the kentucky pharmacist vol. 8 no. 2

News & Information for Members

of the Kentucky Pharmacists Association

Vol. 8, No. 2

March 2013

TTHEHE KKENTUCKYENTUCKY

PPHARMACISTHARMACIST

LEGISLATIVE ACTION

House Bill 217

corrects

pharmacy issues

legislators

learned about

from KPhA led

testimony.

Flanked by bipartisan

supporters, Gov. Steve

Beshear signs HB 217

into law.

135th KPhA Annual Meeting

Tentative Schedule, Topics and Registration

information inside!

Senate Bill 107 Passes with no dissenting votes!

Thanks to your calls, visits and testimony, KPhA’s top priority moved quickly!

March 2013

THE KENTUCKY PHARMACIST 2

Table of Contents

Table of Contents

Table of Contents— Oath— Mission Statement 2 President’s Perspective 3 2012 Bowl of Hygeia Winners 4 135th KPhA Annual Meeting 5 Message from Your Executive Director 6 135th KPhA Annual Meeting Registration Form 7 Kentucky at APhA 8 Board of Directors Election/Professional Awards 9 Board of Pharmacy letter regarding fitting of therapeutic shoes by technicians and interns 10 March 2013 CE—Pertussis 12 March Pharmacist/Pharmacy Tech Quiz 18 Senior Care Corner 19

KPhA New and Returning Members 20 Adventures in Compounding 22 Helping Hands, Big Heart 25 April 2013 CE—Herbals in Cancer Treatment 26 April Pharmacist/Pharmacy Tech Quiz 38 Why should I connect with KPhA? 39 Pharmacy Law Brief 40 Advancing Pharmacy Practice Summit Save the Date 41 Pharmacy Policy Issues 42 Kentucky Renaissance Pharmacy Museum 43 Pharmacists Mutual 44 KPhA Government Affairs Contribution 45 KPhA Board of Directors 46 50 Years Ago/Frequently Called and Contacted 47

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 2013 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.

March 2013


President’s Perspective

This next issue of rele-

vance and relationships

centers on the necessary

infrastructure of YOUR

KPhA in order for the

“business” of the Associa-

tion to move forward.

However, I wanted to make two comments before I get into

the message about the importance of “One Heart, One

Voice” when it comes to Advocacy. In our state, the recent

passage of SB107 through the Kentucky House of Repre-

sentatives and Senate without a dissenting vote shows

without a doubt that Together WE are POWERFUL! I also

wanted to let you know that at the recent APhA Annual

Meeting in Los Angeles, the House of Delegates passed

the following Policy Statement without a dissenting vote:

“Pharmacists are Providers which should be recognized/

compensated by payers.” Sometimes short and sweet gets

the job done best!

Now, we are coming to the time of year when YOUR KPhA

is seeking individuals to step up and volunteer. Every year,

we nominate and elect a President-Elect, a Secretary OR

Treasurer (alternating years) and three Directors. These

individuals join the Board of Directors which will still include

the Chair of the Board, the President, the Secretary OR

Treasurer and the other Directors. Each College of Phar-

macy sends a student pharmacist Director member to

serve as a liaison as well. Our Executive Director, Director

of Communications, Office Manager and Director of Emer-

gency Preparedness also participate in the meetings. Our

lobbyists and legislative experts also drop by to lend their

expertise. It is a dynamic and exciting group that carries

the weight of the Association on its shoulders. We desire

and need the support, knowledge and expertise of the

membership as a whole. Our Standing and Special Com-

mittees are the backbone of the Association. We need indi-

viduals on these committees who bring drive, determination

and creativity to the work of the committee. You may ask

yourself, “How is a committee member relevant to the work

of KPhA?” or “I am just one person; how can I make a dif-

ference?” I would answer these queries by saying it is the

one-to-one relationships that are fostered in the Committee

process that builds and constantly improves the work of the

committee which in turn strengthens YOUR KPhA. This

“call to action” by YOUR KPhA is meant for each of you

reading these words.

Continuing with this theme but in a different vein, this call

also includes nominations of yourself or a peer for a Board

of Pharmacy appointment. By statute, YOUR KPhA pro-

vides a listing of five names annually for the Governor to

choose from for a Board of Pharmacy appointment. Please

consider the people you know who practice pharmacy the

way it should be so that Best Practice is the Standard Prac-

tice across our Commonwealth, protecting the health and

welfare of our citizens and continuing the level of trust we

have established with our patients.

It is also time for nomination to the Professional Awards

given annually at YOUR KPhA Annual Meeting. These in-

clude the Bowl of Hygeia; Pharmacist of the Year; Young

Pharmacist of the Year; Professional Promotion; and Inno-

vative Practice Awards. All of you know pharmacists who

are deserving of these awards. Student Pharmacists and

New Practitioners, consider the awesome preceptors you

honed your practice skills under and nominate them for an

award! Look around at your peers; see the relationships

that the pharmacists you work with forge on a daily basis

with their patients. Pharmacists that you know provide ex-

cellent patient care on a daily basis, and we need you to

tell us about them!

Now to discuss a slightly different matter of relevance and

relationships. I want to tell you of a recent decision by

YOUR KPhA Board of Directors. In response to a “Call for

Action” by Gloria Doughty (Bluegrass), Pharmacist Extraor-

dinaire and Developer-Curator of the KY Renaissance

Pharmacy Museum, YOUR KPhA has offered to provide

storage for the museum’s collections until a permanent

home can be found. Its current home in downtown Lexing-

ton has been found to contain lead in its interior paint that

exceeds federally prescribed limits and the building must

be closed down. Where the museum will reopen in the fu-

ture is still uncertain and so KPhA’s offer of assistance pro-

vides a safe and secure storage location for these precious

pharmacy artifacts until a permanent home (or perhaps

homes) can be found. The Directors of YOUR KPhA felt

this was the least we could offer to do after the time, mon-

ey and expertise Gloria and Lynn Harrelson have donated

to our profession by preserving our pharmacy heritage. I

hope you agree and will consider making a donation to the

museum directly or through the KPERF 501(c)(3) for the

preservation of our heritage now and when it finds its final

home.

Kimberly Sasser

Croley

KPhA President

2012-2013

President’s Perspective

March 2013


2012 Bowl of Hygeia Recipients

March 2013



Register now at

www.kphanet.org

Continuing Education Topics:

New Drugs

Skin/Eye/Ear Complaints in Community Pharmacy

Technician Track

including Creating a Career Ladder, New Drugs Update, Law Update

OTC Self-Care Championship

Finance 101 for Pharmacy

Law Update

Preceptor Training Program

And more clinical topics to come!

Tentative Schedule

Friday, June 7, 2013 (7.5 CE)

7 am Registrations Open

8 am-8:30 am Opening Breakfast

9 am Opening House of Delegates

9 am-10:15 am CE program (1.25 hr)

10:30-11:45 am CE program (1.25 hr)

10:30-noon Pharmacy Transitions Program (Not-CE)

12 noon KPhA Awards Luncheon

1:30-4 pm Finance 101 for Pharmacy (2.5 hr)

1:30 -2:30 pm CE program (1 hr)

2:45-3:45 pm CE program (1 hr)

4-5:30 pm OTC Self-Care Championship (1.5 hr)

4-5:30 pm Clinical CE program (1.5 hr)

5:30-7:30 pm Opening of Hall of Exhibits

8 pm Student/New Practitioner event

8 pm – 9 pm Dessert reception/CE program (1 hr.)

Saturday, June 8, 2013 (5 CE)

7:30 am Continental Breakfast

7:30 am Reference Committee

8 am-10 am New Drugs CE Program (2 hr.)

8 am -9 am CE Program (1 hr.)

9 am-10 am Preceptor CE Program (1 hr.)

10 am to noon Hall of Exhibits Open

12 noon Lunch (UK Preceptor Recognition)

1:30-2:30 pm Law Update CE Program (1 hr)

2:45-3:45 pm Creating a Career Ladder for Pharmacy

Technicians (1 hr)

2:45-3:45 pm MTM CE Program (1 hr)

3:15 pm-5pm House of Delegates Closing Session

4-5 pm CE Program (1hr)

6 pm President’s Reception

7 pm Ray Wirth Banquet

Sunday, June 9, 2013 (2 CE)

7:30 am Continental Breakfast

8 am to 10 am Handling Skin/Eye/Ear Complaints in the

Community Pharmacy CE(2 hr) Preconference events on June 6 include:

Immunization Training (5 hour CE credit)

CPR Recertification

KPERF Golf Scramble

The Kentucky Pharmacy Education & Research

Foundation is accredited by The Accreditation Council

for Pharmacy Education as a provider of continuing

Pharmacy education.

To book your hotel room

online, visit YOUR

www.kphanet.org and follow

the link from the

135th Annual Meeting page.

Or contact Louisville Marriott

Downtown

at 1-800-266-9432 and

reference Group Code KY

Pharmacists Association for

the special rate of

$119/night. Cut-off for this

rate is May 14, 2013.

Lodging rate includes

wireless internet access.

March 2013


From Your Executive Director

Continued on Page 43

MESSAGE FROM YOUR

EXECUTIVE DIRECTOR

Robert “Bob” McFalls It is known as the “Short Session” in Frankfort—the legisla-

tive session in odd-numbered years where no budget is

discussed. It lasts 30 days, which in legislative speak I

have learned means 30 days strategically calendared

across a span of three months with adjournment no later

than March 30.

Working with you, our members and partners, YOUR KPhA

has been very active during the 2013 Regular Legislative

Session. As everyone certainly knows by now, KPhA’s top

legislative priority was SB 107 — developed through the

work of the KPhA Governmental Affairs Committee and

subsequently approved by the House of Delegates. While

KPhA staff was busy at work in generating Grassroots

Alerts, YOU were busy making telephone calls with your

Senator and Representative. Thirty days seems like a long

time until it is time to move a bill through all of the steps of

the legislative process. We had to secure a sponsor, work

through the committee process in each chamber and get

the bill to a vote in both the Senate and the House. First

came the 37-0 vote in the Senate, which was followed sev-

eral days later by the 96-0 House vote. On the day of the

SB 107 vote in the House, only 47 bills had passed both

chambers. KPhA gratefully acknowledges Senator Julie

Denton’s leadership and sponsorship, along with the criti-

cal support of Senate President Robert Stivers, Repre-

sentative Tommy Thompson, Representative Jeff Greer

and SB 107 Senate co-sponsors, Senator Walter Blevins,

Senator Denise Harper Angel, Senator Jimmy Higdon,

Senator Jerry Rhoads and Senator Johnny Ray Turner. At

the same time, we appreciate all 133 Senators and Repre-

sentatives who voted in favor of the bill with not one dis-

senting vote in either chamber.

SB 107 establishes a set of basic disclosures that PBMs

must make in their dealings with contracted pharmacies. It

requires that a PBM disclose in its contract with the phar-

macy the pricing indices used to calculate the reimburse-

ment paid to the pharmacy for drug products. It also speci-

fies that, if the PBM uses maximum allowable cost (MAC)

to determine reimbursement, the PBM must disclose to the

pharmacy what products are subject to MAC and what the

MAC is for each of those drugs. SB 107 also requires

PBMs to update MAC lists at least every 14 days and es-

tablishes parameters for price appeals by pharmacies. The

bill was amended in the Senate to delay the requirement

that PBMs provide retroactive reimbursement for success-

ful MAC appeals. The new language requires the PBM to

include in their contracts with pharmacies a process for

retroactive reimbursement no later than one year following

the effective date of the act. Hopefully, by the time you

read this, the bill will be signed into law by Governor

Beshear.

While SB 107 took most of our focus this legislative ses-

sion, YOUR KPhA also tracked several other bills. HB 1 as

passed in 2012 was amended in 2013 by HB 217 with

strong bi-partisan support by leaders in both chambers and

the Governor’s office. As another of our top legislative pri-

orities, YOUR KPhA worked on two key provisions within

HB 217 with respect to their impact on pharmacies. One

was to repeal the requirement that Schedule II and Sched-

ule III drugs administered directly to the patient be reported

to the state’s electronic prescription drug tracking system

(KASPER). Legislators heard KPhA-led testimony during

the interim that this provision is unnecessary and would

cause significant problems for hospital pharmacies and

pharmacies serving long term care facilities. Another provi-

sion of HB 217 deletes the requirement that pharmacies

report the loss or theft of controlled substances to the state

police. Pharmacies are already required to file reports with

local law enforcement agencies, the Board of Pharmacy

and the DEA. HB 217 enacted a number of other practical

improvements by cleaning up unintended consequences of

the original bill. KPhA attended the bill signing ceremony

with Governor Beshear on March 5.

On a related note, KPhA has worked diligently with the

Board of Pharmacy, APSC and KRF to obtain clarification

on the fitting of therapeutic shoes. Following a series of

meetings and consultations, the Board of Pharmacy has

issued a letter of clarification on this issue in consultation

with the Board of Prosthetics, Orthotics and Pedorthics

(See Page 10-11 for more information.) KPhA would like to

acknowledge and to thank the two boards for their work on

March 2013



March 2013


Kentucky at APhA Annual Meeting 2013

REGISTER REGISTER REGISTER ONLINE AT ONLINE AT ONLINE AT

WWW.KPHANET.ORG!WWW.KPHANET.ORG!WWW.KPHANET.ORG!

For more information, For more information, For more information, contact Scott Sisco at contact Scott Sisco at contact Scott Sisco at [email protected]@[email protected].

Kentucky

at APhA

President Kim Croley congratulates KPhA’s

first female President, Dr. Virginia “Ginger”

Scott, who was elected as an APhA Fellow

by APhA-APRS in 2013.

KPhA congratulates Brian Fingerson on

his election as an APhA-APPM Fellow at

the 2013 APhA Annual Meeting in Los

Angeles.

Kentucky

Delegates

Croley, Joe

Carr and

Greg Baker

attend the

opening

session of

the House of

Delegates.

