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7KH 2I¿FLDO 3XEOLFDWLRQ RI WKH *HRUJLD 3KDUPDF\ $VVRFLDWLRQ -XQH 9ROXPH 1XPEHU ZZZJSKDRUJ GPhA 2011 Convention June 18-22, 2011 Register Now! Pharmacists’ Advocacy Achieves Results June 2011 Journal:Layout 1 6/14/2011 9:25 AM Page 1

The Georgia Pharmacy Journal: June 2011

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Pharmacists’ Advocacy Achieves Results GPhA 2011 Convention June 18-22, 2011 Register Now! June 2011 Journal:Layout 1 6/14/2011 9:25 AM Page 1

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Page 1: The Georgia Pharmacy Journal: June 2011

GPhA 2011 ConventionJune 18-22, 2011

Register Now!

Pharmacists’ Advocacy Achieves

Results

June 2011 Journal:Layout 1 6/14/2011 9:25 AM Page 1

Page 2: The Georgia Pharmacy Journal: June 2011

The Georgia Pharmacy Journal June 20112

Let us be Your Insurance Resource

Join us in celebrating 30 years of serving the membersof the Georgia Pharmacy Association.

To learn more visit www.gpha.org.

Call TODAY to schedule a time to discuss your health insurance needs.

404.237.8435

Celebrating 30 years of service to the Pharmacists of Georgia!

Georgia Pharmacy Association Members Take Advantage ofPremium Discounts Up to 30% on Individual Disability

Insurance

Have you protected your most valuable asset?Many people realize the need to insure personal belongings like carsand homes, but often they neglect to insure what provides their lifestyle and financial well-being - their income!

The risk of disability exists and the financial impact of a long-term disability (90 days or more) can have adevastating impact on individuals, families and businesses.During the course of your career, you are 3½ timesmore likely to be injured and need disability coverage than you are to die. (Health Insurance Association of America,2000)

As a member of the Georgia Pharmacy Association, you can help protect your most valuable asset and receivepremium discounts up to 30% on high-quality Individual Disability Income Insurance from Principal Life InsuranceCompany.

For more information visit www.gpha.org.

* Association Program subject to state approval. Policy forms HH 750, HH 702, HH 703. This is a general summary only. Additional guidelines apply. Disability insurance has limitations and exclusions. Forcosts and details of coverage, contact your Principal Life financial representative.

June 2011 Journal:Layout 1 6/14/2011 9:25 AM Page 2

Page 3: The Georgia Pharmacy Journal: June 2011

The Georgia Pharmacy Journal June 20113

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

10 Pharmacists Visit Washington D.C. to Advocate for Pharmacy

14 APhA Health Care Reform Information

18 AIP Provides Disaster Relief for Highland Pharmacy in Ringgold, GA

23 Continuing Education for Pharmacists: Multiple Sclerosis: Medical Management with Disease-Modifying Therapy

C O L U M N S

4 President’s Message

7 Editorial

6Governor Signs

Pharmacy Bills Into Law

Departments8 Pharm PAC 2010-201113 GPhA New Members31 GPhA Board of Directors

Advertisers2 The Insurance Trust2 Principal Financial Group5 Financial Network Associates9 Logix, Inc.9 Melvin Goldstein, P.C.12 Pharmacists Mutual Companies15 AIP16 GPhA Workers’ Compensation17 GoToWebinar/GoToMeeting20 CPE Cruise21 GPhA Career Center22 PQC22 University of Florida30 PACE Allinace32 The Insurance Trust

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

June 2011 Journal:Layout 1 6/14/2011 9:25 AM Page 3

Page 4: The Georgia Pharmacy Journal: June 2011

P R E S I D E N T ’ S M E S S A G E

The Georgia Pharmacy Journal June 20114

How many times have you heard a lecture, speechor sermon and by the next day, not onlyforgotten the theme of the message, but couldn’t

recall even a single word? If you’re like me, this hasprobably happened to you more than you would like toadmit. While attending my daughter’s hooding andcommencement ceremonies at Mercer School ofPharmacy and Health Sciences, I heard words directed tothe graduating class that I not only remembered the nextday, but I think they will stick with me and bear repeating.

Dr. Steve Wilson, Pharm. D., president of the GeorgiaBoard of Pharmacy, acknowledged in advance that thegraduates had more on their minds than his presentationat their hooding ceremony, but he asked them toremember just a couple of thoughts. The one thoughtthat resonated with me was Steve’s emphasis on theimportance of showing up. I flashed back to some GPhAregion meetings in past years when the meeting space wasfull of pharmacists, then to the past couple of years, whensome of the same meetings only had seven to tenpharmacists in attendance. I think it is easy tounderestimate the value of showing up. VIP day at theCapitol is a prime example. Showing up conveys themessage to your colleagues and to your elected officialsthat you care about the issues that affect how you are ableto practice your profession.

Mercer’s commencement speaker, Dr. R. Kirby Godsey,Ph.D., who was President and CEO of Mercer Universityfor 27 years, gave a poignant message that I wish every

pharmacist in the state could have heard. Dr. Godseyreminisced that he had been sitting in an establishment onRoyal Street in the Big Easy, otherwise known as NewOrleans, contemplating what he would say to thegraduating class of 2011. He wrote three words on anapkin. Those words were thought, passion and grace.Again, I had a flash- back (I swear I never did LSD incollege) to a time in my career when I felt like I was in adead end situation, where I felt that my thinking was beingdone for me, which robbed me of my passion for myprofession. The grace was still there, as I always lived bythe adage of treating my customers the way I would wantto be treated, but I was running on empty because theengine (thought) was not being fueled with passion,because there was no passion left. Fortunately, I made acareer change and rediscovered the passion I felt when Iwas sitting in an auditorium listening to my owncommencement speech, which, sadly to say, I don’tremember one word. To credit Dr. Godsey’s wisdom, hemade an extra effort to ensure remembrance by hand-writing his three words on individual napkins for over1,000 graduates of the combined Mercer schools.

After hearing Dr. Godsey’s presentation , I thought backto what Steve Wilson said about showing up, and came tothe conclusion that passion is what drives me to show up.This is what drives me to make an annual trip toWashington to attend The International Academy ofCompounding Pharmacist’s Compounders on CapitolHill. This event allows me to join with my compoundingpharmacist colleagues to fight for our right to do what

Dale M. Coker, R.Ph., FIACPGPhA President

Words to Remember

June 2011 Journal:Layout 1 6/14/2011 9:25 AM Page 4

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5The Georgia Pharmacy Journal June 2011

pharmacists have done for generations, to preparecompounded prescriptions upon a written order by amedical practitioner for a patient. As unbelievable as itsounds, we have a federal agency which contends thatevery compounded prescription is subject to a new drugapproval process. Battling this kind of logic makes it aneasy decision to show up and show my passion for what Iknow is right.

In summary, never forget the importance of showing up,keep your thinking cap on, find something to bepassionate about, and above all, live a life of grace. I wouldalso like to leave you with a word of caution from Dr.Godsey, who said that passion without thought is reckless.Living a life of grace will keep your passion in check.Thank you for giving me the opportunity to serve ourgreat profession as your president. Selah.

GPhA Needs You and Your

Pharmacy KnowledgeWe are looking for a few goodwriters to write CPE Articles forthe GPhA Journal. If you areinterested in building your resumeand helping GPhA create thepremier CPE program in the stateof Georgia please contact us at404-231-5074.

