the georgia pharmacy journal: july 2010

The Georgia Pharmacy Journal July 20102

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F E A T U R E A R T I C L E S

11 2010 Legislative Session Recap

12 APhA Immunization Program

13 Congratulations to the University of Georgia Graduates

17 Why Kroger Pharmacist Marsha Kapiloff Backs Pharm PAC

18 Congratulations to the Mercer University Graduates

19 Congratulations to the South University Graduates

21 CPE Opportunity: New Drug Update 2010

C O L U M N S

4 President’s Message

9 Editorial

For an up-to-date calendarof events, log onto www.gpha.org.

42010-2011 GPhA President’s

Inaugural Address

Departments14 GPhA New Members31 GPhA Board of Directors

Advertisers2 The Insurance Trust2 Principal Financial Group5 Melvin M. Goldstein, P.C.9 Logix, Inc.10 AIP11 Michael T. Tarrant14 Design Plus Store Fixtures, Inc.15 Pharmacists Mutual Companies16 GPhA Workers Compensation17 Toliver & Gainer32 The Insurance Trust

P R E S I D E N T ’ S M E S S A G E


First, I would like to thank you for allowing me theopportunity to serve as your next president. I have hadthe privilege of serving with some outstanding leaders

of our profession on the Executive Committee the past threeyears. This Executive Committee has a lot of experiencefrom which to draw. I have learned so much from mypredecessors. Eddie M. Madden, R.Ph., has given me abetter understanding of the political process. Robert C.Bowles, Jr,. R.Ph., CDM, CFts, has taught me that youhave to learn to ask the right questions, and in Sharon M.Sherrer, Pharm.D., CDM, I was able to observe first handher passion and love for her profession and for thisassociation.

I would also like to thank Jim Bracewell for his leadership,both on the state and national level. The thing I admire mostabout Jim is the way he has raised the bar for transparency inour organization. I look forward to serving with Jack DunnJr., R.Ph., Robert M. Hatton, Pharm.D., and our newSecond Vice President and hope I can be the mentor to themas our past presidents have been for me.

I could not have committed to do what I have done over thepast three years without a great pharmacy staff. They havecarried the load when I’ve been away on association businesswithout missing a beat. So, thanks Kathy, Chris, Hollie,Kelly, David, John, Gigi, and Sarah. I sincerely appreciatetheir dedication and hard work. I would also like to thankDevera Moeller who helped to make a smooth transitionwhen we opened our compounding pharmacy. And a specialthanks to my long time friend and former business partner,Larry Wilson, who was diagnosed with liver cancer just overtwo years ago. Larry, I could not have realized my dream

without you. You have been like a brother to me. You willalways be in my heart.

Lastly, I would like to thank my family. My mom and dadcould not be at the Convention, but I want to thank them forlaying a solid foundation of principles and work ethic thathas made such a profound impact on all their children. Theirvalue system and love of family has now been extended tothree generations.

Now, I want to recognize my immediate family. Mydaughter, Laura Coker, who many of you already know, justfinished her third year of pharmacy school at MercerUniversity and is now doing her rotations.

Scott will be entering his third year at the University ofGeorgia this fall and is currently counseling at a Christiansummer camp in Dahlonega. He was able to get a 24-hourfurlough in order to attend my inauguration. What a blessingyou two have been in my life. Watching both of you matureinto the people you have become is the greatest reward aparent can have. I am so proud of both of you!

And last, but certainly not least, I would like to thank mywife, Susan. We will be celebrating our thirty-fourth weddinganniversary in August. When I have needed support, youhave always been right there. When I decided to start myown business, even though you probably thought I wascrazy, you stood by me, and supported me, literally. Thenwhen I went two years without a paycheck, you had reasonto believe I was crazy, but you never complained and alwayshad encouraging words. Thank you, honey, for always beingthere for me and always loving me. I would certainly not bewhere I am today without you. I love you.

Dale M. Coker, R.Ph., FIACP

GPhA President

2010-2011 Inaugural Address

5The Georgia Pharmacy Journal July 2010

From my all time favorite movie came this question, “Mama,what’s my destiny?” In the grand scheme of things, ForrestGump wanted to know where he fit in. As we begin a newchapter of health care in this country, we as a profession willneed to find our place. Where will we fit in? So, here, I willask the questions of our profession and our association,“What is the destiny of our profession and our association?”And, on a more personal note, “What are we, individually,willing to do to help shape that destiny?” I have chosen thetheme “Pharmacy Forward: Dispensing Destiny” for my yearas president.

The graphic for the theme on the cover of this issue of theJournal depicts the past and present of our profession. Thescales and the show globe represent the roots of ourprofession, which was compounding, something that is nearand dear to my heart. Compounding is an art that we almostlost through neglect, and is something we must strive tomaintain and defend, as it is our very heritage. The DNAstrand represents the future of pharmacy andpharmaceuticals. This depiction shows the DNA strandoverlapping the mortar & pestle. As compounding hasalways represented individualized care, I believe that as moreand more drugs are genetically engineered, there will onceagain be a greater emphasis on individual approach to

treatment with drugs. The question mark represents the roleof pharmacy in the future. How will we position ourselves totake advantage of the opportunities that will be afforded tous in health care reform and the new age of pharmaceuticals?Will we be ready, or will many of us dispense ourselves out ofexistence?

The dispensing function has more or less defined thepharmacist’s role in health care. If there is any doubt aboutthis, just watch the evening news when a pharmacist isinterviewed (in Atlanta, of course, that would be Ira Katz,R.Ph.). What does the camera man always zoom in on?That’s right, the pharmacist counting pills from a countingtray.

The word “dispense” can have a couple of differentmeanings. The one we are familiar with in our profession is“to prepare and give out.” But to “dispense with” means “toforgo or manage without.” It is my belief that the future ofour profession hinges on our willingness to “dispense with,or manage without,” the traditional dispensing function.

We must move pharmacy forward by championing the idealof dispensing our knowledge and our service instead ofdispensing a product.

As we look to that future of our profession, it is wise to take astep back and look at where we are now, but also wherewe’ve been.

Friedrich Nietzche said “The most fundamental form ofhuman stupidity is forgetting what we were trying to do inthe first place.”

Well, what was this association trying to do in the first place?You need not go any further than our website to find out.Just click on history and here is what you will find:

“In the summer of 1875, a concerned group of Georgiapharmacists sent a notice to all the pharmacists of thestate, requesting them to assemble in Macon on October 20,1875:

“...to consider the organization of a pharmaceuticalassociation, binding each other with closer ties of friendshipand to promote interest in the junior members of thefraternity and exciting the spirit of emulation and ambition;the interchange and dissemination of scientific researches;the framing of laws to be enacted that will result not only inthe protection of the profession but the public in general.”


The first thing I would like to ask “How are we ‘...aconcerned group of Georgia pharmacists?’”

Our pharmacist legislators and our lobbyists talk aboutgrassroots efforts all the time. This is where it all begins. Aspharmacists we must be concerned about decisions thataffect the future of our profession. I remember when JimBracewell called me just over three years ago to encourageme to run for Second Vice President of GPhA. I told himthat I was concerned that as a compounding pharmacist, myissues in the profession would not reflect the vast majority ofour membership. Jim reminded me of the one thing I didhave that would serve me well in representing thisassociation. That one thing is passion for the profession.Concern and passion for the direction of our profession iswhat we must have to ensure our future.

How would we assess ourselves in carrying out theorganizational objectives of our association? First, howhave we done with “...binding each other with closer tiesof friendship?”For me, this has been the most rewarding aspect in myassociation with GPhA. It is the one thing that stands out as Ihave met and talked with pharmacists around the state overthese past three years. What about our membership? Are weoffering networking opportunities that are effective intoday’s world, both socially and professionally?

At this time last year, President Eddie Madden had theforesight to begin the process for a five year strategic plan forour association. Last October, pharmacists representingevery facet of pharmacy and pharmacy school students cametogether to form the framework for a strategic plan. The planwas adopted by our Board of Directors in January of thisyear. There are two key elements of the plan, membershipand advocacy.

It was decided that we must begin by engaging ourmembership and proving the value of membership in GPhA.Strategic directives were identified to attain a twenty percentincrease in our membership over five years. This year, theExecutive Committee will be developing a strategic planscorecard to evaluate and improve the plan to achieve ourgoal.

Let’s take a look at the next organizational objective.How would we assess where we are with “...promotinginterest in the junior members of the fraternity?” There are roughly 76 students at the Convention who havebeen sponsored by many of you in this room. I think we havedone an exceptional job in promoting student participation

at the Convention, but are we engaging them throughout theyear? And how do we keep student members engaged oncethey graduate? How are we using the latest in technology tokeep them engaged? Kelly McLendon is to be commendedfor her work in engaging students and new practicingpharmacists through avenues such as an electronic Journaloption and Facebook. Personally, I was very reluctant at first,but with the help of my children, I took the giant step ofsigning up for Facebook.