March 2013


2013-14 KPhA Board Election

2013 KPhA Professional Awards The Kentucky Pharmacists Association annually recognizes individuals from across the Commonwealth that exhibit exceptional service to patients and their community, continuously promote the profession of pharmacy, and demon-strate innovative pharmacy practice. The KPhA Organizational Affairs Committee is accepting nominations for the professional awards below:

Bowl of Hygeia Distinguished Service Award

Pharmacist of the Year Professional Promotion Award

Young Pharmacist of the Year Excellence in Innovation Award

Technician of the Year Cardinal Health Generation Rx Champions Award

To nominate an individual, please submit a letter of nomination including the award information and the nominee’s

accomplishments with regard to the award criteria. Multiple letters of support are accepted and highly encouraged.

Individuals and recognized pharmacy organizations in Kentucky are encouraged to submit nominations. Individual

nominators need not be a member of the Association; however, pharmacist and technician nominees must be a mem-

ber of KPhA. See www.kphanet.org, click on About, Professional Awards for past winners and criteria.

Nominations:

Nominations may be submitted electronically to Scott Sisco at [email protected] or mailed to KPhA, Attn:

Scott Sisco 1228 US 127 South, Frankfort, KY 40601 no later than March 31, 2013.

The KPhA President, President-Elect, and the Chairman of the Board, participating in any voting for awards shall not be eligible for nomination or selection for any award.

Conferral of any of the awards of the Association shall be at the discretion of the Organizational Affairs Committee and is not mandatory on an annual basis.

KPhA Board of Directors Nominations for 2013-14 Serve YOUR profession by serving on

YOUR KPhA Board of Directors!

The Kentucky Pharmacists Board of Directors is accepting nominations for the following positions to serve on the KPhA Board for the 2013-14 year:

President-Elect Treasurer Director (3 open spots)

Nominations:

Nominations may be submitted electronically to Scott Sisco at [email protected] or mailed to KPhA, Attn: Scott Sisco 1228 US 127 South, Frankfort, KY 40601 no later than March 31, 2013. For

descriptions and nomination form, see www.kphanet.org, click on About, Board of Directors.

The 2013 KPhA Board of Directors Election will be held online at

www.kphanet.org. You will need to log in to the site to cast your vote.

Paper ballots will be available, but ONLY upon request.

Call the KPhA Office at 502-227-2303 for more information.

March 2013


Kentucky Board of Pharmacy Update

March 2013


March 2013 CE—Preventative Treatment of Pertussis

“Don’t Let Pertussis “WHOOP UP” (on) Your Patients” - Preventative Treatment of Pertussis

There are no financial relationships that could be perceived as real or apparent conflicts of interest.

By: Leah Ryan, PharmD Candidate, Tram Thai, PharmD Candidate, Daniel Nguyen, PharmD

Candidate, Holly L. Byrnes, PharmD, BCPS, Sullivan University College of Pharmacy, Louis-

ville, KY

Universal Activity # 0143-0000-13-003-H04-P&T

1 Contact Hour (0.1 CEU)

Goal of the Program: Discuss the recent outbreak of pertussis and review preventative treatment options.

Objectives

At the conclusion of this program, the reader should be able to:

1. Identify the clinical symptoms and possible treatment options for pertussis.

2. Identify at-risk populations for acquiring pertussis.

3. Compare and contrast the DTaP and Tdap vaccinations.

4. Identify patient populations that should receive a Tdap booster versus Td booster.

5. Recognize the impact pharmacists can have to reduce pertussis infections.

KPERF offers all

CE articles to

members online at

www.kphanet.org

Pertussis, more commonly known as whooping cough, is a

highly contagious infection in the respiratory tract.1 Pertus-

sis is extremely important due to the recent outbreaks and

deaths throughout the United States. The Centers for Dis-

ease Control and Prevention (CDC) have reported an in-

crease in the number of outbreaks in 49 states and Wash-

ington, D.C. as of Nov. 21, 2012, compared to this same

time period last year. This increase in pertussis displays

the importance of early vaccination and what we can do as

pharmacists to help control this outbreak. According to re-

cent statistics, more than 41,000 cases of pertussis have

been reported to the CDC throughout 2012, including 18

pertussis-related deaths.2 It is imperative that pertussis is

better controlled in the United States to minimize these out-

breaks and pertussis-related morbidity/mortality. This infec-

tion is not only a public health concern for our nation, but it

is specifically important for our area because Kentucky is

among one of the many states in which the incidence of

pertussis is higher than the national average. According to

Kentucky law, urgent notification of a pertussis occurrence

must be reported to a health facility licensed under KRS

Chapter 216B within 24 hours.3 Weekend or urgent even-

ing notifications require health professionals to report via

electronic submission or telephone, stating only the name

of the disease being reported and a call-back number.3

An important strategy that pharmacists can utilize to help

control the incidence of pertussis is educating caregivers

and ensuring infants are properly vaccinated, as most

deaths occur in infants younger than 3 months of age. Oth-

er vulnerable age groups include children 7 to 10 years of

age, as well as adolescents 13 and 14 years of age.2 By

reviewing the etiology and preventative measures availa-

ble, pharmacists should be well equipped to educate and

vaccinate patients across Kentucky against this preventa-

ble disease.

What is Pertussis?

Pertussis is caused by the bacterium Bordetella pertussis.

Pertussis also is commonly known, as the whooping cough

because someone infected often needs to take deep

breaths, resulting in the characteristic “whooping” sound.

Infants and young children are most commonly affected by

pertussis, which can be fatal.4 Pertussis mainly affects in-

fants younger than 6 months of age due to their incomplete

immunizations and children aged 11 to 18 because of their

fading immunity.

Infected individuals most commonly spread pertussis by

coughing or sneezing while in close contact with others,

who then inhale the bacteria.4 Caregivers of infants may not

even realize that they are infected since symptoms of per-

March 2013



tussis normally do not develop until seven to 10 days after

exposure and may sometimes last as long as six weeks.

This is important because an infected individual may

spread the disease without knowing it.

Pertussis may be difficult to identify because the early

symptoms are very similar to those of a common cold. The

progression of pertussis is divided into three stages: 5

Stage 1 (Catarrhal Stage) - Symptoms runny nose,

sneezing, mild cough, low-grade fever, and apnea

(infants). Patient is highly contagious. May last one to two

weeks.

Stage 2 (Paroxysmal Stage) – Symptoms: fits of numer-

ous, rapid coughs followed by “whoop” sound, vomiting

and exhaustion after coughing fits. Last from one to six

weeks, may extend to 10 weeks.

Stage 3 (Convalescent Stage) – Gradual recovery with a

lessening of cough. Lasts about two to three weeks.

Patients are contagious from the beginning of the catarrhal

stage through the third week after the onset of paroxysmal

stage or until five days after the start of effective antibiotic

treatment.

Since the symptoms of the early stages of pertussis appear

to be just a common cold, the diagnosis of pertussis nor-

mally does not occur until more severe symptoms appear.

If a patient is suspected of having pertussis, it is important

to seek out medical care in order for a proper diagnosis.5 In

addition to a physical examination, a nasopharyngeal spec-

imen for isolation of Bordetella pertussis and a blood test

are utilized to help identify the disease.

Treatment of pertussis normally includes the use of antibi-

otics and it is important for early treatment to help reduce

the chance of spreading the disease.6 Antibiotic use in the

early stages may help lessen the symptoms; however, if

there is a late diagnosis, antibiotics will not help reduce the

course of illness. Macrolides such as azithromycin, clar-

ithromycin and erythromycin are the agents of choice for

persons aged ≥ 1 month when antibiotics are used.7

Azithromycin is the preferred agent for infants < 1 month of

age. Trimethoprim-sulfamethoxazole is an alternative

agent that can be used for persons aged ≥ 2 months of

age.

Prevention of Pertussis

For the prevention of pertussis, there are two different for-

mulations that can be used: DTaP and Tdap. DTap is the

childhood vaccine used in infants and children, while Tdap

is the pertussis booster vaccine used in adolescents and

adults. Tdap is highly recommended, instead of the previ-

ous recommended Td, for adolescents and teens that are

in contact with infants younger than 12 months of age and

pregnant women lacking previous Tdap administration.8

Capitalized letters in the vaccination denote full-strength

doses in the formulation and lower-case letters denote re-

duced doses in the formulation. The “a” refers to “acellular”

pertussis which means the vaccine only contains a portion

of the pertussis organism and the letters “T” and “D” repre-

sent protection against tetanus and diphtheria, respective-

ly. Tetanus, often referred to as “lockjaw”, can cause the

muscles in the head and neck to tighten and restrict open-

ing of the mouth and prevent swallowing. It also can cause

stiffness and painful muscle spasms all over the body. Tet-

anus can enter the body through cuts, scratches or wounds

and is fatal in approximately one out of five infected individ-

uals.9 Diphtheria infection can cause breathing difficulty,

paralysis, heart failure and sometimes death by covering

the back of the throat with a thick membrane. Similar to

pertussis, diphtheria is spread person to person.

DTaP = full strength of diphtheria (D) and tetanus (T)

toxoids and pertussis (P) vaccine

Tdap = full strength of Tetanus (T), reduced doses of

diphtheria (D) and pertussis (p) vaccine

DT and Td do not protect against pertussis and there-

fore DTaP and Tdap are recommended for initial doses

and booster, respectively

Immunizations are the best way to protect against pertus-

sis. Even adults who are fully immunized still can contract

pertussis, as the vaccine wanes over time. In a recent

study, the overall effectiveness of DTaP was measured at

88.7 percent.10

For children who received their fifth DTaP

dose within the past year, the vaccine effectiveness was

98.1 percent.10

For children who were five or more years

past their last DTaP dose, the long-term effectiveness had

fallen to 71.2 percent.10

This study also showed children

who never received doses of DTaP have at least eight

times higher likelihood of developing whooping cough com-

pared to those children who received all five doses.10

Table 1 compares the difference between DTaP and Tdap

immunizations and includes the recommended dosing

schedule for each. If a child’s vaccinations have been de-

layed, refer to Table 2 for the recommended catch-up

schedule. It is not necessary to initiate a new DTaP series

during catch up vaccinations. Table 3 provides a list of all

the FDA approved DTaP and Tdap vaccinations, including

trade names and indications.

Special Populations Recommended to Receive Tdap

Booster

In most cases, all adults age 19 years and older should

receive a booster dose every 10 years with Td vaccination;

March 2013



however, there are special populations that exist in which a

booster dose with Tdap is more beneficial because of its

added protection against pertussis.24

Because infants are

too young to be fully vaccinated and have the highest mor-

tality rates from pertussis, it is crucial adolescents and

adults who have or anticipate coming into close contact

with an infant younger than 12 months of age receive a

single dose of Tdap at least two weeks before to protect the

baby against an infection, if they have not already been

vaccinated.8,24

This includes parents, siblings, grandparents

and child care providers like daycare workers, babysitters

and nannies. People that have direct patient contact in hos-

pitals and clinics also should receive a dose of Tdap to pre-

vent pertussis and decrease transmission to others. For

adults under 65 years of age who have never received

Tdap, Tdap is recommended as their next booster dose.

Adults age 65 and older may receive one booster dose of

Tdap as well. Women who are pregnant or planning to be-

come pregnant should receive one dose of Tdap regardless

of the number of years since prior Td or Tdap vaccination.25

It is recommended for pregnant women to receive Tdap

during 27 to 36 weeks’ gestation for each pregnancy, to

extend the amount of protection that is passed to the new-

born.

What Can Pharmacists Do to Minimize the Pertussis

Outbreak?

Pharmacists are in a unique position to raise awareness

about the importance of vaccinations against pertussis.

Higginbotham et al. reported the considerable impact phar-

macists can have on immunization rates, showing a statisti-

cally significant increase of influenza and Tdap vaccina-

tions to underserved populations when compared to other

health care providers who provided the same awareness.26

Pharmacists are more easily accessible than physicians

and are exceptionally trusted providers in the community to

help increase immunization rates. Additionally, if a patient

presents to the pharmacy with a prescription for pertussis

treatment, education regarding infection control may be

warranted at that time as well. Through advocacy, educa-

tion and administration of vaccine through prescriber-

approved protocols, pharmacists are well suited to reduce

the incidence of pertussis.

Table 1: DTaP and Tdap Comparison Chart(11-16)

Formulation DTaP Tdap

Age Recommendations 6 weeks through 6 years 7-10 years not fully immunized

≥ 11 years

Minimum Age for Dose 1 6 weeks Children 7 years of age not fully

immunized with DTaP series

Number of Doses 5 doses 1 dose only; then booster with Td every

10 years

Recommended Dosing

Schedule

2, 4, 6, 15-18 months,

and 4-6 years

11-12 years for first dose

Adverse Effects Common: Fussiness, tiredness,

poor appetite and vomiting

Fever and redness, swelling or

tenderness more common after

fourth and fifth dose of series

Very Rare: long-term seizure,

coma and permanent brain

damage

Serious allergic reactions

(1 out of 1 million)

Common: Pain, redness or swelling at

injection site, mild fever, headache,

tiredness, nausea, vomiting, diarrhea,

stomach ache

Very Rare: Swelling, severe pain,

bleeding and redness at injection site

Serious allergic reactions (1 out of 1

million)

Comments Do not give to children

≥ 7 years

Tdap can be administered regardless of

when the last Td dose was given

March 2013



Table2: Catch Up Schedule17

*Dose 5 not necessary if Dose 4 was given at age ≥ 4 years

+Unvaccinated or behind schedule children age 7 years and teens should complete a primary Td

+Tdap is preferably to be given as Dose 1 or can be substituted as a 1-time for any dose in the series

Age 4 months through 6 years

Minimum Interval Between Doses

Vaccine Dose 1 to Dose 2 Dose 2 to Dose 3 Dose 3 to Dose 4 Dose 4 to Dose 5

DTaP 4 weeks 8 weeks 6 months 6 months*

Age 7 years through 18 years

Td/Tdap+ 4 weeks 4 weeks

if Dose 1 was given

<12 months of age

6 months if Dose 1 was given

≥12 months of age

6 months if Dose 1 was given

<12 months of age

*not necessary

Table 3: FDA approved DTaP and Tdap vaccinations18-23

*May still be used in persons 7 to 9 years of age that missed any one of the DTaP dose series

IPV= Inactivated poliovirus, Hep B=Hepatitis B, Hib=Haemophilus Influenzae Type b

Vaccine Trade Name Type Route Comments

DTaP Daptacel® Inactivated

Bacterial

IM Approved as five dose series in ages 6 weeks

through 6 years of age (prior to 7th birthday)

DTaP Infanrix® Inactivated

Bacterial

IM Approved as five dose series in ages 6 weeks

through 6 years of age (prior to 7th birthday)

DTaP-IPV Kinrix® Inactivated

Bacterial &

Viral

IM Approved as the 5th dose of the vaccine series

DTaP-HepB-IPV Pediarix® Inactivated

Bacterial &

Viral

IM Approved for Dose 1-3 of the vaccine series at

age 2, 4, and 6 months

DTaP-IPV/Hib Pentacel® Inactivated

Bacterial &

Viral

IM Approved for Dose 1-4 of vaccine series from

age 6 weeks through 4 years (prior to 5th birth-

day)

Tdap* Boostrix® Inactivated

Bacterial

IM Approved for use in ages ≥10 years

Tdap* Adacel® Inactivated

Bacterial

IM Approved for use in ages 11-64 years

March 2013



Conclusion

The best way pharmacists can prevent a further outbreak

of pertussis in the United States is to actively educate pa-

tients and surrounding community. Reviewing the various

formulations and booster indications is vital to identifying

appropriate prevention for at risk populations. Encourage

children and adults to get vaccinated against pertussis to

reduce the amount of outbreaks each year and advise

adults who are planning to come into close contact with an

infant to get vaccinated with Tdap at least two weeks be-

fore, particularly due to the lack of fully immunized infants.

