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Pharmacists’ Advocacy Achieves GPhA 2011 Convention Results June 18-22, 2011 Register Now!
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Celebrating 30 years of service to the Pharmacists of Georgia!
Let us be Your Insurance Resource Join us in celebrating 30 years of serving the members of 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
Georgia Pharmacy Association Members Take Advantage of Premium 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 cars and 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 a devastating impact on individuals, families and businesses. During the course of your career, you are 3½ times more 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 receive premium discounts up to 30% on high-quality Individual Disability Income Insurance from Principal Life Insurance Company.
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. For costs and details of coverage, contact your Principal Life financial representative.
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Departments
Governor Signs Pharmacy Bills Into Law
8 Pharm PAC 2010-2011 13 GPhA New Members 31 GPhA Board of Directors
Advertisers FEATURE ARTICLES
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Pharmacists Visit Washington D.C. to Advocate for Pharmacy APhA Health Care Reform Information AIP Provides Disaster Relief for Highland Pharmacy in Ringgold, GA
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The Insurance Trust Principal Financial Group Financial Network Associates Logix, Inc. Melvin Goldstein, P.C. Pharmacists Mutual Companies AIP GPhA Workers’ Compensation GoToWebinar/GoToMeeting CPE Cruise GPhA Career Center PQC University of Florida PACE Allinace The Insurance Trust
Continuing Education for Pharmacists: Multiple Sclerosis: Medical Management with Disease-Modifying Therapy
COLUMNS
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For an up-to-date calendar of events, log onto
President’s Message
www.gpha.org.
Editorial
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PRESIDENT’S MESSAGE Dale M. Coker, R.Ph., FIACP GPhA President
Words to Remember
ow many times have you heard a lecture, speech or sermon and by the next day, not only forgotten the theme of the message, but couldn’t recall even a single word? If you’re like me, this has probably happened to you more than you would like to admit. While attending my daughter’s hooding and commencement ceremonies at Mercer School of Pharmacy and Health Sciences, I heard words directed to the graduating class that I not only remembered the next day, but I think they will stick with me and bear repeating.
pharmacist in the state could have heard. Dr. Godsey reminisced that he had been sitting in an establishment on Royal Street in the Big Easy, otherwise known as New Orleans, contemplating what he would say to the graduating class of 2011. He wrote three words on a napkin. Those words were thought, passion and grace. Again, I had a flash- back (I swear I never did LSD in college) to a time in my career when I felt like I was in a dead end situation, where I felt that my thinking was being done for me, which robbed me of my passion for my profession. The grace was still there, as I always lived by the adage of treating my customers the way I would want to be treated, but I was running on empty because the engine (thought) was not being fueled with passion, because there was no passion left. Fortunately, I made a career change and rediscovered the passion I felt when I was sitting in an auditorium listening to my own commencement speech, which, sadly to say, I don’t remember one word. To credit Dr. Godsey’s wisdom, he made an extra effort to ensure remembrance by handwriting his three words on individual napkins for over 1,000 graduates of the combined Mercer schools.
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Dr. Steve Wilson, Pharm. D., president of the Georgia Board of Pharmacy, acknowledged in advance that the graduates had more on their minds than his presentation at their hooding ceremony, but he asked them to remember just a couple of thoughts. The one thought that resonated with me was Steve’s emphasis on the importance of showing up. I flashed back to some GPhA region meetings in past years when the meeting space was full of pharmacists, then to the past couple of years, when some of the same meetings only had seven to ten pharmacists in attendance. I think it is easy to underestimate the value of showing up. VIP day at the Capitol is a prime example. Showing up conveys the message to your colleagues and to your elected officials that you care about the issues that affect how you are able to practice your profession.
After hearing Dr. Godsey’s presentation , I thought back to what Steve Wilson said about showing up, and came to the conclusion that passion is what drives me to show up. This is what drives me to make an annual trip to Washington to attend The International Academy of Compounding Pharmacist’s Compounders on Capitol Hill. This event allows me to join with my compounding pharmacist colleagues to fight for our right to do what
Mercer’s commencement speaker, Dr. R. Kirby Godsey, Ph.D., who was President and CEO of Mercer University for 27 years, gave a poignant message that I wish every The Georgia Pharmacy Journal
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pharmacists have done for generations, to prepare compounded prescriptions upon a written order by a medical practitioner for a patient. As unbelievable as it sounds, we have a federal agency which contends that every compounded prescription is subject to a new drug approval process. Battling this kind of logic makes it an easy decision to show up and show my passion for what I know is right.
In summary, never forget the importance of showing up, keep your thinking cap on, find something to be passionate about, and above all, live a life of grace. I would also 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 our great profession as your president. Selah.
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GPhA Needs You and Your Pharmacy Knowledge We are looking for a few good writers to write CPE Articles for the GPhA Journal. If you are interested in building your resume and helping GPhA create the premier CPE program in the state of Georgia please contact us at 404-231-5074. The Georgia Pharmacy Journal
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Compliments of Michael T. Tarrant Financial Network Associates 1117 Perimeter Center West, Suite N-307 Atlanta, GA 30338 • 770-350-2455 mike@fnaplanners.com www.fnaplanners.com i An Independent Financial Planner since 1992 Focusing on Pharmacy since 2002 i 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.
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FEATURE ARTICLE
Governor Signs Pharmacy Bills Into Law by Andy Freeman Director of Government Affairs
any people think of Friday the 13th as a bad day but that was the case for Pharmacists in Georgia on Friday, May 13, 2011. That is the day that Governor Deal signed SB 36 and SB 93 into law, in front of a group of Pharmacists, Law Enforcement, Legislators and Doctors.
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Kerlikowske, issued this statement “This vital piece of legislation is a tremendous step forward in combating our national prescription drug abuse epidemic. It will save lives by identifying, deterring, and preventing drug abuse and diversion, while at the same time allowing access to legitimate use of prescription drugs.”