One of the very first messages I got once I had some picturesposted with my family, was a message from a young manwho said, “Parents, they’re taking over Facebook.” What awelcome into the brave new world of Facebooking.

For me personally, one of the most rewarding aspects ofbeing on the Executive Committee, has been participating inthe New Practitioner’s Leadership Conference each year. Weneed to continue to place more and more emphasis inrecognizing and grooming potential leaders in ourprofession.

How would our association be assessed on “...excitingthe spirit of emulation and ambition?”Now, I’m sure most of you bright pharmacy students goingfor your doctorate degree know what “emulation” means. Asfor me, being just an ordinary R.Ph., I had to look it up.Webster’s defines “emulation” as “ambition or endeavor toequal or excel others.” And I will repeat that… “...ambitionor endeavor to equal or excel others.”

One of GPhA’s tag lines is “A tradition of excellence.” As Ihave traveled around the country to meet withrepresentatives of other state associations, in comparison, wetruly do excel in many areas including leadership,membership, political involvement, but the pursuit ofexcellence never ends. Once it does, the Georgia PharmacyAssociation begins to die. The pursuit of excellence requiresa team effort, avoiding factions that separate and divide.

In some states, the independent pharmacies have formedtheir own associations. And in others, there is littlecooperation between the hospital pharmacists associationsand the state associations. In Georgia, the Academy ofIndependent Pharmacy stands in 100 percent support of theparent organization. I applaud the leadership of AIP for theirdiligence in adopting new by-laws in accordance with themission of GPhA. Also, GPhA and GSHP have made greatstrides in the past few years to work together for thecommon good of our profession and our patients.


As far as our individual members, how have we done toequal or excel others?The list is a long one indeed. Eddie Madden was recentlyhonored with APhA’s Hubert Humphrey award. John T.Sherrer, R.Ph., is Second Vice President of the NationalCommunity Pharmacists Association. Hugh M. Chancy,R.Ph., was named NCPA’s pharmacist of the year in 2009,and was recently inducted as Fifth Vice President of NCPA,and Jonathan G. Marquess, Pharm.D., CDE, CPT, is acandidate for APhA’s Board of Trustees.

I hesitated to name names, for fear of leaving someone out,but the list of leaders in our profession, in our pharmacyschools, in our legislature, and in our communities and localgovernments is truly impressive. All of you need to becommended for your dedication and service.

How about “...interchange and dissemination ofscientific researches?” How would we assess where weare?We now have continuing pharmacy education requirementsthat they didn’t have in 1875, yet those pharmacists wereinterested in sharing information and staying current in theirpractices.

I believe this is the greatest opportunity for growth in ourassociation. Are we providing timely continuing pharmacyeducation geared to the needs of the different practicesettings? Should there be a requirement for live C.P.E.?Should we seek greater involvement from the pharmacyschools to publish research articles in our Journal? Should weredefine the purpose of our Region Meetings to includemore C.P.E.? All questions that I will be seeking answers forduring the coming year.

We will continue to explore continuing pharmacy educationopportunities in some fun and exciting venues, such as aColorado ski trip which was offered in January and theupcoming Alaskan Cruise in August. There is still time tosign up. I hope many of you will join us. I hope you will alsotake advantage of the many continuing pharmacy educationopportunities we will be offering in the future. We wantGPhA to be “The Source” for continuing pharmacyeducation for our membership.

I applaud the action of our State Board of Pharmacy inrequiring three hours of disaster preparedness continuingeducation. This came about largely as a result of the GeorgiaComposite Medical Board and the Georgia Division ofPublic Health recognizing the importance of pharmacists asvaluable members of the health care team who are

positioned to provide critical care in the event of a local ornational public health disaster. Jean Sumner, M.D.,immediate past president of the Medical Board, commentedthat pharmacists are the most over educated and under-utilized health care professionals in the state. Over-educatedand under-utilized: isn’t that a stigma that we would rathernot have associated with our proud profession? Well, gettingout front in responding to a public health disaster could go along way toward doing just that.

And lastly, how have we done with “...the framing of lawsto be enacted that will result not only in the protection ofthe profession but the public in general.”Again, referring to the five year strategic plan beingimplemented this year, the two major initiatives identifiedwere membership and advocacy. The political cry, “get intopolitics, or get out of pharmacy” applies more now than everbefore. We must remain on the offensive to protect andpreserve our profession but we must also be on thedefensive. Sometimes our greatest successes are the bills thatnever become laws. They say that in football, defense winsgames. The same can be said about the legislative process.This is part of the planning each year, to develop a defensiveposture against legislation that would be detrimental to theprofession of pharmacy.

We have had some huge successes the past two years. Two ofthe biggest were passing legislation giving us legal authorityto administer flu vaccines under protocol and most recently,requiring Pharmacy Benefit Managers to register with theInsurance Commissioner.

As big as these successes were, neither got us where we needto be, but as Stuart Griffin has often told us about strategy:sometimes we have to take what we can get in the legislatureto get a foot in the door and start with a solid foundation.Now that the door has been opened, we can build on thefoundation to the ultimate goal of administering anyvaccination without protocol and PBM transparency. Thisstrategy has served us well in the past two legislative sessions,and I believe it will continue to serve us well as we stay thecourse.

As I have contemplated the current state of our professionand my question about the destiny of pharmacy in Georgia, Isee a lot of positives. Many of them I have alreadymentioned. We are highly respected across the country as adynamic and innovative association. We have a lot going forus, but we can’t rest on our laurels.


As much as many of us love the traditions of our association,we can’t continue with the attitude that we have to do thingsa certain way because that’s the tradition, and that’s the wayit was always done. Sometimes holding onto tradition cankeep us from changing with the times. I am a firm believerthat tradition and change can peacefully coexist.

One of the major challenges we face as an organization is tocontinually seek out and engage those who are apathetictoward issues that affect the future of our profession, or whoare just too busy to care.

Arnold Toynbee said, “Apathy can be overcome byenthusiasm, and enthusiasm can only be aroused by twothings: first, an ideal, which takes the imagination by storm,and second, a definite intelligible plan for carrying that idealinto practice.”

The two key words here are ideal and plan. I believe the idealis for pharmacists to be recognized, both professionally andfinancially, for the services we provide to our patients, ratherthan the products we dispense.

So what is our plan for achieving this ideal? Our associationhas undertaken a strategic plan that emphasizes advocacy forour profession. We need a strong PAC, an organizedgrassroots effort and effective lobbying to effect the changesto put our ideal into practice. Such was the case in passing ofthe Safe Medications Practice Act, a bill which wasintroduced by Rep. Ron Stephens, R.Ph., in the House,carried by Sen. E.L. “Buddy” Carter, R.Ph., in the Senate,and championed by Burnis D. Breland, B.S., FASHP,M.S., Pharm.D.

This bill codifies the importance of the pharmacist’sinvolvement in medication therapy management(MTM).This bill also codifies the importance of collaborationbetween the pharmacist, physician and other clinicalpractitioners in the institutional setting.

Are we ready for such an ideal in the community pharmacysetting, where pharmacists would have greater involvementin health care decisions, such as ordering tests andinterpreting test results, making appropriate dosage changes,and monitoring anti-coagulant therapy under protocol? Howabout a third class of drugs or limited prescriptive authority?How far do we want to expand our scope of practice?

I believe that we have perpetuated the notion that we aredispensers of medication rather than providers of services.Now, more than ever before, we are in a position to change

that perception. We have opportunities offered us throughavenues such as MTM. It is time for pharmacyreimbursement to be based on patient care performance andoutcomes. With health care reform, like it or not, we will bechallenged to perform. We must take advantage of theseopportunities if we want to change the perception of ourprofession from the dispensing mode to the professionalhealth care provider mode.

A new generation of pharmacists is coming out of pharmacyschools equipped for pharmacy care services. Our pharmacyschools have done an outstanding job of preparing our futurepharmacists through study, experiential learning, and serviceto the community. As employers, we must ensure that thesebright young pharmacists are given the opportunity todisplay their skills in providing pharmacy care services.

Albert Schweitzer said, “I don’t know what your destiny willbe, but one thing I know: the only ones among you who willbe really happy are those who will have sought and foundhow to serve.”

It has been the mindset of pharmacists for many generations,to serve their patients and their communities.

To quote from my favorite book, the Holy Bible, Proverbs17:11 says “A merry heart doeth good, like a medicine.” Truefulfillment in our profession comes from serving our patientsand their needs.

I would like to close with another quote from AlbertSchweitzer. “An optimist is a person who sees a green lighteverywhere, while a pessimist sees only the red stoplight...the truly wise person is colorblind.” May we all be colorblindin our pursuit to move pharmacy forward as we DispenseOur Destiny.

