Jan2015 updated

PalmettoThe Official Journal of the South Carolina Pharmacy Association • Vol. 53, Num. 5

Palmetto Pharmacist • Volume 55, Number 1 1

PharmacistThe Official Journal of the South Carolina Pharmacy Association • Vol. 55, Num. 1

Palmetto

Make your voice heard Become an SCPhA Leader

Pharmacists should...

Independent pharmacy needs...

That new legislation is going to...

The biggest issue we face is...

I have this idea...

2 Palmetto Pharmacist • Volume 55 Number 1

R

Since we are committed to helping independent

pharmacies grow and prosper, we know that sometimes it

isn’t about volume, it’s about having the one product your

customer needs. That’s why we stock more than 30,000

items. And, just as important, is delivering it when you

need it.

To learn how we can help you serve your customers better,

visit www.smithdrug.com or call 800.554.1216 today.

We focuson the products you need.

Who do you trust to supply your pharmacy?

©2013 J M SMITH CORPORATION. The Smith mark is a registered trademark of the J M Smith Corporation.

800.554.1216

SDC_collage_Final.indd 3 4/11/13 12:00 PM

Palmetto PharmacistVolume 55, Issue 1 January/February 2015The Palmetto Pharmacist, the official publication of the South Carolina Pharmacy Association, is distributed to association members as a membership service. Statements of fact and opinion are made by the authors alone and do no imply an opinion on the part of the officers or members of SCPhA. For advertising rates and other information, contact SCPhA.

What’s Inside...

5 The Future of Pharmacy SCPhA President Patti Fabel discusses upcoming opportunities for pharmacy

7 Member Profile: Kaushik Kotecha A look at one of SCPhA’s members

11 The Boutique Pharmacy The next installment of a series of articles aimed at helping the independent pharmacy

Regular Columns 13 Financial Forum 14 Presbyterian College School of Pharmacy 17 South University School of Pharmacy 23 Journal CE 31 Classifieds

Advertisers 2 Smith 4 Pharmacists Mutual 20 Display Options 20 Mutual Drug 22 PACE 31 Jon Wallace, Attorney at Law 32 QS/1

Events At-A-GlanceJanuary 13: Greenville Pharmacy Night

January 16-18: SE Girls of Pharmacy Leadership WeekendJanuary 27: Columbia Pharmacy NightFebruary 3: Charleston Pharmacy NightFebruary 5: All Pharmacy ConferenceFebruary 10: Florence Pharmacy Night

February 19: Pharmacy Day at the State HouseMarch 28: Cordially Yours at APhA’s Annual Meeting

May 21: All Pharmacy ConferenceJune 11-14: Annual Convention


2014-2015 Board of Directors

President/Board Chair Patti Fabel

Immediate Past PresidentSteve McElmurray

President-Elect William Wynn

Treasurer

Pamela Whitmire

Director-At-Large Michael Gleaton

Midlands Region Director

Bryan Amick

Low Country Region Director Kristy Brittain

Pee Dee Region Director

Jarrod Tippins

Upstate Region Director Ed Vess

Speaker, House of Delegates Sarah Braga

Speaker-Elect, House of Delegates

Kayce Shealy

CEO Craig Burridge

General Counsel

Jon Wallace

Midlands DelegatesLynn ConnellyBetsy BlakeBrian ClarkCraig HarmonMegan Montgomery

Low Country DelegatesJeff BrittainWayne WeartDon Neuroth

Pee Dee DelegatesJim ShulerKelly JonesDan Bushardt

Upstate DelegatesWalter HughesDavid BanksSteve GreeneLinda Reid

SCPhA StaffCraig Burridge Chief Executive Officer Cassandra-Hicks Brown Director of Operations/CELaura Reid Director of EventsLauren Palkowski Director of CommunicationsKatharine Stafford Membership CoordinatorJon Wallace General Counsel Cecily DiPiro PPN Network CoordinatorJennifer Simmons Palmetto Pharmacist Layout

4 Palmetto Pharmacist • Volume 55 Number 1 *Compensated endorsement.

Not licensed to sell all products in all states.

Learn more about Pharmacists Mutual’s solutions for you – contact your local field representative or call 800.247.5930:

www.phmic.com

Our commitment to quality means you can rest easy.

PO Box 370 • Algona Iowa 50511

Endorsed* by:

Pharmacists Mutual has been committed to the pharmacy profession for over a century. Since 1909, we’ve been insuring pharmacies and giving back to the profession through sponsorships and scholarships.

Rated A (Excellent) by A.M. Best, Pharmacists Mutual is a trusted, knowledgeable company that understands your insurance needs. Our coverage is designed by pharmacists for pharmacists. So you can rest assured you have the most complete protection for your business, personal and professional insurance needs.

Robby Peed800.247.5930 ext. 7162

843.319.1330

To say that 2014 was a tough year for pharmacy in the state of South Carolina would be an understatement. We had more students graduate from a pharmacy school than ever before. We saw reimbursement rates cut to catastrophic rates. Prescription drug abuse has become a crisis, not only at the local level, but nationally as well. We have seen hours cut and jobs lost. It has been a tough year to say the least.

However, in the midst of difficulty, you can grow, learn, improve - what doesn’t kill you, makes you stronger! Pharmacy in South Carolina is certainly not dead, nor is it dying. We are the strongest we have ever been!

We have learned from our past challenges and are striving to improve. This is evident in our legislative agenda for this session. We will submit two pieces of legislation:

The first is a MAC Transparency bill that will make sure what occurred in 2014 will not happen again. It aims to level the playing field and prevents the PBM industry from taking advantage of our profession.

PRESIDENT’S PLATFORM

The second is an Immunization bill that will expand our authority to administer vaccines. If passed, it will allow us to administer all CDC approved vaccines to those 12 years of age and older, without a prescription. This will make it easier for pharmacy to help improve the vaccination rates and the overall health of South Carolinians.

In addition to legislation, there are several opportunities to increase our pharmacist health coaching program, where pharmacists coach patients with chronic disease states and get paid for these services. Not only does this program improve the overall health of patients and save payers money, but it also increases revenue for pharmacies and provides additional employment options for individual pharmacists. It’s a win-win!

Help show your support of pharmacy by making a resolution to attend our Pharmacy Day at the State House. A strong presence will show legislators the importance of pharmacy in South Carolina.

Sincerely,Patti Fabel “We are the

strongest we have ever been!”


PRESIDENT’S PLATFORM

The Future of Pharmacy

*Compensated endorsement.Not licensed to sell all products in all states.

Learn more about Pharmacists Mutual’s solutions for you – contact your local field representative or call 800.247.5930:

www.phmic.com

Our commitment to quality means you can rest easy.

PO Box 370 • Algona Iowa 50511

Endorsed* by:

Pharmacists Mutual has been committed to the pharmacy profession for over a century. Since 1909, we’ve been insuring pharmacies and giving back to the profession through sponsorships and scholarships.

Rated A (Excellent) by A.M. Best, Pharmacists Mutual is a trusted, knowledgeable company that understands your insurance needs. Our coverage is designed by pharmacists for pharmacists. So you can rest assured you have the most complete protection for your business, personal and professional insurance needs.

Robby Peed800.247.5930 ext. 7162

843.319.1330


A BIG thank you to SCPhA Members for your

have signed up for our NEW membership levels that come with some great benefits!

Visionary Level $1,200

John Pugh

Leader Level $600

-Beasley

Friend Level $300

William Lee Betsy Blake

Deborah Tapley Roberta Vining

Bryan Amick Janet Thames

Jason Li

Trish Mauney

Besides preferred mem-ber pricing at events,

networking opportuni-

-monthly journals and weekly e-

here’s what else you get: - - - Custom Tervis Tumbler upon signing up - major events - SCPhA bucks (To be used towards

or email at [email protected].

Send payment to: SCPhA • 1350 Browning Road • Columbia, SC 29210 or fax to 803.354.9207

or pay online at www.scrx.org

“We make a living by what we get, but we make a life by what we give.” - Winston Churchill

Peer-to-Peer Challenge There is no substitute for peer-to-peer recruitment.

If every member of SCPhA recruited just one person to become a member, not only would our membership

double, but our voice would grow exponentially.

Many pharmacists are not members simply because they have not been asked by someone that they know. For each new member who you refer that joins SCPhA,

your name will be placed in a drawing for $1,000!

We’ll have a drawing at this year’s Annual Convention.

Help us grow our membership…and our voice!

THE

EG

NELL

AHC


In 1985, he left the Spartanburg City Police Depart-ment to attend the University of South Carolina, School of Pharmacy and graduated in 1989. While at USC, he was vice president of Phi Delta Chi Fraternity, Beta Theta Chapter. He also became a registered pharmacist in North Carolina in 1995. Kaushik also has a certification from UNC in Master of Public Health.

