the direct telephone number to the administrative support member of their PACT team. Administrative personnel are responsible for scheduling patient appointments, check-in and check-out procedures and triaging patient questions or concerns to other members of the PACT team.

Supporting the innovative nature of PACT, the VHA has taken communication one step further. Veterans that have computer and Internet access may establish a MyHealtheVet.com account that gives patients access to trusted, secure, and current health education information and resources. Patients may also elect to participate in secure messaging through MyHealtheVet. Secure messaging is a web-based message system, similar to e-mail, allowing participating VA patients and VA health care teams to communicate non-urgent health-related information in a safe computer environment. For example,

patients may communicate with their PACT provider regarding recent lab values or with their PACT pharmacist regarding renewal of medications.

Veterans who have not previously obtained care through the VA but have an upcoming appointment in primary care are contacted prior to their appointment by their PACT pharmacist and asked about drug allergies and all medications (prescription and OTC) they are currently taking. For coordination of care, a SOAP note is written by pharmacy that summarizes the medication history findings. This note is added to the EMR and thus available to the PACT provider associated with the patient prior to the first provider appointment. In cases where the new Veteran to VHA care is taking a non-formulary medication, formulary alternatives and doses are suggested for consideration by the PCP. If time allows, the PACT pharmacist also pre-reviews established VA patient’s medical record approximately one week in advance of their follow-up provider appointments and makes clinical, compliance, and/or medication monitoring recommendations to the PCP via a note in the EMR. Within the VHA, pharmacists work under an established scope of practice agreement which defines permitted procedures, actions, and processes. This scope of practice agreement also grants pharmacists prescriptive authority to initiate, adjust, or discontinue medication therapy associated with chronic disease states. Pharmacists utilize their prescriptive authority during pre-screening of medical records to renew any chronic medications.

As a result of the pre-screening of patients’ medical records prior to PCP appointments, a 30-minute provider appointment is now spent less on medications. The provider may access the recommendations made by the PACT pharmacist in the EMR and spend more time focusing on the patient’s main health concerns. This maintains the veteran in the center of care and allows for the primary care providers to maximize their contributions to patient care.

Additionally, with approximately 1000 to 1200 patients in a provider panel, tasks must be delegated to best serve the patient.

For example, a PCP may identify a patient with an uncontrolled chronic disease state during a primary care appointment.

Spring 2012 • Arizona Journal of Pharmacy • 21

Featured Article Within the PACT model, the PCP will initiate therapy and designate selected responsibilities to other members of the PACT team, including the pharmacist, for continued management.

The utilization of clinical pharmacists in the management and titration of medication associated with chronic disease states such as diabetes, hypertension, and hyperlipidemia has the potential to increase duration between provider follow-up appointments and allow the primary care provider to again focus on a patient’s main health concern during their appointments. Through the scope of practice agreement, the pharmacist may adjust medication doses, add additional therapy, monitor lab results, educate the patient on lifestyle modifications and/or follow-up with the patient as needed. It is this coordination of care that maximizes the management of all disease states.

PACT pharmacists also foresaw an opportunity to demonstrate their clinical capacity in preventive healthcare management. Monthly reports are generated at the Phoenix VA which identify all patients seen in primary care with a recorded blood pressure greater than 140/90mmHg. Pharmacists review the medical record of every patient identified on this list associated with their designated PACT teams. Upon review, pharmacists aim to evaluate patient compliance with current therapy, blood pressure history, goal blood pressure based on disease states, and potential for improved blood pressure medication therapy management. With identification of improvement strategies, the patient, provider and pharmacist collaborate on the appropriate strategy to gain better blood pressure control. This both improves quality within the site and aids in the early detection of disease states and/or the prevention of disease related complications. Importantly, it also contributes to strong and stable patientprovider relationships.

A traditional pharmacist role that PACT implementation has maintained is prescription order verification.

Approximately 2,000 electronic prescription orders are placed from PCPs at the Phoenix VA every day. Access to the EMR allows pharmacists to assess lab results, disease states, medication profile and prior refill history in determining the appropriateness of therapy prior to medication delivery and patient

administration. The close pharmacistprovider relationships established through PACT allows for effective communication in the event questions arise during order verification.

All members, including pharmacists, can also optimize their contributions to the team through the use of secure messaging or telephone interviews.

Secure messaging can be a substitute for routine outpatient visits, and serve as an enhanced communication tool for patients with chronic illnesses. Phone calls can be quicker alternatives to faceto-face encounters, decrease patient time and travel expenses, and reduce clinic congestion. It is up to the health care provider’s discretion to identify patients that may be appropriate candidates and whose clinical condition does not require a face-to-face appointment2. For example, clinic pharmacists may decide to follow-up via telephone on a patient with borderline hypertension who was instructed to record home blood pressure readings.

The American Pharmacists Association recognizes five core components of a Medication Therapy Management (MTM) Service Model including: Medication therapy review (MTR), Personal medication record (PMR), Medicationrelated action plan, Intervention and/or referral, and Documentation and followup3. PACT has created an interdisciplinary model for patient-centered care that incorporates clinical pharmacy at a level consistent with the APhA’s MTM Service Model. MTM the VA way incorporates clinical pharmacy MTR into pre-screening of patient appointments, and disease-state management appointments. Upon every clinic appointment Veterans are given a printout of their most current PMR from their PACT administrative personnel.

Patients are educated to review their PMR and to contact their PACT provider or pharmacist in regards to any changes, such as new or discontinued medications from a non-VA source, over-the-counter medication changes, or VA prescription medications they are no longer taking.

Within PACT, the ultimate goal is for the patient to drive every decision in the medication action plan. Patient preferences and goals should be easily retrievable, modifiable and reviewed/ discussed regularly between the patient, provider, and pharmacist. To maintain the patient at the center of their own

22 • Arizona Journal of Pharmacy • Spring 2012

care, clinical pharmacists intervene on medication-related problems and refer patient concerns that could be better served through another member of the PACT team. Every interaction between a patient and a PACT provider is documented and placed in the EMR for coordination of care. Tasks are delegated to ensure the patient is followed-up by the appropriate member of the health care team.

The PACT approach to care is based on seven fundamental principles, all of which are needed for its success: patient-driven, team-based, efficient, comprehensive, continuous, communication, and coordination. Recognizing the value of change is the first step toward incorporating the PACT concept into every ambulatory site. This must begin with a shared commitment to establish patientcentered care from every member of the health care team.

The PACT model is the VHA’s expression of the patient-centered medical home within which pharmacists play an essential role in performing MTM and collaborating with other members of the health care team to optimize care.

Pharmacists in every ambulatory site must search for opportunities to demonstrate their clinical capacities and to be valued as a core member of the patient-care team.

References: 1. Patient Centered Primary Care Implementation Work Group. Patient Centered Medical Home Model Concept Paper. U.S. Department of Veterans Affairs. http://www.va.gov/PRIMARYCARE/PACT/index.asp (accessed 2011 Aug 26).

2. Patient Centered Primary Care Implementation Work Group. Make Room for Patient Centered Care.

U.S. Department of Veterans Affairs. http://www. va.gov/PRIMARYCARE/PACT/index.asp(accessed 2011 Aug 26).

3. American Pharmacists Association. Medication Therapy Management in Pharmacy Practice: Core Elements of an MTM Service Model. Version 2.0.

March 2008. Accessed at http://www.pharmacist. com/AM/Template.cfm?Section=Pharmacists &Template=/TaggedPage/TaggedPageDisplay. cfm&TPLID=118&ContentID=18972

Student Perspective Pharmacy Day at the State Capitol: Promoting the Pharmacy Profession

by Jonathan Booker, Pharm.D., Midwestern University College of Pharmacy Glendale, Class of 2012 In today's world, as members of the pharmacy team we are part of a modernizing health care system that is transforming our current pharmacy practice to a more patient-oriented role. Pharmacists, interns, and technicians strive for accuracy, precision, excellence, and integrity when on duty because patients lives are at risk. Pharmacists are in the perfect position to fill the gap in health care delivery created by the economic downturn by being accessible, affordable, and reliable source of health information. Studies have shown that when a pharmacist becomes directly involved in patient care, they significantly reduce treatment costs and improve outcomes. If that's the case, then why are pharmacists continually left out of the debates regarding health care? I don't have an answer to that question, but a simple solution would be to assemble your fellow pharmacy colleagues and head to the capitol.

On Wednesday, January 25, 2012, the colleges of pharmacy from University of Arizona and Midwestern University, along with Arizona Pharmacy Alliance members and staff attended the 14th Annual Pharmacy Day at the Capitol (PD@C). This event provides a unique opportunity for pharmacists and student pharmacists to educate and interact with state legislators on a face-to-face level regarding the important role pharmacists play in improving health care throughout our nation.

Upon walking out of the doors of the Senate building or the House building, legislators were welcomed by a sea of white coats ready and willing to discuss the profession of pharmacy.

Student pharmacists then accompanied the legislators through a host of educational booths and health screenings to demonstrate the services that pharmacists provide for their patients. These services were available to legislators and their staffs, as well as the many individuals visiting the capitol that day.

While at PD@C I was fortunate to have an opportunity to meet with Rep. Kimberly Yee, Sen. Paula Aboud, and Rep. Heather Carter in their offices. I was a bit nervous during the first meeting with Rep. Yee, as this was the first time I spoke to a legislator in a professional setting without my fellow pharmacy student colleagues behind me. She did a wonderful job of putting me at ease and relating to me by telling about a person in her family who also attended Midwestern University College of Pharmacy. My second meeting was with Sen. Aboud who seemed to have a little fun with me by putting me on spot. After a series of questions which seemed like I took an eternity to answer, she smiled and laughed (I imagine around that time I started pouring in sweat), and offered some valuable feedback and encourage me to continue advocating for pharmacy because many individuals, including herself, are unaware of the knowledge pharmacists can provide. My final meeting was with Rep. Carter who is the Vice-Chairman of the Health and Human Services Committee. Rep. Carter was definitely aware of some of the health care concerns being faced and actually wanted to listen to the pharmacist outlook on certain situations.

