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* This is not a claims claim ms reporting site. You cannot electronically ally report a claim to us. To report a claim, call 800.247.5930. 247.5930. ** Compensated endorsement. Not all products available a in every state. The Pharmacists Pharmacissts Life is licensed in the District of allll states except AK, FL, HI, MA, ME, NH, NJ, NY and VT. Check with your Columbia and al representative or the company for details on coverages and carriers.


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Departments 9 10 16 30

2012 GPhA Convention: Save the Date

GPhA New Members Pharm PAC Contributors GPhA Members in the News GPhA Board of Directors

FEATURE ARTICLES

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Advertisers

Pharmacy Time Capsule 2011 New GPhA Member Benefit: Be a Mentor, Get a Mentor Pharmacists for the Future Valuation Research the Right Prescription for Entrepreneurial Pharmacists

Pharmacists Mutual Companies GPhA Career Center Pharmacy Quality Commitment Financial Network Associates Logix, Inc. Melvin Goldstein, P.C. Custom Pharmacy Design AIP GPhA Workers’ Compensation NCPA Convention Information UBS

GPhA EVP Named to Alliance for Patient Medication Safety Board of Directors Rx and the Law: Where Have you Gone, Perry? Pamala Marquess, Pharm.D., Participates in McKesson Public Policy Forum CPE Opportunity: Multiple Sclerosis: Emerging Oral Therapy

COLUMNS

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www.gpha.org.

President’s Message Editorial

The Georgia Pharmacy Journal

For an up-to-date calendar of events, log onto

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August 2011


PRESIDENT’S MESSAGE L. Jack Dunn, Jr., R.Ph. GPhA President

GPhA 2011-2012: New Beginnings

hope everyone has had a great summer. I know the children are getting ready for school. For those of you who made it to Convention, I hope you had a great time and enjoyed the fellowship with your colleagues. I hope you received new ideas from the continuing pharmacy education classes to carry back to your pharmacies.

quotes that I would like you to carry with you in your profession, “Sometimes the things we are most passionate about escape us not because lack of talent, but rather because we lack the resolve necessary to pursue them.” The other quote is, “A lone person you influence positively today has the probability to influence thousands of people tomorrow.” I hope you remember these two quotes and prosper from them in your everyday lives.

I

I feel honored to be the president of your association. I also feel very fortunate to have the members of the executive committee present for my tenure at your association. This group is working real hard to prepare for this upcoming year. Two weeks ago, your executive committee spent 3 days in Hartwell establishing goals for this upcoming year. This year will be like every year in that there will be new problems arising that your association will have to manage. Your executive committee will stay on top of things as they arise.

As your association president, I look forward to working for you this year. The executive committee and I will do everything humanly possible to ensure a great year for your profession.

To those of you who were at the Convention, I hope you realized that your association had two national presidents in attendance. These two presidents, Bob Greenwood, President of NCPA, and Tom Menighan, President of APhA, both spoke at the convention. I want you to know that this is an enormous feat as these two gentlemen usually converse with only two state conventions per year. The fact that we had both presidents speaking at this year’s convention speaks very highly for your association. I hope those who attended the Convention had time to listen to the keynote speaker, Steve Gilliland. I feel pharmacy is in a transitional time and Steve provided the association with some thoughts about you and your profession. Steve did an outstanding job by bringing this association back to reality. He made us realize that we are in our communities to provide a service and that we can “make a difference.” Steve has two

The Georgia Pharmacy Journal

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August 2011


SUPPORTING PHARMACISTS. ADVANCING CAREERS. Find the best jobs and highly qualified pharmacists Georgia has to offer.

ONLINE CAREER CENTER www.gpha.org/jobs


Pharmacy Time Capsules 2011 (Third Quarter) 1986—Twenty-five years ago: 72 accredited US colleges of pharmacy graduated 10,685 students with entry level professional degrees (9,501 B.S. and 1184 Pharm.D.)

1911—One hundred Years Ago: Pharmacy education resumed its operation as The University of Tennessee School of Pharmacy, upon the transfer of the UT medical and dental schools to Memphis.

1961—Fifty Years Ago: 75 accredited US colleges of pharmacy graduated 3,497 students with entry level professional degrees (3,395 B.S. and 102 Pharm.D.).

1886—One hundred twenty-five years ago: John Pemberton, an Atlanta pharmacist, concocted a flavorful syrup which was added to carbonated water at Jacobs Pharmacy and Coke cola was born.

1936—Seventy-five Years Ago: Pentothal (thiopental sodium) is introduced by Abbott Laboratories. Ernest Volwiler, one of the inventors, went on to become president of Abbott. The American Association of Colleges of Pharmacy’s premier research award is given annually in his name. Hospital Pharmacists of Minnesota (HPM formed with the objective of extending and promoting hospital pharmacy.

By: Dennis B. Worthen Lloyd Scholar, Lloyd Library and Museum, Cincinnati, OH One of a series contributed by the American Institute of the History of Pharmacy, a unique non-profit society dedicated to assuring that the contributions of your profession endure as a part of America’s history. Membership offers the satisfaction of helping continue this work on behalf of pharmacy, and brings five or more historical publications to your door each year. To learn more, check out: www.aihp.org

“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.


EXECUTIVE VICE PRESIDENT’S EDITORIAL Jim Bracewell Executive Vice President / CEO

Distractions that can Lead Pharmacists in the Wrong Direction based on short term needs rather than long term career satisfaction.

Have you ever had the opportunity to walk on the beach this time of year along the Georgia coast and notice that certain areas are closed off by fences and signs that say, “Sea Turtle Eggs”?

Instead of following the pure light of the pharmacy profession they often allow bright and shiny artificial things to sabotage their journey.

I have read that female sea turtles swim to shore between May and August to dig nests in the sand and lay their eggs. Months later, the eggs hatch and the baby turtles follow the pure light of the moon back to the surf.

So, what about you GPhA member? Are you following your priorities and pure light to the right destination or did you allow artificial distractions to lead you in the wrong direction?

In a perfect world, the pure light of the moon guides every turtle back safely to the ocean. However, as we all know, we don’t live in a perfect world.

Are you following the path you wanted to follow or did you let unimportant things keep you from being the healthcare professional you wanted to be?

Sea yurtle hatchlings instinctively crawl toward the brightest light. On an undeveloped beach, the brightest light is the moon. On a developed beach, the brightest light can be an artificial light source coming from restaurants, homes and condominiums along the coast.

The great news is that unlike sea turtles we have the ability to think, adapt and change direction when we realize we are following the wrong path and that is much of what the Georgia Pharmacy Association is about helping -pharmacists be successful in their career.

Unfortunately, these powerful artificial sources of light often attract the hatchlings and cause them to move in the wrong direction when they are born.

We can tune out the distractions and focus on our priorities and let the pure light of our chosen profession lead you to an ocean of possibilities and a great future!

Rather than follow the pure light of the moon to the ocean the sea turtles follow the wrong light to a less than desirable outcome.

GPhA will be launching a mentorship program this fall. This will be a great opportunity to share your life and career experiences with anxious and energetic new practitioners. Look for our email notice and get involved in helping young colleagues choose the right course to a successful and fulfilling career in pharmacy.

It occurred to me that young pharmacists face similar challenges. Rather than following the path they originally desired to follow, they are too often distracted by things that move them in different directions.

*Much of the description of the Sea Turtle analogy was taken from Jon Gordon’s Weekly Newsletter with permission.

The pressure of college loans, the feeling and need to materially succeed leads many to make career decisions The Georgia Pharmacy Journal

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August 2011


GPhA MEMBER BENEFIT

New GPhA Member Benefit: Be a Mentor, Get a Mentor Be a Mentor As a Mentor, you will be sharing your knowledge with a pharmacy professional in a similar discipline in your region. In doing so, you will make an impact on the career path of an individual at the beginning of their career or at a crossroads. Based upon your responses to the questionnaire that follows, we will match you up with a Mentee that suites you. Mentor Criteria: •

Your address

Your years of experience

Your field of experience

Concerned about Taxes & Financial Planning?

You and the person you are mentoring will be provided resources to help you in building your relationship. To be a mentor got to GPhA and click “Be a Mentor, Find a Mentor” at the bottom of the Member Benefits Page.

Get a Mentor The “Be a Mentor, Find a Mentor” program is designed to help pharmacy professionals learn and grow in their profession, in addition to helping executives at any level increase their skill set by signing up for a Mentor. As a Mentee, you will be given an opportunity to gain knowledge and experience from pharmacy professionals that can help guide your career. Based upon your responses to the questionnaire that follows, we will match you up with a Mentor that suits you. Mentee Criteria: •

Your address

Your years of experience

Your current practice area

Your desired practice area

Third Thursday Conference Calls Dial our complimentary conference line on the Third Thursday of May, Sept, Oct, & Nov. 800-391-1709, PIN 582280 i

Calls begin at 4:00 and end promptly at 4:30. i

Compliments of Michael T. Tarrant

You and your mentor will be provided resources to help you in building your relationship. To be a mentor or mentee go to www.gpha.org and click “Be a Mentor, Find a Mentor” at the bottom of the Member Benefits Page.

The Georgia Pharmacy Journal

Join in for timely information on Financial Network Associates

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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.

August 2011


GPhA MEMBER NEWS

Welcome to GPhA! The following is a list of new members who have joined Georgia’s premier professional pharmacy association! If you or someone you know would like to join GPhA go to www.gpha.org and click “Join” under the GPhA logo. Individual Pharmacist Members

Pharmacist Technician Members

Thomas E. Lovett, R.Ph., Newnan Sally A. Huston, Ph.D., Athens Suzanne Lipe, R.Ph., Atlanta Charles Perry Kemp, Pharm.D., Acworth Katherine H. Patterson, Alpharetta Deborah C. Hobbs, Pharm.D., Dublin Wendy Bearden Cook, Pharm.D., Dallas Ashley Lynn Maples, Pharm.D., Leesburg Deirdre Brooker Fanning, Pharm.D., Lilburn Yolanda L. Rivers, Pharm.D., Jacksonville, FL Bradford Lee Upchurch, Pharm.D., Athens Laurence Broome, Jr., R.Ph., Peachtree City

Jason E. Smith, CPhT, Fort Valley

Associate Members Peter Oloff, Fletcher, NC

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.