After graduation, Kaushik worked for Mary Black Memorial Hospital as a staff pharmacist. In 1992, he became the manger and PIC at IntraCare Phar-macy, where he worked as an oncology pharmacist and prepared various chemotherapy mixtures, pain management pumps, home infusion medications and dispensed oral medications for patients. Kaushik always missed his career as a police office, so in 1993 he went to work for the SC DHEC Bureau of Drug Control as a Piedmont Inspector. He at-tended the South Carolina Criminal Justice Acad-emy and graduated with honors. He was promoted to Piedmont Director in 1999 and retired from that position 13 years later. During his career at the SC DHEC Bureau of Drug Control, Kaushik investi-gated various types of prescription drug diversion cases and assisted local, state and federal agencies with investigation and prosecution. His expertise in criminal justice and drug regulation includes DEA drug diversion training, basic and advanced certifications in video and audio from the National Intelligence Academy, as well as basic and advanced

Member Spotlight: Kaushik Kotecha, R.Ph.

computer training from National Cyber Crime Cen-ter. Today, Kaushik continues to assist law enforce-ment agencies as an investigator with the 7th Circuit Solicitor’s Office.

During his career, Kaushik has conducted many training sessions for various professions, includ-ing pharmacists, physicians, nurses, attorneys from the solicitor’s office, judges, pharmacy students, law enforcement agencies, civic groups, and high school students. He has participated in many pharmacy forums, discussing how to prevent drug diversions.

Kaushik is currently a member of the South Carolina Pharmacy Association (SCPhA), the South Carolina Law Enforcement Officers’ Association (SCLEOA), the National Association of Drug Diversion Inves-tigators (NADDI), and the National Association of State Controlled Substance Authorities (NASCSA).

As a community volunteer, Kaushik founded the Spartanburg Make-A-Wish Foundation through the Spartanburg City Police Department. He is currently a volunteer at the Spartanburg Soup Kitchen and Carpenter’s Table Food Pantry as well as a member of Nazareth Presbyterian Church.

Kaushik enjoys playing golf, running, working out, reading and spending time with his family. Among his many personal accomplishments, he cites his mar-riage of almost 20 years to Kimberly Norton Kotecha, and raising his children, Kyle and Kathryn.

Since joining Smith Drug Company in March 2012, Kaushik Kotecha, R.Ph. has been promoted twice from his original role as the Director of Controlled Substance Compliance.

Kaushik started his career as a uniform police office with the Spartanburg City Police Department. He obtained a BS degree in Interdisciplinary Studies with a concentration in Criminal Justice from the University of South Carolina Upstate.

MEMBERS



FOR IMMEDIATE RELEASEContact: Judy Armandroff

864-253-8600

QS/1 Partners with ANX, a Leading PCI Protection Company

QS/1 is taking PCI data protection to the next level for its customers by partnering with ANX, an industry leader in helping pharmacies and small retail businesses secure and protect systems and networks from data breaches.

“While the Internet has helped society in many ways, criminals have found ways to use it for their gain,” said Charles Garner, QS/1 Market Analyst. “Every day, they use sophisticated technologies and advanced hacking methods to make their way into the computer networks of small businesses.”

By partnering with ANX, QS/1 is able to recommend an industry leader in data breach protection for phar-macies. Research has found 75 percent of data breaches within small businesses happen in the restaurant and healthcare sectors. ANX can help pharmacies better secure their networks to minimize the risk of network attacks. ANX also offers comprehensive coverage up to $100,000 per location to help cover a mandatory PCI forensic audit, card replacement costs, and fines that result from a data breach.

"ANX is delighted to form a partnership with a pharmacy industry leader like QS/1," said Mark Wayne, EVP of ANX. "Both companies have deep pharmacy expertise and a commitment to protect pharmacies from the perils of data breach."

Information about how to sign up for ANX protection services can be found at http://www.qs1.com/services/anxebusinss-pci-compliance/.

QS/1 Receives PrescribersConnection SCRIPT 10.6 Certification

With NCPDP SCRIPT 10.6 in effect, QS/1 is pleased to assure customers it is certified to transmit electron-ic claims through PrescribersConnection® for long term care facilities.

PrescribersConnection is a point of connection used between facilities, prescribers and pharmacies to trans-mit electronic medical records to fill new orders, send fill confirmations, resupply requests and discontinued medications.

“We are pleased to work with PrescribersConnection to help our customers to transmit their data securely,” said Michael Ziegler, QS/1 Senior Manager for Marketing and Analyst. “Because of new federal mandates, facilities have to find new ways to transmit this vital information.”

Long term care (LTC) facilities were originally excluded from this rule; however, that provision was removed in November 2012 by the Centers for Medicare and Medicaid Services. On November 1, 2014, LTCs were required to begin adhering to the NCPDP SCRIPT 10.6 format.

“Many eMAR vendors are choosing PrescribersConnection as their connection between all points for SCRIPT 10.6 transmissions,” Ziegler added. “QS/1 was quickly certified because we have the infrastructure in place to conduct these transmissions.”

QS/1 customers who need to use PrescribersConnection can contact [email protected] or call 800.845.7558, extension 1424 to sign up.


Charles Henry Dunning, Jr., Registered Pharmacist and Owner of Guerin's Pharmacy in Summerville, SC, the oldest independently owned pharmacy in South Carolina, passed away on Friday, November 7th, 2014 at the age of 87 years old. He received his pharmacy degree from the Medical College of the State of South Carolina in 1951. While in pharmacy school, Charles served as president of Phi Delta Chi Pharmacy Fraternity. Charles was first employed at Guerin's Pharmacy in 1939, delivering packages for the pharmacy when he was 12 years old. In 1951, he began working as a pharmacist at Schwettmann's Drug Store (pictured right) in Charleston, SC. He returned to Summerville in 1959 to work for Dr. Joseph A. Guerin and his uncle, Herbert F. Dunning, at Guerin's Pharmacy. He continued to work at Guerin's Pharmacy until the time of his death. What an inspiration for all of us to continue doing what we love! Charles was a lifelong member of the South Carolina Pharmacy Association. Pharmacy is in this family’s bloodline– a total of three generations of pharma-cists are in the family. Pictured to the right are Charles Dunning and family members Barbara Dunning, Katherine Dunning Calhoun, and Lisa Calhoun, all graduates of SCCP-MUSC.

In Memory of Charles H. Dunning, One of South Carolina’s Oldest Working Pharmacists

Oath of a Pharmacist "I promise to devote myself to a lifetime of service to others through the profession of pharmacy. In fulfilling this vow:

I will consider the welfare of humanity and relief of suffering my primary concerns.

I will apply my knowledge, experience, and skills to the best of my ability to assure optimal outcomes for my patients.

I will respect and protect all personal and health information entrusted to me.

I will accept the lifelong obligation to improve my professional knowledge and competence.

I will hold myself and my colleagues to the highest principles of our pro-fession’s moral, ethical and legal conduct.

I will embrace and advocate changes that improve patient care. I will utilize my knowledge, skills, experiences, and values to

prepare the next generation of pharmacists. I take these vows voluntarily with the full realization of the responsibility with which I am entrusted by the public.”


This is the eighth of a series of topics resulting from my experience in over 2,500 Pharmacies.

Most of us want to be seen as unique by our custom-ers and peers. This can be achieved in a positive or negative way. Differentiating one’s business from competitors is to be applauded if done correctly.

However, we need to put it all in proper perspec-tive. For those of us who remember the first time we saw The Beatles on the Ed Sullivan Show, their long locks was the first thing that caught the viewers’ attention. They looked different. Had their unique appearance been the only thing that made them unique, they would have become a faded memory. But, they had talent and sold more records than any other musical group in history. Therefore, it was their talent, not their appearance, that brought about their huge success. This may not be the best example in which to get my point across but hopefully most will understand where I’m coming from. Creating a unique appearance, or, as most refer to it as a bou-tique pharmacy, can be very eye-catching and attract more publicity than an ordinary looking pharmacy.

As a pharmacy design consultant, I have been a par-ticipant in the concept in the past until I learned that I was not serving my clients in the best way. A few decades ago, American Druggist was one of the most

popular pharmacy publications in America. They initiated what was called “Pharmacy of the Month” with color photos along with a cover story that had been selected from dozens of entries from all over the U.S. For obvious reasons, my colleagues and I aspired to have one of our pharmacy projects appear in this highly respected journal. About two years after the beginning of the “Pharmacy of the Month” it was suddenly curtailed. Why? Many of those unusual pharmacies were no longer in business. The “Pharma-ceutical Center” concept that was developed by a na-tional wholesale drug company also received national attention and was endorsed by a national pharmacy association. Their unusual modernistic appearance swept the country with excitement. Many thought the new design would become the model for future Independent Pharmacies. Both of these examples were presented with good intentions but doomed to fail. The principle that was overlooked in both was that the consumers’ response had not been tested or taken into consideration. We have to remember that consumers drive the market place.

We see many examples of the boutique type phar-macy promoted today. This does not mean that all are doomed to fail. However, I am convinced that the costs involved in creating a unique appearance alone can never be deemed as a good investment. Often, a unique design can become an adversary to work flow,

Creating a Competitive Strategy for Independent Pharmacy Success By Roland Thomas

The Boutique Pharmacy

DESIGN


leaving the potential customers unimpressed and some thinking they are paying too much. I notice that many independent pharmacy owners today either spend too little or too much with a minority making the best investments. My experience over the years has taught me that the typical consumer expects a pharmacy to look like a pharmacy and not like a Tif-fany’s or a department you would find in a Nordstrom store. If you look at most of the fixture company web sites today, you will see lots of dark custom wood fixtures, glass displays, curved or angular casework, along with other very attractive features. Most do not show merchandise on the shelves as that may take away from their thunder.