SB 36 was the legislation that set up an electronic drug monitoring program for Schedule II through Schedule V narcotics. Georgia is the last state in the Southeast and one of the last in the country to enact such legislation. The Board of Pharmacy is busy working with the Federal Government to secure Grant Funding for the start up costs of this legislation.
Governor Deal also signed SB 93 into law which moved Pseudoephedrine to a Schedule V exempt Narcotic. This means that Pseudoephedrine can only be sold behind the counter of a Pharmacy but does not require a prescription. Many states that have enacted similar legislation have seen drastic reductions in methamphetamine production. It is hoped that this will also be the case in Georgia.
Within minutes of Governor Deal’s signing of SB 36 into law, the White House’s Drug Policy Director, Gil
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EXECUTIVE VICE PRESIDENT’S EDITORIAL Jim Bracewell Executive Vice President / CEO
Pharmacy Degree Insurance: Is Yours Up-to-date? While driving on the Memorial Day weekend and seeing an accident or two I pondered how many drivers are on Georgia highways without proper automobile insurance?
Today pharmacists are delivering more Medication Management Therapy than ever before and with increased reimbursement.
As honest citizens and conscientious drivers, we know uninsured drivers cost us additional money for insurance premiums and other related costs of owning and driving our automobile.
Today the state does not utilize mandated mail order but maintains “any willing provider” status for any pharmacy. Today pharmacy technicians are becoming registered for the first time in Georgia.
Do you realize your state pharmacy association is your insurance provider for your pharmacy degree? Is your degree worth more today than when you earned it?
Your profession has four pharmacists serving in the state legislature.
In Georgia, I think you can say an absolute yes and the driving force for that value growth is your membership in the Georgia Pharmacy Association.
GPhA has its first trustee serving on the American Pharmacists Association Board of Trustees. GPhA has two officers in the leadership of the National Community Pharmacy Association.
Has your pharmacy practice improved? Here are a dozen factors to consider.
GPhA has the most powerful Political Action Committee in its history
Today you can immunize under protocol for flu with injection and flu mist.
So why are there so many “uninsured pharmacists” in the practice in Georgia today? It may be because you have not invited them to insure the future value of their degree by joining the Georgia Pharmacy Association like you have done.
Today you can legally accept e-prescriptions even via fax if necessary. Today in Georgia the pharmacist is the only legal source for pseudoephedrine behind the counter.
Yes all pharmacists reap the rewards of GPhA and therefore all ought to be invited to be a part of the association that delivers so much for the profession of pharmacy in Georgia.
Today a new law is in place to establish a electronic drug monitoring program for Georgia to help pharmacists fight illegal controlled substance prescriptions.
Invite a friend today to join you in GPhA.
In Georgia your state pharmacy inspectors are currently mandated to be licensed pharmacists. The Georgia Pharmacy Journal
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Pharm PAC Enrollment Pledge Year 2010-2011
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, Cfts Jim Bracewell T.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., FIACP J. Ashley Dukes, R.Ph. Jack Dunn, R.Ph. Stewart Flanagin, Jr., R.Ph. Andy Freeman Ann 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, CPT Pam S. Marquess, Pharm.D. Kenneth A McCarthy, R.Ph.
Scott Meeks, R.Ph. Drew Miller, R.Ph., CDM Laird Miller, R.Ph. Jay Mosley, R.Ph. Allen Partridge, Jr., R.Rh. Tim Short, R.Ph. Dean Stone, R.Ph., CDM Chris Thurmond, Pharm.D.
Gold Level ($600 minimum pledge) Larry Batten, R.Ph. James Bartling, Pharm.D., ADA, CAC II Liza G. Chapman, Pharm.D. Patrick M. Cook, Pharm.D. Mahlon Davidson, R.Ph., CDM Jim 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. Tarrant Jeffrey Richardson, R.Ph. Houston L. Rogers, Jr., Pharm.D., CDM Robert Anderson Rogers, R.Ph. Daniel C. Royal, R.Ph. Dean Stone, R.Ph., CDM Thomas 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 Kalvelage Willie 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 Ullrich Alan 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. EdKalvelage Steven Kalvelage Marsha Kapiloff, R.Ph. William E. Lee, R.Ph. Earl Marbut, R.Ph. Leslie Ponder, R.Ph. Richard Brian Smith, R.Ph.
If you made a gift or pledge to Pharm PAC and your name does not appear above please, contact Kelly J. McLendon at kmclendon@gpha.org or 404-419-8116. Donations made Pharm PAC are not considered charitable donations and are not tax deductible. The Georgia Pharmacy Journal
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Pharm PAC Contributors’ List Continued Marion Wainright, R.Ph. Steven Wilson, R.Ph. Sharon B. Zerillo, R.Ph. Jackie White John Kalvelage Carey B. Jones, R.Ph. Fred W. Barber, R.Ph. Jeffrey Richardson, Jr., R.Ph.
Members (no minimum pledge) Jill Augustine Claude 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, CDE Joshua Kinsey, Pharm.D. Ashley S. London Charles 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.