Joint Pharmacist Members Yancy Max Witt, Pharm.D., Fayetteville Maurice Bernard Gray, R.Ph., Centerville

New Graduate Pharmacist Members Jamie Lynn Shockley, Pharm.D., Marietta Natalie Nielsen, Pharm.D., Douglasville

The Georgia Pharmacy Journal

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August 2011


Pharm PAC Enrollment Pledge Year 2010-2011

Titanium Level ($2400 minimum pledge) Michael E. Farmer, R.Ph. David B. Graves, R.Ph. Robert A. Ledbetter, R.Ph. Jeffrey L. Lurey, R.Ph. Marvin O. McCord, R.Ph. Judson L. Mullican, R.Ph. William A Murray, R.Ph. Mark L. Parris, Pharm.D. Fred F. Sharpe, R.Ph. Jeff Sikes, R.Ph. Dean Stone, R.Ph., CDM T.M. Bridges, R.Ph. Platinum Level ($1200 minimum pledge) Robert Bowles, Jr., R.Ph., CDM, Cfts Jim R. Bracewell Larry L. Braden, R.Ph. Thomas E. Bryan, Jr., R.Ph. James W. Bartling, Pharm.D., ADC, CACII Barry M. Bilbro, R.Ph. William G. Cagle, R.Ph. Hugh M. Chancy, R.Ph. Keith E. Chapman, R.Ph. Dale M. Coker, R.Ph., FIACP John Ashley Dukes, R.Ph. Patrick Dunham Jack Dunn, Jr. R.Ph. Stewart Flanagin, R.Ph. Neal Florence, R.Ph. Andy Freeman Martin T. Grizzard, R.Ph. John T. Hansford, R.Ph. Robert M. Hatton, Pharm.D. Alan M. Jones, R.Ph. Ira Katz, R.Ph. Hal 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 Marquess, Pharm.D. Kenneth A. McCarthey, R.Ph. Scott Meeks, R.Ph. Drew Miller, R.Ph., CDM Laird Miller, R.Ph. Jay Mosley, R.Ph. Allen Partridge, R.Ph. Houston Lee Rogers, Pharm.D., CDM Time Short, R.Ph. Michael T. Tarrant Christoher R. Thurmond, Pharm.D. Floyd Moon Danny Toth, R.Ph. Gold Level ($600 minimum pledge) Larry Batten, R.Ph. Liza G. Chapman, Pharm.D. Patrick M. Cook, Pharm.D. Mahlon Davidson, R.Ph., CDM James Gordon Elrod, R.Ph. Kevin M. Florence, Pharm.D. Ted M. Hunt, R.Ph. Robert B. Moody, R.Ph. Sherri S. Moody, Pharm.D. Jeffrey Grady Richardson, R.Ph. Andy Rogers, R.Ph. Sharon Mills Sherrer, Pharm.D., CDM Silver Level ($300 minimum pledge) Renee D. Adamson, Pharm.D. John L. Colvard, R.Ph. Terry Dunn, R.Ph. Marshall L. Frost, Pharm.D. James E. Jordan, Pharm.D. John D. Kalvelage

Willie O. Latch, R.Ph. W. Lon Lewis, R.Ph. Michael L. McGee, R.Ph. William J. McLeer, R.Ph. Albert B. Noell, R.Ph. Richard Noell, R.Ph. Sara W. Reece, Pharm.D., BC-ADM, CDE Edward Franklin Reynolds, R.Ph. David J. Simpson, R.Ph. Richard Brian Smith, R.Ph. James N. Thomas, R.Ph. Alex S, Tucker, Pharm.D. Allan Mitchell Voges, R.Ph. Flynn W. Warren, M.S., R.Ph. Oliver C. Whipple, R.Ph. Walter Alan White, R.Ph. William T. Wolfe, R.Ph. Bronze Level ($150 minimum pledge) Monica M. Ali-Warren, R.Ph. Fred W. Barber, R.Ph. John R. Bowen, R.Ph. James R. Brown, R.Ph. Henry H. Cobb, R.Ph. Michael A. Crooks, Pharm.D. William Crowley, R.Ph. Charles Alan Earnest, R.Ph. Randall W. Ellison, R.Ph. Mary Ashley Faulk, Pharm.D. Amanda R. Gaddy, R.Ph. Amy S. Galloway, R.Ph. Johnathan Wyndell Hamrick, Pharm.D. Raymond G. Hickman, R.Ph. Ed Kalvelage Steve D. Kalvelage Marsha C. Kapiloff, R.Ph. Joshua D. Kinsey, Pharm.D. Brenton Lake, R.Ph. William E. Lee, R.Ph.

If you made a gift or pledge to Pharm PAC in the last 12 months and your name does not appear above, please, contact Andy Freeman at afreeman@gpha.org or 404-419-8118. Donations made to Pharm PAC are not considered charitable donations and are not tax deductible. The Georgia Pharmacy Journal

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August 2011


Pharm PAC Contributors’ List Continued Ashley Sherwood London Charles Robert Lott, R.Ph. Earl W. Marbut, R.Ph. Randall T. Maret, R.Ph. Max A. Mason, R.Ph. Amanda McCall, Pharm.D. Susan W. McLeer, R.Ph. Mary P. Meredith, R.Ph. Leslie Ernest Ponder, R.Ph. Kalen Beauchamp Porter, Pharm.D. William Lee Prather, R.Ph. Kristy Lanford Pucylowski, Pharm.D. Leonard Franklin Reynolds, R.Ph. Archie R. Thomason, R.Ph. Marion J. Wainright, R.Ph. Jackie White Steve Wilson, Pharm.D. Sharon B. Zerillo, R.Ph.

Leonard E. Templeton, R.Ph. Heatwole C. Thomas, R.Ph. Erica Lynn Veasley, R.Ph. William D. Whitaker, R.Ph. Elizabeth Williams, R.Ph.

Members (no minimum pledge) Jill Augustine Mark T. Barnes, R.Ph. Walter A. Clark, R.Ph. Carleton C. Crabill, R.Ph. Wendy A. Dorminey, Pharm.D., CDM David M. Eldridge, Pharm.D. Charles C. Gass, R.Ph. Christina Gonzalez Ann R. Hansford, R.Ph. Joel Andrew Hill, R.Ph.

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Carey B. Jones, R.Ph. Susan M Kane, R.Ph. Carroll Mack Lowrey, R.Ph. Roy W. McClendon, R.Ph.

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Tom E. Menighan, R.Ph., MBA, ScD, FAPhA

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Darby R. Norman, R.Ph. Christoher Brown Painter, R.Ph. Steve Gordon Perry, R.Ph. Whitney B. Pickett, R.Ph. Donald Joseph Piela, Pharm.D. Rose Ann Pinkstaff, R.Ph. Michael Roland Reagan, R.Ph. James L. Riggs, R.Ph. Victor Serafy, R.Ph. Harry A. Shurley, R.Ph. James E. Stowe, R.Ph. James R. Stirckland, R.Ph. Celia M. Taylor, Pharm.D.

The Georgia Pharmacy Journal

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August 2011


MEMBERS IN THE NEWS

Pharmacists for the Future Reprinted from Georgia Trends August 2011 ncreasingly, Georgia pharmacy schools are preparing their students for more patient-oriented jobs in settings outside traditional drugstores.The aging baby boomer population will likely keep them busy.

we educated our students [primarily] to be knowledge-based about various compounds and drugs, we now are training them to be more patient-oriented.”

I

At UGA that training can last six years and result in a doctor of pharmacy degree. “That’s a professional doctorate, not a research degree,” Øie says. “But many [students] will have a lot more than six years [of study]. We encourage our students to look at advanced education pharmacy.”

Neal Florence, R.Ph., estimates about 150 people a day come by the Medi-Thrift Pharmacy he and wife Carolyn Florence, R.Ph., operate in LaFayette, a fast growing community in the Georgia suburbs of Chattanooga. Florence says he never knows if his customers are in the store to discuss prescriptions or potholes.

Kevin Florence, Pharm.D., son of Neal and Carolyn, fits Øie’s description of the trend toward specialty pharmacy by recent UGA graduates. The younger Florence is a 2009 graduate of UGA’s College of Pharmacy who decided to work neither in his parents’ community pharmacy nor in a chain drugstore.“When I went to college, I said I wanted to do anything but pharmacy,” he says. Now he works for two pharmaceutical companies in the Athens area, where he assists in compounding drugs or packaging specialty drugs for use in the treatment of cystic fibrosis, hepatitis and other illnesses and for patients of longterm care facilities and assisted-living homes.

“When they come in and say, ‘I need to talk to Neal,’ I don’t know if they have a city problem or a drug problem or if they owe me money,” says Florence, who is also the mayor of Lafayette and has been since 1989. Neal and Carolyn are independent pharmacists, a resilient breed who survived the time when big-box stores and national chains pressed the demand for pharmacists during the 1990s by growing exponentially. “A couple of years ago, Walgreens was opening a new pharmacy Every 19 hours in the United States,” says Jim Bracewell, executive vice president of the Georgia Pharmacy Association (GPhA), “And every time you open one of those pharmacies, you’re creating a demand for about a half-dozen pharmacists because of the longer hours and the seven-days-aweek service. We’re seeing the [pharmacy] schools increase the size of their classes. So now we’re at the junction where the number of new pharmacies has slowed down and the number of new school of pharmacy graduates has increased.” But at the same time, career paths for those graduates have multiplied.

“There is a lot more counseling, monitoring, mixing and making than working with insurance companies,” he says.“I’m doing a lot of different things, and I like that.” More Variety More career variety in the pharmaceutical field opened up six years ago when UGA’s College of Pharmacy began its Regulatory Affairs Program in response to pleas from members of the Georgia Biomedical Partnership (GBP, now Georgia Bio), an economic development group seeking to land life science companies in Georgia. “I was and am a member of that organization,” says Dr. David Mullis, UGA College of Pharmacy director of Regulatory Affairs graduate program. “Back in the late ‘90s, it became very clear, as Atlanta and Georgia tried to establish a life science industry, and as more of the [Georgia Bio] members were coming from established companies in the pharmaceutical industry, medical devices and animal health [companies] were having a hard time recruiting talented people in regulatory affairs.”

“What we see is a downward trend in our students going to the traditional community pharmacy or the chain drugstores,” says Dr. Svein Øie, (pronounced Oy-ah), dean of the University of Georgia College of Pharmacy. “We see an increasing trend toward much more clinical, the specialty that can be in the hospital, in ambulatory care; it can be in a number of different settings where our graduates are now working. In contrast to where we were 30 years ago, when

The Georgia Pharmacy Journal

by Ed Lightsey Georgia Trends

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August 2011


In the past, regulatory affairs Specialists were often recruited from a company’s research and development labs and were likely to get their training on the job, Mullis says. But navigating the regulatory maze of agencies like the Food and Drug Administration required far greater skills, according to Mullis. So UGA’s Regulatory Affairs Program was established to meet a new need in the state’s workforce for people who could assist companies in maintaining regulatory compliance in the development of new drugs and medical devices.

Their administrators say they see a current shortage of pharmacists in the state with the very real possibility of that shortage widening as the economy improves. There are indications in surrounding states that more pharmacy schools have been added to meet anticipated needs of the future, according to Alan Wolfgang, assistant dean for student affairs at the University of Georgia’s College of Pharmacy.