This is not a condemnation, by any means, to creat-ing a very attractive environment but there is a point where the costs are unrecoverable. Most of us would not invest our hard-earned dollars in anything that did not promise to bring about a good return. Going overboard or spending too little can cause prospective customers to go elsewhere. Rather than investing in expensive custom casework and design, I suggest that you concentrate your efforts on the services and con-venience factors along with an attractive environment. You do not have to look different to be different. I made mention in my book about a unique store that opened near my home about two years ago and stated that I would be very reluctant to invest in that type of

store as I have personally been down that road.

The store I mentioned closed its doors about three months ago. Your customers may compliment your pharmacy but think to themselves that they may be paying too much. An Independent Pharmacy is not selling high-end products so placing health-related merchandise on fancy wood shelves has not proved to bring about the best return on your investment. Invest where it counts most with your existing and potential customers. I think more emphasis should be on providing a convenient location, an attractive exterior and interior, but most of all, promote the ser-vices and unique products that will differentiate your pharmacy from your competition.

In the next article, I will express my views regarding the pros and cons of marketing your pharmacy for greater success.

Roland G Thomas is a Pharmacy Planning Special-ist with Rx Planning Solutions – a division of Display Options in Charlotte, NC. Roland has had the privilege of working with pharmacists as far away as Texas and Nevada. Pharmacy Owners have relied on his expertise in this field for over four decades. He published “Indepen-dent Pharmacy Steps to Greater Success” several months ago that covers primarily the physical attributes that had not been fully addressed in other publications.

DESIGN


This series, Financial Forum, is presented by PRISM Wealth Advisors, LLC and your State Pharmacy Association through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to the pharmacy community.

Financial Forum

A big payout leads to a big question. If you are taking a lump sum pension payout from your former em-ployer, what is the next step for that money? It will be integral to your retirement; how can you make it work harder for you? Rolling it over might be the right thing to do. If you don’t have substantial retirement savings, that lump sum may be just what you need. The key is to plan to keep it growing. That money shouldn’t just sit there. Even tame inflation whittles away at the value of money over time. Most corporate pension payments aren’t inflation-indexed, so those monthly payments eventually purchase less and less. Lump sums are just as susceptible: if you receive $100,000 today, that $100,000 will buy 50% less by 2028 assuming con-sistent 3% inflation (and that is quite an optimistic assumption).1,2

Putting it in the bank might cause you some finan-cial pain. If you just take your lump sum payout and deposit it, all that money will be considered taxable income by the IRS. (There are very few exceptions to that rule.) Moreover, you won’t get the whole amount that way: per IRS regulations, your employer must withhold 20% of it.2,3

Don’t you want to postpone paying taxes on those assets? By arranging a rollover of your lump sum dis-tribution to a traditional IRA, you may defer tax on those dollars. You can even defer tax on a distribution already paid to you if you roll over the taxable amount to an IRA within 60 days after receipt of the payout.3 In doing so, you are keeping those assets in a tax-de-

ferred account. They can be invested as you like, and that money will not be taxed until it is withdrawn. (You may only transfer a lump sum distribution from a company pension plan into a traditional IRA – you may not transfer it to a Roth IRA.)4

If you are considering taking a lump sum payout, make sure you position that money for additional tax-deferred growth. Talk to a financial professional who can help you with the paperwork and get your IRA rollover going. Refereces:1 - money.cnn.com/2012/09/01/pf/expert/pension-payments.moneymag/index.html [9/1/12]2 - www.kiplinger.com/article/retirement/T037-C000-S002-pensions-take-a-lump-sum-or-not.html [9/11]3 - www.irs.gov/taxtopics/tc412.html [1/4/13]4 - www.fool.com/retirement/manageretirement/manageretirement2.htm [1/21/13]

Pat Reding and Bo Schnurr may be reached at 800-288-6669 or [email protected].

Registered Representative of and securities and invest-ment advisory services offered through Berthel Fisher & Company Financial Services, Inc. Member FINRA/SIPC. PRISM Wealth Advisors LLC is independent of Berthel Fisher & Company Financial Services Inc.

IRA ROLLOVERS FOR LUMP SUM PENSION PAYOUTSGive those dollars the opportunity for further

tax-deferred growth.

FINANCIAL FORUM


PCSP

As we begin the new year, I would like to provide some highlights from the fall semester at Presbyterian College.

Our students were extremely active during the fall semester. Our American College of Clinical Phar-macy (ACCP) Clinical Pharmacy Challenge team made it to the round of 16 teams nationwide. This was a huge accomplishment! Congratulations to our students: Jason Jones, Steven Robinette, and Caleb Wallace.

At the South Carolina Society of Health-System Pharmacy’s (SCSHP) fall meeting, the top two teams from each of South Carolina’s colleges of pharmacy orally presented their pharmacist care plans for the Clinical Skills Competition. After the oral presenta-tions were delivered, the winner from the PC School of Pharmacy was determined to be the team com-prised of Lizzy Holden and Steven Robinette. Addi-tionally, Lizzy and Steven took home the night’s top honor of Best Oral Presentation of their pharmacist care plan for the entire competition. They repre-sented the PC School of Pharmacy at the American Society of Health-System Pharmacy (ASHP) Mid-year Clinical Meeting, which took place in December in Anaheim, California.

Our students also participated in a National Drug Take Back event in conjunction with the United States Drug Enforcement Administration and Clin-ton Public Safety Department. This one-day event provided Laurens County residents with a no-cost, anonymous collection of unwanted and expired medi-cines. The students collected and disposed of over 100 pounds of medications.

In October, Presbyterian College School of Phar-macy P1 students joined together with students from the Edward Via College of Osteopathic Medicine (VCOM) and students from Lander University’s William Preston Turner School of Nursing for an interprofessional immersion event at Harris Baptist Church in Greenwood, South Carolina. During this event, students heard from Mrs. Kathleen Darragh, a pharmacy technician who’s own family was pro-foundly affected by a medical error that could have been prevented by improved interprofessional

communication. The students also worked together in small interdis-ciplinary groups to evaluate current ethical dilemmas pres-ent in medicine today. Students were asked to work together to determine ways in which interdisciplin-ary collaborative practice can bring about solutions to the problems at the center of each of the ethi-cal dilemmas. PC Pharmacy School, VCOM and Lander Nursing have made a commitment to provide our students with opportunities for interdisciplinary education in hopes that this will result in improved patient care outcomes for the patients they serve in their futures.

One of our other major events in the fall was our research initiative with NIH. Representatives from ten colleges and universities across the nation who hold National Institutes of Health Biomedical/Biobehavioral Research Administration Development (BRAD) grants held their first ever annual network-ing event at the school of pharmacy. Also joining the recipients was our BRAD grant program officer, Dr. Jean Flagg-Newton, the Assistant Director of Health Equity for the Eunice Kennedy Shriver National In-stitute of Child Health and Human Development. It is a rare event for a program officer to have a chance to visit a grantee on site and we were delighted to have Dr. Flagg-Newton and our college and univer-sity guests on our campus to discuss the initiative of developing competitive grantsmanship and sponsored programs.

In December, our PC School of Pharmacy Wellness Center initiated its inaugural Telepharmacy Free Clinic Initiative. Through a grant from the Blue Cross Blue Shield Foundation and collaboration with

Presbyterian College School of Pharmacy Update by Cliff Fuhrman, PhD, RPh, Dean, PCSP


the South Carolina Free Clinic Association, our Well-ness Clinic faculty (Dr. Tiffaney Threatt, Director; Dr. Sarah Wagner; and Dr. Eileen Ward) have devel-oped a telepharmacy connection with two free clinics (Anderson and St. Luke’s-Spartanburg). The teleph-armacy connection is a HIPAA compliant connection via an iPad to patients identified by the clinics that need additional education for diabetes and hyperten-sion therapy. Through these online connections, our faculty and P4 students have the ability to discuss medication usage and education to assist them in improving their health. The project also includes a secure website for clinics to be provided with drug and pharmacy related information upon request. We look forward to advancing the scope of our Teleph-armacy Free Clinic Initiative project to other clinics across the state.

Effective January 1, 2015, Dr. Jennifer Clements was named the Department Chair of our Pharmacy Prac-tice Department. Dr. Clements earned her PharmD from Campbell University School of Pharmacy in 2006 and completed her PGY1 Pharmacy Practice with an emphasis in primary care at Ralph H. John-

son Veterans Affairs Medical Center in Charleston, South Carolina in 2007. After serving as a faculty member at Shenandoah University Bernard J. Dunn School of Pharmacy for six years, she joined the faculty at Presbyterian College School of Pharmacy. Dr. Clements served as Interim Chair of the Phar-macy Practice Department for six months and did an outstanding job managing the department.

As you can see, our fall semester was a busy time. In addition to these projects by students and faculty, classes were taught, exams taken, research papers submitted and countless patients seen by our faculty and students on rotation, many with pharmacists who are members of the South Carolina Pharmacy Asso-ciation (SCPhA).

As always, we appreciate the support of the many pharmacists in our state that help educate our stu-dents. We could not provide such an excellent educa-tion without you. As you advance the profession, we are doing our diligent efforts to also make an impact on pharmacy and patient healthcare.



