the kentucky pharmacist vol. 7 #6

News & Information for Members

of the Kentucky Pharmacists Association

Vol. 7, No. 6

November 2012

TTHEHE KKENTUCKYENTUCKY

PPHARMACISTHARMACIST

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

KPhA is

YOUR voice

in Frankfort!

Help us craft

YOUR message

for 2013

Kentucky Pharmacy loses innovator

Dean Emeritus Joseph V. Swintosky

December 14, 1921—September 13, 2012

2012 CE Reminder:

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!

November 2012

THE KENTUCKY PHARMACIST 2

Table of Contents

Table of Contents

Table of Contents— Oath— Mission Statement 2 President’s Perspective 3 Dean Joseph Swintosky 4 New KPhA Website 5 New KPhA Members 6 Message from your Executive Director 7 KPhA Mid-Year Conference 8-9 Continuing Education Article Guidelines 10 Bowl of Hygeia 11 November CE—Restless Leg Syndrome 12-25

November Pharmacist/Pharmacy Tech Quiz 26 December CE— Patient Assessment Skills 27-33 December Pharmacist/Pharmacy Tech Quiz 34 Kentucky Renaissance Pharmacy Museum 35 Pharmacy Law Brief 36 APSC/HD Smith 37 Pharmacy Policy Issues 38 Pharmacists Mutual 40 Senior Care Corner 41 KPhA Board of Directors 42 50 Years Ago/Frequently Called and Contacted 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.

Kentucky Pharmacists Association

The mission of the Kentucky Pharmacists Associa-

tion is to promote the profession of pharmacy, en-

hance the practice standards of the profession, and

demonstrate the value of pharmacist services within the

health care system.

Editorial Office:

© Copyright 2012 to the Kentucky Pharmacists Asso-ciation. The Kentucky Pharmacist is the official journal of the Kentucky Pharmacists Association published bi-monthly. The Kentucky Pharmacist is distributed to KPhA members, paid through allocations of member-ship 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 [email protected]. Website http://www.kphanet.org.

The Kentucky Pharmacy Education and Research Foun-

dation (KPERF), established in 1980 as a non-profit sub-

sidiary corporation of the Kentucky Pharmacists Associa-

tion (KPhA), fosters educational activities and research

projects in the field of pharmacy including career coun-

seling, student assistance, post-graduate education, con-

tinuing and professional development and public health

education and assistance.

It is the goal of KPERF to ensure that pharmacy in Ken-

tucky and throughout the nation may sustain the continu-

ing need for sufficient and adequately trained pharma-

cists. KPERF will provide a minimum of 15 continuing

pharmacy education hours. In addition, KPERF will pro-

vide at least three educational interventions through oth-

er mediums — such as webinars — to continuously im-

prove 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 im-

prove the overall programming designed by KPERF.

November 2012


President’s Perspective

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 re-

cently learned that my dean, Dean Joseph Swintosky,

passed away at the age of 90 after an illness. I ad-

mired 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 phar-

macist. 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 in-

ternational 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 recruit-

ing 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-

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 pro-

fession 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 Ken-

tucky, 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 din-

ner 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 gradu-

ated a couple of years later, I joined the dinner pro-

viders as well. (Yes, we were all Phi Delta Chi broth-

ers!) I first met Jordan at the APhA meeting in Chica-

go and we invited him to eat with us. When he found

out we were buying dinner for the students in attend-

ance, 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 cer-

tainly our gain! Ken was the “student’s dream dean”.

Kimberly Sasser

Croley

KPhA President

2012-2013

President’s Perspective

Continued on Page 5

November 2012


Dr. Joseph V. Swintosky

Dean Emeritus Joseph V. Swintosky, a leg-

endary educator and scientist who helped

lead the University of Kentucky College of

Pharmacy to national and international promi-

nence during his tenure as dean from 1967 to

1987, passed away Sept. 13, 2012. He was

90 years old.

Dr. Swintosky, who resided in Nicholasville,

Ky., was married to Dorothy (Zevnik) Swin-

tosky, who is also a pharmacist. The couple

had nine sons and one daughter.

Dr. Swintosky, a native of Kewaunee County, Wisc., re-

ceived his bachelor of science degree and PhD in pharma-

cy from the University of Wisconsin. An accomplished edu-

cator, product formulation scientist and recipient of numer-

ous national honors, Dr. Swintosky is probably best known

for his innovative work to transform pharmacy education

and the pharmacy profession while at UK.

On Jan. 1, 1967, he became the fourth Dean of the UK Col-

lege of Pharmacy and, almost immediately, started recruit-

ing 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 Swin-

tosky placed UK on a trajectory to become one of the na-

tion’s top colleges of pharmacy. We would not be the Col-

lege we are today without his innovative spirit and his com-

mitment to excellence in all we do. This College – and the

profession of pharmacy – is forever indebted to Dean Swin-

tosky.”

Under Dr. Swintosky’s leadership, the UK College of Phar-

macy became known worldwide as a place where pharma-

cy 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 phar-

macy in a medical center setting in 1968.

• UK became one of the nation’s first schools to create a

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 Medi-

cal Center, Dr. Swintosky worked with profes-

sors Paul Parker and Charles Walton to

change the face of clinical pharmacy. A phar-

macist joining medical doctors on their daily

rounds was an innovation created at the UK

Medical Center. It is now an industry standard.

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 Ameri-

can Pharmacists Association (APhA) Academy of Pharma-

ceutical Sciences (now known as the APhA Academy of

Pharmaceutical Research and Science) and became its

second president in 1967. He received numerous APhA

awards.

At UK, the Dr. Joseph V. Swintosky Distinguished Lecture

Series was established in his honor in 1994.

Legendary UK College of Pharmacy

Dean Joseph V. Swintosky passes away

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.

November 2012


New KPhA Website

Coming this month!

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

He was the great motivator, he made everyone want

to do better, be better. He dreamed big, and he drew

everyone into his dream. Under his tutelage, we got a

new and bigger and better and amazing building that

would not have happened without him. It should be

named for him but that is another story. When Dean

Roberts stepped away from day to day deanly re-

sponsibilities to become Dean Emeritus, we attracted

Tim Tracy away from the University of West Virginia.

Ginger Scott gave him high praise and deservedly so!

In no time, Dean Tracy’s leadership and administra-

tive abilities have earned him the honor of being

named Interim Provost. Now, I would be remiss if I

stopped here because our state has the honor of now

hosting a second College of Pharmacy at Sullivan

University in Louisville. They have been ably led and

nurtured under the care and tutelage of their Inaugu-

ral Dean, Dr. Hieu Tran. Dean Tran is a quiet, unas-

suming person who uses example and gentle persua-

sion to mold the students at his beloved SUCOP.

Dean Tran and SUCOP have been a welcome addi-

tion to our Kentucky Pharmacy family and his gradu-

ates are the finest examples of his work.

Now you are all saying, how is this relevant? I say to

you, the Dean of your alma mater college of pharma-

cy is the most relevant person from your college of

pharmacy years, even if you didn’t know them by first

name. They set the tone for the education you re-

ceive, the practice choices you make and the dreams

you dream. Relationships with other student pharma-

cists, the faculty and staff, and yes, the dean, help

mold us all into the pharmacists we are now.

Continued from Page 3

November 2012


KPhA New Members

KPhA Welcomes New

and Returning Members

August through October 2012

Pharmacy Time Capsules

1987—Twenty-five years ago:

Clinical Sciences Section formed within the American Pharmaceutical (now Pharmacists) Association Acade-

my 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 organiza-

tions.

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 satisfac-

tion 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

Bobby Bero Frankfort, KY Joseph A. Bickett Louisville, KY Phillip C. Brewer London, KY Sam Brown Murray, KY William Brown Mayfield, KY

Don A. Carpenter Olive Hill, KY Adam Coffman Nortonville, KY Elizabeth Y. Cole Louisville, KY Everett L. Dunaway Jackson, KY Portia Hall Dunaway Jackson, KY Sherri Forrest Brentwood, TN

Kyle T. Harris London, KY Ella Louise Johnson Hazard, KY Heather Johnson Livermore, KY Megan A. Kramer Fairfield, CA Jill E. Lee Frankfort, KY John W. McMeans Ashland, KY

Lindsey Peden Bowling Green, KY Jonathon Ratley Sturgis, KY Joshua Ricketts Harrogate, TN Brian K. Wells Owensboro, KY William David Wiley Glasgow, KY

November 2012


From Your Executive Director

MESSAGE FROM YOUR

EXECUTIVE DIRECTOR

Robert “Bob” McFalls

Although November is a month built upon reflection and

Thanksgiving, it also kindly reminds us of the first year an-

niversary 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 every-

thing before us, we had nothing before us, we were all go-

ing 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 re-

ceived, for good or for evil, in the superlative degree of

comparison only."

It would be an understatement to say that there have been

many changes in the months past, and yet we are quick to

acknowledge there will be even more. Managed care is

being reported to be saving dollars in terms of public ex-

penditures but comes with the concurrent reality of reduc-

tions in reimbursements and dispensing fees for pharma-

cies. On the brighter side of the equation, however, the

pharmacist’s role in Medication Therapy Management

(MTM) programs continues to garner attention and offers a

viable business alternative with respect to providing a valu-

able service to patients. Initially authorized by the Medicare

Modernization Act, CMS established the initial require-

ments for MTM programs, and MTM has evolved since

2006 through Part D, Medicaid in some states and a few

private health plans. In accordance with CMS require-

ments, all targeted Part D beneficiaries who are eligible are

automatically enrolled in MTM, and all programs offer a

comprehensive medication review (CMR) at least annually.

MTM programs offer telephonic consultations, and a grow-

ing number (+25 percent) now offer face-to-face CMRs.

Nationally, 80 percent of the plans target beneficiaries with

three 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

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 pharma-

cy association executives from nine states. Paramount to

our strategic discussion was how pharmacists and the as-

sociations that represent them can work together both to

advance MTM efforts and to achieve provider status in or-

der to be financially recognized as providers. Advancing

the value of MTM is critical given the fact that medication

use and medication related problems are major problems

throughout the current health care system. As cited by

APhA, “medication-related problems and medication mis-

management are a massive public health problem in the

U.S. Experts estimate that 1.5 million preventable adverse

events occur each year that result in $177 billion in injury &

death.” This information is compounded given the dramatic

increases in life expectancy during the past century as a

result of the major shift in the leading causes of death and

disability in all age groups, including disease states for old-

er persons. Causes of death have shifted from infectious

diseases and acute illnesses to chronic and degenerative

diseases (CDC, 2003). Even with these advances, life ex-

pectancy at age 65 in our nation continues to lag behind

that of many other industrialized nations signaling that even

more can be done in terms of health interventions.