The key lesson I learned from my experience at PD@C is that legislators are not pharmacists. As AzPA members we cannot just sit back and assume that legislators are aware of the issues that are important to pharmacists. In order to continue to further the role of pharmacists in the health care arena, it is important to educate and advocate about the profession of pharmacy - not only to lawmakers, but everyone. From the knowledge that we acquire during pharmacy school to the continuing education that we are required to complete throughout our careers, I believe it is time for pharmacists to rise from the shadows of other health care providers and take our rightful place as the frontline health care providers that we are.

Legislators are public servants - you are the public. Contact them on any topic or issue that is of importance to you. The AzPA website (www.azpharmacy.org) has resource links that can help lead you to contact information for your state and federal legislators.

Photos clockwise from left: 1. Tom Bethune, R.Ph., administers a flu shot to legislative staffer Karen Gray.

2. Arizona Speaker of the House Andy Tobin proves he had his glucose screening.

3. Midwestern University CPG student pharmacists Elaine Truong and Sikeat Yip pose with Rep. Brenda Barton (center).

4. Linda Trinh, University of Arizona COP student pharmacist, discusses safe drug disposal with Rep. Doris Goodale.

Spring 2012 • Arizona Journal of Pharmacy • 23

Arizona State Board of Pharmacy

Check (√ ) Please! An Educational Tool.

by Rich Cieslinski, R.Ph., Arizona State Board of Pharmacy

What is one of the most important things you do when getting ready to purchase a home? A home inspection, of course. A process designed to find out what’s wrong and what’s right with the home that will help assure a safe and secure environment to live in. Most people hire a professional to perform this vital task, because they don’t know all of the regulations and laws governing this type of process.

Similarly, in a pharmacy, a ‘Home Away from Home’ for most pharmacists, the pharmacist is the professional who is best suited to perform this ‘Home Inspection’ to assure that a safe and secure pharmacy environment, within the federal and state laws governing the practice of pharmacy, is available for the public.

Aside from routine Board inspections, an inspection of your pharmacy, by yourself, is the best way to determine if you have areas that need attention and may not be in total compliance.

Whether you call them self-inspections, self-assessments, or self-audits, performing these informational and valuable questionnaires helps assure that a pharmacist stays in compliance with most federal and state laws, not to mention the numerous required continuous quality assurance or quality improvement programs.

A recent NABP Law search revealed 7 states - Alaska, Colorado, Michigan, Nebraska, New Jersey, Oregon and Utah require self-inspection information for things like applying for a new permit, reinstating a registration, for display with the most recent pharmacy inspection report, for a pharmacy relocation application, fulfilling the annual inspection requirement, and for Board submission on automated medication systems and as part of proof of appropriate training.

In the State of California, for example, these self-inspections are called ‘Self-Assessments’ and are broken down into sections entitled ‘Community Pharmacy Self-Assessment and Hospital Outpatient Pharmacy Self-Assessment’, ‘Compounding SelfAssessment’, ‘Hospital Pharmacy Self-Assessment’ and ‘Wholesaler-Dangerous Drugs and Dangerous Devices SelfAssessment’. These ‘Check-Off’ lists are required by California Code of Regulations and can run in length from 19 to 23 pages.

NEW PILOT: A SELF-INSPECTION PROGRAM The 2012 Pharmacy Self-Inspection Reports are broken down into 3 categories.

• • •

Community and Limited-Service Pharmacy Sterile and Non-Sterile Compounding Hospital Pharmacy

The Pilot Program self-inspection report will serve as an important tool used by the Compliance Officer during the inspection to evaluate a pharmacy’s level of compliance.

Please ensure your completed report is available at the time of your routine inspection.

24 • Arizona Journal of Pharmacy • Spring 2012

Self-inspection is defined as the act of inspecting or viewing, especially carefully or critically, or a formal or official viewing or examination.

In the State of Washington, the pharmacy self-inspection procedures are broken down into sections entitled, ‘General Requirements’, ‘Patient Health and Safety Requirements’, and ‘Professional Requirements’. Each section has a total ‘Point’ value and a maximum ‘Point’ value that may be subtracted for non-compliance for each sub-category listed under each section.

These self-inspections or self-assessments are never forwarded to that state’s Board of Pharmacy, but rather kept within the pharmacy itself and used by inspectors and compliance staff to help determine if the pharmacy is in compliance with state and federal law during routine inspections. The impetus for the initiation of these self-assessments or self-inspections stems from several sources including the implementation of various required Continuous Quality Improvement Programs, state pharmacy laws, and error prevention programs.

For example, the National Association of Boards of Pharmacy provides boards of pharmacy with model language that may be used when developing state laws or Board rules called ‘The Model State Pharmacy Act and Model Rules’. Within these model rules, under the section called ‘Practice of Pharmacy’ is a descriptive on a ‘Continuous Quality Improvement Program’ that discusses the need to perform a ‘Quality Self-Audit’ at least quarterly and how to investigate and evaluate quality-related events.

Although self-audits or self-inspections may go hand-in-hand with established quality improvement or assurance programs, the distinction here is that information collected in this type of program is peer-review information and usually protected. It is geared toward error-prevention.

Whereas, pharmacy self-inspections required by state law have no specific quality-related event information, but rather address specific federal and state requirements for the practice of pharmacy.

If you happened to have attended the Arizona State Board of Pharmacy meetings during the months of November 2011 and January 2012, you may have heard that a pilot program, involving the use of self-inspections, was approved by Board and is going to be tested in certain pharmacies in 2012.

As compliance officers, our territories are rotated periodically and with the assignment of my new territory this year, I will be sending ‘new’ self-inspection forms out to pharmacies in my territory. If you should receive a copy of one or more of the self-inspection documents, please follow the instructions and complete them. Remember, the primary objective of these selfinspections is to assist you and your staff with an opportunity to identify and correct possible areas of non-compliance with state and federal law. The self-inspection should serve as an educational tool to help you better prepare and have all the necessary documentation to make the routine pharmacy inspection a good learning experience.

Academy News Community Pharmacy Academy Greetings, Community Pharmacy Academy Members, Several valuable continuing education offerings are on the AzPA Calendar of Events to enhance your community pharmacy practice.

On Saturday, May 5, 2012, the APhA-developed certificate training program, Delivering Medication Management Services in the Community will be held at the Crowne Plaza Airport Hotel in Phoenix.

The AzPA 8th Annual Meeting is June 28 to July 1, 2012 at The Wigwam in Litchfield Park, Arizona. In addition to the quality programming included with your annual meeting registration, several optional continuing education activities are available on Thursday, June 28, 2012. AzPA will offer a three-hour workshop Developing a Collaborative Practice Drug Therapy Management Agreement: The ABC’s of CPA’s. Two certificate training programs will also be presented that day: Pharmacy-Based Immunization Delivery and the newly updated APhA Pharmacy and Patient-Centered Diabetes Care.

Planning is already underway for the Community Pharmacy Academy conference in September. Save the date for Saturday, September 17, 2012. Details to follow. Visit the AzPA website at www.azpharmacy.org for information and registration for all of these offerings.

We continue to monitor the proposed merger between ESI and Medco and support the passage of a Patient Choice bill to protect patients and reduce costs. As always, please contact me with your questions, comments, and suggestions.

Sincerely, Teresa Stickler, R.Ph. Community Pharmacy Academy Chair melrosepharmacy@yahoo.com

Geriatric Care Academy Greetings, Geriatric Care Academy Members, The Geriatric Care Academy (GCA) leadership is excited to announce the GCA Conference will be Friday, May 4, 2012 in the late afternoon. The CE sessions will be in a unique and engaging format - think speed-dating for CE!.

Roundtable discussions on various geriatric topics will be approximately 30-45 minutes in length. The presentation is interactive and given in a short lecture format (~20 minutes) followed by discussion (~20 minutes). The topics range from “The future of anticoagulation in the geriatric population” to “Political update: Antipsychotic use in the long-term care setting” to “To DXA or Not to DXA? Fracture Risk Screening in the Long Term Care Setting.”

AzPA will be sending details regarding registration soon! Hope to see you there!

GCA’s monthly conference call is the second Wednesday of each month at noon (January – May 2012) with the next call April 11, 2012 at 12:00PM. Contact the AzPA office for Call-in information. Please call in to have your voice heard!

The American Society of Consultant Pharmacists Spring Conference is May 21-23, 2012 in Anaheim, California. Go to www.ascpspringconference.com to register.

Sincerely, Dawn Knudsen-Gerber, Pharm.D., CGP, FASCP Geriatric Care Academy Chair dknuds@midwestern.edu

26 • Arizona Journal of Pharmacy • Spring 2012

Academy News Health-System Academy News Greetings, Health-System Academy Members, The Health-System Academy continues to strive for achievement in 2012. The AzPA Mentorship Pilot Program began as planned on January 3, 2012. Designed to mentor student pharmacists in areas of personal and professional development, the pilot will run through June 2012. Information regarding the progress and successes will be shared the AzPA 8th Annual Meeting.

As we are all aware, an ongoing issue of concern is the national backorder of many medications. There are two bills currently pending in Congress, H.R. 2245, and S. 296, “The Preserving Access to Life Saving Medications Act,” that will assist the FDA in regulating drug manufacturing practices and drug shortages. The legislation, if it passes, will create a system that will alert of potential drug shortages and help the FDA work with manufacturers to prevent these shortages from occurring. Please contact your House and Senate representatives and encourage them to sponsor these bills. Email and fax are the preferred methods to contact them.