It also is important to inform patients that the risk of devel-

oping pertussis is far more risky than the side effects of the

vaccine. Common minor side effects such as redness,

swelling or tenderness at the injection site usually resolve

after a couple of days and severe problems are very rare.

Since pertussis is difficult to identify and the symptoms of

pertussis closely resemble symptoms of other infections,

prevention is the most effective method to combat the

spread of this preventable tragedy.

References

1. Whooping cough (2/21/2012). Mayo Clinic Web site.

Available at: http://www.mayoclinic.com/health/

whooping-cough/DS00445. Accessed Jan. 21, 2013.

2. Pertussis: Outbreaks Centers for Disease Control and

Prevention Web site. Available at: http://www.cdc.gov/

p.ertussis/outbreaks.html. Accessed Jan. 21, 2013.

3. 902 KAR 2:020-Disease Surveillance. Kentucky Board

of Pharmacy. Available at: http://www.lrc.state.ky.us/

kar/902/002/020.htm. Accessed Jan. 31, 2013.

4. Pertussis: Causes and Transmission (5/7/2012). Cen-

ters for Disease Control and Prevention. Available at:

Web site http://www.cdc.gov/pertussis/about/causes-

transmission.html. Accessed Dec. 13, 2012.

5. Pertussis: Signs and Symptoms (5/7/2012). Centers for

Disease Control and Prevention. Available at: Web site

http://www.cdc.gov/pertussis/about/signs-

symptoms.html. Accessed Dec. 13, 2012.

6. Pertussis: Treatment (4/9/2012). Centers for Disease

Control and Prevention Web site. Available at: http://

www.cdc.gov/pertussis/clinical/treatment.html. Ac-

cessed Dec. 13, 2012.

7. Recommended Antimicrobial Agents for the Treatment

and Postexposure Prophylaxis of Pertussis. Centers

for Disease Control and Prevention Web site. Available

at: http://www.cdc.gov/mmwr/preview/mmwrhtml/

rr5414a1.htm#tab4. Accessed Jan. 27, 2013.

8. Pertussis: Vaccination (1/29/2012). Centers for Dis-

ease Control and Prevention Web site. Available at:

http://www.cdc.gov/pertussis/vaccines.html. Accesses

Dec. 10, 2012.

9. Vaccines and Immunization: Possible Side Effects from

Vaccines (8/29, 2012). Centers for Disease Control

and Prevention Web site. Available at: http://

www.cdc.gov/vaccines/vac-gen/side-effects.htm#dtap.

Accessed on Nov. 24, 2012.

10. Childhood Whooping Cough Vaccine Protects Most

Children For At Least 5 years (n.d.).

11. Available at: http://www.cdc.gov/media/

matte/2011/10_whooping_cough.pdf. Accessed on

Nov. 24. 2012.

12. Vaccine Information Statement: Td & Tdap Vaccines

(1/24/2012). Centers for Disease Control Web site.

Available at http://www.cdc.gov/vaccines/pubs/vis/

downloads/vis-td-tdap.pdf. Accessed on Nov. 24, 2012.

13. Vaccine Information Statement: Diptheria, Pertussis,

and Tetanus Vaccines (5/17/2007). Centers for Dis-

ease Control Web site. Available at http://

www.cdc.gov/vaccines/pubs/vis/downloads/vis-

dtap.pdf. Accessed on Nov. 24, 2012.

14. Centers for Disease Control and Prevention. Recom-

mended immunization schedules for persons aged 0-

18 years-United States, 2012. MMWR. 2012;61(5).

15. Centers for Disease Control and Prevention. Recom-

mended adult immunization schedule-United States,

2012. MMWR. 2012;61(4).

16. Committee on Infectious Diseases. Policy Statement

Recommended Childhood and Adolescent Immuniza-

tion Schedules - United States, 2012. Pediatrics. 2012

Feb;129 (2): 385-386.

17. Advisory Committee on Immunization Practices. Rec-

ommended adult immunization schedule: United

States, 2012. Ann Intern Med. 2012;156(3):211-217.

18. Catch-up immunization schedule for persons aged 4

months through 18 years who start late or who are

more than 1 month behind —United States (2013).

Centers for Disease Control Web site. Available at:

http://www.cdc.gov/vaccines/schedules/downloads/

child/catchup-schedule-bw.pdf. Accessed on Feb. 2,

2013.

19. Daptacel® [package insert]. Swiftwater, PA: Sanofi

Pasteur; 2012 July.

20. Infanrix® [package insert]. Research Triangle Park,

March 2013



NC: GlaxoSmithKline; 2012 March.

21. Kinrix® [package insert]. Research Triangle Park, NC:

GlaxoSmithKline; 2012 March.

22. Pediarix® [package insert]. Research Triangle Park,


23. Boostrix® [package insert]. Research Triangle Park,


24. Adacel® [package insert]. Swiftwater, PA: Sanofi Pas-

teur; 2012 February.

25. Vaccines and Preventable Diseases:Combined Tdap

Vaccine: Tetanus, Diphtheria and Pertussis (Tdap)

Vaccines (12/19/2012). Available at: http://

www.cdc.gov/vaccines/vpd-vac/combo-vaccines/dtap-

td-dt/tdap.htm. Accessed Jan. 23, 2012.

26. CDC. Advisory Committee on Immunization Practices

(ACIP) recommended immunization schedules for per-

sons aged 0 through 18 years and adults aged 19

years and older-United States, 2013. February 1, 2013.

Available at: http://www.cdc.gov/mmwr/pdf/other/

su6201.pdf. Accessed Feb. 27, 2013.

27. Higginbotham S, Stewart A, Pfalzgra A. Impact of a

pharmacist immunizer on adult immunization rates. J

Am Pharm Assoc. 2012;52:367-71.

March 2013 — “Don’t Let Pertussis “WHOOP UP” (on) Your Patients” - Preventative Treatment of Pertussis

1. JG is a 45 year old male who recently started antibiotic treatment for suspected pertussis. After which point is JG no longer contagious? A. The first dose of antibiotic B. Five days of treatment C. Resolution of symptoms D. Three weeks post treatment 2. In which stage of pertussis is a patient considered most contagious? A. Stage 1 B. Stage 2 C. Stage 3 D. All stages are equally contagious 3. During which stage of pertussis would the characteristic “whoop” sound occur? A. Stage 1 B. Stage 2 C. Stage 3 D. May start in any stage 4. Why does pertussis mainly affect infants younger than 6 months of age? A. Caregivers do not know they have it and transmit it to the

infant B. Infants are not as sanitary and therefore are more prone

to infections C. Immune system is not fully vaccinated and more prone to

infection D. Immune system is still developing and more susceptible

to infection 5. What is the antibiotic of choice for pertussis treatment in an infant less than 1 month of age? A. Trimethoprim/Sulfamethoxazole B. Azithromycin C. Cefdinir D. Amoxicillin/Clavulanate Potassium

6. What is the recommended dosing schedule for the 5-dose series of DTaP? A. At birth, 2, 4, 15 to 18 months, and 4 to 6 years B. 6 weeks, 4, 6, 15 to 18 months, and 4 to 6 years C. 2, 4, 6, 15 to18 months, and 4 to 6 years D. 2, 4, 6, 15 to 18 months, and ≥7 years 7. Which vaccination(s) is/are FDA approved as the complete 5-dose series of DTaP? A. Daptacel® B. Infanrix® C. Pediarix® D. A and B 8. Which special population is recommended to receive a sin-gle booster dose of Tdap instead of Td if they have not al-ready received a vaccination? A. Daycare workers B. Health care workers C. Sibling of an infant less than 12 months of age D. All of the above individuals should receive Tdap 9. When coming into contact with an infant less than 12 months of age, a Tdap booster should be administered at least _____________ before contact. A. 1 week B. 2 weeks C. 3 weeks D. 4 weeks 10. NT is a 25 year old female who just found out she was pregnant. She received a Td booster five years ago. When should she receive a Tdap booster? A. In five years due to her tetanus booster five years ago B. During her first trimester or as soon as possible C. Anytime between 27 to 36 weeks’ gestation D. Immediately in the postpartum period

March 2013



The Kentucky Pharmacy Education & Research Foundation is

accredited by The Accreditation Council for Pharmacy

Education as a provider of continuing Pharmacy education.

Quizzes submitted without NABP eProfile

ID # and Birthdate cannot be accepted.

PHARMACISTS ANSWER SHEET March 2013 — “Don’t Let Pertussis “WHOOP UP” (on) Your Patients” - Preventative Treatment of Pertussis Universal Activity # 0143-0000-13-003-H04-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ 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 9. A B C D 2. A B C D 4. A B C D 6. A B C D 8. A B C D 10. 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 _________________________________

NABP eProfile ID #_____________________________ 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.

Expiration Date: March 20, 2016 Successful Completion: Score of 80% will result in 1.0 contact hours or 0.1 CEUs.

Participants who score less than 80% will be notified and permitted one re-examination.

TECHNICIANS ANSWER SHEET. March 2013 — “Don’t Let Pertussis “WHOOP UP” (on) Your Patients” - Preventative Treatment of Pertussis Universal Activity # 0143-0000-13-003-H04-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ 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 9. A B C D 2. A B C D 4. A B C D 6. A B C D 8. A B C D 10. 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 _________________________________


March 2013


Senior Care Corner

Senior Care Corner from the KPhA Academy of Consultant Pharmacists

The KPhA Academy of Consultant Pharmacists and the Kentucky Chapter of ASCP have planned an excellent continuing education program to be held on April 20, 2013. Please see the agenda below for details on the program topics. Registration forms will be available soon but please mark your calendars and plan to attend.

Kentucky Long Term Care Pharmacy Spring CE Program and Exhibition

Co-hosted by

Kentucky Chapter of American Society of Consultant Pharmacists Kentucky Pharmacists Association – Academy of Consultant Pharmacy

Saturday, April 20, 2013 8:30 am – 3:00 pm (registration begins at 8)

At Sullivan University College of Pharmacy, 2100 Gardiner Lane, Louisville, KY 40205

Agenda 8:00 am - all day – Registration / Check-in (Ground Floor Entrance on 2

nd Floor)

8:00 am – 8:30 am – Registration (2nd

Floor)/ Continental Breakfast (3rd

Floor)

8:30 am – 9:30 am – Law/Regulatory Update (Leah Tolliver, Pharm.D.) (3rd

Floor – Auditorium B)

ACPE 1.0 CEU-Pending Approval

9:30 am - 9:35 am – Announcements

9:35 am - 10:30 am – Exhibitors and snacks (2nd

Floor Main Hallway)

Novartis Novo Nordisk Abbott HealthPoint Mylan Specialty Tolliver Management Group

10:30 am - 11:30 am – Geriatric Pharmacotherapy Principles (3rd


(Noll Campbell, Pharm.D)

ACPE 1.0 CEU-Pending approval

11:30 am - 12:25 pm – Lunch (Sponsored by PCA Pharmacy) (1st floor café)

12:25 pm – 1:25 pm - Anticholinergic Medications and Risk of Cognitive Impairment and Delirium

(Demetra Antimisiaris, Pharm.D.) (3rd


ACPE 1.0 CEU-Pending approval

1:25 pm - 1:30 pm – Break (Please visit the organizational tables in the 3rd

Floor Hallway)

1:30 pm–2:30 pm – The Affordable Care Act & Accountable Care Organizations: The changing face of pharmacy

(BC Childress, PharmD; Sean Jeffery, PharmD; Bonnie Lazor, M.D.) (3rd


ACPE 1.0 CEU- Pending approval

2:30 pm – 2:50 pm – ASCP Initiatives (Sean Jeffery, Pharm.D) (3rd


2:50 pm – 3:00 pm – Announcements (3rd


3:00 pm – 3:00 pm – Optional Activity: Thunder Over Louisville (offsite) no CE.

In conjunction with the KPhA Young Practitioners Committee.

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

for Pharmacy Education as a provider of continuing Pharmacy education.

