The Kentucky Pharmacist Vol. 7 #6 by Kentucky Pharmacists Association

Y K C U T N E K E H T T S I C A M PHAR Vol. 7, No. 6 November 2012

KPhA is YOUR voice in Frankfort!

November 30-December 1, 2012 Embassy Suites, Lexington, KY

Help us craft YOUR message for 2013

2012 CE Reminder: Kentucky Pharmacy loses innovator Dean Emeritus Joseph V. Swintosky

December 14, 1921—September 13, 2012

We know Your CE is important to you. To help us help you, all CE must be received in the KPhA office no later than noon on December 28 to be counted for 2012! Don’t wait until it’s too late!

News & Information for Members of the Kentucky Pharmacists Association

Table of Contents

November 2012 November Pharmacist/Pharmacy Tech Quiz December CE— Patient Assessment Skills December Pharmacist/Pharmacy Tech Quiz Kentucky Renaissance Pharmacy Museum Pharmacy Law Brief APSC/HD Smith Pharmacy Policy Issues Pharmacists Mutual Senior Care Corner KPhA Board of Directors 50 Years Ago/Frequently Called and Contacted

Table of Contents Table of Contents— Oath— Mission Statement President’s Perspective Dean Joseph Swintosky New KPhA Website New KPhA Members Message from your Executive Director KPhA Mid-Year Conference Continuing Education Article Guidelines Bowl of Hygeia November CE—Restless Leg Syndrome

2 3 4 5 6 7 8-9 10 11 12-25

26 27-33 34 35 36 37 38 40 41 42 43

Oath of a Pharmacist At this time, I vow to devote my professional life to the service of all humankind through the profession of pharmacy. I will consider the welfare of humanity and relief of human suffering my primary concerns. I will apply my knowledge, experience, and skills to the best of my ability to assure optimal drug therapy outcomes for the patients I serve. I will keep abreast of developments and maintain professional competency in my profession of pharmacy. I will embrace and advocate change in the profession of pharmacy that improves patient care. I take these vows voluntarily with the full realization of the responsibility with which I am entrusted by the public.

The Kentucky Pharmacy Education and Research Foundation (KPERF), established in 1980 as a non-profit subsidiary corporation of the Kentucky Pharmacists Association (KPhA), fosters educational activities and research projects in the field of pharmacy including career counseling, student assistance, post-graduate education, continuing and professional development and public health education and assistance.

Kentucky Pharmacists Association The mission of the Kentucky Pharmacists Association is to promote the profession of pharmacy, enhance the practice standards of the profession, and demonstrate the value of pharmacist services within the health care system.

It is the goal of KPERF to ensure that pharmacy in Kentucky and throughout the nation may sustain the continuing need for sufficient and adequately trained pharmacists. KPERF will provide a minimum of 15 continuing pharmacy education hours. In addition, KPERF will provide at least three educational interventions through other mediums — such as webinars — to continuously improve healthcare for all. Programming will be determined by assessing the gaps between actual practice and ideal practice, with activities designed to narrow those gaps using interaction, learning assessment, and evaluation. Additionally, feedback from learners will be used to improve the overall programming designed by KPERF.

Editorial Office: © Copyright 2012 to the Kentucky Pharmacists Association. The Kentucky Pharmacist is the official journal of the Kentucky Pharmacists Association published bimonthly. The Kentucky Pharmacist is distributed to KPhA members, paid through allocations of membership dues. All views expressed in articles are those of the writer, and not necessarily the official position of the Kentucky Pharmacists Association. Editorial, advertising and executive offices at 1228 US 127 South, Frankfort, KY 40601. Phone 502.227.2303 Fax 502.227.2258. Email ssisco@kphanet.org. Website http://www.kphanet.org.

THE KENTUCKY PHARMACIST

President’s Perspective

Kimberly Sasser Croley KPhA President 2012-2013

This month’s Relevance and Relationships journey takes us back to our alma maters and our deans. I thought about the content of this column when I recently learned that my dean, Dean Joseph Swintosky, passed away at the age of 90 after an illness. I admired Dean Swintosky immensely, but I would not have said he was my friend because he was always “bigger than life” and I would have been way too awestruck to have tried to be friends. But I hope he would be happy with the way I turned out as a pharmacist. He took his position very seriously as our mentor and leader. An excerpt from the press release from UK follows: “Dean Emeritus Joseph V. Swintosky, a legendary educator and scientist who helped lead the University of Kentucky College of Pharmacy to national and international prominence during his tenure as dean from 1967 to 1987, has passed away. On Jan. 1, 1967, he became the fourth Dean of the UK College of Pharmacy and, almost immediately, started recruiting bright, committed pharmacy faculty to campus. Later that same year, the College created its master’s and PhD graduate program, a move that cemented UK as a national leader in graduate education and pharmaceutical research. ‘The world of pharmacy has lost a giant,’ said Timothy S. Tracy, Dean of the UK College of Pharmacy. ‘Dean Swintosky placed UK on a trajectory to become one of the nation’s top colleg-

November 2012 es of pharmacy. We would not be the College we are today without his innovative spirit and his commitment to excellence in all we do. This College – and the profession of pharmacy – is forever indebted to Dean Swintosky.’ “ At the time I attended UKCOP I didn’t know all that about the dean, I just knew I was completely in awe and a little bit afraid to talk to such a great man as a lowly student pharmacist! Dean Swintosky was the last of that breed of dean. The authoritarian dean who stayed until retirement, able to completely focus on making his idea of education come to life, molding students in his own image. Deans of today must be part educator, part politician, part fundraiser, part moderator, part facilitator, part dream-maker and part dream-breaker. They rarely get to stay as long as they would like but lucky for us in the state of Kentucky, we have several more amazing deans of our colleges of pharmacy who have followed in Dean Swintosky’s footsteps. Dean Jordan Cohen, came in with his gap-toothed grin and endeared himself in all our hearts. He and his wife, Jana, a pharmacist who worked for Merck, and their boys immediately joined our pharmacy family and quickly made a difference. For several years, UKCOP alumni attending the APhA annual meeting had picked up the tab for a dinner for all the UK student pharmacists in attendance. You must remember that in the old days(!), we did not have nearly as many students able to attend the meeting but I am sure that Melinda (Joyce), Joe (Carr), Jeff (Danheur) and the others involved still spent quite a few dollars on our behalf. When I graduated a couple of years later, I joined the dinner providers as well. (Yes, we were all Phi Delta Chi brothers!) I first met Jordan at the APhA meeting in Chicago and we invited him to eat with us. When he found out we were buying dinner for the students in attendance, he thought that was a wonderful idea and the “Dean’s Dinner” at APhA was born! Jordan stayed for several years. We got a new building. We got more awards. Then Jordan got lured away and we got Dean Ken Roberts. Mississippi’s loss was most certainly our gain! Ken was the “student’s dream dean”.

Continued on Page 5 3

THE KENTUCKY PHARMACIST

Dr. Joseph V. Swintosky

November 2012

Legendary UK College of Pharmacy Dean Joseph V. Swintosky passes away Dean Emeritus Joseph V. Swintosky, a legendary educator and scientist who helped lead the University of Kentucky College of Pharmacy to national and international prominence during his tenure as dean from 1967 to 1987, passed away Sept. 13, 2012. He was 90 years old.

Doctor of Pharmacy (PharmD) program with full implementation in 1970. • UK’s Pharmacy Residency Program was created in 1970, awarding graduates with PharmD degree and a residency certificate. Following the establishment of the UK Medical Center, Dr. Swintosky worked with professors Paul Parker and Charles Walton to change the face of clinical pharmacy. A pharmacist joining medical doctors on their daily rounds was an innovation created at the UK Medical Center. It is now an industry standard.

Dr. Swintosky, who resided in Nicholasville, Ky., was married to Dorothy (Zevnik) Swintosky, who is also a pharmacist. The couple had nine sons and one daughter. Dr. Swintosky, a native of Kewaunee County, Wisc., received his bachelor of science degree and PhD in pharmacy from the University of Wisconsin. An accomplished educator, product formulation scientist and recipient of numerous national honors, Dr. Swintosky is probably best known for his innovative work to transform pharmacy education and the pharmacy profession while at UK.

Dr. Swintosky's impact on pharmacy continues today through the achievements of former faculty and graduates who now are national and international leaders, including at least 10 deans at other colleges.

He also was known for his work to transform pharmacy on a national level. He helped found and organize the AmeriOn Jan. 1, 1967, he became the fourth Dean of the UK Colcan Pharmacists Association (APhA) Academy of Pharmalege of Pharmacy and, almost immediately, started recruitceutical Sciences (now known as the APhA Academy of ing bright, committed pharmacy faculty to campus. Later Pharmaceutical Research and Science) and became its that same year, the College created its master’s and PhD second president in 1967. He received numerous APhA graduate program, a move that cemented UK as a national awards. leader in graduate education and pharmaceutical research. At UK, the Dr. Joseph V. Swintosky Distinguished Lecture “The world of pharmacy has lost a giant,” said Timothy S. Series was established in his honor in 1994. Tracy, Dean of the UK College of Pharmacy. “Dean Swintosky placed UK on a trajectory to become one of the nation’s top colleges of pharmacy. We would not be the College we are today without his innovative spirit and his commitment to excellence in all we do. This College – and the profession of pharmacy – is forever indebted to Dean Swintosky.”

In honor of Dr. Swintosky’s life and legacy, the Swintosky family requests that all memorial donations can be made to the Dr. Joseph V. Swintosky Memorial Scholarship fund at the UK College of Pharmacy.

Under Dr. Swintosky’s leadership, the UK College of Pharmacy became known worldwide as a place where pharmacy innovation came to life. The College was ranked third nationally in the early 1970s and has remained in the top 10 since that time. Major transformations in how pharmacy was taught, practiced and delivered were incubated at UK, including: • UK created the world’s first department of clinical pharmacy in a medical center setting in 1968. • UK became one of the nation’s first schools to create a 4

THE KENTUCKY PHARMACIST

New KPhA Website

November 2012

Coming this month! A new home for KPhA on the web! Check out the new kphanet.org and update your contact information!

University in Louisville. They have been ably led and nurtured under the care and tutelage of their InauguHe was the great motivator, he made everyone want ral Dean, Dr. Hieu Tran. Dean Tran is a quiet, unasto do better, be better. He dreamed big, and he drew suming person who uses example and gentle persuaeveryone into his dream. Under his tutelage, we got a sion to mold the students at his beloved SUCOP. new and bigger and better and amazing building that Dean Tran and SUCOP have been a welcome addiwould not have happened without him. It should be tion to our Kentucky Pharmacy family and his gradunamed for him but that is another story. When Dean ates are the finest examples of his work. Roberts stepped away from day to day deanly reNow you are all saying, how is this relevant? I say to sponsibilities to become Dean Emeritus, we attracted you, the Dean of your alma mater college of pharmaTim Tracy away from the University of West Virginia. cy is the most relevant person from your college of Ginger Scott gave him high praise and deservedly so! pharmacy years, even if you didnâ&#x20AC;&#x2122;t know them by first In no time, Dean Tracyâ&#x20AC;&#x2122;s leadership and administraname. They set the tone for the education you retive abilities have earned him the honor of being ceive, the practice choices you make and the dreams named Interim Provost. Now, I would be remiss if I you dream. Relationships with other student pharmastopped here because our state has the honor of now cists, the faculty and staff, and yes, the dean, help hosting a second College of Pharmacy at Sullivan mold us all into the pharmacists we are now. Continued from Page 3

THE KENTUCKY PHARMACIST

KPhA New Members

November 2012

KPhA Welcomes New and Returning Members August through October 2012 Bobby Bero Frankfort, KY

Don A. Carpenter Olive Hill, KY

Kyle T. Harris London, KY

Lindsey Peden Bowling Green, KY

Joseph A. Bickett Louisville, KY

Adam Coffman Nortonville, KY

Ella Louise Johnson Hazard, KY

Jonathon Ratley Sturgis, KY

Phillip C. Brewer London, KY

Elizabeth Y. Cole Louisville, KY

Heather Johnson Livermore, KY

Joshua Ricketts Harrogate, TN

Sam Brown Murray, KY

Everett L. Dunaway Jackson, KY

Megan A. Kramer Fairfield, CA

Brian K. Wells Owensboro, KY

William Brown Mayfield, KY

Portia Hall Dunaway Jackson, KY

Jill E. Lee Frankfort, KY

William David Wiley Glasgow, KY

Sherri Forrest Brentwood, TN

John W. McMeans Ashland, KY

Pharmacy Time Capsules 1987—Twenty-five years ago: Clinical Sciences Section formed within the American Pharmaceutical (now Pharmacists) Association Academy of Pharmaceutical Research and Science. 1962—Fifty Years Ago: Legislation introduced (unsuccessfully) to allow the FDA to inspect pharmacy prescription files. Paul Parker at the University of Kentucky established first formalized Drug Information Service. Merrell removes Mer-29 (triparanol) from market for adverse eye events. 1937—Seventy-five Years Ago: Over 100 people were poisoned by S. E. Massengill Company’s Elixir of Sulfanilamide . This led to 1938 legislation requiring proof of safety as a condition for marketing. Loronzo L. Skaggs opened the first store of a new chain of self-service drugstores in the Midwest. Original name was “Pay-Less” later changed to Osco Drug. 1912—One hundred Years Ago: International Pharmaceutical Federation (FIP) established as an international federation of national pharmacy organizations. The Journal of the American Medical Association(JAMA) reports the first diagnosis of death by heart attack By: Dennis B. Worthen Lloyd Scholar, Lloyd Library and Museum, Cincinnati, OH One of a series contributed by the American Institute of the History of Pharmacy, a unique non-profit society dedicated to assuring that the contributions of your profession endure as a part of America's history. Membership offers the satisfaction of helping continue this work on behalf of pharmacy, and brings five or more historical publications to your door each year. To learn more, check out: www.aihp.org

THE KENTUCKY PHARMACIST

From Your Executive Director

November 2012

MESSAGE FROM YOUR

EXECUTIVE DIRECTOR Robert “Bob” McFalls MTM—it is no longer a question of IF, but WHEN… Although November is a month built upon reflection and Thanksgiving, it also kindly reminds us of the first year anniversary of the implementation of Medicaid managed care throughout Kentucky. With managed care and so many other issues, challenges and opportunities facing us, life has many pharmacists either articulating or sighing along the words of Dickens, "It was the best of times, it was the worst of times, …it was the epoch of incredulity, it was the season of Light, it was the season of Darkness, it was the spring of hope, it was the winter of despair, we had everything before us, we had nothing before us, we were all going direct to Heaven, we were all going direct the other way – in short, the period was so far like the present period, that some of its noisiest authorities insisted on its being received, for good or for evil, in the superlative degree of comparison only."

when the Association took steps to create Rx Therapy Management to work with pharmacists to develop and grow a network of provider expertise to perform this essential service for Kentucky state retirees. In this span of time, more than 300 pharmacists have been enrolled into the network and more than 15,831 patients have been served. At the federal level, The Affordable Care Act more recently reaffirmed MTM’s value and authorized funding for “medication management services” in multiple settings.