Enter the role of the pharmacist. In my humble opinion, it is

not a matter of "if", but "when" for the majority of pharma-

cists as a profession to heartily become engaged in ad-

MTM—it is no longer a question of IF, but WHEN…

Continued on Page 10

November 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.

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.

KPhA is YOUR voice in Frankfort!

Help us craft the message for 2013!

The Kentucky Pharmacy Education

& Research Foundation is accredit-

ed by The Accreditation Council for

Pharmacy Education as a provider

of continuing Pharmacy education.

2012 Mid-Year Conference

November 2012


@KyPharmAssoc

@KPhAGrassroots Facebook.com/KyPharmAssoc

Kentucky Pharmacists Association

Are you Connected to KPhA? Join us online!

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)

Conference Agenda

2012 Mid-Year Conference

November 2012



vancing their work with Medication Therapy Management.

The rapid growth in the older population, a health care de-

livery system that is focused on quality outcomes and cus-

tomer interactions, CMS requirements to reduce hospital

readmissions, the inclusion of MTM for long term care resi-

dents under Part D in 2013, the decreasing numbers of pri-

mary 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 en-

vironment that shouts for the pharmacist's expertise and

response. Our health care system has readily reimbursed

acute care services since Medicare and Medicaid were au-

thorized 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 inter-

ventions, leading to an improved quality of life and the po-

tential to maintain functional abilities in terms of personal

independence. Not surprisingly, chronic disease manage-

ment is associated with high prescription drug costs. In

2008, older persons who didn't have chronic health condi-

tions 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 com-

mon combinations of chronic conditions — hypertension

and diabetes, hypertension and heart disease, and hyper-

tension and cancer — increased dramatically from nine to

15 percent; the prevalence of hypertension and heart dis-

ease increased from 18 to 21 percent; and the prevalence

of hypertension and cancer increased from eight to 11 per-

cent. For the most recent 10-year period that was studied

(1999-2000 and 2009-2010), the use of hypertension medi-

cations 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 condi-

tions 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 ex-

perts on the health care team. It is time that we advance

the conversation and get others to recognize what the evi-

dence 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 experi-

enced 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 dis-

charge orders, engage and collaborate with prescribers,

enhance communication and education, dispense needed

prescriptions—all the while assuring better health care out-

comes 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 pa-

tients. Similarly, this Institute encourages patients to active-

ly participate in the health care process to prevent medica-

tion related problems. Clearly, the health care delivery sys-

tem is recognizing through its quality initiatives that the

Boomer generation clearly intends to be involved in their

own health care discussions and deliberations. This para-

digm shift has significant implications for health care provid-

ers 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 con-

vinced through KPhA’s engagement with Rx Therapy Man-

agement — 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 re-

commit to exploring these opportunities that are for phar-

macists to take. If pharmacists do not claim this role, then

other health care professionals will. There are already rum-

blings to this effect. To this end, we were pleased to see

the recent release of a new report that highlights the effec-

tiveness 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 Integrat-

ed Medication Management (AIMM), recently highlighted

how this report is demonstrating how interprofessional

Continued from Page 7

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 ap-

proach to care that includes a pharmacist to help patients

manage their medication. The report, Advancing Clinical

Pharmacy Services in Programs Funded by the Health Re-

sources 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 im-

proving 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 fur-

ther 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 condi-

tions." The report includes a number of important recom-

mendations, 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 col-

leges 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 pharma-

cy 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 Asso-

ciation 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 criti-

cal therapy needs as well as support for addressing provid-

er 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 out-

patient 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 coor-

dination across providers and potentially reduce economic

disincentives…for robust MTM programs.” Like most of the

nation, Kentucky’s older population is on a rapid accelera-

tion trajectory. Between now and the year 2050, the num-

ber of individuals age 65 and older will increase by an in-

credible 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 foreseea-

ble 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. Charles Dickens, A Tale of Two Cities, Book 1, Chapter 1.

ii. 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, Ad-vancing 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 Re-sources 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.

November 2012


Nov 2012 CE—Restless Leg Syndrome

Rotigotine (Neupro®) in the Treatment of Restless Leg Syndrome By: Kathleen Balling, Pharm.D. Candidate 2013, College of Pharmacy, University of Kentucky Samantha Gubser, Pharm.D. Candidate 2013, College of Pharmacy, University of Kentucky, and 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.

KPERF offers all

CE articles to

members online at

www.kphanet.org

Introduction

Approximately 4 to 12 percent of the population experienc-

es 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 subjec-

tive 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 treat-

ment options available.

Rotigotine (Neupro®) is a dopamine agonist formulated as

a once-daily transdermal patch. In addition to being previ-

ously indicated for the treatment of idiopathic Parkinson’s

disease, the FDA recently approved rotigotine for the treat-

ment of moderate-to-severe primary RLS. The only other

medications FDA approved for the treatment of RLS are

pramipexole, ropinirole and gabapentin enacarbil. Rotigo-

tine has been shown to be effective in improving RLS

symptoms and its availability as a transdermal patch differ-

entiates it from other available treatment options

(pramipexole, ropinirole, levodopa/carbidopa, anti-

convulsants, opioids and benzodiazepines). Rotigotine,

therefore, can be utilized as an efficacious alternative to

oral medications in the same class.

Restless Legs Syndrome

Background

RLS, also known as Willis-Ekbom disease, was first de-

scribed by Willis in the 17th century and further investigated

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 im-

mensely.

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 increas-

es 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 fe-

males is about twice than that observed in males.9 Similar-

ly, 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 ac-

curate representation of the amount of people that actually

suffer from RLS symptoms. The diagnosis relies on subjec-

tive 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

Although RLS is a very common disorder, it is generally

November 2012



under-diagnosed.3 Many physicians ignore RLS symptoms

or incorrectly treat RLS.11

Due to the lack of definitive la-

boratory or clinical tests, accurately diagnosing RLS is diffi-

cult. 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.

RLS presents with a varying array of both motor and sen-

sory symptoms, which generally occur while relaxed or

sleeping.13

A specific feature of RLS is motor restlessness

in which patients have akathisia (irresistible need or urge to

move their limbs), and this sensation is partially or com-

pletely resolved by movement.2,14

Because of these symp-

toms, many patients have difficulty sleeping and often ex-

hibit daytime sleepiness.7 RLS is one of the leading causes

of sleep disturbances and approximately nine out of 10

RLS patients report at least one sleep-related problem.13,15

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 ten-

sion, “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. Ap-

proximately 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.

Based upon their symptom presentation, patients can be

divided into three groups for treatment: intermittent symp-

toms, daily symptoms and symptoms that are refractory to

standard treatments.20

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 ac-

cordingly. 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).

IRLS was created by The International Restless Legs Syn-

drome 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 symp-

toms) to 4 (very severe symptoms).21

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 symp-

toms occurring when the patients are resting during the

day. In addition, patients should also disclose the severity

of tiredness during the day and level of sleep satisfaction.

The scales are not combined, however, to calculate a total

score. Instead, the values are assessed independently and

used to observe changes that occur with time.22

The CGI scale is a measure used to obtain global assess-

ments of illness.23

This scale follows the patient over a pe-

riod of time to assess changes in symptoms and disease

progression, and therefore is most often used in therapeu-

tic trials and to assess the efficacy of therapeutic interven-

tions. 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 7-

point 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

Etiology

Although the exact mechanism through which RLS devel-

ops 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

Table 1: Diagnosis Guidelines as

Established by the International RLS Study12

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.

November 2012



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.

Primary RLS

Primary RLS, often referred to as idiopathic or familial, is

the most common type of RLS and is usually a lifelong con-

dition 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 pa-

tients with RLS will eventually develop the disease.12

He-

reditary 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

The exact cause of primary RLS is still not well understood,

but many theories have been proposed. Researchers be-

lieve that the cause of RLS is probably related to the body’s

dopaminergic mechanisms and iron homeostasis. Dopa-

minergic mechanisms are thought to be involved because

symptomatic relief has been observed in RLS patients us-

ing dopamine agonists. Conversely, patients using dopa-

mine antagonists experience a worsening of symp-

toms.15,29,30

Likewise, dopamine also seems to be implicat-

ed in the disease as a result of dopamine’s role in circadian

rhythms and the corresponding worsening of RLS symp-

toms during the night hours.31

Serum iron levels have circa-

dian rhythms similar to dopamine; therefore, iron is also

thought to be implicated in the etiology of RLS.32

In fact,

almost 75 percent of patients with RLS symptoms have

been found to have decreased iron stores.33

The two mech-

anisms may be related through tyrosine hydroxylase, the

rate limiting enzyme for dopamine production, which uses

iron as a cofactor.32

Secondary RLS

Secondary RLS usually develops from an underlying condi-

tion 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

Medications that Exacerbate RLS

Various medications have been associated with the exacer-

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 experi-

ences 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, espe-

cially during forced immobilization such as an airplane

flight.40

Sleep hygiene has also been shown to help with

nighttime symptoms. Patients should go to bed and wake

up at the same time each day. Sleep environments should

be kept quiet and comfortable, and the bed should be used

only for sleep and sexual activity.20,41-43

Avoidance of caf-

feine, nicotine and alcohol which exacerbate RLS symp-

toms also should be utilized.20

Massage, stretching and

moderate exercise also have been shown to possibly de-

crease patients’ symptoms.43

Pharmacologic Treatment Options

Various medications are utilized for the treatment of RLS.

Of these medications, those classified as dopaminergic

agents are considered to be first-line for RLS treatment.42,44

The medication should be chosen on an individualized ba-

sis due to differing levels of efficacy and tolerability

amongst patients. A summary of the medications used for

treating the symptoms associated with RLS can be found in

Table 3.20,45-48

Iron-Replacement Therapy

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 ade-

quate iron and should not be used as treatment in patients

with primary RLS. Patients should receive iron supplemen-

tation 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.

Intravenous iron sucrose is well tolerated and has demon-

Table 2: Medications Associated with RLS

Symptom Exacerbation20,35-39

Tricyclic Antidepressants Selective Serotonin Reuptake Inhibitors Lithium Dopamine Antagonists Antihistamines Caffeine

November 2012



strated the ability to decrease the symptoms of RLS in pa-

tients 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

Supple-

mental oral iron treatments can be used to sustain the im-

provements that were achieved previously with the single

intravenous treatment.45

Maintenance intravenous iron sup-

plementation is considered likely efficacious for secondary

RLS due to end-stage renal disease and remains simply

investigational for RLS patients with normal renal func-

tion.45

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 con-

gestion, swelling of the hands or feet, bloating, chest pain,

nausea and vomiting.42,57,58

Withdrawal symptoms can oc-

cur upon discontinuation of any dopaminergic agent when

treating RLS and are directly related to the dose and dura-

tion of use of the drug. This intensification of RLS symp-

toms is most severe in the first 48 hours and symptoms

often return to baseline after four to seven days.

