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Volume 35, Number 7

www.gpha.org

Hatton Takes GPhA Helm


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Content/Features Departments

feature articles 4

The New Faces of GPhA

9

Report: 36% of All Prescriptions Submitted

Electronically in 2011

10

Austin Scott Fundraiser

13

GPhA Thanks Outgoing Board Members

16

“This Ain’t Your Mama’s Pharmacy Business”

20

GPhA New 2012-13 Board of Directors

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Continuing Education Article

9 11 12 14 15 31

GPhA News GPhA Advocacy Pharm PAC Members Pharm PAC Contribution Form GPhA New Members GPhA Board of Directors

Advertisers

2 Pharmacists Mutual Companies 9 EC Retail Studio 15 Melvin M. Goldstein, P.C. 15 Logix, Inc. 20 Michael T. Tarrant 21 RxAllyTM 22 Meadowbrook Insurance Group 30 AIP 32 UBS

columns 4

President’s Speech from 137th GPhA Convention

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Executive Vice President & CEO’s Message

View GPhA’s Calendar of Events at:

www.gpha.org

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The New Faces of GPhA

It’s quite an honor to be elected the 137th president of GPhA. You had 137 years to get it right….and you wound up here. Wow! And it’s the year 2012, so according to the Mayans…..I’m the last one. My understanding is that the cataclysmic event is supposed to happen prior to the upcoming legislative session making it somewhat difficult to determine our political direction. Somehow, I think we will all make it through and still have to plan for Christmas and the days after. This is normally the part in a speech where people refer to family members in attendance. I can’t, because I’ll cry. My mama's here, Beth Hatton, with my wife and kids and I want everyone to meet them. There…

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Trying to think of a direction for this speech was difficult. There have been so many great leaders ahead of me. Trying to convey some meaningful message when I didn’t feel worthy to be around some of these folks was a daunting task. I told Jim Bracewell recently that I felt like all the adults had left the room, and I’ve got to figure out what to do now. Folks like Robert Bowles, who was Chairman my first year and told me the 2nd VPs job was to sit… and listen. Former Senator Eddie Madden, who has forgotten more about the political process than I will ever know. When introduced to him and he said, “Hi, Eddie Madden,” the tape playing in my head went something like, “Hi, small insignificant peon Robert Hatton. Nice to meet you.”

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And lord… he was a Democrat, but we hit it off anyway. Dale Coker, who by the way was friends with my wife’s parents, was one those people that didn’t say much, but when he did it was a well thought out comment or question, the complete opposite of my own impulsive ramblings.

Then there was “Jumping Jack Dunn.” One of the most giving, caring people I have ever known. He loves this profession and has humbled me from the moment I met him. Even if I do have to diagram his sentences in my head sometimes to make sure we’re on the same page. Then there is Pam Marquess. I’m afraid to say much about Pam because she’s up here next and can say frightful stuff about me...but suffice it to say, Jonathan married up. And of course, Bobby Moody…Georgia fan. Enough said. I’d be remiss if I didn’t mention Jim Bracewell. Jim held my hand for a couple of years, but I’m quite sure what he really wanted to do was look me in the eye and ask, “What are you doing here? How did you get here? Is there a mechanism in the bylaws to get rid of you”? All joking aside, Jim has served as EVP with integrity and enthusiasm and I am proud to have had the opportunity to be on the EC while he was here. I’m

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not sure if you know this or not, but GPhA is known around the country as one of the premier associations and Jim has made sure that under his watch we have maintained that reputation. My question tonight is what are you going to do with the dash? I’m not talking about the 100 yard dash. I’m certainly not referring to it personally, as I can attest to the fact I am only good for about 20 yards of it. I’m talking about the dash next to my name that reads, Robert M Hatton, born August 5th, 1964 - ? You get to thinking about it and there is an awful lot of stuff that happens in that dash. Births, deaths, victories, defeats, graduations. What are you going to do with the opportunities given you during that really small span of time? Think back in your lifetime about the people who have made the most impact on your life. I’ll be willing to bet that the majority of them didn’t give you money. They gave you perspective. One such memory of my own was imparted to me by the late Hubert Chancy when he told me, “Robert, the world doesn’t owe you anything for being smart.” Advice like that is what I have come to refer to as a well-timed spiritual head slap. My own father was the master at this, but on a simple level. My favorite piece of advice he gave me that I can actually share in public was this: “Son, when you get to thinking you’re important, go stick your fist in a bucket of water, take it out and measure the size of the hole you left. That’s a pretty good indication of just how important you are.” I had a hard time in choosing a direction for the upcoming year. When I