March 2013


Valerie Akers

Prestonsburg, KY

Crystal D Akridge

Shepherdsville, KY

Matthew Andrews

Fisherville, KY

Doug Antle

Louisville, KY

Glenn Timothy Armstrong

Mount Washington, KY

Lisa K Babb

Guston, KY

Heidi Bainer

Pedro, OH

Garry J Baker

Russell, KY

Cathy Barker

Flatwoods, KY

Mary E Beimesch

Hebron, KY

Danny Bentley

Russell, KY

Gregory F Blank

Covington, KY

Nick Boggess

Flatwoods, KY

Charles Boggs

Dandridge, TN

Michael P Borders

Williamsburg, KY

Clayton Bridgeman

Flatwoods, KY

Amy Brown

Greenup, KY

Clyde E Brown

Mayfield, KY

John W Bushong

Tompkinsville, KY

Donell N Busroe

Harlan, KY

Mark A Capps

Burkesville, KY

Shelia Ann Carrico

Lawrenceburg, KY

Wayne Keith Carter

Russell, KY

Alan D Cash

Albany, KY

Timothy P Castagno

Louisville, KY

Brian Cheek

Louisville, KY

Jane Cheek

Louisville, KY

Carolyn Chou

Louisville, KY

Carrie Christofield

Ft Mitchell, KY

David M Conyer

Paducah, KY

William A Conyers

Glasgow, KY

Karen Cornelius

Middlesboro, KY

Freddie Lee Cox

Corbin, KY

Terry Lee Coyle

Campbellsville, KY

Helen L Danser

Tyner, KY

Joey Darling

Wheelersburg, OH

Amy Delcourt

Greenup, KY

Jane Dunbar-Suwalski

Longmont, CO

Barry L. Eadens

Paducah, KY

Catherine Elmes

Louisville, KY

Paul Elmes

Louisville, KY

Kay Collins Embrey

Brandenburg, KY

Nikita M Evans

South Shore, KY

Edward J Feeney

Louisville, KY

Brooke Feltner

London, KY

Dana Fuller

Lexington, KY

John Martin Fuller

Versailles, KY

Lynn Z Fuller

Versailles, KY

Patty Gayheart

Hindman, KY

Lisa Goodlett

Springfield, KY

Charles L Gore

Russell Springs, KY

Lauren W Grant

Louisville, KY

Darrell T Greenwalt

Livermore, KY

Scott A Greenwell

Louisville, KY

Michael Gruber

Carrollton, KY

Dale Gunkel

Madisonville, KY

Carolyn Loy Hale

Columbia, KY

Jessica Hall

Flatwoods, KY

Kristin Hall

Quincy, KY

Tina Hall

Greenup, KY

Deborah A Harden

Campbellsville, KY

David Harris

Mayfield, KY

Greg Hayse

Shelbyville, KY

Dale Heise

Harrodsburg, KY

Linette Hieneman

Flatwoods, KY

Kristina Hinkle

Heidrick, KY

Susan Hogsten

Flatwoods, KY

Barry W Horne

Danville, KY

Brooke Hudspeth

Lexington, KY

Tawnya Hunt

Greenup, KY

John Inabnitt

Somerset, KY

H Dale Johnson

Corbin, KY

Rene Kendrick

Taylorsville, KY

Christopher Killmeier

Louisville, KY

Kay Lloyd

Louisville, KY

Morris Lloyd

Louisville, KY

Joseph Mashni

Florence, KY

Tom Mattingly

Olive Hill, KY

Okey Mbadike

Louisville, KY

Ronald Moreland

Falmouth, KY

KPhA Welcomes New

and Renewing Members

January –February 2013

New and Returning KPhA Members

March 2013


Jerry B. Morris

Louisville, KY

Shelley Nall

Lexington, KY

Burnice Napier

Hazard, KY

Patrick Noonan

Louisville, KY

Karl Andrew Tucker O'Dell

Flatwoods, KY

Kathy O'Dell

Ashland, KY

Tara Olash

Louisville, KY

Peter Orzali

Cold Spring, KY

Beth Parks

Coralville, IA

Duane Parsons

Richmond, KY

Jarred Patrick

Russell, KY

George Patterson

Gilbertsville, KY

Richard Preece

Ashland, KY

Vicky Pulliam

Bardstown, KY

Timothy Quillen

Greenup, KY

James Rhodes

Louisville, KY

Jill Rhodes

Louisville, KY

Patricia D Robinson

Whitesburg, KY

Helen E Rose

Kevil, KY

Scott Ross

Hopkinsville, KY

Jesse L Rudd

Salyersville, KY

Thomas Russell

Independence, KY

Larry Schaefer

Madisonville, KY

Jim Scott

Earlington, KY

Becky Sue Sergent

Bowling Green, KY

Catherine l Shely

Morehead, KY

Harold Shields

Ashland, KY

Jennifer Shugars

Liberty, KY

Barry Siegel

Evansville, IN

Roberta Sloan

Lexington, KY

Richard Slone

Lexington, KY

Sheel Slone

Lexington, KY

Billy Smith

Shepherdsville, KY

R James Spencer

Beaver Dam, KY

Cheryl Stevens

Louisville, KY

David Bradley Stultz

Flatwoods, KY

Leslie Stultz

Flatwoods, KY

Judy B Thompson

Argillite, KY

Mykel Tidwell

Mayfield, KY

Gisela Torres

Louisville, KY

Elizabeth Traxel

Maysville, KY

John Turpin

Pineville, KY

Terry Vest

Russell, KY

Melissa Vice

Dry Ridge, KY

Joseph Wagner

Louisville, KY

Kathy Wagner

Louisville, KY

Nancy Walker

Cynthiana, KY

Jason Wallace

Dry Ridge, KY

Sara Wells

Gilbertsville, KY

Sandy Wethington

Liberty, KY

Paul Williams

Hardinsburg, KY

Christine Windham

London, KY

Dan P Yeager

Lexington, KY

Jane B Yeager

Lexington, KY

Artie L Young

Brownsville, KY

Saving the Bowl of Hygeia The Bowl of Hygeia has a rich history within pharma-cy, and we need to step up and make sure this history continues. Given that this is an award presented at the state lev-el, the State Pharmacy Associations — including YOUR KPhA — along with NASPA, are working to-gether to help make sure this award we hold so dear-ly is never at risk of being extinguished. In order to sustain the award, each state association is working to build an endowment sufficient to generate divi-dends that will fund the program in perpetuity. The APhA Foundation, a national nonprofit 501 (c) (3), has agreed to be the home of the endowment ac-count, and to date we are almost half way to our goal of $600,000.

Our goal is to raise $5,000 as a collective gift from members of the Kentucky Pharmacists Association. As of March 2013, we have collected $900. We’re eager to show our state pride by either meeting or exceeding this goal. Won’t you please help by making a contribution? There are two ways to give:

Online at: http://www.aphafoundation.org and

choose the Bowl of Hygeia endowment button. Kentucky will get credit by your address.

Or, you can send your check to:

APhA Foundation – Bowl of Hygeia 2215 Constitution Ave., NW

Washington, DC 20037-2985 Thank you in advance for joining YOUR KPhA in this effort.

New and Returning KPhA Members

March 2013


Adventures in Compounding

Adventures In Compounding:

Through The Eyes Of A Pharmacy Student By: Emily G. Boone, PharmD Candidate 2013, University of Kentucky College of Pharmacy

As the last summer break for the Class of 2013 drew to a

close, I took advantage of one of the best-kept secrets in

student compounding educational opportunities. On Aug.

11-12, 2011, I made the trip to Houston, Texas, to experi-

ence the Professional Compounding Centers of America

(PCCA) Compounding Boot Camp. After learning about this

student oriented crash course in compounding at the 2010

NCPA Annual Convention in Philadelphia, I decided this

would be an excellent summer activity to enhance my prep-

aration for entry into the increasingly competitive world of

pharmacy practice.

Why Compounding?

Progressive Patient Care

As the evolution of pharmacy practice gives way to the fu-

ture, the art and science of compounding medication re-

mains a staple in the scope of practice for the modern phar-

macist. The mortar and pestle has been a widely recog-

nized symbol of pharmacy since the dawn of practice, and

this is not likely to change any time soon.

Despite the vast number of manufactured drug products

currently available, there remains a vast number of patient

needs that simply cannot be met through this traditional

market. Pharmacists have the unique ability to create drug

products that are tailored to the individual patient, which

can dramatically improve the quality of care. The increasing

problem of drug shortages is also a significant challenge

that can sometimes be overcome through compounding.

A Spoonful of Sugar

Patient compliance is an ongoing battle that all healthcare

providers face in trying to implement effective treatments,

as no medication is less effective than one the patient does

not take. Some of these obstacles can be overcome

through consultation with a compounding pharmacist.

These professionals are equipped to recommend and cre-

ate a more pleasing dosage form for the sensitive palette of

a very young patient, or perhaps a combination product that

can reduce pill burden for an older patient being treated for

several chronic conditions. Other patients need a strength

of drug that is simply not available commercially, or require

ongoing therapy with a product that is on backorder. A com-

pounding pharmacist has the broad skill set necessary to

provide a flexible, ever-changing menu of services to a vari-

ety of patients who do not fit the manufactured mold. From

researching innovative formulations, to laboratory activities,

to patient consultation and counseling, this specialty area of

pharmacy practice promises a stimulating environment that

will satisfy the pharmacists who desire the challenge of

both clinical problem solving and direct patient care in their

daily practice.1

Something for Everyone

Compounding practice provides no shortage of opportunity

for the pharmacist who desires a career centered on a par-

ticular niche area of expertise. For example, 20 percent of

the US population is under the age of 14. With only 1,000 of

250,000 pharmacists in the United States specializing in

pediatrics, and 99 percent of those specialists working in

hospitals, there lies a wealth of opportunity in the communi-

ty setting for the development of services focused in this

area.2

Another specialty area of practice is veterinary compound-

ing. There are millions of families in the United States that

include at least one pet, and there is a great deal of value

placed on the health of these furry family members. Other

patient sources can include animal shelters, breeders, zoos

and theme parks. With a wide range of needs introduced by

such a diverse clientele, this specialty may appeal to phar-

macists who enjoy creating the extraordinary measures that

March 2013



are sometimes needed for the

successful administration of

medication to the animal king-

dom. One clever pharmacist

was able to develop a delivery

system for giving eye drops to

an angry gorilla without intro-

ducing the risks of repeated

sedation – via a Super Soaker

water gun.1 Chris Simmons,

RPh and Vice President of

Creative Development at

PCCA, jokingly referred to

compounding as the Mac-

Gyver of medicine thanks to unconventional methods such

as this.3

A newer area of practice that is appearing in pharmacies is

called cosmeceutical compounding. This field utilizes cos-

metic bases such as skin cream or shampoo to deliver

dermatologic medications to the aesthetically minded pa-

tient.1 As a licensed cosmetologist, I find this area particu-

larly fascinating as an opportunity to fuse the beauty in-

dustry with the specialized treatment of skin conditions

that create obstacles for so many

patients.

A Profitable Opportunity

Once the passion has been ignited to

pursue business ownership, the first

thing any entrepreneur must ask him-

or herself is, “Will this be profitable?”

Compounding services offer the

pharmacy owner the most generous

profit margin available in community

pharmacy practice. A testament to

this success is Cheri Garvin, RPh,

and owner of Leesburg Pharmacy in

Virginia. While 49 percent of her pharmacy’s total sales

come from traditional manufactured prescriptions, an

astonishing -0.2 percent of the net profit can be attributed

to this area. Compounding services demonstrate a sharp

contrast to this figure, with 20 percent of total pharmacy

sales and 21 percent of net profit credited to this area.4

Why such a difference? One reason is due to the modest

reimbursements paid to community pharmacies by third

party insurance providers for traditional prescriptions. Very

often these payments barely cover dispensing cost, leav-

ing little room for profit for the pharmacy. Many compound-

ed prescriptions are less expensive, as they are often

made from bulk raw chemicals rather than from the more

costly manufactured products. This allows a number of

patients the freedom to pay cash

for their medication, thus elimi-

nating the cost of the middleman

and the reliance on reimburse-

ments. Additionally, the use of

raw materials allows a com-

pounding pharmacy to maintain

a much less expensive inventory

than the manufactured inventory

of a traditional retail pharmacy.1

Summer Experience at

PCCA Compounding Boot

Camp

The Compounding Boot Camp at PCCA is an introductory

class that serves as a prerequisite for two other PharmD

student course offerings. The class consists of both class-

room instruction and hands-on lab experience.

Prior to attending the Boot Camp, I was curious how they

would manage to squeeze 11 unique dosage forms into

the two eight hour sessions, but I had ample time to com-

plete each and every lab. I felt like a celebrity compounder

having the PCCA staff heat up my hot water bath prior to

lab and doing my dishes for me after I

was finished, but this assistance is

what allowed the class to move seam-

lessly from one topic to the next.

Some of the most interesting labs in-

cluded making Kahlua flavored lolli-

pops, peppermint lip balm and my first

time working with a capsule machine.

After punching capsules by hand in

the University of Kentucky pharmacy

lab, I had a true appreciation for the

efficiency of the capsule machine.

Advanced Student Opportunities with PCCA

After completing the Compounding Boot Camp, PharmD

students have the option of taking two more compounding

courses with PCCA: the Advanced Compounding Training

Program and the Veterinary Compounding Training Pro-

gram. Both advanced courses consist of a 10 module

online component followed by a two-day lab experience at

the PCCA facility in Houston.

Although PCCA has not yet been established as a rotation

site for pharmacy students in Kentucky, the facility offers

three unique APPE rotation opportunities, including an

Academia/Compounding (Non Patient Care) rotation, a

Pharmacy Management Rotation and a Drug Information

Rotation. Students choosing to spend a rotation at PCCA

Emerging Specialties in Compounding Practice

Bio-Identical Hormone Replacement Therapy

Nutritionals Thyroid & Adrenal Fatigue Veterinary Pediatric Pain Management Cosmeceuticals

March 2013



KPPAC Contribution 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)

have the opportunity to develop skills in areas such as

teaching, compounding pharmacy ownership and formula-

tion development. Consultant pharmacists at PCCA field

roughly 500 calls per day from member pharmacists seek-

ing advice on compound formulation, offering students a

wide range of creative challenges from which to learn.1

A Link to the Past

As new pharmacy graduates prepare to enter the work-

force, they are presented with a professional landscape

that is hard to match with regard to the wide variety of

opportunities. Modern day pharmacists can be found

working in a range of settings, from the operating room to

a home office, and can be employed by anyone from a

major insurance company to their very own conscience.

With so many career paths to choose from and the uncer-

tain climate of healthcare reform, compounding offers

both new and seasoned pharmacists an avenue to contin-

ue a long-standing, profitable tradition in pharmacy prac-

tice. Even with so many changes on the horizon it’s diffi-

cult to envision a healthcare world where compounding

skills are not in demand, as pharmacists in this field con-

tinue to thrive as they fulfill the needs of each individual

patient in a way that no one else can.

A Special Thanks to:

1. PCCA Staff. Compounding Pharmacy Practice. Lecture presented at: PCCA Compounding Boot Camp;

August 2011; Houston, TX.