E X E C U T I V E V I C E P R E S I D E N T ’ S E D I T O R I A L

Jim Bracewell

Executive Vice President / CEO


Ihave always been inspired by those words and thespirit of John Paul Jones. What a patriot. What a loverof America. What an inspiration to all of us as we

celebrate our nation’s birthday this month.

I respect Jones so much that I sought out and visited histomb in the basement of the United States NavalAcademy Chapel in Annapolis, Maryland. It is guarded24/7 by an armed Marine. What honor and love they havefor Jones. But, enough of my emotion driven commentson history. What I want to ask you, the pharmacists of theGeorgia Pharmacy Association, is, “Have you yet begun tofight?”

This year in our state we have a watershed event. A perfectstorm if you will, that can change health care and morespecifically pharmacy in our state for years to come. Thisyear we elect a new Governor. This year we elect a newInsurance Commissioner. This year we elect a newAttorney General. This year there is a new beginning forpharmacy in Georgia.

Like John Paul Jones, pharmacy has been out gunned bythe bigger ships of Pharmacy Benefit Managers. Pharmacyhas been out run by insurance companies. Pharmacy hastoo long been on the menu of health care reform ratherthan at the table. In this issue we rolled up our sleeves andlike John Paul Jones, we took their ships. We passed sixpro- pharmacy pieces of legislation. We helped elect apharmacist to the Georgia Senate. We stopped all negativepharmacy legislation, and we “...have not yet begun tofight...” for pharmacy in our state. We are ready, more thanever, to challenge all those who challenge this profession.

What can you do to assure our continued success? Youcan become politically active. GPhA is determined not tolet the government put pharmacy out of business. GPhA is determined not to let the unregulated practices ofPBMs put pharmacy out of business. GPhA Pharm PAC isour source for ammunition for the guns of GPhA. Are yousending ammunition to GPhA for the fight? Are you amonthly contributing member to Pharm PAC? We canonly fight for you with the ammunition you give us.

Go to the GPhA website www.gpha.org today or call KellyMcLendon and 404-419-8116 and “Back Pharm PAC!” –Pharm PAC needs your help like you need GPhA’s help.

“I Have Not Yet Begun to Fight.”~John Paul Jones

Do you want to work for anIndependent Pharmacy?

Do you want to own your ownpharmacy?

Call Jeff Lurey, R.Ph.AIP Director404 419 8103

[email protected]

Upcoming AIP Events Save the Date:

AIP Fall Meeting Sunday, September 12, 2010

Macon Marriott & Centreplex, Macon, GA


F E A T U R E D A R T I C L E

2010 Legislative Sessions Recap

Many of you are wondering whyGPhA is putting the legislativerecap in the July Journal. Many

of you remember how disappointed wewere when the Governor decided to vetothe PBM bill in May of last year that weworked so hard to pass. This year GPhAwanted to give the Governor ample timeto sign our bills. GPhA appreciates theGovernor’s positive response to all pro-pharmacy legislation that was passedduring the 2010 legislative session.

The Executive Vice President of GPhA.Jim Bracewell, mentioned the other daythat he cannot remember a year in thehistory of GPhA, nor can he think ofanother state pharmacy association thathas had such a run passing pro-pharmacylegislation as Georgia during the 2009-2010 legislative term.

Below is a list of what GPhAGovernment Affairs has accomplishedover the 2009-2010 legislative term.

HB217 & HB1154In 2009, GPhA passed HB217 thatallowed pharmacists to administer the

influenza vaccine via injection through aphysician protocol. During the 2010session we came back and extended theprotocol in HB1154 to allow influenzavaccine to be given via nasaladministration (Flu-Mist).

HB368 & SB353HB368 and SB353 are the drug updatebills that pass the General Assemblyevery session to update the drugschedules accordingly. This type oflegislation doesn’t take much to pass, butwe have had the ability to stop any antipharmacy amendments that attempted tomake their way onto these bills.

SB195As e-prescribing becomes moreprevalent, there are certain things that arenot consistent with the way Georgia codeis written concerning prescribing ingeneral. Two of these inconsistenciesthat dealt with a physician’s digitalsignature and the notation of “BrandNecessary” written digitally opposed toin the physicians own handwriting, havebeen fixed via SB195.

HB361HB361 was introduced during the 2009Legislative Session by Rep. RonStephens. HB361 specifically focuses onpharmacy practiced in an institutionalsetting. The bill codifies the importanceof the pharmacist’s involvement inmedication therapy management. HB361also codifies the importance of thecollaboration between the pharmacist,

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physician and other clinical practitioners.

Although the bill only pertains topharmacists in an institutional setting,the bill is very important for the practiceof pharmacy as a whole as it recognizespharmacists as highly trained medicationtherapy experts and as vital componentsin the welfare of their patients.

SB310This year was a success with GPhA’snumber one priority of PBM regulationfinally passing the Georgia GeneralAssembly. On June 2, 2010, theGovernor signed this bill into law. SB310becomes effective January 1, 2011, andrequires all PBM entities that operate inthe State of Georgia to be licensedthrough the Department of Insurance.

SB310 was used as a vehicle to passlegislation that reduced the barriers ofentry for MEWA insurance plans. As youknow, GPhA owns the only MEWA inthe state of Georgia. The new languagerequired all MEWAs to take part in jointand several liability. Although good fornew MEWAs, joint and several liabilitywould have damaged the financialstructure of an existing MEWA. Wesuccessfully exempted the GeorgiaPharmacy Association’s Insurance Trustfrom the joint and several liabilitylanguage.

DefenseMany industries that operate governmentaffairs programs know that at some pointsome other entity will introducelegislation to harm their industry in oneway or another. The pharmacy

association is no different. Over the pasttwo years there have been multiple piecesof legislation that would harm the wayyou practice pharmacy in Georgia. GPhAhas a record of 100 percent in stoppinglegislation that would be harmful to thepharmacy industry.

Now that we are heading into an electionyear, I hope all of you will get involved inhelping pro-pharmacy candidates.Between AIP and the GPhA Pharm PAC,the Georgia Pharmacy Association willbe giving over $330,000.00 in politicalcontributions over the 2010 electioncycle. We hope that the Georgialegislators will see how important thepractice of pharmacy is to us and how weare willing to “put our money where ourmouth is” in order to promote pro-pharmacy legislation.

APhA Immunization Program

APharmacy Based ImmunizationProgram was held on April 17,2010, in Macon, GA. This is an

innovative and interactive trainingprogram that teaches pharmacists theskills necessary to become a primarysource for vaccine information andadministration. The program teachesthe basics of immunology and focuseson practice implementation andlegal/regulatory issues. As part of thetraining the participants gave (andreceived) subcutaneous andintramuscular injections. Thirty-sevenparticipants attended this program.Each participant was awarded acertificate of achievement, and a totalof 20 hours of continuing educationcredit for successful completion of allcomponents of the program.

The goals of the program were to:• Provide comprehensiveimmunization education and training.• Provide pharmacists with theknowledge, skills, and resourcesnecessary to establish and promote asuccessful immunization service.

• Teach pharmacists to identify at-riskpatient populations needingimmunizations.• Teach pharmacists to administerimmunizations in compliance with legaland regulatory standards.

Thanks to Daniel K. Forrister,Pharm.D., and Sukhmani K. Sarao,Pharm.D., who are Clinical AssistantProfessors at the University of Georgia.

Participants who attended theprogram:

Genevieve McArthur BettsAmber D. BrandtAnita G. BrowneSherrie B. Collins, R.Ph.Kari M. Coody, Pharm.D.Herman Mike DavisAmy ElhamsharyKhirsty FrizzellCarson W. Gleaton, Pharm.D.Cari Schroeder Happe, Pharm.D.Earl R. Henderson, Jr., R.Ph.Wayne M. HerndonWillene B. Hodges, R.Ph.