“It takes 12 to 15 years for a new molecular entity to traverse all the phases that are involved with new drug development, and it can be anywhere from $700 million to $1.25 billion to do that,” Mullis says. “The key to that whole thing is having these regulatory affairs professionals, individuals who come from a very strong science background and different walks of life. Most of our students are full-time professionals.”

“Tennessee has opened probably five or six more in the last half-dozen years,” Wolfgang says. “And the University of Florida has four campuses now where they teach pharmacy; South Carolina has added two more in the last couple of years. Even if we do have a greater demand in the future, and I think we will, I still think we’re going to be fine because the [pharmacy graduate] capacity has increased so much.”Wolfgang says there are and will continue to be “pockets” of shortages in the rural areas.

The Regulatory Affairs Professional Program offers both certificate and master’s studies and normally takes two years to complete; the program is growing in popularity. “There are far more job openings for regulatory affairs professionals than there are people to fill them,” Mullis says. “We have a number of students who have Ph.D.s in other areas but they want to change careers. And we are finding companies that will send employees to us for further education or training.”

Dr. Mark Okamoto, is founding dean and a professor at Georgia’s newest school of pharmacy at the private Philadelphia College of Osteopathic Medicine (PCOM) in Suwanee. The pharmacy school started last year with 79 students and expects 90 this year. PCOM administrators were itching to add a pharmacy school to its main Philadelphia campus, but there was already one at Temple University in the City of Brotherly Love.

Numbers Growing

“So they started looking down South at our campus in Suwanee,” says Okamoto. “We started doing the [needs] analysis, and at the time the school was conceived, about 2005 or 2006, pharmacy was the No. 2 needed profession, Right after nursing. They talked to the pharmacy organizations in the state, and they all supported the idea; that’s how it came to be.”

In 2000, there were 6,020 registered pharmacists in Georgia, and today there are about 13,000 pharmacy licenses held in Georgia, according to a report by the U.S. Department of Health and Human Services. But there are mixed opinions on whether the next generation of pharmacists will have the numbers to meet the rising demand for their services coming from the aging baby boomer generation and the accompanying rise in prescriptions.

In 2003, South College in Savannah, a proprietary or for-profit institution, added a School of Pharmacy and became South University (SU). According to a pharmacy school administrator, the school filled a void.

“About 3,000 of the Georgia licenses belong to people living in other states and holding dual licenses, so we have roughly 10,000 licensed pharmacists living in Georgia,” GPhA’s Bracewell says, adding another significant number in the highest prescription user demographic. “There are 10,000 people in America turning 65 every day,” he says.

“[Founder] John South’s business model has been to focus on career paths for individuals in basically underserved types of populations, especially where there is a need. And pharmacy, especially over the past 10 years or so, has developed a significant shortage of pharmacists,” says Curtis Jones, SU’s pharmacy school associate dean for Administration and Academic Affairs. South has an accelerated program, allowing students to receive their pharmacy degree, a Pharm.D., in three years instead of four, according to Jones. In most cases, the doctor of pharmacy is earned with two to four years of study following the baccalaureate degree award. “The program is fully accredited by SACS, the Southern Association of Colleges and Schools,” Jones says. “And our school is accredited by the

In the past six years, the number of schools of pharmacy in Georgia has doubled from two – the public University of Georgia and the private Mercer University – to four, but the two most recent pharmacy schools to open in the state, one private and one proprietary, have come from outside the University System of Georgia or the traditional in-state private college sphere.

The Georgia Pharmacy Journal

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August 2011


Accreditation Council for Pharmacy Education, ACPE.” The Changes

the new clinical training facility was seen as a milestone reflecting a dramatic shift in the duties of the pharmacist, notably those of the hospital pharmacist who often toiled in anonymity in the lower regions of the hospital.“We’ve been able to experience the migration of the pharmacist from the basement to the bedside,” says Dr. Doug Patten, senior vice president of medical affairs at Phoebe Putney.

UGA’s Wolfgang has perhaps had the best vantage point to observe the changes in Georgia’s pharmacy schools over the past 30 years or so, first as a pharmacy student in the late 1970s and now as the assistant dean of student affairs at UGA’s College of Pharmacy. He’s seen the most dramatic change in the composition of pharmacy students in what could be called the pharmacy gender switch. “We have more females in pharmacy than ever before, though that has kind of leveled out,” says Wolfgang. “We’ve been around 65 percent [female pharmacy student population] for about the last 10 years, whereas 30 years ago it was about a 65 to 75 percent male population.”

Dr. Ted Matthews, dean of the College of Pharmacy and Health Sciences at Mercer University, sees the modern pharmacist as requiring more training in bedside manner than ever before. “Our entire curriculum is now being modified to be totally patient-focused,” Matthews says. “Social skills have entered the curriculum. I think that is one of the major Changes over the last 10 years that has occurred in pharmacy education.”

The reason for the growth in the number of female pharmacy students has more to do with the marketplace demand and job flexibility than the evolution of social mores, Wolfgang says. “It is one profession in Georgia that is so easy to move in and out of,” he says. “The salaries are so much higher, so if you want to start a family and focus on that, you can leave the profession or have your hours reduced and Then come back full time when you’re ready. There are always plenty of jobs available.”

Another change in the marketplace being reflected in the classroom is the arrival of specialty drugs, Matthews says. “I think we’re going to see more specialties in drugs, drugs used in gene therapy, for instance, and very potent drugs used in cancer treatment,” he says.“I think that will require more specialization in managing those patients, and we have genomics, drugs specialized for a specific patient. “But it is not enough to just have a knowledge base about drugs and therapy,” he says. “What you also have to have is all the communications skills in order to effectively counsel the patient about the medication, because one of the biggest problems is not the medication, it is the compliance with the medication.All of this is changing what is going on in the classroom.”

Meanwhile, the curriculum and training has slowly changed in the 32 years since Wolfgang finished his studies. “The biggest change in the coursework to me is that when we were in school we were taught to fill prescriptions correctly, and that is about as far as it went,”he recalls. “We really didn’t talk about how you interacted with other health professionals; we didn’t talk a whole lot about helping people manage their health like pharmacists do now. Now pharmacists give immunizations, and we would never have dreamed of a pharmacist doing that when I was in school.” Present shortages or surpluses of pharmacists aside, there seems to be a consensus that the future will hold a demand for the profession’s dispensers of drugs. “The number of opportunities is increasing for graduates,” says PCOM’s Okamoto.“Predominately, the economy is going to have a major impact on that. Jobs in the urban areas are really thinning out, but there are still jobs in the more rural sites. We’re going to be sending our students down to those rural sites so they can learn more about rural practice and decide if that is something they want to invest in.” More pharmacists-in-training will get an opportunity to take a look at life in rural Georgia when UGA students begin arriving in Albany in 2012 for their clinical training. The community’s Phoebe Putney Memorial Hospital has expanded its clinical teaching environment to include UGA’s College of Pharmacy Southwest Georgia Pharmacy Program. The announcement of

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August 2011


MEMBER NEWS

Valuation Research the Right Prescription for Entrepreneurial Pharmacists By Jennifer Giarratano Reprinted from GEORGIA TREND’s Small Business Guide “The valuation was really important to us,” says Laird. “It confirmed that the numbers the Lula owner showed us were not pulled out of thin air.” Amy and Karen purchased the Lula Pharmacy.

aird Miller, R.Ph., and Butch Bowling, R.Ph., have been partners in Medical Park Pharmacy of Gainesville for nearly 30 years. Their wives, Amy Miller, R.Ph., and Karen Bowling, R.Ph., fill prescriptions at the Lula Pharmacy.

L

Laird, Butch and a third partner quickly followed, recently closing on the purchase of the Jennings Pharmacy in Demorest, but only after Sanford and his students conducted a valuation of that store.

As former chairman of the Georgia Pharmacy Association’s Academy of Independent Pharmacy, Laird agrees in the importance of keeping independent pharmacies independent. “I always said that when I stepped down as chair, I’d buy another pharmacy," he says.

“I hope we haven’t bought our last pharmacy. Ideally, we’d like to find stores ready to transition, bring in junior partners and eventually allow the junior partner to buy us out,” says Laird. “If we buy any more stores, Jeff and his group will be involved in the process.”

He did, but only after Amy and Karen beat him to it. About four years ago, the Lula store’s owner decided to sell her business. Amy thought it would be a smart purchase, but they needed help determining its true value. So the Millers contacted Jeff Sanford, the Georgia SBDC Network’s director of Entrepreneurial Studies.

“We’ve developed a ‘keeping independent’ program to help young pharmacists understand that ownership is the way to improve their financial future, and it’s great when Jeff visits our meetings,” Laird says. “His enthusiasm is contagious as he gives an upbeat message about the advantages of owning and operating your own business. People leave his sessions feeling like the little engine that could.”

“Jeff often comes to our association meetings to offer help from the SBDC,” says Laird. “He and his students conduct valuation research to determine whether it makes good business sense to purchase a store. Amy was buying from her employer and her friend. We needed an objective third party to come in and tell us what this store was worth.”

“Laird Miller is an outstanding advocate for keeping independent pharmacies independent in Georgia,” says Sanford. “His and Amy’s dedication to their patients and to the profession have resulted in a successful, growing enterprise.”

Sanford created a validation tool he uses specifically for pharmacies. He and two pharmacy students from the University of Georgia spend two weeks analyzing the market, financial and other performance data for the store. “The standard pharmacy valuation models use industry ‘rules of thumb’ to determine fair market value,” says Sanford. “It assumes that all pharmacies work on a level playing field with no consideration of market growth or decline, the diversity of products and services offered, or the pharmacy’s management, financial trends, and the condition of its equipment and inventory. Using my model, the students and I conducted a more thorough due diligence, incorporating all considerations, so the Millers could make a more objective decision.”

The Georgia Pharmacy Journal

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August 2011


MEMBER NEWS

GPhA Members in the News If you have news that you would like to share with your pharmacy colleagues please email kmclendon@gpha.org and tell us all about it. We will add you to the member news section of the GPhA Journal Workshop Presenter and Facilitator. Denver, CO. June 11, 2011.

James Bruckner, R.Ph., University of Georgia College of Pharmacy professor, was appointed a member of the Food Quality Protection Act (FRACP) Scientific Advisory Board of the US EPA.

Trina von Waldner, University of Georgia public service associate and director of postgraduate continuing education, served as faculty advisor and preceptor for 13 rising third-year pharmacy students from June 12 to 24 at the Farm Worker Family Health Program in Moultrie, with Dee Dee McEwen, Pharm.D., Public Service Assistant.

Three students at the University of Georgia College of Pharmacy, along with their faculty mentors, were named 2011 Walmart Scholars at the national meeting of the American Association of Colleges of Pharmacy (AACP) in July. A total of 75 student/mentor teams were chosen nationwide.

Matthew Perri, University Georgia College of Pharmacy professor, published a book, with Keith Herist, clinical associate professor, and Brent Rollins, former grad student, entitled Financial Analysis in Pharmacy Practice.