The Georgia Pharmacy Journal
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FEATURE ARTICLE
Pharmacists Visit Washington D.C. to Advocate for Pharmacy by Andy Freeman Director of Government Affairs
uring May 23-25, a group of GPhA AIP members attended the National Community Pharmacists Association meeting in Washington, DC. While in DC, they learned about legislation making it’s way through Congress that benefit that benefit the practice of Pharmacy including S. 1058 and its House companion bill HR 1971. These bills
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Give patients a true choice of pharmacy. Establish new consumer protections against the sale of sensitive patient information. Help eliminate wasteful pharmaceutical spending generated by pharmacy benefit managers (PBMs) switching patients to costlier drugs, hoarding manufacturer rebates and billing plans inflated amounts for prescription claims. Level the playing field among pharmacies by allowing “any willing provider” that agrees to accept a health plan’s terms and reimbursement rates to participate in that plan, so long as the pharmacy is licensed in that particular state and eligible to participate in federal and state health plans (which remove any providers that commit fraud). Allow legitimate oversight for fraud, not abusive pharmacy audits. GPhA members in attendance met with their member of Congress and senior staff members of both Senators Isakson and Chambliss to discuss these pieces of legislation. Plans are being made now for Georgia’s Congressional Delegation to visit Pharmacies across the state during Congress’s August recess. The Georgia Pharmacy Journal
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GPHA MEMBER NEWS
Welcome to GPhA! The following is a list of new members who have joined Georgia’s premier professional pharmacy association! Pharmacy School Student Members New Graduate Pharmacist Members Vanaessa L. Clark, Dublin Maryanna Bishop Durden, Athens Ashley Nicole Turk, Savannah Tracy Voechting, Sharpsburg Zachary Phillips, Gainesville Trina Nguyen Vuong, Lawrenceville Heather Dawn Taxeras, Savannah Carmen Erica Ward, Cedartown Ashley Wilkins, Richmond Hill Paul Prescott Langford, Shellman Ifeoma Nnebe, Douglasville Tracie Ngo Lee, Woodstock Cynthia Sue Kratina, Topeka, KS Sophia Thomas, Marieta
Abraham Jacob Duncan, Clayton Blake Powell, Tifton Ofori Julius Quarcoo, Canton Stephanie Louise Wood, Athens
Joint Pharmacist Members Amy Smith Ryan, Thomasville Donald Earl Maner, Evans
Individual Pharmacist Members Vaspar H. Eddings, Stockbridge Jay E. Ceesay, Fayetteville Roger Kevin O’Neal, Decatur Omishola Adeyemo, Stone Mountain Wafiyyah Moore, Ellenwood Joshua Timothy Mizelle, Vidalia Stephen Joseph Mouton, Milledgeville Traci Wilkerson, Gray Jacqueline Williams Davis, Valdosta Melanie L. Rudisill, Atlanta Krystin Tran, Atlanta Robert L. Peterson
Pharmacist Technician Members Bonnie Ann Eidson, Whitesburg William Ronell Wood, Columbus Teresa G. Jordan, Ball Ground Stephanie Nicole Norris, Thomson Jackie Marie Verscharen, Temple Amy Lea Lester, Grovetown Tiffany M. Stoney, Fairburn Amy Brinkley Cosby, Thomson Kelly Anissa Bragg, Matinez Jennifer Deann Beamer, Augusta Nancy Kay Burke, Evans Brandy Nicole Reese, Augusta
Associate Members Christopher Canter, Kennesaw
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hubonpolicyandadvocacy
Policy adopted on health care reform
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Regulatory scorecard:
hile regulations are being written for last year’s Affordable Care Act (ACA) and APhA advocates for implementation of the health care reform law’s pharmacy-friendly provisions, the Association’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.
www.pharmacist.com
The Georgia Pharmacy Journal
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What is happening NOW! Proposed regulation receiving public comments: Comments due by July 5 on proposed rule that would require specified providers (hospitals, federally qualified health centers, rural health clinics to offer annual (and if necessary, pandemic) influenza vaccination to patients Requests for information for which comment 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 Transitions Program under ACA provides funding to community-based organizations 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 leadership 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 Government Affairs section of pharmacist.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.pharmacytoday.org.
APhA policy on the pharmacist’s role in health care reform
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“This new policy on health care reform reaffirms the Association’s current 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 profession. In addition, it includes statements that articulate the profession’s beliefs regarding implementation by decision makers.”
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Be vigilant The 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 implementation 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,” Bennett said. “It is a time of great opportunity 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 advocacy for the role of the pharmacist in key initiatives in ACA, including integrated
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APhA affirms that pharmacists are the medication experts whose accessibility uniquely positions them to increase access to and improve quality of health care while decreasing overall costs. APhA asserts that pharmacists must be recognized as the essential and accountable patient care provider on the health care team responsible for optimizing outcomes through medication therapy management (MTM). 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. APhA asserts that pharmacists must be included as essential patient care providers and compensated as such in every health care model, including but not limited to, the medical home and accountable care organizations. 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. APhA supports the development and delivery of interprofessional education programs that facilitate team based delivery of care. APhA strongly recommends that a comprehensive medication review conducted at least annually by pharmacists should be standard practice and a required component of health benefit programs for all patients.
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FEATURE ARTICLE
AIP Provides Disaster Relief for Highland Pharmacy in Ringgold, GA byJim Bracewell
He and neighbors began to check on each family they could reach on their street. Chainsaws were necessary to clear a path through the wreckage.
On Wednesday evening Dale Cope and his wife who own Highland Pharmacy in Ringgold, GA., were planning to go to church, but services had been canceled due to the severe weather in the area.
On that night Dale and his family, lost Highland Pharmacy, their home and their cars, but not their friends at the Academy of Independent Pharmacy of the Georgia Pharmacy Association.
When Dale arrived home he turned on his television to stay up to date with the weather developing in his area. Dale remembers that the TV blinked a couple of times. He heard a loud rumble so he went to his front porch where he found the wind blowing and the sky extremely dark. Suddenly his ears popped and he knew the tornado was about to descend upon his house.
As the photos show, Jim Bracewell on behalf AIP delivered first of several checks to help Dale and his family recover from this ordeal. AIP has also invited Dale and his family also to their guests at the GPhA Convention and Annual meeting in Amelia Island, FL
He raced back into the house and in his words “in my most severe commanding voice, I ordered my two sons and wife into our basement. It was about 8:30 p.m. and a matter of a couple of minutes it was over. I climbed the steps from the basement, opened the door and the house was gone and so were all four of the family automobiles.� Dale said all he could see was devastation in all directions.