Daniel Hays has been elected to represent Arizona in the ASHP House of Delegates for the 2012-2014 term. Mindy Burnworth and Carol Rollins also represent Arizona in the HOD. The delegates will meet at the ASHP Summer Meeting June 9 to June 13, 2012 in Baltimore, Maryland.

The HSA is always looking to foster leadership by providing opportunities to get involved including volunteers from the academy to author articles for the HSA publication eHeartbeat and for the Arizona Journal of Pharmacy. Additionally, if you are interested in participating with the Health-System Academy, please contact me at the email address listed below.

Please attend the 2012 Health-System Academy Conference, LEADING THE WAY THROUGH THE HUMAN BODY: A Systems Approach, this April 14, 2012 from 8:00 AM to 5:00 PM at Banner Desert Health System in Mesa, Arizona. This is an outstanding networking and educational opportunity. Go to www.azpharmacy.org for more information. Enjoy the spring season and thanks for your support.

Jon Merchen, Pharm.D. Health-System Academy Chair jonathan.merchen@va.gov

PAAS Membership Benefits

• Expert Third-Party Audit Assistance • Monthly Third-Party Newsline • PAAS Member Manual & Third-Party Guide • PBM Resource/Advice & Contract Information • Valuable Forms & Reference Tools

2012 Health-System Academy Conference LEADING THE WAY THROUGH THE HUMAN BODY: A Systems Approach Saturday, April 14, 2012 8:00 am to 5:00 pm Banner Desert Medical Center 1400 S. Dobson Rd. Mesa, Arizona 85202 Early Registration Fees until April 6, 2012

Be Proactive. Be Protected. Be Prepared.

JOIN PAAS TODAY!

AzPA Member Pharmacist Non-Member Pharmacist AzPA Member Allied Pharmacy Non-Member Allied Pharmacy

$60 $90 $25 $35

Visit www.azpharmacy.org to register.

888.870.7227 | PAASnational.com

Spring 2012 • Arizona Journal of Pharmacy • 27

Academy News Managed Care Academy News Greetings, Managed Care Academy!

Two fantastic continuing education activities offering 2.5 hours (.25 CEUs) were presented at the 2012 Managed Care Academy Conference on March 15, 2012. More than 30 people attended the evening program held at the Crowne Plaza Phoenix Airport Hotel.

Darin T. Okuda, M.D., Associate Professor, Chief Neuro-Immunology Division, and Director, Barrow Neurological Institute Multiple Sclerosis Center, Phoenix, Arizona, discussed Multiple Sclerosis Medication Management. Dr. Okuda’s presentation was sponsored by PRIME®.

William Francis, Pharm.D., Director of Pharmacy, University of Arizona Health Plans, Tucson, Arizona, presented Partnership of Patients: Care Transitions to Reduce Readmissions.

During the conference, Ann Sears, R.Ph, received the Managed Care Academy Award for her outstanding leadership to the academy and the patients she serves. Congratulations, Ann. Thank you to the speakers, PRIME®, the conference planning committee, AzPA staff, and all who attended for making this a successful event.

Join your MCA colleagues on Sunday, April 1, 2012, for a spring training game between the Los Angeles Angels at Anaheim and the Chicago Cubs. Game time is 1:05 PM at Tempe Diablo Stadium, 2200 West Alameda Drive, Tempe. Tickets are just $22.

Hope to see you there!

Warm regards, Julie Hernandez, RPh, PharmD MCA Chair rxchica@cox.net

“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.

28 • Arizona Journal of Pharmacy • Spring 2012

Academy News Student Pharmacist Academy News Greetings, Student Pharmacists, Both colleges of pharmacy participated in Pharmacy Day at the State Capitol (PD@C.) Student pharmacists offered health screenings in diabetes, hypertension, and asthma. Information booths on drug disposal, smoking cessation, poison control, immunizations, and medication therapy management were displayed on the Senate Lawn. Free flu shots were available for state legislators and their staffs.

This annual event was well-organized and presented an opportunity for student pharmacists to interact with their state legislators.

Thank you to Nathan Smith, U of A COP, and Phillip Le, MWU-CPG, for co-chairing this year’s PD@C and Fry’s Food & Drug for providing the lunch for all who attended.

The 2nd Annual Student Pharmacist Leadership Conference will be held on Saturday, April 28, 2012 at the Westin La Paloma Resort & Spa in Tucson, Arizona. Members of the AzPA Student Pharmacist Academy were invited to submit their application, including a resume and essay, to the selection committee. Students from both colleges of pharmacy in Arizona will be chosen to attend this prestigious program designed to develop future pharmacy leaders.

Be sure to attend the AzPA 8th Annual Meeting at The Wigwam in Litchfield Park, Arizona, June 28 to July 1, 2012. Special pricing is available for AzPA Student Pharmacist members at just $25 per day or $75 for the three-day event. On Saturday, June 30, 2012, AzPA presents a special Student Track that will include workshops on mentoring, interviewing, and more. We hope to see you there!

Sincerely, Valerie Bostel and Jessica DiLeo AzPA Student Pharmacy Academy Co-Chairs valerie.bostel@gmail.com dileo@pharmacy.arizona.edu

Technician Academy News Greetings, Pharmacy Technician Academy Members, The 2012 AzPA Technician Academy Conference was held Saturday, February 18, 2012, at Banner Good Samaritan Medical Center in Phoenix. More than 70 technicians attend the day-long event. Five continuing pharmacy education activities specifically developed for pharmacy technicians were offered: • • • • •

Innovative Pharmacy Practice for Technicians - Judi Day, C.Ph.T, Linda Peralta, C.Ph.T., Nicole Scovis, Pharm.D. Pharmacy Technician Law Update - Ken Baker, R.Ph., J.D. Diabetes Care in a Grocery Chain Pharmacy: The Role of the Pharmacy Technician - Joy Davis, C.Ph.T Nutrition: Antioxidant functions and updates - Chris Lesaca, C.Ph.T. What’s Your Rock Bottom: Drug Diversion Roles for Pharmacy Personnel - Mike Severn, C.Ph.T

Many thanks to the conference planning committee, the speakers, and the AzPA staff for their efforts in creating an informative and successful event.

The AzPA 8th Annual Meeting will be held June 28 to July 1, 2012 at The Wigwam in Litchfield Park, Arizona. Certified pharmacy technicians may earn up to 12 hours (0.12 CPEs) of continuing pharmacy education. Please plan to attend.

Sincerely, Mike Severn, C.Ph.T. Technician Academy Chair amsevern@gmail.com

Spring 2012 • Arizona Journal of Pharmacy • 29

Drug Information Question

Question: What evidence is available on linagliptin (Tradjenta®) for the treatment of type 2 diabetes?

Thomas Combahee, Pharm.D. Candidate, and Stacy L. Haber, Pharm.D., Associate Professor, Midwestern University College of Pharmacy-Glendale

Answer: Introduction Diabetes mellitus is a condition characterized by physiological imbalance of glucose homeostasis, attributed most commonly to impaired insulin secretion and insulin resistance.1 Its most common form is type 2 diabetes mellitus (T2DM), which affects close to 250 million people worldwide as of 2011 and is expected to reach 380 million by 2025.2 It is traditionally known as adultonset, but recent rises in childhood obesity and changes in dietary habits have led to increasing numbers of juvenile-onset cases.3 Metformin is typically the first-line treatment for T2DM unless there is a contraindication; sulfonylureas (glipizide, glimepiride, glyburide) are often used in combination with metformin, but they have the unwanted side effects of hypoglycemia and weight gain.4 Pioglitazone is another option for add-on or monotherapy, but it may cause weight gain, increase the risk of heart failure, and be associated with bladder cancer and osteoporosis. If diabetic goals are not achieved with these medications, use of dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide (GLP-1) agonists, and/or insulin injections would be considered.2,4 The DPP-4 inhibitors include sitagliptin, saxagliptin, and linagliptin. The DPP-4 enzyme degrades the hormone GLP-1, which is released in response to food ingestion for enhancing glucose-dependent insulin secretion. Although DPP-4 inhibitors do not reduce glycated hemoglobin (HbA1c) and fasting plasma glucose (FPG) as much as other agents, they do reduce postprandial glucose levels more, as their mechanism of action would suggest.1,5,6 The newest agent in this class is linagliptin, which was FDA-approved in May of 2011.7 In a search of Medline, four randomized controlled trials have investigated the safety and efficacy of linagliptin.8-11 Clinical Trials Linagliptin 5-mg monotherapy was evaluated in patients with inadequately controlled T2DM, using measurements of glycemic control and markers of β-cell function in a study by Del Prato et al.8 All patients were required to discontinue their current antidiabetic medications, go through a four-week washout, and follow that with a two-week placebo run-in. This trial randomized 336 patients to linagliptin and 167 to placebo from 66 sites in 11 countries. The primary endpoint was the change from baseline in HbA1c after 24 weeks. Secondary endpoints included the percentages of patients who reached a goal HbA1c of < 7.0% or < 6.5% and experienced a lowering of HbA1c of ≥ 0.5%, reduction of HbA1c over time, and change from baseline in FPG and 2hPPG. Other endpoints included homeostasis model assessment (HOMA) indices for insulin resistance and β-cell function and changes in body weight and lipids. HbA1c changed in the linagliptin group by -0.44% versus +0.25% in placebo (p<0.0001). FPG was changed by -0.5 mmol/L versus +0.8 30 • Arizona Journal of Pharmacy • Spring 2012

mmol/L in placebo (p<0.0001), and 2hPPG was changed by -1.9 mmol/L versus +1.4 mmol/L in placebo (p<0.0001). Statistically significant changes were reported for several biomarkers and indices that favored linagliptin versus placebo. More patients reached a goal HbA1c of < 7% or < 6.5% with linagliptin versus placebo (25.2% versus 11.6%, p=0.0006). Similar results were reported for lowering of HbA1c of ≥ 0.5%. One case of hypoglycemia was reported in both the linagliptin and placebo groups. Adverse events more common with linagliptin included headache (2.7% versus 1.2%), hypertension (3.6% versus 1.2%), and back pain (2.7% versus 1.8%). No differences were noted in laboratory values, vital signs, or renal function. Body weight and waist circumference did not differ significantly. This study concluded that linagliptin monotherapy effectively reduced laboratory markers of T2DM with limited adverse events.