2. Wolsoncroft L. Pediatric Pharmacy Practice. Lecture presented at: NCPA Annual Convention; October

2011; Nashville, TN.

3. Simmons C. Innovations in Veterinary Compounding. Lecture presented at: NCPA Annual Convention;

October 2011; Nashville, TN.

4. Garvin C. Innovations in Compounding Pharmacy. Lecture presented at: NCPA Annual Convention; Oc-tober 2011; Nashville, TN.

March 2013


Helping hands, big hearts

Helping hands, big hearts By Lance Murphy, second-year PharmD candidate at Sullivan University College of Pharmacy

At its core, volunteerism means embracing the desire and

passion to give back to the community. A community, how-

ever, is not simply defined as the nearby geographic area.

In colleges of pharmacy across the nation, local APhA–

ASP Chapters are leaders in volunteering and patient care

events. At the Sullivan University College of Pharmacy we

define community as those sharing the same values and

beliefs representing the best of our profession, our country

and the idea of freedom.

Showing our thanks

Starting in August 2011, the chapter decided to do some-

thing extra to support the men and women fighting in the

United States Armed Forces. We started the annual Sup-

port our Troops drive, where our APhA–ASP Chapter lead-

ers conduct fundraisers and donation drives to make care

packages, and buy telephone cards to send to troops over-

seas and to the families of military personnel.

Various events held during the drives include hopper ball

races, penny wars, material item collections and soliciting

private donations from the school and community. Since

2011, we have raised more than $2,000 to purchase phone

cards and collected a large number of items donated to the

troops. On top of the items we sent, we also included a

panoramic picture of our students holding letters spelling

out “We Love Our Troops” with American flags in the care

packages to add a personal touch.

Always do more

Those of us involved in the Support our Troops drive, were

proud to receive a letter last year from a commanding of-

ficer in Afghanistan thanking us and letting us know that

the items were very much appreciated. Given this event’s

success, we are seeking more involvement for our local

community as well as other colleges of pharmacy and

APhA–ASP Chapters.

Some of the needed items outlined by troops include the

following:

Phone cards

Visa or MasterCard gift cards

Personal hygiene items

CD/DVD/iPod

Books/magazines

Non-perishable snack foods (beef jerky, peanuts, can-

dy, gum, mints)

If you are interested in starting your own local Support our

Troops drive, e-mail our faculty advisor Stacy Rowe,

PharmD, at [email protected], our APhA–ASP Chapter

Vice-President of Patient Care Amelia Wiechart at

[email protected], or our APhA–ASP Chapter

President Lance Murphy at [email protected].

Congressman Andy Barr

visits Capital Pharmacy

New Congressman Andy Barr visited Capital

Pharmacy and Medical Equipment in February,

thanks to a program with the UK College of

Pharmacy. Pictured are: KPhA Executive Direc-

tor Robert McFalls, KPhA Board Director Trish

Freeman, UKCOP students Rachel Clark and

David Roy, Barr, Capital Pharmacy co-owner

and UKCOP professor Tera McIntosh, UKCOP

students Jessica Stokes and Brent Simpkins,

and Capital Pharmacy co-owner Aaron McIn-

tosh.

March 2013


A Review of Herbals in Cancer Patients: Use This Not That? By: Lesley Hall Volz, PharmD, Jill Rhodes, PharmD, BCOP, Aimee Ruder Cloud, PharmD, BCOP University of

Louisville Health Care

There are no financial relationships that could be perceived as real or apparent conflicts of interest. Universal Activity # 0143-0000-13-004-H04-P&T 1.5 Contact Hour (0.15 CEUs)

Objectives: At the conclusion of this lesson, the reader should be able to:

1. Review recent literature regarding the use of complementary and alternative medicine (CAM) in cancer patients.

2. Identify reasons cancer patients utilize CAM.

3. Categorize common herbals used to treat pain, sleep disturbances, depression and menopausal symptoms.

4. Identify herbal-drug interactions amongst various herbals and anticancer agents.

KPERF offers all

CE articles to

members online at

www.kphanet.org

Background

According to the National Center for Complementary and

Alternative Medicine (NCCAM), complementary and alter-

native medicine (CAM) is defined as “a group of diverse

medical and health care systems, practices and products

that are not presently considered to be part of conventional

medicine.”1 In the past two decades, worldwide expendi-

ture on CAM has dramatically increased depending on the

geographical region.2 The expenditure for CAM in the Unit-

ed States is remarkable, totaling $33.9 billion in 2007.

Based on a National Health Interview Survey, 75 percent of

US adults have used some form of CAM.3 Since the advent

of the World Wide Web and increased media exposure

through television, radio and magazines, patients can read-

ily access information regarding CAM. Cited sources of

information include internet, media, support groups and

family or friends.4-6

The most influential group, family and

friends, is reported to be the source of information 49 per-

cent of the time.5 The quality and accuracy of this readily

retrievable information is questionable when obtained from

non-validated sources. As patients take a more active role

in their own healthcare, inaccurate information may lead

patients to self-treat using ineffective and potentially dan-

gerous remedies.2

Several studies have indicated that utilization of CAM

amongst cancer patients is higher than the general pub-

lic.2,4,7

The most common forms of CAM used by cancer

patients are herbals, vitamins and minerals.2,5,8

While the

majority of cancer patients seek CAM as an additional ther-

apy modality, many of their perceptions about CAM are

false. Consumers consider CAM safe and effective, though

scientific evidence proving such is inconclusive. Following

the 1994 Dietary Supplements Health Education Act, man-

ufacturers may freely distribute dietary supplements with-

out proving their safety and efficacy. Consequently, con-

sumers believe CAM is ‘natural’ and often consider the

therapies innocent. As a result of relaxed regulations, the

quality of products varies and may be contaminated with

pollutants, microorganisms and metals.2 Microorganisms

such as E.coli and Aspergillus are of particular concern in

immunocompromised cancer patients and can potentially

cause serious infections. Furthermore, the safety of CAM is

a concern when used concurrently with conventional thera-

pies. Tascilar and colleagues reported that 65 percent of

patients receiving chemotherapy were concurrently using

CAM.2 Conventional therapies used concurrently with CAM

raises concern for significant herb-drug interactions, poten-

tially leading to serious adverse effects and toxicities.9 This

article will discuss the motivation behind cancer patients

that seek CAM as a therapy and focus specifically on

agents that are often used for the primary causes, including

pain, depression, insomnia and menopausal symptom

management.3,10

The effectiveness of the natural medicine

for each particular condition will be described using the

effectiveness ratings provided by the Natural Medicines

Comprehensive Database. The rating description can be

found in Table 1.

Reasons for Use

Previous studies have indicated a variety of demographics

and socioeconomic factors influence higher CAM use

amongst cancer patients. Factors observed include: female

gender, younger age, higher level of education, lower quali-

ty of life and advanced disease.2,4,5,7,11

Documented rea-

sons cancer patients use CAM include: to improve their

April 2013 CE — Review of Herbals in Cancer Patients

March 2013



well-being, prevent progression of dis-

ease or treat disease, gain a sense of

control over their health, boost immun-

ity and manage side effects of conven-

tional therapies.4-6,12-14

The most com-

monly utilized herbals in the United

States, irrespective of the diagnosis of

cancer, are outlined in Table 2.2 Sup-

plementation within the cancer popula-

tion is often initiated for symptomatic

relief of adverse effects related to con-

ventional treatment modalities and for

purposes of enhancing their quality of

life.

It is estimated that 25 percent of pa-

tients newly diagnosed with cancer

and 75 percent of patients with ad-

vanced disease will experience pain.15-

17 As one of the most feared conse-

quences of cancer, it is imperative for

healthcare providers to perform contin-

ual assessments to ensure adequate

relief. Pain is often not an isolated

symptom, but rather clusters with de-

pression and insomnia, ultimately

leading to cancer-related fatigue. All of

these symptoms are subjective based

on patient report and contribute to the

patient’s quality of life. The incidence

of cancer-related fatigue is difficult to quantify due to

inconsistency in assessment methods, yet rates as high

as 70 to 100 percent have been reported.18

Depression

occurs in approximately one-third of cancer patients

and is often experienced simultaneously with cancer-

related fatigue.19

Additionally, sleep disturbances

whether hypersomnia or insomnia, occur in up to three-

fourths of cancer patients.20

When patients do not ob-

tain adequate control of their cancer-related symptoms

through conventional therapies they may seek alterna-

tive medicine.

Herbals Used

Pain

The most common herbal supplements patients utilize

for symptomatic pain control include: ginger, cat’s claw,

turmeric, willow bark, marijuana and glucosamine/

chondroitin. Their application in pain management will

be described and summarized below.

Ginger has multiple indications including motion sick-

ness, morning sickness, colic, dyspepsia, nausea, oste-

Table 110

Rating Level Definition

Effective Very high level of reliable clinical evidence support-

ing its use for a specific indication. Products rated

“Effective” are generally considered appropriate to

recommend.

Likely Effective Very high level of reliable clinical evidence support-

ing its use for a specific indication. Products rated

"Likely Effective" are generally considered appro-

priate to recommend.

Possibly Effective Some clinical evidence supporting its use for a spe-

cific indication; however, the evidence is limited by

quantity, quality or contradictory findings. Products

rated "Possibly Effective" might be beneficial, but

do not have enough high-quality evidence to recom-

mend for most people.

Possibly Ineffective Some clinical evidence showing ineffectiveness for

a specific indication; however, the evidence is lim-

ited by quantity, quality or contradictory findings.

People should be advised NOT to take products with

a "Possibly Ineffective" rating.

Likely Ineffective Very high level of reliable clinical evidence showing

ineffectiveness for its use for a specific indication.

People should be discouraged from taking products

with a "Likely Ineffective" rating.

Ineffective Very high level of reliable clinical evidence showing

ineffectiveness for its use for a specific indication.

People should be discouraged from taking products

with an "Ineffective" rating.

Insufficient Evidence There is not enough reliable scientific evidence to

provide an effectiveness rating.

Table 22

Rank Herb Primary Indication

1 Garlic hypercholesterolemia

2 Gingko biloba dementia, intermittent

claudication

3 Echinacea common cold prevention

4 Soy menopausal symptoms

5 Saw palmetto benign prostate hyperplasia

(BPH)

6 Ginseng fatigue

7 St. John’s wort depression

8 Black cohosh menopausal symptoms

9 Cranberry urinary tract infection (UTI)

10 Valerian insomnia, stress

11 Milk thistle alcoholic cirrhosis, hepatitis

12 Evening primrose premenstrual syndrome

(PMS), menopausal symptoms

13 Kava anxiety

14 Bilberry diabetic retinopathy

15 Grape seed allergic rhinitis

March 2013



*Doses refer to adults only **Anticoagulant interactions data limited with newer agents

Table 3 Indication Herbal Doses* Adverse Effects Drugs to avoid** Contraindications Pain Ginger 1 gram/daily

(1 to 4 divided doses orally) abdominal discomfort,

heartburn and diarrhea antiepileptics,

antidepressants Diabetes

Cat’s Claw 60 to 100 mg orally daily headache, dizziness and

vomiting Autoimmune

disorders

Turmeric 500 mg orally 2 to 4 times daily dyspepsia, nausea,

vomiting, dizziness, and

diarrhea

Willow Bark 120 to 240 mg orally daily Heartburn, nausea anticoagulants aspirin allergy, renal

dysfunction

Marijuana 16-195 mg tachycardia, hypertension,

anxiety, and cognitive

impairment

barbiturates, CNS depressants, theophylline

Seizure disorder,

immunocompromised

Glucosamine/ Chondroitin

glucosamine 1500 mg/ chondroitin

1200 mg orally daily gas, bloating, abdominal

cramping anticoagulants warfarin, shellfish

allergy, diabetes,

hyperlipidemia,

hypertension, asthma

Sleep disturb-

ances Melatonin 0.3 to 6 mg orally daily daytime drowsiness,

headache and dizziness CNS depressants Diabetes, seizure

disorder,

hypertension

Valerian 400 to 900 mg orally 2 hours

before bedtime headache, gastrointestinal

upset, cardiac

disturbances, morning

drowsiness, vivid dreams

and dry mouth

alcohol,

benzodiazepines,

CNS depressants

Chamomile 9 to 15 grams orally daily Hypersensitivity reaction tamoxifen Allergic to ragweed,

chrysanthemums,

marigolds, or daisies

Kava 100 mg three times daily gastrointestinal upset,

headache, dizziness, dry

mouth and vision

disturbances

alcohol, barbiturates,

benzodiazepines Liver disease

Lavender Instill 2 to 4 drops in 2 to 3 cups of

boiling water in an aromatic

diffuser

constipation, headache

and increased appetite

Depression St. John’s wort 300 mg orally three times daily photosensitivity,

insomnia, vivid dreams,

restlessness

gastrointestinal

discomfort, dry mouth,

dizziness, diarrhea and

headache

MAOI, SSRI, TCAs,

oral contraceptives,

cyclosporine,

tacrolimus, digoxin,

imatinib, irinotecan,

NNRTIs, phenytoin,

protease inhibitors,

alprazolam,

meperidine, warfarin,

barbiturates

SAM-e 400 to 1600 mg orally daily gastrointestinal upset, dry

mouth, headache,

insomnia, anorexia,

sweating, dizziness,

nervousness

MAOI, SSRI

5-HTP 150 to 300 mg orally daily heartburn, nausea,

vomiting, abdominal pain

and anorexia

MAOI, SSRI

Inositol 12 grams orally daily nausea, fatigue, headache

and dizziness

Menopausal

symptoms

Soy 20 to 60 grams orally daily gastrointestinal upset,

migraines and insomnia MAOI Renal failure,

hypothyroid

Black cohosh 40 to 80 mg orally twice daily gastrointestinal upset,

headache, dizziness,

weight gain, cramping,

breast tenderness and

vaginal spotting

Liver disease

Flaxseed 40-50 grams orally daily bloating and flatulence Diabetes

Gingko 120 to 160 mg orally daily divided

in two doses headache, nausea, diarrhea

and occasional dermatitis anticoagulants Diabetes, epilepsy

Ginseng 200 mg orally twice daily hypertension, insomnia,

vomiting, headache and

epistaxis

anticoagulants Diabetes

March 2013



Table 4

Herbal Likely Effective Possibly Effective Inconclusive Possibly Ineffective Likely ineffective