SUSP

South University School of Pharmacy by Richard O’Brocta, PharmD, Associate Dean of Academic Operations, SUSOP

South University School of Pharmacy (SUSOP) closed out the year with excitement and enthusiasm! We look forward to a new year helping students to achieve their goals and dreams.

Community Service is an important component of the SUSOP experience. Listed below are examples of recent community service projects: • KappaPsiblooddrive• StudentAPhADiabetesWalk• SUSOPBloodDrive

Faculty honors:• Dr.ErikaTilleryhasreceivedBCPP(BoardCertification in Psychiatric Pharmacy)

We thank the SC pharmacy community for all of the support in educating the pharmacists of the future.


Want to help SCPhA make a bigger, brighter impact during our Pharmacy Day at the State House? Help us let the leaders of South Carolina know what’s on the minds of

pharmacists by participating in our NEW poster contest!

GUIDELINES: • Create and bring a poster to Pharmacy Day at the State House. • Posters must be relevant to current legislation. • All participants will have their name entered into a drawing to win a Jawbone Jambox wireless speaker. • One entry per person.

For more information, contact SCPhA at 803.354.9977 or [email protected].


Where would you prefer to have your HIPAA training?

Option A Option B

Yep. That’s what we thought. Get your HIPAA training online, 24 hours a day, 7 days a week with SCPhA’s on-line HIPAA training program.

Assessing Your Pharmacy’s HIPAA Policies & Procedurescreated by Craig Burridge, MS, CAE, CEO, South Carolina Pharmacy Association

Goals and Objectives:1. Identify the laws covering confidentiality and their lead up to HIPAA.2. Recognize the standard principles governing confi-dentiality as it relates to patient records.3. Identify the need for and responsibilities of a pri-vacy officer and workforce training requirements.4. Differentiate between the proper uses and disclos-ers of protected health information and permitted uses and disclosures.5. Recognize when authorization is necessary for protected information.6. Identify the requirements for the distribution of Privacy Practices Notices.7. Know how to develop an electronic protected health information policy.8. Recognize how to mitigate and notify affected individuals in case of a breach of protected health information.9. Identify the expanded HIPAA requirements under the Health Information Technology for Economic and Clinical Health Act (HITECH)

Fees:SCPhA Members: $15\Non-Members: $25Please note that this is required in order to obtain 2 hours of CE Credit.

The South Carolina Pharmacy Association is accredited by the Accreditation Coun-cil for Pharmacy Education as a provider of continuing pharmacy education. This home study is approved for 2 contact hours of continuing pharmacy education credit (ACPE UAN: 0171-0000-13-074-H03-P). This CE credit expires 8/08/2016.

Register online at www.scrx.org, or follow the QR code to the right!


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Second Update Regarding Industry Progress in Implementing

Electronic Prescribing for Controlled Substances (EPCS)

To: State Boards of PharmacyState Controlled Substance AgenciesState and National Pharmacy Organizations

From: Ken Whittemore, Jr., RPh, MBASenior VP, Professional & Regulatory Affairs

Date: December 16, 2014

It has been four years since the Drug Enforcement Administration (DEA) published its interim final rule (IFR) allowing electronic prescribing for controlled substances (EPCS). Over the past four years, Surescripts, as the primary network facilitating e-prescribing in the U.S., has worked with the pharmacy and prescriber application vendors that connect to its network to ensure that EPCS is implemented in the ambulatory healthcare setting in a way that is fully compliant with the DEA’s EPCS rules.

Surescripts published an update similar to this two years ago and distributed it to the pharmacy community with the goal of answering the questions that were being asked most frequently about EPCS by a variety of stakeholders, both within and without the industry. Given that Surescripts continues to receive general and technical questions from the field with respect to the adoption and utilization of EPCS processes, this second update seems appropriate, and a question and answer format is being used again as a vehicle to share such information. We hope you find this information useful.

Question: How can prescribers and pharmacists confirm that EPCS is legal according to the DEA?

Answer: This might seem to be an unusual question, but Surescripts continues to receive reports of both pharmacists and prescribers not believing that EPCS is a legal practice. The best resource for confirming the legality of EPCS is the section of the DEA website that discusses the issue at: http://www.deadiversion.usdoj.gov/ecomm/e_rx/index.html

At this website, the following highly recommended FAQs can be found:

• General: http://www.deadiversion.usdoj.gov/ecomm/e_rx/faq/faq.htm

• Pharmacies: http://www.deadiversion.usdoj.gov/ecomm/e_rx/faq/pharmacies.htm

• Prescribers: http://www.deadiversion.usdoj.gov/ecomm/e_rx/faq/practitioners.htm

2800 Crystal Drive 920 2nd Avenue SouthArlington, VA 22202 www.surescripts.com Minneapolis, MN 55402T: 703.921.2121 F: 703.921.2191 T: 866.267.9482 F: 651.855.3001


The South Carolina All Pharmacy Conference (APC) meets three times annually to allow phar-macy and healthcare stakeholders the opportunity to exchange their vision of our practice and to help each other navigate the healthcare provider waters. I liken it to an inter-professional team with varying perspec-tives all trying to advance the care of one patient. In this case our patient is the profession of pharmacy. The best way to promote our professional agenda is through monitoring and advocating for legislation that enhances our practice and protects our rights. The APC allows all opinions to gain an audience among pharmacy stakeholders. The upcoming legisla-tive session will be very busy for pharmacy as well as other healthcare professions; some examples of legislation to watch are below:

South Carolina All Pharmacy Conference: A Forum for all Stakeholders

All-Pharmacy Conference One profession. One license. One voice.


The South Carolina All Pharmacy Conference (APC) meets three times annually to allow pharmacy and healthcare stakeholders the opportunity to exchange their vision of our practice and to help each other navigate the healthcare provider waters. I liken it to an inter-professional team with varying perspectives all trying to advance the care of one patient. In this case our patient is the profession of pharmacy.

The best way to promote our professional agenda is through monitoring and advocating for legislation that enhances our practice and protects our rights. The APC allows all opinions to gain an audience among pharmacy stakeholders. The upcoming legislative session will be very busy for pharmacy as well as other healthcare professions; some examples of legislation to watch are below:

Pre-filed State House Legislation of Interest

Pre-filed State Senate Legislation of Interest

H. 3020 ACA Anti-Commandeering Act S. 34 Abortions H. 3078 Nursing Professionals S. 75 Insurance Trade Practices H. 3083 SC Overdose Prevention Act S. 100 Volunteer Health Care Providers H. 3091 Limited Immunity S. 102 Exportation of Prescription Drugs

H. 3159

Pharmacy Patient Protection Act—PBMs S. 103 Freedom of Choice in Health Care Act

H. 3140 Put Patients First Act S. 128 Prepaid Medical Services H. 3160 Medication Requiring Prescriptions S. 107 Fee Schedules H. 3161 Compounding

H. 3204 Cervical Cancer Prevention Act H. 3241 Hiring With this brief list of legislation in mind you can see how important it is for your voice to be heard. The current pharmacy-related stakeholders involved are listed below:

APC Member Organizations SC Medicaid ACCP SC Workers' Compensation Commission Consultant Pharmacists Long-Term Care SC Retail Association SC Board of Pharmacy SCPhA DHEC CPNP SC Solicitor’s Office NACDS Colleges of Pharmacy SCSHP

With this brief list of legislation in mind you can see how important it is for your voice to be heard. The cur-rent pharmacy-related stakeholders involved are listed below:


The South Carolina All Pharmacy Conference (APC) meets three times annually to allow pharmacy and healthcare stakeholders the opportunity to exchange their vision of our practice and to help each other navigate the healthcare provider waters. I liken it to an inter-professional team with varying perspectives all trying to advance the care of one patient. In this case our patient is the profession of pharmacy.

The best way to promote our professional agenda is through monitoring and advocating for legislation that enhances our practice and protects our rights. The APC allows all opinions to gain an audience among pharmacy stakeholders. The upcoming legislative session will be very busy for pharmacy as well as other healthcare professions; some examples of legislation to watch are below:

Pre-filed State House Legislation of Interest

Pre-filed State Senate Legislation of Interest

H. 3020 ACA Anti-Commandeering Act S. 34 Abortions H. 3078 Nursing Professionals S. 75 Insurance Trade Practices H. 3083 SC Overdose Prevention Act S. 100 Volunteer Health Care Providers H. 3091 Limited Immunity S. 102 Exportation of Prescription Drugs

H. 3159

Pharmacy Patient Protection Act—PBMs S. 103 Freedom of Choice in Health Care Act

H. 3140 Put Patients First Act S. 128 Prepaid Medical Services H. 3160 Medication Requiring Prescriptions S. 107 Fee Schedules H. 3161 Compounding

H. 3204 Cervical Cancer Prevention Act H. 3241 Hiring With this brief list of legislation in mind you can see how important it is for your voice to be heard. The current pharmacy-related stakeholders involved are listed below:

APC Member Organizations SC Medicaid ACCP SC Workers' Compensation Commission Consultant Pharmacists Long-Term Care SC Retail Association SC Board of Pharmacy SCPhA DHEC CPNP SC Solicitor’s Office NACDS Colleges of Pharmacy SCSHP


As you can see there is a diverse group of pharmacy practice represented, as such additional perspectives are welcomed and needed. Likewise, the APC is a tremendous conduit for networking. Our next meeting will be on February 5, 2015 at 10am and as a member of SCPhA I want to encourage you to attend or contact the a board member or the SCPhA office so your voice is heard at the APC. We must take advantage of every op-portunity to advocate for our profession and the APC is another step in the further growth of pharmacy.