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Securities, certain advisory services and insurance products are offered through INVEST Financial Corporation (INVEST),

member FINRA/SIPC, a federally registered Investment Adviser, and affiliated insurance agencies. INVEST is not affiliated with

Financial Network Associates, Inc. Other advisory services may be offered through Financial Network Associates, Inc., a registered

investment adviser.

June 2011 Journal:Layout 1 6/14/2011 9:25 AM Page 5

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The Georgia Pharmacy Journal June 20116

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

Governor Signs Pharmacy Bills Into Law

Many people think of Friday the 13th as a bad daybut that was the case for Pharmacists in Georgiaon Friday, May 13, 2011. That is the day that

Governor Deal signed SB 36 and SB 93 into law, in frontof a group of Pharmacists, Law Enforcement, Legislatorsand Doctors.

SB 36 was the legislation that set up an electronic drugmonitoring program for Schedule II through Schedule Vnarcotics. Georgia is the last state in the Southeast andone of the last in the country to enact such legislation. TheBoard of Pharmacy is busy working with the FederalGovernment to secure Grant Funding for the start upcosts of this legislation.

Within minutes of Governor Deal’s signing of SB 36 intolaw, the White House’s Drug Policy Director, Gil

Kerlikowske, issued this statement “This vital piece oflegislation is a tremendous step forward in combating ournational prescription drug abuse epidemic. It will savelives by identifying, deterring, and preventing drug abuseand diversion, while at the same time allowing access tolegitimate use of prescription drugs.”

Governor Deal also signed SB 93 into law which movedPseudoephedrine to a Schedule V exempt Narcotic. Thismeans that Pseudoephedrine can only be sold behind thecounter of a Pharmacy but does not require a prescription.Many states that have enacted similar legislation have seendrastic reductions in methamphetamine production. It ishoped that this will also be the case in Georgia.

by Andy FreemanDirector of Government Affairs

June 2011 Journal:Layout 1 6/14/2011 9:25 AM Page 6

Page 7: The Georgia Pharmacy Journal: June 2011

While driving on the Memorial Day weekend and seeingan accident or two I pondered how many drivers are onGeorgia highways without proper automobile insurance?

As honest citizens and conscientious drivers, we knowuninsured drivers cost us additional money for insurancepremiums and other related costs of owning and drivingour automobile.

Do you realize your state pharmacy association is yourinsurance provider for your pharmacy degree? Is yourdegree worth more today than when you earned it?

In Georgia, I think you can say an absolute yes and thedriving force for that value growth is your membership inthe Georgia Pharmacy Association.

Has your pharmacy practice improved? Here are a dozenfactors to consider.

Today you can immunize under protocol for flu withinjection and flu mist.

Today you can legally accept e-prescriptions even via fax ifnecessary.

Today in Georgia the pharmacist is the only legal sourcefor pseudoephedrine behind the counter.

Today a new law is in place to establish a electronic drugmonitoring program for Georgia to help pharmacists fightillegal controlled substance prescriptions.

In Georgia your state pharmacy inspectors are currentlymandated to be licensed pharmacists.

Today pharmacists are delivering more MedicationManagement Therapy than ever before and with increasedreimbursement.

Today the state does not utilize mandatedmail order butmaintains “any willing provider” status for any pharmacy.

Today pharmacy technicians are becoming registered forthe first time in Georgia.

Your profession has four pharmacists serving in the statelegislature.

GPhA has its first trustee serving on the AmericanPharmacists Association Board of Trustees.

GPhA has two officers in the leadership of the NationalCommunity Pharmacy Association.

GPhA has the most powerful Political Action Committeein its history

So why are there so many “uninsured pharmacists” in thepractice in Georgia today? It may be because you have notinvited them to insure the future value of their degree byjoining the Georgia Pharmacy Association like you havedone.

Yes all pharmacists reap the rewards of GPhA andtherefore all ought to be invited to be a part of theassociation that delivers so much for the profession ofpharmacy in Georgia.

Invite a friend today to join you in GPhA.

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 BracewellExecutive Vice President / CEO

7The Georgia Pharmacy Journal June 2011

Pharmacy Degree Insurance:

Is Yours Up-to-date?

June 2011 Journal:Layout 1 6/14/2011 9:25 AM Page 7

Page 8: The Georgia Pharmacy Journal: June 2011

The Georgia Pharmacy Journal June 20118

Titanium Level($2400 minimum pledge)Michael E. Farmer, R.Ph.David Graves, R.Ph.Jeffrey L. Lurey, R.Ph.Robert A. Ledbetter, R.Ph.Marvin O. McCord, III, R.Ph.Judson L. Mullican, R.Ph.W.A. (Bill) Murray, R.Ph.Mark L. Parris, Pharm.D.Fred F. Sharpe, R.Ph.Jeff Sikes, R.Ph.

Platinum Level($1200 minimum pledge)Robert Bowles, Jr., R.Ph., CDM, CftsJim BracewellT.M. Bridges, R.Ph.Bruce L. Broadrick, Sr., R.Ph.Thomas E. Bryan, Jr., B.S.William G. Cagle, Jr., R.Ph.Keith Chapman, R.Ph.Hugh M. Chancy, R.Ph.Dale M. Coker, R.Ph., FIACPJ. Ashley Dukes, R.Ph.Jack Dunn, R.Ph.Stewart Flanagin, Jr., R.Ph.Andy FreemanAnn Hansford, R.Ph.Robert M. Hatton, Pharm.D.Alan M. Jones, R.Ph.Ira Katz, R.Ph.Harold M. Kemp, Pharm.D.J.Thomas Lindsey, R.Ph.Brandall S. Lovvorn, Pharm.D.Eddie M. Madden, R.Ph.Jonathan Marquess, Pharm.D., CDE, CPTPam S. Marquess, Pharm.D.Kenneth A McCarthy, R.Ph.

Scott Meeks, R.Ph.Drew Miller, R.Ph., CDMLaird Miller, R.Ph.Jay Mosley, R.Ph.Allen Partridge, Jr., R.Rh.Tim Short, R.Ph.Dean Stone, R.Ph., CDMChris Thurmond, Pharm.D.

Gold Level($600 minimum pledge)Larry Batten, R.Ph.James Bartling, Pharm.D., ADA, CAC IILiza G. Chapman, Pharm.D.Patrick M. Cook, Pharm.D.Mahlon Davidson, R.Ph., CDMJim Elrod, R.Ph.H. Neal Florence, R.Ph.Kevein Florence, R.Ph.Ted Hunt, R.Ph.Robert B. Moody, III, R.Ph.Sherri S. Moody, Pharm.D.Sharon M. Sherrer, Pharm.D.Michael T. TarrantJeffrey Richardson, R.Ph.Houston L. Rogers, Jr., Pharm.D., CDMRobert Anderson Rogers, R.Ph.Daniel C. Royal, R.Ph.Dean Stone, R.Ph., CDMThomas H. Whitworth, R.Ph., CDM

Silver Level($300 minimum pledge)Renee D. Adamson, Pharm.D.John L. Colvard, J. R.Ph.Chandler Conner, R.Ph.F. Al Dixon, R.Ph.Marshall L. Frost, Pharm.D.