The College of Pharmacy teams were Tara Fogleman, R.Ph., and clinical professor Henry Cobb, III, CDM, R.Ph.; Bryan White, R.Ph., and clinical associate professor Keith Herist, Pharm.D., AAHIVE, CPA; and Allison Young, Pharm.D. and associate dean George Francisco, R.Ph.

Whitney Unterwagner, Pharm.D., University of Georgia College of Pharmacy public service associate, presented “Building Community Partnerships through IPPE Service Learning” at the American Association of Colleges of Pharmacy (AACP) Annual Meeting in San Antonio, Texas.

The Walmart Scholarships, which began in 2005, aim to strengthen the recipients’ skills and commitment to careers in academic pharmacy through their participation at the AACP Annual Meeting and Seminars. Each student-mentor pair received $1,000 to help cover registration and travel expenses for the AACP Annual Meeting and Seminars in San Antonio, Texas.

Lindsey Welch, Pharm.D., University of Georgia College of Pharmacy public service assistant, presented two posters at the American Association of Colleges of Pharmacy (AACP) annual meeting in San Antonio: “A Two-Campus Model for Providing an Influenza Immunization Introductory Pharmacy Practice Experience (IPPE)” with Dianne Williams May, Pharm.D., Dee Dee McEwen, Lori Duke, and Whitney Unterwagner and “Providing Sustainable Immunization Introductory Pharmacy Practice Experiences (IPPEs) through Entrepreneurship and Community Partners” with Dee Dee McEwen, Lori Duke, Whitney Unterwagner, and Charles McDuffie, Pharm.D..

Kyle Burcher, University of Georgia College of Pharmacy Third-year Student, received the June Walmart/PHARMACY TIMES RESPy (Respect, Excellence, and Service in Pharmacy) award for demonstrating excellence in patient care; eight RESPy award winners are chosen each year and featured in PHARMACY TIMES along with their respective college of pharmacy. RESPy winners receive a cash award and are offered a summer internship with Walmart.

Lindsey Welch, Pharm.D., University of Georgia College of Pharmacy Public Service Assistant, accepted to the 2011-12 UGA Writing Fellows Program which works with the UGA Writing Initiative Program to foster greater attention to and practice of writing on campus.

Beth Phillips, R.Ph., BCPS, University of Georgia College of Pharmacy clinical associate professor, published journal article: Haines SL, DeHart RM, Flynn AA, Hess KM, Marciniak MW, Mount JK, Phillips BB, Saseen JJ, Zatzkin SW. Academic pharmacy and patient-centered healthcare: A model to prepare the next generation of pharmacists. J Am Pharm Assoc 2011;51:194–202. She also Presented “Residency Learning System Workshop: PGY1 and PGY2 New and Existing Programs.” American Society of Health System Pharmacists Summer Meeting.

The Georgia Pharmacy Journal

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August 2011


STAFF NEWS

GPhA EVP Jim Bracewell Named to Alliance for Patient Medication Safety Board of Directors im Bracewell has been elected to the Alliance for Patient Medication Safety (APMS) Board of Directors effective July 2011.

J

culture of quality within the profession of pharmacy that promotes a continuous systems analysis to develop best practices that will reduce medication errors, improve medication use and enhance patient care.

His term will end in March 2013.

Learn more about programs offered by APMS, visit www.medicationsafety.org.

APMS was established by the National Alliance of State Pharmacy Associations (NASPA) and is listed as a Patient Safety Organization with the Agency for Health Research and Quality (AHRQ). The mission of APMS is to foster a

The Georgia Pharmacy Journal

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August 2011


Please save the date for our 137th Annual Convention! Georgia Pharmacy Association 137th Annual Convention Hilton Head Marriott Resort & Spa Hilton Head Island, SC July 7-11, 2012 The Georgia Pharmacy Journal

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August 2011


AIP Fall Meeting Sunday, October 23, 2011 Macon Marriott & Centreplex Macon, GA

ARE YOU COMING? LEARN TO IMPROVE YOUR BUSINE$$ 1. 3 hour CE course on Pharmacy Law for Certified Technicians and Registered Technicians (pharmacists may also attend for CE credit) 2. Multiple programs on business management A. How to evaluate your Pharmacy B. How to generate additional revenue outside the prescription department C. Financial planning and retirement plans 3. Afternoon business meeting (includes an update from the PBM Task Force and the GPhA Governmental Affairs team)

BRING YOUR STAFF AND NETWORK WITH YOUR COLLEAGUES 1. 2. 3. 4.

Come meet and network with fellow independent pharmacists Bring your staff to network with other technicians and get CE Join us for a continental breakfast and lunch Visit with our AIP partners during breaks and lunch

SHOW YOUR SUPPORT²ATTEND THIS <($5¶6$,3)$//0((7,1*


Get Ready to Meet. Learn. Succeed. Registration is Now Open!

SellingaPharmacy:TheCommunityPharmacist’sRoadmapto Meeting friends, learning from experts, and succeeding back home with new ideas and knowledge. These are the top reasons pharmacists tell us why they attend NCPA's Annual Convention and Trade SuccessfulTransition SellingaPharmacy:TheCommunityPharmacist’sRoadmapto Exposition. Join us October 8-12 this year in Nashville and we're sure you'll agree. 

SuccessfulTransition Saturda ,October8,1 6:30 Welcome to Nashville

.m. Se aratere istrationfee

In As the the heart of Nashville, the Gaylord Oprylandyou Resort and Convention Center daily is located on the banks owner of a community important decisions regarding the Saturda ,October8,1 6:30 .m.pharmacy Se aratere make istrationfee of the Cumberland River. Centrally located and close to everything, this resort won the 2010 Toast health of your patients and your business, the well being of your staff and a host of issues of Music City, award, andinmany more. You'll find everything you inside thatowner comeThe from your involvement the There comes adaily timeneed when youthe are As the of aTennessean community pharmacy youcommunity. makeimportant decisions regarding the Opryland complex and nearby. Featured attractions right outside thestaff complex thehave Grand Ole faced with another important decision – how when to sell the and business health of your patient s and your business, the welland being of your ainclude hostyou of issues nurtured and grown. Opry (celebrating 86involvement years Octoberin7-8) the General Jackson Showboat that come from your theand community. There comes a timecruise. when Twelve you aremiles from Gaylord Country Music Hall of Fame and Museum offers a visceral faced withOpryland, another the important decision – how and when to sell the business youexperience. have This program is designed help you with process: nurtured and Preserving thegrown. evolving historytoand traditions of that country music and to educating its audiences, this x arts Financial planning afans, preparation for retirement international organization servesnd students, scholars, and the music industry. The collection is This program is designed to help you with that process: x Normalizing Books managed from this location, asYour it travels the 8,000 museums nationwide. Elvis, Hank Williams, and x Financial ainductees. preparation retirement xareSellers Checklist – The details offor sale Gene Autry amongplanning the manynd A must see! x Normalizing Books x ContractsYour and the legalities Sellers ChecklistGuidelines – Programming The details sale x atAccounting forof Sale Sneak xPeek Educational x Contracts and theperspective legalities x The Bankers •The PBM Landscape: A Critical Update - Valuation x Accounting for or Sale x Should I Guidelines do this myself rely on Prices a broker Tools for Decision •In-Depth PBM Briefing: Generics First and MAC and –Reimbursement x The Bankers perspective - Valu ation x Ask the Experts PanelYou •340B Opportunity Knocks—Should Answer? x Should I do this The myself or rely onGuide a broker – Tools for Decision •Opportunities in Diabetes: Pharmacist's to Insulin Pumps and Training Your Patients All registrants receive a copy of “Selling A Pharmacy: A How To Guide” ($90 value!) x Ask the Experts Panel •Opportunities in Long-Term Care •A Critical Guide to Audit Survival for the Community Pharmacy The first 50receive registrants will aA 25% discount onHow a listing on the NCPA site, All registrants copy ofreceive “Selling A To Guide” ($90 value!) •Closing the Image Gap:aMerchandising With aPharmacy: Critical Difference linking independent owners www.pharmacymatching.com, •Mastering Your Message: Crystal Communication of Yourpharmacy Pharmacy's Valuepreparing to sell, existing looking buy additional stores, and for the right The first 50inowners registrants will to receive a 25% on entrepreneurs aYour listing on thesearching NCPA site, •A Lesson 5-Star Leadership: 7 Principles todiscount Fully Engage Pharmacy Staff opportunity to become a pharmacy owner. linking independent pharmacyowners preparing to sell, www.pharmacymatching.com, existing owners looking to buy additional stores, and entrepreneurs searching for the right Registration fee: NCPA members: Non-Members: $325 opportunity to become a pharmacy owner.$225 todaymembers: at http://www.ncpanet.org/index. php/events/2011-convention RegistrationRegister fee: NCPA $225 Non-Members: $325 For more information, contact the NCPA Convention Department at1.800.544.7447 Register today at http://www.ncpanet.org/index.php/events/2011-convention For more information, contact the NCPA Convention Department at1.800.544.7447 The Georgia Pharmacy Journal

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August 2011


Pharmacy Marketing Group, Inc. Presents:

Rx and the Law: Where Have you Gone, Perry? Kenneth R. Baker, B.S., Pharm, J.D. This series, Pharmacy and the Law, is presented by Pharmacists Mutual Insurance Company and your State Pharmacy Association through Pharmacy Marketing Group, Inc. a company dedicated to providing quality products and services to the pharmacy community.

o you remember Perry Mason? How about Matlock? OK then, Denny Crane? Depending on your age, you should be familiar with at least one of these famous TV attorneys and their courtroom performances. This makes for entertaining TV, but in real life, the story is a little bit different. In most jurisdictions, the number of civil cases filed has been steady or increasing, but the number of trials has been decreasing. Why is this so?

Mediation has no third party decision maker. A neutral mediator works to get both sides to agree to a mutually acceptable settlement of the case. The mediator does that by moving between the parties, sharing information where necessary, and listening to the strengths and weaknesses of each side. If no agreement is reached, the parties move on in the litigation process. Nothing that is said or offered at a mediation is admissible at trial, so parties are motivated to be as open and honest as possible with the mediator. In many jurisdictions, at least one round of ADR is required before any case can go to trial. It is not uncommon for a judge to order the parties to a second, or even a third, mediation.

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The first reason is the discovery process. Discovery is the phase of the litigation process where the opponents share or exchange information and evidence. This includes documents, oral testimony (depositions), and written questions & answers (interrogatories). This exchange is mandated by the court rules. When discovery is complete, both parties should have all of the information that they need to evaluate the case and evaluate their chances of prevailing at trial. This typically makes at least one party reluctant to take the case to trial because they know what their chances are. No more surprise piece of evidence or last minute, surprise witness. These Perry Mason staples are virtually unheard of today. There are still some surprises at trial, but they tend to be smaller issues rather than earth-shattering ones.