Bilberry diabetic retinopathy

Black cohosh menopausal

symptoms

Cat’s claw Pain Chamomile Insomnia Cranberry urinary tract

infection

Echinacea common cold

prevention

Evening primrose Premenstrual

syndrome, menopausal

symptoms

Flaxseed gastrointestinal

disorders

Garlic Hypercholesterolemia

Ginger morning sickness,

nausea,

osteoarthritis

colic,

dyspepsia motion sickness,

rheumatoid arthritis,

myalgias

Ginkgo biloba dementia,

intermittent

claudication

menopausal

symptoms Hearing loss

Ginseng fatigue,

menopausal

symptoms

Glucosamine/chondroitin pain

Grape seed allergic rhinitis

Inositol OCD, panic

disorder, PCOS,

respiratory distress

syndrome

depression

Kava Anxiety insomnia

Lavender insomnia

Marijuana pain

Melatonin Circadian

rhythm disrup-

tion

insomnia, jet lag shift-work disorder

Milk thistle alcoholic

cirrhosis,

hepatitis

SAM-e depression,

arthritis dementia,

alzheimer’s,

parkinson’s

disease

Saw palmetto BPH St. John’s wort depression menopausal

symptoms OCD, SAD,

anxiety ADHD

Soy hyperlipidemia,

menopausal

symptoms,

osteoporosis

prevention of

cardiovascular

disease

Turmeric dyspepsia,

osteoarthritis pain

Valerian Insomnia anxiety, mood

disorders

Willow bark Pain

March 2013



oarthritis, rheumatoid arthritis and myalgias.21-23

Ginger is

thought to reduce nausea by acting on muscarinic and

serotonin receptors in the gastrointestinal tract. Additional-

ly, ginger may mediate inflammation and reduce pain

through cyclooxygenase inhibition.23

Although ginger is

utilized for pain and considered possibly effective for ar-

thritis, it is not unexpected to require up to three months

before relief of symptoms is observed. The more common

indication where ginger is used and considered possibly

effective is to provide acute improvement in symptoms of

morning sickness and nausea. Ginger is available as a

dried powder, topical oil or fresh root. Ginger should be

used cautiously in combination with anticoagulants as

these agents may cause prolonged bleeding. Patients with

epilepsy should avoid ginger due to the risk of lowering the

seizure threshold.21

Cat’s claw, a proposed anti-inflammatory herbal supple-

ment is primarily taken by individuals for symptomatic con-

trol of gastrointestinal disorders such as diverticulitis, pep-

tic ulcers, colitis and gastritis, yet it only has reliable evi-

dence to support being possibly effective for pain manage-

ment specifically related to arthritic joint pain.23

Ingested

orally, cat’s claw is available as an aqueous solution or

freeze dried powder packaged into a capsule. Cat’s claw,

may cause headache, dizziness and vomiting.24

Turmeric, whose active constituent is curcumin, is thought

to control pain by inhibiting cyclooxygenase-2 (COX-2),

prostaglandins and leukotrienes.25

While indications are

abundant, turmeric’s activity in providing symptomatic re-

lief in dyspepsia and osteoarthritis is plausible and consid-

ered possibly effective.26,27

However, it should be noted

that turmeric may need to be taken up to eight weeks be-

fore symptomatic relief occurs. Turmeric is available as a

topical oil or orally as an analgesic.23

Common adverse

effects seen with turmeric administration are dyspepsia,

nausea, vomiting, dizziness and diarrhea.27

Willow bark is utilized for multiple pain indications such as

headache, myalgia, osteoarthritis, dysmenorrhea, rheuma-

toid arthritis and gout.23

As a treatment option

for pain, willow bark is possibly effective and

has been shown to be at least as effective as

rofecoxib for back pain.23

Willow bark’s active

ingredient, salicin, is metabolized to salicylic

acid, which functions similar to aspirin. Similar

to aspirin, willow bark may cause gastrointes-

tinal adverse effects and should not be used

concurrently with other anticoagulants without

first seeking medical advice. Due to the simi-

larity between willow bark and aspirin, it is

advisable to use aspirin in lieu of willow bark,

since efficacy and safety with aspirin is proven and it is

regulated by the FDA. Patients who are allergic to aspirin

should avoid use of willow bark.10

Willow bark is available

orally as a liquid or capsule.

Glucosamine and chondroitin are endogenous substrates

in the formation of cartilage used in combination common-

ly for relief of arthritis pain.28,29

Glucosamine is likely effec-

tive and chrondroitin is possibly effective in providing knee

pain relief due to arthritis.23

It is recommended to not ex-

ceed daily dosing as it may lead to toxic levels of manga-

nese causing central nervous system toxicity when greater

than 11 mg of elemental manganese is ingested.30,31

Last-

ly, recommend patients to avoid with shellfish allergy as

the supplement is derived from crab or shrimp skeletons.

Additionally, there is a potential interaction with anticoagu-

lants and glucosamine may increase anticoagulant ef-

fects.32

Marijuana is commonly used for treatment of pain, nausea

and glaucoma. The active constituent tetrahydrocanna-

binol (THC) acts on opiate receptors in the forebrain there-

by directly reducing pain and indirectly inhibiting the emet-

ic center.33

Although regulations vary from state to state,

marijuana is still considered an illicit drug within the United

States rendering a lack of the product’s quality control.

Currently, two products containing THC are FDA approved

in the United States for antiemesis and/or appetite stimula-

tion: dronabinol and nabilone. When marijuana is used in

its natural form, it is considered possibly effective for glau-

coma and anorexia but has insufficient reliable evidence to

rate effectiveness for pain. Whether marijuana is orally

ingested or smoked, both are considered unsafe. Smoking

marijuana can lead to a multitude of acute effects including

tachycardia, hypertension, anxiety and cognitive impair-

ment. Additionally, when smoked a variety of carcinogens

are inhaled which may lead to decreased pulmonary func-

tion and increased risk of cancer. Due to quality control

issues, not only does the amount of THC vary based on

the source of supply, studies have shown that marijuana is

Table 5

Hormonal Therapy Herbals with Estrogenic Activity

Raloxifene alfalfa fennel red clover

Tamoxifen chasteberry genestein (soy) sage

Exemestane black cohosh ginseng valerian

Letrozole DHEA gingko

anastrozole dong quai hops

flaxseed licorice

March 2013



often contaminated. Contaminants include heavy metals,

pesticides, shards of glass and sand as well as harmful

bacteria and fungi such as Aspergillus, which could ulti-

mately lead to pneumonia in an immunocompromised

host.34

Sleep Disturbances

The majority of cancer patients suffer from sleep disturb-

ances such as hypersomnia or insomnia. Supplements

commonly used include melatonin, valerian, chamomile,

kava and lavender. Each of these agents will be described

and summarized in their effectiveness in management of

sleep disturbances.

Melatonin, in an oral formulation is used for a multitude of

sleep disturbances such as jet lag, insomnia, shift-work

disorder or circadian rhythm disruption.23

Melatonin is syn-

thesized endogenously in the pineal gland and functions

primarily to regulate circadian rhythm and sleep patterns.

The efficacy of melatonin in regulating sleep stems from a

multitude of actions within the brain. Melatonin increases

the binding of gamma-aminobenzoic acid (GABA) and de-

creases neurotransmission, and has been reported to be

useful in circadian rhythm disruption, causing a minor re-

duction in sleep latency. It is considered to be possibly ef-

fective for insomnia; however, more research is needed.23

Common side effects of melatonin include daytime drowsi-

ness, headache and dizziness.35

Valerian is possibly effective for treatment of insomnia by

decreasing sleep latency and reportedly improves sleep

quality. In addition to insomnia, valerian is often used for

anxiety and mood disorders.21

The root or rhizome of vale-

rian is the source of the active constituent responsible for

valerian’s sedative properties. Side effects reported with

the use of valerian include headache, gastrointestinal up-

set, cardiac disturbances, morning drowsiness, vivid

dreams and dry mouth.21,36

Valerian also has been reported

to cause hepatic failure.23

Chamomile, a German flower available as a tea, is another

remedy for insomnia as it is mildly sedating; however, the

level of effectiveness is unknown. Overall chamomile is

well tolerated with the exception of individuals who are al-

lergic to members of the Asteraceae/Compositae family

which includes ragweed, chrysanthemums (“mums”), mari-

golds and daisies. These patients are at higher risk of an

allergic reaction. An allergic reaction to chamomile may

present as abdominal cramps with or without anaphylactic

symptoms such as tongue thickness, tight sensation in the

throat and angioedema.21,37

Kava, an herbal supplement used for insomnia, also is

commonly utilized in the treatment of anxiety. Kava is pos-

sibly effective for the treatment of anxiety whereas there is

insufficient reliable evidence to rate effectiveness for in-

somnia, and evidence available does not indicate that it

improves sleep.23

The active components of kava are the

root, stem and rhizome. Kava is a central nervous system

depressant (CNS); the exact mechanism of action is un-

known. As a CNS depressant, concomitant use with other

CNS depressants such as alcohol, barbiturates and benzo-

diazepines should be avoided.38

When taken orally, kava

may cause gastrointestinal upset, headache, dizziness, dry

mouth, extrapyramidal side effects and vision disturb-

ances.39

Additionally, case reports indicate kava is associ-

ated with hepatoxicity. Kava is available as a beverage,

oral tablet or capsule.

Lavender is available as oil and originates from an aromatic

evergreen sub-shrub. Lavender has been historically rec-

ognized to relieve agitation by increasing relaxation and

sedation, although the exact mechanism is unknown. How-

ever, there is insufficient reliable evidence to rate laven-

der’s efficacy for the treatment of insomnia or agitation.23

Lavender is thought to decrease electroencephalogram

(EEG) potentials and alertness.40

Active components of

lavender include the flower, leaves and oil.41

Administration

can occur via multiple routes such as orally, as an inhala-

tion and topically.42

Typically for treatment of insomnia lav-

ender is vaporized and inhaled as aromatherapy.43

Laven-

der taken orally as one to four drops often given on a sugar

cube may cause constipation, headache and increased

appetite when an excess of four drops is ingested.42

Im-

portant to note, lavender containing supplements may in-

crease anticoagulant effects when given concurrently as

well as increase sedation with CNS depressants and anti-

convulsants.

Depression

A cancer diagnosis can leave a huge impact on an individu-

al’s psychological health. Depression is a common comor-

bidity among cancer patients that is often under-recognized

and undertreated.44

Herbal supplements that have been

used to treat depression include but are not limited to St.

John’s wort, SAMe (S-adenosylmethionine), 5-HTP (5-

hydroxytryptophan) and inositol. All of the aforementioned

herbal supplements exhibit their antidepressant effects by

interfering with neurotransmitters such as dopamine, sero-

tonin and norepinephrine. Due to this purported mechanism

of action, it would be appropriate to caution patients in con-

comitant administration of these herbal supplements, as

well as avoid using with MAOIs (monoamine oxidase inhibi-

tors), SSRIs (selective-serotonin reuptake inhibitors) or

SNRIs (selective-norepinephrine reuptake inhibitors).

St. John’s wort, used for depression, anxiety, obsessive

March 2013


compulsive disorder (OCD), attention deficit-hyperactivity

disorder (ADHD,) seasonal affective disorder (SAD) and

menopausal symptoms, is thought to act as an MAOI and/

or SSRI. St. John’s wort is likely effective for depression

and possibly ineffective for ADHD. Unfortunately, there is

insufficient reliable evidence to rate efficacy in OCD and

SAD. Pharmacists should instruct patients to avoid con-

suming tyramine containing foods just as they would if pre-

scribed an MAOI. St. John’s wort is likely effective for treat-

ment of insomnia and possibly effective in relieving meno-

pausal symptoms.23

Therapeutic activity is primarily derived

from the flower of St. John’s wort. When using St. John’s

wort patients should take precautions to reduce sun expo-

sure to avoid photosensitivity resulting from the dose relat-

ed hypericin component of St. John’s wort.45

Other reported

adverse effects include insomnia, vivid dreams, restless-

ness gastrointestinal discomfort, dry mouth, dizziness, diar-

rhea and headache.46

SAM-e is thought to reduce symptoms of depression by

increasing serotonin turnover as well as increasing the

availability of dopamine and norepinephrine in the neural

synapse. It is found on all living cells and is a naturally oc-

curring precursor of amino acids cysteine, glutathione and

taurine. SAM-e is commercially produced in yeast cell cul-

tures. In addition to depression, SAM-e is commonly used

for arthritis, dementia, Alzheimer’s and Parkinson’s dis-

ease. It is available orally, intravenously or intramuscular-

ly.23

Of the previous indications, SAM-e is likely effective

when used for depression and arthritis.23

Side effects com-

mon with higher doses are similar to those seen with St.

John’s wort with the addition of sweating, constipation,

vomiting and anorexia.47

Caution in bipolar disorder as

SAM-e increases anxiety and mania in depressed patients.

5-HTP a precursor to serotonin crosses the blood brain

barrier and aids in the synthesis of serotonin within the cen-

tral nervous system. 5-HTP comes from seeds of the

woody climbing shrub G. simplicifolia found in tropical Afri-

ca. Indications aside from depression include headache,

fibromyalgia, binge eating disorder and pre-menstrual syn-

drome.23

5-HTP is considered possibly effective for both

fibromyalgia and depression, whereas it is possibly ineffec-

tive for headache. Efficacy for other indications is un-

known.23

Similar to St. John’s wort and SAM-e, the majority

of side effects seen with 5-HTP are gastrointestinal related

such as heartburn, nausea, vomiting, abdominal pain and

anorexia.48

Inositol endogenously functions as part of the intracellular

second messenger system linked to serotonin, norepineph-

rine and cholinergic receptors. Due to its interaction with

serotonin, inositol is thought to function similar to a selec-

tive-serotonin reuptake inhibitor to treat depression. It is

most commonly found in beans, fruits, nuts and grains. Un-

fortunately, inositol is considered possibly ineffective for

depression. Indications other than depression in which ino-

sitol is possibly effective include obsessive-compulsive dis-

order (OCD), panic disorder, polycystic ovary syndrome

(PCOS) and respiratory distress syndrome.23

Adverse

events commonly reported are nausea, fatigue, headache

and dizziness.49

Menopausal Symptoms

Breast cancer patients are the most frequent users of com-

plementary and alternative medicine. Individuals treated for

breast cancer are subject to menopausal symptoms as a

result of estrogen deprivation therapy and/or chemotherapy

-induced menopause.4 As the majority of breast cancer

patients are estrogen and/or progesterone receptor posi-

tive, treatment modalities aim to ablate endogenous hor-

mone concentrations to reduce the risk of breast cancer

recurrence.50

However, many pre-menopausal women di-

agnosed with non-breast cancers often seek CAM as well.