James Jordan, R.Ph.Michael O. Iteogu, Pharm.D.John KalvelageWillie O. Latch, R.Ph.W. Lon Lewis, R.Ph.Michael McGee, R.Ph.William J. McLeer, Sr., R.Ph.Albert Nichols, R.Ph.Kalen Beauchamp Porter, Pharm.D.Bill Prather, R.Ph.Sara Mandy Reece, Pharm.D.Edward Franklin Reynolds, R.Ph.David Jack Simpson, R.Ph.James Thomas, R.Ph.Alex S. Tucker, R.Ph.Brandon UllrichAlan M. Voges, Sr., R.Ph.Flynn W. Warren, M.S., R.Ph.Oliver C. Whipple, R.Ph.Walter Alan White, R.Ph.

Bronze Level($150 minimum pledge)Monica M. Ali-Warren, R.Ph.John Bowen, R.Ph.James R. Brown, R.Ph.Mark C. Cooper, R.Ph.Michael A. Crooks, Pharm.D.Charles Alan Earnest, R.Ph.Amanda R. Gaddy, R.Ph.Amy S. Galloway, R.Ph.Johnathan Hamrick, R.Ph.EdKalvelageSteven KalvelageMarsha Kapiloff, R.Ph.William E. Lee, R.Ph.Earl Marbut, R.Ph.Leslie Ponder, R.Ph.Richard Brian Smith, R.Ph.

Pharm PAC Enrollment

Pledge Year 2010-2011

If you made a gift or pledge to Pharm PAC and your name does not appear above please, contact Kelly J. McLendon [email protected] or 404-419-8116. Donations made Pharm PAC are not considered charitable donations and arenot tax deductible.

June 2011 Journal:Layout 1 6/14/2011 9:25 AM Page 8

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The Georgia Pharmacy Journal June 20119

Pharm PAC Contributors’ List ContinuedMarion Wainright, R.Ph.Steven Wilson, R.Ph.Sharon B. Zerillo, R.Ph.Jackie WhiteJohn KalvelageCarey B. Jones, R.Ph.Fred W. Barber, R.Ph.Jeffrey Richardson, Jr., R.Ph.

Members(no minimum pledge)Jill AugustineClaude W. Bates, B.S.Chad J. Brown, R.Ph.Max C. Brown, R.Ph.Lucinda F. Burroughs, R.Ph.Shobhna D. Butler Pharm.D.Waymon M. Cannon, R.Ph.Walter A. Clark, Jr., R.Ph.Jean N. Courson, R.Ph.Carleton C. Crabill, R.Ph.Charles Gass, R.Ph.Alton D. Greenway, R.Ph.J. Clarence Jackson, Jr., R.Ph.Gina R. Johnson, Pharm.D., BCPS, CDEJoshua Kinsey, Pharm.D.Ashley S. LondonCharles Lott, R.Ph.Tracie D. Lunde, Pharm.D.Randall Marett, R.Ph.Ralph K. Marett, M.S.Roy McClendon, R.Ph.Steve Perry, R.Ph.Whitney B. Pickett, Pharm.D.Donald Piela, R.Ph.Rose Ann Pinkstaff, R.Ph.Michael Reagan, R.Ph.Leonard Franklin Reynolds, III, R.Ph.James Riggs, R.Ph.Victor Serafy, R.Ph.Harry A. Shurley, Jr., R.Ph.James Strickland, R.Ph.Leonard Templeton, R.Ph.Heatwole Thomas, R.Ph.James. E. Stowe, Jr., R.Ph.Erica Veasley, R.Ph.William D. Whitaker, R.Ph.Jonathon A. Williams, Pharm.D.Michael R. Williams, R.Ph.

June 2011 Journal:Layout 1 6/14/2011 9:25 AM Page 9

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The Georgia Pharmacy Journal June 201110

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

Pharmacists Visit Washington D.C. to Advocate

for Pharmacy

During May 23-25, a group of GPhAAIP members attended theNational Community Pharmacists

Association meeting in Washington, DC.While in DC, they learned about legislationmaking it’s way through Congress thatbenefit that benefit the practice of Pharmacyincluding S. 1058 and its House companionbill HR 1971. These bills

Give patients a true choice of pharmacy.

Establish new consumer protections againstthe sale of sensitive patient information.

Help eliminate wasteful pharmaceuticalspending generated by pharmacy benefitmanagers (PBMs) switching patients tocostlier drugs, hoarding manufacturerrebates and billing plans inflated amountsfor prescription claims.

Level the playing field among pharmacies byallowing “any willing provider” that agreesto accept a health plan’s terms andreimbursement rates to participate in thatplan, so long as the pharmacy is licensed inthat particular state and eligible toparticipate in federal and state health plans(which remove any providers that commitfraud).

Allow legitimate oversight for fraud, notabusive pharmacy audits.

GPhA members in attendance met withtheir member of Congress and senior staffmembers of both Senators Isakson andChambliss to discuss these pieces oflegislation. Plans are being made now forGeorgia’s Congressional Delegation to visitPharmacies across the state duringCongress’s August recess.

by Andy FreemanDirector of Government Affairs

June 2011 Journal:Layout 1 6/14/2011 9:25 AM Page 10

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The Georgia Pharmacy Journal June 201111

June 2011 Journal:Layout 1 6/14/2011 9:25 AM Page 11

Page 12: The Georgia Pharmacy Journal: June 2011

*This is not a claims reporting site. You cannot electronically report a claim to us. To report a claim, call 800.247.5930.**Compensated endorsement.Not all products available in every state. The Pharmacists Life is licensed in the District of Columbia and all states except AK, FL, HI, MA, ME, NH, NJ, NY and VT. Check with your representative or the company for details on coverages and carriers.

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June 2011 Journal:Layout 1 6/14/2011 9:25 AM Page 12

Page 13: The Georgia Pharmacy Journal: June 2011

The Georgia Pharmacy Journal June 201113

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

Pharmacy School Student MembersVanaessa L. Clark, Dublin

Maryanna Bishop Durden, AthensAshley Nicole Turk, SavannahTracy Voechting, SharpsburgZachary Phillips, Gainesville

Trina Nguyen Vuong, LawrencevilleHeather Dawn Taxeras, SavannahCarmen Erica Ward, CedartownAshley Wilkins, Richmond HillPaul Prescott Langford, ShellmanIfeoma Nnebe, DouglasvilleTracie Ngo Lee, Woodstock

Cynthia Sue Kratina, Topeka, KSSophia Thomas, Marieta

Pharmacist Technician MembersBonnie Ann Eidson, WhitesburgWilliam Ronell Wood, ColumbusTeresa G. Jordan, Ball Ground

Stephanie Nicole Norris, ThomsonJackie Marie Verscharen, TempleAmy Lea Lester, GrovetownTiffany M. Stoney, Fairburn

Amy Brinkley Cosby, ThomsonKelly Anissa Bragg, Matinez

Jennifer Deann Beamer, AugustaNancy Kay Burke, Evans

Brandy Nicole Reese, Augusta

Associate MembersChristopher Canter, Kennesaw

New Graduate Pharmacist MembersAbraham Jacob Duncan, Clayton

Blake Powell, TiftonOfori Julius Quarcoo, CantonStephanie Louise Wood, Athens

Joint Pharmacist MembersAmy Smith Ryan, ThomasvilleDonald Earl Maner, Evans

Individual Pharmacist MembersVaspar H. Eddings, StockbridgeJay E. Ceesay, FayettevilleRoger Kevin O’Neal, Decatur

Omishola Adeyemo, Stone MountainWafiyyah Moore, Ellenwood

Joshua Timothy Mizelle, VidaliaStephen Joseph Mouton, Milledgeville

Traci Wilkerson, GrayJacqueline Williams Davis, Valdosta

Melanie L. Rudisill, AtlantaKrystin Tran, AtlantaRobert L. Peterson

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

professional pharmacy association!