John L. Lee, R.Ph.Arthur C. LeeMariam MajidiRegina Maniquis, Pharm.D.Carey Martin, IIISuzanne MartinLen McCook, R.Ph.W. Troy McCorkle, R.Ph.Valeria McIntyre, Pharm.D.Vimal Dinesh Parag, Pharm.D.Misty Jones Potts, R.Ph.Dwayne R. Ragan, R.Ph.Anthony Boyd Ray, R.Ph.Holly Walker RitterAmanda T. Roberson, R.Ph.Paul Alex SandstromJan Webb Satterfield, R.Ph.Dean Stone, R.Ph., CDMKrista D. Stone, R.Ph.William A. Strickland, R.Ph.Edwin Studstill, R.Ph.Tim Thompson, R.Ph.Kristopher TidwellAustin Tull


P H A R M A C Y S C H O O L N E W S

GPhA Congratulates University of Georgia College of

Pharmacy 2010 GraduatesNavid Reza AmlaniEvan Darwin AndersonMathur Husam BadrMegan Jeanette BaggettOra Jessica BaileyBishakha BandyopadhyayChristi Creighton BellKimesh BhanaLauren Rachel BiehleAmy Tarrer BlountTravis Elliot BoardCaitlin Anne BowersRobert Bowen Brady, Jr.Elizabeth Hutto BrownLaura Taylor BrownLora K. BrownKatie Beth CampbellWeston Ryan CarterChristy Cathryn CecilJane ChangAmeen Hussain ChaudhrySeon Mee ChungChristopher Elton ColemanMargaret Haden CottinghamSamantha Kate DempseyCaroline Carlisle DennisJoseph Michael DobrySarah Elizabeth Davis DorseyAbraham J. DuncanLeigh Anne DyeKristin Dee-Dee EdwardsHumphrey Nosayaba EhigiatorAmy Meredith EllisChristine Leigh ElsonRola Mousa FranksCristy Marie GaddyAnna Harden GassettMeghan Amy GettisMiller Walton GibbonsBailey Holland GuestChristopher Ryan GurleyChristopher Ryan Haire

Jennifer Nicole HallJamie Leighanne HarrisAdriana Aneta HasselbringMelissa Jean HerndonQuynh-Nhu H. HoJustin Thomas HollandRoxanne Askins HotzJamie Leigh HuckabyIkpeme I. IkpemeCecilia J. InhulsenTemitayo Latifah IsolaKatherine Leigh JacksonLindsey Ann JacksonMelinda Edwina JamesSherita Latoya JamesChristopher Zachary JohnsonNatalie Dianne JohnsonHeather Michelle JonesJennifer Marie JonesKimberly Ann KaptainHeather Marie KerstnerBryant Jerrell KnightRobert Dak Chi KoAlina Maylene KuoDavid Bishop LaistJamie Diane LakeWilliam Tyler LandersKara Michelle LavinRobert Cecil LuschenYen Kim MachRegina Bernadette ManiquisMerinda Barbara MasonPhilip Tyler MayotteJonathan Courtney McKoyKatherine Ann McMichaelElaine Rachel MebelSaleha Hina MehmoodKimberly Anne MillwardBen Collier MoonKristen Leigh MotlowLisa Marie MurphyElizabeth Lynn Myhrberg

Kayla Nicole MyliusVidya NairKiet Tuan NgoOlubusola Opeoluwa OluyemiMatthew Scott OwensManav B. PatelManisha PatelSunil P. PatelEmily Carroll PeckWilliam Joseph PendergrastJay Allen PerdueJina Helmey PerdueAndy Wild PerezMarissa Ann PetersonElizabeth Kathryn PoirierRoss Daniel RaineyElizabeth Engelmann RavenTimothy Wayne RiceAshley Nicole RochesterAlexandre RogalevitchAnthony Carlos ScottMegan Brittany ShawMansi Tushar ShethOlufunke Jadesola ShittuHeather Diane StatonCarl Craig StingelRebecca Jean Hutchinson StoneElizabeth Stark StrohsnitterVincent Michael StrohsnitterStephen Andrew ThomasLaura Elizabeth ThompsonMaria Miller ThurstonKimberly Heather TooleSarah Elizabeth WalkerLindsey Lee WarrenTyler Cole WhitakerWilliam David WhiteSidwin Delnee WilcoxAngela Barry WilliamsWilliam Burt Wrenn, III


G P H A M E M B E R N E W S

Jennifer Bass, Pharm.D., SmyrnaJames Brent Brown, O.D., Atlanta

Blake Daniel, R.Ph., GriffinScott Hill, Pharm.D., Charleston, SC

Asmerom Mosazghi Hagos, Pharm.D., LawrencevilleLarry G. Holt, R.Ph., Cassville

Jessica Ruth Humphries, Pharm.D., AtlantaLinus Amaechi Igbokwe, R.Ph., LawrencevilleHeather Michelle Jones, Pharm.D., Chatsworth

Stanley Richard Lenchner, R.Ph., Marietta

Jun Li, R.Ph., DublinMelissa F. Luce, Pharm.D., Saint Simons Island

James Reid Malone, R.Ph., CGP, AtlantaMarie McBryde, Lillington, NC

Zachary McBryde, Pharm.D., Johns CreekClementine Ebenye Nanje, Powder SpringsMinh James Pham, Pharm.D., Chamblee

Allene Pitts, ColumbusWilla Xu Qiang, Pharm.D., Alpharetta

Jonathan L. Sinyard, Pharm.D., Cordele

Welcome to GPhA!The following is a list of new members who have joined Georgia’s premier

professional pharmacy association!

If you or someone you know wishes to join the Georgia Pharmacy Association you needonly visit www.gpha.org and click “Join” at the top of the page. You can pay by credit cardand your membership begins immediately. If you have any questions please call KellyMcLendon at 404-419-8116.

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Pharmacists Mutual Insurance Company is not licensed in HI or FL. � Pro Advantage Services,

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*Dividends cannot be guaranteed; however, they have been returned uninterrupted since 1909.†Notice: � is is not a claims reporting site. You cannot electronically report a claim to us. To report a claim, call 800-247-5930.Not all products available in every state. Pharmacists Mutual Insurance Company is not licensed in HI or FL. � e Pharmacists Life Insurance Company is not licensed in AK, FL, HI, MA, ME, NH, NJ, NY or VT. Pro Advantage Services, Inc., d/b/a Pharmacists Insurance Agency (in CA) is not licensed in HI. Check with a representative or the company for details on coverages and carriers.

Contact your Pharmacists Mutual representative to discuss comprehensive insurance products to help your business prosper.

Like most independent pharmacies, you present yourself as:• a pharmacy that patients trust• a friendly, knowledgeable pharmacist• knowing and caring for your patients• giving high quality care to every patient• providing be� er service for the co-pay dollar• a specialist in disease management

Like YOU, Pharmacists Mutual competes with large corporations. Pharmacists Mutual:

• is trusted by its pharmacy customers• has a friendly, knowledgeable sta� • knows its customers and the pharmacy industry• provides quality service to every customer• has provided policyholder dividends every year since 1909*

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Like YOU, Pharmacists Mutual is successful because we have been taking care of our customers... since 1909!

A. Hu� on MaddenMobile: 404-375-7209 • Toll Free: 800-247-5930 ext. 7149

Ihave been employed with The Kroger Company since Igraduated from the University of Georgia. I worked in theAtlanta metro area for ten years then moved to Macon,

Georgia. I have mostly worked as a pharmacy manager, butcurrently I am a floater for middle Georgia. This allows me thefreedom to teach fifth graders on Sunday at church.

As a child I observed my mother volunteering all the time onone committee or another. Hers was the example for me tofollow. As a student at University of Georgia I became an activemember of the Student Pharmacy Association. It was justnatural for me to remain active in the Georgia PharmacyAssociation after graduation. Each year I would take myvacation from work to attend the GPhA Conventions. Byattending the business sessions I was able to see how theassociation worked for the profession, and I knew that I wantedto be an active participant. Since then I have served on most ofthe GPhA Standing Committees, as Region President, and onthe Board of Directors for several years.

One of the duties of the Region President is to seek newmembers. I realized very few chain pharmacists were membersof GPhA at that time. My goal was to change thatnumber. When I asked them why they were not members theoverall response was because the association did nothing forthem. So I asked questions like, “Do you want your job or doyou want a mail order pharmacy to have your job?”

“Do you want to be paid fairly for the prescriptions youdispense?”

“Do you want to have to call the doctor every time yougenerically substitute a prescription?”

“Do you want to have to get a prior authorization on everyMedicaid prescription?” The list went on and on.

These pharmacists were unaware what GPhA did for them. Iasked then GPhA President, David B. Graves, R.Ph., toconsider an academy for the employed pharmacists so theywould feel more included in GPhA. That became the Academyof Employee Pharmacists, now the largest membershipacademy in GPhA.

Our association has a duty to protect our profession. Many ofus do not have the time or the expertise to lobby for our issues.That is where Pharm PAC shines. They are able to determinethe issues and where each candidate stands on these issues.

Unfortunately politics is not free. I have been a contributorto Pharm PAC for many years and will continue to alwayssupport Pharm PAC. We are little fish fighting the sharks likeinsurance companies, Medicaid, PBMs, and drugmanufacturers. We need to know that those in the legislaturewill know where we stand to protect the pharmacy communityand our patients. Through the years we have seen thereductions in reimbursements from the state. Ourreimbursements cannot be the first area of government cuts.With the economy the way it is we need Pharm PAC more thanever. This is a crucial year for elections. Many people arediscouraged with the economy and want to change the currentelected officials. This year sees many offices up for grab. I feelit is especially important to ensure we support those candidateswho support pharmacy. With this in mind I made an additionalcontribution this year. I encourage every pharmacist thatbelieves in our trusted profession to stretch this year and giveExtra to Pharm PAC. This is why I back Pharm PAC.