The Georgia Pharmacy Journal
All AIP owners should be proud of their relief efforts to help a fellow pharmacy owner when disaster struck. The next time a pharmacist wonders if a state association is good for your practice and good for your future, ask Dale Cope as he rebuilds in Ringgold, GA.
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“We implemented PQC in our pharmacy four months ago – it was easy. I have noticed an enhanced effort from the staff to work together to avoid and eliminate quality-related events.” Pharmacy Quality Commitment® (PQC) is what you need! PQC is a continuous quality improvement (CQI) program that supports you in responding to issues with provider network contracts, Medicare Part D requirements under federal law, and mandates for CQI programs under state law. When PQC is implemented in your pharmacy, you will immediately improve your ability to assure quality and increase patient safety. Do you have a CQI program in place?
Call toll free (866) 365-7472 or go to www.pqc.net for more information. PQC is brought to you by your state pharmacy association.
Online Master of Science in Pharmaceutical Outcomes & Policy Part Time • 30 Credits • Non Thesis Specialty Tracks: (WWSPLK 7OHYTHJVLJVUVTPJZ 7OHYTHJ` 9LN\SH[PVU 7VSPJ` *SPUPJHS 9LZLHYJO 9LN\SH[PVU ,[OPJZ 7H[PLU[ :HML[` 9PZR 4HUHNLTLU[ +Y\N 9LN\SH[VY` (MMHPYZ UF MS / Stetson University MBA option
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continuing education for pharmacists Volume XXIX, No. 5
Multiple Sclerosis: Medical Management with Disease-Modifying Therapy Thomas A. Gossel, R.Ph., Ph.D., Professor Emeritus, Ohio Northern University, Ada, Ohio and J. Richard Wuest, R.Ph., PharmD, Professor Emeritus, University of Cincinnati, Cincinnati, Ohio Dr. Thomas A. Gossel and Dr. J. Richard :XHVW KDYH QR UHOHYDQW ÀQDQFLDO UHODWLRQships 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 FODVVLĂ€FDWLRQ DQG GXUDWLRQ RI DFtion for drugs used in treatment of multiple sclerosis; 2. demonstrate an understanding of the mechanism of action, major adverse events and therapeutic applications associated with the drugs; 3. identify the route and means of administering the drugs; and 4. exhibit knowledge of information relative to multiple sclerosis pharmacotherapy to convey to patients and their caregivers.
Multiple Sclerosis – Past, Present and Future
Multiple sclerosis (MS) was PHQWLRQHG EULHĂ \ LQ WKH PHGLFDO 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 concerning etiology and pathogenesis throughout the 20th century. As the PLOOHQQLXP HQGHG WKH DIĂ LFWLRQ yielded somewhat to parenterallyadministered disease-modifying
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)QUUGN
9WGUV
therapy (DMT). In 2010 approval ZDV JUDQWHG IRU PDUNHWLQJ WKH ÀUVW drug in a new category of therapies to follow – an orally-administered DMT. Future studies will no doubt continue to resolve issues of heterogeneity and complexity of MS, and we can expect a mechanismEDVHG FODVVLÀFDWLRQ WKDW GHÀQHV successful strategies that will limit and repair the damage to central neurons.
Disease Overview
MS is a chronic, neurodegenerative DQG GHELOLWDWLQJ LQĂ DPPDWRU\ GLVease 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, secondaryprogressive MS, primary-progressive 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
23
a gradual progression of disability within 10 years of their initial attack, and 90 percent will develop LQWHQVLĂ€FDWLRQ RI WKHLU GLVHDVH SURFHVV ZLWKLQ \HDUV 06 DIĂ LFWV 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 LQĂ DPPDWLRQ IROORZHG E\ GHP\HOLnation of neurons within the CNS, while sparing peripheral nerves and muscles. Myelin, the white lipid-protein complex (i.e., the “white matterâ€? of the CNS) consists of parallel layers of lipids including cerebroside (a general description of an acid amide of a fatty acid), phospholipids and cholesterol, which constitute 75 percent of myelin’s dry weight. This inhibits sodium and potassium movement across the neuronal membrane almost completely, thus preventing generation of neuronal action potentials. Damage to the myelin sheath can lead to disruption of electrical impulses 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 coordination of movement. MS symptoms appear when the immune system can no longer prevent interaction between autoreactive T-lymphocytes and myelinassociated 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 several centimeters, is the hallmark of MS, and source of the descriptive terminology multiple sclerosis that GHĂ€QHV WKH GLVHDVH 'HP\HOLQDWLRQ is followed by scar tissue formation. 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 VLJQLĂ€FDQW SURJUHVV LQ XQGHUVWDQGing 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 pathophysiologic mechanisms are diverse, currently available therapies are RQO\ SDUWLDOO\ HIIHFWLYH DQG HIĂ€FDF\ is achieved only when treatment begins early in its relapsing forms. As a chronic and so far incurable disease, therapy is required for an LQGHĂ€QLWH LI QRW OLIHORQJ SHULRG RI time. MS management may be categorized into two objectives: (1) PRGLĂ€FDWLRQ RI WKH SULPDU\ GLVHDVH process and (2) treatment of specific symptoms. The most important therapeutic goal for controlling the disease is to postpone or prevent long-term disability. $QWL LQĂ DPPDWRU\ $JHQWV in Acute Relapses. It was noted in 1951 that MS patients treated
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with adrenocorticotropic hormone (ACTH), an agent that stimulates synthesis and release of adrenocortical hormones, appeared to recover more quickly from acute exacerbations (relapses). The undesirable adverse effects associated with ACTH stimulated development and use of many synthetic glucocorticoids. At this time, methylprednisolone (Medrol, and others) is the treatment of choice when corticosteroid therapy is chosen for treatment during periods of acute relapses. Current therapeutic management of severe acute relapses of MS involves use of the drug administered in a daily dose of 500 mg or 1 gm given IV. Treatment should be initiated promptly after symptom onset and continued three to ÀYH GD\V 7KHUH LV QR HYLGHQFH WKDW 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 intracellular mediators in the generation of an immune response): tumor necrosis factor (TNF) and interleukin (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 timing or severity of future relapses. Corticosteroids provide short-term EHQHÀW IRU DFFHOHUDWLQJ IXQFWLRQDO recovery in patients with acute MS attacks. There does not appear to EH ORQJ WHUP EHQHÀW IROORZLQJ WKHLU brief use.