June 2011 Journal:Layout 1 6/14/2011 9:25 AM Page 13

Page 14: The Georgia Pharmacy Journal: June 2011

The Georgia Pharmacy Journal June 201114

www.pharmacist.com

While regulations are being written for last year’s Affordable Care Act

(ACA) and APhA advocates for imple-mentation of the health care reform law’s pharmacy-friendly provisions, the Asso-ciation’s House of Delegates adopted additional policy on the pharmacist’s role in health care reform at the 2011 APhA Annual Meeting & Exposition in Seattle.

“This new policy on health care reform reaffirms the Association’s cur-rent activities,” Brian Lawson, PharmD, APhA Associate Director of Governance, told Pharmacy Today. “It really gives APhA staff and leaders guidance in their advocacy work on behalf of the profes-sion. In addition, it includes statements that articulate the profession’s beliefs regarding implementation by decision makers.”

Be vigilantThe official Association policy emerged from 2010–11 APhA Policy Committee recommendations resulting from its review of the topic assigned to it by the APhA Board of Trustees.

APhA President Marialice S. Bennett, BPharm, FAPhA, noted that health care reform was moving into the implementa-tion phase. She added that much of what pharmacy has asked for, and received, in health care reform remains unfunded.

“We need to be vigilant in making sure the role of the pharmacist in increasing access and quality while decreasing cost is not lost during implementation,” Ben-nett said. “It is a time of great opportu-nity and is an important time to lead from where we stand and advocate for what we can bring to the table to meet the goals of health care reform.”

Bennett called for continuing advo-cacy for the role of the pharmacist in key initiatives in ACA, including integrated

hubonpolicyandadvocacy

Policy adopted on health care reform

Regulatory scorecard: What is happening NOW!Proposed regulation receiving public comments:

Comments due by July 5 on proposed rule that would require specified providers (hospitals, federally quali-fied health centers, rural health clin-ics to offer annual (and if necessary, pandemic) influenza vaccination to patients

Requests for information for which com-ment periods have closed:

HHS: Survey, to be approved by the Office of Management and Budget, of employers to learn about their experiences and attitudes regarding workplace wellness programs

CMS: Community-based Care Tran-sitions Program under ACA provides funding to community-based orga-nizations in partnership with acute care hospitals for the provision of care transition services delivered to high-risk Medicare beneficiaries

CMS: Advance Payment Initiative, one of three initiatives intended to help providers become accountable care organizations (ACOs)

Etc.: CMS: ACO Accelerated Development

Learning Session on June 20–22 in Minneapolis for ACO executive lead-ership teams, to be repeated in four regions of the country, with follow-up Web-based seminars and modules

For a complete list of all the issues and regulations being monitored and acted on by APhA, access the Gov-ernment Affairs section of pharma-cist.com. Also, print readers of the Hub should know that hyperlinks to pharmacist.com, Federal Register notices, and other useful websites can be accessed in the online version of the Hub, located at www.pharma-cytoday.org.

APhA policy on the pharmacist’s role in health care reform

1. APhA affirms that pharmacists are the medication experts whose ac-cessibility uniquely positions them to increase access to and improve quality of health care while decreas-ing overall costs.

2. APhA asserts that pharmacists must be recognized as the essen-tial and accountable patient care provider on the health care team responsible for optimizing outcomes through medication therapy man-agement (MTM).

3. APhA asserts the following: a. Medication Therapy

Management Services: Definition and Program Criteria is the standard definition of MTM that must be recognized by all stakeholders.

b. Medication Therapy Management in Pharmacy Practice: Core Elements of an MTM Service Model, as adopted by the profession of pharmacy, shall serve as the foundational MTM service model.

4. APhA asserts that pharmacists must be included as essential patient care providers and compen-sated as such in every health care model, including but not limited to, the medical home and accountable care organizations.

5. APhA actively promotes the outcomes based studies, pilot programs, demonstration projects, and other activities that document and reconfirm pharmacists’ impact on patient health and well being, process of care delivery, and overall health care costs.

6. APhA supports the development and delivery of interprofessional education programs that facilitate team�based delivery of care.

7. APhA strongly recommends that a comprehensive medication review conducted at least annually by phar-macists should be standard practice and a required component of health benefit programs for all patients.

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Page 16: The Georgia Pharmacy Journal: June 2011

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Page 17: The Georgia Pharmacy Journal: June 2011

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June 2011 Journal:Layout 1 6/14/2011 9:25 AM Page 17

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The Georgia Pharmacy Journal June 201118

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

AIP Provides Disaster Relief for Highland

Pharmacy in Ringgold, GAbyJim Bracewell

On Wednesday evening Dale Cope and his wife who ownHighland Pharmacy in Ringgold, GA., were planning to goto church, but services had been canceled due to thesevere weather in the area.

When Dale arrived home he turned on his television tostay up to date with the weather developing in his area.Dale remembers that the TV blinked a couple of times. Heheard a loud rumble so he went to his front porch wherehe found the wind blowing and the sky extremely dark.Suddenly his ears popped and he knew the tornado wasabout to descend upon his house.

He raced back into the house and in his words “in mymost severe commanding voice, I ordered my two sonsand wife into our basement. It was about 8:30 p.m. and amatter of a couple of minutes it was over. I climbed thesteps from the basement, opened the door and the housewas gone and so were all four of the family automobiles.”Dale said all he could see was devastation in all directions.

He and neighbors began to check on each family theycould reach on their street. Chainsaws were necessary toclear a path through the wreckage.

On that night Dale and his family, lost HighlandPharmacy, their home and their cars, but not their friendsat the Academy of Independent Pharmacy of the GeorgiaPharmacy Association.

As the photos show, Jim Bracewell on behalf AIPdelivered first of several checks to help Dale and his familyrecover from this ordeal. AIP has also invited Dale and hisfamily also to their guests at the GPhA Convention andAnnual meeting in Amelia Island, FL

All AIP owners should be proud of their relief efforts tohelp a fellow pharmacy owner when disaster struck. Thenext time a pharmacist wonders if a state association isgood for your practice and good for your future, ask DaleCope as he rebuilds in Ringgold, GA.

June 2011 Journal:Layout 1 6/14/2011 9:25 AM Page 18

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The Georgia Pharmacy Journal June 201119

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June 2011 Journal:Layout 1 6/14/2011 9:26 AM Page 21

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The Georgia Pharmacy Journal June 201122

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June 2011 Journal:Layout 1 6/14/2011 9:26 AM Page 22

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The Georgia Pharmacy Journal June 201123

Thomas A. Gossel, R.Ph., Ph.D., Professor Emeritus, Ohio Northern University, Ada, Ohio andJ. Richard Wuest, R.Ph., PharmD, Professor Emeritus, University of Cincinnati, Cincinnati, Ohio

continuing educat ion for pharmacists

Mult iple Sclerosis : Medical Management with Disease-Modifying Therapy

Volume XXIX, No. 5

Dr. Thomas A. Gossel and Dr. J. Richard -

ships to disclose.

Goal. The goal of this lesson is to discuss disease-modifying therapy for treatment of multiple sclerosis. Objectives. At the conclusion of this lesson, successful participants should be able to:

1. recognize the pharmacologic -

tion for drugs used in treatment of multiple sclerosis;

2. demonstrate an understand-ing of the mechanism of action, major adverse events and thera-peutic applications associated with the drugs;

3. identify the route and means of administering the drugs; and

4. exhibit knowledge of infor-mation relative to multiple sclero-sis pharmacotherapy to convey to patients and their caregivers.