William P. Wynn, III, Pharm.D., R.Ph.Chairman, All Pharmacy ConferencePresident-Elect, South Carolina Pharmacy Association

Attendees at the All-Pharmacy Conference


Reading body language can significantly help you to improve your communication skills. Unfortunately many seem to make mistakes when using body lan-guage and non-verbal signals to the extent that their attempt in reading actually reduces the quality of the communication. In this article you will explore a number of common mistakes made when people read body language.

Ignoring a Person’s HistoryPeople have different habits, sense of humour and style. A particular gesture or the way they stand may not mean something specific other than the fact they are follow-ing a particular habit that have done for years or the gesture is natural given their specific circumstances or body shape. By comparing a person’s current body language to their baseline you can improve your understanding when you aim to read their body language.

Reading a Single Gesture to Make ConclusionsGestures and postures must be read in a cluster. You must use a combination of non-verbal signals to decide how a person might be feeling or intending in comparison with what they are saying.

Not Considering the ContextWhen it comes to reading body language, context is everything. In cold weather, people with cross their arms. This should not be read as a defensive posture; it’s just that the person might be cold. Look for non-verbal signals that give you a clue on the state of the person. Is he tired, is she depressed, is he in a rush? Based on the context you can then consider other signals to make an informed decision.

Reading Body Language With Personal BiasIf you like a particular person, you tend to read his signals positively. If you don’t like a person you tend

to read them negatively. This can lead to misunder-standings and bad communication. For example a person you are interacting with makes a particular gesture and just because you don’t like the person you may read it as rude, aggressive or suggestive. Instead, you need to learn to judge a person without this per-sonal bias and look for context and read other non-verbal signals to confirm your understanding of the situation. Use a cluster of signals along with verbal signals to decide.

Using Wrong Non-Verbal SignalsThere has been a lot of recent research in the field of body language, however some old techniques are still circu-lated and even used to train people on body language. These signals are now shown to be inconclusive. Signals such as touching the nose or scratch-ing the eye were historically associ-ated by lying. Research shows that these signals alone may not indicate that the person is a liar; just that he is stressed. The distinction is critical and can easily lead to misinterpretation.

Reading Body Language With Cultural BiasSimilarly, a cultural bias can get

in the way when reading body language of people from other countries. You may dislike a gesture and consider it rude in your own culture while in reality the person from the other culture has not been rude at all. Sometimes the difference between cultures is so much that a particular posture or gesture is read exactly as the opposite. By increasing your knowledge about other cultures and their body language you can maximise your chances of interpreting it correctly and improve your communication skills with them.

Paul Anderson is a training consultant at Skills Con-verged. The company provides training resources on soft skills, management skills and interpersonal skills which are used by the training community to deliver interactive face-to-face training courses.

Top 6 Mistakes Made When Reading Body LanguagePharmacists use effective communication to treat their patients. However, communication is not just verbal. In this article, sourced from www.articlesfactory.com, author Paul Anderson discusses some of the common mistakes that people make when reading body language.


ObjectivesAfter completing this activity, the participant should be able to:• State the importance of mutation status in non-small cell lung cancer • Describe how mutation status plays a role in clinical practice of NSCLC• Distinguish proper doses of erlotinib based on diag-nosis and potential drug interactions present• Counsel patient on management of the side effects of erlotinib• State the clinical controversy of erlotinib and when it is appropriate in clinical practice

Objective: Educate pharmacists and pharmacy technicians on pharmacotherapy for the treatment of non-small cell lung cancer (NSCLC) with a focus on the use of erlotinib, including a discussion on its use in NSCLC, important counseling points for use, and clinical controversies for its use in practice.

Summary: Non-small cell lung cancer is the third most common cancer and is responsible for the most cancer related deaths in the United States. Convention-al treatment for non-surgical candidates is chemother-apy and leads to numerous hematologic side effects. Erlotinib is an oral medication that is an alternative to chemotherapy to select patients with NSCLC. It is a tyrosine kinase inhibitor with activity against mutant EGFR. The pertinent mutations are present in up to fifty percent of Asian and ten percent of Caucasian patients with NSCLC. The most common side effects of erlotinib are rash and diarrhea, both of which can be managed with proper pharmacist counseling and OTC products. Data from the OPTIMAL trial supports that erlotinib offers longer progression-free survival and a

Hope in a Bottle for NSCLC: erlotinibACPE UAN: 0171-9999-14-103-H01-P Katherine Bliven, PharmD Candidate 2015, Kristy Brittain, PharmD, BCPS, CDE1,21 South Carolina College of Pharmacy – MUSC Campus2 Medical University of South Carolina Department of Pharmacy Services

Katherine Bliven is a Doctor of Pharmacy student at the South Carolina College of Pharmacy – MUSC Campus, Charleston, SC and is currently completing her APPE rotations with anticipated graduation in May 2015.

Kristy Brittain is Assistant Professor at the South Carolina College of Pharmacy – MUSC Campus, Charleston, SC and Clinical Pharmacy Specialist with the Medical University of South Carolina Depart-ment of Pharmacy Services in the Outpatient Pharmacies.

Corresponding Author: Kristy Brittain, PharmD, BCPS, CDE; 280 Calhoun Street, QE213C, MSC140, Charleston, South Carolina 29425; (843) 792-0050; [email protected]

better side effect profile than standard chemotherapy in patients with EGFR mutations.

Conclusion: Erlotinib is first-line for patients with advanced, recurrent, or metastatic NSCLC who have known active sensitizing EGFR mutations.

Keywords: erlotinib; Tarceva; non-small cell lunger cancer; NSCLC

Introduction Lung cancer is the leading cause of cancer-related death in the United States1. According to the National Cancer Institute, over 150,000 people are expected to die from lung and bronchus cancer in 20141. This is more than the estimated number of deaths due to breast, colon and prostate cancer combined1. Lung cancer is not only the deadliest cancer, but it is also becoming increasingly more common. Lung cancer is ranked the third most common cancer behind prostate and breast cancer1.

There are three distinct types of lung cancer: non-small cell lung cancer, small cell lung cancer, and lung carci-noid tumor2. Non-small cell lung cancer (NSCLC) is the most prevalent and accounts for nearly 85% of all cases of lung cancer2. Numerous risk factors exist for NSCLC including smoking, exposure to asbestos, radon and arsenic3. Although smoking illustrates the most positive correlation with the development of lung cancer, many cases of NSCLC have been diagnosed in both men and women without a history of tobacco smoking3. Approxi-mately 19% of females and 9% of males who present with lung cancer have no history of tobacco use4.

All cancers are staged to determine prognosis. Higher

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stages are associated with worse prognoses and there-fore more aggressive treatment regimens. The progno-sis of NSCLC varies based on tumor stage at diagno-sis1. More favorable 5-year relative survival rates exist for earlier tumor stages. Tumor staging is based on the TNM system5,6 (see Table 1).

Every type of cancer has its own classifications of staging while implementing the TMN system. The American Joint Committee on Cancer has defined NSCLC stages as illustrated in Table 25. Stage I is classified as localized. The 5-year relative survival rates for individuals who are diagnosed with localized non-small cell lung cancer is nearly 54 percent.1 The prognosis for patients diagnosed at regional and distant stages are much less optimistic. The 5-year relative survival rates for those groups are 27 percent and 4 percent, respectively1. Regional indicates that the cancer has spread to nearby lymph nodes and distant indicates the cancer has metastasized1. Stage IV is classified as distant.

Treatment of non-small cell lung cancer varies based on several factors. The most important factor is stage with surgery and radiation being the main treatments for early disease (Stage I, II, and potentially IIIa)5.

First-line treatment options for NSCLC differ based on the mutation status, histology cancer cells and patient’s comorbidities. Because of this, further molecular diagnostic studies must be performed once pathology results are provided from a biopsy or surgical excision5. Several first-line treatment approaches exist based on the results from genetic testing. A two-drug regimen consisting of carbo-platin (or cisplatin) plus paclitaxel (can substitute for gemcitabine, pemetrexed or docetaxel) if no gene mutations or arrangements are identified.5 Bevacizumab may be added to the combination for non-squamous histologies of NSCLC. Bevacizumab should not be given to patients with squamous cell NSCLC because of the risk of pulmonary bleeding.5 Four cycles of the chemotherapy are usually given to treat NSCLC.5

Several mutations exist for NSCLC. These key mutations help determine the appropriate therapy for the patient. The epidermal growth factor receptor is a receptor that is present on the surface of epithelial cells5. Over expressions and/or mutations in EGFR have been discovered in an assortment of malignan-cies, especially non-small cell lung cancer5. The most common EGFR mutations found in patients

13

Table 16: TNM Staging System for Malignant Tumors Classification T Tumor TX Tumor cannot be measured T0 No evidence of primary tumor Tis in-situ cancer (pre-cancer) T1-4 Numbers describe tumor size and/or amount it has spread

to nearby tissues; the higher the number, the larger the size/more the tumor has spread