In recognition of our leadership in this practice area, KPhA was invited in September to participate in a Joint APhA Board of Trustees and NASPA meeting with state pharmacy association executives from nine states. Paramount to our strategic discussion was how pharmacists and the associations that represent them can work together both to advance MTM efforts and to achieve provider status in orIt would be an understatement to say that there have been der to be financially recognized as providers. Advancing many changes in the months past, and yet we are quick to the value of MTM is critical given the fact that medication acknowledge there will be even more. Managed care is use and medication related problems are major problems being reported to be saving dollars in terms of public exthroughout the current health care system. As cited by penditures but comes with the concurrent reality of reducAPhA, “medication-related problems and medication mistions in reimbursements and dispensing fees for pharmamanagement are a massive public health problem in the cies. On the brighter side of the equation, however, the U.S. Experts estimate that 1.5 million preventable adverse pharmacist’s role in Medication Therapy Management events occur each year that result in $177 billion in injury & (MTM) programs continues to garner attention and offers a death.” This information is compounded given the dramatic viable business alternative with respect to providing a valu- increases in life expectancy during the past century as a able service to patients. Initially authorized by the Medicare result of the major shift in the leading causes of death and Modernization Act, CMS established the initial requiredisability in all age groups, including disease states for oldments for MTM programs, and MTM has evolved since er persons. Causes of death have shifted from infectious 2006 through Part D, Medicaid in some states and a few diseases and acute illnesses to chronic and degenerative private health plans. In accordance with CMS requirediseases (CDC, 2003). Even with these advances, life exments, all targeted Part D beneficiaries who are eligible are pectancy at age 65 in our nation continues to lag behind automatically enrolled in MTM, and all programs offer a that of many other industrialized nations signaling that even comprehensive medication review (CMR) at least annually. more can be done in terms of health interventions. MTM programs offer telephonic consultations, and a growEnter the role of the pharmacist. In my humble opinion, it is ing number (+25 percent) now offer face-to-face CMRs. not a matter of "if", but "when" for the majority of pharmaNationally, 80 percent of the plans target beneficiaries with cists as a profession to heartily become engaged in adthree or more chronic diseases, and 60 percent of the MTM programs require patients to be taking eight or more drugs. YOUR KPhA recognized the importance of MTM in 2010

Continued on Page 10

THE KENTUCKY PHARMACIST

2012 Mid-Year Conference

November 2012

2012 KPhA MID-YEAR CONFERENCE ON LEGISLATIVE PRIORITIES & EMERGENCY PREPAREDNESS Make your voice heard as we determine our Legislative Priorities for the 2013 Kentucky Legislative Session. November 30-December 1, 2012 Embassy Suites, Lexington Call 1-859-455-5000 or 1-800-EMBASSY to make your reservation today! KPhA rate is $109.95 before Nov. 13, 2012.

Visit www.kphanet.org to register! Highlights: 

House of Delegates to meet to discuss and approve legislative priorities.



CE programs on KASPER, Grassroots Legislative Advocacy, Emergency Preparedness and Immunization Training.



Updates on how YOU can be involved in KPhA’s Emergency Preparedness Initiatives. The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education.

KPhA is YOUR voice in Frankfort! Help us craft the message for 2013! 8

THE KENTUCKY PHARMACIST

2012 Mid-Year Conference

November 2012

Conference Agenda Friday, November 30, 2012 8:00 a.m.

CPR Recertification (preregistration required; $50 additional fee.)

10:00 a.m.

Registration

11:00 a.m.

KASPER Continuing Education (1.5 hr.)

12:30 p.m.

Lunch is served

12:45 p.m.

Welcome and Introductions (Robert McFalls/Kim Croley) Presentation of Meritorious Service Award to Sen. Julie Denton

1:00 p.m.

How the Legislature Works (Sen. Julie Denton)

1:30 p.m.

Break

1:45 p.m.

Board of Pharmacy (Joel Thornbury)

2:15 p.m.

Grassroots Legislative Advocacy CE (Jan Gould) (1 hr.)

3:15 p.m.

Lessons Learned from the Kentucky Optometrist Association (Darlene Eakin)

3:45 p.m.

Break

4:00 p.m.

Issues Briefing and House of Delegates meets to discuss and approve legislative priorities

6:00 p.m.

Dinner and networking (on your own)

6:30 p.m.

KPhA Board Meeting with working dinner

Saturday, December 1, 2012 8:00 a.m.

Breakfast Advancing Pharmacy Practice in Kentucky Coalition Update

8:30 a.m.- 10:00 a.m.

Emergency Preparedness CE (1.5 hr.)

10:00 a.m.-11:00 a.m.

Disaster Response demonstrations

11:15 a.m. -12:15 p.m. HB1 Panel Discussion 12:30 - 1:30 p.m.

Lunch and KPhA Emergency Preparedness Introduction Program

2:00 p.m. -6 p.m.

Immunization Training CE (4 hr.) ($50 materials fee)

Are you Connected to KPhA? Join us online! @KyPharmAssoc @KPhAGrassroots

Facebook.com/KyPharmAssoc

Kentucky Pharmacists Association

THE KENTUCKY PHARMACIST

From Your Executive Director

November 2012

Continued from Page 7 vancing their work with Medication Therapy Management. The rapid growth in the older population, a health care delivery system that is focused on quality outcomes and customer interactions, CMS requirements to reduce hospital readmissions, the inclusion of MTM for long term care residents under Part D in 2013, the decreasing numbers of primary care providers, fewer providers taking coursework or option for certification in geriatrics along with increasing medication adherence challenges and deficiencies for our patients are converging with force to create the perfect environment that shouts for the pharmacist's expertise and response. Our health care system has readily reimbursed acute care services since Medicare and Medicaid were authorized in 1965. Since then, however, chronic health care needs have grown. We recognize that chronic diseases are long-term illnesses that are rarely cured. Chronic diseases such as heart disease, diabetes, arthritis, stroke and cancer are among the most common and chronic diseases lead to six of the seven leading causes of death for elders. Many of these chronic conditions can be prevented, modified and/or managed with medication therapies and/or behavioral interventions, leading to an improved quality of life and the potential to maintain functional abilities in terms of personal independence. Not surprisingly, chronic disease management is associated with high prescription drug costs. In 2008, older persons who didn't have chronic health conditions incurred average prescription drug costs of $1,230 while those who had five or more chronic diseases incurred on average $5,300 in prescription drug costs. Other health care costs also varied by health status. Individuals with no chronic conditions incurred $5,520 in health care costs on average. Those with five or more conditions incurred $24,658. According to the National Health Interview Survey, the number of older persons age 65+ with the most common combinations of chronic conditions — hypertension and diabetes, hypertension and heart disease, and hypertension and cancer — increased dramatically from nine to 15 percent; the prevalence of hypertension and heart disease increased from 18 to 21 percent; and the prevalence of hypertension and cancer increased from eight to 11 percent. For the most recent 10-year period that was studied (1999-2000 and 2009-2010), the use of hypertension medications increased and death rates for heart disease, cancer and stroke declined. The report concludes by noting that, "the rising prevalence of MCC (multiple chronic conditions) has implications for the financing and delivery of health care. Persons with MCC are more likely to be hospitalized, fill more prescriptions and have higher annual prescription

drug costs, and have more physician visits. Out-of-pocket spending is higher for persons with multiple chronic conditions and has increased in recent years.... The increasing prevalence of MCC presents a complex challenge to the U.S. health care system, both in terms of quality of life and expenditures for an aging population." As we have long held, pharmacists are the medication experts on the health care team. It is time that we advance the conversation and get others to recognize what the evidence supports. Pharmacists undergo years of training and experience in managing medication therapies, and you are the best qualified health care providers to help patients manage and effectively use medications. I have experienced this on a personal level as a family caregiver with my home town pharmacy, Coleman's Drug Store in Stanford, where time and time again the expertise of our community pharmacist has engaged with my family to reconcile discharge orders, engage and collaborate with prescribers, enhance communication and education, dispense needed prescriptions—all the while assuring better health care outcomes and medication adherence. Pharmacists support guiding principles from the Institute of Medicine that healthcare should be safe, effective, patient centered, timely and efficient in meeting the needs of patients. Similarly, this Institute encourages patients to actively participate in the health care process to prevent medication related problems. Clearly, the health care delivery system is recognizing through its quality initiatives that the Boomer generation clearly intends to be involved in their own health care discussions and deliberations. This paradigm shift has significant implications for health care providers at all levels but offers a critical opportunity in particular for pharmacists as a trusted community resource. In considering my message for this edition, it was not my intent to write an essay or scientific article, but I am convinced through KPhA’s engagement with Rx Therapy Management — and with many of you as pharmacist providers — that MTM is a critical space that rightfully belongs to pharmacists and to pharmacy. My request is that you recommit to exploring these opportunities that are for pharmacists to take. If pharmacists do not claim this role, then other health care professionals will. There are already rumblings to this effect. To this end, we were pleased to see the recent release of a new report that highlights the effectiveness and success of MTM by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services. Our colleague and good friend, Jimmy Mitchell, RPh, President, Alliance for Integrated Medication Management (AIMM), recently highlighted how this report is demonstrating how interprofessional

THE KENTUCKY PHARMACIST

From Your Executive Director

November 2012

health care teams are helping people with multiple chronic conditions to be healthier and safer by effectively managing their prescriptions. Teams are using an integrated approach to care that includes a pharmacist to help patients manage their medication. The report, Advancing Clinical Pharmacy Services in Programs Funded by the Health Resources and Services Administration and its Safety-Net Partners, is based on a study conducted by Mathematica, one of the nation's leading research organizations. The report notes the struggle that many patients have in taking the correct medications in the correct dosages at the correct times, and notes that they are at constant risk of a serious health crisis that could land them in the hospital for expensive care. Add to that the fact that 1.5 million people are injured each year because of medication errors and our rapidly aging population, and we have a serious problem on our hands. As noted by AIMM, "the HRSA report not only demonstrates how these health care teams are improving the care and lives of their patients by ensuring that those patients understand how, when and why to take their medications, and are closely monitored. This report is further proof that the Patient Safety and Clinical Pharmacy Collaborative (PSPC) approach is sound medicine. It also confirms that the approach should be expanded to offer care to all people who suffer from multiple chronic conditions." The report includes a number of important recommendations, including:  



Encourage linkages between safety net providers and schools of pharmacy. Provide more training sites for pharmacy students in underserved areas through the HRSA-funded Area Health Education Centers. Create national networking opportunities between colleges and schools that have partnered with safety-net organizations and those that have not. Increase the number of tele-pharmacy networks that State Boards of Pharmacy approve, so that patients in remote locations have access to traditional and clinical pharmacy services. Have foundations partner with the federal government to sponsor studies into cost-savings generated by PSPC teams. Have foundations provide financial assistance to safety -net providers that want to incorporate clinical pharmacy services. Have state Medicaid agencies amend their plans to pay for clinical pharmacy services, and Medicaid managed care plans pay for these services. Increase the number of members of the National Association of Chain Drug Stores that enter contractual rela-

tionships with safety-net providers to provide pharmacy services.  Encourage safety-net provider organizations, like the National Association of Community Health Centers and the National Association of Public Hospitals to educate their members about the value of pharmacy services. In summary, MTM holds much promise for addressing critical therapy needs as well as support for addressing provider status and reimbursement strategies. To this end, I was encouraged by a related publication by the AARP Public Policy Institute earlier this year which supports our desire and efforts to have MTM recognized as a Part B covered service. The report notes in its conclusion that “Medicare’s A/B/D framework treats inpatient care, physician and outpatient services, and prescription drugs in their respective silos, but this is an artificial division for beneficiaries who require care to be coordinated across programs. Providing MTM through Part B could help to minimize such silos, complement ACO models, build valuable clinical care coordination across providers and potentially reduce economic disincentives…for robust MTM programs.” Like most of the nation, Kentucky’s older population is on a rapid acceleration trajectory. Between now and the year 2050, the number of individuals age 65 and older will increase by an incredible 87 percent, growing from 578,227 to 1,080,215 elders. The evidence is clear with respect to expanding need and available expertise. And, as we reflect on our current patients and their growing numbers in the foreseeable future, let us recall Dickens once more, who said, “No one is useless in this world who lightens the burdens of another.” When indeed. References i. ii.

Charles Dickens, A Tale of Two Cities, Book 1, Chapter 1. American Pharmacists Association, Washington, D.C., http:// www.pharmacist.com/. iii. Older Americans 2012: Key Indicators of Well-Being, Federal Interagency Forum on Aging-Related Statistics, Washington, DC. iv. National Health Interview Survey, 2011, CDC/National Center for Health Statistics, http://www.cdc.gov/nchs/nhis.htm. v. Special Report to the Senate Appropriations Committee, Advancing Clinical Pharmacy Services in Programs Funded by the Health Resources and Services Administration and its Safety-Net Partners, Requested by Senate Report 110-107, U.S. Department of Health and Human Services, Health Resources and Services Administration, October 2012. vi. Ibid. vii. Medicare Part D’s Medication Therapy Management: Shifting from Neutral to Drive, N. Lee Rucker, AARP Public Policy Institute, Insight on the Issues 64, June 2012. viii. Kentucky State Data Center, University of Louisville at http:// ksdc.louisville.edu/index.php/kentucky-demographic-data/ projections.

THE KENTUCKY PHARMACIST

Nov 2012 CE—Restless Leg Syndrome

November 2012

Rotigotine (Neupro®) in the Treatment KPERF offers all of Restless Leg Syndrome CE articles to

By: Kathleen Balling, Pharm.D. Candidate 2013, College of Pharmacy, University of Kentucky members online at Samantha Gubser, Pharm.D. Candidate 2013, College of Pharmacy, University of Kentucky, and www.kphanet.org Melody Ryan, Pharm.D., MPH, Associate Professor, Department of Pharmacy Practice and Science, College of Pharmacy and Associate Professor, Department of Neurology, College of Medicine There are no financial relationships that could be perceived as real or apparent conflicts of interest. Universal Activity # 0143-0000-12-011-H01-P&T 2 Contact Hours (0.2 CEUs) Objectives: At the conclusion of this lesson, the reader should be able to: 1) Provide an overview of Restless Legs Syndrome (RLS) and current treatment options available. 2) Describe the mechanism of action, side effects, and formulation of rotigotine. 3) Discuss rotigotine's place in therapy for RLS treatment and important patient counseling information. Introduction Approximately 4 to 12 percent of the population experiences debilitating symptoms related to restless legs syndrome (RLS).1-4 RLS is associated with symptoms that negatively impact various aspects of a person’s life and often is not diagnosed or treated adequately. Because the diagnosis and assessment of disease severity rely mainly on subjective information, many patients go undiagnosed and fail to receive proper treatment. As a result of this, it is crucial that healthcare professionals are able to differentiate RLS from other conditions and are aware of the most effective treatment options available. Rotigotine (Neupro®) is a dopamine agonist formulated as a once-daily transdermal patch. In addition to being previously indicated for the treatment of idiopathic Parkinson’s disease, the FDA recently approved rotigotine for the treatment of moderate-to-severe primary RLS. The only other medications FDA approved for the treatment of RLS are pramipexole, ropinirole and gabapentin enacarbil. Rotigotine has been shown to be effective in improving RLS symptoms and its availability as a transdermal patch differentiates it from other available treatment options (pramipexole, ropinirole, levodopa/carbidopa, anticonvulsants, opioids and benzodiazepines). Rotigotine, therefore, can be utilized as an efficacious alternative to oral medications in the same class. Restless Legs Syndrome Background

by Ekbom, who found that the disease had a significant impact on sleep quality and daytime functional status.5,6 Since then, the understanding of RLS has improved immensely. Prevalence The prevalence of RLS in North America and Europe has been found to be between 4 and 12 percent.1-4 Symptoms of the disease can present at any age, but the risk increases directly as the person gets older.7 In addition, a higher prevalence of the disease in women in comparison to men has been observed. In the United States, for example, women account for nearly two-thirds of RLS patients.8 When assessing data from all population groups and age ranges, it was found that the prevalence rate of RLS in females is about twice than that observed in males.9 Similarly, when comparing different geographic areas, it was found that the southern region of the United States has a higher prevalence of RLS compared to other regions in the nation.10 The prevalence of RLS found in studies may not be an accurate representation of the amount of people that actually suffer from RLS symptoms. The diagnosis relies on subjective information; thus, the reported severity of symptoms differs from patient to patient based upon varying levels of patient tolerability. Some patients may be able to tolerate more severe symptoms before sleep disturbances occur, while other patients have sleep disturbances with minor symptoms.