Multiple Sclerosis – Past, Present and Future Multiple sclerosis (MS) was

literature early in the 19th century. It achieved full clinic-pathological characterization during the late decades of that century and began to reveal many of its mysteries con-cerning etiology and pathogenesis throughout the 20th century. As the

yielded somewhat to parenterally-administered disease-modifying

therapy (DMT). In 2010 approval

drug in a new category of therapies to follow – an orally-administered DMT. Future studies will no doubt continue to resolve issues of het-erogeneity and complexity of MS, and we can expect a mechanism-

successful strategies that will limit and repair the damage to central neurons.

Disease Overview MS is a chronic, neurodegenerative

-ease of the central nervous system (CNS) that affects an estimated 400,000 persons in the United States, and 2.5 million worldwide. It may be progressive or episodic. The disease course varies among patients and is categorized into four subtypes by clinical course: relapsing-remitting MS, secondary-progressive MS, primary-progres-sive MS, and progressive-relapsing MS. At onset, approximately 85 percent of all MS patients present with relapsing-remitting MS, of whom almost half will experience

a gradual progression of disability within 10 years of their initial at-tack, and 90 percent will develop

females more often than males, but males experience a later average age of onset of disease along with a faster progression to disability than females.

Pathogenesis. MS onsets when the immune system cannot prevent peripheral autoreactive T-cells (i.e., those outside the CNS) from becoming activated against myelin-associated antigens. These T-cells then cross a compromised blood-brain-barrier to enter into the CNS where they initiate

-nation of neurons within the CNS, while sparing peripheral nerves and muscles.

Myelin, the white lipid-protein complex (i.e., the “white matter” of the CNS) consists of parallel lay-ers of lipids including cerebroside (a general description of an acid amide of a fatty acid), phospholip-ids and cholesterol, which con-stitute 75 percent of myelin’s dry weight. This inhibits sodium and potassium movement across the neuronal membrane almost com-pletely, thus preventing genera-tion of neuronal action potentials. Damage to the myelin sheath can lead to disruption of electrical im-pulses to regions beyond the axons. Normal neuronal transmission is, therefore, delayed or terminated, thereby disrupting functions such

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as vision, sensation and coordina-tion of movement.

MS symptoms appear when the immune system can no longer prevent interaction between auto-reactive T-lymphocytes and myelin-associated antigens. Demyelination is noted as well-demarcated, focal, scattered and hardened lesions (i.e., plaques, or scleroses) upon the central neurons. The presence of these plaques, which may vary in size from 1 to 2 millimeters to sev-eral centimeters, is the hallmark of MS, and source of the descriptive terminology multiple sclerosis that

is followed by scar tissue forma-tion. Once neuronal injury occurs, the damage is usually irreversible; however, if remyelination should occur, it tends to be abnormal and incomplete.

Management of MS Altering the natural course of MS and diminishing the risk for progressive disability over time are pivotal aims in the clinical management of MS. The past three decades, especially, have shown

-ing the pathogenesis of MS, which has led to development of effective DMTs (Table 1), with many more currently in development. Despite this progress, huge challenges remain. The precise cause(s) of MS remains unknown, its pathophysi-ologic mechanisms are diverse, currently available therapies are

is achieved only when treatment begins early in its relapsing forms. As a chronic and so far incurable disease, therapy is required for an

time.MS management may be

categorized into two objectives: (1)

process and (2) treatment of specif-ic symptoms. The most important therapeutic goal for controlling the disease is to postpone or prevent long-term disability.

in Acute Relapses. It was noted in 1951 that MS patients treated

with adrenocorticotropic hormone (ACTH), an agent that stimulates synthesis and release of adrenocor-tical hormones, appeared to recover more quickly from acute exacerba-tions (relapses). The undesirable adverse effects associated with ACTH stimulated development and use of many synthetic gluco-corticoids. At this time, methyl-prednisolone (Medrol, and others) is the treatment of choice when corticosteroid therapy is chosen for treatment during periods of acute relapses. Current therapeutic man-agement of severe acute relapses of MS involves use of the drug admin-istered in a daily dose of 500 mg or 1 gm given IV. Treatment should be initiated promptly after symp-tom onset and continued three to

tapered doses of prednisone are useful or even desirable. Although corticosteroids hasten recovery from acute attacks, they do not prevent relapses.

It is speculated that these agents inhibit secretion of at least two cytokines (any of a number of regulatory proteins released by the immune system that act as intra-cellular mediators in the genera-tion of an immune response): tumor necrosis factor (TNF) and interleu-kin (IL)-6. Corticosteroids may also interfere with the synthesis and/or secretion of interferon (IFN)-gamma and IL-2 by activated T-cells. Consequently, DMTs result in faster recovery from relapses, but exhibit no demonstrable effect on the degree of disability, or tim-ing or severity of future relapses. Corticosteroids provide short-term

recovery in patients with acute MS attacks. There does not appear to

brief use.

The Multiple Sclerosis Council for Clinical Practice Guidelines and the National Multiple Sclerosis Society recommend the early use of DMTs in patients who have relaps-ing forms of MS. The interferons,

-ment in patients with relapsing-remitting MS. Mitoxantrone is used in relapsing disease that is intensifying, but is also given to patients with worsening secondary-progressive MS with or without relapses. Natalizumab is recom-mended primarily for patients who are unable to tolerate or have not responded adequately to other DMTs. Although clinical trials of some DMTs in patients with progressive forms of MS have failed to provide conclusive evidence of

are still used in these patients. There is strong evidence that early

the course of the disease. Indi-vidual decision for one or the other therapies is currently based on the preferred route of administration and individual tolerability of the agent used.

Neuronal injury due to demy-elination, which is responsible for the permanent disability in MS, is known to occur early in the disease process. Studies suggest a causal

and loss of neuronal function along with the accepted role of chronic demyelination. Moreover, highly active disease early on correlates positively with increased disabil-ity at a later stage, along with increased likelihood of secondary progression. Thus, early treatment could potentially delay or prevent onset of permanent disability. Therapy should also be continued in the absence of overt symptoms during periods of remission, to prevent or slow the development of new plaques or worsen existing plaques. Despite the recommenda-tion for initiating treatment early

about one-half of all MS patients are believed to currently use a DMT.

Interferons. These drugs are successful DMTs for treating MS. They alter the immune system in an attempt to control the immu-nologic events that lead to demy-elination of central neurons. They include the four IFN-beta products,

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The Georgia Pharmacy Journal June 201125

which differ only slightly in their pharmacodynamics and pharma-cokinetics, and glatiramer acetate. (see Table 1).

The three known forms of

), and are produced by different cells in the body. Each IFN possesses antiviral activity, but they have different actions on the immune system. In MS, the immune system is “deregu-lated,” which permits damage to the myelin sheath that normally insulates central neurons. Of the

bearing protein produced by cells in the skin and connective tissues

-clusively to be effective in treating relapsing forms of MS.

the immune system by interrupt-ing proliferation of T-lymphocytes. This down-regulation is not spe-

pathogenesis of MS. Moreover, the IFNs may also modify non-autoim-mune functions.

-lapses, retards disease progression, and reduces the number of MS lesions within the CNS. The exact mechanism of action is unknown. Its immune-modulating propensity may include the ability to inhibit synthesis of IFN , augment activity of T-suppressor cells, and inhibit antigen expression induced by IFN on the surfaces of antigen-presenting cells.