A trial by Forst et al. evaluated the safety and efficacy of linagliptin as add-on therapy to metformin.9 This trial randomized 333 patients to linagliptin 1, 5, or 10 mg, glimepiride, or placebo. Each group required concomitant use of metformin, either from continued use or from a twoweek run-in. Primary endpoints were similar to Del Prato et al., except this trial was done over 12 weeks, the minimum necessary to accurately acquire HbA1c values. Change from baseline in HbA1c was -0.40% for 1 mg (p=0.01), -0.73% for 5 mg (p<0.0001), -0.67% for 10 mg (p<0.0001), and -0.90% for glimepiride (p<0.0001). FPG changed by -1.1 mmol/L for 1 mg (p=0.002), -1.9 mmol/L for 5 mg (p<0.0001), and -1.6 mmol/L for 10 mg (p<0.0001); FPG was not evaluated in the glimepiride group. The percentages of patients who reached a goal HbA1c of < 7% or < 6.5% and experienced a lowering of HbA1c of ≥ 0.5% were not reported. No hypoglycemic events were reported for the linagliptin or placebo groups, but 5% of patients receiving glimepiride experienced hypoglycemia. The authors concluded that linagliptin was safe and effective for improving T2DM glycemic control in combination with metformin, but that the 5-mg dose was more effective than the 10-mg dose.

Taskinen et al. also evaluated linagliptin as add-on therapy to metformin.10 Patients with T2DM must have already been taking metformin at a dose ≥ 1500 mg/day. This trial randomized 524 patients to linagliptin 5 mg and 177 to placebo. Study design, primary endpoints, and secondary endpoints were the same as the study by Del Prato et al., except FPG over time and the need for rescue medications were also evaluated. Linagliptin reduced HbA1c levels by 0.49% versus 0.15% with placebo (p<0.0001).

For FPG, linagliptin resulted in a mean change of -0.6 versus +0.6 for placebo (p<0.0001), and for 2hPPG, it resulted in a mean change of -2.7 versus +1.0 for placebo (p<0.0001). Rate of change in HbA1c increased over time until about 18 weeks, when it leveled out. A similar pattern was seen in the rate of change in FPG. A goal HbA1c of < 7% was reached by 26% of patients in the linagliptin group versus 9% in the placebo group (p=0.0001). Similar results were reported for a goal of < 6.5%. The percentage of patients who experienced a lowering of

Drug Information Question (continued from page 30) HbA1c of ≥ 0.5% was 50% for linagliptin and 22% for placebo (p<0.001). In the linagliptin group, significant reductions were reported for the biomarker, C-peptide, and there was a significant increase in β-cell function. Rescue medications were needed by fewer patients in the linagliptin group compared to the placebo group (8% versus 19%, p=0.0001). No significant change in body weight was reported. The authors concluded that linagliptin 5 mg daily was effective and well-tolerated as add-on therapy with metformin.

A study by Gomis et al. conducted at 43 sites across seven countries evaluated the safety and efficacy of linagliptin 5 mg + pioglitazone 30 mg daily (treatment) versus placebo + pioglitazone 30 mg daily (control).11 Unlike the previous two trials, patients were not taking pioglitazone prior to randomization or if they were, they discontinued it with a washout period. This trial randomized 259 patients to linagliptin and 130 to placebo. Study design, primary endpoints, and secondary endpoints were the same as Del Prato et al., but hypoglycemia was also evaluated. The treatment group experienced a change in HbA1c of -1.06% versus -0.56% in the control (p<0.0001). A goal HbA1c of < 7.0% was reached by 42.9% of patients in the treatment group versus 30.5% in the control (p<0.0001). A significantly greater number of patients in the treatment group experienced a lowering of HbA1c of ≥ 0.5%. For FPG, there was a -1.8 mmol/L change in the treatment group versus -1.0 mmol/L in the control (p<0.0001). Biomarker measurements showed significant improvements in the treatment group versus the control. Weight gain was reported in 2.3% of patients in the treatment group versus 0.8% in the control.

Furthermore, the two groups had no clinically or statistically significant differences in cholesterol, triglycerides, and renal function. The authors concluded that linagliptin + pioglitazone was effective and well-tolerated.

The studies by Del Prato et al., Taskinen et al., and Gomis et al. had similar limitations.8,10,11 The durations were only 24 weeks, meaning long-term efficacy and safety could not be determined.

Washout periods of four weeks with two-week placebo run-ins were used, but because HbA1c values can go unchanged for up to 12 weeks, prior use of antidiabetic medications could have affected the results. The trial by Forst et al. involved a shorter duration of 12 weeks and an open-label design for the glimepiride group.9 Additionally, no washout period was used and metformin was allowed as a two-week run-in, which may have affected HbA1c values more than the other three trials.

Discussion These four randomized controlled trials presented beneficial results regarding the use of linagliptin either as monotherapy or combination therapy with metformin and pioglitazone.8-11 Furthermore, each trial reported few to no adverse events with linagliptin, except possible weight gain in combination with pioglitazone.11 As monotherapy, linagliptin was shown to be effective in reducing both HbA1c and FPG, but there was no evidence to show that it should be used before metformin.8 When used as combination therapy, linagliptin decreased HbA1c 2-4 times more than metformin or pioglitazone used alone.9-11 One study found that glimepiride + metformin was better than linagliptin + metformin for absolute HbA1c reduction but caused more hypoglycemia, which gives clinicians flexibility with

glycemic control because they can choose to lower HbA1c more with more adverse effects (sulfonylureas) or less with fewer adverse effects (linagliptin).9 Although these studies show positive results for linagliptin, none of them compare linagliptin directly to other DPP-4 inhibitors. All DPP-4 inhibitors have been shown to decrease HbA1c values by approximately 0.5 percentage points.1 Phamacodynamic studies have been performed comparing sitagliptin, saxagliptin, and linagliptin.1,4,5 Linagliptin’s extent of inhibition on the DPP-4 enzyme is the same as the other agents, but its sensitivity to it, as opposed to other DPP enzymes, is considerably higher, suggesting a better side effect profile.5 Linagliptin is also the only DPP-4 inhibitor that does not require renal adjustment, mostly due to its extrarenal metabolism and fecal excretion.7 All DPP-4 inhibitors are minimally metabolized

by CYP3A4, but linagliptin is also metabolized by p-glycoprotein so it may cause more drug interactions. In summary, due to safety concerns with thiazolidinediones, DPP-4 inhibitors may become used more often in the management of T2DM; linagliptin is the newest agent in this class and has some advantages, but more studies are needed to know its long-term effects.

References: 1. Scott LJ. Linagliptin: in type 2 diabetes mellitus. Drugs. 2011; 71:611-24.

2. Sacks DB, Arnold M, Bakris GL et al. Clinical Chemistry. 2011; 57:e1–e47.

3. Prasad AN. Type 2 diabetes mellitus in young need for early screening. Indian Pediatr. 2011; 48:683-8.

4. Abramowicz M, Zucotti G, Pflomm JM et al. Linagliptin (Tradjenta) – a new DPP-4 inhibitor for type 2 diabetes. Med Lett Drugs Ther. 2011; 53:49-50.

5. Baetta R, Corsini A. Pharmacology of dipeptidyl peptidase-4 inhibitors. Drugs.

2011; 71:1441-67.

6. Toth PP. Linagliptin: a new DPP-4 inhibitor for the treatment of type 2 diabetes mellitus. Postgrad Med. 2011; 123:46-53.

7. Tradjenta (linagliptin) package insert. Ridgefield, CT: Boehringer Ingelheim and Indianapolis, IN: Eli Lilly; 2011 May. 8. Del Prato S, Barnett AH, Huisman H et al. Effect of linagliptin monotherapy on glycaemic control and markers of β-cell function in patients with inadequately controlled type 2 diabetes: a randomized controlled trial. Diabetes Obes Metab.

2011; 13:258-67.

9. Forst T, Uhlig-Laske B, Ring A et al. Linagliptin (BI 1356), a potent and selective DPP-4 inhibitor, is safe and efficacious in combination with metformin in patients with inadequately controlled type 2 diabetes. Diabet Med. 2010; 27:1409-19.

10. Taskinen MR, Rosenstock J, Tamminen I et al. Safety and efficacy of linagliptin as add-on therapy to metformin in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study. Diabetes Obes Metab. 2011; 13:65-74.

11.Gomis R, Espadero RM, Jones R et al. Efficacy and safety of initial combination therapy with linagliptin and pioglitazone in patients with inadequately controlled type 2 diabetes: a randomized, double-blind, placebocontrolled study. Diabetes Obes Metab. 2011; 13:653-61.

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.

Spring 2012 • Arizona Journal of Pharmacy • 31

Feature Pharmacist The Lady and the Law

by Jonathan Booker, Pharm.D. Candidate, Midwestern University College of Pharmacy Glendale, Class of 2012 Since the dawn of man, mentors/teachers wield a powerful skill that has helped change men and women to become greater men and woman. This ability is known as teaching and in the right hands it has the power to sculpt the human mind and even offers the opportunity to work with a student/apprentice soul. The power of a superb teacher is unrivaled because they are willing to go above and beyond the call of duty to deliver knowledge to their students. I recently was given the opportunity to visit Mary K. Gurney, Ph.D., R.Ph., who is an assistant professor at Midwestern University College of Pharmacy - Glendale, and I must say that she is deeply committed to her profession and to the students she influences. Dr. Gurney is the prime example of a superb teacher whose reward is seeing her students grow and mature into intelligent pharmacists. Currently she is in the process of acquiring her tensureship at Midwestern University College of Pharmacy Glendale which I believe would be a well deserved title given her commitment and dedication to the school and students.