P H A R M P A C N E W S


Why Kroger Pharmacist, Marsha C.Kapiloff, R.Ph., Backs Pharm PAC

Lawyer and Pharmacist Leroy Toliver, Pharm.D., R.Ph., J.D.

• Professional LicensureDisciplinary Proceedings

• Medicaid Recoupment Defense• Challenges in Medicaid Audits• OIG List Problems• SCX or Other Audits

Leroy Toliver has been a Georgia RegisteredPharmacist for 34 years. He has been a practicing

attorney for 25 years and has represented numerouspharmacists and pharmacies in all types of cases.Collectively, he has saved his clients millions of

dollars.

Toliver and Gainer,LLP

942 Green Street, SWConyers, GA 30012-5310

[email protected]

Marsha C. Kapiloff, R.Ph.

Kroger Pharmacist and Pharm PAC Contributor



GPhA Congratulates Mercer University College of

Pharmacy and Health Sciences 2010 GraduatesPharm.D. GraduatesLinsi E. AdamsTerry Michael AldridgeLeena AmineCarrie L. AshleyJennifer Rhea AusenbaughJustin D. AustinAllyson Marie BergShacey Lynn BishopBrian Gregory BlanarAkosua Kumiwa BoatengRandi Lynette BridgesGinger Sanders BrownMary Katherine BrownSarah Larae BrownHolly Elizabeth CagleLaverne A. CameronMelody Crystalle CastroOmolola ColeCharles CordaroHoneylit Katje CuecoJennifer Leigh DawsonKara Ray DeBordSarah Ahmed DesokyAnn Hoang DinhMark Anthony DowellMatthew Forbes DuffPierre-Alex DuvivierJustin Todd EasonEbony N. ErvinCarolyn Ekwutosi EzeDavid Michael FarinoBrannon Scott FloresRaena Colleen GarciaKevin Wayne GarrettAndrea Rose GauldKatherine Park GilletteRia Lynn GoberEric Jeffrey GoldsteinBrandi Fannon GreggApril Faith GrinerAsmerom Mosazghi HagosLyndrick Lee HamiltonJohnathan W. Hamrick

Jancie S. HatcherJanet Rose MartinezTyler Clark HickmanBenjamin James HigleyPatrick L. HoltChase Mahon HyerMegan Brock JacobsMark C. JerrisAnthony JohnJacob Allen JollyJessica Lynn JonesBrandon M. JumpJonathan Michael KaupShae Nicole KennedySaad KhanKenneth B. Kicklighter, Jr.Michael Scott KilpinenMolly Snyder KnowlesTekla Rahayu KovashGlenda L. KuhlmeierNgoc My LaLiana Ngoc LeChloe Rebecca HansonMelissa Litchfield CayceBlake Mark LordMohamad N. LotfiAdriene AubRay LucasSalome Ligia LulusaJoyce N. NgugiArthur Howard MannMandana ManouchehriLindsey Erin MansellZachary Wesley MartinAbby Church MassengaleCourtney Anne MaysJoseph Hilbert McCoySarah Elizabeth McCranieJessica L. MirandaDina M. MokhtarJason Dean MontegnaShannon Leigh MoskowitzSheila Robin NasrePeter Kamau NdarayaApryl Gloria Nelson

Stephanie Marie NemyerSally Elizabeth NeubauerStephanie Nicole NielsenAmy Elizabeth NoonkesterJulie Reagan NormanGuillermo Enrique Nun'ezMark Olanrewaju OgunsusiJeehoon John OhOmotola M. OluyideStephen Obehi Osakue Jr.Shirish Kishor ParbhooAvi PatelBiral V. PatelDimple PatelNeelam Kishar PatelPurvish D. PatelAshley Elizabeth PatrickClint Douglas PatrickBenjamin Karl PearsonHang T. PhamMinh James PhamMy Quang Thi PhamTimothy Parris PopeMolly Coker PrenticeBobby Jermaine PricePaige Vickery PriceNisha Ashwini RajasekaranMonali B. RathodAimee Craven ReinhardTina RezakhaniAlexis Theresa RobinsonYeimi Yairel RodriguezAmy Newman RogersMelinda Dawn RowlandThomas C. Rumph, IIIChrista Lynne RussieMomo X. RuthsatzAdam Richard SchneppPaul McCollumSchrimsherLisa Lynn SoderlindTerry McGraw StatonTristen LeAnne StatonJohn Adam Titak

Tom Vinh TranApril Dawn TuttleLida Murray ValentineHillary Leigh VolsteadtLong M. VuJennifer Ann Walters-SennAlysha Renee WarnerMichael Seth WeinsteinMichelle Renee WilliamsSusana M. WilliamsTrey P.H. Williams IIIJanna Lynn WyattDouglas Reid WylieVivian Yun-Thayer

Ph.D.Sahitya KatikaneniSatya Surya Shankar LankeGuohua LiJyotsna Paturi



GPhA Congratulates South University Pharmacy School

2010 GraduatesAshley AcostaOlubunmi Nikki AdeniyiSveta Rashesh AminBrandon Robert BankierisDavid Logan BeasleyScott Kenric BehrensJennifer Marie BergAngelica Santiago BontilaoRichard Allen BrookShuritheran ChinniahDana Leigh ChiulliBrian Joseph CohenRebecca Lynn CrunelleRebecca Phillips CubbedgeDaniel Alexander De ArazozaPascale Marie-Christine DesplanqueJoseph Leman DukeStephanie FongNicole Marie FowlerMatthew John FoxKristen Marie FrancisLaura FrancisChristina Maria GomezDonya Dean GoodlyMichael GrenonAndrea Whittnye HambyHanny Sayed HassanLaura Lee HillmanLauren Ellis HoganJeffrey David HoggPamela Peiwen HungTerica Shellene JohnsonVeronica Morton KilpatrickEmilie Victoria LandrethLauren LantzThaovy Nguyen LeTrucvy Nguyen LeMitchell Ryan LeeBryan Wade LewisAily Liem

Lindsey Michelle LovvornKim Phuong Thi LyMariam MajidiAmanda Kay MulherinJames Wesley MurphyJosephine Wangari NdingiuDuyvy Vu NguyenMarissa Anne NolanDesalegn Asihel OgbamicaelUchechi Enyinnaya OkerekeEmi OnukiElizabeth Marie OwenSheree Danielle PackNilesh Manokbhai PatelNisha Narayan PatelSonia Chandrakant PatelBlake Andrew PowellJessica Louise RoderyManav SainiPaul Alex SandstromWendy Carol SatterwhiteApril SimmonsBeth Amber SimpsonJonathan Ryan SlocumJeffrey Wayne SmithAustin SnyderChristine Reneé SomersBarbara Senze SonaManali Mihir Soni-TalsaniaCharity Williams SpeedJustin Glenn SpinksDeja Marie StephensonJulia StricklandBenjamin McBeen ThomasonEmanuel Scott ThompsonKristopher Richard TidwellKimberly Dianne TuckerJoni Marie VickersDouglas Thomas WunderlichBrant Matthew Zauner


Continuing Education for PharmacistsNew Drug Update 2010

Puja Patel, Pharm.D. is a PGY-1 Resident at Kaiser Permanente, Atlanta. She was the Drug Information Resident at Mercer University College

of Pharmacy and Health Sciences at the time this article was written.

David Farino, Pharm.D. and Asmerom Hagos, Pharm.D. were fourth year pharmacy students at Mercer University College of Pharmacy and

Health Sciences at the time this article was written.

Lisa M. Lundquist, Pharm.D., BCPS is Assistant Dean for Administration and Clinical Associate Professor at Mercer University College of

Pharmacy and Health Sciences.

Goal: The goal of this lesson is tointroduce new medications approvedby the Food and Drug Administration(FDA) in 2010.

Objectives: For each newlyapproved medication, participantsshould be able to:1. Define the mechanism of action 2. Identify the dosage forms andstrengths 3. Recognize common dosingregimens4. Define the efficacy endpointsassociated with each medication5. Describe common warnings andadverse drug reactions 6. Sufficiently counsel patients

To date, the FDA has approved ninenew medications in 2010: Victoza®(liraglutide), Actemra® (tocilizumab),Ampyra® (dalfampridine), Vpriv™(velaglucerase alfa for injection),Xiaflex™ (collagenase clostridiumhistolyticum), Menveo®[meningococcal (Groups A, C, Y andW-135) oligosaccharide diphtheriaCRM197 conjugate vaccine], Prevnar13™ [pneumococcal 13-valentconjugate vaccine (diphtheriaCRM197 protein)], Provenge®(sipuleucel-T), and Zortress®(everolimus).

Victoza® (liraglutide)Liraglutide (lir a GLOO tide) is anacylated human Glucagon-LikePeptide-1 (GLP-1) receptor agonistindicated to improve glycemic controlin adults with type 2 diabetesmellitus.