This biosynthetic form of type 1 IFN is a product of recombinant DNA technol-

cultures of Escherichia coli. It is not glycosylated like naturally

acid sequence differs slightly from the native form in that cysteine has been substituted in the drug for serine in the natural form. The drug (Betaseron, Extavia) is self-administered by subcutaneous injection every other day.

The most frequent adverse event reported in clinical trials was

symptoms of fever, chills, head-

ache, myalgia, arthralgia, nau-sea, vomiting and diarrhea. This usually resolved within 12 hours and tolerance developed gradually in most patients. Acetaminophen, ibuprofen, or aspirin can gener-ally control symptoms although the syndrome may be particularly troublesome for some patients. Depression, anxiety, confusion, and other mental changes are also re-ported. Patients to be treated with Betaseron should be informed that depression with suicidal tendency may be an adverse effect. It is sug-gested that patients be evaluated carefully if they show tendencies

decreases in white blood cell counts and elevation of liver enzymes have been reported for type 1 IFNs. Baseline, along with periodic labo-ratory tests are, therefore, recom-mended to monitor for possible leukopenia (reduced leukocytes), thrombocytopenia (decreased plate-lets), and abnormal liver function.

. The second IFN in

Rebif). Originally extracted from

arduous, produced only limited amounts of IFN and required a

-cedure. Today, these products are manufactured via recombinant DNA technology using Chinese

hamster ovary cells. Mammalian cells are an ideal medium because they are able to facilitate addition of sugar molecules to the structure, a process known as glycosylation, which produces a carbohydrate structure similar to that found in

The most common adverse ef--

za-like symptoms, abdominal pain, depression, liver enzyme elevations and hematologic abnormalities. Patients should be aware of signs of jaundice such as yellowing of the skin or whites of the eyes, easy bruising and loss of appetite. Ther-apy should be stopped if jaundice or other adverse symptoms sugges-tive of liver dysfunction appear.

Avonex is administered by once-weekly IM injection; Rebif is given SC, three times weekly.

Glatiramer Acetate. The

glatiramer acetate (Copaxone) is a synthetic non-IFN, nonsteroi-dal agent that is a member of the glatiramoid class of compounds. It is described as the acetate salt of a standardized, random-sequence polypeptide consisting of four natu-rally occurring amino acids, L-glu-tamic acid, L-lysine, L-alanine, and L-tyrosine, that results in a copoly-mer structurally similar to myelin basic protein, a major component of myelin.

of multiple sclerosis

Glatiramer Copaxone SC injection 20 mg daily Fingolimod Gilenya Oral capsule 0.5 mg once daily

Second-line Mitoxantrone Novantrone, IV injection 12 mg/m2 given as a short

& others (5-15 min) infusion every 3 months

Natalizumab Tysabri IV injection 300 mg infused over 1 hour every 4 weeks

SC, subcutaneous; IM, intramuscular; IV, intravenous

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Page 26: The Georgia Pharmacy Journal: June 2011

the frequency of clinical exacer-

when clinically indicated.

months after discontinuing use of

back pain, liver transaminase

ketoconazole and vaccines should

The Georgia Pharmacy Journal June 201126

Although its mechanism of action is unknown, it is proposed that glatiramer acts by modifying immune processes responsible for the pathogenesis of MS. It works through a unique mechanism. Each of the two processes that appear to be triggered by the drug, induc-

T-cells in the periphery and the inhibition of effector T-cells, has the capacity to interrupt the auto-

results in demyelination of central neurons.

Controlled clinical trials have shown that glatiramer is at least

noted early after therapy is begun, and appears to increase with time. Glatiramer has the most favorable

-proved parenterally-administered drugs for MS. It may be the drug of choice for individuals who can-not tolerate IFN therapy or, who after taking the drugs awhile, must reduce their dosage due to labora-tory abnormalities or onset of other problems.

Following administration of glatiramer, patients may experi-ence a transient, systemic, immedi-ate post-injection reaction consist-

-tations, anxiety, dyspnea, throat constriction and urticaria. There are no known drug-drug interac-tions with glatiramer. It does not increase the risk of hepatotoxicity or depression, as is the case with IFN therapy.

Glatiramer is administered as a SC injection each day.

Mitoxantrone. Mitoxantrone (Novantrone, and others) is an analog of doxorubicin (Adriamycin). Before approval for use in MS, it was used to treat prostate cancer and nonlymphocytic leukemia. It is the only drug indicated for treat-ment of secondary-progressive MS, and is also approved for patients with progressive-relapsing MS. It is used in patients refractory to other immunomodulators and in worsening disease. At this point, mitoxantrone is the only DMT available generically.

Mitoxantrone acts via several mechanisms. It is taken into DNA strands where it inhibits prolifera-tion of T-cells, B-cells and macro-phages. Moreover, it decreases

cytokines and increases an anti--

tion of the T-cell suppressor func-tion. In addition, mitoxantrone inhibits macrophage-mediated myelin degradation.

In patients receiving mitox-antrone, adverse reactions that can usually be managed include transient leukopenia and neutro-penia peaking around 10 to 14 days post-infusion, liver enzyme elevation, nausea, alopecia, urinary tract infections and bluish urine discoloration. Like its counterpart doxorubicin, more serious effects include functional cardiac changes.

decrease in left ventricular ejection fraction among patients receiving mitoxantrone. Reports of irrevers-ible congestive heart failure, some-times appearing years after drug discontinuation, are also recorded. Therefore, mitoxantrone use should be limited to persons with normal cardiac function, at a dose and frequency of 12 mg/m2 once every three months. Periodic cardiac monitoring is required throughout treatment. The lifetime cumulative dose is limited to 140 mg/m2 (ap-proximately eight to 12 doses over two to three years). Because mitox-antrone can increase the risk for infection by decreasing the number of white blood cells, blood counts should be obtained and liver func-tion evaluated prior to each dose.

Natalizumab. Natalizumab (Tysabri) is a humanized monoclo-nal antibody approved as mono-therapy for treatment of relapsing-remitting MS in patients who have experienced an inadequate response to or cannot tolerate alter-

patients with chronic progressive MS have not been fully established.

Natalizumab is an integrin receptor (a family of cell-surface receptors that mediate interactions among cells and components of

the extracellular matrix) antago-4 subunit of

4 1 4 7 integrins expressed on the surface of all leukocytes except neutrophils. This action inhibits adhesion of leukocytes to their counter-receptor(s). Natali-zumab is believed to inhibit the

4 1 integrin with vascular cell adhesion molecule 1,

4 7 integrin with mucosal adhesion cell adhesion molecule 1, respectively. By inhibiting these interactions, natalizumab may

responsible for CNS lesions. Natalizumab was originally

approved in 2004 for treatment of relapsing-remitting MS. It was withdrawn in 2005 after three pa-tients developed progressive multi-focal leukoencephalopathy (PML), a rare but serious opportunistic viral infection of the brain. Market-ing resumed in 2006 with a boxed warning cautioning about the risk of PML. Subsequently, more than

have been reported in association with natalizumab therapy. In 2008 FDA issued another warning advis-ing of a risk of hepatic injury with natalizumab. At present, the drug is available only through a special restricted distribution program called the “TOUCH Prescribing Program.”