Diagnosis RLS, also known as Willis-Ekbom disease, was first deth scribed by Willis in the 17 century and further investigated Although RLS is a very common disorder, it is generally 12

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Table 1: Diagnosis Guidelines as Established by the International RLS Study12

Scales Used for RLS Symptom Assessment Several rating scales to clinically assess RLS severity have been created. Clinicians utilize these scales to evaluate treatment efficacy and make changes to the regimen accordingly. In addition, clinical trials also use these scales as a means of evaluating the efficacy of different treatment options by comparing scores during treatment to the scores obtained at baseline. The most common scales used include the International Restless Legs Syndrome Study Group Rating Scale (IRLS), the RLS-6 Scale and the Clinical Global Impressions Scale (CGI).

An urge to move the legs, often accompanied by an unpleasant sensation in the legs or other body parts. Symptoms aggravated by rest. Symptoms alleviated by movement. Symptoms must be worse in the evening or night, with an urge to move the legs, usually accompanied by an unpleasant sensation in the legs. under-diagnosed.3 Many physicians ignore RLS symptoms or incorrectly treat RLS.11 Due to the lack of definitive laboratory or clinical tests, accurately diagnosing RLS is difficult. Physicians often attribute the symptoms of RLS to other medical conditions that occur more frequently; for example, symptoms of back pain, arthritis, varicose veins, depression or anxiety.2 Because of this, specific criteria for RLS diagnosis were established by the International RLS Study Group in 2003.12 A list of the criteria can be found in Table 1.

IRLS was created by The International Restless Legs Syndrome Study Group and includes a 10-item scale with questions that relate to the severity of sensory and motor symptoms, sleep disturbance, daytime fatigue and impact of RLS on activities of daily living. Responses to each question are graded on a scale from 0 (absence of symptoms) to 4 (very severe symptoms).21

The symptom of akathisia is usually accompanied by an uncomfortable sensation located deep within the leg.12,16 Patients may describe the feeling as a muscle ache or tension, “creepy-crawly” sensation, tingling or like soda in the veins.12,17 Symptoms are brought on by sitting or lying down and often resolve with movement. These symptoms often worsen at night with the relaxation that comes prior to and during sleep. Legs are affected first and most severely, but other body parts can become involved over time. Approximately 80 percent of RLS patients experience periodic limb movements of sleep (PLMS), which are semi-rhythmic limb movements that occur during sleep.18,19 These limb movements can disrupt the sleep of not only the patient, but also his/her bed partner.

progression, and therefore is most often used in therapeutic trials and to assess the efficacy of therapeutic interventions. CGI consists of three different global items that are rated on varying scales. The items, listed from items 1 to 3, are Severity of Illness, Global Improvement and Efficacy Index, respectively. The severity of the illness is measured on a 7-point scale from 1 (normal) to 7 (most severely ill).23 The scale measuring global improvement also is a 7point scale ranging from 1 (very much improved) to 7 (very much worse). The efficacy is measured on a 4-point scale from a value of 0 (marked improvement and absence of side-effects) to 4 (unchanged or worse and side-effects that outweigh the therapeutic effects).23

Based upon their symptom presentation, patients can be divided into three groups for treatment: intermittent symptoms, daily symptoms and symptoms that are refractory to standard treatments.20

Although the exact mechanism through which RLS develops is still debated, three mechanisms have been found to be contributory factors. Genetic factors have been found to be a significant component, as well as alterations in iron

The RLS-6 severity scale uses six 10-point scales ranging from 0 (not present) to 10 (very severe) to evaluate the severity of symptoms during the day and night hours.22 A unique component of this scale is the evaluation of sympRLS presents with a varying array of both motor and sentoms occurring when the patients are resting during the sory symptoms, which generally occur while relaxed or sleeping.13 A specific feature of RLS is motor restlessness day. In addition, patients should also disclose the severity in which patients have akathisia (irresistible need or urge to of tiredness during the day and level of sleep satisfaction. The scales are not combined, however, to calculate a total move their limbs), and this sensation is partially or com2,14 pletely resolved by movement. Because of these symp- score. Instead, the values are assessed independently and used to observe changes that occur with time.22 toms, many patients have difficulty sleeping and often exhibit daytime sleepiness.7 RLS is one of the leading causes The CGI scale is a measure used to obtain global assessof sleep disturbances and approximately nine out of 10 ments of illness.23 This scale follows the patient over a peRLS patients report at least one sleep-related problem.13,15 riod of time to assess changes in symptoms and disease

Etiology

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November 2012 Table 2: Medications Associated with RLS Symptom Exacerbation20,35-39

homeostasis and dopaminergic function. 24 In addition, RLS is further classified as either primary or secondary based upon symptom characteristics, the cause and symptom development.

Tricyclic Antidepressants Selective Serotonin Reuptake Inhibitors Lithium Dopamine Antagonists Antihistamines Caffeine

Primary RLS Primary RLS, often referred to as idiopathic or familial, is the most common type of RLS and is usually a lifelong condition once symptoms occur.12,25,26 Primary RLS has been found to have a hereditary component with an autosomal dominant mode of inheritance.6,27 Allen, et al. reported that approximately 50 percent of first-degree relatives of patients with RLS will eventually develop the disease.12 Hereditary RLS has been shown to have an earlier age of symptom onset. In comparison to patients who developed symptoms after the age of 45, patients whose symptoms occurred at a younger age tended to have a significantly higher number of affected relatives.28

bation of RLS symptoms. A list of these medications can be found in Table 2.20,35-39 Non-pharmacologic Treatment Options

Several non-pharmacological treatments are often used to help decrease a patient’s symptoms. If the patient experiences symptoms during the day, activities which make the mind more alert such as video games, intricate needlework, painting or reading may help to decrease symptoms, especially during forced immobilization such as an airplane The exact cause of primary RLS is still not well understood, flight.40 Sleep hygiene has also been shown to help with but many theories have been proposed. Researchers benighttime symptoms. Patients should go to bed and wake lieve that the cause of RLS is probably related to the body’s up at the same time each day. Sleep environments should dopaminergic mechanisms and iron homeostasis. Dopabe kept quiet and comfortable, and the bed should be used minergic mechanisms are thought to be involved because only for sleep and sexual activity.20,41-43 Avoidance of cafsymptomatic relief has been observed in RLS patients usfeine, nicotine and alcohol which exacerbate RLS symping dopamine agonists. Conversely, patients using dopatoms also should be utilized.20 Massage, stretching and mine antagonists experience a worsening of sympmoderate exercise also have been shown to possibly detoms.15,29,30 Likewise, dopamine also seems to be implicatcrease patients’ symptoms.43 ed in the disease as a result of dopamine’s role in circadian Pharmacologic Treatment Options rhythms and the corresponding worsening of RLS symp31 toms during the night hours. Serum iron levels have circa- Various medications are utilized for the treatment of RLS. dian rhythms similar to dopamine; therefore, iron is also Of these medications, those classified as dopaminergic thought to be implicated in the etiology of RLS.32 In fact, agents are considered to be first-line for RLS treatment.42,44 almost 75 percent of patients with RLS symptoms have The medication should be chosen on an individualized babeen found to have decreased iron stores.33 The two mech- sis due to differing levels of efficacy and tolerability anisms may be related through tyrosine hydroxylase, the amongst patients. A summary of the medications used for rate limiting enzyme for dopamine production, which uses treating the symptoms associated with RLS can be found in iron as a cofactor.32 Table 3.20,45-48 Secondary RLS

Iron-Replacement Therapy

Secondary RLS usually develops from an underlying condition that leads to a deficiency in iron. Any condition that involves altered iron homeostasis or low iron storage such as pregnancy, end-stage renal disease, iron deficiency, rheumatic disease or drug intake can cause symptoms of RLS to present.27 These symptoms of secondary RLS, caused by iron deficiency, can sometimes be improved or resolved with the administration of oral or intravenous iron therapy.34

Iron-replacement therapy has been used to treat patients with secondary RLS. Iron-replacement treatments are only efficacious in patients determined to have a lack of adequate iron and should not be used as treatment in patients with primary RLS. Patients should receive iron supplementation if serum ferritin concentrations are below 50mcg/ L.20,49 Despite possibly improving RLS symptoms, oral iron therapy often is not used as a result of its low efficacy and poor tolerability/absorption at doses required to treat RLS.50 -52 Intravenous iron, on the contrary, does not have these limitations.

Medications that Exacerbate RLS

Various medications have been associated with the exacer- Intravenous iron sucrose is well tolerated and has demon14

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November 2012 Table 3: Pharmacologic Treatment Options20,45-48

strated the ability to decrease the symptoms of RLS in patients with varying severities of iron deficient RLS. 53 In later studies, Ondo, et al. determined iron dextran to be superior to other intravenous iron preparations for RLS.54 Supplemental oral iron treatments can be used to sustain the improvements that were achieved previously with the single intravenous treatment.45 Maintenance intravenous iron supplementation is considered likely efficacious for secondary RLS due to end-stage renal disease and remains simply investigational for RLS patients with normal renal function.45

Iron Replacement Iron Dextran Iron Sucrose Levodopa/Carbidopa Dopamine Agonists Ropinirole Pramipexole Rotigotine Anti-convulsants Gabapentin Enacarbil Carbamazepine Lamotrigine Valproate Levetiracetam Pregabalin Opioids Oxycodone Methadone Tramadol Benzodiazepines Clonazepam

Dopaminergic Agents Dopaminergic agents are the cornerstone of therapy and are commonly used to treat moderate-to-severe forms of RLS.42,44,55,56 These agents can provide 90-100 percent relief of symptoms and 70-100 percent reduction in PLMS. However, these medicines can cause insomnia, nasal congestion, swelling of the hands or feet, bloating, chest pain, nausea and vomiting.42,57,58 Withdrawal symptoms can occur upon discontinuation of any dopaminergic agent when treating RLS and are directly related to the dose and duration of use of the drug. This intensification of RLS symptoms is most severe in the first 48 hours and symptoms often return to baseline after four to seven days.

irole, have longer half-lives than levodopa and generally work throughout the sleep period. DA also are associated with much lower levels of augmentation development in comparison to levodopa. Generally, these agents are often given 2-4 hours prior to bedtime.71 In the case that the paLevodopa is the most studied dopaminergic agent and is always combined with a dopa-decarboxylase inhibitor (e.g., tient presents with daytime symptoms, the usual dose can be divided up to provide longer intervals of symptom recarbidopa). Levodopa has been shown to increase sleep lief.72 In one study, prolonged therapy with these agents for time, quality of sleep and quality of life for patients with greater than six months showed maintained efficacy. Slight RLS.59,60 Levodopa can cause adverse effects such as augmentation, however, requiring an earlier onset of treatnausea, headaches and dry mouth, but the possibility of ment occurred in 48.2 percent of patients, and severe augrebound and augmentation are the greatest hindrances to 60-62 mentation was seen in 21.7 percent of patients. The risk of its use. Rebound refers to the return of symptoms as the medication wears off and can occur in 20-35 percent of augmentation development varies depending upon the DA medication utilized. The rates of augmentation observed patients.20,62 These symptoms can return in the middle of with the long-term use of DA include: pramipexole (8 perthe night, causing sleep disturbances for the patient and cent to 32 percent)73-75 and ropinirole (2.3 percent)76. Adhis/her partner. The utilization of combined sustained release and regular release formulations can combat this.59,63 verse effects such as daytime sleepiness, nausea, peripheral edema, dizziness or light headedness, gastrointestinal Similarly, augmentation, which involves the worsening of and rash were RLS symptoms at an earlier time of day, earlier onset while upset, constipation, headache, itchiness 48 reported by 56.7 percent of subjects. at rest, more severe symptoms or shorter relief after the Anti-convulsants administration of medication, is the most commonly encountered complication of long-term levodopa therapy and Gabapentin is the most used second-line drug among the occurs in about 80 pecent of patients.42,64-66 While more anticonvulsant medications for RLS. The disease benefits prominent with levodopa, it can be seen to a lesser extent from a combination of sedative and sensory modulating with long term use of any dopaminergic agent and affects activity that gabapentin provides.45,77,78 Gabapentin enacarabout 20-30 percent of patients taking dopamine agobil, a gabapentin prodrug with better absorption and a betnists.45,67-70 Augmentation can be treated by changing to a ter pharmacokinetic profile, is FDA-indicated for the treatdifferent medication or giving the dose of medication earlier ment of RLS.79 Other agents such as carbamazepine, in the day.20 lamotrigine, valproate, levetiracetam and pregabalin have Dopamine agonists (DA), such as pramipexole and ropin-

been used in the treatment of RLS, but their efficacy has 15

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not been confirmed. The studies that did demonstrate efficacy consisted of few subjects or were open-label.80-87

Table 4: Patch Size and Rotigotine Content Patch Size

Opioids The use of opiates such as oxycodone, methadone, propoxyphene and tramadol is limited by adverse effects and possibility of dependence, but these agents are the best choice for patients with resistant or unremitting symptoms.45,88-92 Open-label studies have shown an improvement in subjective ratings of the patient’s symptoms and reduced occurrence of PLMS with opioid therapy.42,44

5 cm2 10 cm2

4.5 mg

2 mg/24 h

15 cm

6.75 mg

3 mg/24 h

20 cm

9 mg

4 mg/24 h

13.5 mg

6 mg/24 h

18 mg

8 mg/24 h

40 cm

Benzodiazepines carry a low risk of adverse effects while improving sleep and reducing arousals due to PLMS.46 Clonazepam was shown to be efficacious in improving sleep quality and decreasing time awake and number of awakenings.93-95 Early morning sedation could prove to be an issue for some patients because of clonazepam’s long half-life. Benzodiazepines also present a threat in the elderly population as a result of increased sedation escalating a patient’s risk of falling.