How did you end up where you are today?

After I received my B.S. in Pharmacy from Drake University, I went to work for Osco in Indianapolis. I became involved with the state pharmacy association around the time when the Omnibus Budget Reconciliation Act of 1990 (OBRA '90) came out. While involved with the state pharmacy association I held a few different committee chair positions. I also did an ambulatory certificate program through Purdue University. Since high school I have always had a passion for policy and politics. I then went to the University of Wisconsin where I received my Master's and Ph.D. While working as a teacher's assistant I started to witness many students’ “aha moments” (a moment of clarity, where you gain real wisdom) and I thought to myself, "I kinda like this!", and at that point I realized, "I want to be a teacher!". This idea was confirmed by my law professor’s husband who was part of the computer science faculty at the University of Maryland.

When he overheard me during my office hours for law and after hearing me lecture to students, he said to me, "I have no doubt in my mind that you will become a great professor." After teaching at South Dakota State for 3 years I then discovered the opportunity at Midwestern University College of Pharmacy Glendale where I am now currently employed.

What is a typical day like for you?

It depends on if it is a teaching day or a non-teaching day. On a teaching day I’m either catching up on grading or working on lectures. At Midwestern the faculty has an open door policy which gives me the chance to mentor students on a daily basis.

During the non-teaching period of time I'm usually collaborating with fellow faculty members to improve the curriculum for pharmacy students. I also conduct the AzPA online law review moderating the discussions and replying to e-mails for my students.

32 • Arizona Journal of Pharmacy • Spring 2012

From where does your interest in pharmacy stem?

During my sophomore year of high school I missed 6 weeks of school in the fall quarter. Because of all the free time I had, I started sending out requests for college catalogs before acquiring a tutor. I also had an older cousin who was a pharmacist, and due to my illness I also started seeing my local pharmacist quite a lot. Throughout the rest of high school I encountered a few more periods of time where I was ill, and that helped bridge a relationship with my pharmacist and physician at the time. After seeing a brown recluse spider bite get lanced, I decided that practicing medicine wasn't for me, but the idea of pharmacy, "seemed like a really great idea!" and on top of that there was also a little bit of family influence from my cousin.

And your interest in policy and law?

During my senior year in high school, I was in a class called American Civilization Travel Seminar, which gave me a chance to work on a political campaign. I also had the opportunity to travel to Washington D.C. to participate in The Congressional Seminar hosted by the Washington Workshops Foundation who offers a one-week experiential leadership programs on government and politics.

How did you become involved in AzPA? I actually took the AzPA Online Pharmacy Law Review class.

Since I already taught law I wanted to see what someone else's perspective was to teaching pharmacy law. After taking the class I was given the opportunity to become the Online Law Review course coordinator.

I understand that currently you are not a licensed pharmacist in the state of Arizona, but you do plan on taking the MPJE in the near future. Why? Students have asked me to participate in patient care activities, but at the moment I can't be the pharmacist on record because I'm not licensed. "For the students!" is my reason why I want to take the MPJE to be license. I do have my code to take the test and I'm currently planning to take the law exam sometime during February or March 2012. After acquiring my license I plan to precept students and to facilitate some volunteer activities and also do some volunteer work with some of the clinics.

Mary Gurney, R.Ph., Ph.D., Associate Professor at Midwestern University College of Pharmacy Glendale

Feature Pharmacist What are your thoughts on Pharmacy Day at the Capitol (PD@C)?

I thought it was fantastic! It gives our representatives, state senators, and even the staff a chance to see what pharmacy is all about. PD@C provides an opportunity for pharmacists and student pharmacists to educate individuals on the services that can and are provided by pharmacies.

If you could change one thing about pharmacy what would it be?

It would be the perception that pharmacy receives from patients and other health care providers. I want patients to be as responsive as they are to their physician. Pharmacists are part of the health care team and deserve an equal amount of respect that is given to the other health care providers.

Do you have any advice for pharmacy students that are interested in government and politics?

If you have any issues that you are passionate about, write, e-mail or call your legislators. Drop by and talk to your school's faculty to see if you could be introduced to someone that could act as a mentor. You probably have heard countless of times that pharmacy is a small world and this is true. Somebody always knows somebody an as faculty it's our job to help bridge that gap for our students. Use social media network to your advantage to get out information related to professional issues that you want other people to engage in.

Any advice that you would like to give the pharmacy world?

Yessssss! It's a quote from Eleanor Roosevelt: "Do what you feel in your heart to be right - for you'll be criticized anyway. You'll be damned if you do and damned if you don't."

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Spring 2012 • Arizona Journal of Pharmacy • 33

Continuing Education

Issues in Pharmacy Malpractice

by Ken Baker, BS Pharm, JD

Goal To educate pharmacists and Pharmacy Technicians on the legal concepts of pharmacy malpractice and how to react when an error occurs.

Objectives: 1. List the most common types of errors that lead to pharmacy malpractice claims and lawsuits 2. Describe the elements of the law of negligence as they apply to pharmacy malpractice lawsuits 3. Differentiate between the roles of the state boards of pharmacy board when a pharmacist’s negligence causes a medication error and the role of the patient’s lawyer in filing a civil lawsuit.

4. Describe how the changes in laws and regulations, such as OBRA 90 rules, have impacted pharmacy malpractice claims.

5. Identify court decisions that have evidenced evolving pharmacy duties.

Pharmacy law has undergone many changes over the last few years. These changes have taken place for many reasons including, changes in laws, changes in pharmacist training, changes in medication and prescribing habits, and perhaps more most importantly, changes in the needs of the patient.

While these changes within the profession have been occurring, most of the state and federal courts have been hard-pressed to keep up. The result has been a wide disagreement among the courts as to the extent of pharmacist legal duties and even the rules to apply to determine what those duties are.

Within the relative short span of time of 3 to 5 years some of these courts have revised the standards to be applied to a pharmacy practice in some cases resulting in a pharmacist being informed years later what the rules were at the time the prescription was filled.

In 1994 Peter Spalitto was the pharmacist on duty when a patient, Franklin Horner, presented two prescriptions. One of the prescriptions was for a hypnotic ethchlorvynol 750 mg, with the directions of “take one every eight hours.” A standard dose is normally indicated to be 500 mg at bedtime. Six days after the prescriptions were filled, Horner was found dead of an apparent

drug overdose. The autopsy revealed that the death was a result of multiple drugs, especially ethchlorvynol, “which was near toxic range.” A lawsuit was brought by Horner’s children and mother for wrongful death against the pharmacy and the prescribing physician.

Two years before pharmacist Spalitto filled Mr. Horner’s prescriptions, an appellate court in the same state, Missouri, ruled that: “By properly filling legal prescriptions that contained no apparent discrepancies on their face, the pharmacy fulfilled its duty to appellant.” This ruling in the case of Kampe v. Howard Stark Professional Pharmacy created binding precedent in the state, which, in essence, had the force of law behind it. In 1994, when Peter Spalitto filled the prescription this ruling was the law in Missouri.

Peter knew the rule: fill the prescription accurately, as prescribed by the physician and the pharmacist had legally fulfilled his or her duty. There was no duty to inquire and no duty to warn either the patient or the prescriber.

When the Horner family sued, Spalitto’s attorneys raised these points in a hearing at the trial court level and asked the trial judge to dismiss the case. The trial court, based upon the earlier ruling in Kampe v. Stark, agreed. The pharmacist had no legal duty beyond filling the prescription correctly as prescribed. The family appealed the trial court’s dismissal to the court of appeals and, two years after Spalitto filled the Horner prescription, the court changed the rules. Actually, the appellate court said the Kampe case was wrong and that what every pharmacist in Missouri thought was the rule, was not.

We study pharmacy malpractice law because the practice of pharmacy is today going through changes in the standards that define those duties. Pharmacists need to be able to predict what the courts may say are pharmacists’ legal duties three or five years from now. Laws change, regulations change, expert opinions from pharmacists themselves change over time and courts, which today are very sure of how these rules should be applied to the question of pharmacists’ legal duties, may decide at some future time on a different set of rules.

Prediction, of course, is an inexact science at best. Perhaps the best we can

34 • Arizona Journal of Pharmacy • Spring 2012

do is to make an educated guess. In this article, we review case decisions to give pharmacists information which may allow them to do just that – predict what the world of pharmacy malpractice will look like in three, five, or ten years from now.

One thing is certain; with the changes in the way pharmacy is practiced, there will be changes in the way courts interrupt legal duties.

Problem or Just Hype Do pharmacists have a real problem with errors leading to malpractice claims or is it just journalists’ hype? The answer is, it is a little of both. In 2003 the Journal of the American Pharmacists Association published an Auburn University observational study of 50 community pharmacies in the United States which reach the conclusion, “Dispensing errors are a problem on a national level, at a rate of about four errors per day in a pharmacy filling 250 prescriptions daily. An estimated 51.5 million errors occur during the filling of 3 billion prescriptions each year.”

Four errors in 250 prescriptions equals an error rate of 1.8%. The number is somewhat misleading however. Many of the errors found were unlikely to cause any injury, such as errors involving an inaccurate count of the tablets in the bottle. For this reason, Drs. Flynn, Carnahan and Barker, the primary Auburn professors involved in the study, asked a group of pharmacists examine the errors and determine how many of the errors found were likely to cause serious injury.

This group of pharmacy concluded, “of the 77 errors detected, 5 (6.5%) were judged to be potentially clinically important . . . This represents 0.1% of the 4,481 prescriptions and evaluated in this study.”

While newspapers sensationalize stories of individual prescription errors, it should be noted that pharmacists fill the vast majority of all prescriptions correctly. Pharmacists know, however, that the only acceptable error rate is zero.