Levodopa is the most studied dopaminergic agent and is

always combined with a dopa-decarboxylase inhibitor (e.g.,

carbidopa). Levodopa has been shown to increase sleep

time, quality of sleep and quality of life for patients with

RLS.59,60

Levodopa can cause adverse effects such as

nausea, headaches and dry mouth, but the possibility of

rebound and augmentation are the greatest hindrances to

its use.60-62

Rebound refers to the return of symptoms as

the medication wears off and can occur in 20-35 percent of

patients.20,62

These symptoms can return in the middle of

the night, causing sleep disturbances for the patient and

his/her partner. The utilization of combined sustained re-

lease and regular release formulations can combat this.59,63

Similarly, augmentation, which involves the worsening of

RLS symptoms at an earlier time of day, earlier onset while

at rest, more severe symptoms or shorter relief after the

administration of medication, is the most commonly en-

countered complication of long-term levodopa therapy and

occurs in about 80 pecent of patients.42,64-66

While more

prominent with levodopa, it can be seen to a lesser extent

with long term use of any dopaminergic agent and affects

about 20-30 percent of patients taking dopamine ago-

nists.45,67-70

Augmentation can be treated by changing to a

different medication or giving the dose of medication earlier

in the day.20

Dopamine agonists (DA), such as pramipexole and ropin-

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 pa-

tient presents with daytime symptoms, the usual dose can

be divided up to provide longer intervals of symptom re-

lief.72

In one study, prolonged therapy with these agents for

greater than six months showed maintained efficacy. Slight

augmentation, however, requiring an earlier onset of treat-

ment occurred in 48.2 percent of patients, and severe aug-

mentation was seen in 21.7 percent of patients. The risk of

augmentation development varies depending upon the DA

medication utilized. The rates of augmentation observed

with the long-term use of DA include: pramipexole (8 per-

cent to 32 percent)73-75

and ropinirole (2.3 percent)76

. Ad-

verse effects such as daytime sleepiness, nausea, periph-

eral edema, dizziness or light headedness, gastrointestinal

upset, constipation, headache, itchiness and rash were

reported by 56.7 percent of subjects.48

Anti-convulsants

Gabapentin is the most used second-line drug among the

anticonvulsant medications for RLS. The disease benefits

from a combination of sedative and sensory modulating

activity that gabapentin provides.45,77,78

Gabapentin enacar-

bil, a gabapentin prodrug with better absorption and a bet-

ter pharmacokinetic profile, is FDA-indicated for the treat-

ment of RLS.79

Other agents such as carbamazepine,

lamotrigine, valproate, levetiracetam and pregabalin have

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

Table 3: Pharmacologic Treatment Options20,45-48

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

November 2012



not been confirmed. The studies that did demonstrate effi-

cacy consisted of few subjects or were open-label.80-87

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 symp-

toms.45,88-92

Open-label studies have shown an improve-

ment in subjective ratings of the patient’s symptoms and

reduced occurrence of PLMS with opioid therapy.42,44

Benzodiazepines

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 elder-

ly population as a result of increased sedation escalating a

patient’s risk of falling.

Rotigotine (Neupro®) as a New Treatment Option

Mechanism of Action

Rotigotine is classified as non-ergot dopamine agonist that

exerts agonistic activity on the D1 through D5 dopamine

receptors with the highest activity at the D3 receptor.96

In

addition, rotigotine acts as a serotonergic agonist on 5-

HT1A receptors and as an α-adrenergic antagonist on α2B

receptors.96,97

Labeled Indications

Rotigotine is indicated for (1) the treatment of the signs and

symptoms of idiopathic Parkinson’s disease and (2) the

treatment of moderate-to-severe primary restless legs syn-

drome.47

Formulation

Transdermal Patch

Rotigotine possesses a very low oral bioavailability due to

undergoing extensive first-pass metabolism.98

Because of

this, rotigotine was formulated as a silicone-based trans-

dermal patch.97

The patch is formulated as a matrix-type

transdermal system that contains a backing film, a matrix

containing the drug, and a protective layer.99

This formula-

tion allows for once daily dosing and continuous stimulation

of dopamine receptors.100

The medication delivered trans-

dermally through the utilization of a patch results in a

steady release of the drug and stable concentrations in the

plasma for a duration of 24 hours.101

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

amount of the drug placed in the matrix is greater than the

saturation solubility of the drug in the adhesive, a supersat-

urated, unstable matrix results.104-106

A medication in this

type of supersaturated matrix will eventually recrystallize

and cause changes in drug delivery. Crystallization results

in the patch becoming unstable and possessing less adhe-

siveness, the reduction in the amount of drug contained in

the patch and a decrease in the original drug delivery

demonstrated by a specific formulation of the patch.107,108

A

number of additives are available to inhibit crystallization

from occurring by stabilizing the system.108

In 2008, rotigotine was withdrawn from the market as a re-

sult of crystal formation in the patches.109

Recently, the

FDA approved a new formulation of the patch that became

available in the United States in July. In addition to rotigo-

tine, the patch also consists of inactive ingredients which

include ascorbyl palmitate, povidone, sodium metabisulfite,

dl-alpha-tocopherol and a silicone adhesive.47

Povidone

inhibits crystallization as well as enhancing the solubility of

the medication.110

The remaining inactive ingredients, with

the exclusion of the silicone adhesive, are antioxidants

used to prevent a possible decline in medication penetra-

tion as a result of oxidation.

Pharmacokinetics

In a study conducted to assess the pharmacokinetics of

rotigotine, Cawello, et al. found the absolute bioavailability

of transdermal rotigotine to be 37 percent with an apparent

Table 4: Patch Size and Rotigotine Content

Patch Size Actual Rotigotine

Content

Strength

of Patch

5 cm2 2.25 mg 1 mg/24 h

10 cm2 4.5 mg 2 mg/24 h

15 cm2 6.75 mg 3 mg/24 h

20 cm2 9 mg 4 mg/24 h

30 cm2 13.5 mg 6 mg/24 h

40 cm2 18 mg 8 mg/24 h

November 2012



ATTENTION PHARMACISTS AND PHARMACY TECHNICIANS

TAKING THIS QUIZ!

You MUST provide YOUR NABP e-Profile ID and birthdate

(Month and Day only) on the answer sheet to receive

CE credit for this activity.

Visit www.kphanet.org/CPEMonitor for more.

dose equal to 61.4 percent of the total drug contained in

the patch; thus, greater than 60 percent of the dose ab-

sorbed is bioavailable.111

Rotigotine is extensively metabo-

lized by the liver through conjugation and N-dealkylation

into metabolites that do not exhibit any pharmacologic ac-

tivity.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 por-

tion 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 remov-

ing the patch.111

Clinical Studies

A number of clinical studies have been conducted to as-

sess the effectiveness and safety of rotigotine in the treat-

ment of RLS. These studies vary in the methods imple-

mented, 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

Oertel, et al. conducted a study to evaluate the efficacy and

safety of five rotigotine doses during a six-week period and

also used a placebo group for comparison.114

The study

consisted of 341 patients and the doses used were 0.5

mg/24 h, 1 mg/24 h, 2 mg/24 h, 3 mg/24 h and 4 mg/24 h.

Patient outcomes were assessed to determine the lowest

dose in which the medication was effective in improving

symptoms. The efficacy was measured through the utiliza-

tion of baseline scores from IRLS, RLS-6 and CGI scales.

Symptom improvement with administration of rotigotine

was found to be statistically significant in comparison to

placebo for all of the doses except 0.5 mg/24 h.114

The

IRLS score after the six-week treatment period in compari-

son to the baseline score improved by -10.6 (0.5 mg/24 h),

-15.1 (1 mg/24 h), -15.7 (2 mg/24 h), -17.5 (3 mg/24 h) and

-14.8 (4 mg/24 h) in comparison to the placebo.114

As de-

termined by statistical analysis, significant benefits of rotig-

otine in comparison to placebo occurred in the treatment

groups receiving 4 mg/24 h (p=0.0013), 3 mg/24 h

(p=<0.0001), 2 mg/24 h (p=0.0003) and 1 mg/24 h

(p=0.0004).114

The benefits observed with the 0.5 mg/24 h

dose were not significant when compared to placebo (p-

value=0.2338).

Application site reactions and nausea were the most com-

mon adverse effects reported and became more frequent

as the dose increased.114

Because no further improve-

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 partic-

ipated in the 6-week dose-finding trial. A total of 295 pa-

tients enrolled in the open-label trial with 220 patients com-

pleting 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

Re-

sults from the first year of the open-label extension demon-

strated continuous benefits that were clinically significant

with the use of rotigotine.114,116

After two years of rotigotine treatment, the average reduc-

tion in the IRLS score from baseline for all of the partici-

pants in the trial was 15.4±10.115

Likewise, similar improve-

ments also were seen in the changes in CGI-1 and RLS-6

scores. The efficacy was rated as “good” to “very good” by

89 percent of the participants that completed two years of

treatment.115

Although the six-week trial determined that

the 4 mg/24 h dose did not provide additional benefits,114

it

was found to be the most frequently applied dose at the

end of the second year of treatment. It can be concluded,

therefore, that the dose should be individualized based up-

on the patient’s symptom presentation and tolerability.115

During the two-year interval, 87 percent of the participants

reported experiencing at least one adverse effect.115

Of

these adverse effects, most were classified as mild to mod-

erate with 22 percent determined to be severe. As ob-

served in the six-week trial, application site reactions were

the most frequent adverse event seen and were document-

ed in 34.5 percent of participants in the first year and in

16.4 percent the second year.115

In regards to tolerability,

77 percent of the participants rated rotigotine tolerability as

“very good” or “good,” whereas 5.8 percent rated the tolera-

bility as “very bad.” Augmentation is a common complaint

of those on long-term dopamine agonist therapy. During

the two-year duration, augmentation had an occurrence of

only 2.4 percent and may be a possible advantage of rotig-

otine therapy as this augmentation rate is lower than the

rates commonly observed with other dopamine agonist

November 2012



medications.115

A Six-month Randomized, Double-blind,

Placebo-controlled Trial in the United States

Hening, et al. implemented a study to assess the safety

and effectiveness of rotigotine at four different doses in

participants determined to have moderate to severe idio-

pathic RLS.117

The four dosages of rotigotine used included

0.5 mg/24 h, 1 mg/24 h, 2 mg/24 h and 3 mg/24 h. In addi-

tion, a placebo group also was utilized to allow for compari-

son to those treated. The study included 505 participants

who were diagnosed with idiopathic RLS according to the

guidelines established by International RLS Study Group

(IRLSSG) and ranged from 18 to 75 years of age.117

Of

these 505 participants, however, only 63 percent complet-

ed the study. In addition, the subjects must also have had a

baseline sum score of at least 15 according to the IRLS

scale and a baseline CGI-1 score of at least 4 to be includ-

ed in the study. The subjects were then placed randomly

into one of the five groups and received treatment for six

months.