Strength of Patch 1 mg/24 h

30 cm2

Benzodiazepines

Actual Rotigotine Content 2.25 mg

The transdermal system is currently available in 1 mg, 2 mg, 3 mg, 4 mg, 6 mg and 8 mg strengths delivered over 24 hours.47 The size of the patch becomes larger as the dose administered increases. A summary of patch sizes and amount of rotigotine contained within each patch can be found in Table 4.47 Crystallization

An obstacle faced when utilizing a matrix type transdermal patch is the crystallization of the medication. 102,103 If the Rotigotine (Neupro®) as a New Treatment Option amount of the drug placed in the matrix is greater than the Mechanism of Action saturation solubility of the drug in the adhesive, a supersat104-106 A medication in this Rotigotine is classified as non-ergot dopamine agonist that urated, unstable matrix results. type of supersaturated matrix will eventually recrystallize exerts agonistic activity on the D1 through D5 dopamine 96 and cause changes in drug delivery. Crystallization results receptors with the highest activity at the D3 receptor. In in the patch becoming unstable and possessing less adheaddition, rotigotine acts as a serotonergic agonist on 5siveness, the reduction in the amount of drug contained in HT1A receptors and as an α-adrenergic antagonist on α2B 96,97 the patch and a decrease in the original drug delivery receptors. demonstrated by a specific formulation of the patch.107,108 A Labeled Indications number of additives are available to inhibit crystallization 108 Rotigotine is indicated for (1) the treatment of the signs and from occurring by stabilizing the system. symptoms of idiopathic Parkinson’s disease and (2) the In 2008, rotigotine was withdrawn from the market as a retreatment of moderate-to-severe primary restless legs synsult of crystal formation in the patches.109 Recently, the 47 drome. FDA approved a new formulation of the patch that became available in the United States in July. In addition to rotigoFormulation tine, the patch also consists of inactive ingredients which Transdermal Patch include ascorbyl palmitate, povidone, sodium metabisulfite, Rotigotine possesses a very low oral bioavailability due to dl-alpha-tocopherol and a silicone adhesive.47 Povidone 98 undergoing extensive first-pass metabolism. Because of inhibits crystallization as well as enhancing the solubility of this, rotigotine was formulated as a silicone-based transthe medication.110 The remaining inactive ingredients, with dermal patch.97 The patch is formulated as a matrix-type the exclusion of the silicone adhesive, are antioxidants transdermal system that contains a backing film, a matrix used to prevent a possible decline in medication penetra99 containing the drug, and a protective layer. This formulation as a result of oxidation. tion allows for once daily dosing and continuous stimulation Pharmacokinetics of dopamine receptors.100 The medication delivered transdermally through the utilization of a patch results in a In a study conducted to assess the pharmacokinetics of steady release of the drug and stable concentrations in the rotigotine, Cawello, et al. found the absolute bioavailability plasma for a duration of 24 hours.101 of transdermal rotigotine to be 37 percent with an apparent 16

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Nov 2012 CE—Restless Leg Syndrome dose equal to 61.4 percent of the total drug contained in the patch; thus, greater than 60 percent of the dose absorbed is bioavailable.111 Rotigotine is extensively metabolized by the liver through conjugation and N-dealkylation into metabolites that do not exhibit any pharmacologic activity.111 Despite being metabolized by the liver, rotigotine has not been found to have significant interactions with other medications.112 The kidney is the primary route of elimination and is responsible for removing 70 percent of the drug and its metabolites.111 Although a significant portion of the medication is eliminated renally, the dose does not require adjustment in those with renal impairment.113 In addition, the observed half-life was 5.3 hours after removing the patch.111 Clinical Studies A number of clinical studies have been conducted to assess the effectiveness and safety of rotigotine in the treatment of RLS. These studies vary in the methods implemented, but all resulted in an improvement of symptoms after initiation of rotigotine treatment. A Six-week Randomized, Double-blind, Placebo-controlled Dose-finding Trial in Europe

November 2012 ments were seen with the 4 mg/24 h dose and the 0.5 mg/24 h was not efficacious, it was concluded that the maintenance dose range for rotigotine should be between 1 mg/24 h to 3 mg/24 h.114 A Two-year Multicenter, Multinational, Single-arm, Open-label Extension Trial An open-label extension was offered to subjects that participated in the 6-week dose-finding trial. A total of 295 patients enrolled in the open-label trial with 220 patients completing the first year of treatment and 191 completing the second year.115 During the first year, the dose of rotigotine was titrated from 0.5 mg/24 h to a maximum of 4 mg/24 h based upon the subject’s clinical manifestations. As in the previous study, tools used to analyze efficacy included the IRLS, the RLS-6 scales and the CGI. Various physiological parameters (vital signs, an elecotrocardiogram and body weight) and patient reports of adverse effects were used to determine the medication’s safety and tolerability.115 Results from the first year of the open-label extension demonstrated continuous benefits that were clinically significant with the use of rotigotine.114,116

After two years of rotigotine treatment, the average reduction in the IRLS score from baseline for all of the particiOertel, et al. conducted a study to evaluate the efficacy and pants in the trial was 15.4±10.115 Likewise, similar improvesafety of five rotigotine doses during a six-week period and ments also were seen in the changes in CGI-1 and RLS-6 also used a placebo group for comparison.114 The study scores. The efficacy was rated as “good” to “very good” by consisted of 341 patients and the doses used were 0.5 89 percent of the participants that completed two years of mg/24 h, 1 mg/24 h, 2 mg/24 h, 3 mg/24 h and 4 mg/24 h. treatment.115 Although the six-week trial determined that Patient outcomes were assessed to determine the lowest the 4 mg/24 h dose did not provide additional benefits,114 it dose in which the medication was effective in improving was found to be the most frequently applied dose at the symptoms. The efficacy was measured through the utilizaend of the second year of treatment. It can be concluded, tion of baseline scores from IRLS, RLS-6 and CGI scales. therefore, that the dose should be individualized based upSymptom improvement with administration of rotigotine on the patient’s symptom presentation and tolerability. 115 was found to be statistically significant in comparison to During the two-year interval, 87 percent of the participants placebo for all of the doses except 0.5 mg/24 h.114 The reported experiencing at least one adverse effect.115 Of IRLS score after the six-week treatment period in comparithese adverse effects, most were classified as mild to modson to the baseline score improved by -10.6 (0.5 mg/24 h), erate with 22 percent determined to be severe. As ob-15.1 (1 mg/24 h), -15.7 (2 mg/24 h), -17.5 (3 mg/24 h) and served in the six-week trial, application site reactions were -14.8 (4 mg/24 h) in comparison to the placebo.114 As dethe most frequent adverse event seen and were documenttermined by statistical analysis, significant benefits of rotiged in 34.5 percent of participants in the first year and in otine in comparison to placebo occurred in the treatment 16.4 percent the second year.115 In regards to tolerability, groups receiving 4 mg/24 h (p=0.0013), 3 mg/24 h 77 percent of the participants rated rotigotine tolerability as (p=<0.0001), 2 mg/24 h (p=0.0003) and 1 mg/24 h “very good” or “good,” whereas 5.8 percent rated the tolera(p=0.0004).114 The benefits observed with the 0.5 mg/24 h bility as “very bad.” Augmentation is a common complaint dose were not significant when compared to placebo (pof those on long-term dopamine agonist therapy. During value=0.2338). the two-year duration, augmentation had an occurrence of Application site reactions and nausea were the most com- only 2.4 percent and may be a possible advantage of rotigmon adverse effects reported and became more frequent otine therapy as this augmentation rate is lower than the as the dose increased.114 Because no further improverates commonly observed with other dopamine agonist

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115

percent, 20.8 percent), somnolence (8.1 percent, 10 percent, 13.1 percent, 15.1 percent), headache (14.1 percent, A Six-month Randomized, Double-blind, 12 percent, 10.1 percent, 10.4 percent), insomnia (1 perPlacebo-controlled Trial in the United States cent, 4 percent, 2 percent, 8.5 percent), dry mouth (2 perHening, et al. implemented a study to assess the safety cent, 3 percent, 1 percent, and 7.5 percent), pruritis (9.1 and effectiveness of rotigotine at four different doses in percent, 2 percent, 3 percent, 7.5 percent), fatigue (10.1 participants determined to have moderate to severe idiopercent, 3 percent, 7.1 percent, 6.6 percent), and dizziness pathic RLS.117 The four dosages of rotigotine used included (4 percent, 3 percent 7.1 percent, 6.1 percent).117 During 0.5 mg/24 h, 1 mg/24 h, 2 mg/24 h and 3 mg/24 h. In addi- the course of the study, only 1.5 percent (6 participants) tion, a placebo group also was utilized to allow for compari- developed clinically significant augmentation.117 Based upson to those treated. The study included 505 participants on these results, it can be concluded that the augmentation who were diagnosed with idiopathic RLS according to the rate for six months of rotigotine treatment is low.117,118 guidelines established by International RLS Study Group Dose (IRLSSG) and ranged from 18 to 75 years of age.117 Of these 505 participants, however, only 63 percent complet- The recommended dosage range for the treatment of RLS ed the study. In addition, the subjects must also have had a is between 1 mg to 3 mg over a 24 hour time frame.119 baseline sum score of at least 15 according to the IRLS When treating Parkinsonâ&#x20AC;&#x2122;s disease, however, higher doses scale and a baseline CGI-1 score of at least 4 to be includ- are needed to be clinically effective. ed in the study. The subjects were then placed randomly Common Adverse Events into one of the five groups and received treatment for six The most common adverse events reported in clinical trials months. and the incidence of these events as observed with the 3 The primary methods for assessing efficacy include measmg/24 h dose are as follows: application site reactions (43 uring the change from baseline of the IRLS sum score and percent), nausea (21 percent), somnolence (10 percent), the CGI-1 score. The safety of the medication was deterheadache (16 percent), insomnia (10 percent), dry mouth mined through the observation of a number of different (7 percent), pruritis (7 percent) and dizziness (6 percent).47 physiological parameters. These parameters included obThese reactions were classified as mild-to-moderate and serving the adverse events experienced, adhesiveness of became more frequent as the dose increased.114,115,117 the patch, application site reactions, changes in laboratory values, vital signs and a number of other physical assess- Contraindications ments (12-lead ECG, physical and neurological examinations, etc). Assessment of the results observed in the study indicate that treatment with the 2 mg and 3 mg doses of rotigotine over 24 hours lead to a statistically significant decrease in IRLS and CGI-1 scores in comparison to placebo (p<0.001).117 Treatment with the other two doses resulted in improvements in these scores, but the results were determined to not be statistically significant. The response rates, however, were higher in all of those receiving rotigotine treatment compared to the placebo.

Rotigotine should not be used in patients who have a hypersensitivity to rotigotine or any of the other patch components.47 In addition, the medication should not be used in those with an allergy to sulfite because it contains a sulfite moiety and could cause an allergic reaction.47 Precautions

Rotigotine is classified as pregnancy category C because of the absence of sufficient and well-controlled studies that assess the safety of this medication in pregnant women.47 Because rotigotine is a dopamine agonist, it can potentially decrease the secretion of prolactin and should subsequentIn regards to safety, 84 percent of those in the placebo ly not be utilized in lactating mothers. Currently, there are group and 88 percent of those in the rotigotine groups reno studies that indicate the safe and effective use of rotigoported adverse effects.117 In the rotigotine groups, the most tine in the pediatric population; thus, the medication should frequent adverse effect was reactions at the application site not be used in pediatric patients.47 with 27 percent of treatment groups reporting it.117 The perPharmacoeconmoics centage of subjects reporting adverse effects generally increased with higher doses of rotigotine. The rates of adRotigotine currently is not available as a generic medicaverse events observed in groups treated with 0.5 mg/24 h, tion; therefore, the drugâ&#x20AC;&#x2122;s cost is higher than the cost asso1 mg/24 h, 2 mg/24 h and 3 mg/24 h of rotigotine, listed ciated with other generically available dopamine agonists respectively, were nausea (13.1 percent, 20 percent, 18.2 (pramipexole, ropinirole). Likewise, insurance companies 18

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Table 5: Average Wholesale Prices for Dopaminergic Agents Drug

Average Wholesale Price

Carbidopa/Levodopa tablet, po 10 mg-100 mg 25 mg-100 mg 25 mg-250 mg Pramipexole Dihydrochloride tablet, po 0.125 mg 0.25 mg 0.5 mg 1 mg 1.5 mg Ropinirole Hydrochloride tablet, po (film coated): 0.25 mg 0.5 mg 1 mg 2 mg 3 mg 4 mg 5 mg Rotigotine, transdermal 2 mg/24 h

100 count bottle: $70.88 $80.02 $101.97

of medication over an extended period. Because rotigotine currently is not available generically, the financial circumstances of each patient need to be considered before initiating therapy. Important Counseling Information

63 count bottle: $185.83 90 count bottle: $265.47 $265.47 $265.47 $265.47 100 count bottle: $250.52 $250.52 $250.52 $250.52 $259.86 $259.86 $259.86

In order for patients to receive the full dose of their patch and experience optimal symptom improvements, the patch must be applied properly. Because of this, it is crucial that the patients receive accurate information in regards to patch application and possible adverse events associated with this medication. A summary of important counseling points can be found in Table 6.47 Conclusion

Rotigotine has been proven to be effective in the improvement of symptoms associated with RLS and should be considered as alternative option to the conventional oral dopamine agonist medications. The medicationâ&#x20AC;&#x2122;s availability Pack of 7 patches: $18.90 as a transdermal patch is unique to other mediPack of 30 patches: $81.00 cations in this class and may provide additional 4 mg/24 h Pack of 7 patches: $64.68 benefits to patients with RLS. This formulation Pack of 30 patches: is a convenient way to administer a continuous 6 mg/24 h $277.20 dose of medication over an extended period; Pack of 7 patches: $64.68 therefore, rotigotine is beneficial for patients Pack of 30 patches: that experience symptoms during the day. Be$277.20 cause rotigotine is not generically available, The prices displayed for these medications, with the exception of rotigotine, in this table are based upon data from Teva Phar- other dopamine agonists that are available as a maceuticals. The wholesale prices of rotigotine are based upon generic formulation may be more favorable to use in patients with financial concerns. data obtained from UCB, the manufacturer of this medication. Because a significant amount of people experience the debilitating symptoms associated with RLS, it is may place these generic medications on a lower tier than crucial that healthcare professionals are aware of the backthe tier assigned to brand-name rotigotine; thus, there is a ground of the disease and the current treatment options possibility that the patient may be financially responsible for available. The decision as to which treatment to initiate a higher percentage of rotigotineâ&#x20AC;&#x2122;s cost. A summary of the should be based upon symptom severity, patient tolerabilaverage wholesale prices of dopaminergic agents can be ity, medication cost and adverse effects associated with the 120 found in Table 5. medication. Place in Therapy References Dopamine agonists are considered to be first-line in the 1. Allen RP, Stillman P, Myers AJ. Physiciantreatment of RLS and have been proven effective in imdiagnosed restless legs sundrome in a large sample of priproving associated symptoms.42,44 As a dopamine agonist, mary medical care patients in western Europe: prevalence rotigotine can be considered an effective alternative to curand characteristics. Sleep Med 2010;11:31-7. rently available oral dopamine agonist medications. In addiAllen RP, Walters AS, Montplaisir J, et al. Restless tion, the continuous release of medication will be beneficial 2. legs syndrome prevalence and impact. REST general popto those that experience daytime symptoms.121 The transulation study. Arch Intern Med 2005;165:1286-92. dermal formulation may be favored by some patients beNichols DA, Sallen RP, Grauke JH, et al. Restless cause it is a convenient way to administer a steady amount 3. 19

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Nov 2012 CEâ&#x20AC;&#x201D;Restless Leg Syndrome Table 6: Rotigotine Counseling Information

November 2012 47

Areas of the skin recommended for patch application: Front of the abdomen Upper arm Hip Shoulder Flank Thigh Patch should be applied to an intact, hairless area of the skin that is clean and dry. Portions of the skin that possess hair should be shaved at least 3 days before applying the patch. Avoid applying the patch to areas of the skin that are damaged, irritated, or oily. Do not apply to areas that may be rubbed by tight clothing or are located under a waist band. Do not apply cream, ointments, powders, or lotions to areas of the skin used for patch application. The patch should be applied at approximately the same time every day to different application sites. The same site should not be used more than once in a 14-day period. Once removed from the package, the patch should immediately be placed on the skin and held firmly in place for at least 30 seconds. After applying the patch, avoid contact with the eyes or any other objects until washing hands thoroughly. The patch may be held in place by a bandage, but should not be cut or damaged. Exposing the patch to sources of heat should be avoided because changes in medication absorption could result. If the patch happens to fall off, a new patch should be immediately applied to a different area of the skin. The new patch should still be removed, however, at the usual time of patch application the following day. Remove the patch slowly and wash the application site with soap and water. Fold the patch over onto itself before discarding. Do not discontinue treatment suddenly, the medication should be tapered. Store at room temperature. legs syndrome symptoms in primary care: a prevalence study. Arch Intern Med 2003;163:2323-9.