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looked at the changes that have occurred and the changes we’re anticipating, I decided to go with the idea of “Answering Opportunity”. It seemed appropriate, not just because I always had trouble spelling both of those words, but because the future of our profession depends on doing just that: “Answering Opportunity.” In times of great change, there are always great opportunities. Great opportunities to fail, and great opportunities to succeed. How are we going to respond? Doing what we have always done as a profession will, in the future, likely result in limited opportunities. We have been saying this for years. So…the dash is on. We find ourselves in the middle of it. In keeping with making our lives count for something, I want to tell you a story. The first year I was on the EC, Kim and I took the kids to Washington DC. It was April and the weather was beautiful. I had always been there in the middle of summer and all you did was sweat. We had a great time. The most remarkable thing about the trip for me, however, was the plane ride home. I sat next to a young girl on the plane and we were 20-30 minutes into the flight before I started a conversation. I asked her name and she told me it was Ana. Her full name was actually Anahita, but I guess she had learned that’s a bit much for us westerners.

July 2012


“Where are you from?” I asked. I knew she was foreign, but after a week in DC, you start to wonder if you are foreign. She said, “Guess”. I thought this was awkward and strange but I went for it anyway knowing I could be fixing on thin ice. “India?” She said no. “Pakistan?” Once again, “no” was the answer. I shrugged as if to say, look, I’m just a good old boy and don’t want to incite an international incident and damage trade relations, so, just help me out. “Iran”, she told me. Wow…I haven’t met someone from Iran before, I thought. How long have you been here?” Seven years, she said. I asked, “How did you end up in the US?” This is where my little world got shook up. She said her family escaped Iran as refugees. I was real quiet for a second. I asked if she had ever been back. She answered “No. I can’t, the president there is bad, many victims.”

Well, Bubba. What do you ask now? “What does your father do?” I asked. “Cool air repair,” and she pointed to the vent over the seat in the airplane. Even I could figure this one out pretty quick. Does your mother work? “Yes, at Walmart.” She laughed when she told me this, then she said something that kind of got to me, “We are very poor.” After I thought for a moment, I told her that both of her parents work and there is honor

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in that (yes, I really said that). She said she was “glad” for them. I’m pretty sure she meant “proud,” but I let that go. “What did your father do in Iran?” I asked. She said he was a genius math teacher, but they fired him. Then it got really interesting. She said, “We’re not Muslim. If not Muslim, then no job and can’t get into college as woman.” We struggled on in conversation through her broken English and my myopic sense of the world and I was finally able to find out that she was trying to get into school in DC and was currently attending a small college in North Florida. She wanted to be an actress or a plastic surgeon. Oh, to be young and idealistic, I thought. I asked if she was Christian and she said she was B’Hai Faith. Granted, that ain’t the team I play for, but you had to admire the faith. Her family had left their country, never to see their relatives or home again, all for the hope and dream that is America. I was actually starting to tear up when I asked if they were here on work Visa or political amnesty. The smile across her face was remarkable when she told me “I am citizenship.” I felt small. I was born with what they risked their lives for. I can go to any church I want to, drive down the road to wherever I want. Go to work where I want and I have the privilege of working as hard as I want to. I can choose to get up on Sunday morning and take my kids to church or I can sleep in. I can turn on the TV and watch one of hundreds of channels or I don’t have to watch TV at all. What a gift!

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On top of all that, I find myself in an occupation where I get to help people. The story about Ana would be remarkable by itself, but that’s not the kicker. The kicker is that Ana was completely and totally deaf. The conversation we had was written out on the back of itineraries and boarding passes. She knew 3 languages, Persian, English and French but I couldn’t sign and all I speak is redneck, so we had to write everything. I figured out she was deaf when she had to point to a picture of “Coke” to get one on the plane and she signed “thank you” when I threw her cup away for her. Now I told you that story for 2 reasons. One, to make you cry, the other to help you realize what an opportunity we have. But it is not a guarantee.