The primary methods for assessing efficacy include meas-

uring the change from baseline of the IRLS sum score and

the CGI-1 score. The safety of the medication was deter-

mined through the observation of a number of different

physiological parameters. These parameters included ob-

serving the adverse events experienced, adhesiveness of

the patch, application site reactions, changes in laboratory

values, vital signs and a number of other physical assess-

ments (12-lead ECG, physical and neurological examina-

tions, 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 de-

termined to not be statistically significant. The response

rates, however, were higher in all of those receiving rotigo-

tine treatment compared to the placebo.

In regards to safety, 84 percent of those in the placebo

group and 88 percent of those in the rotigotine groups re-

ported adverse effects.117

In the rotigotine groups, the most

frequent adverse effect was reactions at the application site

with 27 percent of treatment groups reporting it.117

The per-

centage of subjects reporting adverse effects generally

increased with higher doses of rotigotine. The rates of ad-

verse events observed in groups treated with 0.5 mg/24 h,

1 mg/24 h, 2 mg/24 h and 3 mg/24 h of rotigotine, listed

respectively, were nausea (13.1 percent, 20 percent, 18.2

percent, 20.8 percent), somnolence (8.1 percent, 10 per-

cent, 13.1 percent, 15.1 percent), headache (14.1 percent,

12 percent, 10.1 percent, 10.4 percent), insomnia (1 per-

cent, 4 percent, 2 percent, 8.5 percent), dry mouth (2 per-

cent, 3 percent, 1 percent, and 7.5 percent), pruritis (9.1

percent, 2 percent, 3 percent, 7.5 percent), fatigue (10.1

percent, 3 percent, 7.1 percent, 6.6 percent), and dizziness

(4 percent, 3 percent 7.1 percent, 6.1 percent).117

During

the course of the study, only 1.5 percent (6 participants)

developed clinically significant augmentation.117

Based up-

on these results, it can be concluded that the augmentation

rate for six months of rotigotine treatment is low.117,118

Dose

The recommended dosage range for the treatment of RLS

is between 1 mg to 3 mg over a 24 hour time frame.119

When treating Parkinson’s disease, however, higher doses

are needed to be clinically effective.

Common Adverse Events

The most common adverse events reported in clinical trials

and the incidence of these events as observed with the 3

mg/24 h dose are as follows: application site reactions (43

percent), nausea (21 percent), somnolence (10 percent),

headache (16 percent), insomnia (10 percent), dry mouth

(7 percent), pruritis (7 percent) and dizziness (6 percent).47

These reactions were classified as mild-to-moderate and

became more frequent as the dose increased.114,115,117

Contraindications

Rotigotine should not be used in patients who have a hy-

persensitivity to rotigotine or any of the other patch compo-

nents.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 subsequent-

ly not be utilized in lactating mothers. Currently, there are

no studies that indicate the safe and effective use of rotigo-

tine in the pediatric population; thus, the medication should

not be used in pediatric patients.47

Pharmacoeconmoics

Rotigotine currently is not available as a generic medica-

tion; therefore, the drug’s cost is higher than the cost asso-

ciated with other generically available dopamine agonists

(pramipexole, ropinirole). Likewise, insurance companies

November 2012



may place these generic medications on a lower tier than

the tier assigned to brand-name rotigotine; thus, there is a

possibility that the patient may be financially responsible for

a higher percentage of rotigotine’s cost. A summary of the

average wholesale prices of dopaminergic agents can be

found in Table 5.120

Place in Therapy

Dopamine agonists are considered to be first-line in the

treatment of RLS and have been proven effective in im-

proving associated symptoms.42,44

As a dopamine agonist,

rotigotine can be considered an effective alternative to cur-

rently available oral dopamine agonist medications. In addi-

tion, the continuous release of medication will be beneficial

to those that experience daytime symptoms.121

The trans-

dermal formulation may be favored by some patients be-

cause it is a convenient way to administer a steady amount

of medication over an extended period. Be-

cause rotigotine currently is not available gener-

ically, the financial circumstances of each pa-

tient need to be considered before initiating

therapy.

Important Counseling Information

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 sum-

mary 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 ago-

nist medications. The medication’s availability

as a transdermal patch is unique to other medi-

cations in this class and may provide additional

benefits to patients with RLS. This formulation

is a convenient way to administer a continuous

dose of medication over an extended period;

therefore, rotigotine is beneficial for patients

that experience symptoms during the day. Be-

cause rotigotine is not generically available,

other dopamine agonists that are available as a

generic formulation may be more favorable to

use in patients with financial concerns.

Because a significant amount of people experi-

ence the debilitating symptoms associated with RLS, it is

crucial that healthcare professionals are aware of the back-

ground of the disease and the current treatment options

available. The decision as to which treatment to initiate

should be based upon symptom severity, patient tolerabil-

ity, medication cost and adverse effects associated with the

medication.

References

1. Allen RP, Stillman P, Myers AJ. Physician-

diagnosed restless legs sundrome in a large sample of pri-

mary medical care patients in western Europe: prevalence

and characteristics. Sleep Med 2010;11:31-7.

2. Allen RP, Walters AS, Montplaisir J, et al. Restless

legs syndrome prevalence and impact. REST general pop-

ulation study. Arch Intern Med 2005;165:1286-92.

3. Nichols DA, Sallen RP, Grauke JH, et al. Restless

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

100 count bottle: $70.88 $80.02 $101.97

Pramipexole Dihydrochloride tablet, po 0.125 mg 0.25 mg 0.5 mg 1 mg 1.5 mg

63 count bottle: $185.83 90 count bottle: $265.47 $265.47 $265.47 $265.47

Ropinirole Hydrochloride tablet, po (film coated): 0.25 mg 0.5 mg 1 mg 2 mg 3 mg 4 mg 5 mg

100 count bottle: $250.52 $250.52 $250.52 $250.52 $259.86 $259.86 $259.86

Rotigotine, transdermal 2 mg/24 h 4 mg/24 h 6 mg/24 h

Pack of 7 patches: $18.90 Pack of 30 patches: $81.00 Pack of 7 patches: $64.68 Pack of 30 patches: $277.20 Pack of 7 patches: $64.68 Pack of 30 patches: $277.20

The prices displayed for these medications, with the exception of rotigotine, in this table are based upon data from Teva Phar-maceuticals. The wholesale prices of rotigotine are based upon data obtained from UCB, the manufacturer of this medication.

November 2012



Table 6: Rotigotine Counseling Information47

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 applica-

tion. 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 thorough-

ly. 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.

4. Hogl B, Kiechl S, Willeit J, a l. et. Restless legs

syndrome: a community-based study of prevalence, severi-

ty , and risk factors. Neurology 2005;64:1920-4.

5. Willis T. The London practice of physick. In. Lon-

don, England: Basset & Crooke; 1685.

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.

Sleep medicine reviews 2011.

10. Phillipps B, Hening W, Britz P, Mannino D. Preva-

lence and correlates of restless legs syndrome-results from

the 2005 National Sleep Foundation Poll. Chest

2006;129:76-80.

11. O'Keeffe ST, Egan D, Myers A, Redmond S. The

frequency and impact of restless legs syndrome in primary

care. Ir Med J 2007;100:539-42.

12. Allen RP, Picchietti D, Hening WA, et al. Restless

legs syndrome:diagnostic criteria, special considerations,

and epidemiology. A report from the restless legs syn-

drome diagnosis and epidemiology workshop at the Nation-

al Institute of Health. Sleep Med 2003;4:101-19.

13. Abetz L, Allen R, Follet A, et al. Evaluating the

quality of life of patients with restless legs syndrome. Clin

Ther 2004;26:925-35.

14. Meilak C, Dhawan V, Chaudhuri KR. Clinical fea-

tures. In: Chaudhuri KR, Olanow CW, Odin P, eds. Rest-

less Legs Syndrome. New York: Informa Healthcare; 2004.

November 2012



15. Earley CJ. Clinical practice. Restless legs syn-

drome. N Engl J Med 2003;348:2103-9.

16. Ekbom KA. Restless legs syndrome. Neurology

1960;10:868-73.

17. Garcia-Borreguero D, Egatz R, Winkelmann J, et

al. Epidemiology of restless legs syndrome: the current sta-

tus. Sleep medicine reviews 2006;10:153-67.

18. Scofield H, Roth T, Drake C. Periodic limb move-

ments during sleep: populations prevalence, clinical corre-

lates, and racial differences. Sleep 2008;21:1221-7.

19. Saletu B, Anderer P, Saletu M, Hauer C, Lindeck-

Pozza L, Saletu-Zyhlarz G. EEG mapping, psychometric,

and polysomnographic studies in restless legs syndrome

(RLS) and periodic limb movement disorder (PLMD) pa-

tients as compared with normal controls. Sleep Med 2002;3

Suppl:S35-S42.

20. Silber MH, Ehrenberg BL, Allen RP, et al. An algo-

rithm for the management of restless legs syndrome. Mayo

Clin Proc 2004;79:916-22.

21. Walters AS, LeBrocq C, Dahr A, a l. et. Validation

of the international restless legs syndrome study group rat-

ing scale for restless legs syndrome. Sleep Med

2003;4:121-32.

22. Kohnen R, Stiasny-Kolster K, Oertel WH, Benes H,

Trenkwalder C. Severity rating of restless legs syndrome:

validation of the RLS-6 scales. Sleep 2004;27 (Abstract

Suppl.):A342.

23. Guy W, Ed. Clinical Global Impressions. In: EC-

DEU Assessment Manual for Psychopharmacology, re-

vised. Rockville, MD: National Institute of Mental Health;

1976.

24. Winkelman JW. Considering the causes of RLS.

Eur J Neurol 2006;13:8-14.

25. Montplaisir J, Boucher S, Poirier G, et al. Clinical,

polysomnographic, and genetic characteristics of restless

legs syndrome: a study of 133 patients diagnosed with new

standard criteria. Mov Disord 1997;12:61-5.

26. Rodrigues RN, Rodrigues AA, Faber J, Corso JT,

Peixoto TF. Evolution of non-treated restless legs syn-

drome. Arq Neuropsiquiatr 2009;67:16-20.

27. Allen RP, Earley CJ. Restless legs syndrome: a

review of clinical and pathophysiologic features. J Clin Neu-

rophysiol 2001;18:128-47.

28. Allen RP, Earley CJ. Defining the phenotype of the

restless legs syndrome (RLS) using age-of-symptoms on-

set. Sleep Med 2000;1:11-9.

29. Hening W, Walters AS, Allen RP, Montplaisir J,

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) pri-

mary care study. Sleep Med 2004;5:237-46.