The pharmacist primary duty is, “First to do no harm.” While in the Auburn study 4,476 prescriptions were filled without a clinically important error, one out of every thousand prescriptions did contain a significant error. Every pharmacist knows that number is unacceptable.

Continuing Education (continued from page 34) Professional Liability Claims The most significant pharmacy medication errors are those that cause injury. Each year Pharmacists Mutual Insurance Company publishes its study of claims filed against pharmacist insured by the company. The importance of this study, shown in Figure 1, is that it represents those mistakes which actually reach a patient and which, for the most part, are alleged to cause some damage or injury. These are the mistakes that lead to malpractice suits.

Perhaps the most significant changes in claims against pharmacist over the years of the Pharmacists Mutual Claims Study is the rise in drug review claims.

Figure 2 shows that the number of these claims has grown steadily since 1989, the first year of the study. Pharmacists Mutual characterizes drug review claims as allegations of overdose of medication, under dose, allergies and contraindications. In legal terms these are the “duty to warn” cases and the ones which have shown the greatest change in terms of pharmacist legal duty over the last 30 years. The modern study of pharmacist malpractice claims is, in essence, the evolution of these cases and legal theories.

The Law of Malpractice The law of malpractice is the tort of negligence. Negligence is made up of two parts, duty and damage. In order to bring a lawsuit in negligence a plaintiff must show that the person being sued owed a duty to this particular plaintiff and that the defendant failed to perform that duty.

In addition, the plaintiff must show that he or she was damaged or injured in that the damages were the proximate cause of the defendant’s failure to perform her or his duty. The best way to understand proximate cause is to apply a “but for” test. In other words, the plaintiff would not have been injured but for the defendant’s failure of duty.

The tort of negligence is the same whether we are speaking of an automobile accident or a pharmacy malpractice case.

The difference is how the appropriate legal duty is defined. Legal duty, in the terms of any professional, means to perform to the minimum standards of practice of that profession.

Generally speaking, legal duty has three sources, but all emanating from the same foundation – the profession itself.

It was not just the way courts looked

at pharmacy practice that had changed between 1992, the time of the Kampe decision, and 1994 when Peter Spalitto filled Mr. Horner’s prescriptions. The law had under gone a dramatic change with the passing of OBRA 90 followed by the adoption of OBRA 90 regulations by every state by January 1, 1993. The Missouri court of appeals court in Horner specifically pointed to the Missouri Board of Pharmacy OBRA 90 regulations when it overruled Kampe. That was not, however, the sole reason that the court gave for its decision. The Horner Court said, We reverse because Kampe caused the circuit court to apply the wrong standard. The Kampe court confused duty with what specific functions that duty obligated a pharmacist to do.

It ruled that a pharmacist fulfills his professional duties when he accurately fills a prescription – that he has no duty to warn or monitor. This is miscomprehended duty. Duty is an obligation imposed by law to conform to a standard of conduct toward another to protect others against unreasonable, foreseeable risks. . . .

Spalitto’s duty was to exercise the care and prudence that a reasonably careful and prudent pharmacist would exercise in the same or similar circumstances--that is, his duty was to endeavor to minimize the risks of harm to Horner and others which a reasonably careful and prudent pharmacist would foresee. (Horner v.

Spalitto, supra at 522.)

The test, according Horner, was what would the careful, prudent pharmacist do under similar circumstances with similar knowledge? The way we prove to a jury what that careful, prudent pharmacist would do is to call an expert witness.

The expert witness is a pharmacist who is familiar with the practice of pharmacy.

The standard of practice of pharmacy is what pharmacists themselves believe it is.

How does a pharmacist expert determine what a reasonable prudent pharmacist would do under the circumstances in the case in which she or he is testifying? Because the standard of practice defines legal duty and a legal duty is defined as the minimum that any pharmacist would do in that sense, the expert will examine question, “What is the least any pharmacist would do here?” To find an answer the expert can look in three places.

1. What law or regulation could a pharmacist be punished for not doing,

since every pharmacist must obey the law?

2. What have the courts in the state ruled regarding pharmacists’ duties?

3. What is the expert witness’ own understanding as to what the local standards require every pharmacist to do in a case similar to the one involved at trial?

Not all courts have agreed with the Horner ruling and many decisions may be seen as more akin to the Kampe v.

Stark language. Until state courts develop a more uniform theory of pharmacists’ professional duties, pharmacists need to explore common threads contained in decisions. These may help predict the rules as they may be applied to standards of pharmacy practice over the years. In attempting to do so, we will look at some of the more recent cases in this area.

Evolution of Legal Duty In 2004 the Connecticut Superior Court decided in the case of Deed v. Walgreen that the pharmacist did not have a duty to warn a customer that she was “being overmedicated”, but, rather, that this was the physician’s duty. A wrongful death case was brought against the pharmacy by the administrator of Ms. Deed’s estate. The court indicated that in the year prior to her death the pharmacy filled “approximately 149 prescriptions,” including medication “for pain relief, muscle tension, anxiety, depression and nausea.” According to the state medical examiner Pauline Deed died of “acute carisoprodol and oxycodone toxicity.”

In exonerating the pharmacy the court said this doctrine meant that the prescribing physician is the person best able to recommend precautions to be used with the prescribed drug. The exception, the court said, would be in those cases “when a pharmacy or pharmacist has specific knowledge of potential harm to specific persons in particular cases.” In such a case a pharmacist could be held to have a duty to warn. Here, the Court said, Deed knew all the drugs she was taking, from whom she had obtained them, how frequently and for what purpose; so, the pharmacy had no knowledge superior to hers and no duty to warn. Further, the duty to inform her physician of the drugs she was taking was Deed’s.

The Learned Intermediary Rule and Pharmacist Liability The court in Deed applied a doctrine known as the “learned intermediary rule,” which it held applicable to pharmacist

Spring 2012 • Arizona Journal of Pharmacy • 35

Continuing Education (continued from page 35) dispensing cases. Under this rule, originally applied to drug manufacturers, the physician is seen as the professional between the manufacturer (and here the pharmacist) and the patient. One of the cases this Connecticut Court relied upon in reaching its decision was Morgan v.

Wal-Mart, a 2000 Texas case. That court also applied the learned intermediary rule to a pharmacist duty to warn case.

In Morgan the plaintiff alleged that her son’s death was caused by an adverse reaction to Desipramine, and that the pharmacy failed to warn her of known dangers associated with the drug. All other defendants, including several physicians, a manufacturer and another pharmacy settled with the plaintiff and were dismissed out prior to trial and appeal, leaving Wal-Mart as the only defendant in the case. A jury found WalMart to be 15% at fault and awarded over a million dollars in damages to be paid

by Wal-Mart. The verdict was appealed

by Wal-Mart and the Court of Appeals reversed the judgment and reduced the verdict to zero.

The child, Cameron, has been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) and was prescribed Desipramine 25 mg. Wal-Mart provided no counseling, but it should be noted that the prescription was originally filled at another pharmacy from which the mother asked to have it transferred to Wal-Mart because it was cheaper. In addition, the records indicated that printed material had been provided with each fill, although the mother testified she did not receive any.

The doctor who performed the autopsy testified “that Cameron suffered the hypereosinophilic syndrome as a result of taking Desipramine.”

The court summarized the legal basis of the lawsuit, saying, “the threshold question in this case is whether Wal-Mart owed a legal duty to the plaintiffs to warn of the risks associated with Cameron’s use of Desipramine. . . . If no duty exists, there can be no negligence liability.”

The Morgan Court then analyzed pharmacists’ liability: This Court has held that pharmacists owe purchasers of prescription medication “the highest practicable degree of prudence, thoughtfulness and vigilance and the most exact and reliable safeguards consistent with the reasonable conduct of the business in order that human life may not constantly be exposed to the

danger flowing from the substitution of deadly poisons for harmless medicines.” . . .. A pharmacist who inaccurately fills a prescription is therefore liable to the customer for resulting harm. [Citations omitted] For Texas, whether or not pharmacists also had a duty to warn of the dangers of the drug they dispensed was new. The Court said, While it is apparent then that Wal-Mart owed the plaintiffs a duty to dispense Desipramine in accordance with Dr. Schroeder’s prescription, no Texas court has yet considered whether a pharmacist is also obligated to warn customers of potential hazards or side effects of prescribed drugs.

To answer that question they had to examine two underlying questions. First, did pharmacy law require a duty to warn?

This required a look at Texas’ OBRA-90 type regulations and ask if those created a special duty. The Court said: A court will not adopt a statute or an administrative rule or regulation as a standard for negligence unless the purpose of the statute or rule is to afford protection to the class of persons to which the injured party belongs against the hazard involved in the particular case. . .

What was the purpose of OBRA-90? The ruling in this case found: The Texas Pharmacy Act provides that its purpose is to regulate the legal storage and distribution of prescription drugs and to promulgate standards within which pharmacies and pharmacists must operate. . . . Furthermore, none of the administrative rules cited by the plaintiffs are consistent with the imposition of a mandatory duty to warn; rather, the rules speak in terms of a pharmacist (1) making “reasonable efforts” to obtain and record patient information at the time a prescription is presented for dispensing; (2) reviewing a patient’s medication record and consulting with the prescribing physician if there is a problem; and (3) communicating to the patient information about the prescription which “in the exercise of the pharmacist’s professional judgment the pharmacist deems significant.” Thus, while “common severe side effects or adverse effects or interactions” are some of the hazards of which a pharmacist, in the exercise of his professional judgment, may warn a patient, none of the cited rules mandate that pharmacists must give such warnings.

36 • Arizona Journal of Pharmacy • Spring 2012

Nor does any rule address a pharmacist’s role with respect to uncommon adverse reactions.

If, as this Texas Courts said laws such as OBRA 90 do not impose a duty to warn for the pharmacist, could a duty be found elsewhere? To answer that question the Morgan Court looked at court decisions in other states.