What a “dash” we can make for ourselves. We can be as involved in government decisions affecting what we do and who we want to be, or we can choose to ignore it. We have organizations such as GPhA and NCPA that for a small yearly fee will do their dead-level best to fight the fight for us or we can know that in our numbers and voices, the more of us there are the stronger we are. I can choose to call my congressman when asked to do so or I can throw the “blast-fax” in the trash. Someone will do that, and I’m so busy. I can send an e-mail or not. I can invite someone to a region meeting or not…you get the picture. We have to fill our dash with things that are different then what we thought they

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we're going to be when we graduated. But you can do it… you can do it. We have got to take the attitude that it ain’t over till we win. Repeat that with me …it ain’t over till we win. One more time: It ain’t over till we win. In closing, I’m going to do something I rarely do. I’m going to give you a quote from one of my favorite philosophers…Kermit the frog.

are all things that make you green. When you step out of the box that others have put you in and defined you as, you’re green. Most of us got into this profession because we wanted to help people. In order to remain viable in this profession, we have to be active. We have to make calls to senators and representatives. We have to educate ourselves on the issues and we have to educate our patients. GPhA is your advocate to make sure that opportunities continue to exist for pharmacists, but we can’t do it alone.

Folks…we have to be green. That’s it, I’m done. I thank you for your time and this chance to speak to you tonight. I thank you for the opportunity to share in the leadership of this organization. I want everyone to plan on hanging around and having a great time. I’ll see you on the dance floor. Thank you!

Kermit says it ain’t easy being green. Sticking your neck out, taking responsibility and accepting accountability

L to R: Jim Bracewell, Robert Hatton and Jack Dunn

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E X E C UTI V E V I C E P RESI D ENT & C EO ’ S MESSA G E Jim Bracewell Executive Vice President & CEO Georgia Pharmacy Association

Pharmacy’s Favorable Juncture of Circumstances

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liked that phrase a great deal, but it can be better summed up in one word – OPPORTUNITY. That is what is before the profession. In a way, opportunity has not presented itself before.

The growing crisis in the delivery of healthcare in our country has placed an intense spotlight on the underutilization of pharmacists as a key component to improved outcomes, reduced costs and a healthier population. While today we are experiencing unprecedented drug supply shortages, there are thousands of other drug formulations in the market than ever before and more people taking more drugs. According to the Kaiser Foundation some 3,703,594,389 prescriptions were filled in the U.S. in 2010 at a cost of $220,338,509,960 dollars. That is almost 4 billion prescriptions costing over 220 billion dollars. For the favorable juncture of circumstances for the pharmacy profession, consider this statement: “Medication adherence is America’s new drug problem.” So says Dr. Carolyn Clancy, director of the Agency for Healthcare Research and Quality with the Department of Health and Human Services. Unfortunately, Dr. Clancy is correct. The following statistics on medication non-adherence tell the story by the numbers: $300B1 125,0002 33%3 50%4

Annual excess medical costs due to non-adherence Number of deaths annually in US due to non-adherence Percentage of patients who never even fill their prescriptions Average rate of patient non-adherence

Medication Therapy Management (MTM) has become a widely used term relating to a consortium of efforts by pharmacy to address this more than $240 billion dollar annual problem. Improving Patient and Health System Outcomes through Advanced Pharmacy Practice, a Report to the US Surgeon General 2011 by Rear Admiral Scott Giberson, our keynote speaker at the First General Session of our meeting in Hilton Head, S. C. presents irrefutable evidence for expanding the role of the pharmacist in solving our health crisis in America. A full copy of his report is available this month on the home page of www.gpha.org where you can read it or download it to share with your colleagues. Opportunity is at hand for the pharmacy profession to move forward and take up this expanded mantle of service. Pharmacy should never relinquish control of the drug product, but no longer should your career or your livelihood be yoked to the margin on drug cost that is dictated by a third party. The American health system is knocking at pharmacy’s door. Will our profession answer the call? 1 Balkrishnan, R. 2005. The Importance of medication adherence in improving chronic disease related outcomes. Med Care 43:517-520 2 Norman, G. “It takes more than Wireless to unbind Healthcare.” Presentation at Healthcare Unbound 2007 Conference. 3 Norman, G. “It takes more than Wireless to unbind Healthcare.” Presentation at Healthcare Unbound 2007 Conference. 4 Balkrishnan, R. 2005. The Importance of medication adherence in improving chronic disease related outcomes. Med Care 43:517-520

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GPhA News Report: 36% of All Prescriptions Submitted Electronically in 2011 More than one-third of U.S. prescriptions now are electronic, according to a new report from electronic prescribing network Surescripts, the AP/Washington Post reports. Key Findings The report found that by the end of 2011, 36% of all prescriptions in the U.S. were electronic, up from 22% in the previous year (AP/Washington Post, 5/17). The number of electronic prescriptions issued increased from 326 million in 2010 to 570 million in 2011. According to the report, 58% of office-based physicians were e-prescribing by the end of 2011. At that time, the report found that: • 55% of physician practices with six to 10 physicians were e-prescribing; • 53% of practices with two to five physicians were e-prescribing; and • 46% of solo practitioners were e-prescribing.