Liraglutide is safe and effective whenused as a monotherapy agent but canalso be used concomitantly whenadministered with insulinsecretagogues.1

PharmacologyLiraglutide activates the GLP-1receptor in pancreatic beta cells.Activation causes an increase inintracellular cyclic AMP (cAMP)leading to insulin release in thepresence of elevated glucoseconcentrations. The mechanism ofblood glucose lowering also involves adelayed gastric emptying.

Formulation Liraglutide exists as a solution forsubcutaneous (SC) injection, pre-filled, multi-dose pen that deliversdoses of 0.6 mg, 1.2 mg, or 1.8 mg.

DosingAll patients should receive a startingdose of 0.6 mg SC daily for one week.The 0.6 mg dose is intended toreduce gastrointestinal symptomsduring initial titration, and is not

effective for glycemic control. Afterone week of receiving 0.6 mg per day,the patient’s dose can be increased to1.8 mg.1 Liraglutide is advantageousbecause it does not require any renalor hepatic dosage adjustment and hasonce daily dosing.

EfficacyA total of three trials were conductedto measure the efficacy of liraglutide.The primary endpoint in all trials wasthe change from baseline A1c at theend of the study period. Table 1provides information regarding thesetrials.

Warnings and PrecautionsLiraglutide has a black box warningfor causing thyroid C-cell tumors.Studies have shown an incidence ofthyroid C-cell tumors in rats; it isunknown whether liraglutide causesthyroid C cell tumors in humans.

Liraglutide is contraindicated inpatients with a personal or familyhistory of medullary thyroidcarcinoma or multiple endocrineneoplasia syndrome type 2 (MEN2).

Adverse ReactionsThe following side effects have beenreported to occur in >10% ofpatients: nausea (29%), diarrhea(17%), vomiting (11%), andconstipation (10%). Hypoglycemia


has been reported in seven patientsreceiving liraglutide combinationtherapy in clinical trials (6 withsulfonylureas, 1 with metformin).

CommentsLiraglutide is a pregnancy category Cmedication. Byetta® (exenatide) isanother FDA approved medication inthis drug class. Exenatide is injectedtwice a day and is excreted renally.Liraglutide is degraded byendogenous peptides, which may bebeneficial in patients with renalimpairment. Liraglutide is moreexpensive than exenatide but patientsmay find the convenience of oncedaily injection worth the extra cost.

Patient CounselingAdvise patients to discontinueliraglutide and to contact their healthcare provider if persistent severeabdominal pain occurs.

Patients should be instructed on theproper use of liraglutide as follows:• Do not share a liraglutide pen withanother person, even if the needle ischanged. Sharing of the pen betweenpatients increases the risk oftransmission of infection. • Liraglutide solution should beinspected prior to each injection, andthe solution should be used only if itis clear, colorless, and contains noparticles. • Liraglutide can be administered

once daily at any time and should beinjected subcutaneously in theabdomen, thigh, or upper arm.• Before the initial use, liraglutideshould be stored in a refrigerator.After the first use, the pen can bestored for 30 days at roomtemperature.

Advise patients that the mostcommon side effects of liraglutide areheadache, nausea, and diarrhea.Nausea is most common when firststarting liraglutide but decreases overtime in the majority of patients anddoes not typically requirediscontinuation of liraglutide.


Actemra® (tocilizumab)Tocilizumab (toe si LIZ oo mab) isan interleukin-6 (IL-6) receptorinhibitor for treatment of moderate tosevere active rheumatoid arthritis(RA) in adult patients who have hadan inadequate response to one ormore tumor necrosis factor (TNF)antagonist therapies.

Tocilizumab may be used asmonotherapy or concomitantly withmethotrexate or other disease-modifying antirheumatic drugs(DMARDs). It has not been studied,and should not be used, incombination with other biologicDMARDs because of the risk ofincreased toxicity. Examples ofbiologic DMARDs include:abatacept, tocilizumab, certolizumab,entanercept, adalimumab, anakinra,infliximab, golimumab, andrituximab.4

PharmacologyTocilizumab is the first in the class ofIL-6 inhibitors and binds specificallyto both soluble and membrane-boundIL-6 receptors. Interleukins, a type of

cytokines, are hormone-likemolecules that regulate immuneresponses. In general, interleukinsexert their effects by influencing geneactivation that results in cellularactivation, growth, anddifferentiation. Therefore interleukinshave effects on the regulation ofimmune responses, such asinflammation, in rheumatoid arthritis.Tocilizumab can block interleukin-6receptor leading to a decrease inimmune responses.

Formulation Tocilizumab is supplied as anintravenous (IV) infusion solution ata concentration of 20 mg/ml.Strengths of 80 mg/4 ml, 200 mg/10ml, and 400 mg/20 ml come in single-use vials.

DosingThe initial dose of 4 mg/kg IV every 4weeks is recommended and may beincreased to 8 mg/kg. Infusionsshould be diluted to 100 ml using0.9% normal saline over the course ofone hour; bolus or push infusions arenot recommended.

EfficacyA total of three trials were conductedto measure the efficacy outcomes oftocilizumab. The primary end pointfor all three trials was the proportionof tocilizumab patients with a 20%improvement in RA signs andsymptoms, such as tender or swollenjoints and pain, according toAmerican College of Rheumatologycriteria (ACR20) response at week24. Table 2 provides informationregarding these trials.

Warnings and PrecautionsTocilizumab has a black box warningfor the occurrence of serious infectionleading to hospitalization or death forsome patients. Patients should bemonitored for the development ofsigns and symptoms of infection,including the possible development oftuberculosis (TB). If a patient ispositive for TB, start the treatmentfor TB prior to starting tocilizumab.Tocilizumab should not be initiatedin patients with an absoluteneutrophil count (ANC) <200/mm3,platelet count <100,000/mm3, oralanine transaminase (ALT) or


aspartate aminotransferase (AST)levels 1.5 times above the uppernormal limit.

Adverse ReactionsThe most commonly reportedadverse reactions occurring in ≥ 5%of patients were: upper respiratorytract infections (8%), nasopharyngitis(7%), headache (7%), hypertension(6%), and increased ALT levels (6%).

CommentsTocilizumab is a pregnancy categoryC medication.

Patient CounselingInform patients to contact theirhealth care provider immediately if heor she experiences symptoms ofinfection or severe abdominal pain.

Ampyra® (dalfampridine)Dalfampridine (dal FAM pri deen) isindicated to improve walking inpatients with multiple sclerosis(MS).8

PharmacologyThe full mechanism of action ofdalfampridine is unknown; however,it is known to be a broad spectrumpotassium channel blocker.Potassium channel blockers inhibitthe efflux of potassium ions out of thecell allowing a greater concentrationof potassium inside the cell. Blockingpotassium channels essentially

prolongs the duration of actionpotentials, which allow moreelectrical activity to occur in a cell.Deficiencies in potassium ions canlead to symptoms such as musclecramps.

Formulation Dalfampridine is available as anextended release tablet.

DosingThe maximum recommended dose ofdalfampridine is one 10 mg tablet POtwice daily.

EfficacyA total of two trials were conductedto measure the efficacy ofdalfampridine. The primary endpointin both trials was walking speed(feet/second) using responderanalysis. A responder was defined as apatient who showed faster walkingspeed for three out of four visits.Table 3 provides informationregarding these trials.

Warnings and PrecautionsThe use of dalfampridine iscontraindicated in patients with ahistory of seizures and/or moderateor severe renal impairment (CrCl ≤50 ml/min).8

Adverse ReactionsThe most commonly reportedadverse reactions that occurred in

≥5% of patients were: urinary tractinfections (12%), insomnia (9%),headache (7%), dizziness (7%),asthenia (7%), nausea (7%), backpain (5%), and balance disorder(5%).8

CommentsDalfampridine is a pregnancycategory C medication.

Patient CounselingInform patients to discontinue theuse of dalfampridine if theyexperience a seizure.

Inform patients that the tablets can betaken with or without food andshould be taken whole; do not divide,crush, chew, or dissolve.

Vpriv™ (velaglucerase alfa)Velaglucerase alfa (vel a GLOO serase AL fa) is indicated for long-termenzyme replacement therapy (ERT)for pediatric and adult patients withtype 1 Gaucher disease.10

Pharmacology Velaglucerase alfa catalyzes thehydrolysis of glucocerebroside,reducing the amount of accumulatedglucocerebroside. Foam cells or"Gaucher cells" are formed from theaccumulation of glucocerebrosidecaused by the enzymatic deficiency.The accumulation of Gaucher cells inthe liver and spleen leads to


organomegaly. Presence of Gauchercells in the bone marrow and spleenlead to clinically significant anemiaand thrombocytopenia.

Formulation Velaglucerase alfa is a lyophilizedpowder which requires reconstitutionand dilution. Doses available are 200units/vial and 400 units/vial.