Sleep medicine reviews 2011.

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10. Phillipps B, Hening W, Britz P, Mannino D. Preva4. Hogl B, Kiechl S, Willeit J, a l. et. Restless legs lence and correlates of restless legs syndrome-results from syndrome: a community-based study of prevalence, severi- the 2005 National Sleep Foundation Poll. Chest ty , and risk factors. Neurology 2005;64:1920-4. 2006;129:76-80.

6. Ekbom KA. Restless legs: a clinical study. Acta Med Scand Suppl 1945;158:1-123. 7. Rothdach AJ, Trenkwalder C, Haberstock J, Keil U, Berger K. Prevalence and risk factors of RLS in an elderly population: the MEMO study. Memory and morbidity in Augsburg elderly. Neurology 2000;54:1064-8. 8. Allen RP, Bharmal M, Calloway M. Prevalence and disease burden of primary restless legs syndrome: results of a general population survey in the United States. Mov Disord 2011;26:114-20. 9. Ohayon MM, O'Hara R, Vitiello MV. Epidemiology of restless legs syndrome: A synthesis of the literature.

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November 2012 Myers A, L F-S. Impact, diagnosis and treatment of restless legs syndrome (RLS) in a primary care population : the REST (RLS epidemiology, symptoms, and treatment) primary care study. Sleep Med 2004;5:237-46.

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Sleep Medicine review. Sleep 1999;22. 43. Parker KP, Rye DB. Restless legs syndrome and periodic limb movement disorder. Nurs Clin North Am 2002;37. 21

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55. Hening WA, Allen RP, Earley CJ, Picchietti DL, MH S. Restless Legs Syndrome Task Force of the Standards of Practice Committee of the American Academy of Sleep Medicine. An update on the dopaminergic treatment of restless legs syndrome and periodic limb movement disorder. Sleep 2004;27:560-83.

68. Garcia-Borreguero D, Williams AM. Dopaminergic augmentation of restless legs syndrome. Sleep medicine reviews 2010.

65. Hogl B, Garcia-Borreguero D, Kohnen R, et al. Progressive development of augmentation during long52. Davis BJ, Rajput A, Rajput ML, et al. A randomterm treatment with levodopa in restless legs syndrome: ized, double-blind placebo-controlled trial of iron in restless results of a prospective multi-center study. J Neurol legs syndrome. Eur Neurol 2000;43:70-5. 2010;257:230-7.

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73. Silber MH, Girish M, Izurieta R. Pramipexole in the management of restless legs syndrome: an extended study. Sleep 2003;26:819-21.

87. Conti CF, Oliveira MM, Valbuza JS, Prado LB, Carvalho LB, Prado GF. Anticonvulsants to treat idiopathic restless legs syndrome: systematic review. Arq Neurop74. Ferini-Strambi L. Restless legs syndrome augmen- siquiatr 2008;66:431-5. tation and pramipexole treatment. Sleep Med 2002;3 88. Walters AS, Wagner ML, Hening WA, et al. SucSuppl:S23-S5. cessful treatment of the idiopathic restless legs syndrome in a randomized double-blind trial of oxycodone versus pla75. Winkelman JW, Johnston L. Augmentation and tolerance with long-term pramipexole treatment of restless cebo. Sleep 1993;16. legs syndrome (RLS). Sleep Med 2004;5:9-14.

89. Hogl B, Trenkwalder C, Poewe W. More on the 76. Garcia-Borreguero D., Grunstein R., Sridhar G., et. restless legs syndrome and spinal anesthesia. N Engl J Med 2009;360:1155-6. al. A 52-week open-label study of the long-term safety of ropinirole in patients with restless legs syndrome. Sleep 90. Kaplan PW, Allen RP, Buchholz DW, et al. A douMed 2007;8:742-52. ble-blind, placebo-controlled study of the treatment of peri77. Garcia-Borreguero D, Larrosa O, De La Llave Y, et odic limb movements in sleep using carbidopa/levodopa al. Treatment of restless legs syndrome with gabapentin: a and propoxyphene. Sleep 1993;16. double-blind, cross-over study. Neurology 2002;59:1573-9. 91. Ondo WG. Methadone for refractory restless legs syndrome. Mov Disord 2005;20:345-8. 78. Thorp ML, Morris CD, Bagby SP. A crossover study of gabapentin in treatment of restless legs syndrome among hemodialysis patients. Am J Kidney Dis 2001;38:104-8.

92. Lauerma H, Markkula J. Treatment of restless legs syndrome with tramadol: an open study. J Clin Psychiatry 1999;60:241-4.

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80. Zucconi M, Coccagna G, Petronelli R, et al. Nocturnal myoclonus in restless legs syndrome: effect of carbamazepine treatment. Funct Neurol 1989;4:263-71.

94. Saletu M, Anderer P, Saletu-Zyhlarz G, et al. Restless legs syndrome (RLS) and periodic limb movement disprder (PLMD): acute placebo-controlled sleep laboratory studies with clonazepam. Eur Neuropsychopharmacol 2001;11:153-61.

81. Eisensehr I, Ehrenberg BL, Rogge Solti S, et al. Treatment of idiopathic restless legs syndrome (RLS) with slow-release valproic acid compared with slow-release levodopa/benserazid: a randomized, placebo-controlled, double-blind, cross-over study. J Neurol 2004;251:579-83.

95. Boghen D, Lamothe L, Elie R, et al. The treatment of the restless legs syndrome with clonazepam: a prospective controlled study. Can J Neurol Sci 1986;13:245-7.

82. Telstad W, Sorensen O, Larsen S, et al. Treatment 96. Scheller D, Ullmer C, Berkels R, Gwarek M, LĂźbof the restless legs syndrome with carbamazepine: a dou- bert H. The in vitro receptor profile of rotigotine: a new ble blind study. Br Med J 1984;288:444-6. agent for the treatment of Parkinson's disease. Naunyn83. Lundvall O, Abom PE, Holm R. Carbamazepine in Schmiedeberg's Arch Pharmacol 2009;379:73-86. restless legs. A controlled pilot study. Eur J Clin Pharmacol 97. Jenner P. A novel dopamine agonist for the trans1983;25:323-4. dermal treatment of Parkinson's disease. Neurology 84.

Mellick GA, Mellick LB. Management of restless

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98. Nugroho AK, Li G, Grossklaus A, Danhof M, Bouwstra JA. Transdermal iontophoresis of rotigotine: influence of concentration, temperature and current density in human skin in vitro. J Control Release 2004;96:159-67.

111. Cawello W, Braun M, Boekens H. Absorption, Disposition, Metabolic Fate, and Elimination of the Dopamine Agonist Rotigotine in Man: Administration by Intravenous Infusion or Transdermal Delivery. Drug Metab Dispos 99. Pfeiffer RF. A promising new technology for Parkin- 2009;37:2055-60. son's disease. Neurology 2005;65:S6-S10. 112. Hansen K, Braun M, Horstmann R. Low drug-drug 100. Kehr J., Hu X.-J., Goiny M., Scheller D. Continuous interaction potential of rotigotine. J Clin Pharmacol delivery of rotigotine decreases extracellular dopamine sug- 2005;45:1091. gesting continuous receptor stimulation. J Neural Transm 2007;114:1027-31. 101. Braun M, Cawello W, Poole K, Horstmann R. Steady-state pharmacokinetics of rotigotine in patients with early-stage Parkinson's disease. Eur J Neurol 2005;12:96. 102. Minghetti P, Cilurzo F, Pagani S, Casiraghi A. Formulation study of oxybutynin patches. Pharm Dev Technol 2007;12:239-46.

113. Cawello W, Ahrweiler S, et. al. Single dose pharmacokinetics of the transdermal rotigotine patch in patients with impaired renal function. Br J Clin Pharmacol 2011;73:46-54. 114. Oertel WH, Benes H, Garcia-Borreguero D, Geisler P, et. al. Efficacy of rotigotine transdermal system in severe restless legs syndrome: a randomized, double-blind, placebo-controlled, six-week dose-finding trial in Europe. Sleep Med 2008;9:228-39.

103. Variankaval NE, Jacob KI, Dinh SM. Crystallization Hogl B, Oertel W, Stiasny-Kolster K, et. al. Treatof beta-estradiol in an acrylic transdermal drug delivery sys- 115. ment of moderate to severe restless legs syndrome: 2-year tem. J Biomed Mater Res 1999;44:397-406. safety and efficacy of rotigotine transdermal patch. BMC 104. Hadgraft J. Passive enhancement strategies in topNeurol 2010;10:86. ical and transdermal drug delivery. Int J Pharm 1999;184:1116. Oertel WH, Benes H, Garcia-Borreguero D, Geisler 6. P, et. al. One year open-label safety and efficacy trial with 105. Latsch S, Selzer T, Fink L, Kreuter J. Determination rotigotine transdermal patch in moderate to severe idioof the physical state of norethindrone acetate containing pathic restless legs syndrome. Sleep Med 2008;9:865-73. transdermal drug delivery systems by isothermal microcalo117. Hening WA, Allen RP, Ondo WG, et al. Rotigotine rimetry, X-ray diffraction, and optical microscopy. Eur J improves restless legs syndrome: a 6-month randomized, Pharm Biopharm 2004;57:383-95. double-blind, placebo-controlled trial in the United States. 106. Cilurzo F, Minghetti P, Casiraghi A, Tosi L, Pagani Mov Disord 2010;25:1675-83. S, Montanari L. Polymethacrylates as crystallization inhibi118. Garcia-Borreguero D, Ferini-Strambi L, Kohnen R. tors in monolayer transdermal patches containing ibuAugmentation in the therapy of restless legs syndrome with profen. Eur J Pharm Biopharm 2005;60:61-6. transdermal rotigotine: a retrospective systematic analysis 107. Ma X, Taw J, Chiang CM. Control of drug crystalliof two large double-blind 6-month trials. Eur J Neurol zation in transdermal matrix system. Int J Pharm 2008;15:110;P1293 Abstract. 1996;142:115-9. 119. Baldwin CM, Keating GM. Rotigotine transdermal 108. Kim JH, Choi HK. Effect of additives on the crystalpatch: in restless legs syndrome. CNS drugs 2008;22:797lization and the permeation of ketoprofen from adhesive 806. matrix. Int J Pharm 2002;236:81-5. 120. Red Book: Pharmacy's Fundamental Reference: 109. Chen J, Swope D, Dashtipour K, Lyons K. TransThomson Reuters; 2010. dermal Rotigotine: A Clinically Innovative Dopamine121. Stiasny-Kolster K, Kohnen R, Schollmayer E, Receptor Agonist for the Management of Parkinson's DisMoller J, WH. O. Patch application of the dopamine agonist ease. Pharmacotherapy 2009;29:1452-67. rotigotine to patients with moderate to advanced stages of 110. Wang S, Xue H, Wang L, et. al, inventors; Patent restless legs syndrome: a double-blind, placebo-controlled application title: Composition containing rotigotine and use pilot study. Mov Disord 2004;19:1432-8. thereof and transdermal patch containing the composition. United States of America. 2011.

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November 2012

November 2012 — Rotigotine (Neupro®) in the Treatment of Restless Leg Syndrome 1. There is a higher prevalence of RLS in men than in women. A. True B. False

8. Why was rotigotine removed from the market in 2008? A. Increased the risk of death B. Caused heart failure C. Increased the risk of stroke D. Patch crystallization

2. Which of the following are included in the diagnosis guidelines established by the International RLS Study Group? A. An urge to move the legs, often accompanied by an unpleasant sensation in the legs or other body parts B. Symptoms aggravated by rest C. Symptoms alleviated by movement D. Symptoms must be worse in the evening or night, with an urge to move the legs, usually accompanied by an unpleasant sensation in the legs E. All of the above 3. What is the most common type of RLS? A. Primary B. Secondary C. Drug-induced D. Iron-deficient

9. What is the primary route of elimination of rotigotine? A. Liver B. Kidney C. Lungs D. Feces 10. What is the recommended dosage range of rotigotine for the treatment of RLS? A. 0.5 mg to 2 mg over 24 hours B. 1 mg to 2 mg over 24 hours C. 1 mg to 4 mg over 24 hours D. 1 mg to 3 mg over 24 hours 11. What is the most common adverse event associated with rotigotine? A. Application site reactions B. Nausea C. Insomnia D. Dry mouth

4. Which agents are considered to be the cornerstone of therapy for RLS treatment? A. Anti-convulsants B. Dopaminergic Agents C. Benzodiazepines D. Opioids

12. If a patient wishes to stop using rotigotine, treatment can be discontinued suddenly. A. True B. False

5. What is the classification of rotigotine? A. Sodium channel blocker B. Dopamine antagonist C. Dopamine agonist D. Acetylcholinesterase inhibitor 6. Which of the following is not a labeled indication for rotigotine? A. The treatment of the signs and symptoms of idiopathic Parkinson’s disease. B. The treatment of the signs and symptoms of Alzheimer’s disease. C. The treatment of moderate-to-severe primary restless legs syndrome.

13. How long should the patient wait before applying the patch to a site that has been previously used for patch application? A. 2 days B. 3 days C. 7 days D. 14 days 14. The patch should be applied at approximately the same time every day. A. True B. False 15. The patch cam be applied to areas of the skin that are damaged or irritated. A. True B. False

7. How often is rotigotine dosed? A. Once daily B. Twice daily C. Three times daily D. Every other day

We know Your CE is important to you. To help us help you, all CE must be received in the KPhA office no later than noon on December 28 to be counted for 2012! Don’t wait until it’s too late!