N Node NX Nearby lymph node cannot be measured N0 Nearby lymph nodes do not contain cancer N1-3 Numbers describe the size, location, and number of lymph

nodes affected; the higher the number, the more the lymph nodes involved

M Metastasis MX Metastasis cannot be evaluated M0 No distant cancer was found M1 Cancer has metastasized to distant sites Table 26: NSCLC classifications and prognostic groups with respect to TNM system Anatomical stage/prognostic groups

Occult Carcinoma

TX N0 M0

Stage 0 Tis N0 M0 Stage IA T1a N0 M0

T1b N0 M0 Stage IB T2a N0 M0 Stage IIA T2b N0 M0

T1a N1 M0 T1b N1 M0 T2a N1 M0

Stage IIB T2b N1 M0 T3 N0 M0

Stage IIIA T1a N2 M0 T1b N2 M0 T2a N2 M0 T2b N2 M0 T3 N1 M0 T3 N2 M0

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with non-small cell lung cancer are deletions in exon 19 and a substitution in exon 215. Both of these modifications in the EGFR result in activation of the tyrosine kinase domain, which leads to uncontrolled growth of the cancer cells5. “These sensitizing muta-tions are present in about 10% of Caucasian patients with NSCLC and up to 50% of Asian patients.5” There is a notable association between exon 19 dele-tion, exon 21 substitution and response to tyrosine kinase inhibitors (TKIs).5,7, 8 These mutations are known as sensitizing EGFR mutations because they are indicative of therapeutic efficacy towards that drug class5. Multiple clinical trials have shown that patients with NSCLC who present with sensitizing EGFR mutations should be treated first-line with TKI.7, 8 Therefore, it is imperative that patients diag-nosed with NSCLC be screened for these pertinent mutations.

13

Table 16: TNM Staging System for Malignant Tumors Classification T Tumor TX Tumor cannot be measured T0 No evidence of primary tumor Tis in-situ cancer (pre-cancer) T1-4 Numbers describe tumor size and/or amount it has spread

to nearby tissues; the higher the number, the larger the size/more the tumor has spread

N Node NX Nearby lymph node cannot be measured N0 Nearby lymph nodes do not contain cancer N1-3 Numbers describe the size, location, and number of lymph

nodes affected; the higher the number, the more the lymph nodes involved

M Metastasis MX Metastasis cannot be evaluated M0 No distant cancer was found M1 Cancer has metastasized to distant sites Table 26: NSCLC classifications and prognostic groups with respect to TNM system Anatomical stage/prognostic groups

Occult Carcinoma

TX N0 M0

Stage 0 Tis N0 M0 Stage IA T1a N0 M0

T1b N0 M0 Stage IB T2a N0 M0 Stage IIA T2b N0 M0

T1a N1 M0 T1b N1 M0 T2a N1 M0

Stage IIB T2b N1 M0 T3 N0 M0

Stage IIIA T1a N2 M0 T1b N2 M0 T2a N2 M0 T2b N2 M0 T3 N1 M0 T3 N2 M0

ErlotinibErlotinib is an oral kinase inhibitor indicated in ad-vanced or metastatic non-small cell lung cancer and metastatic pancreatic cancer9. Erlotinib reversibly in-hibits tyrosine kinase activity of the epidermal growth factor receptor (EGFR).9,10 This blockade results in the inhibition of autophosphorylation of tyrosine resides associated with EGFR, which furthermore reduces tumor cell signaling, survival and proliferation (see Figure 1).9,10 Multiple studies have verified that the response of erlotinib is enhanced when exon 19 dele-tion or exon 21 L858R substitution for the wild type receptor are identified.3,5,7-10

Dosing of erlotinib varies based on its indication. See Table 3. Therapy is to be continued until disease progression or unacceptable toxicity occurs in all indications.9

There are situations when dose reductions or dose increases are indicated (see Table 4). If a patient achieves smoking cessation during treatment, the dose of ertolinib must be immediately reduced to the thera-peutic dose.10 “Concomitant use of [erlotinib] and proton pump inhibitors should be avoided. If treat-ment with a H2-receptor antagonist such as ranitidine is required, erlotinib must be taken 10 hours after the H2-receptor antagonist dosing and at least 2 hours before the next dose of the H2-receptor antagonist.”10 The most common side effects of erlotinib are rash and diarrhea. It is imperative that the patient does not discontinue the medication at the onset of rash

14

T3 N0 M0 T4 N1 M0

Stage IIIB T1a N3 M0 T1b N3 M0 T2a N3 M0 T2b N3 M0 T3 N3 M0 T4 N2 M0 T4 N3 M0

Stage IV Any T Any N M1a Any T Any N M1b

Figure 115: Erlotinib mechanism of action

Table 39:Erlotinib Dosing

Indication Dose Non-small cell lung cancer

First-line in patients with EGFR exon 19 deletion of exon 21 substitution

Maintenance therapy Refractory

150mg by mouth, once daily

Pancreatic cancer

100 mg by mouth, once daily

(in combination with gemcitabine)

Table 410: Common Dose Adjustments of erlotinib

Scenario Dose adjustment Erlotinib is used in combination with a CYP3A4 inhibitor and CYP1A2 inhibitor

Decrease erlotinib by 50mg

Severe reaction occurs when erlotinib is used in combination Decrease erlotinib by 14

T3 N0 M0 T4 N1 M0









Pancreatic cancer






Severe reaction occurs when erlotinib is used in combination Decrease erlotinib by


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or diarrhea unless instructed to do so by his health care provider. Pharmacists must properly counsel on these side effects because it is thought to be related to the efficacy of the kinase inhibitor (see Role of the Pharmacist). Other side effects include shortness of breath, fatigue, and cough.9,10 Erlotinib is classi-fied as minimal emetic potential (<10%) – however nausea, vomiting and diarrhea are still possible side effects of the medication.9 Patient should be advised to contact his health care provider if he experiences serious or ongoing gastrointestinal upset (including nausea, vomiting, diarrhea and loss of appetite), new or worsening shortness of breath including cough, eye irritation, new or worsening blistering or peeling of the skin or any changes in smoking habits.9,10 All these warnings are related to the warnings or precau-tions for the kinase inhibitor.

There currently are not any contraindications to the use of erlotinib.10 Warnings and precautions exist for the following conditions: interstitial lung disease (ILD), renal failure, hepatotoxicity with or without hepatic impairment, gastrointestinal perforation, bullous and exfoliative skin disorders, myocardial

14

T3 N0 M0 T4 N1 M0









Pancreatic cancer






Severe reaction occurs when erlotinib is used in combination Decrease erlotinib by

15

Table 410: Common Dose Adjustments of erlotinib Scenario Dose adjustment

Erlotinib is used in combination with a CYP3A4 inhibitor and CYP1A2 inhibitor


Severe reaction occurs when erlotinib is used in combination with a strong CYP3A4 inhibitor (clarithromycin, atazanavir, ketoconazole)


Erlotinib is used in combination with CYP3A4 inducer (rifampin, carbamazepine, phenobarbital, St. John’s Wort)

Increase erlotinib by 50mg at 2-week intervals to a maximum of 450mg

Concurrent cigarette smoking Increase erlotinib by 50mg at 2-week intervals to a maximum of 300mg

infarction/ischemia (MI), cerebrovascular accident

(CVA), microangiopathic hemolytic anemia (MAHA) with thrombocytopenia, ocular disorders, hemorrhage in patients taking warfarin, and embryo-fetal toxicity.10 It is recommended to discontinue the use of erlotinib in patients with interstitial lung disease, severe renal failure, severe hepatotoxicity, gastrointestinal perfora-tions, bullous and exfoliative skin disorders and ocular disorders.10 The risk of MI, CVA and MAHA are increased in patients with pancreatic cancer; therefore, the risks and benefits on the use of erlotinib in this patient population should be discussed with the patient and their medical oncologist.10 Erlotinib carries a preg-nancy category of D (positive evidence of human fetal risk but potential benefits may warrant use).9,10 Women of childbearing age must be advised of the fetal risks and counseled on the use of effective contraception.10

Erlotinib is to be taken on an empty stomach.9,10 Oral administration of this medication is to occur one hour before or two hours after a meal.9,10 Grapefruit juice should be avoided due to a potential drug interaction via cytochrome 3A4 metabolism9.


JOURNAL CEErlotinib is an oral tablet that is to be stored at room temperature of 25C (77F); excursions are permitted between 15C and 30C (59F and 86F). 9,10 This novel kinase inhibitor is classified as a hazardous agent. 9,10 Appropriate storage and handling measures must be taken in accordance to the National Institute for Occupational Safety and Health (NIOSH). Erlotinib is recommended to be stored in a glass, polyethylene or polypropylene container.11 The containers must be clearly labeled and leak-free.11 NIOSH requires that “antineoplastic (cytotoxic) wastes must be packed directly, ready for incineration, into color-coded, secure, labeled, leak-proof containers sufficiently ro-bust to withstand handling without breaking, bursting or leaking.”11

A suspension can be prepared for oral or feeding tube administration9. The preparer is to dissolve the num-ber of tablets for proper dose into 100mL of water, then rinse the container adequately to ensure 100% of the medication has been properly prepared. The aver-age cost of 30 tablets of 150mg erlotinib is $7,454.44 based on AWP and/or AAWP from Genetech USA, Inc9. This product is available under the branded name Tarceva ®.