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Additional Findings Of the physicians who started e-prescribing in 2008, up to 60% have met the Stage 1 meaningful use requirement for e-prescribing and about 38% would meet the proposed Stage 2 e-prescribing requirement if it were in effect, according to Surescripts (McCann, Healthcare IT News, 5/17). Under the 2009 federal economic stimulus package, health care providers who demonstrate meaningful use of certified EHR systems can qualify for Medicaid and Medicare incentive payments. The report also cited a previous report--conducted by Surescripts, pharmacies and pharmacy benefit managers --that found that the percentage of patients who picked up new prescriptions increased by about 10% after physicians adopted e-prescribing technology (AP/Washington Post, 5/17).

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GPhA news

AUSTIN SCOTT FUNDRAISER

L to R: Hugh Chancy, Congressman Austin Scott, Robert Hatton

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GPhA ADVOCACY Andy Freeman Director of Government Affairs Georgia Pharmacy Association

PharmPAC

True friends... like Austin Scott

In even numbered years, I get a lot of phone calls from candidates asking for campaign contributions. You would think by the way they talk that we have no better friend than the person currently calling to ask for money. Even if they rarely vote for pro-pharmacist legislation, when they make the phone call they claim to be our best advocate. Fortunately not all of the calls we get are from those faux friends.

In 1996, a 26 year old man was elected to the Georgia House of Representatives from Tifton named Austin Scott. He served 14 years in the State House and quickly rose up the ranks into leadership positions and became a committee chairman. One of the things Austin worked on in the Georgia General Assembly was legislation to regulate Pharmacy Benefit Managers because he didn’t think they were treating pharmacists or patients well.

Two years ago, Austin was elected to Congress. His peers respected him and elected him as President of the Freshman class. Austin has become a leader in Congress on many issues and has continued his battle against the unfair practices used by many PBMs. He has co-signed onto every piece of legislation to bring transparency to how PBMs conduct their businesses from MAC pricing to unfair audit procedures. Austin has already reached out to GPhA and some others to help craft legislation that he will introduce next year to regulate PBMs on a National level. Because of his support for us and our issues, GPhA recently helped NCPA hold a fundraiser in Congressman Scott’s district. GPhA does not have a Federal PAC so we helped raise Austin over $10,000 from mostly checks that were for just a couple hundred dollars apiece.

Many of our true friends, like Austin Scott, need our help this year and PharmPAC is there to help those that are running for local or state office. Next year we hope to attack PBM’s, move the Board of Pharmacy out from under the Secretary of State and allow pharmacists to give more immunizations under a physician protocol. We cannot successfully accomplish these things unless we have more friends elected or re-elected. And we can’t help get more friends elected unless we have more pharmacists giving to PharmPAC. If you are not a member of PharmPAC please fill out the membership form online today at www.gpha.org or email your interest to me at afreeman@gpha.org. Together we can make PharmPAC stronger and elect more legislators that are truly our friends.

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PharmPAC Members

GPhA is leading the way in influencing pharmacy-related legislation in Georgia.

Titanium Level ($2400 minimum pledge) T.M. Bridges, R.Ph. Ben Cravey, R.Ph. Michael E. Farmer, R.Ph. David B. Graves, R.Ph. Raymond G Hickman, R.Ph. Robert A. Ledbetter, R.Ph. Jeffrey L. Lurey, R.Ph. Marvin O. McCord, R.Ph. Scott Meeks, R.Ph. Judson Mullican, R.Ph. Mark Parris, Pharm.D. Fred F. Sharpe, R.Ph. Jeff Sikes, R.Ph. Dean Stone, R.Ph., CDM Platinum Level ($1200 minimum pledge) Ralph W. Balchin, R.Ph. Barry M. Bilbro, R.Ph. Robert Bowles, Jr., R.Ph., CDM, Cfts Jim R. Bracewell Larry L. Braden, R.Ph. Thomas E. Bryan Jr., R.Ph. William G. Cagle, R.Ph. Hugh M. Chancy, R.Ph. Keith E. Chapman, R.Ph. Dale M. Coker, R.Ph., FIACP W.C. Conley, Jr., R.Ph. Jack Dunn, Jr. R.Ph. Neal Florence, R.Ph. Andy Freeman Martin T. Grizzard, R.Ph. Robert M. Hatton, Pharm.D. Ted Hunt, R.Ph. Alan M. Jones, R.Ph. Ira Katz, R.Ph. Hal M. Kemp, Pharm.D. Brandall S. Lovvorn, Pharm.D. Eddie M. Madden, R.Ph. Jonathan Marquess, Pharm.D., CDE, CPT Pam Marquess, Pharm.D. Kenneth A. McCarthy, R.Ph. Drew Miller, R.Ph., CDM Laird Miller, R.Ph. Cynthia K. Moon Jay Mosley, R.Ph. Allen Partridge, R.Ph. Houston Lee Rogers, Pharm.D., CDM Tim Short, R.Ph.