'LVHDVH 0RGLI\LQJ 7KHUDS\ The Multiple Sclerosis Council for Clinical Practice Guidelines and the National Multiple Sclerosis Society recommend the early use of DMTs in patients who have relapsing forms of MS. The interferons, JODWLUDPHU DQG ÀQJROLPRG DUH
24
UHFRPPHQGHG IRU ÀUVW OLQH WUHDWment in patients with relapsingremitting MS. Mitoxantrone is used in relapsing disease that is intensifying, but is also given to patients with worsening secondaryprogressive MS with or without relapses. Natalizumab is recommended 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 GLVHDVH PRGLÀFDWLRQ WKHVH GUXJV are still used in these patients. There is strong evidence that early WUHDWPHQW PD\ VLJQLÀFDQWO\ DOWHU the course of the disease. Individual 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 demyelination, which is responsible for the permanent disability in MS, is known to occur early in the disease process. Studies suggest a causal OLQN EHWZHHQ DFXWH LQà DPPDWLRQ and loss of neuronal function along with the accepted role of chronic demyelination. Moreover, highly active disease early on correlates positively with increased disability 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 recommendation for initiating treatment early DIWHU FRQÀUPHG GLDJQRVLV RQO\ 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 immunologic events that lead to demyelination of central neurons. They include the four IFN-beta products,
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which differ only slightly in their pharmacodynamics and pharmacokinetics, and glatiramer acetate. (see Table 1). The three known forms of QDWLYH ,)1 DUH WDJJHG DOSKD Ç‚ EHWD ǃ DQG JDPPD Č–), 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 “deregulated,â€? which permits damage to the myelin sheath that normally insulates central neurons. Of the WKUHH RQO\ ,)1ǃ D FDUERK\GUDWH bearing protein produced by cells in the skin and connective tissues Ă€EUREODVWV KDV EHHQ VKRZQ FRQclusively to be effective in treating relapsing forms of MS. 7KH ,)1ǃ FRPSRXQGV PRGLI\ the immune system by interrupting proliferation of T-lymphocytes. This down-regulation is not speFLĂ€F IRU WKH IDFWRUV LQYROYHG LQ WKH pathogenesis of MS. Moreover, the IFNs may also modify non-autoimmune functions. ,)1ǃ UHGXFHV WKH QXPEHU RI UHlapses, 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 IFNČ–, augment activity of T-suppressor cells, and inhibit antigen expression induced by IFNČ– on the surfaces of antigenpresenting cells. ,)1ǃ E This biosynthetic form of type 1 IFN is a product of recombinant DNA technolRJ\ XWLOL]LQJ JHQHWLFDOO\ PRGLĂ€HG cultures of Escherichia coli. It is not glycosylated like naturally RFFXUULQJ ,)1ǃ E DQG LWV DPLQR 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 DQ LQĂ XHQ]D OLNH V\QGURPH ZLWK symptoms of fever, chills, head-
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7DEOH $SSURYHG GLVHDVH PRGLI\LQJ WKHUDS\ IRU WUHDWPHQW of multiple sclerosis )LUVW OLQH ,QWHUIHURQǃ E ,QWHUIHURQǃ E ,QWHUIHURQǃ D ,QWHUIHURQǃ D Glatiramer Fingolimod Second-line Mitoxantrone Natalizumab
7UDGH QDPHV %HWDVHURQ ([WDYLD $YRQH[ 5HELI Copaxone Gilenya
'RVDJH IRUP 6& LQMHFWLRQ 6& LQMHFWLRQ ,0 LQMHFWLRQ 6& LQMHFWLRQ SC injection Oral capsule
5HFRPPHQGHG GRVH PJ HYHU\ RWKHU GD\ PJ HYHU\ RWKHU GD\ —J RQFH ZHHNO\ —J WLPHV ZHHNO\ 20 mg daily 0.5 mg once daily
Novantrone, & others
IV injection
Tysabri
IV injection
12 mg/m2 given as a short (5-15 min) infusion every 3 months 300 mg infused over 1 hour every 4 weeks
SC, subcutaneous; IM, intramuscular; IV, intravenous
ache, myalgia, arthralgia, nausea, vomiting and diarrhea. This usually resolved within 12 hours and tolerance developed gradually in most patients. Acetaminophen, ibuprofen, or aspirin can generally control symptoms although the syndrome may be particularly troublesome for some patients. Depression, anxiety, confusion, and other mental changes are also reported. Patients to be treated with Betaseron should be informed that depression with suicidal tendency may be an adverse effect. It is suggested that patients be evaluated carefully if they show tendencies WRZDUG WKHVH HIIHFWV 6LJQLĂ€FDQW decreases in white blood cell counts and elevation of liver enzymes have been reported for type 1 IFNs. Baseline, along with periodic laboratory tests are, therefore, recommended to monitor for possible leukopenia (reduced leukocytes), thrombocytopenia (decreased platelets), and abnormal liver function. ,)1ǃ D. The second IFN in WKH QRQVSHFLĂ€F LPPXQRPRGXODWRU FDWHJRU\ LV ,)1ǃ D $YRQH[ DQG Rebif). Originally extracted from KXPDQ Ă€EUREODVWV WKH SURFHVV ZDV arduous, produced only limited amounts of IFN and required a ODERU LQWHQVLYH SXULĂ€FDWLRQ SURcedure. Today, these products are manufactured via recombinant DNA technology using Chinese
25
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 QDWLYH ,)1ǃ The most common adverse efIHFWV LQ FOLQLFDO WULDOV ZHUH LQĂ XHQza-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. Therapy should be stopped if jaundice or other adverse symptoms suggestive of liver dysfunction appear. Avonex is administered by once-weekly IM injection; Rebif is given SC, three times weekly. Glatiramer Acetate. The Ă€UVW LQ D XQLTXH FODVV RI 06 GUXJV glatiramer acetate (Copaxone) is a synthetic non-IFN, nonsteroidal 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 naturally occurring amino acids, L-glutamic acid, L-lysine, L-alanine, and L-tyrosine, that results in a copolymer structurally similar to myelin basic protein, a major component of myelin.