The cobas ® Mutation Test is an FDA approved medical device used to determine patient’s eligibility for Tarceva (erlotinib).12 The automated molecular as-say examines the patient’s tumor biopsy.12 The results will indicate whether or not the two pertinent EGFR mutations are present in the NSCLC cells: exon 19 deletion or exon 21 substitution.12 Presence of either mutation indicates a high likelihood of response to erlotinib.12 It is recommended that all patients diag-nosed with non-small cell lung cancer provide a bi-opsy to undergo the cobas ® Mutation Test and there are no current contraindications to its use.3, 5, 12

Role of a pharmacistProper patient counseling on the use of erlotinib is essential. The development of a skin rash is likely to occur with the use of erlotinib. In most other medica-tion classes, the onset of a rash may indicate a serious allergic reaction. The onset of skin reactions while on erlotinib is a positive occurrence and may be indica-tive of treatment response. It is essential that phar-macists counsel patients on this and how to manage the reaction because it is likely to raise concern in the patient. In many cases, the skin reaction resembles acne.10 The rash is not acne and should not be treated as such. Product such as benzyl peroxide (commonly

used to treat acne) will worsen the rash associated with erlotinib.10 There are multiple steps that can be taken to minimize the burden of erlotinib-associated rash. First, proper skin hygiene should be initiated including cleansing the skin with mild soap products, moisturizing with alcohol-free products, and protect-ing skin from damage with sunscreen.10 Sunscreen with SPF of 30 or higher should be used daily. If a rash does develop, it is important the patient does not scratch the affected areas. This can spread and/or worsen the reaction. Taking erlotinib with food can increase the likelihood of rash development.10. Proper administration on an empty stomach can help minimize the onset of skin rash, but if the patient still experiences difficult to manage rash, advise him to see his medical oncologist. Medical oncologists can prescribe prescription products to better manage erlotinib-associated rash.

Diarrhea is another common side effect of erlotinib that patients endure. The diarrhea associated with erlotinib use can normally be managed with over-the-counter products such as loperamide. The onset of diarrhea is common in the first month of erlotinib therapy.10 It is important to counsel the patient on non-pharmacologic treatment of diarrhea such as proper hydration (at least 8 glasses of a non-caffein-ated beverage daily), eat mild foods, eat multiple small meals and snacks throughout the day rather than three large meals10. Recommend that the patient limit caffeine, tea, hot beverages, spicy foods, foods high in fiber and dairy products10. The patient should be aware of signs and symptoms of dehydration and is encouraged to keep a log of the number of times of diarrhea per day, weight loss, food and water con-sumed daily.10 The medical oncologist can prescribe a prescription product to better manage the diarrhea associated to erlotinib if self-care measures do not suffice.

Regular liver function tests, renal function tests and hydration status should be assessed while a patient in on erlotinib.9 Transaminase, bilirubin and alkaline phosphatase should be included in the liver function tests.9 Elevated ALT was a common side effect of erlotinib in the OPTIMAL trial (see Clinical Contro-versy).7 Creatnine and BUN are markers of kidney function and hydration status, respectively. Pharmacists are patient advocates and therefore, they should be the person to ensure adequate insurance


JOURNAL CEcoverage of the medication. Erlotinib should be cov-ered if the patient tests positive for NSCLC whose tumor presents with an exon 19 deletion or exon 21 substitution in the EGFR. It is important to note that all insurance policies differ, but proper coverage must be verified prior to the start of treatment due to its high cost.

Pharmacists also must inform their staff of proper stor-age and handling of the product. Erlotinib is classified as a hazardous substance and must be handled as such. Proper MSDS (material safety data sheet) sheets must be available to employees and training should be of-fered. Several medication safety issues exist with this class of medication. Erlotinib is also a sound-alike-look-alike medication.9 Therefore, proper labels and storage must be implemented in the pharmacy. In addi-tion, erlotinib is classified as a high alert medication.9 “This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.”9

Clinical controversyEarly clinical trials failed to show a survival benefit of erlotinib when used in NSCLC. These primary trials such as the TALENT trial and TRIBUTE trial did not select patients based on EGFR mutation status.13, 14 Multiple phase-3, randomized trials have been per-formed since the sensitizing EGFR mutations were discovered. The first head-to-head phase-3 prospec-tive study analyzing erlotinib in patients with positive EGFR mutation status was the OPTIMAL trial. The OPTIMAL trial concluded that patients with advanced EGFR-positive NSCLC who were treated with erlotinib had a longer survival period with tolerable side effects compared to those treated with conventional therapy (gemcitabine plus carboplatin).7 OPTIMAL was a mul-ticenter, open-label, randomized phase-3 study based out of China.7 It reinforced the importance of proper routine EGFR mutation testing in advanced non-small cell lung cancer. Neutropenia, thrombocytopenia, nau-sea/vomiting, and fatigue were all significantly more pronounced in the chemotherapy group.7 Rash and in-creased alanine aminotransferase (ALT) concentration were the two most common adverse effects within the erlotinib group.7 The National Comprehensive Cancer Network (NCCN) Guidelines reflect the conclusion of the OPTIMAL trial.5 Erlotinib is first-line for patients with “advanced, recurrent, or metastatic NSCLC who have known active sensitizing EGFR mutations.”5

References1. SEER Stat Fact Sheets: Lung and Bronchus Can-cer. National Cancer Institute. Seer.cancer.gov/statfacts/html/lungb.html. Accessed May 7, 2014.2. Lung Cancer. American Cancer Society. http://www.cancer.org/cancer/lungcancer/index. Accessed May 7, 2014.3. Peters S, Adeji AA, Gridelli C, et al. Metastatic non-small-cell lung cancer (NSCLC): ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Annals of Oncology 23 (Supplement 7): Vii56-vii64, 20124. Wakalee HA, Chang ET, Gomez SL et al. Lung cancer incidence in never smokers. J Clin Oncol 2007; 25: 472-478.5. NCCN Clinical Practice Guidelines in Oncol-ogy: Non-small cell lung cancer. National Comprehensive Cancer Network. http://www.nccn.org/professionals/physi-cian_gls/pdf/nscl.pdf. Accessed May 7, 2014.6. Lung Cancer Staging. American Joint Committee on Cancer. http://cancerstaging.org/references-tools/quick-references/documents/lungmedium.pdf. Assessed May 14, 2014.7. Zhou C, Wu Y, Chen G, et al. Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicenter, open-label, randomised, phase 3 trial. Lancet Oncol 2011; 12: 735-42.8. Rosell R, Carcereny E, Gervais, et al. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicenter, open-label, randomised phase 3 trial. Lancet Oncol 2012; 13: 239-46.9. Lexi-Comp OnlineTM, Hudson, Ohio: Lexi-Comp, Inc.; May 7, 2014. 10. Tarceva [package insert]. Genentech, Inc., 2004. http://www.gene.come/download/pdf/tarceva_prescribing.pdf. Accessed May 8, 2014.11. Erlotinib-d6, Hydrochloride Salt. MSDS. http://datasheets.scbt.com/sc-218329.pdf. Accessed May 11, 2014. 12. Medical Devices. US Food and Drug Administra-tion. http://www.fda.gov/medicaldevices/productsandmedi-calprocedures/deviceapprovalsandclearances/recently-approveddevices/ucm352932.htm. Assessed May 14, 2014. 13. Herbst R, Prager D, Hermann R, et al. TRIBUTE: A phase III trial of erlotinib hydrochloride (OSI-774) combined with carboplatin and paclitaxel chemotherapy in advanced non-small-cell lung cancer. J Clin Oncol 2005; 23(25):5892-5899.14. Gatzemeier U, Pluzanska A, Szczesna A, et al. Phase III study of erlotinib in combination with lung can-cer investigation trial. J Clin Oncol 2007; 25 (12):1545-1552. 15. Tarceva – erlotinib tablets. www.tarceva.com/patient/advanced-stage-non-small-cell-lung-cancer/how-tarceva-works. Accessed May 14, 2014.


Self-assessment questions:

1. Which of the following is the most appropriate dose of erlo-tinib for NSCLC? a. 150 mg by mouth twice daily with meals b. 150 mg by mouth once daily with meals c. 150 mg by mouth once daily one hour before or two hours after a meal** d. 150 mg by mouth twice daily one hour before or two hours after a meal 2. Which of the following is the most accurate conclusion of the OPTIMAL trial? a. Erlotinib was superior to conventional therapy in both EGFR-positive and EGFR-negative patients with NSCLC b. Erlotinib was superior to conventional therapy in EGFR-positive patients with NSCLC** c. Erlotinib was inferior to conventional therapy in both EGFR-positive and EGFR-negative patients with NSCLC d. Erlotinib was inferior to conventional therapy in EGFR-positive patients with NSCLC

3. A 36 year-old female was recently diagnosed with stage IV metastatic NSCLC. Tumor tissue was tested for EGFR and ALK mutation and found to be negative. She is treatment naïve and has no known drug allergies. What dose of erlotinib should be started in this patient? a. 150mg by mouth once daily one hour before or two hours after a meal b. 150mg by mouth once daily with mealss c. It is not appropriate because no ALK mutation was identifiedus d. It is not appropriate because no EGFR mutation was identified**

4. Which of the following side effects are the least likely to occur in patients on erlotinib? a. Diarrhea b. Rash c. Thrombocytopenia** d. Nausea

Additional Questions On Reverse

JOURNAL CEHOPE IN A BOTTLE FOR NSCLC: ERLOTINIB Corresponding Course Program Number: 0171-9999-14-103-H01-P 1. Complete and mail entire page. SCPhA members can take the Journal CE for free; $15 for non-members. Check must accompany test. You may also complete the test and submit payment online at www.scrx.org. 2. Mail to: Palmetto Pharmacist CE, 1350 Browning Road, Columbia, SC 29210-6309. 3. Continuing Education statements of credit will be issued within 6 weeks from the date the quiz, evaluation form and payment are received. 4. Participants scoring 70% or greater and completing the program evaluation form will be issued CE credit. Participants receiving a failing grade on any examination will have the examination returned. The participant will be permitted to retake the examination one time at no extra charge.