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Benjamin Lake Stanley, Pharm.D. Danny Toth, R.Ph. Christopher Thurmond, Pharm.D. Tommy Whitworth, R.Ph., CDM Gold Level ($600 minimum pledge) James Bartling, Pharm.D., ADC, CACII William F. Brewster, R.Ph. Bruce L. Broadrick, Sr., R.Ph. Liza G. Chapman, Pharm.D. J. Ernie Culpepper, R.Ph. Mahlon Davidson, R.Ph., CDM Stewart Flanagin, Jr., R.Ph. Kevin M. Florence, Pharm.D. Kerry A. Griffin, R.Ph. Marsha C. Kapiloff, R.Ph. Earl W. Marbut, R.Ph. Robert B. Moody, R.Ph. Sherri S. Moody, Pharm.D. William A. Moye, R.Ph. Anthony Boyd Ray, R.Ph. Jeffrey Grady Richardson, R.Ph. Andy Rogers, R.Ph. Daniel C. Royal, Jr., R.Ph. Sharon Mills Sherrer, Pharm.D., CDM Michael T. Tarrant Walter Alan White, R.Ph. Henry Dallas Wilson, III, Pharm.D. Silver Level ($300 minimum pledge) Renee D. Adamson, Pharm.D. Ed Stevens Dozier, R.Ph. Terry Dunn, R.Ph. Marshall L. Frost, Pharm.D. Johnathan Wyndell Hamrick, Pharm.D. James A. Harris, Jr., R.Ph. Michael O. Iteogu, Pharm.D. Willie O. Latch, R.Ph. Kalen Porter Manasco, Pharm.D. William J. McLeer, R.Ph. Sheri D. Mills, C.Ph.T. Albert B. Nichols, R.Ph. Richard Noell, R.Ph. Leslie Ernest Ponder, R.Ph. William Lee Prather, R.Ph. Kristy Lanford Pucylowski, Pharm.D. Sara W. Reece, Pharm.D., BC-ADM, CDE Ola Reffell, R.Ph. Edward Franklin Reynolds, R.Ph.

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Sukhmani Kaur Sarao, Pharm.D. David J. Simpson, R.Ph. James N. Thomas, R.Ph. Alex S. Tucker, Pharm.D. William H. Turner, R.Ph. Flynn W. Warren, M.S., R.Ph. William T. Wolfe, R.Ph. Bronze Level ($150 minimum pledge) Monica M. Ali-Warren, R.Ph. Michael A. Crooks, Pharm.D. William Crowley, R.Ph. Rabun E. Deckle, Pharm.D. Helen DuBiner, Pharm.D. Charles Alan Earnest, R.Ph. Vaspar Eddings, R.Ph. Randall W. Ellison, R.Ph. Mary Ashley Faulk, Pharm.D. Amanda R. Gaddy, R.Ph. Charles C. Gass, R.Ph. Ed Kalvelage John D. Kalvelage Steve D. Kalvelage Brenton Lake, R.Ph. Allison L. Layne, C.Ph.T. William E. Lee, R.Ph. Michael Lewis, Pharm.D. Ashley Sherwood London Max A. Mason, R.Ph. Amanda McCall, Pharm.D. Susan W. McLeer, R.Ph. Mary P. Meredith, R.Ph. Armon B. Neel, Jr., Pharm.D. Amanda Rose Paisley, Pharm.D. Rose Pinkstaff, R.Ph. Leslie Ernest Ponder, R.Ph. Sara W. Reece Pharm.D., BC-ADM, CDE Leonard Franklin Reynolds, R.Ph. Don K. Richie, R.Ph. Laurence Neil Ryan, Pharm.D. Charles Iverson Storey, III, R.Ph. Archie Thompson, Jr., R.Ph. William C. Thompson, R.Ph. Carrie-Anne Wilson Sharon B. Zerillo, R.Ph. Members (No minimum pledge) John J. Anderson, Sr., R.Ph. Thomas Bagby Garner, Jr., R.Ph.