DosingThe recommended dose ofvelaglucerase alfa is 60 Units/kgadministered every other week as a60-minute intravenous infusion.Patients previously treated onimiglucerase can be switched over tovelaglucerase alfa at that same dose.Velaglucerase alfa should beadministered under the supervision ofa healthcare professional.

EfficacyA total of two trials were conductedto measure the efficacy ofvelaglucerase alfa. The primary

endpoint was the mean change frombaseline for hemoglobinconcentration, platelet counts, liverand spleen volume in patients aftertreatment. Table 4 providesinformation regarding these trials.

Adverse ReactionsInfusion-related reaction (such asflushing, erythema, and tachycardia)was the most commonly observedadverse reaction in patients (53%)during clinical trials. Othercommonly reported adverse reactionsthat occurred in ≥10% of patientswere: headache (35%), upperrespiratory tract infection (32%),dizziness (22%), back pain (17%),joint pain (15%), and asthenia (13%).

CommentsVelaglucerase alfa is a pregnancycategory B medication

Patient CounselingPatients should be informed that onlya healthcare professional can

administer velaglucerase infusion,which typically takes up to 60minutes.

Advise patients that velaglucerase alfamay cause infusion-related reactions.Infusion-related reactions can usuallybe managed by slowing the infusionrate and treatment with medicationssuch as antihistamines, antipyreticsand/or corticosteroids.

Xiaflex™ (collagenaseclostridium histolyticum)Collagenase clostridium histolyticum(KOL la je nase) is indicated in adultsfor the treatment of Dupuytren’scontracture with a palpable cord.11

PharmacologyCollagenases are proteinases thathydrolyze collagen resulting in lysis ofcollagen deposits. Injection ofcollagenase clostridium histolyticuminto a Dupuytren’s cord, which iscomprised mostly of collagen, may


result in enzymatic disruption of thecord.

Formulation Collagenase clostridium histolyticum,supplied as a lyophilized powder,must be reconstituted with theprovided diluent prior to use.

DosingThe dose of collagenase clostridiumhistolyticum is 0.58 mg per injectioninto a palpable cord with acontracture of a metacarpophalangeal(MP) joint or a proximalinterphalangeal (PIP) joint.Injections may be administered up to3 times per cord at approximately 4-week intervals. Collagenaseclostridium histolyticum must beadministered by a healthcareprovider.

EfficacyA total of two trials were conductedto measure the efficacy of collagenaseclostridium histolyticum. Theprimary endpoint was the proportionof patients who achieved a reductionin contracture of the selected primaryjoint (MP or PIP). Table 5 comparesthe two trials.

Adverse ReactionsThe most commonly reportedadverse reactions that occurred in≥25% of patients included: peripheraledema (73%), contusion (70%),injection site hemorrhage (38%),injection site reaction (35%), andpain in the treated extremity (35%).

CommentsCollagenase clostridium histolyticumis a pregnancy category B medication.

Patient CounselingAdvise parent or guardian to useOTC analgesics (i.e. acetaminophen,ibuprofen) for fever, pain, ordiscomfort at injection site and tonotify health care provider ifbothersome side effects last morethan 24 hours.

Menveo® [meningococcal(Groups A, C, Y and W-135)oligosaccharide diphtheriaCRM197 conjugate vaccine]Meningococcal (me NIN joe kok al)oligosaccharide diphtheria conjugatevaccine is indicated in people 11 to 55years old for active immunization toprevent invasive meningococcaldisease caused by Neisseria

meningitidis serogroups A, C, Y andW-135.13

PharmacologyVaccination leads to the productionof bactericidal antibodies againstserogroups A, C, Y and W-135.

FormulationMeningococcal oligosaccharidediphtheria conjugate vaccine isavailable as a solution for injectionand is stored in the refrigerator. Itmust be prepared for administrationthrough reconstitution with alyophilized vaccine component.

DosingThe vaccine is administered as asingle 0.5mL intramuscular injection.Observation for 15 minutes afteradministration is recommended inorder to avoid syncope.

Warnings and PrecautionsMeningococcal oligosaccharidediphtheria conjugate vaccine shouldnot be administered to anybody witha bleeding disorder or receivinganticoagulant therapy, unless thepotential benefit outweighs the risk ofadministration. Furthermore, there isa potential for an increased risk of


Guillain-Barré Syndrome (GBS)associated with the use of thisvaccine.

Adverse ReactionsThe most frequently occurringadverse events in all patients werepain at the injection site (41%),headache (30%), myalgia (18%),malaise (16%) and nausea (10%).

CommentsThis vaccine is a pregnancy categoryB medication.

Patient CounselingAdvise parent or guardian to useOTC analgesics (i.e. acetaminophen,ibuprofen) for fever, pain, ordiscomfort at injection site and tonotify health care provider ifbothersome side effects last morethan 24 hours.

Prevnar 13™ [pneumococcal13-valent conjugate vaccine(diphtheria CRM197protein)]Pneumococcal 13-valent conjugatevaccine is indicated for activeimmunization for the prevention ofinvasive disease and otitis mediacaused by Streptococcuspneumoniae.14

PharmacologyPneumococcal 13-valent conjugatevaccine produces antibodies throughstimulation of T-cells. Protein carrier-specific T-cells provide the signalsneeded for maturation of the B-cellresponse and generation of B-cellmemory. This type of responseinduces immune memory and elicitsbooster responses on re-exposure ininfants and children to pneumococcalpolysaccharides.

FormulationThis vaccine is available as asuspension and should be stored inthe refrigerator.

DosingThe four-dose immunization seriesconsists of a 0.5 ml intramuscularinjection administered at 2, 4, 6, and12-15 months of age. Preferred sitesfor injection are the thighs or upperarms in toddlers and children.

Warnings and PrecautionsApnea following intramuscularvaccination has been observed insome infants born prematurely.

Adverse ReactionsReactions occurring in greater than1% of infants and toddlers includeddiarrhea, vomiting, and rash.

CommentsThis vaccine is a pregnancy categoryC medication. Other vaccines foundin the same class as this agent includePrevnar® and Synflorix™.Pneumococcal 13-valent conjugatevaccine is a 13-valent vaccine. Thismeans it contains 13 serotypes toStreptococcus pneumoniae to whichit provides immunity. The originalPrevnar® is 7-valent, while Synflorix™is a 10-valent vaccine.

Patient CounselingAdvise parent or guardian thatvaccine provides protection againstthe 13 most common and seriouspneumococcal infections in infantsand toddlers but does not provideprotection from other causes ofbacterial infection.

Advise parent or guardian to useOTC analgesics (i.e. acetaminophen,ibuprofen) for fever, pain, or

discomfort at injection site and tonotify health care provider ifbothersome side effects last morethan 24 hours.

Provenge® (sipuleucel-T)Sipuleucel-T (si pu LOO sel tee) isindicated for the treatment ofasymptomatic or minimallysymptomatic metastatic castrateresistant (hormone refractory)prostate cancer.15

PharmacologySipuleucel-T is classified as anautologous cellular immunotherapy.While the precise mechanism ofaction is unknown, sipuleucel-Tinduces an immune response targetedagainst prostatic acid phosphatase(PAP), an antigen expressed in mostprostate cancers.

FormulationSipuleucel-T is available as aninjection and should be prepared in250 ml infusion bags.

DosingEach dose of sipuleucel-T contains atleast 50 million autologous CD54+cells. Sipuleucel-T is given as threedoses IV (infused over 1 hour) atapproximately 2-week intervals.

EfficacyTwo trials were conducted tomeasure the efficacy of sipuleucel-T.The primary endpoint was time todisease progression. All patients werealso followed until death. Table 6 liststhe results from this trial.

Warnings and PrecautionsAcute infusion reactions may occurwithin 1 day of infusion; theincidence of severe reaction may behigher with the second infusion, while


the third infusion is associated with adecrease in the incidence of severereactions.

Adverse ReactionsThe following side effects have beenreported to occur in >15% ofpatients: chills (53%), fatigue (41%),fever (31%), back pain (30%), nausea(22%), joint ache (20%), andheadache (18%).

Patient CounselingRemind patients that therecommended course of therapy forsipuleucel-T is 3 complete doses.Each infusion of sipuleucel-T ispreceded by a leukapheresisprocedure.

Advise patients to report signs andsymptoms of acute infusion reactionssuch as fever, chills, and fatigue.Patients can take acetaminophen andan antihistamine approximately 30minutes prior to administration ofsipuleucel-T to minimize acuteinfusion reactions.

Encourage patients to tell their doctorif they are taking immunosuppressiveagents.