South Carolina Pharmacy Association is accredited by the Accreditation Council for Pharmacy Education as providers for continuing pharmacy education. This article is approved for 1 contact hour of continuing pharmacy education credit (ACPE UAN: 0171-9999-14-103-H01-P). This CE credit begins 12/04/2014 and expires 12/04/2017. CE credits will be uploaded to the CPE Monitor System.

Name License # Birth Month/Day (MM/DD)

Address

NABP eID Phone Email

EVALUATION (circle the appropriate response)

1. Did the article achieve the stated objectives? (Not at all) 1 2 3 4 5 (Completely)

2. Overall evaluation of the article? (Poor) 1 2 3 4 5 (Excellent)

3. Was the information relevant to your practice? (No) 1 2 3 4 5 (Yes)

4. How long did it take you to read the article and complete the exam? CE credit will ONLY be awarded when a submitted test is accompanied by completing the evaluation above or online at www.scrx.org.


5. A 47-year-old male was diagnosed with metastatic NSCLC three weeks ago. The tumor tissue was found to be positive for EGFR mutation (exon 19 deletion). Erlotinib 150mg daily was started at that time. The patient presents to your pharmacy today and complains of worsening rash on his face, upper back and shoulders. You notice that the rash resembles acne. What is the most appropriate recom-mendation for the patient? a. Start an OTC product such as benzyl peroxide or salicylic acid b. Start cleansing his skin with a mild soap and moisturizing with alcohol-free products** c. Discontinue erlotinib because patient is experiencing a hypersensitivity reaction d. Take erlotinib with food to decrease the severity of the rash

6. A 58-year-old man with refractory NSCLC presents to your pharmacy. He has been on erlotinib 300mg for 9 weeks with adequate response. Patient denies any side effects. His past medical history includes hypertension x 10 years, dyslipidemia x 5 years, and smoking 2ppd x 30 years. His medications include lisinopril 20mg and atorv-astatin 10mg. The patient states he recently quit smoking and has not smoked a cigarette in 2 weeks. The dose of erlotinib: a. Must be immediately reduced to therapeutic dose of 150mg daily** b. Must be increased by 50mg in 2-week increments to a maximum of 400mg daily c. Must be reduced by 50mg in 2-week increments to 100mg daily d. Is not affected by cigarette smoking

7. A 71-year-old man with stage IV NSCLC presents to your pharmacy. His past medical history includes type-2 diabetes, dyslipidemia and hypertension. His current medications include erlotinib (x 3 weeks), metformin (x 10 years), atorvastatin (x 8 years) and lisinopril (x 12 years). The patient has dry mucus membranes, is lethar-gic and thirsty. Patient states that he has had 6 episodes of diarrhea in the last 48 hours. What is the least appro-priate recommendation? a. Drink at least 8 glasses of caffeinated beverages per day** b. Limit the amount of spicy food, dairy and fiber consumed c. Take loperamide as needed – 4mg initially, followed by 2mg after each loose stool, up to 16 mg/day d. Keep a log of the number of times of diarrhea per day, weight loss, food and beverages consumed

JOURNAL CE

GAMECOCK/USC MERCHANDISEOfficial collegiate licensed merchandise for sale. T-shirts, car flags, tailgate gear. All de-signed by a SC Pharmacist. Please email Daniel Bundrick at [email protected] or call/text 803.603.8622. Original designs, unique, edgy new designs too. Also look for our two mobile stores, our huge vans that go to events and football games. Check us out online at www.carolinagamecocktees.com STORE FIXTURES/PLANNING

Planning to expand, remodel or open a new pharmacy? Since 1973 Display Options, Inc. has provided professional store planning, In-stallation, quality store fixtures and customer service to Pharmacies across the Southeast. Please allow us the opportunity to assist you with your plans & dreams. Call us toll free at (800)321-4344 or visit our web site at www.displayoptions.com.

TRANSFORMING THE SOUL OF PHARMACY, BY MINISTERING TO THE

HEARTS OF PHARMACISTSChristian Pharmacists Fellowship International, a nonprofit organization, is a worldwide fellow-ship of individuals working in all areas of phar-maceutical services and practices. For member-ship information, call (888) 253-6885 or visit our website at www.cpfi.org.

FOR SALENEED HELP WITH MEDICATION

THERAPY MANAGEMENT?Contact: Bryan Ziegler, PharmD, MBA, Pharmacy Service Consulting, LLC Phone: (803) 269-6333 Email: [email protected] Provided: MTM education, Identifi-cation of MTM Opportunities, Staff Training, Workflow Analysis, Business Analysis

PHARMACY OPERATIONS CONSULTANTPharmacists interested in changing you existing design and operation of your pharmacy - let the best in the business help you make those changes. Contact: Paul J. Hyer, Jr., RPh, PD at 843-814-2542 or write to 301 S. Magnolia St. Summerville, SC 29483.

PHARMACIST SEEKING EMPLOYMENTSouth Carolina Licensed Pharmacist would like to work in an independent pharmacy, prefer small-town setting. Tim McKittrick 704-585-6690

FOR SALE: MORTAR AND PESTLESSet of 8 Schering Pharmaceutical Corporation commemorative bronzed-like metal mortar and pestles, dated from the late 1960s and 1970s. They have been on display in our independent pharmacy in Florence, SC for over 40 years. We know those who are familiar with these will appreciate them and want them for their collections. They are all about 4 inches tall by 4 inches wide. They are in good condition. Call 843-992-0981 with offer, plus $30 ship-ping. Nights and weekends call 843-669-7439 or email [email protected]

RELIEF RPh

Services

RELIEF PHARMACIST AVAILABLEExperienced (retail, clinic, consulting, nursing home)pharmacist available on PRN or regular basis. Will travel. Competitive Rate. M-F, oc-casional Sat. JOHN W. OWEN, [email protected], (H)803-783-2979 (C)803-466-4783

ETC.

FOR SALE: OWENS ILLINOIS PROMOTIONAL CHINA

Owens Illinois Promotional China, glass ware and “silver” cutlery. About 85 assorted pieces. Please e-mail me at [email protected] if you are interested. I can send you a list if you wish. Ralph Wilkie, 843-884-5751

CLASSIFIEDS

BEACH HOME FOR SALE OR RENTPawley’s Island Beachhome - 5 Bedroom and 5 Baths. Beautiful view on the creek with eleveator. For sale or rent. Checkout [email protected].

FOR SALE: ROBOTFor sale: Innovation PharmASSIST Robot X automated dispensing system. Any inquiries should be directed to Kenneth Mungin, Phar-macy Manager at (803) 731-0203 Ext 126 or at [email protected].


BOOKS FOR SALEChristian Book Available at Amazon, Barnes and Noble, and etc. It is Called Choices ( The secret to Making Wise Choices) by Carolyn Gault wife of pharmacist Horace Gault Jr. The book is about our moments in history as we face choices that are confusing, in out rapidly changing culture. The proceeds will go to Mission to the World to help missionaries and their families.

OXYGEN EQUIPMENT18-Portable oxygen cylinders, 1 devilbiss oxygen conservator, 1-5 liter concentrator invacare, 7-oxygen regulators,1-Salter labs ul-trsonic oxygen indicator. Call 864-843-9207, liberty family pharmacy $400

♦ South Carolina Board of Pharmacy/licensing matters

♦ Corporate legal counsel specific to pharmacies including purchase and sale

♦ OBRA-90 and South Carolina patient counseling requirements

♦ HIPAA and related privacy issues

♦ Third Party issues including pharmacy benefit managers

♦ Medicaid audits

♦ DHEC and DEA/controlled substances

♦ Risk management

♦ Pharmacy Technicians

♦ Federal compliance

Jon A. Wallace, B.S.Pharm., J.D.

602 Rutledge Avenue ♦ Charleston, SC 29403 ♦ (843) 266-2626 ♦ [email protected]

715 King Street, Charleston, SC 29403 • Direct Dial (843) 266-2625 • [email protected]


“Thanks to QS/1, we’ve become much more efficient. It helped us get ahead of managed care and has enabled us to increase our inventory turns from 12 to 36 times a year. Its reports provide great documentation and let me know what payer plans are working for us. Our customers benefit because it reduces their visits and helps them manage their medications more effectively. It also enables us to review the cost effectiveness of their medications each month for opportunities to reduce their out of pocket expenses.”Learn how QS/1 can help maximize your pharmacy’s performance. Call 866.929.9067 or visit www.qs1.com today.

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