In today’s legal environment, the possibility, or desirability, of trial is quite different from TV lawyers. They try a case almost every week. Non-TV lawyers might have as few as two or three civil trials per year. Some commentators have actually expressed concern that we don’t have enough trials. Case law is built on appellate decisions and with fewer trials, there are fewer appeals. But with all of our cards on the table and court rules that favor ADR, we shouldn’t be surprised that there are more settlements and fewer trials. Maybe that is a good thing because it puts the parties in control of the ultimate resolution of their case and reduces the emotional toll on the parties. It won’t be as entertaining to watch Matlock take more depositions.

The second reason is alternative dispute resolution (ADR). This ADR is different from the acronym that pharmacists are familiar with. ADR in the legal sense is a process of resolving cases without a trial. The most common forms are arbitration and mediation. In arbitration, the issues are presented to a neutral arbitrator who issues a ruling on the case. The process is greatly streamlined from that of a trial. For instance, in most cases, arbitration will not have live witness testimony. It is quicker and less expensive than a trial. The ruling can be binding or non-binding. In the non-binding situation, the parties can evaluate the ruling and compare it to their own predictions, but are not forced to accept it. Binding arbitration is considered a final ruling.

The Georgia Pharmacy Journal

© Don McGuire, R.Ph., J.D., is a Professional Liability Claims Attorney at Pharmacists Mutual Insurance Company.

This article discusses general principles of law and risk management. It is not intended as legal advice. Pharmacists should consult their own attorneys and insurance companies for specific advice. Pharmacists should be familiar with the policies and procedures of their employers and insurance companies, and act accordingly.

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August 2011


GPhA MEMBER NEWS

Pamala Marquess, Pharm.D., Participates in Public Policy Forum at McKesson ideaShare 2011 housands of independent pharmacy owners joined McKesson, the nation’s largest healthcare services company, to share in the success of independent pharmacy at the McKesson ideaShare Conference which took place in San Francisco on June 29-July 2, 2011. At the annual business gathering, retail independent pharmacy owners learned about new pharmacy solutions and technology from McKesson and its partners, as well as shared best practices with peers to strengthen their ability to compete and grow in today’s market.

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As part of ideaShare, McKesson hosted a Public Policy Forum to help attendees learn about the deep forces changing healthcare in the U.S. and the opportunity for pharmacy. The forum was hosted by Ann Berkey, McKesson’s Senior Vice President of Public Affairs, who provided an update on key federal and state policy issues impacting pharmacy, and also included a keynote presentation by Joe Flower, world-renowned healthcare futurist and author. Berkey also moderated a panel discussion with the following policy experts and pharmacy owners who shared insights and best practices on how policy is shaping community pharmacy, and how to thrive in the evolving landscape:

and federal legislators to navigate positive change for independent pharmacy, including: • Participating and supporting state events that introduce legislators to the value of independent pharmacy. Pam was very involved with “Georgia VIP (Very Important Pharmacists)”, an event that connected pharmacists from across the state with state and federal legislators.

• Health Mart Pharmacist, Pam Marquess, Pharm.D., East Marietta Drugs, GA • Health Mart Pharmacist Amber Woehl, Cith Pharmacy Health Mart, KS

• Advocating and promoting clinical services like Medication Therapy Management (MTM), as an additional source of revenue for independent pharmacy. Pam helped distribute flyers to all the community pharmacies in her area educating them on the importance of MTM to a community pharmacy business.

• Mark Kinney, VP, Government Affairs, IPC “Pam Marquess shared practical ideas and solutions with her pharmacy peers that can be implemented to help their businesses thrive now and into the future,” said Ann Berkey, senior vice president, McKesson Public Affairs. “Every year we continue to generate rich dialogue with our pharmacy customers to explore how their businesses can continuously take on the challenges in healthcare.”

• Staying current with the policy landscape in other states and how it affects pharmacy, and learning from it and identifying pitfalls to avoid as it applies to Georgia. Pam’s husband and co-owner/pharmacist of four independent pharmacies, Jonathan Marquess, participated on the Public Policy Forum in 2010.

GA Health Mart pharmacist, Pam Marquess shared specific examples of how she has engaged with local, state The Georgia Pharmacy Journal

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August 2011


continuing education for pharmacists Volume XXIX, No. 6

Multiple Sclerosis: Emerging Oral 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 :XHVWKDYHQRUHOHYDQWĂ&#x20AC;QDQFLDOUHODWLRQships to disclose.

Goal. The goal of this lesson is to describe emerging oral therapy for treatment of multiple sclerosis.

Objectives. At the conclusion of this lesson, successful participants should be able to: 1. identify factors known to reduce adherence with parenterally administered drugs in multiple sclerosis, and the factors that enhance adherence; 2. recognize the pharmacologic FODVVLĂ&#x20AC;FDWLRQRIWKHHPHUJLQJRUDO therapy discussed in this lesson; 3. demonstrate an understanding of the mechanism of action, major adverse events and therapeutic applications associated with the drugs; and 4. exhibit knowledge of information relative to multiple sclerosis pharmacotherapy to convey to patients.

Multiple sclerosis (MS) is a chronic, potentially debilitating immunemediated disease of the central nervous system (CNS) that affects about 400,000 people in the United States, with another 200-plus new cases diagnosed each week. It is not an homogeneous disease entity and, therefore, as new pharmacotherapies emerge, it will require individual therapy regimens. As a chronic and so far incurable dis-

The Georgia Pharmacy Journal

)QUUGN

9WGUV

ease, therapy is required for an LQGHĂ&#x20AC;QLWHSHUKDSVOLIHORQJSHULRG of time. The current concept of MS treatment entails use of drugs that LQĂ XHQFHLPPXQRORJLFDOUHDFWLRQV These therapies alter the course of this pathology and reduce the grade of disability. There are no GHĂ&#x20AC;QLWHV\PSWRPVWRSUHGLFWWKH individual course of disease in its early stages, and the individual grade of disability in the future cannot be anticipated with certainly. Consequently, ideal treatment RI06ZRXOGIXOĂ&#x20AC;OOWKHJHQHUDO FULWHULDRIPD[LPDOHIĂ&#x20AC;FDF\ LGHDO cure), minimal adverse effects (ideal: none), maximal patient adherence (ideal: 100 percent), and easy dosing regimens. Current disease modifying therapy (DMT) [Table 1] for the chronic treatment of relapsingremitting multiple sclerosis (RRMS), such as interferon-beta ,)1Ç&#x192; E %HWDVHURQ([WDYLD  ,)1Ç&#x192;D $YRQH[5HELI JODWLramer (Copaxone), mitoxantrone (Novantrone, and others) and naWDOL]XPDE 7\VDEUL KDVEHQHĂ&#x20AC;WWHG 7 24

WKHFRXUVHRI06IDYRUDEO\,)1Ç&#x192; or glatiramer acetate have become WKHJROGVWDQGDUGRIFDUH Ă&#x20AC;UVWOLQH  for modifying the course of RRMS, with mitoxantrone or natalizumab XVHGZKHQWKHĂ&#x20AC;UVWOLQHDJHQWVIDLO to provide suitable relief or when adverse events prevail. In randomized controlled Phase III trials, all of these parenterally-administered agents demonstrate superiority to placebo regarding clinical end points. Recently published comparative trials failed to provide evidence for superiority of one or the RWKHUĂ&#x20AC;UVWOLQH'07V6WLOOWKHUH are opportunities for additional improvements by further reducing relapse rates, slowing disease progression and providing more convenient treatments that do not rely on administration by injection. 7KHĂ&#x20AC;UVWRUDOO\DGPLQLVWHUHG'07 Ă&#x20AC;QJROLPRG *LOHQ\D ZDVDSSURYHG in September 2010 for treating RRMS.

Clinical Benefit with Disease-Modifying Therapy

'07VRIIHUVRPHGHJUHHRIEHQHĂ&#x20AC;W to most patients with MS. At the same time, certain patients reVSRQGRQO\WRVSHFLĂ&#x20AC;F'07VZKLFK suggests there may be geneticallybased differences in drug response (pharmacogenomics) and perhaps also, based on recent pathologic studies in MS, immunopathologic disease subtypes that may require different therapeutic approaches. Approval of new drugs that have different physicochemical proper-

August 2011


Table 1 Approved disease-modifying therapy for treatment of multiple sclerosis First-line ,QWHUIHURQÇ&#x192;E ,QWHUIHURQÇ&#x192;E ,QWHUIHURQÇ&#x192;D ,QWHUIHURQÇ&#x192;D *ODWLUDPHU )LQJROLPRG



Second-line Mitoxantrone Natalizumab

Trade names %HWDVHURQ ([WDYLD $YRQH[ 5HELI &RSD[RQH *LOHQ\D

Dosage form 6&LQMHFWLRQ 6&LQMHFWLRQ ,0LQMHFWLRQ 6&LQMHFWLRQ 6&LQMHFWLRQ 2UDOFDSVXOH

Recommended dose PJHYHU\RWKHUGD\ PJHYHU\RWKHUGD\ Â&#x2014;JRQFHZHHNO\ Â&#x2014;JWLPHVZHHNO\ PJGDLO\ PJRQFHGDLO\

Novantrone, RWKHUV

IV injection 

Tysabri

IV injection

12 mg/m2 given as a short PLQ LQIXVLRQHYHU\ months 300 mg infused over 1 hour every 4 weeks

SC, subcutaneous; IM, intramuscular; IV, intravenous

ties and different mechanisms of action compared to currently available DMTs may offer a means to achieve treatment goals in a broader spectrum of patients.