30. Montplaisir J, Nicholas A, Godbout R, et al. Rest-

less legs syndrome and periodic limb movement disorder.

In: Kryger MH, Roth T, Dement WC, eds Principles and

practice of sleep medicine. 3rd ed. Philadelphia: W. B.

Saunders; 2000:742-52.

31. Garcia-Borreguero D, Larrosa O, Granizo JJ, de la

Llave Y, Hening WA. Circadian variation in neuroendocrine

response to L-dopa in patients with restless legs syndrome.

Sleep 2004;27:669-73.

32. Cooper JR, Bloom FE, Rother RH. The biochemi-

cal basis of neuropharmacology. New York: Oxford Univer-

sity Press; 1991.

33. Aul EA, Davis BJ, Rodnitzky RL. The importance of

formal serum iron studies in the assessment of restless

legs syndrome. Neurology 1998;51:912.

34. Sun ER, Chen CA, Ho G, Earley CJ, Allen RP. Iron

and the restless legs syndrome. Sleep 1998;21:371-7.

35. Garvey MJ, Tolefson GD. Occurrence of myoclo-

nus in patients treated with cyclic antidepressants. Arch

Gen Psychiatry 1987;44:269-72.

36. Bakshi R. Fluoxetine and restless legs syndrome. J

Neurol Sci 1996;142:151-2.

37. Terao T, Terao M, Yoshimura R, Abe K. Restless

legs syndrome induced by lithium. Biol Psychiatry

1991;30:1167-70.

38. Ward NG. Akathisia associated with droperidol dur-

ing epidural anesthesia. Anesthesiology 1989;71:786-7.

39. Lutz EG. Restless legs, anxiety and caffeinism. J

Clin Psychiatry 1987;39:693-8.

40. Aukerman MM, Aukerman D, Bayard M, et al. Ex-

ercise and restless legs syndrome: a randomized controlled

trial. J Am Board Fam Med 2006;19:487-93.

41. Hogl B, Paulus W, Clarenbach P, Trenkwalder C.

Restless legs syndrome: diagnostic assessment and the

advantages and risks of dopaminergic treatment. J Neurol

2006;253:IV22-IV8.

42. Hening W, Allen R, Earley C, Kushida C, Picchietti

D, Silber M. The treatment of restless legs syndrome and

periodic limb movement disorder: an American Academy of

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.

November 2012



44. Chesson AL Jr, Wise M, Davila D, et al. Practice

parameters for the treatment of restless legs syndrome and

periodic limb movement disorder: an American Academy of

Sleep Medicine report. Sleep 1999;22:961-8.

45. Trenkwalder C, Hening WA, Montagna P, a l. et.

Treatment of restless legs syndrome: an evidence-based

review and implications for clinical practice. Mov Disord

2008;23:2267-302.

46. Mitler MM, Browman CP, Menn SJ, Gujavarty K,

Timms RM. Nocturnal myoclonus: treatment efficacy of

clonazepam and temazepam. Sleep 1986;9:385-92.

47. Neupro® (Rotigotine Transdermal System): United

States prescribing information. UCB, 2012. (Accessed May

24, 2012, at http://www.accessdata.fda.gov/

drugsatfda_docs/label/2012/021829s002lbl.pdf.)

48. Ondo W, Romanyshyn J, Vuong KD, a l. et. Long-

term treatment of restless legs syndrome with dopamine

agonists. Arch Neurol 2004;61:1393-7.

49. Avecillas JF, Golish JA, Giannini C, et al. Restless

legs syndrome: keys to recognition and treatment. Cleve

Clin J Med 2005;72.

50. O'Keeffe ST, FGavin K, Lavan JN. Iron status and

restless legs syndrome in the elderly. Age Ageing 1994;23.

51. Wang J, O'Reilly B, Venkataraman R, Mysliwiec V,

Mysliwiec A. Efficacy of oral iron in patients with restless

legs syndrome and a low-normal ferritin: a randomized,

double-blind, placebo-controlled study. Sleep Med

2009;10:973-5.

52. Davis BJ, Rajput A, Rajput ML, et al. A random-

ized, double-blind placebo-controlled trial of iron in restless

legs syndrome. Eur Neurol 2000;43:70-5.

53. Grote L, Leissner L, Hedner J, Ulfberg J. A ran-

domized, double-blind placebo controlled, multi-center

study of intravenous iron sucrose and placebo in the treat-

ment of restless legs syndrome. Mov Disord 2009;24:1445-

52.

54. Ondo WG. Intravenous iron dextran for severe re-

fractory restless legs syndrome. Sleep Med 2010;11:494-6.

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 disor-

der. Sleep 2004;27:560-83.

56. Satija P, Ondo WG. Restless legs syndrome: path-

ophysiology, diagnosis and treatment. CNS drugs

2008;22:497-518.

57. Wetter TC, Stiasny K, Winkelmann J, et al. A ran-

domized controlled study of pergolide in patients with rest-

less legs syndrome. Neurology 1999;52:944-50.

58. Montplaisir J, Nicolas A, Denesle R, Gomez-

Mancilla B. Restless legs syndrome improved by pramipex-

ole: a double-blind randomized trial. Neurology

1999;52:938-43.

59. Collado-Seidel V, Kazenwadel J, Wetter TC, et al.

A controlled study of additional sr-L-dopa in L-dopa-

responsive restless legs syndrome with late-night symp-

toms. Neurology 1999;52:285-90.

60. Trenkwalder C, Stiasny K, Pollmacher T, et al. L-

dopa therapy of uremic and idiopathic restless legs syn-

drome: a double-blind, crossover trial. Sleep 1995;18:681-

8.

61. Benes H, Kurella B, Kummer J, et. al. Rapid onset

of action of levodopa in restless legs syndrome: a double-

blind, randomized, multicenter, crossover trial. Sleep

1999;22:1073-81.

62. Schapira AH. Restless legs syndrome: an update

on treatment options. Drugs 2004;64:149-58.

63. Guilleminault C, Cetal M, Philip P. Dopaminergic

treatment of restless legs and rebound phenomenon. Neu-

rology 1993;43:445.

64. Allen RP, CJ E. Augmentation of the restless legs

syndrome with carbidopa/levodopa. Sleep 1996;19:205-13.

65. Hogl B, Garcia-Borreguero D, Kohnen R, et al.

Progressive development of augmentation during long-

term treatment with levodopa in restless legs syndrome:

results of a prospective multi-center study. J Neurol

2010;257:230-7.

66. Earley CJ, Allen RP. Pergolide and carbidopa/

levodopa treatment of the restless legs syndrome and peri-

odic leg movements in sleep in a consecutive series of pa-

tients. Sleep 1996;19:801-10.

67. Silber MH, Shepard JW Jr, Wisbey JA. Pergolide

in the management of restless legs syndrome: an extend-

ed study. Sleep 1997;20:878-82.

68. Garcia-Borreguero D, Williams AM. Dopaminergic

augmentation of restless legs syndrome. Sleep medicine

reviews 2010.

69. Staedt J, Hunerjager H, Ruther E, Stoppe G. Per-

golide: treatment of choice in restless legs syndrome (RLS)

and nocturnal myoclonus syndrome (NMS): longterm follow

up on pergolide. J Neural Transm 1998;105:265-8.

70. Stiasny K, Wetter TC, Winkelmann J, et al. Long-

term effects of pergolide in the treatment of restless legs

November 2012



syndrome. Neurology 2001;56:1399-402.

71. Ferini-Strambi L, Aarskog D, Parinen M, et al. Ef-

fect of pramipexole on RLS symptoms and sleep: a ran-

domized, double-blind, placebo-controlled trial. Sleep Med

2008;9:874-81.

72. Kushida CA, Geyer J, Tolson JM, Asgharian A.

Patient- and physician-rated measures demonstrate the

effectiveness of ropinirole in the treatment of restless legs

syndrome. Clin Neuropharmacol 2008;31:281-6.

73. Silber MH, Girish M, Izurieta R. Pramipexole in the

management of restless legs syndrome: an extended

study. Sleep 2003;26:819-21.

74. Ferini-Strambi L. Restless legs syndrome augmen-

tation and pramipexole treatment. Sleep Med 2002;3

Suppl:S23-S5.

75. Winkelman JW, Johnston L. Augmentation and

tolerance with long-term pramipexole treatment of restless

legs syndrome (RLS). Sleep Med 2004;5:9-14.

76. Garcia-Borreguero D., Grunstein R., Sridhar G., et.

al. A 52-week open-label study of the long-term safety of

ropinirole in patients with restless legs syndrome. Sleep

Med 2007;8:742-52.

77. Garcia-Borreguero D, Larrosa O, De La Llave Y, et

al. Treatment of restless legs syndrome with gabapentin: a

double-blind, cross-over study. Neurology 2002;59:1573-9.

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.

79. Ondo W. Restless Legs Syndrome. In: Movement

disorders in clinical practice. London: Springer-Verlag;

2010.

80. Zucconi M, Coccagna G, Petronelli R, et al. Noc-

turnal myoclonus in restless legs syndrome: effect of car-

bamazepine treatment. Funct Neurol 1989;4:263-71.

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.

82. Telstad W, Sorensen O, Larsen S, et al. Treatment

of the restless legs syndrome with carbamazepine: a dou-

ble blind study. Br Med J 1984;288:444-6.

83. Lundvall O, Abom PE, Holm R. Carbamazepine in

restless legs. A controlled pilot study. Eur J Clin Pharmacol

1983;25:323-4.

84. Mellick GA, Mellick LB. Management of restless

legs syndrome with gabapentin (neurontin). Sleep

1996;19:224-6.

85. Youssef EA, Wagner ML, Martinez JO, Hening W.

Pilot trial of lamotrigine in the restless legs syndrome.

Sleep Med 2005;6:89.

86. Sommer M, Bachmann CG, Liebetanz KM,

Schindehutte J, Tings T, Paulus W. Pregabalin in restless

legs syndrome with and without neuropathic pain. Acta

Neurol Scand 2007;115:347-50.

87. Conti CF, Oliveira MM, Valbuza JS, Prado LB, Car-

valho LB, Prado GF. Anticonvulsants to treat idiopathic

restless legs syndrome: systematic review. Arq Neurop-

siquiatr 2008;66:431-5.

88. Walters AS, Wagner ML, Hening WA, et al. Suc-

cessful treatment of the idiopathic restless legs syndrome

in a randomized double-blind trial of oxycodone versus pla-

cebo. Sleep 1993;16.

89. Hogl B, Trenkwalder C, Poewe W. More on the

restless legs syndrome and spinal anesthesia. N Engl J

Med 2009;360:1155-6.

90. Kaplan PW, Allen RP, Buchholz DW, et al. A dou-

ble-blind, placebo-controlled study of the treatment of peri-

odic limb movements in sleep using carbidopa/levodopa

and propoxyphene. Sleep 1993;16.