Zortress® (everolimus)Everolimus (e ver OH li mus) is animmunosuppressant for prevention ofkidney transplant rejection used in

combination with reduced dosecyclosporine. Combination therapyshould be initiated as soon as possibleafter kidney transplantation.16

PharmacologyEverolimus is a macrolideimmunosuppressant and an m-TORinhibitor. It reduces protein synthesis,cell proliferation, angiogenesis,hypoxia-inducible factor, and theexpression of vascular endothelialgrowth factor (VEGF). With theinhibition of angiogenesis and VEGF,the growth of new blood vessels isinhibited. All of these activities aid insuppressing the body’s immunesystem.

FormulationEverolimus is available as a 0.25 mg,0.5 mg, and 0.75 mg tablet.

DosingFor renal transplantation, the initialdose is 0.75 mg PO twice daily incombination with reduced dosecyclosporine. Avoid the use ofconcomitant strong CYP3A4inducers and/or inhibitors. The doseof everolimus should be reduced byhalf if moderate hepatic impairment(Child-Pugh Class B) exists.

EfficacyOne trial was conducted to measurethe efficacy of everolimus. The

primary endpoint was efficacy failure,defined as treated biopsy-provenacute rejection, graft loss, death orloss to follow-up. Table 7 lists theresults from this trial.

Warnings and PrecautionsEverolimus has a black box warningfor increased susceptibility toinfection and thus the possibledevelopment of malignancies. Ifeverolimus is being prescribed withcyclosporine, reduce doses ofcyclosporine in order to reducenephrotoxicity. An increased risk ofkidney arterial and venousthrombosis has been reported, mostlywithin the first 30 days posttransplantation.

Adverse ReactionsThe following side effects have beenreported to occur in > 30% ofpatients: stomatitis (44%), infections(37%), asthenia (33%), fatigue(31%), cough (30%), and diarrhea(30%).

CommentsEverolimus is a pregnancy category Cmedication.

Drug levels of everolimus need to bemonitored 4 to 5 days after anydosage change. The recommendedtherapeutic range is 3-8 ng/ml.Everolimus is also available as a 10mg


tablet (Afinitor®) and indicated forthe treatment of advanced renal cellcarcinoma. Afinitor® is dosed 10 mgPO once daily at the same time everyday.

Patient CounselingAdvise patients to take everolimuswhole; do not divide, crush, chew ordissolve. Everolimus can be takenwith or without food.

Patients should be instructed to notdrink grapefruit juice or eat grapefruitduring treatment.

Recommend that mouthwashesand/or topical treatments that do notcontain alcohol or peroxide should beused if mouth ulcers or sores develop.

Advise patients to avoid the use oflive vaccines and close contact withthose who have received live vaccines.

Advise women of childbearingpotential that everolimus may causefetal harm and to use an effectivemethod of contraception duringtherapy and for 8 weeks after endingtreatment.

References1. Victoza® [package insert]. Princeton, NJ:Novo Nordisk Inc.; Revised January 2010.

2. Garber A, Henry R, Ratner R, et al.Liraglutide versus glimepiride monotherapy fortype 2 diabetes (LEAD-3 Mono): a randomised,52-week, phase III, double-blind, parallel-treatment trial. Lancet. 2009;373(9662):473-81.

3. Nauck M, Frid A, Hermansen K, et al.Efficacy and safety comparison of liraglutide,glimepiride, and placebo, all in combinationwith metformin, in type 2 diabetes: The LEAD(Liraglutide Effect and Action in Diabetes)-2Study,” Diabetes Care. 2009;32(1):84-90.

4. Actemra® [package insert]. San Francisco,CA: Genentech Inc.; Issued January 2010.

5. Jones G, Sebba A, Gu J, et al. Comparison oftocilizumab monotherapy versus methotrexatemonotherapy in patients with moderate tosevere rheumatoid arthritis: The AMBITIONstudy. Ann Rheum Dis. 2010;69:88–96.

6. Smolen JS, Beaulieu A, Rubbert-Roth A, et al.Effect of interleukin-6 receptor inhibition withtocilizumab in patients with rheumatoidarthritis (OPTION study): a double-blind,placebo-controlled, randomised trial. Lancet.2008;371:987–97.

7. Emery P, Keystone E, Tony HP, et al. IL-6receptor inhibition with tocilizumab improvestreatment outcomes in patients with rheumatoidarthritis refractory to anti-tumour necrosisfactor biologicals: results from a 24-weekmulticentre randomised placebo-controlled trial.Ann Rheum Dis. 2008;67:1516–23.

8. Ampyra®[package insert]. Hawthorne, NY:Acorda Therapeutics, Inc.; 2010.

9. Goodman AD, Brown TR, Krupp LB, et al.Sustained-release oral fampridine in multiplesclerosis: a randomised, double-blind, controlledtrial. Lancet. 2009;373(9665):732-8.

10. Vpriv™ [package insert]. Wayne, PA: ShirePharmaceuticals; 2010.

11. Xiaflex™ [package insert]. Malvern, PA:Auxilium Pharmaceuticals, Inc.; 2010.

12. Hurst LC, Badalamente MA, Hentz VR, etal. Injectable collagenase clostridiumhistolyticum for Dupuytren's contracture. NEngl J Med. 2009; 361(10):968-79.

13. Menveo®[package insert]. Basel,Switzerland: Novartis Vaccines andDiagnostics, Inc.; 2010.

14. Prevnar 13™ [package insert]. Philadelphia,PA: Wyeth Pharmaceuticals Inc.; RevisedFebruary, 2010.

15. Provenge®[package insert]. Seattle, WA:Dendreon Corporaton.; Unissued Date

16. Zortress®[package insert]. East Hanover,NJ: Novartis Pharmaceutical Co; 2010.


Continuing Education for PharmacistsQuiz and Evaluation New Drug Update 2010

1. Dalfampridine is indicated for which of thefollowing disease states?

a. Tourette’s syndromeb. Multiple sclerosisc. Epilepsyd. Degenerative spine disorder

2. Tocilizumab has a black box warning for:a. Causing thyroid C-cell tumorsb. Increasing the risk for severe liver injury

and acute liver failurec. Causing serious infection leading to

hospitalization or death d. Increasing the risk for GI perforation

3. The pneumococcal 13-valent conjugate vaccineshould be initiated at which of the following ages?

a. 2, 4, 6, and 12-15 months b. 3, 6, 9, and 12 monthsc. 4 and 6 monthsd. 6 and 9 months

4. Velaglucerase alfa is available as which of thefollowing formulations?

a. Extended release tabletb. Intravenous infusionc. Solutiond. Lyophilized powder

5. Sipuleucel-T is indicated for the treatment of: a. Lung cancerb. Breast cancerc. Colon cancerd. Prostate cancer

6. Liraglutide has a black box warning for:a. Increasing the risk for neurotoxicity b. Causing thyroid C-cell tumorsc. Causing serious infection leading to

hospitalization or death for some patientsd. Increasing the risk of suicidal thinking and

behavior

7. Collagenase clostridium histolyticum injectionsmay be given at approximately:

a. 2-week intervalsb. 4-week intervalsc. 6-week intervalsd. 8-week intervals

8. The use of meningococcal conjugate vaccine maybe associated with an increased risk of:

a. Guillain-Barré syndromeb. Kimura diseasec. Chédiak–Higashi syndromed. Kostmann syndrome

9. Which of the following is the mechanism of actionfor liraglutide?

a. GLP-1 receptor agonistb. GLP-1 receptor antagonistc. GLP-2 receptor agonistd. GLP-2 receptor antagonist

10. When everolimus is prescribed with cyclosporine,the dose of cyclosporine should be:

a. Increasedb. Decreasedc. Remain the samed. None of the above


J o u r n a l C P E A n s w e r S h e e t

The Georgia Pharmacy Association is accredited by the Accreditation Council for Pharmacy Education as a provider ofcontinuing pharmacy education. No financial was received for this activity. This article was originally published in theGeorgia Pharmacy Association under UAN# 0142-0000-10-007-H01-P. Participants should not seek duplicate credit.

New Drug Update 2010This lesson is a knowledge-based CPE activity and is targeted to pharmacists.GPhA code: J10-07ACPE#: 0142-0000-10-007-H01-PContact Hours: 1.0 (0.10 CEU)Release Date: 07/01/2010Expiration Date: 07/01/20131. Select one correct answer per question and circle the appropriate letter below using blue or black ink (no red ink orpencil.)2. Members submit $4.00, Non-members must include $10.00 to cover the cost of grading and issuing statements ofcredit/ Please send check or money order only. Note: GPhA members will receive priority in processing CE.Statements of credit for GPhA members will be emailed or mailed within four weeks of receipt of the course quiz.

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PharmacySonny Rader Ex Officio - Chairman, GSHPGina Ryan Johnson Ex Officio MercerJill Augustine Ex Officio Mercer ASPRusty Fetterman Ex Officio South Olivia Santoso Ex Officio South ASPDaniel Forrister Ex Officio UGARobb Hutherson Ex Officio UGA ASP

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