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This activity is a FREE service to members of the Kentucky Pharmacists Association. The fee for non-members is $30. Mail completed forms to: KPERF, 1228 US 127 South, Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile. Expiration Date: October 15, 2015 Successful Completion: Score of 80% will result in 2.0 contact hours or 0.2 CEUs. Participants who score less than 80% will be notified and permitted one re-examination. November 2012 — Rotigotine (Neupro®) in the Treatment of Restless Leg Syndrome TECHNICIANS ANSWER SHEET. Universal Activity # 0143-0000-12-011-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ________________________________________________________________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B 3. A B C D 2. A B C D E 4. A B C D

5. A B C D 6. A B C

7. A B C D 8. A B C D

9. A B C D 10.A B C D

11. A B C D 12. A B

13. A B C D 14. A B 15. A B

Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature _________________________________________________ Date _________________________________

Personal NABP #_____________________________ Birthdate ____________________(MM/DD) November 2012 — Rotigotine (Neupro®) in the Treatment of Restless Leg Syndrome Universal Activity # 0143-0000-12-011-H01-P PHARMACISTS ANSWER SHEET Name ________________________________________________ KY Lic. # __________________________________ Address ________________________________________________________________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B 3. A B C D 2. A B C D E 4. A B C D

5. A B C D 6. A B C

7. A B C D 8. A B C D

9. A B C D 10.A B C D

11. A B C D 12. A B

13. A B C D 14. A B 15. A B

Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature _________________________________________________ Date _________________________________

Personal NABP #___________________________ Birthdate _______________________(MM/DD)

The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education.

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Dec. 2012 CE — Patient Assessment Skills

November 2012

Patient Assessment Skills for Optimizing Self-Care, Part 1 of 4: Introduction and KPERF offers all Evaluation of Skin, Hair and Nails CE articles to Reprinted with permission of the authors and the South Dakota Pharmacists Association where this article originally appeared. This activity may appear in other state pharmacy association journals.

members online at www.kphanet.org

By: Kimberly A. Messerschmidt, Pharm.D., Professor of Pharmacy Practice, SDSU College of Pharmacy, Clinical Pharmacist, Sanford USD Medical Center and Kelley J. Oehlke, Pharm.D., Residency Program Director, Clinical Pharmacy Specialist, Ambulatory Care, Sioux Falls VA Medical Center Universal Activity # 0143-9999-12-012-H04-P&T 2 Contact Hours (0.2 CEUs) Goal - To enhance pharmacists’ knowledge regarding patient assessment. Learning Objectives - Upon successful completion of this course, the pharmacist should be able to: 1. Utilize communication skills that enhance information exchange between the patient and the pharmacist. 2. Effectively evaluate a patient using the QuEST/SCHOLAR process for OTC counseling. 3. Define characteristics of febrile patients that indicate a need for physician evaluation. 4. Assess the skin, hair and nails to identify common medical conditions. 5. Recognize opportunities for utilizing basic patient assessment skills in the ambulatory care setting. exploratory questions on the part of the pharmacist in order to clarify and assess the patient’s needs and determine the JW is a 28-year-old female who approaches the pharmacy appropriateness of self-care. QuEST is an acronym used to reporting that she has been experiencing a cold for several describe a systematic approach developed by the Ameridays. The patient explains that the rhinorrhea has resolved can Pharmacists Association (APhA) that was designed to but the dry, hacking cough persists, waking her up at night. help pharmacists elicit the information needed and provide She asks you what cough syrup would be best to treat her appropriate recommendations regarding self-care.1 problem. You take her temperature, which is normal, and complete a respiratory assessment with no significant find- QuEST Process1 ings. Upon further questioning to review her symptoms and Quickly and accurately assess the patient (e.g., symptoms, medical history, you determine the patient is an appropriate current medications and medical conditions, allergies) candidate for self-care and proceed to assist her with the selection of an appropriate over the counter (OTC) product. Establish that the patient is an appropriate candidate for self-care As illustrated in the case above, one of the most important Suggest appropriate strategies for self-care roles of a community pharmacist is to help patients make Talk with the patient about: decisions regarding self-care and to provide counseling Introduction

regarding proper use of the products selected. In order to do this in a safe and appropriate manner, the pharmacist must use effective communication skills, both when gathering patient information and also when providing information regarding medication use. Over the counter medication counseling differs from prescription drug counseling in that it generally requires more

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The medication’s actions, proper administration and potential adverse effects

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What to expect from treatment

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Appropriate follow-up

The first step of the QuEST process is to quickly and accurately assess the patient and this first involves talking with 27

THE KENTUCKY PHARMACIST

Dec. 2012 CE — Patient Assessment Skills

November 2012

him or her in order to gather the needed information. The pharmacist’s physical appearance and attitude can either hinder or enhance this communication; therefore, it is always important to be well groomed and professionally dressed. In most cases, a white lab coat helps convey a professional image, but it may not be the optimal apparel when working with children or psychiatric patients. In these instances, more casual attire (i.e., no white lab coat) may be more appropriate and will usually help the patient feel less threatened and more at ease. A concerned, unhurried and nonjudgmental approach also will help promote open and honest communication. Always strive to make the interview area as comfortable and private as possible. Ideally, the area should be relatively quiet and free of any distractions or interruptions. It also should be clean, wellorganized, and have a sufficient amount of lighting.

the pharmacist. Use your body language to convey an interested and unhurried impression. An open and relaxed posture, with arms and legs uncrossed, shows interest and encourages conversation and trust. Good eye contact helps you recognize subtle non-verbal cues in the patient’s body language. Whenever possible, come out from behind the counter and position yourself at the patient’s eye level. This usually makes the patient feel more comfortable and less like they are being looked down upon. Maintaining an optimal “social distance” of three to five feet between yourself and the patient is usually comfortable for most individuals.

Good communication skills are essential to a successful interaction. Unless you are very familiar with the patient, always start the interview by introducing yourself with your name and professional title. It is generally best to address adult patients by their last name and appropriate titles (e.g., Mr. Johnson) until you are invited to do otherwise. In some cultures, using a patient’s first name is a sign of disrespect. If you are unsure of how to pronounce their name, don’t be afraid to ask. It also is imperative to know who the patient is, for example, is the patient asking for a recommendation for himself or herself, or for another family member. While gathering information from the patient, make sure to avoid judgmental or leading statements. Questions such as “You certainly don’t smoke around your children, do you?” will only make a patient feel bad and hinder open and honest communication. Always use language and terminology the patient can easily understand (e.g., stroke instead of cerebrovascular accident). A combination of open and closed-ended questions may be used, but in general, open -ended questions (i.e., the kind starting with who, what, where, why or when) will elicit a more complete and accurate response than closed-ended questions (i.e., those with a yes or no answer). Closed-ended questions are best for clarifying specific details once you have gathered the general information (e.g., “Our records show that you usually get a flu shot each year. Have you received your vaccination yet?”).

To get a complete picture of the problem, it is important to know exactly what kind of information needs to be collected. The SCHOLAR acronym provides a systematic method of evaluating a symptom by collecting pertinent information about its history and present status1. Each symptom has seven attributes that must be considered and evaluated. These seven characteristics include: Symptoms: What is the current symptom of concern? Are there any other associated symptoms? Characteristics: (e.g., quality, quantity, timing) How severe is the symptom? Does it interfere with daily activities? History: What was the patient doing when the symptom started? Has the patient ever had this symptom before? Onset: When did the symptom start? Did it come on gradually or suddenly? Location: Where is the symptom located? Is it in a specific area, or is it generalized? Aggravating factors: What makes the symptom worse? (e.g., activity, rest, eating, a recent medication change) Remitting/relieving factors: What makes the symptom better? (e.g., activity, rest, eating, medication) It is important to remember that positive findings (e.g., fever and chills present), as well as negative findings (e.g., no nausea, vomiting or diarrhea) should be noted. As you explore these attributes, you will come to have a much better understanding of the nature of the problem and it will help you decide whether self-treatment or physician referral is the most appropriate course.

During this initial assessment, it is also important to ask about current medications, other co-existing medical condiTrue or False? It is always important to use medical tertions (including pregnancy and lactation), and known mediminology when communicating with patients so they know cation allergies. Don’t forget to ask specifically about OTC you are a professional and they can trust your recommendrugs, herbals and dietary supplements. If the patient dedations. nies taking non-prescription medications, ask about common medical conditions such as the frequency of headNon-verbal communication also impacts both the quality and quantity of information shared between the patient and aches or minor aches and pains and how they are treated. 28

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November 2012

Dec. 2012 CE — Patient Assessment Skills Once you have completed the initial patient interview, you may need to perform some basic physical assessments in order to complete the picture (e.g., measure blood pressure, examine a rash or sore throat). In order to decrease patient anxiety, always explain what you are about to do. Also, make sure the examination area is comfortable and private and any needed equipment or supplies are readily available. GENERAL

panic membrane temperature measurement, infrared technology provides a reading by measuring blood flow in the tympanic membrane. Ear temperature reflects the body’s temperature because the tympanic membrane shares its blood supply with the hypothalamus. Although tympanic thermometers are simple to use, accurate measurement depends on following manufacturer’s instructions. An advantage to this type of measurement is that results may be obtained in seconds, making them ideal for use in the clinic or hospital setting. ReTable 1. Characteristics of febrile patients that indicate a need ferral guidelines for fefor physician evaluation2 brile patients are listed in A rectal temperature of 38°C (100.4°F) or higher in a child younger Table 1. than 3 months A temperature of 38.9°C (102°F) or higher in a child 3 month or older In general, a fever that is lower than 38.9°C (102° Any oral temperature over 39.4°C (103°F) F) in an adult doesn’t A fever lasting more than three days, or more than one day in a child need to be treated unless than 2 years of age less the patient is very Symptoms of a severe infection such as meningitis (e.g., severe uncomfortable. Aspirin headache, light sensitivity, stiff neck, confusion) products should not be Risk of dehydration (e.g., severe or persistent vomiting or diarrhea, recommended for use in unable to keep liquids down) any child with a suspectDifficulty breathing or chest pain, or a history of significant heart or ed viral illness due to a lung disease potential association with Abdominal pain, or pain with urination Reye’s syndrome. Altered mental status, or extreme listlessness or irritability True or False? Any Severe throat pain or swelling body temperature greatUnusual skin rash er than 98.6 °F is conA child with a history of febrile seizures sidered a fever and Any patient in an immunocompromised state should be treated.

Some general observations about the patient’s outward appearance, mood and behavior can sometimes provide valuable clues about his or her mental and physical health. Do patients hear you well when you speak? Do they rise from their chair easily, or do they grimace with pain? Do they ambulate without difficulty? Is there any involuntary motor activity? Do they show any obvious signs of respiratory distress, pain or anxiety? Do they appear frail or malnourished? Is excessive weight adversely affecting their health? Is their clothing appropriate for the weather? Is their speech clear and appropriate? Normally a patient’s physical appearance should correlate with their stated age. When an individual appears significantly older, it may be a sign of chronic disease or poor physical care (e.g., alcoholism or malnutrition).

If an ongoing infectious process is suspected, an assessment of body temperature may provide an important clue regarding the etiology of a patient’s symptoms. Electronic thermometers have essentially replaced glass thermometers due to environmental and health concerns associated with mercury. The average normal body temperature in adults, when measured orally, is 37°C (98.6°F), but this can vary considerably, ranging from 35.8°C (96.4°F) in the early morning hours, up to 37.3°C (99.1°F) in the evening. The axillary (under the arm) route is generally reserved for infants and toddlers, but it may also be used in adults when the oral route is not accessible. Normal axillary temperatures in adults are around 36.5°C (97.7°F), which is approximately 0.5°C (1°F) lower than the oral route. For tym-

SKIN, HAIR AND NAILS Due to the size and complexity of the skin, susceptibility to pathologic conditions is high. The pharmacist’s role is important, as many of the conditions may be treated with OTC medications while others are more serious and require a physician referral. Skin Overall assessment of the skin includes identifying changes in color, texture, temperature, turgor (elasticity or resiliency), odor and the presence or lack of lesions. Table 2 describes basic medical terms that are commonly associated with the skin. Pharmacists should familiarize themselves with these terms. Inflammatory Conditions of the Skin Common inflammatory skin conditions include contact dermatitis, acne, eczema and diaper rash. Contact dermatitis presents as a rash that is divided into two types, irritant or allergic. The rash may appear within hours (irritant) to several days (allergic) and is usually confined to the area of

THE KENTUCKY PHARMACIST

Dec. 2012 CE — Patient Assessment Skills

November 2012

Table 2. Terms describing the clinical presentation of the skin Term

Description

Examples

Macule

A flat lesion, flush with the skin with Freckles, flat moles (nevi), petechiae, meaa color different from the surrounding sles, scarlet fever rash tissue.

Patch

A macule which exhibits some scale Vitiligo, portwine stains, Mongolian spots, café or fine wrinkles and is greater than 1 au lait patch cm in diameter.

Papule

A solid, elevated lesion less than 0.5 Wart (verruca), elevated moles, lichen planus cm in diameter.

Plaque

A lesion greater than 0.5 cm in diam- Psoriasis, seborrheic and actinic keratoses eter but with marginal depth.

Lichenification

Thickening of the skin which can be Chronic dermatitis seen as well as palpated and which has ridged skin markings.

Nodule

A lesion greater than 0.5 cm in both Erythema nodosum, lipomas width and depth.

Wheal

A transitory papule or plaque arising Insect bites, urticaria (hives), allergic reaction out of edema of the dermis which almost always produces pruritis.

Cyst

A nodule containing a liquid or semi- Sebaceous cyst, cystic acne solid which can be expressed.

Vesicle

A blister less than 0.5 cm in diameter Varicella (chickenpox), herpes zoster filled with clear liquid (shingles)

Bulla

A blister more than 0.5 cm in diame- Blister, pemphigus vulgaris ter filled with clear liquid.

Pustule Crust

A vesicle filled with a purulent liquid. Exudate from a lesion which has dried on the skin. Aggregation of loose, hyperkeratotic cells of the stratum corneum. They normally are dry and appear to be white in color.

Impetigo, acne Scab on abrasion, eczema

Fissure

A thin tear of the epidermis which may extend to the dermis.

Athlete’s foot, cracks at the corner of the mouth

Erosion

Wider than a fissure but limited to the epidermis.

Varicella, variola after rupture

Ulcer

Destruction of the epidermis (with or Decubiti, stasis ulcers without dermal injury) which exposes the dermis.