Shortcomings of Parenteral DMT

:LWKWKHH[FHSWLRQRIĂ&#x20AC;QJROLPRG currently approved DMTs must be delivered parenterally. Parenteral administration necessitates frequent injections, which may be uncomfortable and/or inconvenient for patients. Although self-administration is an option with the interferons and glatiramer, giving the patient greater freedom, this can also be a constant reminder of their chronic disease. Regular hospital or clinic visits are needed for intravenous infusions of natalizumab or mitoxantrone for relapsing forms of MS that continue to worsen. 2QHLQĂ&#x20AC;YHSHUVRQVLQWKHJHQeral population suffers from injection anxiety (needle phobia). This anxiety may prevent those with MS IURPVHOILQMHFWLQJWKHLUGUXJV2WKer factors (Table 2), such as misunderstanding concerning risks of self-injection or a lack of knowledge about how best to manage injection pain and side effects, can contribute to inability to self-administer injections. Many patients view injections as a bothersome burden, rather than a means to manage

The Georgia Pharmacy Journal

their disease. Patient acceptance of treatment may be negatively affected by injection-site reactions. These local reactions such as edema, redness and pain may be initiated by subcutaneous administration and to less extent, with intramuscular injection. They are a common reason for switching from subcuWDQHRXV,)1Ç&#x192;WRLQWUDPXVFXODU therapy. Usually mild, injectionsite reactions are reported to occur in up to 80 percent of patients XVLQJVXEFXWDQHRXV,)1Ç&#x192;3DWLHQW discomfort during and after injections contributes to treatment dissatisfaction and is a known factor DIIHFWLQJDGKHUHQFH(LJKWWR percent of patients who switch or VWRS,)1Ç&#x192;LQMHFWLRQVGRVREHFDXVH of injection-site reactions. Although uncommon, injection-site necrosis has also been reported. The Importance of Adherence. Poor adherence with DMT regimens correlates with poor FOLQLFDOEHQHĂ&#x20AC;W,PSURYLQJHIĂ&#x20AC;FDF\ of drugs used to treat MS requires close adherence to DMT protocols. Poor adherence to treatment regimens is associated with increased patient morbidity, poorer quality of OLIHDQGLQFUHDVHGĂ&#x20AC;QDQFLDOEXUGHQ on healthcare programs and institutions. MS is a chronic disease that requires treatment lasting over many years, often a lifetime. This 825

places a burden on patients to adhere closely to their therapy inGHĂ&#x20AC;QLWHO\5HSHWLWLYHVWXGLHVKDYH FRQĂ&#x20AC;UPHGVLJQLĂ&#x20AC;FDQWGURSRXWVIURP WKHUDS\ZLWKLQWKHĂ&#x20AC;UVWWZR\HDUV DQGVRPHWLPHVZLWKLQWKHĂ&#x20AC;UVWVL[ months of treatment. A long-term, follow-up study over 4.2 years found that discontinuation rates were as high as 46 percent. Twenty-eight percent of these patients suspended therapy because of a SHUFHLYHGODFNRIHIĂ&#x20AC;FDF\ Studies in patients with MS support the contention that the same principles underlying adherence to treatment in other chronic disease states such as hypertension and diabetes mellitus also apply to MS. Potential barriers to therapeutic adherence with DMTs include denial of illness especially early in its course, interference in lifestyle by treatment requirements, adverse effects of treatment, cost of WKHUDS\LQMHFWLRQDQ[LHW\GLIĂ&#x20AC;FXOties with self-injection techniques, cognitive impairment, unrealistic expectations for the drugs, depresVLRQDQGODFNRIFRQĂ&#x20AC;GHQFHLQGUXJ HIĂ&#x20AC;FDF\)RUH[DPSOHDEUHDNthrough relapse in MS following a long period without visible symptoms may convince the patient that the therapy is ineffective, which can lead to a perception that the costly medicine is not effective, and lead to missed doses or other actions that amount to poor adherence. It has also been reported that many patients have unrealistic H[SHFWDWLRQVRIHIĂ&#x20AC;FDF\ZKLFKFDQ lead to poor adherence. An interview with 99 MS patients who ZHUHVWDUWHGRQ,)1Ç&#x192;EWKHUDS\ UHYHDOHGWKDWSHUFHQWKDGXQUHalistically optimistic expectations regarding reduction in relapse UDWH(GXFDWLRQRQWKHH[SHFWHG outcomes of therapy lowered that percentage to 33 percent. Among patients who discontinued therapy, 64 percent had overly optimistic expectations. In contrast, only 28 percent of the patients who were compliant with therapy expressed overly optimistic expectations.

August 2011


Table 2 Non-adherence to treatment: contributory factors, strategies adopted in MS therapy to address adherence, and currently unmet needs for improvement Factors that have a negative effect on adherence to treatment for chronic disease Â&#x2021;7LPHWDNHQWRDGPLQLVWHU Â&#x2021;&RPSOH[LW\RIWUHDWPHQWUHJLPHQ Â&#x2021;'LIĂ&#x20AC;FXOW\ZLWKDGPLQLVWUDWLRQRI treatment Â&#x2021;$GYHUVHHIIHFWVRIWUHDWPHQW Â&#x2021;'LVUXSWLRQRIOLIHVW\OHE\WKHUDS\ Â&#x2021;+LJKIUHTXHQF\RIGRVLQJ Â&#x2021;&RVWRIPHGLFDWLRQ Â&#x2021;,QMHFWLRQSKRELD Â&#x2021;8QUHDOLVWLFWKHUDSHXWLFH[SHFWDWLRQV Â&#x2021;'HSUHVVLRQ Â&#x2021;7UHDWPHQWIDWLJXH Approaches that have been applied to improve treatment adherence in MS Â&#x2021;&RPHGLFDWLRQZLWKRUDOGUXJV (e.g., acetaminophen, ibuprofen) that UHGXFHĂ XOLNHV\PSWRPVDVVRFLDWHG with DMTs Â&#x2021;$XWRLQMHFWLRQGHYLFHVWRPDNHVHOI injection easier Â&#x2021;1HZIRUPXODWLRQVRI'07VWKDWGR not require refrigeration and reconstitution Â&#x2021;7UHDWPHQWRIGHSUHVVLRQ Â&#x2021;,PSOHPHQWLQJHGXFDWLRQDOLQWHUYHQtions to improve understanding of rationale, expectations and potential adverse effects, including nurse training programs to optimize injection techniques at treatment initiation Â&#x2021;5HLQIRUFHPHQWRIDGKHUHQFHRQD regular basis to encourage use as directed Unmet needs for improving treatment adherence in MS* Â&#x2021;$YDLODELOLW\RIQRQLQMHFWHGWKHUDS\ Â&#x2021;6LPSOHWUHDWPHQWUHJLPHQV Â&#x2021;/HVVH[SHQVLYHWKHUDS\ Â&#x2021;,PSURYHGEHQHĂ&#x20AC;WWRULVNUDWLR *Unmet needs were decreased with the 6HSWHPEHUDSSURYDORIĂ&#x20AC;QJROLPRG *LOHQ\D  MS, Multiple sclerosis; DMT, diseasemodifying therapy $GDSWHGIURP&RKHQ%$5LHFNPDQQ3 Int J Clin Pract. 2007;61:1922-1930.

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Achieving Optimal Adherence. Helping patients achieve optimal adherence to their medical treatment protocol is an area where pharmacists can play a VLJQLĂ&#x20AC;FDQWUROH,WKDVEHHQVKRZQ that patients who have positive feelings toward prescribed therapy adhere more closely to their regimen than those who have more negative feelings. Adherence, WKHUHIRUHUHĂ HFWVDQDFWLYHGHFLsion process on the part of patients, DQGWKLVFDQEHLQĂ XHQFHGSRVLtively with pharmacist counseling. Advising against skipping doses or discontinuing therapy is certainly within the realm of counseling information to convey to patients. To counter non-adherence, the patient must understand the purpose of the therapy and have reasonable H[SHFWDWLRQVIRULWVEHQHĂ&#x20AC;WXQGHUstand the potential adverse effects and perceive value in taking the therapy correctly to control or prevent disease manifestations that outweigh inconvenience or negative effects. It is anticipated that the development of drugs with easier means for administration, such as oral agents, would further promote strong patient adherence. There are examples of disease requiring long-term therapy where a move towards non-injected agents has been a valuable and important addition to the treatment regimen. The availability of effective oral DMTs does not eradicate non-adherence, but represents improved OLNHOLKRRGIRUDVLJQLĂ&#x20AC;FDQWDGYDQFH in treatment of patients with relapsing forms of MS compared with parenterally-administered drugs.

The Floodgate for Oral Therapies Has Opened

Fingolimod.$SSURYDORIDĂ&#x20AC;UVW OLQHRUDOIRUPXODWLRQ *LOHQ\D IRU treating relapsing forms of MS is welcome news for patients. Formerly known as FTY720, the drug is a synthetic structural analog of sphingosine 1-phosphate (S1P), which is an endogenous lysophospholipid, a potent signaling lipid that targets sphingosine 1-phos9 26

phate receptors. S1P interacts with Ă&#x20AC;YHNQRZQVXEW\SHVRI63UHFHStors (S1P) distributed throughout the body. 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. S1P4UHVSRQVHLVJHQHUDOO\FRQĂ&#x20AC;QHG to the hematopoietic and lymphoid tissues, and S1P is expressed in the white matter of the CNS. Fingolimod undergoes rapid phosphorylation in vivo within the CNS by sphingosine kinase into Ă&#x20AC;QJROLPRGSKRVSKDWHWKHELRORJLcally active compound. Fingolimodphosphate is a nonselective S1P agonist that binds with four of the Ă&#x20AC;YH63UHFHSWRUVXEW\SHV 631, S1P3, S1P4 and S1P) to modify their signaling pathways. The drug readily crosses the bloodbrain-barrier to interact with S1P receptors that are widely expressed WKURXJKRXWWKH&16%LQGLQJWR S1P1 receptors that are highly H[SUHVVHGRQ7DQG%O\PSKRF\WHV is responsible for regulating their egress from lymphoid tissue. This egress is essential for normal imPXQHIXQFWLRQ%LQGLQJWR631 down-regulates the receptor with subsequent sequestration (isolation) of lymphocytes in the lymph tissue, to prevent their recirculation, and reduce peripheral lymphocyte counts. Fingolimod is not believed to destroy lymphocytes; therefore, many immune functions including activation, proliferation DQGHIIHFWRUIXQFWLRQVRI7DQG% lymphocytes remain undisturbed during treatment. However, immune function that relies on naĂŻve T cells and central memory cells, such as activity that is necessary to combat viral infections, may be reGXFHGRUGHOD\HG*LYHQWKHWKHRU\ that aggressive lymphocyte penetration into the CNS contributes WRLQĂ DPPDWLRQDQGQHXUDOGHJHQeration via demyelination found in 06WKHGUXJ¡VPDMRUEHQHĂ&#x20AC;WPD\ be due to its ability to sequester lymphocytes within the lymphoid

August 2011


tissues. Moreover, S1P1 receptors expressed in the CNS are known to modulate neurogenesis (production of neurons) and neural function. Fingolimod may, therefore, be able to facilitate restoration of nerve cell function and supplement endogenous CNS repair. The most common adverse events reported in 10 to 20 perFHQWRIĂ&#x20AC;QJROLPRGWUHDWHGSDWLHQWV in pre-marketing trials included fatigue, melanocytic nevus (moles), LQĂ XHQ]DYLUXVLQIHFWLRQORZHU respiratory tract or lung infection, back pain, diarrhea, cough and abQRUPDOOLYHUIXQFWLRQWHVWV(IIHFWV occurring in more than 20 percent RIĂ&#x20AC;QJROLPRGWUHDWHGSDWLHQWVZHUH nasopharyngitis and headache. Serious adverse events occurred in 7 to 11 percent of patients and included MS relapse, basal cell carcinoma and transient sinus bradycardia. 2WKHUFOLQLFDODGYHUVHHYHQWV observed during these trials are notable. Macular 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 II testing. In two trials, Ă&#x20AC;QJROLPRGWUHDWHGSDWLHQWV were found to have skin cancer, all VXFFHVVIXOO\H[FLVHG/DERUDWRU\ abnormalities included decreased lymphocyte count, mild decrease in mean forced expiratory volume in RQHVHFRQG )(91), and a reversible increase of alanine transferase to greater than three times the upper limit of normal. The productâ&#x20AC;&#x2122;s manufacturer lists four drugs or drug classes that should be used cautiously, if at DOOZLWKĂ&#x20AC;QJROLPRG7KHVHLQFOXGH class Ia (e.g., quinidine) or Class III (e.g., amiodarone) antiarrhythmics, beta-adrenergic blockers, ketoconazole and vaccines.