A majority of courts considering this question have held that a pharmacist has no such duty when the prescription is proper on its face and neither the physician nor the manufacturer has required that the pharmacist give the customer any warning.

This court then adopted what has come to be known as the learned intermediary rule, which it considered majority doctrine from the other states. Based on that rule, the Court found Wal-Mart had no duty to warn Cameron’s mother of possible effects of the medication.

To explain the learned intermediary rule, let us examine a case before the Utah Supreme Court in 2003. While the Schaerrer v. Stewart’s Plaza Pharmacy, Inc. suit is a compounding pharmacy case, in this article we are interested in its treatment of the theory of the learned intermediary. The plaintiff, Jeanne Schaerrer, filled her prescriptions for fenfluramine and phentermine at a local pharmacy, until a friend told her that Stewart’s Plaza Pharmacy could compound these drugs into a once-a-day dosage form of fen-phen. The doctor later testified he was not familiar with a one a day formulation, but agreed to write the prescription, assuming the pharmacy had investigated and determined it was safe.

After taking the drug for a time, Mrs. Schaerrer began experiencing problems and eventually had open heart surgery to repair two damaged heart valves.

She filed suit based on several theories, including strict products liability (similar to a drug manufacturer) and what was in essence a duty to warn the patient of the risks of fen-phen.

In its decision the Utah Court discussed the learned intermediary rule. It explained that the rule was originally promulgated in the context of drug manufacturers whose duty it was to warn prescribers. If they did so they were relieved of any duty to warn patients directly. The Court said, The physician, after having received complete and appropriate warnings from the drug manufacturer, acts as a

Continuing Education (continued from page 36) learned intermediary between the drug manufacturer and the patient when preparing the drug prescription. It is the physician who is best situated to weigh the potential risks associated with a prescription drug against the possible benefits of the drug and the unique needs and susceptibilities of each patient. The physician thus has the ability to combine medical knowledge and training with an individualized understanding of the patient’s needs, and is the best conduit for any warnings that are deemed necessary.

[Citations omitted] Turning then to pharmacists, the Court extended the rule: [I]t would be “incongruous” to impose upon pharmacists a duty to warn patients directly when the manufacturer did not have a similar duty. Requiring a pharmacist to warn patients of the potential risks of a prescription drug would “have the effect of undermining the physician-patient relationship by engendering fear, doubt, and secondguessing.” Id. Pharmacists might present patients with confusing or contradictory information, cast doubt on the propriety of a physician’s legitimate exercise of sound medical judgment, or even refuse to fill valid prescriptions in an effort to avoid liability. [Citations omitted] While looking at a more limited question of strict liability, such as that of a manufacturer, the Utah Court’s decision can be read in a broader context. The Court concluded: “[W]e will not impose a duty upon the pharmacist to warn of the risks associated with the use of prescription drugs.” The Supreme Court of Utah confirmed this finding in another compounding case in 2008.

Also using the “learned intermediary doctrine,” but reaching a different decision was the Illinois Supreme Court case of Happle v Wal-Mart. Heidi Happle was allergic to aspirin, acetaminophen, and ibuprofen. When she asked her doctor for something to relieve her pain caused by severe menstrual cramps, he prescribed Toradol. The doctor testified later he did not know Toradol was contraindicated for a patient allergic to aspirin. If he had, he said, he would not have prescribed it.

The pharmacy was aware of Heidi’s allergies. According to the Illinois Supreme Court findings, prior to presenting her prescription for Toradol: Heidi had been to the Wal-Mart pharmacy in McHenry about six times to

have other prescriptions filled. Each time she went, pharmacy workers asked her if she had any drug allergies, and each time she told them she was allergic to aspirin, acetaminophen, and ibuprofen. Wal-Mart pharmacy manager Steven Odes testified in his deposition that in August 1993, it was the pharmacy’s policy and procedure to ask customers about their known allergies prior to dispensing medication.

The purpose of this practice, Odes said, was to alert the pharmacist to any drug interactions or allergies.

The pharmacist who was on duty when Heidi’s husband presented the Toradol prescription, “ . . . indicated that she was aware that Toradol was contraindicated for persons who were sensitive to aspirin and ibuprofen,” however she said she did not receive the information which was in the computer regarding the allergy. She also testified, “. . . a pharmacist is required to know a customer’s drug allergies and contraindications.” The fact that the pharmacists did not know suggests that someone other than her overrode the computer warning.

The Court record tells us what happened next.

Heidi took the first dose of Toradol at about 4 p.m. on August 4, and within 40 minutes she began to experience respiratory problems including a tightness in her chest. She began a breathing treatment with a nebulizer, and called the pharmacy to ask if she could be having a reaction to Toradol. Her call was disconnected. She called again, and was told that there should be no drug reaction problem. Heidi then called a friend who was a pharmacist and was aware of her allergies. He told her to begin a nebulizer treatment if she had not already done so, and to go to the emergency room if her condition worsened. She went to the emergency room, and was found to be experiencing anaphylactic shock. Heidi testified in her deposition that, as a result of taking Toradol, she subsequently experienced more frequent asthma attacks, as well as seizures and a worsening of her multiple sclerosis. [Citations and Footnotes omitted] A negligence action was filed against the doctor and the pharmacy. The doctor settled out of the suit, leaving Wal-Mart as the sole defendant. The pharmacy’s defense was “. . . that there was no legal duty for it to warn, and it did not voluntarily assume such a duty.” The trial

court agreed and dismissed the case.

This trial court decision was reversed by the appellate court and the case was finally decided by the Illinois Supreme Court.

The question was whether the pharmacy had a duty to warn its patient and/or to alert the physician of the possible allergic reaction and the contraindication. In this regard, the Court said: In determining whether a duty exists, courts look to certain relevant factors.

These include: (1) the reasonable foreseeability that the defendant’s conduct may injure another, (2) the likelihood of an injury occurring, (3) the magnitude of the burden of guarding against such injury, and (4) the consequences of placing that burden on the defendant. [Citations omitted] The Illinois Supreme Court, after discussing and adopting the learned intermediary rule, found that a duty did exist in this case. There are exceptions to the rule, the court found, saying, Both the likelihood and the reasonable foreseeability of injury here were great.

These factors thus favor the imposition of a duty on Wal-Mart.

The burden on defendant of imposing this duty is minimal. All that is required is that the pharmacist telephone the physician and inform him or her of the contraindication. Alternatively, the pharmacist could provide the same information to the patient.

Since this burden of warning about a contraindication is extremely small, this factor also favors the imposition of a duty here.

One of the reasons courts have given in their reluctance to find a duty to warn on pharmacists has been the burden such a rule would place on the pharmacist who does not, in most cases, have knowledge of each patient’s specific diagnosis and medical history. Here, however, the Illinois Court found this was not the case.

The Court said, Next, we consider the consequences of imposing a duty to warn on defendant. As is discussed more fully below, defendant is not being asked to learn the customer’s condition, nor is defendant being required to render a medical judgment or interject itself into the doctor-patient relationship.

Instead, Wal-Mart need only pass along to the customer or the physician the information it already possesses about the contraindication for this specific customer.

What is the purpose, the Court asked,

Spring 2012 • Arizona Journal of Pharmacy • 37

Continuing Education (continued from page 37) in soliciting allergy information, if there is no duty to use it? In asking for the information, the pharmacy has impliedly said it was taking steps to safeguard the patient. The Court said, Wal-Mart contends that the learned intermediary doctrine precludes the imposition of a duty to warn here. We disagree. Given the particular facts in the instant case, we conclude that this case is outside the purview of the learned intermediary doctrine.

Holding the pharmacy did, in this case, have a duty, the Court said, [The] reasons for not imposing a duty to warn on pharmacists do not apply in the instant case. Here, Wal-Mart was aware not only of Heidi’s drug allergies, but also that Toradol was contraindicated for persons such as Heidi with allergies to aspirin. Imposing a duty to warn of this contraindication would not require the pharmacist to “learn the customer’s condition and monitor his drug usage.”

Conclusion With some exceptions, Courts have been reluctant to apply a generalized duty to warn a patient of dangers associated with their prescribed drugs upon pharmacists.

Each state that has looked at the questions have adopted slightly (and sometimes larger) different rules, but there have been some areas that allow a look into the future, providing an opportunity to determine what the rules may be when more uniform positions are finally agreed upon.

In Morgan v. Wal-Mart, the Texas Court took exception with Horner v.

Spalitto, which found that Missouri’s OBRA-90 regulations did place a duty on the pharmacist which the courts would follow. The Texas Court differed as to both the purpose of OBRA 90 and the professional manner in which it is designed to be used. How would pharmacists, who would be the expert witnesses in future cases, look at these two views? Pharmacists may think that the requirements to maintain patient records, perform a prospective drug review and counsel were implemented for purpose of providing pharmaceutical care for the benefit of the patient. The wording, these expert pharmacists might say, rather than removing a mandate to counsel and perform a prospective drug review, was designed to allow pharmacists to exercise professional judgment depending on the drugs involved and the needs of a

particular patient. Here these pharmacists would differ with the Morgan decision and more closely identify with Horner.

The OBRA 90 regulations require the pharmacist only to consider counseling concerning “common severe side effects or adverse effects or interactions.” It could be argued that it is worded in this way because is those affects that do not require detailed knowledge of the patient’s diagnosis or condition, information which the pharmacist usually does not have. Pharmacists may also say that the purpose of pharmacist counseling is not to second guess the prescribing physician’s decision, but to assist the patient in using the prescribed medication to its best advantage. On the other hand warning about “uncommon adverse reactions” could be seen as not generally be within the pharmacists’ purview, but rather a duty that would be left to the prescriber who has very specific information about a particular patient. It is in these points where the Morgan and Horner Courts diverge.