Chemotherapy can advance the onset of menopause in

young women leading to the early development of peri-

menopausal symptoms. As a result, many women treated

for cancer within the pre- and peri-menopausal period of

life may utilize herbal supplements to relieve typical meno-

pausal symptoms such as hot flashes, vaginal dryness,

mood changes and decreased libido.51

Phytoestrogens, agents which endogenously mimic estradi-

ol, are commonly utilized for symptomatic relief of meno-

pausal symptoms.52

While multiple herbal supplements are

classified as phytoestrogens, those with the highest utiliza-

tion and/or most sales within the United States include soy,

black cohosh, flaxseed, gingko and ginseng.3,53

Soy is in-

gested orally via herbal supplements or food products and

may cause gastrointestinal upset, migraines and insom-

nia.54

Soy has a multitude of proposed indications, yet the most

common indications are treatment of menopausal symp-

toms, hyperlipidemia and prevention of osteoporosis and

cardiovascular disease.23

Soy is considered possibly effec-

tive for menopausal symptom management, hyperlipidemia

and osteoporosis prevention. The relief rendered for meno-

pausal symptoms with soy use is limited to a reduction in

the rate and severity of hot flashes.23

Due to the fermenta-

tion process in manufacturing some soy products, patients

taking MAOIs should avoid soy due to the increased risk of

serotonin syndrome.55

The maximum safe dosing quantity

is unknown; yet it is recommended to not exceed the

amount contained in food.


March 2013


Black cohosh, unlike soy, is indicated predominantly for

relief of menopausal symptoms and dysmenorrhea. Black

cohosh, derived from the rhizome and root of the plant, is

possibly effective in relieving menopausal symptoms, in-

cluding lowering the frequency of hot flashes.23

Similar to

soy, black cohosh may cause gastrointestinal upset, head-

ache, dizziness, weight gain, cramping, breast tenderness

and vaginal spotting.56

Patients with aspirin allergies should

use caution due to salicylate content. Black cohosh has

sound alike look alike herbals that should not be confused

with blue and white cohosh.23

Flaxseed, gingko and ginseng are less commonly used

than soy and black cohosh to relieve menopausal symp-

toms. However, flaxseed does have a wide range of other

indications including gastrointestinal disorders and symp-

toms such as constipation, diarrhea, diverticulitis, irritable

bowel syndrome and ulcerative colitis.23

Flaxseed is con-

sidered possibly effective for menopausal symptom man-

agement and has been shown to reduce both hot flashes

and night sweats.23

Being a naturally occurring dietary fiber,

flaxseed is generally well tolerated most commonly causing

bloating and flatulence.57

Flaxseed is a rich source of fiber

due to the seed coating.23

Ginkgo biloba has other commonly reported uses including

dementia, circulatory disorders and hearing loss. Ginkgo is

possibly effective for treatment of dementia and intermittent

claudication.23

There is little data to state it is useful in the

management of menopausal symptoms although it has

evidence for possible efficacy for mood disorders during

premenstrual syndrome..23

The definite mechanism of ac-

tion is unknown; yet ginkgo biloba is thought to be an anti-

oxidant, thus reducing oxidative stress and minimizing cell

damage.58

Ginkgo biloba, derived from the leaf of the

world’s oldest living tree, should be used cautiously in pa-

tients on anticoagulation due to antagonism of platelet-

activating factor and increased risk of bleeding. Less seri-

ous side effects of ginkgo biloba include headache, nau-

sea, diarrhea and occasional dermatitis.59

Ginseng also is commonly used as an adaptogen to aid in

environmental adaptation to stressors and regulation of

blood sugar in diabetics. As an adaptogen it is thought to

be a stimulant, diuretic and digestive aid. There is some

evidence-based literature to support ginseng as an effec-

tive option for menopausal symptom management, alt-

hough more data is needed to elucidate its true potential.60-

62 The root of ginseng is considered the applicable part of

the plant.23

Common adverse effects of ginseng include

hypertension, insomnia, vomiting, headache and epistaxis.

Like ginkgo biloba, ginseng should also be avoided in com-

bination with anticoagulants to avoid an increased risk of

bleeding.21

Herb-Drug and Herb-Disease Interactions: Anticancer

Agents

As the interest in complementary and alternative medicine

grows, there is concern for herbal-drug interactions with

cancer as well as anticancer agents. Nearly three-fourths of

patients taking CAM do not voluntarily inform their physi-

cian. Use of herbal medications in conjunction with anti-

cancer agents can alter critical drug pharmacokinetic pa-

rameters such as absorption, distribution, metabolism and

excretion. The most commonly known herbal-drug interac-

tions affect the metabolism of anticancer agents, thus af-

fecting the functionality of the cytochrome P450 system.

Specifically, many chemotherapeutic agents are metabo-

lized via the CYP3A4 enzyme. Herbal agents that induce

CYP3A4 may lead to sub-therapeutic blood concentrations

of the antineoplastic agent, ultimately leading to decreased

efficacy. Contrarily, herbal agents that inhibit CYP3A4 may

lead to supra-therapeutic blood concentrations of chemo-

therapy increasing the likelihood of toxicity. A final mecha-

nism of herbal-drug interactions occurs via drug transport-

ers found in the gut lumen such as P-glycoprotein, multi-

drug resistance-associated protein-1 and breast cancer-

resistance protein. If chemotherapeutic agents are unable

to be transported across the intestinal lumen for absorption,

systemic concentrations are limited impairing efficacy.53

Since the majority of breast cancer patients are hormone

receptor positive, caution is advised before recommending

herbal products that manipulate hormone exposure. Phy-

toestrogens as an herbal class pose significant herbal-

disease interactions for breast cancer patients that are es-

trogen and/or progesterone receptor positive receiving en-

docrine therapy (anastrazole, exemestane, letrozole, raloxi-

fene, tamoxifen). The purpose of endocrine therapy within

this population is to cease estrogen and/or progesterone

stimulation of tumor proliferation. Phytoestrogens, even

though weakly estrogenic, can reach concentrations of

100-fold higher than endogenous estrogen. As a result of

the agonistic effects phytoestrogens impose on breast tis-

sue of hormone receptor positive breast cancer patients,

women should not concurrently receive phytoestrogens

and hormonal therapy. Caution is advised for patients who

have a history of hormone receptor breast cancer prior to

initiating phytoestrogens following completion of hormonal

treatment as well.63

See Table 5 for a list of phytoestrogen

herbal supplements.

While human studies are limited, the most commonly stud-

ied herb-anticancer drug interactions have been done with


March 2013


St. John’s wort. The drug-drug interaction between St.

John’s wort and irinotecan provides a good example of the

resulting harm of herb-anticancer drug interactions. Iri-

notecan is a prodrug which must be converted into its ac-

tive metabolite and used for colorectal and lung cancer.

Concurrent use of St. John’s wort with irinotecan can inhibit

the conversion of the prodrug to the active metabolite by up

to 42 percent, greatly diminishing its activity and any poten-

tial benefit to the patient. To obtain maximal efficacy, pa-

tients receiving irinotecan should be counseled to avoid

use of St. John’s wort. The tyrosine kinase inhibitor drug

class used to treat chronic myeloid leukemia, which in-

cludes imatinib, dasatinib, nilotinib, bosutinib and ponatinib,

also have been shown to interact with St. John’s wort. Sev-

eral studies have shown that coadministration of St. John’s

wort significantly reduces the efficacy of these drugs and

could potentially lead to inadequate control of disease or

promote drug resistance.64

Discussion

As interest and use of CAM in the United States continues

to rise, the necessity of herbal knowledge within the

healthcare profession also must follow sequence. Due to

loose regulations regarding the manufacturing and quality

of these products, the safety and efficacy of CAM is ques-

tionable.2 In particular, utilization of CAM amongst cancer

patients is higher than that of the general public.2 Patients

most commonly rely on the internet or family and friends as

sources of information regarding CAM, rather than

healthcare professionals.4 While a multitude of reasons

have been identified for CAM usage amongst this popula-

tion, the most common reason is to improve quality of life.

Cancer patients often suffer from pain, sleep disturbances,

depression and menopausal symptoms as a result of their

disease and conventional therapy.3 Herbal supplements

indicated to treat such symptoms are numerous.

Many herbal supplements are metabolized via the same

enzymatic pathway as anticancer agents. Herbals pose a

significant risk for anticancer-herb drug interactions putting

the patient at risk of harm.65

By administering herbals con-

currently with anticancer agents, plasma concentrations of

anticancer agents can significantly differ resulting in unan-

ticipated toxicity or treatment failure.65

Additionally, use of

specific CAM agents may negatively affect patients with

particular types of cancer, such as breast cancer. By hav-

ing an adequate knowledgebase regarding CAM,

healthcare professionals can continually assess CAM utili-

zation amongst patients and identify whether the herbal is

safe and effective for the individual. By assessing herbal

utilization at each visit, healthcare professionals can antici-

pate herbal-drug interactions, as well as optimize patient

safety and therapeutic efficacy. In doing so, one can endow

optimal patient care.

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March 2013


The Kentucky Pharmacists Board of Directors is accepting nominations for the following positions to serve on the KPhA

Board for the 2013-14 year: President-Elect, Treasurer, Director (3 open spots) Nominations may be submitted elec-

tronically to Scott Sisco at [email protected] or mailed to KPhA, Attn: Scott Sisco 1228 US 127 South, Frankfort, KY

40601 no later than March 31, 2013.

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clinical evidence. Fundamental & clinical pharmacology

2005;19:1-16.

April 2013 — A Review of Herbals in Cancer Patients: Use This Not That?

1. What percentage of adults in the United States are reported to utilize CAM? A. 75 percent B. 50 percent C. 33 percent D. 25 percent 2. Which law allowed manufacturers to freely distribute dietary supplements without proving safety and efficacy? A. Complementary and Alternative Medicine Act B. Dietary Supplements Health Education Act C. Vitamin and Herbal Supplement Act D. Homeopathic Regulations and Policies Act 3. Which of the following are reasons cancer patients utilize CAM? A. Pain B. Depression C. Sleep disturbances D. Menopausal symptoms E. All of the above 4. Which of the following herbals CAN be used concurrently with anticoagulants? A. Ginger B. Gingko C. Willow bark D. Kava 5. Patients allergic to which of the following should not take chamomile? A. Cat dander B. Ragweed C. Black tea D. Lavender

6. Kava should not be used concurrently with all of the following EXCEPT? A. Alcohol B. Barbiturates C. Benzodiazepines D. Antiepileptics 7. Which of the following herbals used to treat depression can be used concurrently with MAOIs and SSRIs? A. Inositol B. SAM-e C. 5-HTP D. St. John’s wort 8. Which of the following is an approved FDA indication for THC? A. Pain B. Insomnia C. Nausea D. Anxiety 9. Which herbal supplement is the most likely to interact with anticancer agents? A. Gingko B. Kava C. Black Cohosh D. St. John’s wort 10. Which of the following is NOT a phytoestrogen? A. Chamomile B. Soy C. Flaxseed D. Licorice


March 2013



PHARMACISTS ANSWER SHEET April 2013 — A Review of Herbals in Cancer Patients: Use This Not That? Universal Activity # 0143-0000-13-004-H04-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D E 5. A B C D 7. A B C D 9. A B C D 2. A B C D 4. A B C D 6. A B C D 8. A B C D 10. 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: March 20, 2016 Successful Completion: Score of 80% will result in 1.5 contact hours or 0.15 CEUs.

Participants who score less than 80% will be notified and permitted one re-examination.

TECHNICIANS ANSWER SHEET. April 2013 — A Review of Herbals in Cancer Patients: Use This Not That? Universal Activity # 0143-0000-13-004-H04-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D E 5. A B C D 7. A B C D 9. A B C D 2. A B C D 4. A B C D 6. A B C D 8. A B C D 10. 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 _________________________________


Quizzes submitted without NABP eProfile

ID # and Birthdate cannot be accepted.

March 2013


Why should I connect with KPhA?

Why should I connect with KPhA? The Value of Membership

Professionals are frequently and continu-

ally asked to join one or more profession-

al organizations. Many pharmacists will

join the Kentucky Pharmacists Associa-

tion; many will not. Having been involved

in the workings of the association since

my college days and a member since

graduation, it is my belief that it is in the

best interest of all professionals to join

and participate in the professional associ-

ation that represents the comprehensive

challenges of that specific profession.

I have spoken to many practitioners over

the years and they have always wanted

to get something done, an initiative start-

ed, changed or stopped. They can’t get

it by themselves but want others or another “body” to listen

to and address their “call to action.” Singularly, that is why

we have professional associations. There is strength in

numbers.

In the years since my graduation, I have seen tremendous

changes in our profession; in my humble opinion, each and

every one of them needed a pharmacist or a representative

for the profession at these “tables of change” to address

the changes, to get them started, changed or stopped.

Simply put, the Board of Pharmacy’s obligation is to protect

the public and provide for its well-being by oversight of our

profession. The Board’s charge is to police the regulations

put in place by governing bodies that may not understand

or appreciate the intricacies of our professional practice.

Simply put, employers provide each professional a liveli-

hood within these regulations as well at the direction and

demand from their governing bodies, owners, managers,

stock holders, etc.

As we continue to strive for the advancement of the profes-

sion, it is even more important that we give the Association

that represents all pharmacy practitioners in the state our

greatest support by membership and involvement. Your

membership and involvement in your professional associa-

tion is truly your greatest voice. The bottom line is that the

Board of Pharmacy does not represent you nor does your

employer. Your best interests as a professional are best

served by the association dedicated to start, change or

stop initiatives. They give us voice in today’s changing and

challenging business climate and they support our commit-

ment to the public consistent with the pharmacist’s oath

that we repeated at graduation.