ProtocolMS has a progressive course that

strict adherence to DMT protocol. Adherence is the extent to which a patient’s behavior coincides with a treatment plan. Patients with good adherence can expect a 30 percent decrease in relapse rates; missed dosages or increased frequency of parenteral therapy, however, are associated with continued disease progression. Relapses may sig-nify poor adherence, underscoring the need for monitoring therapy closely. This is particularly hard to sustain because these drugs require parenteral administration throughout life, with a modest reduction in the rate of disease pro-

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gression such that the patient may not easily perceive improvement. For many patients, especially those with newly diagnosed MS, the thought of self-injection is unpleas-ant and may add undue stress to

to accept. Convincing patients to use a drug that requires parenteral administration every other day or

only suffer from symptoms they may consider to be mild.

A number of studies have estimated the proportion of MS patients who discontinue treatment with DMTs. One post-marketing trial of IFN therapy revealed that the proportion discontinuing treat-ment within three years ranged be-

Similar results were obtained by other studies, including 39 percent of relapsing-remitting MS pa-

over a two-year period following

1a or glatiramer. Patients in all

relapsing-remitting MS.The factors that affect adher-

ence with treatment in MS patients are well known. In the literature,

or glatiramer, most of them dis-

two years of treatment with 30 to 50 percent reportedly due to a

to 70 percent were due to adverse effects, the primary ones included

like symptoms and depression. Fingolimod. The long awaited

-tion (Gilenya) for treating relapsing forms of MS is welcome news for patients. The potential advantages of oral therapy for modifying the course of relapsing-remitting MS

in 1993, patients and practitioners have been eagerly anticipating ap-proval of a therapy that avoids the use of needles.

Fingolimod (Table 2) is a syn-thetic structural analog of sphin-gosine 1-phosphate (S1P), which is a naturally occurring lysophospho-lipid, a potent signaling lipid. S1P

of S1P receptors (S1P1-5) distrib-uted throughout the body, which lead to a variety of physiologic pro-cesses. S1P1-3 are found throughout the immune, cardiovascular and central nervous systems. Their activation on smooth muscle and endothelial cells regulates vascu-lar homeostasis and permeability. Activation of S1P1 receptors on atrial muscle regulates heart rate. S1P4to the hematopoietic (pertaining to or affecting the formation of blood cells) and lymphoid tissues, and S1P5 is expressed in the white mat-ter of the CNS.

Fingolimod is a prodrug that undergoes rapid phosphorylation in vivo by sphingosine kinase into

-cally active compound. The drug has a novel mechanism of action. Fingolimod-phosphate is a nonse-lective S1P receptor agonist that

receptor subtypes to modify their signaling pathways. Because of its lipophilic nature, the drug readily crosses the blood-brain-barrier to interact with S1P receptors widely expressed throughout the CNS. Binding to S1P1 receptors is of particular importance to the drug’s proposed mechanism of action in MS. S1P1, highly expressed on T- and B-lymphocytes, is respon-sible for regulating their egress from lymphoid tissue. Binding of

1 acts to down-regulate the receptor with subsequent sequestration (isola-tion) of lymphocytes in the lymph tissue, to prevent their recircula-tion, and reducing peripheral lym-phocyte counts. Fingolimod is not believed to destroy lymphocytes; therefore, many immune functions including activation, proliferation and effector functions of T- and B- lymphocytes remain undisturbed during treatment. However, im-mune function that relies on naïve

T-cells and central memory cells may be reduced or delayed. Given the theory that aggressive lympho-cyte penetration into the CNS con-

Highlights of prescribing information for fingolimod

: GilenyaManufacturer: Novartis Pharmaceutical Corp, East Hanover, New JerseyApproval date: September 2010Indications & use: Treatment

of patients with relapsing forms of multiple sclerosis to reduce

the frequency of clinical exacer- bations and to delay the accumu- lation of physical disability.

Dosage & administration: 0.5 mg orally once daily, with or without food

Dosage form & strength: 0.5 mg hard capsules

Contraindications: NoneWarnings & precautions: Bradycardia and/or atrioventricu-

lar block Gilenya: Observe patients.

Infections: Gilenya may increase risk of infection.

Macular edema: Macular edema may occur with or without visual symptoms.

Decreased pulmonary tests with Gilenya: Obtain spirometry & diffusion lung capacity for CO

when clinically indicated. Hepatic effects: Drug may in-

crease liver transaminases. Fetal risk: Women of childbearing

age should use effective contra- ception during & for two

months after discontinuing use of the drug.

Adverse effects: Reported at incidence of >10 percent were

back pain, liver transaminase elevations and cough.

Drug interactions: Class 1a or Class III antiarrhythmic drugs, beta-adrenergic blockers,

ketoconazole and vaccines should be used cautiously.

Medication Guide: An FDA- approved Medication Guide must be dispensed with each new

Gilenya.

The Georgia Pharmacy Journal June 201127

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The Georgia Pharmacy Journal June 201128

Release date: 5-15-11 Expiration date: 5-15-14

CE Hours: 1.5 (0.15 CEU)

This lesson is a knowledge-based CE activity and is targeted to phar-macists in all practice settings.

The Ohio Pharmacists Foundation Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

neural degeneration via demyelina-tion found in MS, the drug’s major

sequester lymphocytes within the lymphoid tissues. Moreover, S1P1 receptors expressed in the CNS are known to modulate neurogen-esis (development of neurons) and neural function. Fingolimod may, therefore, have the ability to facili-tate restoration of nerve cell func-tion and supplement endogenous CNS repair.

Fingolimod has been shown to improve myelination in animal models of experimental allergic

wide variety of graft-rejection and autoimmune models. In these situ-

-tion of macrophages to the CNS, conserves expression of myelin genes, and is active in prophylactic and therapeutic regimens. It has even been shown to reverse demy-elination in experimental models.

The most common adverse events reported in 10 to 20 percent

-cluded fatigue, melanocytic nevus (also known as a banal nevus or ne-

virus infection, lower respiratory tract or lung infection, back pain, diarrhea, cough and abnormal liver function tests. Effects occurring in

treated patients in premarketing clinical trials were nasopharyngitis and headache. Serious adverse events occurred in 7 to 11 percent and included three deaths, the causes listed as disseminated pri-mary varicella zoster infection, her-pes simplex encephalitis and sui-cide. Serious adverse events noted in more than 1 percent of patients included MS relapse, basal cell car-cinoma and sinus bradycardia. The cardiovascular events were consis-tent with the known presence of S1P receptors in myocytes. Brady-cardia appears to be transient and

maximal reduction in heart rate of eight beats per minute in the 0.5-mg group and 10 beats per minute in the 1.25-mg group occurred four

began restoring at six hours. Most cases of bradycardia were asymp-tomatic and resolved within 24 hours. The long-term implications of this are unclear.

Other clinical adverse events observed during these trials are notable. Edema was reported in a small percentage of patients. Six of seven cases resolved within six months upon drug discontinua-tion. Skin cancer was reported in phase 2 testing. In two trials, 15

found to have skin cancer, all successfully excised. Laboratory abnormalities included decreased lymphocyte count, mild decrease in mean forced expiratory volume in one second (FEV1), and a reversible increase of alanine transferase to greater than three times the upper limit of normal.

DMT can be considered in all MS -

ease. The drugs currently available

appear to delay the progression of

wave of active therapies and will be followed by other, possibly more potent and less toxic, oral drugs. Fingolimod’s novel mechanism of action and convenient route of administration distinguish it from all other FDA-approved DMTs for treating relapsing forms of MS. The future should bring improved understanding of how the immune

-ences, and genetics interact in MS. Reversing disability is a goal for therapy. At this point, the future for patients with MS looks much brighter than it did at the onset of the 21st century.