Scale

contact. Examples of causative agents for an irritant type rash include soap, detergents, cosmetics and any substance that may irritate the skin. The patient may present with erythema, vesicles, crusts, scaling and/or pruritis. Allergic dermatitis may be caused by such things as poison ivy, metals (e.g., nickel found in jewelry), latex and drugs such as neomycin. Allergic dermatitis may appear as papules, vesicles, erosions, crusts, erythema, blackheads, whiteheads and/or pruritis. It is important to remember the

Flaking of skin with seborrheic dermatitis following scarlet fever, or flaking of skin following a drug reaction; dry skin

first step in treatment is to remove the offending agent. Acne presents as comedones (blackheads), closed comedones (whiteheads), papules, pustules and nodules. Generally, acne is most common during puberty due to the androgenic hormones and is most frequently found on the face and upper trunk. Mild acne may be treated with OTC products but moderate to severe acne should be referred to a physician for care. Eczema often appears during infancy or early childhood 30

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Dec. 2012 CE â&#x20AC;&#x201D; Patient Assessment Skills

November 2012

Table 3. Common infectious skin conditions and is commonly found in the skin folds Infectious Characteristics (e.g., elbow, knee). Risk factors may inCondition clude family history of allergic rhinitis, hay fever and asthma. Eczema may present Impetigo Caused by bacterial infection Risk factors may include warm temperature with high with pruritis, erythematous patches, plaques humidity, any breakage in the skin, poor hygiene, or papules and lichenification from chronic pre-existing skin disorders scratching. Remember that the best recomLesions with purulent exudate that dries and forms mendation is to get the patient to stop honey-colored crusts scratching. Initial self-treatment may involve cold packs, wet dressings, skin hydration, Fungal infections Most common types: tinea pedis (athletes foot), tinea corporis (ringworm), tinea cruris (jock itch) topical steroids and oral antihistamines. If Erythema, scaling and pruritis these measures are not sufficient, then the patient should be referred to his or her phyCellulitis Bacterial infection sician. Hot, painful, red, non-elevated, poorly defined Diaper rash is most commonly found in inmargins fants and may be caused by irritation (e.g., Abscess Contains necrotic debris, bacteria and inflammatory alkaline urine or stool), moisture (e.g., occells clusion, infrequent diaper changes), CanOpen or closed sore, domed nodule, red and may dida albicans, and chemicals (e.g., laundry drain fluid detergents, fabric softeners, soap, medicaCommunityAppear as pustules or boils which often are red, tions or lotions applied locally). Treatment Acquired MRSA swollen, painful, or have pus or other drainage includes keeping the area dry with frequent Lesions often have necrotic centers similar to spider diaper changes, washing the area with plain bites water, avoiding friction when drying the skin symptoms, followed by a rash (painful, red or purplish in and using a skin protectant. color) which spreads and blisters, with eventual skin shedInfectious Conditions ding. SJS should be immediately referred to a physician since hospitalization is often required. The underlying Examples of infectious skin conditions include impetigo, cause must be identified and permanently avoided. If a fungal infections, cellulitis, abscesses and CommunityAcquired Methicillin-Resistant Staphylococcus Aureus (CA- specific medication is identified as the cause, then additional medications with cross-sensitivity also must be avoided. MRSA). Table 3 depicts the various conditions and their common signs and symptoms. Bacterial conditions should Potential non-drug causes of SJS include various infections such as herpes, HIV, typhoid, hepatitis, diphtheria and inbe referred to a physician. fluenza, as well as physical causes like radiation therapy or Drug-induced Conditions even UV light. Medications may also be a culprit in various skin condiOther skin concerns of patients may be related to skin cantions. Most commonly, skin reactions present as urticaria, cer. It is important to remember the acronym ABCDE for angioedema, fixed drug eruptions, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis or photosensitivity common signs and symptoms of melanoma: reactions. The medications causing the skin condition and Asymmetry the reactions themselves are generally unpredictable and Border is irregular can range from mild to severe. Anticonvulsants, sulfonaColor is changed or variegated mide antibiotics, allopurinol, nonsteroidal anti-inflammatory Diameter is greater than 6 mm (eraser-end of a pencil) drugs (NSAIDs) and dapsone are some of the more comEvolution - enlargement or elevation of a mole over time mon examples of medications that are known to cause Generally, a patient should see a physician if any of these drug reactions.3 Patients should contact his or her physiare present.3 cian if a drug-related skin condition is suspected; however, Hair most reactions disappear within a few days after discontinAssessment of the patient may also include identifying uing the agent. Symptomatic control of the affected area is changes in hair loss or growth, distribution, texture and colthe primary intervention. or. It is important to ask the patient if the change had a sudden or gradual onset, was symmetric or asymmetric or was Stevens-Johnson syndrome initially flares up with flu-like 31

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Dec. 2012 CE — Patient Assessment Skills a reoccurrence of a previous condition. Associated symptoms such as pain, itching, lesions, presence of systemic disease, high fever or recent psychological or physical stress should be addressed. Examples of common hair disorders include folliculitis (inflammation of the hair follicle), furuncles (deep-seated folliculitis caused by Staphylococcus aureus) and carbuncles (boils that can penetrate into the subcutaneous layer), alopecia (baldness) and hirsutism (abnormal hair growth).

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November 2012

Directions for appropriate follow-up (when to contact their physician if they don’t experience desired effect) Since a majority of information shared between patients and pharmacists consists of verbal or written instruction, pharmacists need to be sure the information is being provided at a level the patient can fully understand. Functional health literacy (FHL) is a measure of a person’s ability to perform basic tasks within the context of healthcare (e.g., reading medication labels or insurance forms, understanding and performing tasks associated with proper medication Nails administration), and problems with FHL are one of many Inspection of the nails involves evaluation of their color, factors that can contribute to nonadherence. Millions of length, configuration, symmetry and cleanliness. Any Americans are functionally illiterate when it comes to change in the structure, shape or color may be suggestive healthcare, and as a result, these patients are likely to have of a potential systemic disease and should be referred to a difficulty taking medications as intended by the prescriber. physician. Because of potential embarrassment, patients may be reInspect the nail for atrophy, hypertrophy, abnormal shape luctant to admit lack of understanding, and this can make it (spoon nails can be caused by iron deficiency or Raynaud’s difficult to determine the appropriate level of information to syndrome), pitting (seen in psoriasis), color changes offer. A preferred method of assessing understanding is to (caused by kidney or pulmonary disease or cancers) and use the “teach back” method where the patient is asked to clubbing (associated with chronic hypoxia). Evaluate the restate the instructions back to the provider (e.g., “Can you nail bed for separation from the nail plate (onycholysis) and tell me in your own words how you should take this medicahemorrhage. Examine the nail folds for erythema, inflamtion?”). mation, swelling, tenderness and separation from the nail True or False? Problems with functional health literacy plate. can make it difficult for a patient to understand how to take QuEST PROCESS CONTINUED their medications appropriately. After the initial patient assessment and interview are com- Once you have verified patient understanding, make sure pleted, the second step of the QuEST process involves you have allowed the patient to express all concerns. Slowdetermining whether or not the patient is an appropriate ing down and taking the time to really listen to the patient candidate for self-care. Most medical conditions that can be will help create an atmosphere of mutual trust and respect. safely self-treated are characterized as having no severe When closing the interview, always thank the patient for his symptoms, and no symptoms that are persistent or repeat- or her time and extend an offer to be available to answer edly return without an identifiable cause. Additionally, paany further questions should they arise. tients should not pursue self-treatment in an attempt to CONCLUSION avoid medical evaluation and treatment by a physician. The pharmacist in the introductory case could have easily Based upon this evaluation, a decision can be made redirected JW to the cough syrup aisle. However, by using garding referring the patient to a physician, or making an appropriate self-treatment recommendation. Strategies for the QuEST process, the pharmacist was able to accurately self-care may include non-pharmacological measures such assess the nature of her cough and determine that she was an appropriate candidate for self-care. Patient assessment as rest, hydration, dietary alterations and suggestions for skills, along with strong communication skills, are essential preventing recurrence of the problem, as well as nonfor making appropriate self-care recommendations. Togethprescription medications. er, these skills allow the pharmacist to formulate a comIf self-treatment is determined to be appropriate, the final plete picture of the patient’s overall health status and make step of the process involves talking with the patient about the most appropriate recommendations for optimizing payour recommendations. Key information to convey should tient care. include a discussion of the following:   

Medication actions and what to expect from treatment (including expected time course) Specific administration instructions The most common adverse effects and how to manage them

REFERENCES 1. Leibowitz K, Ginsburg D. Counseling self-treating patients quickly and effectively. Proceedings of the APhA Inaugural SelfCare Institute; May 17-19, 2002. 2. Fever: first aid. Available from: URL: http:// www.mayoclinic.com/health/first-aid-fever/FA00063 Updated Jan. 13, 2010.

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Dec. 2012 CE — Patient Assessment Skills 3. Dipiro JT, et al (eds): Pharmacotherapy: A Pathophysiologic Approach. 7th ed. McGraw Hill; 2008. SUGGESTED READINGS Beardsley, RS, Kimberlin CL, Tindall WN. Communication Skills in Pharmacy Practice. 5th ed. Philadelphia: Lippincott Williams & Wilkins; 2007. Berardi RR, Ferreri SP, Hume AL, Kroon LA, Newton GD, Popovich NG et al, editors. Handbook of Nonprescription Drugs: An

November 2012 Interactive Approach to Self-Care. 16th ed. Washington DC: The American Pharmaceutical Association; 2009. Jones RM and Rospond RM. Patient Assessment in Pharmacy Practice. 2nd ed. Baltimore (MD): Lippincott Williams & Wilkins; 2006. Longe RL and Calvert JC. Physical Assessment: A Guide for Evaluating Drug Therapy.1st ed. Vancouver: Applied Therapeutics, Inc; 1994.

December 2012—Patient Assessment Skills for Optimizing Self-Care: Introduction and Evaluation of Skin, Hair & Nails

1. Which of the following statements regarding the QuEST/ SCHOLAR process is FALSE? A. It was developed to give pharmacists a structured format for gathering patient information and providing appropriate recommendations for self-care. B. The SCHOLAR method can be used to help evaluate patient symptoms. C. The second step of the QuEST process is to determine whether a patient is an appropriate candidate for selfcare. D. The final step of the QuEST process is to always talk with the patient’s physician before making any self-care recommendations. 2. Which of the following promotes good communication between a patient and a pharmacist? A. Counseling the patient near the phone so you don’t miss any important calls B. Using professional language and terminology to demonstrate your expertise in the area C. Maintaining an open posture and good eye contact D. Using closed-ended questions to make efficient use of your time 3. When evaluating a patient for appropriateness of selfcare, it is important to ask about: A. Current prescription medications and medical conditions B. Dietary supplements and OTC medications C. Current symptoms D. All of the above 4. A child with a fever of 102.5° F should be: A. Self-treated with an OTC anti-pyretic such as acetaminophen or ibuprofen B. Referred to their physician for evaluation C. Self-treated with appropriate non-pharmacologic measures such as fluids and rest D. No treatment or evaluation is necessary 5. A blister less than 0.5 cm in diameter filled with clear liquid is a: A. Papule B. Cyst C. Vesicle D. Bulla 6. ABCDE is an acronym to help remember the signs and symptoms of: A. Melanoma B. Fungal infections C. Chicken pox D. Measles

7. A. B. C. D. E.

Potential causes of Stevens-Johnson syndrome include: Radiation therapy Allopurinol HIV Sulfonamide antibiotics All of the above

8. Stevens-Johnson syndrome is a self-limiting condition that does not require physician referral. A. True B. False 9. Patients that are appropriate candidates for self-care include: A. Adult patients who do not have severe symptoms B. Adults who have symptoms that recur repeatedly without an identifiable cause C. Any patient who prefers to use a “natural” approach in order to avoid seeing a physician D. Most children since OTC treatments are safer than most prescription medications 10. Functional health literacy refers to a person’s ability to: A. Read a physician’s handwriting B. Understand written or verbal health information that is directed toward a patient C. Use appropriate medical terminology D. Understand prescribing information in drug information references such as the Physician’s Desk Reference (PDR) 11. Aspirin should NOT be recommended for the treatment of a fever in a child with a suspected viral illness due to: A. The possibility of stomach upset and diarrhea B. The potential association with Reye’s syndrome C. Poor efficacy when compared to acetaminophen D. The risk of bleeding 12. Which of the following patients’ needs to be referred to a physician for further evaluation? A. An adult patient with a fever accompanied by a severe headache and a stiff neck B. An elderly patient with a temperature of 101.2°F who is on chronic corticosteroids for her underlying lung disease C. An otherwise healthy patient with an oral temperature of 103.5°F D. All of the above

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Dec. 2012 CE — Patient Assessment Skills

November 2012

This activity is a FREE service to members of the Kentucky Pharmacists Association. The fee for non-members is $30. Mail completed forms to: KPERF, 1228 US 127 South, Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile. Expiration Date: October 15, 2015 Successful Completion: Score of 80% will result in 2.0 contact hours or 0.2 CEUs. Participants who score less than 80% will be notified and permitted one re-examination. December 2012 — Patient Assessment Skills for Optimizing Self-Care, Part 1 of 4: Introduction and Evaluation of Skin, Hair and Nails TECHNICIANS ANSWER SHEET. Universal Activity # 0143-9999-12-012-H04-T Name _______________________________________________KY Cert. # __________________________________ Address ________________________________________________________________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 2. A B C D

3. A B C D 4. A B C D

5. A B C D 6. A B C D

7. A B C D E 8. A B

9. A B C D 10.A B C D

11. A B C D 12. A B C D

Personal NABP #___________________________ Birthdate _______________________(MM/DD) December 2012 — Patient Assessment Skills for Optimizing Self-Care, Part 1 of 4: Introduction and Evaluation of Skin, Hair and Nails Universal Activity # 0143-9999-12-012-H04-P PHARMACISTS ANSWER SHEET Name ________________________________________________ KY Lic. # __________________________________ Address ________________________________________________________________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 2. A B C D

3. A B C D 4. A B C D

5. A B C D 6. A B C D

7. A B C D E 8. A B

9. A B C D 10.A B C D

11. A B C D 12. A B C D

Personal NABP #___________________________ Birthdate _______________________(MM/DD) The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education.

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Kentucky Renaissance Pharmacy Museum

November 2012

Congratulations to the Kentucky Renaissance Pharmacy Museum for being recognized as Volunteer Organization of the Year as part of the 2012 Kentucky History Awards! Way to go Gloria Doughty and Lynne Harrelson and the rest of the supporters! The Kentucky Renaissance Pharmacy Museum offers several ways way to show support of the Museum, our state's leading preservation organization for pharmacy. While contributions of any size are greatly appreciated, the following levels of annual giving have been established for your consideration. Friend of the Museum $100  Proctor Society $250 Damien Society $500 Galen Society $1,000 Name_________________________________ Specify gift amount________________________ Address ______________________________ City____________________Zip______________ Phone H_______________W____________ Email___________________________________ Employer name_____________________________________________for possible matching gift Tributes in honor or memory of_____________________________________________________ Mail to: Kentucky Renaissance Pharmacy Museum, P.O.Box 910502, Lexington, KY 40591-0502 The Kentucky Renaissance Pharmacy Museum is a non-profit 501(c)(3) business entity and as such donations are tax deductible. A notice of your tax deductible contributions will be mailed to you annually.