Pharmacists deserve a strong, committed voice at the

“tables of change.” Do you value the future of your

profession enough to support that voice by your mem-

bership and involvement?

Lynn Harrelson, Pharm BS

KPhA Past President, 1991-1992

One of Kentucky’s Outstanding Young Women, 1983

KPhA Bowl of Hygeia for Outstanding

Community Service, 1990

Wyeth’s True Caring National Recipient, 2006

KPhA Distinguished Service Award, 2010

KPhA Professional Promotion Recipient, 2010

Lambda Kappa Sigma Meritorious Service Award (international) 2011

KPhA Excellence in Innovation, 2012

Visit www.kphanet.org today to connect with YOUR KPhA!

“As we continue to strive for the advancement of the

profession, it is even more important that we give the

Association that represents all pharmacy practitioners in the

state our greatest support by membership and involvement.”

Upon the passage of SB 107, George Hammons, KPhA Past President (2003-04), noted: “A great day for Pharma-

cy! Thanks to KPhA Government Affairs, KPhA Board, Senator Stivers and Senator Denton, APSC, APCI, EPIC, KIPA,

all our lobbyists and those who made calls to legislators on behalf of SB107. It shows what we can do as one voice. No

pharmacist in the state of Kentucky should question why they should belong to KPhA nor that they cannot afford the

dues. Passage of this bill alone is more valuable than a lifetime of dues. Thank you Bob for all you and staff do.

George Hammons, Past President

March 2013


Pharmacy Law Brief

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

Author: Joseph L. Fink III, B.S.Pharm., J.D., Professor of Pharmacy Law and Policy and KPhA Professor of Leadership, Department of Pharmacy Practice and Science, UK College of Pharmacy

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 issue and that was followed with “II” and “III”.

This installment addresses issues related to the IRS Form

990 filed by tax exempt non-profit organizations and will

supplement or extend those earlier discussions.

The official title of IRS Form 990 is “Return of Organization

Exempt from Income Tax.” In recent years the Internal

Revenue Service has placed increased emphasis on the

role this form plays in the governance of tax exempt organ-

izations. During 2011, it was announced that more than

3,000 formerly tax exempt organizations in Kentucky had

lost this favored status because they had failed to file a

Form 990 for three consecutive years.

The IRS has enhanced the Form 990 with several goals in

mind: [1] enhance transparency to provide the IRS and the

public with an accurate and realistic snapshot of the organ-

ization; [2] promote compliance with the tax laws; and [3]

minimize the burden on tax exempt organizations.

The revised form collects expanded information regarding

governance of the organization, such as identifying who

has voting rights on the governing body. It also embodies

an expectation that members of the governing board re-

view the content of the form before it is filed and that the

board be primarily composed of independent board mem-

bers. Some of this can be traced back to a piece of federal

legislation known as the Sarbanes-Oxley Act of 2002.

While rooted in the Enron financial scandal and aimed

primarily at the functioning and organization of publicly

traded for-profit entities, this legislation had a spill over im-

pact on nonprofit organizations.

The IRS expects that a nonprofit will have a policy in place

to protect individuals who come forward to report suspect-

ed irregularities, known as a “whistleblower” policy, as well

as a policy regarding retention of documents of the organi-

zation. Board members should be expected to know about

and review these policies.

Board members are expected to be actively engaged in

independent and informed oversight of the organization’s

activities. The board should adopt a conflict of interest poli-

cy as discussed in an earlier installment in this series.

The bottom line is that pharmacists can make very sub-

stantial contributions to the nonprofit organizations in their

communities, be they health-related, youth or elderly ser-

vice oriented, or religiously affiliated through service as a

member of the governing board. But such responsibilities

should not be undertaken lightly and the time commitment

should be understood before entering the relationship. The

days of “lending my name” to be on a board are no longer

here.

Submit Questions: [email protected]

@KyPharmAssoc

@KPhAGrassroots

Facebook.com/KyPharmAssoc

KPhA Company Page Are you connected

to KPhA?

Join us online!

Disclaimer: The information in this column is intended for educational use and to stimulate professional discussion among col-

leagues. It should not be construed as legal advice. There is no way such a brief discussion of an issue or topic for educational or

discussion purposes can adequately and fully address the multifaceted and often complex issues that arise in the course of profes-

sional practice. It is always the best advice for a pharmacist to seek counsel from an attorney who can become thoroughly familiar

with the intricacies of a specific situation, and render advice in accordance with the full information.

March 2013


Advancing Pharmacy Practice in Kentucky

March 2013


Pharmacy Policy Issues

PHARMACY POLICY ISSUES:

Clinical Assisted Suicide Author: William M. Black is a third professional year PharmD student at the UK College of Pharmacy. He hails

from Paducah where he completed his pre-professional course work at West Kentucky Community and Technical College as well as at UK.

Issue: Several states have statutes authorizing “physician assisted suicide”, known specifically as “Death with Dignity” statutes. What is the role for pharmacists with that?

Discussion: Physician assisted suicide (PAS) is a prac-

tice that has been around for years but is slowly gaining

acceptance in the United States. With statutes already in

place in Oregon1 and Washington

2, and court cases in

Montana3,4

that allow for the practice, it could end up in

Kentucky in the not so distant future. For example, during

the past two decades California, Hawaii, Maine and Michi-

gan have had unsuccessful attempts, either through ballot

initiatives or through legislative proposals, to create the

opportunity for PAS.5

While “physician assisted suicide” is the commonly accept-

ed term, it gives the impression that this is merely an inter-

action between a patient and his doctor. In reality there are

multiple individuals, both practitioners and laypeople, who

are involved in this process from start to finish. These addi-

tional people include nurses, therapists, family and friends,

caregivers and even pharmacists. While the role of the

pharmacist is not an intensive one, it is nonetheless im-

portant and for some may even pose a moral or religious

obstacle.

The statutes in Oregon and Washington clearly outline the

proper legal process for those participating in PAS right

down to how the prescription may be filled. Just as in Ken-

tucky, the prescriber has the option to directly dispense the

life-ending medication (LEM) to the patient. Most commonly

used medications are rapid-acting barbiturate elixirs, usual-

ly secobarbital or pentobarbital.6 Prescribers who cannot or

do not want to do this can send the prescriptions to the

pharmacy. This is where the difference exists. Under the

systems in place in states where this is authorized, a pre-

scription for a LEM may not be handled by the patient or

given orally or electronically to the pharmacist. The pre-

scriptions must be delivered directly to the pharmacist who

is to dispense the medication. This can happen in person or

through the mail and is true for any ancillary medications as

well, such as anti-emetics to prevent vomiting and ensure

adequate absorption. In addition, the prescriber must dis-

close to the pharmacist the intended use of the medica-

tions. At this time, the pharmacist must decide if he or she

wants to honor the prescription. Once prepared, the patient

or a designated agent may pick up the medications.1,2

Every year Oregon and Washington publish reports sum-

marizing PAS activity for the previous year, and Washing-

ton includes information regarding the number of pharma-

cists participating. The number of pharmacists has risen in

parallel with the number of prescriptions issued each year,

with 2.2 prescriptions per participating pharmacist over the

last three years.7,8,9

This of course does not mean that the

average participating pharmacist dispenses approximately

two prescriptions each, because prescribers have the op-

tion of dispensing directly to the patient.

While PAS is not yet allowed in Kentucky, it is not unrealis-

tic to think that it may happen in the near future, certainly

before my time as a practicing pharmacist comes to an

end. For now, the Kentucky pharmacist should begin to

consider his or her opinion on the matter and be prepared

should he or she ever have to make the decision, “to fill or

not to fill” a life-ending medication.

References:

1. Oregon Death with Dignity Act, Oregon Code §127.800.

2. Washington Death with Dignity Act, Wash, Rev. Code

§70.245 (2008).

3. Baxter et al. v. State of Montana, 2008 Mont. Dist. Lexis

482 (First Jud. Dist. Ct.) (2008).

Have an Idea?:

This column is designed to address timely and practical issues of interest to pharmacists, pharmacy interns and phar-

macy 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].

March 2013


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]

Continued from Page 6

4. Baxter et al. v. State of Montana, 354 Mont. 234, 224

P.3d 1211 (2009).

5. Ganzini L, Dobscha S. Clarifying Distinctions between

Contemplating and Completing Physician-Assisted Suicide.

The Journal of Clinical Ethics. (2004); 15:119-22.

6. Oregon Department of Public Health. Oregon DWDA

Summary, Year 14 - 2011 Table 1. Available at http://

public.health.oregon.gov/ProviderPartner Resources/

EvaluationResearch/DeathwithDignityAct/Documents/

year14-tbl-1.pdf.

7. Washington State Department of Health. 2009 Death

with Dignity Act Report Executive Summary. Available at

http://www.doh.wa.gov/ Portals/1/Documents/5300/

DWDA2009.pdf.



http://www.doh.wa.gov/Portals/1/Documents/5300/

DWDA2010.pdf.



http://www.doh.wa.gov/Portals/1/Documents/5300/

DWDA2011.pdf.

Special Acknowledgement: The work reported here was

completed with support from the Summer Research Pro-

gram of the UK College of Pharmacy.

this issue and for working together to ensure that pharma-

cies can continue to provide this valuable service to pa-

tients.

KPhA staff and lobbyists have worked with members in

both chambers to inform legislators about the impacts

these bills (and others as outlined in our regular legislative

updates) would have on YOU. But the biggest impact in

Frankfort doesn’t come from me or our lobbyists in Frank-

fort. It comes from YOU and YOUR contacts with YOUR

legislators. It also comes from YOUR donations to the

Kentucky Pharmacists Political Advocacy Council, which

funds donations to legislative candidates friendly to the

profession as well as your additional support of our legisla-

tive work through YOUR contributions to KPhA’s Govern-

ment Affairs fund.

YOUR engagement continues to make the difference.

March 2013


Pharmacists Mutual

March 2013


KPhA Government Affairs Contribution

I first want to say what a great victory it is for the practice of

pharmacy with the passage of SB 107. It should remind us

what can be accomplished when all segments of our pro-

fession work together. If I may borrow from Armstrong’s

thinking, "One small step for a pharmacist, one giant step

for the Practice of Pharmacy."

Congratulations and a very much deserving thank you to

our Executive Director Robert McFalls, Jan Gould and Gay

Dwyer—KPhA's lobbyist team, and to our partners APSC,

APCI, EPIC and KIPA for a collective and focused ap-

proach. Their combined leadership and dedicated work

during this session was endless. Thanks to all those phar-

macists that answered the call when needed and contacted

their legislators, and those that made many trips many

times to Frankfort to aid in this cause. Congratulations to

our President Kim Croley, our leadership and to our entire

Board of Directors for leading the Association in this victory

charge and supporting the Governmental Affairs Commit-

tee’s recommendations. Congratulations to our Govern-

mental Affairs Committee members who unanimously and

with very active participation decided to stay focused on

one major legislative agenda item during this short session.

I also would like to congratulate the staff at KPhA who

worked countless hours behind the scenes so KPhA’s front

line team could stay in the field. I would be remiss if I did

not thank Senator Denton for undying and rock hard sup-

port for Pharmacy by introducing and spearheading SB

107 through the Senate and the House.

I would like to remind each of you to thank your senator

and representative personally now and before the next

session with a monetary contribution to show them just

how much they are needed and appreciated. Pharmacy will

need each one of these who unanimously supported us,

without a single no vote, again in the future. Let us not

leave a bad taste in their minds by not supporting them

either by active participation when they may request or

need it or by monetary support through a campaign contri-

bution.

Congratulations and enjoy, but let us stay vigilante. Re-

member to support KPPAC and KPhA's Governmental Af-

fairs Fund. These resources aided our association and pro-

fession in this great victory and will help with the next one.

A Message from Richard Slone, Chairman,

KPhA Governmental Affairs Committee

Editor’s Note: KPhA gratefully acknowledges the leadership of Richard Slone, Government Affairs Committee Chair-

man, for his relentless devotion to Grassroots Advocacy and shepherding SB 107 through the legislative process.

March 2013


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]

Chris Killmeir, Louisville

[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 & Continuing Education

[email protected]

Kelli Sheets

Office Manager

[email protected]

Christine Richardson, PharmD

Clinical Pharmacist, Director of Professional

& Clinical Services

[email protected]

Leah Tolliver, PharmD

Director of Pharmacy Emergency Preparedness

[email protected]

Nancy Baldwin

Receptionist/Office Assistant

[email protected]

KPhA Board of Directors

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 list.

March 2013


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]

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 Kentucky Regional Poison Center (800) 222-1222

Frequently Called and Contacted

50 Years Ago/Frequently Called and Contacted

50 Years Ago at KPhA From A talk given by Fred B. Kluth, prominent Louisville pharmacist at the

Pharmaceutical Workshop in Lexington on March 20th.

Computing the Professional Fee: There are three basic factors that must be

considered in determining the prescription charge, regardless of the method

used. These are — 1. The cost of the ingredient or ingredients and container,

2. The cost incurred in dispensing the prescription, 3. The profit necessary to

sustain the enterprise and to permit its growth.

— From The Kentucky Pharmacist, April 1963, Volume XXVI, Number 4.

For more information on how you can be involved in the KPhA Emergency Preparedness Initiative,

contact Leah Tolliver, KPhA Director of Pharmacy Emergency Preparedness at 502-227-2303 or by

email at [email protected]. KPhA is a partner with the Kentucky Department of Public Health for

emergency preparedness and disaster response.

For more resources, visit YOUR www.kphanet.org and

click on Resources—Emergency Preparedness.

March 2013


THE

Kentucky PHARMACIST

1228 US 127 South

Frankfort, KY 40601

Register now!

135th KPhA

Annual Meeting

June 6-9, 2013

Louisville Marriott Downtown

Visit www.kphanet.org to register.

the kentucky pharmacist vol. 8 no. 2

Documents

kentucky pharmacy education

profession of pharmacy

kpha members

board of pharmacy letter

kpha new

kpha board of directors

pharmacy policy issues

pharmacy issues legislators