The authors, the Ohio Pharmacists Founda-tion and the Ohio Pharmacists Association disclaim any liability to you or your patients resulting from reliance solely upon the infor-mation contained herein. Bibliography for additional reading and inquiry is available upon request.

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The Georgia Pharmacy Journal June 201129

may 2011

continuing educat ion quiz Mult iple Sclerosis : Medical Management with Disease-Modifying Therapy

Program 0129-0000-11-005-H01-P0.15 CEUPlease print.

Name________________________________________________

Address_____________________________________________

City, State, Zip______________________________________

Email_______________________________________________

Return to Correspondence Course, OPA,2674 Federated Blvd, Columbus, OH 43235

or fax to 614.586.1545

To receive CE credit, your quiz must be postmarked no later than May 15, 2014. A passing grade of 80% must be attained. CE state-ments of credit are mailed February, April, June, August, October, and December. Send inquiries to [email protected].

your answer.1. [a] [b] [c] [d] 6. [a] [b] [c] 11. [a] [b] [c] [d]2. [a] [b] 7. [a] [b] [c] [d] 12. [a] [b] [c] 3. [a] [b] 8. [a] [b] [c] [d] 13. [a] [b] 4. [a] [b] [c] [d] 9. [a] [b] [c] 14. [a] [b] [c] [d] 5. [a] [b] [c] [d] 10. [a] [b] [c] [d] 15. [a] [b] [c] [d]

I am enclosing $5 for this month’s quiz made payable to: Ohio Pharmacists Association.

1. Rate this lesson: (Excellent) 5 4 3 2 1 (Poor)2. Did it meet each of its objectives? yes no If no, list any unmet_______________________________3. Was the content balanced and without commercial bias? yes no4. Did the program meet your educational/practice needs? yes no5. How long did it take you to read this lesson and complete the quiz? ________________ 6. Comments/future topics welcome.

1. At onset, the highest percentage of patients with MS present with which of the following forms? a. Primary-progressive c. Relapsing-remitting b. Progressive-relapsing d. Secondary-progressive 2. Myelin is the CNS’: a. grey matter. b. white matter.

3. Once neuronal injury occurs in patients with MS, it is usually: a. irreversible. b. reversible. 4. Therapy with corticosteroids in patients with MS: a. prevents relapses, but does not hasten recovery from acute attacks. b. hastens recovery from acute attacks and prevents relapses. c. does not prevent relapses nor hasten recovery from acute attacks. d. hastens recovery from acute attacks, but does not prevent relapses.

5. Despite the recommendation for initiating treatment

patients believed to use disease-modifying therapy is: a. one-fourth. c. one-half. b. one-third. d. two thirds.

6. Which of the following forms of interferon has been shown to be effective in treating relapsing forms of MS?

)

-lowing trade name products should be dispensed? a. Betaseron c. Copaxone

8. Which of the following is the only currently available oral form of MS therapy? a. Betaseron c. Copaxone

9. Controlled clinical trials have shown that glatiramer is: a. less effective than the interferons. b. at least as effective as the interferons. c. more effective than the interferons.

10. Mitoxantrone was used to treat which of the follow-ing types of cancer? a. Breast c. Lung b. Colon d. Prostate

11. Natalizumab antagonizes which of the following types of receptors? a. Integrin c. Hyalin b. Insulin d. Hemoglobin

12. The response to S1P4 -phoid and which of the following types of tissues? a. Hematophagic c. Hematopoietic b. Hematoplegic

13. Fingolimod is: a. believed to destroy lymphocytes. b. not believed to destroy lymphocytes.

a. once daily. c. three times a day. b. twice daily. d. four times a day.

15. Only three deaths occurred in patients in clinical tri-

each of the following EXCEPT: a. disseminated primary varicella zoster infection. b. herpes simplex encephalitis. c. myocardial infarction. d. suicide.

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The Georgia Pharmacy Journal June 2011 31

The Georgia Pharmacy Journal

Editor: Jim [email protected]

Managing Editor & Designer: Kelly [email protected]

The Georgia Pharmacy Journal® (GPJ) is the official publication of theGeorgia Pharmacy Association, Inc. (GPhA). Copyright © 2011, GeorgiaPharmacy Association, Inc. All rights reserved. No part of this publicationmay be reproduced or transmitted in any form or by any means, electronicor mechanical including by photocopy, recording or information storageretrieval systems, without prior written permission from the publisher andmanaging editor.

All views expressed in bylined articles are the opinions of the author anddo not necessarily express the views or policies of the editors, officers ormembers of the Georgia Pharmacy Association.

ARTICLES AND ARTWORKThose who are interested in writing for this publication are encouraged torequest the official GPJ Guidelines for Writers. Artists or photographerswishing to submit artwork for use on the cover should call, write or e-mailthe editorial offices as listed above.

SUBSCRIPTIONS AND CHANGE OF ADDRESSThe Georgia Pharmacy Journal® (GPJ) (ISSN 1075-6965) is distributed asa regular membership service, paid for through allocation of membershipdues. Subscription rate for non-members is $50.00 per year domestic and$10.00 per single copy; international rates $65.00 per year and $20.00single copy. Subscriptions are not available for non-GPhA memberpharmacists licensed and practicing in Georgia.

The Georgia Pharmacy Journal® (GPJ) (ISSN 1075-6965) is publishedmonthly by the GPhA, 50 Lenox Pointe NE, Atlanta, GA 30324.Periodicals postage paid at Atlanta, GA and additional offices.POSTMASTER: Send address changes to The Georgia PharmacyJournal®, 50 Lenox Pointe, NE, Atlanta, GA 30324.

ADVERTISINGAdvertising copy deadline and rates are available at www.gpha.org uponrequest. All advertising and production orders should be sent to the GPhAheadquarters as listed above.

GPHA HEADQUARTERS50 Lenox Pointe, NEAtlanta, Georgia 30324Office: 404.231.5074Fax: 404.237.8435 www.gpha.org

Print: Star Printing - 770.974.6195

2010 - 2011 GPhA

BOARD OF DIRECTORS

Name PositionEddie Madden Chairman of the BoardDale Coker PresidentJack Dunn President-ElectRobert Hatton First Vice PresidentPamala Marquess Second Vice PresidentJim Bracewell Executive Vice President/CEOHugh Chancy State-at-LargeRobert Bowles State-at-LargeKeith Herist State-at-LargeJonathan Marquess State-at-LargeSharon Sherrer State-at-LargeLiza Chapman State-at-LargeMary Meredith State-at-LargeHeather DeBellis Region One PresidentFred Sharpe Region Two PresidentJohn Drew Region Three PresidentAmanda Gaddy Region Four PresidentShobhna Butler Region Five PresidentAshley Faulk Region Six PresidentMike Crooks Region Seven PresidentLarry Batten Region Eight PresidentDavid Gamadanis Region Nine PresidentChris Thurmond Region Ten PresidentMarshall Frost Region Eleven PresidentKen Eiland Region Twelve PresidentRenee Adamson ACP ChairmanJosh Kinsey AEP ChairmanDon Davis AHP ChairmanIra Katz AIP ChairmanDeAnna Flores APT ChairmanLance Faglie ASA ChairmanJohn T. Sherrer Foundation ChairmanMichael Farmer Insurance Trust ChairmanSteve Wilson Ex Officio - President, GA Board of

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 ASPSukh Sarao Ex Officio UGADavid Bray Ex Officio UGA ASP

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