Emerging Options for Oral Therapy in MS The new generation of MS therapies will continue to expand. Intensive research into the complex interplay of biochemical and physiological processes involved

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in the pathophysiologic cascade of WKHGLVHDVHKDVLGHQWLĂ&#x20AC;HGDYDULety of potentially new targets for oral therapeutic strategies. Data VKRZLQJHIĂ&#x20AC;FDF\IRUWKHVHQHZRUDO agents are impressive, and reveal they have the potential to eventually replace injectable DMT options. Any new treatment regimen, however, brings concerns relating to safety and cost. In addition as noted above, patients with MS have poor treatment adherence to the currently available parenteral therapies, and it remains uncertain whether the introduction of oral agents will improve patient adherence. Moreover, advancement into Phase III trials may not always result in a new therapy, as was recently shown when an oral version of glatiramer failed to improve the rate of relapses in a clinical WULDOLQYROYLQJSDWLHQWVZLWK RRMS. Cladribine. Cladribine (2-chlorodeoxyadenosine) is a purine nucleoside analogue prodrug. It is selectively toxic for lymphocytes and monocytes, appears to cross the blood-brain-barrier with ease, and has preferential lymphocytedepleting properties. It is currently used in an intravenous formulation /HXVWDWLQ DVDQHIIHFWLYHDSproved therapy for hairy cell leukemia and other hematologic malignancies, in patients unresponsive to other therapy. It has also been assessed in clinical trials for treatment of a variety of autoimmune diseases. Administered orally, the drug has been shown to be effective in treatment of RRMS. The mechanism by which cladribine acts in MS is not fully known; however, there is evidence that it is phosphorylated intracellularly by deoxycytidine kinase to 2-chlorodeoxyadenosine triphosphate, which accumulates within cells to disrupt cellular metabolism and inhibit DNA synthesis and repair, and subsequently induce apoptosis (natural or programmed cell death). This occurs preferentially in lymphocytes, thus depleting the level of activated lymphocytes that induce central neuron 10 27

demyelination in MS. It also spares other hematologic and immune FHOOVVXFKDV%FHOOVDQGQDWXUDO killer cells. The primary effect of cladribine is immune cell depletion, and the drug depletes both proliferating and inactive lymphocytes. Results of Phase II and III trials in MS employing an injectable formulation of cladribine demonstrated suppression of gadoliniumenhancing lesions in patients with RRMS who received cladribine for six months compared with placebo. Cladribine also reduced the frequency and severity of relapses compared with placebo at the 12and 18-month time points. The sustained immunosuppressive effects of cladribine would make it ideal for intermittent dosing, which should improve patient adherence and tolerability. Current trials are evaluating oral cladribine for use as monotherapy or in combinaWLRQZLWK,)1Ç&#x192;DWRDXJPHQWLWV HIĂ&#x20AC;FDF\ A standard dosing regimen for oral cladribine has yet to be established and two possible dosing regimens are being explored in these studies. These doses have been associated with a good safety and tolHUDELOLW\SURĂ&#x20AC;OH0\HORVXSSUHVVLRQ is the dose-limiting toxicity, and culture-negative fever is the most common adverse effect. No events related to cardiotoxicity, nephrotoxicity or neurotoxicity have been reported. While lymphopenia that occurs following a single course of cladribine may be considered a risk factor for infection, opportunistic infection has occurred in only a few patients with cases limited to mild herpes zoster along with one fatal KHSDWLWLV%LQIHFWLRQ BG00012. This is an oral formulation of dimethylfumarate WKDWKDVDQWLLQĂ DPPDWRU\DQG neuroprotective properties, and is used for treatment of psoriasis in VRPH(XURSHDQFRXQWULHV7KHGUXJ is being evaluated in two Phase III trials. Studies in psoriasis patients indicate that it decreases peripheral counts of CD4+ and CD8+ lymphocytes, particularly the latter. 7UHDWPHQWZLWK%*OHGWR

August 2011


DVWDWLVWLFDOO\VLJQLĂ&#x20AC;FDQWUHGXFWLRQ in the total number of gadoliniumenhancing brain lesions, as measured by MRI over six months of treatment. The most commonly reported adverse events included Ă XVKLQJJDVWURLQWHVWLQDOGLVRUGHUV headache and nasopharyngitis. /LYHUHQ]\PHHOHYDWLRQVZHUH UHSRUWHGLQWRSHUFHQWRIWKH WUHDWPHQWJURXSVFRPSDUHGZLWK percent in the placebo group. Its exact mechanism of action is still unclear, but it appears the drug has a novel mechanism of action as potential therapy for MS. It possesses both cytoprotective DQGDQWLLQĂ DPPDWRU\SURSHUWLHV through inhibiting expression of SURLQĂ DPPDWRU\F\WRNLQHVDQG cell adhesion molecules. Studies have demonstrated that dimethyl fumarate treatment may suppress peripheral CD4+ and CD8+ lymphocytes and may also shift the predominant T lymphocyte population from a T helper (Th1) to a Th2 phenotype. This is also one of the presumed mechanisms of action of glatiramer. Firategrast./LNHQDWDOL]XPDEĂ&#x20AC;UDWHJUDVWLVDQDOSKDLQWHJrin antagonist that interferes with WKHELQGLQJRIÇ&#x201A;4Ç&#x192;1DQGÇ&#x201A;4Ç&#x192;7 integrins to its ligand, VCAM-1. This prevents the migration of immune cells into the CNS. Clinical trials have shown a decrease in new lesions with a trend toward fewer relapses with increasing doses. Firategrast was generally well tolerated in clinical trials. Adverse events included vomiting; infections, particularly of the urinary and respiratory tract; and rash. At this time, there are no reports of progressive multifocal leukoencephalopathy (disease of the white substance of the brain). Unlike natalizumab, it is a small molecule in the form of an oral preparation. This confers the EHQHĂ&#x20AC;WRIDPRUHFRQYHQLHQWPRGH of delivery along with improved patient adherence to therapy. Laquinimod./DTXLQLPRGD quinoline-3-carboxamide derivative, is chemically distinct from URTXLQLPH[ /LQRPLGH DQDJHQW

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WKDWKDVGHPRQVWUDWHGHIĂ&#x20AC;FDF\LQ the oral treatment of MS but is associated with substantial adverse HIIHFWV/DTXLQLPRGLVPRUHSRWHQW at inhibiting MS symptoms than its parent compound and reportedly causes fewer adverse effects. Although its pharmacologic WDUJHWKDVQRWEHHQGHĂ&#x20AC;QLWHO\ LGHQWLĂ&#x20AC;HGODTXLQLPRGLVEHOLHYHG WRLQKLELWWKHLQĂ&#x20AC;OWUDWLRQRIERWK CD4+ T cells and macrophages LQWRWKH&16,WVHIĂ&#x20AC;FDF\LVDOVR believed to be at least partially due to shifting the balance of the T lymphocyte population in favor of cells expressing Th2/Th3 cytoNLQHVLQWHUOHXNLQ ,/ ,/DQG transforming growth factor-beta. This novel action produces an immunomodulatory response (altered immune response) without causing immunosuppression. The T cell VKLIWLQGLFDWHVWKHEHQHĂ&#x20AC;FLDOHIIHFWV of laquinimod occur because of a deviation of the immune response, rather than suppression. Results of a recently published study that compared the effects of laquinimod in the peripheral blood mononuclear cells of healthy subjects and patients with RRMS showed that the drug induced suppression of genes associated with antigen preVHQWDWLRQDQGWKHUHVXOWLQJLQĂ DPmatory pathways. /DTXLQLPRGKDVEHHQVKRZQ to suppress active lesions on MRI scans in patients with RRMS. In a Phase II trial in patients with RRMS, laquinimod showed a favorDEOHVDIHW\SURĂ&#x20AC;OHZLWKRXWVLJQLĂ&#x20AC;cant clinical or laboratory signs of XQGHVLUHGLQĂ DPPDWRU\PDQLIHVWDWLRQVVXFKDVVHURVLWLV LQĂ DPPDtion of serous membranes) or myocardial infarction. In a 24-month open-label extension trial, laquinimod was well tolerated. The most frequently reported adverse events ZHUHQDVRSKDU\QJLWLV SHUcent), back pain (12.4 percent), and headache (8.1 percent). 7HULĂ XQRPLGH7HULĂ XQRmide is the active metabolite of OHĂ XQRPLGH $UDYD DQDSSURYHG treatment for rheumatoid arWKULWLV7HULĂ XQRPLGHLQKLELWV7 cell activation through reversible 11 28

inhibition of dihydroorotate dehydrogenase, the rate-limiting step in the de novo synthesis of pyrimidine, leading to decreased DNA synthesis. This novel action during the induction of cellular immune responses is thought to contribute to its clinical effectiveness in diseases characterized by exaggerated immune reactions. Further effects RQLQĂ DPPDWRU\FHOOUHFUXLWPHQW and other in vivo immunomodulatory processes are postulated. In a 3KDVH,,WULDORISDWLHQWVZLWK RRMS and 22 with progressive MS, RUDOWHULĂ XQRPLGHZDVVKRZQWRGHcrease the number of unique, active MRI lesions. The treatment seems to be well tolerated and the frequency of adverse events was similar across groups. This drug has entered Phase III trials as monotherapy, and is also being investigated in FRPELQDWLRQZLWKHLWKHU,)1Ç&#x192;RU glatiramer in Phase II trials. Dalfampridine. Also known as fampridine, dalfampridine (Ampyra) is an old drug in new clothing. Its active ingredient is 4-aminopyridine (4-AP), a compound developed initially as a bird poison. For more than three decades, 4-AP has enjoyed off-label use in humans for treatment of MS. At the same time, it remained a niche drug because of limited effectiveness, limited availability only through specialized compounding pharmacies, and a substantial seizure risk. It is a selective potassium channel antagonist that is believed to relieve MS symptoms by restoring conduction in demyelinated axons via voltage-dependent potassium channel blockade. The drug was approved for treatment of patients with MS in January 2010, and is unique among MS pharmacotherapy in being indicated specifically for improving walking ability and lower leg strength (as opposed to reducing relapses or improving disability). The drug is not a DMT, DQGKDVQRWVKRZQHIĂ&#x20AC;FDF\LQDQ\ other domain apart from improved walking. Dalfampridine is an extendedrelease formulation of 4-AP that

August 2011


has favorable pharmacologic properties compared with its generic forebear, including twice-daily instead of three-times-daily dosing without regard to meals. In preliminary trials, seizures were still a problem at doses of 20 mg twice daily and above. Therefore, a dose of 10 mg twice daily was chosen IRUWKHSKDVH,,,WULDOV*LYHQWKH low safety factor for the drug, it is likely that seizures will ultimately emerge as an expected adverse effect with continued use. To date, no formal drug interaction studies with dalfampridine KDYHEHHQFRQGXFWHG%HFDXVHLW may lower the seizure threshold, precaution should be taken in patients who are concomitantly taking medications that may also induce seizures, such as tricyclic antidepressants, phenothiazines and venlafaxine. Ampyra is distributed exclusively through a network of specialty pharmacies, which are coordinated by Ampyra Patient Support Services.