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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, inducWLRQ RI DQWLJHQ VSHFLĂ€F VXSSUHVVRU T-cells in the periphery and the inhibition of effector T-cells, has the capacity to interrupt the autoLPPXQH LQĂ DPPDWRU\ SURFHVV WKDW results in demyelination of central neurons. Controlled clinical trials have shown that glatiramer is at least DV HIIHFWLYH DV WKH ,)1V (IĂ€FDF\ LV noted early after therapy is begun, and appears to increase with time. Glatiramer has the most favorable DGYHUVH HIIHFWV SURĂ€OH RI DOO DSproved parenterally-administered drugs for MS. It may be the drug of choice for individuals who cannot tolerate IFN therapy or, who after taking the drugs awhile, must reduce their dosage due to laboratory abnormalities or onset of other problems. Following administration of glatiramer, patients may experience a transient, systemic, immediate post-injection reaction consistLQJ RI Ă XVKLQJ FKHVW SDLQ SDOSLtations, anxiety, dyspnea, throat constriction and urticaria. There are no known drug-drug interactions 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 treatment 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.
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Mitoxantrone acts via several mechanisms. It is taken into DNA strands where it inhibits proliferation of T-cells, B-cells and macrophages. Moreover, it decreases WKH VHFUHWLRQ RI SUR LQĂ DPPDWRU\ cytokines and increases an antiLQĂ DPPDWRU\ UHVSRQVH YLD SURPRtion of the T-cell suppressor function. In addition, mitoxantrone inhibits macrophage-mediated myelin degradation. In patients receiving mitoxantrone, adverse reactions that can usually be managed include transient leukopenia and neutropenia 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. 7KHUH DUH UHSRUWV RI D VLJQLĂ€FDQW decrease in left ventricular ejection fraction among patients receiving mitoxantrone. Reports of irreversible congestive heart failure, sometimes 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 (approximately eight to 12 doses over two to three years). Because mitoxantrone can increase the risk for infection by decreasing the number of white blood cells, blood counts should be obtained and liver function evaluated prior to each dose. Natalizumab. Natalizumab (Tysabri) is a humanized monoclonal antibody approved as monotherapy for treatment of relapsingremitting MS in patients who have experienced an inadequate response to or cannot tolerate alterQDWLYH '07 6DIHW\ DQG HIĂ€FDF\ LQ 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
26
the extracellular matrix) antagoQLVW WKDW ELQGV WR WKH Ç‚4 subunit of Ç‚4ǃ1 DQG Ç‚4ǃ7 integrins expressed on the surface of all leukocytes except neutrophils. This action inhibits adhesion of leukocytes to their counter-receptor(s). Natalizumab is believed to inhibit the LQWHUDFWLRQ RI WKH Ç‚4ǃ1 integrin with vascular cell adhesion molecule 1, DQG WKH Ç‚4ǃ7 integrin with mucosal adhesion cell adhesion molecule 1, respectively. By inhibiting these interactions, natalizumab may SUHYHQW DQ LQĂ DPPDWRU\ FDVFDGH responsible for CNS lesions. Natalizumab was originally approved in 2004 for treatment of relapsing-remitting MS. It was withdrawn in 2005 after three patients developed progressive multifocal leukoencephalopathy (PML), a rare but serious opportunistic viral infection of the brain. Marketing resumed in 2006 with a boxed warning cautioning about the risk of PML. Subsequently, more than DGGLWLRQDO FRQĂ€UPHG 30/ FDVHV have been reported in association with natalizumab therapy. In 2008 FDA issued another warning advising 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.â€?
$GKHUHQFH WR 7KHUDS\ Protocol
MS has a progressive course that PD\ EH VORZHG VLJQLÀFDQWO\ E\ 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 signify 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 unpleasant and may add undue stress to D VLWXDWLRQ WKDW LV DOUHDG\ GLIĂ€FXOW to accept. Convincing patients to use a drug that requires parenteral administration every other day or HYHQ ZHHNO\ FDQ EH GLIĂ€FXOW LI WKH\ 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 treatment within three years ranged beWZHHQ SHUFHQW IRU ,0 ,)1ǃ D DQG SHUFHQW IRU 6& ,)1ǃ E Similar results were obtained by other studies, including 39 percent of relapsing-remitting MS paWLHQWV RYHU D Ă€YH \HDU SHULRG ZKR ZHUH VWDUWHG RQ HLWKHU ,)1ǃ E RU ,)1ǃ D DQG SHUFHQW RI SDWLHQWV over a two-year period following LQLWLDWLRQ ZLWK ,)1ǃ E ,)1ǃ 1a or glatiramer. Patients in all WKUHH VWXGLHV KDG FOLQLFDOO\ GHĂ€QHG relapsing-remitting MS. The factors that affect adherence with treatment in MS patients are well known. In the literature, DPRQJ SDWLHQWV WUHDWHG ZLWK ,)1ǃ or glatiramer, most of them disFRQWLQXHG WKHUDS\ ZLWKLQ WKH Ă€UVW two years of treatment with 30 to 50 percent reportedly due to a SHUFHLYHG ODFN RI HIĂ€FDF\ ZKLOH to 70 percent were due to adverse effects, the primary ones included LQMHFWLRQ VLWH UHDFWLRQV LQĂ XHQ]D like symptoms and depression. Fingolimod. The long awaited DUULYDO RI D Ă€UVW OLQH RUDO IRUPXODtion (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 DUH VLJQLĂ€FDQW 6LQFH SXEOLFDWLRQ RI WKH Ă€UVW SLYRWDO WULDO RI ,)1ǃ E in 1993, patients and practitioners have been eagerly anticipating approval of a therapy that avoids the use of needles.