91. Ondo WG. Methadone for refractory restless legs

syndrome. Mov Disord 2005;20:345-8.

92. Lauerma H, Markkula J. Treatment of restless legs

syndrome with tramadol: an open study. J Clin Psychiatry

1999;60:241-4.

93. Montagna P, Sassoli De Bianchi L, Zucconi M, et

al. Clonazepam and vibration in restless legs syndrome.

Acta Neurol Scand 1984;69.

94. Saletu M, Anderer P, Saletu-Zyhlarz G, et al. Rest-

less legs syndrome (RLS) and periodic limb movement

disprder (PLMD): acute placebo-controlled sleep laboratory

studies with clonazepam. Eur Neuropsychopharmacol

2001;11:153-61.

95. Boghen D, Lamothe L, Elie R, et al. The treatment

of the restless legs syndrome with clonazepam: a prospec-

tive controlled study. Can J Neurol Sci 1986;13:245-7.

96. Scheller D, Ullmer C, Berkels R, Gwarek M, Lüb-

bert H. The in vitro receptor profile of rotigotine: a new

agent for the treatment of Parkinson's disease. Naunyn-

Schmiedeberg's Arch Pharmacol 2009;379:73-86.

97. Jenner P. A novel dopamine agonist for the trans-

dermal treatment of Parkinson's disease. Neurology

2005;65:S3-S5.

November 2012



98. Nugroho AK, Li G, Grossklaus A, Danhof M,

Bouwstra JA. Transdermal iontophoresis of rotigotine: influ-

ence of concentration, temperature and current density in

human skin in vitro. J Control Release 2004;96:159-67.

99. Pfeiffer RF. A promising new technology for Parkin-

son's disease. Neurology 2005;65:S6-S10.

100. Kehr J., Hu X.-J., Goiny M., Scheller D. Continuous

delivery of rotigotine decreases extracellular dopamine sug-

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. For-

mulation study of oxybutynin patches. Pharm Dev Technol

2007;12:239-46.

103. Variankaval NE, Jacob KI, Dinh SM. Crystallization

of beta-estradiol in an acrylic transdermal drug delivery sys-

tem. J Biomed Mater Res 1999;44:397-406.

104. Hadgraft J. Passive enhancement strategies in top-

ical and transdermal drug delivery. Int J Pharm 1999;184:1-

6.

105. Latsch S, Selzer T, Fink L, Kreuter J. Determination

of the physical state of norethindrone acetate containing

transdermal drug delivery systems by isothermal microcalo-

rimetry, X-ray diffraction, and optical microscopy. Eur J

Pharm Biopharm 2004;57:383-95.

106. Cilurzo F, Minghetti P, Casiraghi A, Tosi L, Pagani

S, Montanari L. Polymethacrylates as crystallization inhibi-

tors in monolayer transdermal patches containing ibu-

profen. Eur J Pharm Biopharm 2005;60:61-6.

107. Ma X, Taw J, Chiang CM. Control of drug crystalli-

zation in transdermal matrix system. Int J Pharm

1996;142:115-9.

108. Kim JH, Choi HK. Effect of additives on the crystal-

lization and the permeation of ketoprofen from adhesive

matrix. Int J Pharm 2002;236:81-5.

109. Chen J, Swope D, Dashtipour K, Lyons K. Trans-

dermal Rotigotine: A Clinically Innovative Dopamine-

Receptor Agonist for the Management of Parkinson's Dis-

ease. Pharmacotherapy 2009;29:1452-67.

110. Wang S, Xue H, Wang L, et. al, inventors; Patent

application title: Composition containing rotigotine and use

thereof and transdermal patch containing the composition.

United States of America. 2011.

111. Cawello W, Braun M, Boekens H. Absorption, Dis-

position, Metabolic Fate, and Elimination of the Dopamine

Agonist Rotigotine in Man: Administration by Intravenous

Infusion or Transdermal Delivery. Drug Metab Dispos

2009;37:2055-60.

112. Hansen K, Braun M, Horstmann R. Low drug-drug

interaction potential of rotigotine. J Clin Pharmacol

2005;45:1091.

113. Cawello W, Ahrweiler S, et. al. Single dose phar-

macokinetics 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, place-

bo-controlled, six-week dose-finding trial in Europe. Sleep

Med 2008;9:228-39.

115. Hogl B, Oertel W, Stiasny-Kolster K, et. al. Treat-

ment of moderate to severe restless legs syndrome: 2-year

safety and efficacy of rotigotine transdermal patch. BMC

Neurol 2010;10:86.

116. Oertel WH, Benes H, Garcia-Borreguero D, Geisler

P, et. al. One year open-label safety and efficacy trial with

rotigotine transdermal patch in moderate to severe idio-

pathic restless legs syndrome. Sleep Med 2008;9:865-73.

117. Hening WA, Allen RP, Ondo WG, et al. Rotigotine

improves restless legs syndrome: a 6-month randomized,

double-blind, placebo-controlled trial in the United States.

Mov Disord 2010;25:1675-83.

118. Garcia-Borreguero D, Ferini-Strambi L, Kohnen R.

Augmentation in the therapy of restless legs syndrome with

transdermal rotigotine: a retrospective systematic analysis

of two large double-blind 6-month trials. Eur J Neurol

2008;15:110;P1293 Abstract.

119. Baldwin CM, Keating GM. Rotigotine transdermal

patch: in restless legs syndrome. CNS drugs 2008;22:797-

806.

120. Red Book: Pharmacy's Fundamental Reference:

Thomson Reuters; 2010.

121. Stiasny-Kolster K, Kohnen R, Schollmayer E,

Moller J, WH. O. Patch application of the dopamine agonist

rotigotine to patients with moderate to advanced stages of

restless legs syndrome: a double-blind, placebo-controlled

pilot study. Mov Disord 2004;19:1432-8.

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 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 4. Which agents are considered to be the cornerstone of therapy for RLS treatment? A. Anti-convulsants B. Dopaminergic Agents C. Benzodiazepines D. Opioids 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 ro-tigotine? A. The treatment of the signs and symptoms of idiopathic

Parkinson’s disease. B. The treatment of the signs and symptoms of Alzhei-

mer’s disease. C. The treatment of moderate-to-severe primary restless

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

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

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!

November 2012



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 5. A B C D 7. A B C D 9. A B C D 11. A B C D 13. A B C D 2. A B C D E 4. A B C D 6. A B C 8. A B C D 10.A B C D 12. A B 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)

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.

The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for

Pharmacy Education as a provider of continuing Pharmacy education.

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 5. A B C D 7. A B C D 9. A B C D 11. A B C D 13. A B C D 2. A B C D E 4. A B C D 6. A B C 8. A B C D 10.A B C D 12. A B 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


Dec. 2012 CE — Patient Assessment Skills

Patient Assessment Skills for Optimizing

Self-Care, Part 1 of 4: Introduction and

Evaluation of Skin, Hair and Nails

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.

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.

KPERF offers all

CE articles to

members online at

www.kphanet.org

Introduction

JW is a 28-year-old female who approaches the pharmacy

reporting that she has been experiencing a cold for several

days. The patient explains that the rhinorrhea has resolved

but the dry, hacking cough persists, waking her up at night.

She asks you what cough syrup would be best to treat her

problem. You take her temperature, which is normal, and

complete a respiratory assessment with no significant find-

ings. Upon further questioning to review her symptoms and

medical history, you determine the patient is an appropriate

candidate for self-care and proceed to assist her with the

selection of an appropriate over the counter (OTC) product.

As illustrated in the case above, one of the most important

roles of a community pharmacist is to help patients make

decisions regarding self-care and to provide counseling

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 gather-

ing patient information and also when providing information

regarding medication use.

Over the counter medication counseling differs from pre-

scription drug counseling in that it generally requires more

exploratory questions on the part of the pharmacist in order

to clarify and assess the patient’s needs and determine the

appropriateness of self-care. QuEST is an acronym used to

describe a systematic approach developed by the Ameri-

can Pharmacists Association (APhA) that was designed to

help pharmacists elicit the information needed and provide

appropriate recommendations regarding self-care.1

QuEST Process1

Quickly and accurately assess the patient (e.g., symptoms,

current medications and medical conditions, allergies)

Establish that the patient is an appropriate candidate for

self-care

Suggest appropriate strategies for self-care

Talk with the patient about:

The medication’s actions, proper administration and

potential adverse effects

What to expect from treatment

Appropriate follow-up

The first step of the QuEST process is to quickly and accu-

rately assess the patient and this first involves talking with

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 al-

ways 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 in-

terview area as comfortable and private as possible. Ideal-

ly, the area should be relatively quiet and free of any dis-

tractions or interruptions. It also should be clean, well-

organized, and have a sufficient amount of lighting.

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 dis-

respect. 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 recom-

mendation for himself or herself, or for another family mem-

ber.

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 hon-

est 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 accu-

rate 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 gen-

eral information (e.g., “Our records show that you usually

get a flu shot each year. Have you received your vaccina-

tion yet?”).

True or False? It is always important to use medical ter-

minology when communicating with patients so they know

you are a professional and they can trust your recommen-

dations.

Non-verbal communication also impacts both the quality

and quantity of information shared between the patient and

the pharmacist. Use your body language to convey an in-

terested 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 your-

self and the patient is usually comfortable for most individu-

als.

To get a complete picture of the problem, it is important to

know exactly what kind of information needs to be collect-

ed. 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 se-

vere 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 gradu-

ally 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., fe-

ver 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 bet-

ter 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 condi-

tions (including pregnancy and lactation), and known medi-

cation allergies. Don’t forget to ask specifically about OTC

drugs, herbals and dietary supplements. If the patient de-

nies taking non-prescription medications, ask about com-

mon medical conditions such as the frequency of head-

aches or minor aches and pains and how they are treated.

November 2012



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 pres-

sure, 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

Some general observa-

tions about the pa-

tient’s outward appear-

ance, mood and be-

havior 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 activ-

ity? Do they show any

obvious signs of respir-

atory distress, pain or

anxiety? Do they ap-

pear frail or malnour-

ished? Is excessive

weight adversely affecting their health? Is their clothing

appropriate for the weather? Is their speech clear and ap-

propriate? 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 assess-

ment of body temperature may provide an important clue

regarding the etiology of a patient’s symptoms. Electronic

thermometers have essentially replaced glass thermome-

ters 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 tempera-

tures in adults are around 36.5°C (97.7°F), which is ap-

proximately 0.5°C (1°F) lower than the oral route. For tym-

panic membrane temperature measurement, infrared tech-

nology 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 ad-

vantage to this type of measurement is that results may be

obtained in seconds, making them ideal for use in the clinic

or hospital setting. Re-

ferral guidelines for fe-

brile patients are listed in

Table 1.