Side Note

Several monoclonal antibodies are under study as possible treatments for RRMS. These therapies will not be orally administered; however, they do target different sites on immune cells and may offer alternatives for patients who have not responded adequately to current treatment options. Alemtuzumab (Campath). Alemtuzumab is currently apSURYHGDVDWUHDWPHQWIRU%FHOO chronic lymphocytic leukemia. The drug was given an FDA Fast Track designation in 2010 for study in RRMS, and Phase III trials are underway. Daclizumab (Zenapax). This appears to increase numbers of &'QDWXUDONLOOHUFHOOVDQGLQD Phase II clinical trial reduced the number of new or enlarging gadolinium-enhancing lesions by 72 SHUFHQWZKHQFRPELQHGZLWK,)1Ç&#x192; EFRPSDUHGWR,)1Ç&#x192;EDORQH The drug is currently approved for prophylaxis against acute rejection in renal transplant patients. Rituximab (Rituxan). Ap-

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proved for treatment of nonHodgkinâ&#x20AC;&#x2122;s lymphoma, rheumatoid arthritis and chronic lymphocytic leukemia, rituximab, which targets and depletes CD20+%O\PSKRF\WHV reduced lesion burden and relapse rate compared with placebo, and reduced relapses when used as an add-on to conventional injectable therapies in Phase II trials of patients with RRMS.

Overview and Summary

Newer treatment options for patients with MS have improved HIĂ&#x20AC;FDF\RYHUĂ&#x20AC;UVWJHQHUDWLRQWKHUDpies; however, they still necessitate the use of weekly or monthly injecWLRQV(PHUJHQFHRIDQHZJHQHUDtion of oral MS agents would, in theory, not only eliminate the need for painful injections and provide patients with a more user friendly alternative to currently approved choices, but these compounds also show promise in reducing the number and volume of brain lesions. Although the results of Phase II and III oral therapy trials are encouraging, all agents have VLJQLĂ&#x20AC;FDQWDGYHUVHHIIHFWVWKDWPD\ RXWZHLJKSRVLWLYHEHQHĂ&#x20AC;WLQFHUWDLQ individuals. These oral therapies may, therefore, not displace the existing platform therapies, but be used along with them.

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. 7KLVOHVVRQLVDNQRZOHGJHEDVHG&(DFWLYLW\DQG is targeted to pharmacists in all practice settings.

Program 0129-0000-11-006-H01-P 5HOHDVHGDWH ([SLUDWLRQGDWH

&(+RXUV &(8

7KH2KLR3KDUPDFLVWV)RXQGDWLRQ,QFLV accredited by the Accreditation Council IRU3KDUPDF\(GXFDWLRQDVDSURYLGHURI continuing pharmacy education.

12 29

August 2011


2011 - 2012 GPhA BOARD OF DIRECTORS

The Georgia Pharmacy Journal Editor:

Jim Bracewell jbracewell@gpha.org

Managing Editor & Designer:

Kelly McLendon kmclendon@gpha.org

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.

ARTICLES AND ARTWORK Those who are interested in writing for this publication are encouraged to request the official GPJ Guidelines for Writers. Artists or photographers wishing to submit artwork for use on the cover should call, write or e-mail the editorial offices as listed above.

SUBSCRIPTIONS AND CHANGE OF ADDRESS The Georgia Pharmacy Journal® (GPJ) (ISSN 1075-6965) is distributed as a regular membership service, paid for through allocation of membership dues. Subscription rate for non-members is $50.00 per year domestic and $10.00 per single copy; international rates $65.00 per year and $20.00 single copy. Subscriptions are not available for non-GPhA member pharmacists licensed and practicing in Georgia. The Georgia Pharmacy Journal® (GPJ) (ISSN 1075-6965) is published monthly 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 Pharmacy Journal®, 50 Lenox Pointe, NE, Atlanta, GA 30324.

ADVERTISING Advertising copy deadline and rates are available at www.gpha.org upon request. All advertising and production orders should be sent to the GPhA headquarters as listed above.

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Chairman of the Board President President-Elect First Vice President Second Vice President State At Large State At Large State At Large State At Large State At Large State At Large State At Large 1st Region President 2nd Region President 3rd Region President 4th Region President 5th Region President 6th Region President 7th Region President 8th Region President 9th Region President 10th Region President 11th Region President 12th Region President ACP Chairman AEP Representative AHP Chairman AIP Chairman APT Chairman ASA Chairman Foundation Chairman Insurance Trust Chairman Georgia State Board of Pharmacy Representative Georgia Society of Health Systems Pharmacists Mercer Faculty Representative South Faculty Representative UGA Faculty Rep. ASP Mercer University Rep. ASP South University Rep. ASP UGA Rep. Executive Vice President

Patricia Knowles

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Amy Grimsley Rusty Fetterman Sukh Sarao Negin Sovaidi Annie Tran David Bray Jim Bracewell

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August 2011


continuing education quiz

Please print.

Name________________________________________________ Address_____________________________________________

Multiple Sclerosis: Emerging Oral Therapy

City, State, Zip______________________________________

1. All of the following are correct descriptions of multiple sclerosis (MS) EXCEPT: a. chronic. c. heterogeneous. b. debilitating. d. immune-mediated.

Email_______________________________________________ Return quiz and payment (check or money order) to Correspondence Course, OPA, 2674 Federated Blvd, Columbus, OH 43235-4990

7. By hindering S1P1, Gilenya causes all of the following EXCEPT: a. prevention of recirculation of lymphocytes. b. increased peripheral lymphocyte count. c. sequestration of lymphocytes in the lymph tissue.

2. Which of the following types of interferon (IFN) has become the gold standard of care for modifying the course of relapsing-remitting multiple sclerosis (RRMS)? a. Alpha c. Gamma b. Beta d. Delta

7KHPDMRUEHQHĂ&#x20AC;WRI*LOHQ\DLVWKRXJKWWREHLWVDELOity to cause: a. prevention of recirculation of lymphocytes. b. increased peripheral lymphocyte count. c. sequestration of lymphocytes in the lymph tissue.

 7KHĂ&#x20AC;UVWRUDOO\DGPLQLVWHUHGGLVHDVHPRGLI\LQJ therapy (DMT) for treating patients with MS is:  D Ă&#x20AC;QJROLPRG F PLWR[DQWURQH b. glatiramer. d. natalizumab. 4. The intramuscularly administered DMT product for treating patients with MS is: a. Rebif. c. Betaseron.  E ([WDYLD G $YRQH[

9. The manufacturer of Gilenya warns that all of the following drugs should be used cautiously, if at all, with Gilenya EXCEPT: a. amiodarone. c. mirtazapine. b. ketoconazole. d. quinidine.

5. It has been reported that more than half (57 percent) of patients with poor adherence for MS therapy have XQUHDOLVWLFDOO\RSWLPLVWLFH[SHFWDWLRQVUHJDUGLQJWKH  D GLIĂ&#x20AC;FXOW\LQVHOIDGPLQLVWHULQJWKHLQMHFWLRQV b. feeling they will ever get better. c. high incidence of injection site reactions. d. reduction in relapse rate.

&ODGULELQHLVVHOHFWLYHO\WR[LFIRUO\PSKRF\WHVDQG a. erythrocytes. c. leukocytes. b. granulocytes. d. monocytes. 11. By inhibiting DNA synthesis and repair, cladribine subsequently induces natural or programmed cell death, a process referred to as:  D DSRSWRVLV F F\WRWR[LFLW\ b. biodegradation. d. necrosis.

6. The type of sphingosine 1-phosphate receptor targeted by Gilenya that is located on atrial muscles that regulates heart rate is: c. S1P3. a. S1P1. b. S1P2. d. S1P4.

12. Firategrast: a. decreases DNA synthesis by affecting the synthesis of pyrimidine. b. prevents migration of immune cells into the CNS. c. regenerates neuronal tissue into its functioning form. d. stimulates the production of myelin in central neurons.

&RPSOHWHO\Ă&#x20AC;OOLQWKHOHWWHUHGER[FRUUHVSRQGLQJWR your answer.

1. 2. 3. 4. 5.

[a] [a] [a] [a] [a]

[b] [b] [b] [b] [b]

[c] [c] [c] [c] [c]

[d] 6. [a] [d] 7. [a] [d] 8. [a] [d] 9. [a] [d] 10. [a]

[b] [b] [b] [b] [b]

[c] [d] [c] [c] [c] [d] [c] [d]

11. [a] 12. [a] 13. [a] 14. [a] 15. [a]

[b] [b] [b] [b] [b]

[c] [d] [c] [d]

13. Laquinimod produces an: a. immunosuppressant response. b. immunomodulatory response.

[c] [d] [c] [d]

7HULĂ XQRPLGH a. decreases DNA synthesis by affecting the synthesis of pyrimidine. b. prevents migration of immune cells into the CNS. c. regenerates neuronal tissue into its functioning form. d. stimulates the production of myelin in central neurons.

Â&#x2030; I am enclosing $5 for this monthâ&#x20AC;&#x2122;s quiz made payable to: Ohio Pharmacists Association. 5DWHWKLVOHVVRQ ([FHOOHQW  3RRU

2. Did it meet each of its objectives? Â&#x2030; yes Â&#x2030; no If no, list any unmet_______________________________ 3. Was the content balanced and without commercial bias? Â&#x2030; yes Â&#x2030; no 4. Did the program meet your educational/practice needs? Â&#x2030; yes Â&#x2030; no 5. How long did it take you to read this lesson and complete the quiz? ________________ 6. Comments/future topics welcome.

The Georgia Pharmacy Journal

Program 0129-0000-11-006-H01-P 0.15 CEU

15. Dalfampridine was developed initially as a: a. rat poison. c. insecticide. b. fungicide. d. bird poison.

To receive CE credit, your quiz must be postmarked no later than June 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.

31

june2011 2011 August


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The Georgia Pharmacy Journal: August 2011  

2011-2012 GPhA eme

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