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Fingolimod (Table 2) is a synthetic structural analog of sphingosine 1-phosphate (S1P), which is a naturally occurring lysophospholipid, a potent signaling lipid. S1P LQWHUDFWV ZLWK ÀYH NQRZQ VXEW\SHV of S1P receptors (S1P1-5) distributed throughout the body, which lead to a variety of physiologic processes. S1P1-3 are found throughout the immune, cardiovascular and central nervous systems. Their activation on smooth muscle and endothelial cells regulates vascular homeostasis and permeability. Activation of S1P1 receptors on atrial muscle regulates heart rate. S1P4 UHVSRQVH LV JHQHUDOO\ FRQÀQHG to the hematopoietic (pertaining to or affecting the formation of blood cells) and lymphoid tissues, and S1P5 is expressed in the white matter of the CNS. Fingolimod is a prodrug that undergoes rapid phosphorylation in vivo by sphingosine kinase into ÀQJROLPRG SKRVSKDWH WKH ELRORJLcally active compound. The drug has a novel mechanism of action. Fingolimod-phosphate is a nonselective S1P receptor agonist that ELQGV ZLWK IRXU RI WKH ÀYH 6 3 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 responsible for regulating their egress from lymphoid tissue. Binding of ÀQJROLPRG SKRVSKDWH WR 6 31 acts to down-regulate the receptor with subsequent sequestration (isolation) of lymphocytes in the lymph tissue, to prevent their recirculation, and reducing peripheral lymphocyte counts. Fingolimod is not believed to destroy lymphocytes; therefore, many immune functions including activation, proliferation and effector functions of T- and Blymphocytes remain undisturbed during treatment. However, immune function that relies on naïve
27
7DEOH Highlights of prescribing information for fingolimod 7UDGH QDPH: Gilenya Manufacturer: Novartis Pharmaceutical Corp, East Hanover, New Jersey Approval date: September 2010 Indications & use: Treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability. Dosage & administration: 0.5 mg orally once daily, with or without food Dosage form & strength: 0.5 mg hard capsules Contraindications: None Warnings & precautions: Bradycardia and/or atrioventricular block DIWHU ÀUVW GRVH RI 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 increase liver transaminases. Fetal risk: Women of childbearing age should use effective contraception during & for two months after discontinuing use of the drug. Adverse effects: Reported at incidence of >10 percent were KHDGDFKH LQà XHQ]D GLDUUKHD 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 FDAapproved Medication Guide must be dispensed with each new DQG UHÀOOHG SUHVFULSWLRQ IRU Gilenya.
T-cells and central memory cells may be reduced or delayed. Given the theory that aggressive lymphocyte penetration into the CNS conWULEXWHV WR WKH LQĂ DPPDWLRQ DQG
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neural degeneration via demyelination found in MS, the drug’s major EHQHÀW PD\ EH GXH WR LWV DELOLW\ WR sequester lymphocytes within the lymphoid tissues. Moreover, S1P1 receptors expressed in the CNS are known to modulate neurogenesis (development of neurons) and neural function. Fingolimod may, therefore, have the ability to facilitate restoration of nerve cell function and supplement endogenous CNS repair. Fingolimod has been shown to improve myelination in animal models of experimental allergic HQFHSKDOLWLV DQG LV EHQHÀFLDO LQ D wide variety of graft-rejection and autoimmune models. In these situDWLRQV ÀQJROLPRG UHGXFHV LQÀOWUDtion 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 demyelination in experimental models. The most common adverse events reported in 10 to 20 percent RI ÀQJROLPRG WUHDWHG SDWLHQWV LQcluded fatigue, melanocytic nevus (also known as a banal nevus or neYRF\WLF QHYXV RU D PROH LQà XHQ]D virus infection, lower respiratory tract or lung infection, back pain, diarrhea, cough and abnormal liver function tests. Effects occurring in PRUH WKDQ SHUFHQW RI ÀQJROLPRG 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 primary varicella zoster infection, herpes simplex encephalitis and suicide. Serious adverse events noted in more than 1 percent of patients included MS relapse, basal cell carcinoma and sinus bradycardia. The cardiovascular events were consistent with the known presence of S1P receptors in myocytes. Bradycardia appears to be transient and GRVH UHODWHG LQ UHVSRQVH WR WKH ÀUVW GRVH RI ÀQJROLPRG ,Q RQH VWXG\ maximal reduction in heart rate of eight beats per minute in the 0.5mg group and 10 beats per minute in the 1.25-mg group occurred four
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WR ÀYH KRXUV DIWHU WKH ÀUVW GRVH DQG began restoring at six hours. Most cases of bradycardia were asymptomatic 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 discontinuation. Skin cancer was reported in phase 2 testing. In two trials, 15 ÀQJROLPRG WUHDWHG SDWLHQWV ZHUH 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.