There have been other decisions that should be considered. These decisions, like the Happel court, while agreeing that there is no generalized duty, ruled there may be a duty on the pharmacist to warn of common, severe side effect, contraindications, or over-use of a drug. These other courts have indicated pharmacists could be held liable for failure to warn a patient based upon some special knowledge possessed by the pharmacist involving a specific patient. In one of the earliest cases to find a duty to warn, a New York court in Hand v. Krakowski , ruled that a pharmacist could have a duty to warn where the pharmacist knew the prescribed drug was contraindicated with alcohol and knew that the patient was an alcoholic.

In the Pennsylvania case of Riff v.

Morgan Pharmacy, the court found the pharmacy had a duty to warn the physician and the patient when there was an “obvious errors on face of prescription itself.” In that case the error was incomplete directions. The prescription for cafergot suppositories indicated, “insert one every four hours” without any indication of maximum doses for a migraine attack or to be taken in a week.

An overdose resulted in cafergot poisoning and hospitalization.

In 1990 an appellate court in Tennessee found a pharmacy could be held liable

38 • Arizona Journal of Pharmacy • Spring 2012

for failing to warn the parents of a child allegedly injured by an overdose of theophylline when the physician prescribed erythromycin, causing the theophylline levels in the body to increase to dangerous levels. In Dooley v. Everett an expert pharmacist witness testified that the standard of practice dictated that a pharmacist know all medications a patient is receiving from his or her pharmacy; to know that there was a potential interactions between theophylline and erythromycin; and to warn the physician and the patient of potential harm caused by taking the two concurrently, such as when there are known contraindications.

Pharmacy is evolving as a profession.

The duties, professional and legal, are also changing and evolving. Today the legal duties, as applied by state courts, are not uniform. Just as the pharmacist in Horner v Spalitto discovered years after filling the prescription in question that the rules in Missouri had changed, so pharmacists in other states may find rules and duties are changing. This is the reason we study pharmacy law – to try to predict the future.

The best rule for pharmacists is for them to decide on what their job is and to fulfill those duties.

Peter Spalitto eventually won the case in Horner v. Spalitto. After the Court of Appeals ruling the case was sent back to the original court for a jury trial. In that case Spalitto testified that he recognized the high does, consulted reference material, which indicated that the dose was not necessarily lethal and, under some circumstances could be used. He testified he called the physician’s office (duty to inquire), told them of his findings and questioned the dose was a mistake or not.

Only when he was told that the physician indicated the dose was not a mistake and was what he intended did pharmacist Spalitto fill the prescription. He also testified he counseled Horner, telling him of the high dose and of his discussion with the physician’s office, warning Horner of the nature of the drug and the way he was taking it. The jury found the pharmacist did his duty and ruled in his favor. The physician was ordered to pay, however.

The real lesson from this case, is that Spalitto won not because the earlier Kampe case said a pharmacist had no legal duty to warn and inquire, but because Peter Spalitto did what he saw as his duty and not what a court told him it was.

Times change, laws change, and legal

Continuing Education (continued from page 38) opinions change, so do pharmacists and their professional practices.

Note to Pharmacists: This article is not intended to be a complete review of all pharmacy malpractice laws or cases. This article is also not intended to give legal advice. It is rather hoped that through articles like this pharmacists can gain some understanding of the complexities of pharmacist malpractice and the issues associated with it now and in the future.

Laws, particularly the laws regarding negligence and products liability differ by state. Pharmacists should consult their own attorney who is familiar with the laws pertaining to pharmacy and malpractice in their state.

References: 1. Kampe v. Howard Stark Professional Pharmacy, Inc. [,] 841 S.W.2d 223, 227 (Mo.App.1992) 2. Horner v. Spalitto, 1 S.W.3d 519 (Mo. Ct App. Western Dist. 1999).

3. Flynn, EA, Barker, KN, Carnahan, BJ, National Observational Study of Prescription Dispensing Accuracy and Safety in 50 Pharmacies, J Am Pharm Assoc. 2003;43:191–200.

4. Pharmacists Mutual Insurance Company Claims Study 2010, http://www.phmic.com/ phmc/services/RM/profliab/claimsstudy/Pages/ ThePharmacistsMutualClaimsStudy.aspx, assessed 7/3/2010.

5. Pharmacists Mutual Insurance Company Claims Study 2010, Drug Review Claims, http://www.phmic. com/phmc/services/RM/profliab/claimsstudy/Pages/ DrugReviewClaimsbyYear.aspx assessed 7/3/2010.

6. Deed v Walgreen Co, 927 A 2d 1001, (CN 2004); also see, Morgan v. Wal-Mart Stores, 30 S.W.3d 455, 466 (Tex.App.2000). Hand v. Krakowski, 89 A.D.2d 650, 453 N.Y.S.2d 121 (1982), (pharmacist knew patient to be an alcoholic.) Riff v. Morgan Pharmacy, 353 Pa.Super. 21, 508 A.2d 1247 (1986) (obvious errors on face of prescription); Dooley v. Everett, 805 S.W.2d 380 (Tenn.Ct.App.1990) (incompatible prescriptions).

7. Morgan v. Wal-Mart Stores, 30 S.W.3d 455, 466 (Tex.App.2000).

8. Here the Court cited the following regulations, in order: (1) Tex. Admin. Code § 291.34(c); (2) §§ 291.33(c)(2)(A)(i)(I), 291.36(d)(4)(ii)(II); and (3) §§ 291.33(c)(1)(A); 291.36(c)(2)(B)(vi), (d)(3)(A)(i)(IV).

9. Schaerrer v. Stewart’s Plaza Pharmacy, Inc., 79 P.3d 922 (2003).

10 In this case the duty to warn the patient was based more on the question of whether the pharmacy was acting as a manufacturer when it compounded the prescriptions. The discussion of learned intermediately, however, it essentially the same as the court applied it.

11. Downing v. Hyland Pharmacy, 194 P.3d 944 (2008) 12. Happel v. Wal-Mart Stores, Inc., 199 Ill. 2d 179, 186, 766 N.E.2d 1118, 1123 (2002).

13. Hand v. Krakowski, 89 A.D.2d 650, 453 N.Y.S.2d 121 (1982).

14. Riff v. Morgan Pharmacy, 353 Pa.Super. 21, 508 A.2d 1247 (1986).

15. Dooley v. Everett, 805 S.W.2d 380 (Tenn.

Ct.App.1990).

An additional continuing pharmacy education home-study article titled The Changing Landscape for Vaccine Administration in the US: Managing vaccine storage and delivery at the pharmacy level is available on the AzPA website in the AJP Archives. Member login is required.

Free CPE credit from home study articles published in the Arizona Journal of Pharmacy is a member benefit for AzPA Members.

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FIGURE 1 [Used with permission, Pharmacists Mutual Insurance Co.]

FIGURE 2 [Used with permission, Pharmacists Mutual Insurance Co.]

ACPE UAN#0100-0000-12-019-H03-P Spring 2012 • Arizona Journal of Pharmacy • 39

Continuing Education Quiz

Issues in Pharmacy Malpractice

1. Which of the following combination of elements best describes Pharmacy Malpractice? a. Duty to warn and duty to inquire b. negligence and duty c. The “but for” test and damages d. Duty plus damages 2. The most common type of error to lead to a malpractice suit is wrong directions for the medication. a. True b. False 3. The courts have within the past 25 years discussed a new type of malpractice claims against pharmacists. These are often described as ____________________________ cases. (fill in the blank) a. Libel and slander b. Immunization c. Mechanical d. Duty to Warn 4. Referring to the Pharmacists Mutual Claims Study, which of the following fastest growing type of claims against pharmacies? a. Wrong directions b. Wrong strength of the drug c. Wrong Drug d. Drug Review This activity was developed by the Arizona Pharmacy Alliance for pharmacists as a knowledge-based learning activity. The Arizona Pharmacy Alliance is accredited by the Accreditation Council for pharmacy Education as providers of continuing pharmacy education.

5. The legal importance in the Horner v Spalitto case in Missouri was what? a. It was the first time a case regarding a prescription overdose was decided by a United States court. b. It was the first time a Missoui court had considered a pharmacy misfill case. c. The case overruled and earlier case of Kampe v Stark which held the pharmacist’s only duty was to fill the prescription as ordered by the doctor. d. All of the above 6.In the study of errors by Auburn University, published in the Journal of the APhA in 2003, the percent of errors judged to be clinically significant – capable of serious injury, as what? a. 1.8% b. 5% c. 0.1% d. 2% 7. True or False, a pharmacist completely fulfills their legal duty to their patients when the patients’ prescriptions are correctly filled. a. True a. False 8. According to a study of medication errors by professors from Auburn University College of Pharmacy published in the Journal of the APhA in 2003 a pharmacy filling 250 prescriptions in a day would on average have how many errors that day? a. 4 b. 1 c. 6 d. 8

9. Which of the following best described a pharmacist’s “duty to inquire”? a. To ask the prescriber for clarification when there appears to be a possible error on the face of the prescription. b. To ask the patient what they are taking the medication for. c. To ask a family member/significant other is the patient needs assistance taking medications. d. To ask the patient if he has any complaints about the prescriber.

10. One key legal issue that the pharmacist and pharmacy technician face is that the law is not static, and they need to anticipate possible legal changes in the future. a. True b. False

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Arizona Pharmacy Foundation Issues in Pharmacy Malpractice

ACPE UAN#0100-0000-12-019-H03-P Certificates will be mailed within 60 days.

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. List the most common types of errors that lead to pharmacy malpractice claims and lawsuits 2. Describe the elements of the law of negligence as they apply to pharmacy malpractice lawsuits 3. Differentiate between the roles of the state boards of pharmacy board when a pharmacist’s negligence causes a medication error and the role of the patient’s lawyer in filing a civil lawsuit 4. Describe how the changes in laws and regulations, such as OBRA 90 rules, have impacted pharmacy malpractice claims 5. Identify court decisions that have evidenced evolving pharmacy duties

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