In general, a fever that is

lower than 38.9°C (102°

F) in an adult doesn’t

need to be treated un-

less the patient is very

uncomfortable. Aspirin

products should not be

recommended for use in

any child with a suspect-

ed viral illness due to a

potential association with

Reye’s syndrome.

True or False? Any

body temperature great-

er than 98.6 °F is con-

sidered a fever and

should be treated.

SKIN, HAIR AND NAILS

Due to the size and complexity of the skin, susceptibility to

pathologic conditions is high. The pharmacist’s role is im-

portant, as many of the conditions may be treated with

OTC medications while others are more serious and re-

quire a physician referral.

Skin

Overall assessment of the skin includes identifying chang-

es in color, texture, temperature, turgor (elasticity or resili-

ency), odor and the presence or lack of lesions. Table 2

describes basic medical terms that are commonly associat-

ed with the skin. Pharmacists should familiarize themselves

with these terms.

Inflammatory Conditions of the Skin

Common inflammatory skin conditions include contact der-

matitis, 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 sev-

eral days (allergic) and is usually confined to the area of

Table 1. Characteristics of febrile patients that indicate a need

for physician evaluation2

A rectal temperature of 38°C (100.4°F) or higher in a child younger

than 3 months A temperature of 38.9°C (102°F) or higher in a child 3 month or older Any oral temperature over 39.4°C (103°F) A fever lasting more than three days, or more than one day in a child

less than 2 years of age Symptoms of a severe infection such as meningitis (e.g., severe

headache, light sensitivity, stiff neck, confusion) Risk of dehydration (e.g., severe or persistent vomiting or diarrhea,

unable to keep liquids down) Difficulty breathing or chest pain, or a history of significant heart or

lung disease Abdominal pain, or pain with urination Altered mental status, or extreme listlessness or irritability Severe throat pain or swelling Unusual skin rash A child with a history of febrile seizures Any patient in an immunocompromised state

November 2012



contact. Examples of causative agents for an irritant type

rash include soap, detergents, cosmetics and any sub-

stance that may irritate the skin. The patient may present

with erythema, vesicles, crusts, scaling and/or pruritis. Al-

lergic 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 pap-

ules, vesicles, erosions, crusts, erythema, blackheads,

whiteheads and/or pruritis. It is important to remember the

first step in treatment is to remove the offending agent.

Acne presents as comedones (blackheads), closed come-

dones (whiteheads), papules, pustules and nodules. Gen-

erally, acne is most common during puberty due to the an-

drogenic 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

Table 2. Terms describing the clinical presentation of the skin

Term Description Examples

Macule A flat lesion, flush with the skin with a color different from the surrounding tissue.

Freckles, flat moles (nevi), petechiae, mea-sles, scarlet fever rash

Patch A macule which exhibits some scale or fine wrinkles and is greater than 1 cm in diameter.

Vitiligo, portwine stains, Mongolian spots, café au lait patch

Papule A solid, elevated lesion less than 0.5 cm in diameter.

Wart (verruca), elevated moles, lichen planus

Plaque A lesion greater than 0.5 cm in diam-eter but with marginal depth.

Psoriasis, seborrheic and actinic keratoses

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

Chronic dermatitis

Nodule A lesion greater than 0.5 cm in both width and depth.

Erythema nodosum, lipomas

Wheal A transitory papule or plaque arising out of edema of the dermis which almost always produces pruritis.

Insect bites, urticaria (hives), allergic reaction

Cyst A nodule containing a liquid or semi-solid which can be expressed.

Sebaceous cyst, cystic acne

Vesicle A blister less than 0.5 cm in diameter filled with clear liquid

Varicella (chickenpox), herpes zoster (shingles)

Bulla A blister more than 0.5 cm in diame-ter filled with clear liquid.

Blister, pemphigus vulgaris

Pustule A vesicle filled with a purulent liquid. Impetigo, acne

Crust Exudate from a lesion which has dried on the skin.

Scab on abrasion, eczema

Scale Aggregation of loose, hyperkeratotic cells of the stratum corneum. They normally are dry and appear to be white in color.

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

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 without dermal injury) which exposes the dermis.

Decubiti, stasis ulcers

November 2012



and is commonly found in the skin folds

(e.g., elbow, knee). Risk factors may in-

clude family history of allergic rhinitis, hay

fever and asthma. Eczema may present

with pruritis, erythematous patches, plaques

or papules and lichenification from chronic

scratching. Remember that the best recom-

mendation is to get the patient to stop

scratching. Initial self-treatment may involve

cold packs, wet dressings, skin hydration,

topical steroids and oral antihistamines. If

these measures are not sufficient, then the

patient should be referred to his or her phy-

sician.

Diaper rash is most commonly found in in-

fants and may be caused by irritation (e.g.,

alkaline urine or stool), moisture (e.g., oc-

clusion, infrequent diaper changes), Can-

dida albicans, and chemicals (e.g., laundry

detergents, fabric softeners, soap, medica-

tions or lotions applied locally). Treatment

includes keeping the area dry with frequent

diaper changes, washing the area with plain

water, avoiding friction when drying the skin

and using a skin protectant.

Infectious Conditions

Examples of infectious skin conditions include impetigo,

fungal infections, cellulitis, abscesses and Community-

Acquired Methicillin-Resistant Staphylococcus Aureus (CA-

MRSA). Table 3 depicts the various conditions and their

common signs and symptoms. Bacterial conditions should

be referred to a physician.

Drug-induced Conditions

Medications may also be a culprit in various skin condi-

tions. Most commonly, skin reactions present as urticaria,

angioedema, fixed drug eruptions, Stevens-Johnson syn-

drome (SJS), toxic epidermal necrolysis or photosensitivity

reactions. The medications causing the skin condition and

the reactions themselves are generally unpredictable and

can range from mild to severe. Anticonvulsants, sulfona-

mide antibiotics, allopurinol, nonsteroidal anti-inflammatory

drugs (NSAIDs) and dapsone are some of the more com-

mon examples of medications that are known to cause

drug reactions.3 Patients should contact his or her physi-

cian if a drug-related skin condition is suspected; however,

most reactions disappear within a few days after discontin-

uing the agent. Symptomatic control of the affected area is

the primary intervention.

Stevens-Johnson syndrome initially flares up with flu-like

symptoms, followed by a rash (painful, red or purplish in

color) which spreads and blisters, with eventual skin shed-

ding. SJS should be immediately referred to a physician

since hospitalization is often required. The underlying

cause must be identified and permanently avoided. If a

specific medication is identified as the cause, then addition-

al medications with cross-sensitivity also must be avoided.

Potential non-drug causes of SJS include various infections

such as herpes, HIV, typhoid, hepatitis, diphtheria and in-

fluenza, as well as physical causes like radiation therapy or

even UV light.

Other skin concerns of patients may be related to skin can-

cer. It is important to remember the acronym ABCDE for

common signs and symptoms of melanoma:

Asymmetry

Border is irregular

Color is changed or variegated

Diameter is greater than 6 mm (eraser-end of a pencil)

Evolution - enlargement or elevation of a mole over time

Generally, a patient should see a physician if any of these

are present.3

Hair

Assessment of the patient may also include identifying

changes in hair loss or growth, distribution, texture and col-

or. It is important to ask the patient if the change had a sud-

den or gradual onset, was symmetric or asymmetric or was

Table 3. Common infectious skin conditions Infectious Condition

Characteristics

Impetigo Caused by bacterial infection Risk factors may include warm temperature with high

humidity, any breakage in the skin, poor hygiene, pre-existing skin disorders

Lesions with purulent exudate that dries and forms honey-colored crusts

Fungal infections Most common types: tinea pedis (athletes foot), tinea corporis (ringworm), tinea cruris (jock itch)

Erythema, scaling and pruritis

Cellulitis Bacterial infection Hot, painful, red, non-elevated, poorly defined

margins

Abscess Contains necrotic debris, bacteria and inflammatory cells

Open or closed sore, domed nodule, red and may drain fluid

Community- Acquired MRSA

Appear as pustules or boils which often are red, swollen, painful, or have pus or other drainage

Lesions often have necrotic centers similar to spider bites

November 2012



a reoccurrence of a previous condition. Associated symp-

toms 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 folli-

cle), furuncles (deep-seated folliculitis caused by Staphylo-

coccus aureus) and carbuncles (boils that can penetrate

into the subcutaneous layer), alopecia (baldness) and hir-

sutism (abnormal hair growth).

Nails

Inspection of the nails involves evaluation of their color,

length, configuration, symmetry and cleanliness. Any

change in the structure, shape or color may be suggestive

of a potential systemic disease and should be referred to a

physician.

Inspect the nail for atrophy, hypertrophy, abnormal shape

(spoon nails can be caused by iron deficiency or Raynaud’s

syndrome), pitting (seen in psoriasis), color changes

(caused by kidney or pulmonary disease or cancers) and

clubbing (associated with chronic hypoxia). Evaluate the

nail bed for separation from the nail plate (onycholysis) and

hemorrhage. Examine the nail folds for erythema, inflam-

mation, swelling, tenderness and separation from the nail

plate.

QuEST PROCESS CONTINUED

After the initial patient assessment and interview are com-

pleted, the second step of the QuEST process involves

determining whether or not the patient is an appropriate

candidate for self-care. Most medical conditions that can be

safely self-treated are characterized as having no severe

symptoms, and no symptoms that are persistent or repeat-

edly return without an identifiable cause. Additionally, pa-

tients should not pursue self-treatment in an attempt to

avoid medical evaluation and treatment by a physician.

Based upon this evaluation, a decision can be made re-

garding referring the patient to a physician, or making an

appropriate self-treatment recommendation. Strategies for

self-care may include non-pharmacological measures such

as rest, hydration, dietary alterations and suggestions for

preventing recurrence of the problem, as well as non-

prescription medications.

If self-treatment is determined to be appropriate, the final

step of the process involves talking with the patient about

your recommendations. Key information to convey should

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

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 pro-

vided 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, understand-

ing and performing tasks associated with proper medication

administration), and problems with FHL are one of many

factors that can contribute to nonadherence. Millions of

Americans are functionally illiterate when it comes to

healthcare, and as a result, these patients are likely to have

difficulty taking medications as intended by the prescriber.

Because of potential embarrassment, patients may be re-

luctant to admit lack of understanding, and this can make it

difficult to determine the appropriate level of information to

offer. A preferred method of assessing understanding is to

use the “teach back” method where the patient is asked to

restate the instructions back to the provider (e.g., “Can you

tell me in your own words how you should take this medica-

tion?”).

True or False? Problems with functional health literacy

can make it difficult for a patient to understand how to take

their medications appropriately.

Once you have verified patient understanding, make sure

you have allowed the patient to express all concerns. Slow-

ing down and taking the time to really listen to the patient

will help create an atmosphere of mutual trust and respect.