This lesson is a knowledge-based CE activity and is targeted to pharmacists in all practice settings. 3URJUDP + 3 Release date: 5-15-11
Expiration date: 5-15-14
CE Hours: 1.5 (0.15 CEU)
The Ohio Pharmacists Foundation Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
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DMT can be considered in all MS SDWLHQWV ZLWK GHÀQLWH UHODSVLQJ GLVease. The drugs currently available RIIHU SDUWLDO EHQHÀW KRZHYHU WKH\ appear to delay the progression of 06 )LQJROLPRG UHSUHVHQWV WKH ÀUVW 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 V\VWHP HQYLURQPHQWDO LQà Xences, 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 Foundation and the Ohio Pharmacists Association disclaim any liability to you or your patients resulting from reliance solely upon the information contained herein. Bibliography for additional reading and inquiry is available upon request.
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continuing education quiz
Please print.
Program 0129-0000-11-005-H01-P 0.15 CEU
Name________________________________________________ Address_____________________________________________
Multiple Sclerosis: Medical Management with Disease-Modifying Therapy
City, State, Zip______________________________________ Email_______________________________________________
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.
Return to Correspondence Course, OPA, 2674 Federated Blvd, Columbus, OH 43235 or fax to 614.586.1545
:KHQ ,QWHUIHURQǃ E LV SUHVFULEHG ZKLFK RI WKH IROlowing trade name products should be dispensed? a. Betaseron c. Copaxone E 5HELI G *LOHQ\D
b. white matter.
3. Once neuronal injury occurs in patients with MS, it is usually: a. irreversible. b. reversible.
8. Which of the following is the only currently available oral form of MS therapy? a. Betaseron c. Copaxone E 5HELI G *LOHQ\D
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.
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 following types of cancer? a. Breast c. Lung b. Colon d. Prostate
5. Despite the recommendation for initiating treatment HDUO\ DIWHU D FRQĂ€UPHG GLDJQRVLV WKH SRUWLRQ RI 06 patients believed to use disease-modifying therapy is: a. one-fourth. c. one-half. b. one-third. d. two thirds.
11. Natalizumab antagonizes which of the following types of receptors? a. Integrin c. Hyalin b. Insulin d. Hemoglobin
6. Which of the following forms of interferon has been shown to be effective in treating relapsing forms of MS? D $OSKD ,)1Ç‚ F *DPPD ,)1Č–) E %HWD ,)1ǃ
12. The response to S1P4 LV JHQHUDOO\ FRQĂ€QHG WR O\Pphoid and which of the following types of tissues? a. Hematophagic c. Hematopoietic b. Hematoplegic
&RPSOHWHO\ ÀOO LQ WKH OHWWHUHG ER[ FRUUHVSRQGLQJ WR your answer. 1. 2. 3. 4. 5.
[a] [a] [a] [a] [a]
[b] [c] [d] 6. [a] [b] 7. [a] [b] 8. [a] [b] [c] [d] 9. [a] [b] [c] [d] 10. [a]
[b] [b] [b] [b] [b]
[c] [c] [d] [c] [d] [c] [c] [d]
11. [a] 12. [a] 13. [a] 14. [a] 15. [a]
[b] [b] [b] [b] [b]
13. Fingolimod is: a. believed to destroy lymphocytes. b. not believed to destroy lymphocytes.
[c] [d] [c]
[c] [d] [c] [d]
7KH FRUUHFW GRVDJH IRU *LOHQ\D LV PJ a. once daily. c. three times a day. b. twice daily. d. four times a day.
‰ I am enclosing $5 for this month’s quiz made payable to: Ohio Pharmacists Association.
15. Only three deaths occurred in patients in clinical triDOV ZLWK ÀQJROLPRG WKH FDXVH RI ZKLFK ZDV DWWULEXWHG WR each of the following EXCEPT: a. disseminated primary varicella zoster infection. b. herpes simplex encephalitis. c. myocardial infarction. d. suicide.
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 ‰ no 4. Did the program meet your educational/practice needs? ‰ yes ‰ no 5. How long did it take you to read this lesson and complete the quiz? ________________ 6. Comments/future topics welcome.
To receive CE credit, your quiz must be postmarked no later than May 15, 2014. A passing grade of 80% must be attained. CE statements of credit are mailed February, April, June, August, October, and December. Send inquiries to opa@ohiopharmacists.org.
may 2011
The Georgia Pharmacy Journal
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.O MORE .O MORE MONKEY BUSINESS
)T S A JUNGLE OUT THERE 0ACE !LLIANCE OFFERS YOU THE CHANCE TO MAKE YOUR PHARMACY A PROSPEROUS BUSINESS ONE THAT STAYS AHEAD OF THE GAME 7E KNOW WHAT IT TAKES TO SURVIVE !FTER ALL WE HAVE BEEN IN THE BUSINESS OF HELPING PHARMACIES FOR YEARS 0LUS TEAMING UP WITH 0ACE BENEFITS THE 'EORGIA 0HARMACY !SSOCIATION 4HERE S NO SENSE IN MONKEYING AROUND *OIN THE GROUP OF YOUR PEERS WHO WANT TO CONTROL THE DESTINY OF THEIR BUSINESSES IN ORDER TO PROSPER .O MORE MONKEY BUSINESS #ONTACT 0ACE !LLIANCE TODAY s WWW PACEALLIANCE COM
June 2011 Journal:Layout 1 6/14/2011 9:26 AM Page 31
2010 - 2011 GPhA BOARD OF DIRECTORS
The Georgia Pharmacy Journal Editor:
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The Georgia Pharmacy Journal® (GPJ) is the official publication of the Georgia Pharmacy Association, Inc. (GPhA). Copyright © 2011, Georgia Pharmacy Association, Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical including by photocopy, recording or information storage retrieval systems, without prior written permission from the publisher and managing editor. All views expressed in bylined articles are the opinions of the author and do not necessarily express the views or policies of the editors, officers or members of the Georgia Pharmacy Association.
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