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PharmPAC Members (continued from previous page) Members (continued) (No minimum pledge) Fred W. Barber, R.Ph. Henry Cobb, III, R.Ph., CDM Jean N. Courson, R.Ph. Guy Anderson Cox, R.Ph. Carleton C. Crabill, R.Ph. Wendy A. Dorminey, Pharm.D., CDM Benjamin Keith Dupree, Sr., R.Ph David M. Eldridge, Pharm.D. James Fetterman, Jr., Pharm.D. Charles A. Fulmer, R.Ph.

Thomas Bagby Garner Jr., R.Ph. Christina Gonzalez Kimberly Dawn Grubbs, R.Ph. Christopher Gurley, Pharm.D. Fred C. Gurley, R.Ph. Keith Herist, Pharm.D., AAHIVE, CPA Carey B. Jones, R.Ph. Emily Kraus Tracie Lunde, Pharm.D. Ralph K. Marett, R.Ph.,M.S. Tom E. Menighan, R.Ph., MBA, ScD, FAPhA Darby R. Norman, R.Ph.

Debbie Nowlin Whitney B. Pickett, R.Ph. Negin Sovaidi James E. Stowe, R.Ph. James R. Strickland, R.Ph. Leonard E. Templeton, R.Ph. Carey Austin Vaughan, Pharm.D. Erica Lynn Vesley, R.Ph. William D. Whitaker, R.Ph. Elizabeth Williams, R.Ph. Jonathon Williams, Pharm.D. Rogers W. Wood, R.Ph.

Thank you to all of our generous PharmPAC supporters.

To join PharmPAC, complete the form on the next page and mail it in with your contribution. If you made a gift or pledge to PharmPAC in the last 12 months and your name does not appear on this list, please contact Andy Freeman at afreeman@gpha.org or 404-419-8118. PharmPAC donations are not charitable donations and are not tax deductible.

GPhA Thanks Outgoing Board Members As one of our most precious resources, GPhA extends gratitude to the following volunteers for their time and support. Dale Coker, Chair of the Board Robert Bowles, At Large Hugh Chancy, At Large Keith Heirst, At Large Eddie Madden, At Large Jonathan Marquess, At Large Tim Short, At Large Richard Smith, At Large Fred Sharpe, Region 2 Amanda Gaddy, Region 4 Ashley Faulk, Region 6 Larry Batten, Region 8 Chris Thurmond, Region 10 Ken Eiland, Region 12 Thomas Jeter, ACP Chair Josh Kinsey, AEP Chair

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Sonny Rader, AHP Chair Ira Katz, AIP Chair Gail Lowney, APT Chair Christina Gonzalez, ASA Chair John Sherrer, GA Pharmacy Foundation Chair Michael Farmer, Insurance Trust Chair Bill Prather, Board of Pharmacy President Ken Jozefczyk, GA Society of Healthsystems Pharmacists, President Amy Grimsley, Mercer Dean’s Representative Rusty Fetterman, South Dean’s Representative Sukh Sarao, UGA Dean’s Representative Negin Sovaidi, Mercer ASP Representative Annie Tran, South ASP Representative David Bray, UGA ASP Representative

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Join PharmPAC Today!

GPhA is leading the way in influencing pharmacy-related legislation in Georgia

PharmPAC is Georgia Pharmacy Association’s Political Action Committee. Your generous donations help GPhA to be able to lobby and advocate on the behalf of Georgia pharmacy professionals.

You have two PharmPAC membership options: 1) A Monthly Contribution: (Please complete the following.) Name: _________________________________________________________________________ Address: _______________________________________________________________________ Phone#: ________________________________________________________________________ Email Address: __________________________________________________________________

*You will be contacted for additional information to set up your monthly contribution.