When closing the interview, always thank the patient for his

or her time and extend an offer to be available to answer

any further questions should they arise.

CONCLUSION

The pharmacist in the introductory case could have easily

directed JW to the cough syrup aisle. However, by using

the QuEST process, the pharmacist was able to accurately

assess the nature of her cough and determine that she was

an appropriate candidate for self-care. Patient assessment

skills, along with strong communication skills, are essential

for making appropriate self-care recommendations. Togeth-

er, these skills allow the pharmacist to formulate a com-

plete picture of the patient’s overall health status and make

the most appropriate recommendations for optimizing pa-

tient care.

REFERENCES 1. Leibowitz K, Ginsburg D. Counseling self-treating patients quickly and effectively. Proceedings of the APhA Inaugural Self-Care 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.

November 2012



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 appropri-ate recommendations for self-care.

B. The SCHOLAR method can be used to help evaluate pa-tient symptoms.

C. The second step of the QuEST process is to determine whether a patient is an appropriate candidate for self-care.

D. The final step of the QuEST process is to always talk with the patient’s physician before making any self-care rec-ommendations.

2. Which of the following promotes good communication be-tween 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 demon-

strate 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 self-care, 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 acetamino-

phen 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 liq-uid 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. Potential causes of Stevens-Johnson syndrome include: A. Radiation therapy B. Allopurinol C. HIV D. Sulfonamide antibiotics E. 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 in-clude: 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

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, Popo-vich NG et al, editors. Handbook of Nonprescription Drugs: An

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 Therapeu-tics, Inc; 1994.

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

November 2012



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 3. A B C D 5. A B C D 7. A B C D E 9. A B C D 11. A B C D 2. A B C D 4. A B C D 6. A B C D 8. A B 10.A B C D 12. A B C D 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 _________________________________


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.

The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a

provider of continuing Pharmacy education.

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 3. A B C D 5. A B C D 7. A B C D E 9. A B C D 11. A B C D 2. A B C D 4. A B C D 6. A B C D 8. A B 10.A B C D 12. A B C D 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 _________________________________


November 2012


Kentucky Renaissance Pharmacy Museum

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 [email protected]

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. Con-tributions by cashier’s check or money order are lim-ited to $50 per election unless the instrument identi-fies the payor and payee. KRS 121.150(4)

Anonymous Contributions: $50 per contributor, per elec-tion, maximum total of $1,000 per election.

(This information is in accordance with KRS 121. 150)

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!

November 2012


Pharmacy Law Brief

Question: I am new to serving on the board of a non-

profit 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

role. We had no orientation session for new board mem-

bers. What is that?

Response: At the outset it should be noted that an

earlier column in this series, appearing in the November

2008, issue, was entitled “Potential Legal Exposure with

Community Service as a Board Member of a Non-Profit

Agency.” Further, a column entitled “Contemporary Legal

Issues for Leadership in Non-Profits-I” appeared in the

September 2012, issue. This installment addresses fiduci-

ary obligations other than potential conflict of interest board

members may encounter and supplements or extends

those earlier items.

Directors of non-profit organizations, irrespective of how

one arrived in that position – whether directly elected, ap-

pointed 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 organiza-

tion of whose board they serve. A fiduciary duty may be

described as an obligation to use the faith and trust accord-

ed 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

she reasonably believes to be in the best interest of the

organization.

Duty of Confidentiality – Highly confidential information

will be made available to members of the organization’s

governing body in conjunction with such service. It is the

duty of a member of the board to maintain such confidenti-

ality.

Duty of Loyalty – A director may not disclose confidential

information, compete with the organization or assist others

who so compete, usurp a business opportunity of the or-

ganization, or obtain unfair or secret profits through a trans-

action with the organization.

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 acknowl-

edging their fiduciary obligations and pledging to abide by

them.

Disclaimer: The information in this column is intended

for educational use and to stimulate professional discus-

sion 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 ade-

quately and fully address the multifaceted and often com-

plex issues that arise in the course of professional practice.

It is always the best advice for a pharmacist to seek coun-

sel from an attorney who can become thoroughly familiar

with the intricacies of a specific situation, and render advice

in accordance with the full information.

Submit Questions: [email protected]

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

KPhA sends email announcements weekly.

If you aren’t receiving: eNews, Legislative Updates, Grassroots Alerts and other important

announcements, send your email address to [email protected] to get on the distribution list.

November 2012


APSC/HD Smith

November 2012


Pharmacy Policy Issues

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 Uni-versity of Kentucky.

Issue: More and more patients are coming into the pharmacy asking questions about drugs they see adver-

tised 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 bea-

vers, dancing balloon bladders and songs like “Viva Viag-

ra” 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

drug advertising, updat-

ed the regulations for

promotional drug mate-

rials. The 1999 update

allowed for advertise-

ments to include only

major risks associated

with the drug’s use in-

stead of every risk. The

change in FDA regula-

tion removed the time

constraining issue of

describing every risk

associated with a drug

and led to the utilization

of DTCA television advertisements.

Today, DTCA is an extremely controversial topic. Propo-

nents of DTCA argue that it may improve patients’

knowledge of drugs and drug availability, encourage pa-

tient-provider discussion about health problems, increase

patient participation in health care, remove stigmas at-

tached to certain disease states, remind patients to refill

prescriptions and improve adherence. Opponents of DTCA

reason that DTCA may confuse patients about drugs, over-

state 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, pharma-

cists are encouraged to understand the four basic require-

ments 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 ap-

proved 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 877-

RX-DDMAC (877-793-3622) and the email address is Ba-

[email protected]. Pharmacists are well positioned to recog-

nize DTCA firsthand and through interactions with patients.

Reporting suspected violations to the FDA will help to en-

sure that patients’ receive appropriate information.

Beyond recognizing and reporting suspected DTCA viola-

tions to the FDA, pharmacists should be prepared to en-

gage in conversations with patients about drugs they have

seen advertised on television. The pharmacist should dis-

Have an Idea?:

This column is designed to

address timely and practical

issues of interest to

pharmacists, pharmacy

interns and pharmacy

technicians with the goal

being to encourage thought,

reflection and exchange

among practitioners.

Suggestions regarding topics

for consideration are

welcome. Please send them

to [email protected].

November 2012


Pharmacy Policy Issues

2012 KPhA Mid-Year Conference on Legislative Priorities & Emergency Preparedness

November 30-December 1 * Embassy Suites Lexington

cuss why the patient thinks the medication is needed and

respond with accurate information regarding the medication

and disease state. If the medication is for an undiagnosed

condition, it is important to remind the patient that they need

to discuss the symptoms with their prescriber. The pharma-

cist should note that many times the condition many appear

more common in DTCA than in reality. Additionally, the

pharmacist should remind the patient that the medication on

television may not be the best treatment option or the most

cost efficient option.

References

1. Mulligan L. You Can't Say That on Television: Constitu-

tional Analysis of a Direct-to-Consumer Pharmaceutical

Advertising Ban. American Journal of Law & Medicine,

June 2011;37(2/3):444-467.

2. Keeping Watch Over Direct-to-Consumer Ads. FDA

Consumer Health Information: U.S. Food and Drug Ad-

ministration. May 10, 2010. Available at: http://

www.fda.gov/ForConsumers/ ConsumerUpdates/

ucm107170.htm. Accessed February 12, 2012.

3. Truthful Prescription Drug Advertising and Promotion

(Bad Ad Program). U.S. Food and Drug Administra-

tion’s Division of Drug Marketing, Advertising, and

Communications. October 17, 2011. Available at: http://

www.fda.gov/Drugs/

GuidanceComplianceRegulatoryInformation/ Surveil-

lance/DrugMarketingAdvertisingandCommunications/

default.htm. Accessed February 12, 2012.

KPhA Government Affairs Contribution

Election Year Appeal—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

November 2012


Pharmacists Mutual

November 2012


Senior Care Corner

Senior Care Corner from the KPhA Academy of Consultant Pharmacists

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.

Planning for the Joint KPhA LTC Academy - ASCP KY Chapter Spring CE

meeting has begun! If you’d like to get involved as a participant, speaker,

or sponsor, please contact [email protected] / 502-741-6578 or

[email protected] / 1-800-445-8917

mailto:[email protected]

mailto:[email protected]

November 2012


KPhA BOARD OF DIRECTORS

Lewis Wilkerson, Frankfort Chairman

[email protected] 502.695.6920

Kimberly Croley, Corbin President


Duane Parsons, Richmond President-Elect


Frankie Hammons Abner, Barbourville Secretary


Glenn Stark, Frankfort Treasurer

[email protected]

Donnie Riley, Russelville Past President

[email protected]

Directors

Molly Trent, Georgetown Student Representative

[email protected]

Lance Murphy, Louisville Student Representative

[email protected]

Matt Carrico, Louisville

[email protected]

Chris Clifton, Erlanger

[email protected]

Trish Freeman, Lexington*

[email protected]

Joey Mattingly, Prospect

[email protected]

Jeff Mills, Louisville

[email protected]

Bob Oakley, Louisville

[email protected]

Richard Slone, Hindman

[email protected]

Sam Willett, Mayfield

[email protected]

* At-Large Member to Executive Committee

HOUSE OF DELEGATES

Matt Martin, Louisville Speaker of the House

[email protected]

Cassandra Beyerle, Louisville Vice Speaker of the House

[email protected]

KPERF ADVISORY COUNCIL

Kim Croley, Corbin

[email protected]

Ann Amerson, Lexington

[email protected]

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

[email protected]

Scott Sisco, MA

Director of Communications and Continuing Education

[email protected]

Kelli Sheets

Office Manager

[email protected]

Christine Richardson, PharmD

Clinical Pharmacist, Interim Director of Professional &

Clinical Services

[email protected]

Leah Tolliver, PharmD

Director of Pharmacy Emergency Preparedness

[email protected]

Nancy Baldwin

Receptionist/Office Assistant

[email protected]

Angela Gibson

Administrative Coordinator & Billing Specialist

(Temporary placement)

[email protected]

KPhA Board of Directors

November 2012


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 [email protected]

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 [email protected]

Drug Information Center Sullivan University College of Pharmacy 2100 Gardiner Lane Louisville, KY 40205 (502) 413-8638 www.sullivan.edu

Frequently Called and Contacted

50 Years Ago/Frequently Called and Contacted

KPhA Remembers KPhA desires to honor members who are no longer with us.

Please keep KPhA informed by sending this information to [email protected].

Deceased members for each year will be honored permanently at the KPhA office.

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. – From

The Kentucky Pharmacist, November 1962, Volume XXIV, Number 1.

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 vol. 7 #6

Documents

kentucky pharmacy education

profession of pharmacy

field of pharmacy

ky kpha

kpha office

pharmacists mutual

new kpha members

pharmacy law brief