Questions: Contact Lynn Harrelson @ 502-425-8642 or Lharrelsonky@aol.com

KPPAC Contribution Election Year Appeal—Donate Today! Name: _________________________________ Pharmacy: __________________________________________ Address: _________________________ City: ___________________ State: _________ Zip: ____________ Phone: ________________ Fax: __--_______________ E-Mail: ______________________________________ Contribution Amount: $_________ Check ____ (make checks payable to KPPAC)

Mail to: Kentucky Pharmacists Political Advocacy Council, 1228 US Highway 127 South, Frankfort, KY 40601

CONTRIBUTION LIMITS The primary, runoff primary and general elections are separate elections. The maximum contribution from a PAC to a candidate or slate of candidates is $1,000 per election. Individuals may contribute no more than $1,500 per year to all PACs in the aggregate. In-kind contributions are subject to the same limits as monetary contributions.

Cash Contributions: $50 per contributor, per election. Contributions by cashier’s check or money order are limited to $50 per election unless the instrument identifies the payor and payee. KRS 121.150(4) Anonymous Contributions: $50 per contributor, per election, maximum total of $1,000 per election. (This information is in accordance with KRS 121. 150)

THE KENTUCKY PHARMACIST

November 2012

Pharmacy Law Brief

Pharmacy Law Brief: Contemporary Legal Issues for Leadership in Non-Profits - II Author:

Joseph L. Fink III, B.S.Pharm., J.D., Professor of Pharmacy Law and Policy and Kentucky Pharmacists Association Professor of Leadership, Department of Pharmacy Practice and Science, UK College of Pharmacy

Question: I am new to serving on the board of a nonprofit community health agency in my area. During one of the meetings an experienced board member mentioned something called “fiduciary obligations” that I have in that she reasonably believes to be in the best interest of the role. We had no orientation session for new board mem- organization. bers. What is that? Duty of Confidentiality – Highly confidential information Response: At the outset it should be noted that an will be made available to members of the organization’s earlier column in this series, appearing in the November governing body in conjunction with such service. It is the 2008, issue, was entitled “Potential Legal Exposure with duty of a member of the board to maintain such confidentiCommunity Service as a Board Member of a Non-Profit ality. Agency.” Further, a column entitled “Contemporary Legal Duty of Loyalty – A director may not disclose confidential Issues for Leadership in Non-Profits-I” appeared in the information, compete with the organization or assist others September 2012, issue. This installment addresses fiduciwho so compete, usurp a business opportunity of the orary obligations other than potential conflict of interest board ganization, or obtain unfair or secret profits through a transmembers may encounter and supplements or extends action with the organization. those earlier items.

Submit Questions: jfink@uky.edu

Directors of non-profit organizations, irrespective of how one arrived in that position – whether directly elected, appointed or designated by an affiliated organization to serve in that role – have a fiduciary obligation to exercise their powers and judgment in the best interest of the organization of whose board they serve. A fiduciary duty may be described as an obligation to use the faith and trust accorded an individual in the best interest of the organization or entity extending that trust. One’s fiduciary obligations are based on and performed for advancing the interests of the organization, not one’s personal interests. The fiduciary relationship comes into existence when an organization places confidence in a person and that individual accepts that grant of trust. The fiduciary obligation can be broken down into three main categories: Duty of Care – Discharging duties in good faith with the care an ordinarily prudent person in a like position would exercise under similar circumstances in a manner he or

Perhaps the most succinct and best description of fiduciary duty is that one must put aside personal interests to focus on advancing only the interests of the organization being served. Some organizations will ask that members of the board of directors execute a document on an annual basis acknowledging their fiduciary obligations and pledging to abide by them. Disclaimer: The information in this column is intended for educational use and to stimulate professional discussion among colleagues. It should not be construed as legal advice. There is no way such a brief discussion of an issue or topic for educational or discussion purposes can adequately and fully address the multifaceted and often complex issues that arise in the course of professional practice. It is always the best advice for a pharmacist to seek counsel from an attorney who can become thoroughly familiar with the intricacies of a specific situation, and render advice in accordance with the full information.

KPhA sends email announcements weekly. If you aren’t receiving: eNews, Legislative Updates, Grassroots Alerts and other important announcements, send your email address to ssisco@kphanet.org to get on the distribution list. 36

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APSC/HD Smith

November 2012

THE KENTUCKY PHARMACIST

Pharmacy Policy Issues

November 2012

PHARMACY POLICY ISSUES:

What is a Pharmacist’s Role in Direct-to-Consumer Advertising? Author:

Kathleen E. Monson is a fourth-year PharmD student in the College of Pharmacy as well as an MPA degree student in the Martin School of Public Policy and Administration at the University of Kentucky. A native of Rolling Meadows, Ill., she completed her pre-professional work as a Spanish major at the University of Kentucky.

Issue:

More and more patients are coming into the pharmacy asking questions about drugs they see advertised on television. What are the implications of this for the pharmacist?

Discussion: Direct-to-consumer advertising (DTCA) is a relatively new phenomenon that has exploded in the past 15 years. It is estimated that an average American citizen will watch 16 hours of pharmaceutical advertisements per year.1 While images of President Lincoln and talking beavers, dancing balloon bladders and songs like “Viva Viagra” and “Celebrate! Celebrate!” may be entertaining, the surge in DTCA undoubtedly has consequences for the pharmacist. Historically, prescription drug advertisements have been aimed only at prescribers and pharmacists. The surge in DTCA occurred in 1999 when the FDA, which regulates prescription This column is designed to drug advertising, updataddress timely and practical ed the regulations for issues of interest to promotional drug matepharmacists, pharmacy rials. The 1999 update interns and pharmacy allowed for advertisetechnicians with the goal ments to include only being to encourage thought, major risks associated reflection and exchange with the drug’s use instead of every risk. The among practitioners. change in FDA regulaSuggestions regarding topics tion removed the time for consideration are constraining issue of welcome. Please send them describing every risk to jfink@uky.edu. associated with a drug and led to the utilization of DTCA television advertisements.

Have an Idea?:

Today, DTCA is an extremely controversial topic. Proponents of DTCA argue that it may improve patients’ knowledge of drugs and drug availability, encourage patient-provider discussion about health problems, increase

patient participation in health care, remove stigmas attached to certain disease states, remind patients to refill prescriptions and improve adherence. Opponents of DTCA reason that DTCA may confuse patients about drugs, overstate efficacy and downplay risks of using the drug, strain the patient-prescriber relationship, encourage overuse of prescription drugs and increase inappropriate prescribing of expensive drugs.2 Despite the controversy surrounding DTCA, DTCA remains a part of society and impacts patients’ health care. Under the FDA’s new “Bad Ad Program”, which seeks to promote fair, balanced and not false or misleading DTCA, pharmacists are encouraged to understand the four basic requirements of DTCA and report suspected violations to the FDA.3 DTCA is required to: 1. Be accurate. 2. Balance risk and benefit information. 3. Be consistent with the prescribing information approved by the FDA. 4. Only include information that is supported by strong evidence from clinical trials. Suspected violations may be reported to the FDA by phone, email, fax or in writing. The phone number is 877RX-DDMAC (877-793-3622) and the email address is BadAd@fda.gov. Pharmacists are well positioned to recognize DTCA firsthand and through interactions with patients. Reporting suspected violations to the FDA will help to ensure that patients’ receive appropriate information. Beyond recognizing and reporting suspected DTCA violations to the FDA, pharmacists should be prepared to engage in conversations with patients about drugs they have seen advertised on television. The pharmacist should dis-

THE KENTUCKY PHARMACIST

November 2012

Pharmacy Policy Issues

cuss why the patient thinks the medication is needed and June 2011;37(2/3):444-467. respond with accurate information regarding the medication 2. Keeping Watch Over Direct-to-Consumer Ads. FDA and disease state. If the medication is for an undiagnosed Consumer Health Information: U.S. Food and Drug Adcondition, it is important to remind the patient that they need ministration. May 10, 2010. Available at: http:// to discuss the symptoms with their prescriber. The pharmawww.fda.gov/ForConsumers/ ConsumerUpdates/ cist should note that many times the condition many appear ucm107170.htm. Accessed February 12, 2012. more common in DTCA than in reality. Additionally, the pharmacist should remind the patient that the medication on 3. Truthful Prescription Drug Advertising and Promotion (Bad Ad Program). U.S. Food and Drug Administratelevision may not be the best treatment option or the most tionâ&#x20AC;&#x2122;s Division of Drug Marketing, Advertising, and cost efficient option. Communications. October 17, 2011. Available at: http:// References www.fda.gov/Drugs/ 1. Mulligan L. You Can't Say That on Television: ConstituGuidanceComplianceRegulatoryInformation/ Surveiltional Analysis of a Direct-to-Consumer Pharmaceutical lance/DrugMarketingAdvertisingandCommunications/ Advertising Ban. American Journal of Law & Medicine, default.htm. Accessed February 12, 2012.

2012 KPhA Mid-Year Conference on Legislative Priorities & Emergency Preparedness November 30-December 1 * Embassy Suites Lexington

KPhA Government Affairs Contribution Election Year Appealâ&#x20AC;&#x201D;Donate Today! Name: ______________________________________________________________

Pharmacy: ___________________________________________________________ Email: ______________________________________________________________ Address: _____________________________________________________________ City: _______________________________________________ State: _________ Zip: ____________ Phone: ________________ Fax: __--_______________ E-Mail: ______________________________ Contribution Amount: $_________ Check ____ (make checks payable to KPhA Government Affairs) Credit Card (AMEX; Discover; MasterCard; VISA) Account #: ____________________________________________________ Expiration date: _______ Address to which credit card statement is mailed (if different from above) ___________________________________________________________________________________

Mail to: Kentucky Pharmacists Association, 1228 US Highway 127 South, Frankfort, KY 40601

THE KENTUCKY PHARMACIST

November 2012

Pharmacists Mutual

THE KENTUCKY PHARMACIST

Senior Care Corner

November 2012

Senior Care Corner from the KPhA Academy of Consultant Pharmacists Planning for the Joint KPhA LTC Academy - ASCP KY Chapter Spring CE meeting has begun! If youâ&#x20AC;&#x2122;d like to get involved as a participant, speaker, or sponsor, please contact Jason.Baker@flexiblerx.com / 502-741-6578 or elisha.bischoff@pcapharmacy.com / 1-800-445-8917

135th KPhA Annual Meeting June 6-9, 2013 Louisville Marriott Downtown Mark your calendars today! More details to come on www.kphanet.org and social media sites.

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KPhA Board of Directors

November 2012

KPhA BOARD OF DIRECTORS

HOUSE OF DELEGATES

Lewis Wilkerson, Frankfort rphs2@aol.com

Chairman 502.695.6920

Matt Martin, Louisville matt67martin@gmail.com

Kimberly Croley, Corbin kscroley@yahoo.com

President 606.304.1029

Cassandra Beyerle, Louisville Vice Speaker of the House cbeyerle01@gmail.com

Duane Parsons, Richmond dandlparsons@roadrunner.com

President-Elect 502.553.0312

KPERF ADVISORY COUNCIL

Frankie Hammons Abner, Barbourville frankiehammons@gmail.com

Secretary 606.627.7575

Glenn Stark, Frankfort glennwstark@aol.com

Treasurer

Donnie Riley, Russelville Past President donnierileyatclinicpharmacy@msn.com Directors Molly Trent, Georgetown mjtren2@uky.edu

Student Representative

Lance Murphy, Louisville lmurph8942@my.sullivan.edu

Student Representative

Matt Carrico, Louisville matt@boonevilledrugs.com Chris Clifton, Erlanger chrisclifton@hotmail.com Trish Freeman, Lexington* trish.freeman@uky.edu Joey Mattingly, Prospect joeymattingly@gmail.com Jeff Mills, Louisville jeff.mills@nortonhealthcare.org Bob Oakley, Louisville roborx13@aol.com Richard Slone, Hindman richardkslone@msn.com Sam Willett, Mayfield duncancenter@bellsouth.net * At-Large Member to Executive Committee

Speaker of the House

Kim Croley, Corbin kscroley@yahoo.com Ann Amerson, Lexington amerson@insightbb.com

KPhA/KPERF HEADQUARTERS 1228 US 127 South, Frankfort, KY 40601 502.227.2303 (Phone) 502.227.2258 (Fax) www.kphanet.org www.facebook.com/KyPharmAssoc www.twitter.com/KyPharmAssoc Robert McFalls, M.Div. Executive Director rmcfalls@kphanet.org Scott Sisco, MA Director of Communications and Continuing Education ssisco@kphanet.org Kelli Sheets Office Manager ksheets@kphanet.org Christine Richardson, PharmD Clinical Pharmacist, Interim Director of Professional & Clinical Services crichardson@kphanet.org Leah Tolliver, PharmD Director of Pharmacy Emergency Preparedness ltolliver@kphanet.org Nancy Baldwin Receptionist/Office Assistant nbaldwin@kphanet.org Angela Gibson Administrative Coordinator & Billing Specialist (Temporary placement) agibson@kphanet.org

THE KENTUCKY PHARMACIST

50 Years Ago/Frequently Called and Contacted

November 2012

50 Years Ago at KPhA Jacob Wishnia, R.Ph, Louisville, will open a new drug store in the Middletown Plaza Shopping Center. A feature of the store will be a luncheonette which will be a vending machine type, serving hot and cold sandwiches, soups, juices, pastries, coffee, milk and ice cream. Mrs. Wishnia, who is also a registered pharmacist, will assist her husband in the operation of the new store. â&#x20AC;&#x201C; From The Kentucky Pharmacist, November 1962, Volume XXIV, Number 1.

Frequently Called and Contacted Kentucky Pharmacists Association 1228 US 127 South Frankfort, KY 40601 (502) 227-2303 www.kphanet.org Kentucky Board of Pharmacy State Office Building Annex, Ste. 300 125 Holmes Street Frankfort, KY 40601 (502) 564-7910 www.pharmacy.ky.gov Pharmacy Technician Certification Board 2215 Constitution Avenue Washington, DC 20037-2985 (800) 363-8012 www.ptcb.org Kentucky Society of Health-System Pharmacists P.O. Box 4961 Louisville, KY 40204 (502) 456-1851 x2 (502) 456-1821 (fax) www.kshp.org info@kshp.org

Kentucky Regional Poison Center (800) 222-1222 American Pharmacists Association (APhA) 2215 Constitution Avenue NW Washington, DC 20037-2985 (800) 237-2742 www.aphanet.org National Community Pharmacists Association (NCPA) 100 Daingerfield Road Alexandria, VA 22314 (703) 683-8200 info@ncpanet.org Drug Information Center Sullivan University College of Pharmacy 2100 Gardiner Lane Louisville, KY 40205 (502) 413-8638 www.sullivan.edu

KPhA Remembers KPhA desires to honor members who are no longer with us. Please keep KPhA informed by sending this information to ksheets@kphanet.org. Deceased members for each year will be honored permanently at the KPhA office. 43

THE KENTUCKY PHARMACIST

November 2012

THE

Kentucky PHARMACIST 1228 US 127 South Frankfort, KY 40601

Save the Dates! KPhA Mid-Year Conference on Legislative Priorities & Emergency Preparedness November 30-December 1, 2012 Embassy Suites, Lexington 135th KPhA Annual Meeting June 6-9, 2013 Louisville Marriott Downtown Visit www.kphanet.org for more.

THE KENTUCKY PHARMACIST