Circle the level of monthly support you would like to provide: Titanium ($200/month) Platinum ($100/month) Gold ($50/month) Silver ($25/month)

Bronze ($12.50/month)

2) A One-Time Gift: To make a one-time contribution, simply write the amount you wish to contribute here: $_________ and mail your check with this completed form. To finalize your membership, complete and mail this form to: PharmPAC, Georgia Pharmacy Association, 50 Lenox Pointe, NE, Atlanta, GA 30324

Thank you for supporting PharmPAC Your gift allows GPhA to continue to advocate for improvements within the pharmacy profession.

Welcome to our new PharmPAC members!

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G P h A NEW M e m b e r S

Welcome New GPhA Members! GPhA is pleased to welcome the following new members: Individual Pharmacist Members: Dan Alday, R.Ph. – Sugar Hill Karen S. Kelley, R.Ph. – Hayesville Matt Kennedy, R.Ph. – Warner Robins Nelson J. Mainor, Jr., Pharm.D. – Dublin Victoria A. Moore, R.Ph. – LaGrange Ronnie Pao, R.Ph. – Roswell Sarah Rowan, Pharm.D. – Macon Whitney Unterwagner, Pharm.D. – Marietta Associate Members: Phillip H. Howell, Pharm.D. – White Christopher Vaughan – Atlanta Pharmacy Technician Members: Ekow K. Ogoe-Anderson - Austell Shikica Jackson, C.Ph.T. – Macon

Student Members: Emilia Elangwe –Johnson City, TN Edjona K. Ehe - Savannah Emily F. Kawesa-Bass – Omaha, NE Adina Klima – Columbia, MO Jaime Kroll – Marietta Cara McCalley – Moultrie James Spence – Athens Kristy Patterson – Forston Elizabeth C. Pittman – Savannah John T. Sherrer, Jr. – Marietta Christopher Waters – Glennville Melissa G. Weaver – Augusta Daniel C. Wiley – Augusta Victoria Witherspoon - Jacksonville, FL

Melvin M. Goldstein, P.C. A T T O R N E___ Y AT

LAW

248 Roswell Street Marietta, Georgia 30060 Telephone 770/427-7004 Fax 770/426-9584 www.melvinmgoldstein.com

n Private practitioner with an emphasis on representing healthcare professionals in administrative cases as well as other legal matters n Former Assistant Attorney General for the State of Georgia and Counsel for professional licensing boards including the Georgia Board of Pharmacy and the Georgia Drugs and Narcotics Agency

Correction to 2012 June Journal The Mercer Univeristy College of Pharmacy and Health Sciences logo was misprinted in the June 2012 issue of the Journal.

n Former Administrative Law Judge for the Office of State Administrative Hearings

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The correct logo is seen here.

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“This ain’t your mama’s pharmacy business” by Amy DeFaveri, GPhA Membership & Communications

I recently sat down with incoming GPhA President, Robert Hatton, just weeks before the 137th GPhA Convention to talk about his focus and message to the association’s members for 2012-13.

Q. As the upcoming new president of GPhA, what will be your top priorities for the organization?

A. In a nutshell, increasing membership and increasing relevancy and value to existing members. I personally think we have too many membership categories. We have split up our categories by type of practice. Sometimes the political motivations for a particular type of practice overlap and sometimes they do not, but that it how they are delineated. We have different practice sites and different goals when it comes to legislative issues. The independents, for

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example, are not as large a group as far as being able to lobby on their own so they work with us on a lot of issues, but sometimes it’s from a different angle. Some of our member types like employee pharmacists aren’t in control as an independent would be, but our issues as far as insurance reimbursement are identical. With the exception of those large chains who own their own insurance companies, our practices are starting to line up closer together than we have in the past and I think that’s the going to be the tool for membership growth.

Q. What would you cite as some of the reasons for membership being flat? A. Relevancy is why we’re flat--we’ve got to show the pharmacists why we’re relevant. We have to find a way to grow with our young adults as they leave school. That’s what my speech is about this year. We have to realize this ain’t your mama’s pharmacy business. In this day and age where you can pick up any kind of information you want, you have to find a reason for pharmacists to join an organization. Like everyone else, pharmacists get information at their fingertips anytime. I think the strongest cases we can make for being relevant are in two areas: political advocacy, which is probably our strongest service to the organization now, and continuing education, which we can bring live to our members much easier than other organizations.

Q. How do you characterize the current healthcare environment in reference to pharmacists? What are the biggest challenges and opportunities for pharmacists on both a state and national level?

A. The current environment is muddled. What are our opportunities? The opportunities are endless. A lot of people are waiting around to see what the Supreme Court does. Whatever the Supreme court decides is going to changed anyway. We have to quit waiting to see what’s going to happen before we pave our own way. It’s not that it’s a no win scenario. We have to get pharmacists to take action. Pharmacists are notorious for not relying on their training. They still lean on the door – they don’t want to pick up the ball and run with it. Q. What does ‘lean on the door’ mean? A. That’s what a doctor once told me at MCE. He said that when he would ask a pharmacist to collaborate with him on a patient, he would walk up to the patient’s bed while the pharmacist would lean on the door. We don’t step forward like other professions do. Nurse assistants will be the first ones who’ll say, “I’ll do it, give it to me”. Pharmacists have a certain personality. I think we’re a little more wait and see, a little more apprehensive to dive in on the front lines. I think the younger pharmacists are probably better at it. You’ve got pharmacists that saw what their elders were doing and thought that’s what my life will be as a pharmacist. Now you’ve got a group in their 20s and 30s that are being trained completely different, and so they have a lot of this information because they already do it. We need to rely on what we already know. Pharmacists have been relegated to a certain position which is what my speech is about. We’re going to have to step outside that expected position. You see Walgreens trying to do it with their ads on television. You see the pharmacist jumping out from behind the counter, which isn’t reality.

Q. What role do you see pharmacists playing in the national healthcare reform debate? A.

President Obama has got some provisions in the healthcare reform legislation pushing Medication Therapy Management which is something we’re already doing. Sitting down with your patients and looking at what prescriptions they’re taking and figuring out maybe they shouldn’t be taking all of these medications. The problem with our profession has always been that as a pharmacist, we’re helping our customers by taking them off certain medications and then being penalized for it. We’ve never been able to incentivize that behavior. If you

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could incentivize that behavior and if you could narrow down a patient’s medication from 10 drugs down to 4, a patient is much better off. They’ve been going to 15 doctors because that’s the way medicine is set up now. Doctors want to be hands off; no doctor wants to discuss the patient with another doctor. The only one who is looking at all the medications a patient is taking is their pharmacist. Electronic medical records aren’t going to help either. The physicians aren’t going to look at them and they aren’t going to care. They’ll just click it off and get it out of their way so they can get to their page. It’s still going to be us that are looking at everything if we can do something about mail order. But if you’re the only one looking at it, what incentive do you have to at least send a letter to the doctor telling them you’ve got the patient on this and on this and both drugs are basically doing the same thing, pick one. It’s not like you’re the one automatically taking them off the medication. You’re just making a suggestion and there’s no enticement to do that. Healthcare reform does have an incentive for us to do MTM. It’s not needed in the patient who is on just a few medications, but that will help the patient whose on 14 different medications and you can’t tell me we can’t something about this.

Q. How do you envision social media playing a role in membership growth this year? A.

Well, that’s interesting. It’s going have to be someone other than me because I don’t have a clue. Social media is all these young adults talked about when we went to the New Practitioners Leadership Conference up at Lake Lanier. The older folks just looked at each other and scratched their heads. Look, we understand that we have a need to be in social media, but we also understand the need to be a little careful. If we’re going to set up a Facebook page, we have to police it pretty closely. We don’t need one irate member controlling a negative conversation. I’ve had businesses in my hometown that have made that mistake. Once something damaging is said online it takes more than 100 people to turn it around, but just one person to cut your opportunities. We have to be careful how we set this up. As far as Twitter goes, I can see us using it to inform people of reminders like there’s a CE program on Diabetes in Lowell Hall at convention. Our kids are perfect examples of using social media like this. My kids will be sitting around the dining room table on their phones on Facebook. I tell them you need to be present in the moment. It’s rude that they’re not paying attention, but that’s how these kids communicate and it’s instant. I think we can use Twitter and Facebook as reminders for upcoming events because people have so much going on. As an organization, we have to tell our members what’s going on in the near future. You can’t plan 6 weeks out. My parents planned for a trip they wanted to take in 6 months, but that doesn’t happen in todays’ world.

Q. How important is it that GPhA attract and maintain younger pharmacists? In what ways will you and the new board support such efforts?

A. It’s essential. We’ve been relying so much on the same members to do the work that they don’t want to serve anymore. Every year we find new people that understand their profession is more than just a paycheck. There’s got to be more. What I found out about my generation is that we don’t mind being plugged into something for the long haul. But the next generation wants a task and then be done with it. They don’t want a 5-yr commitment. We’re dinosaurs. Q. What key state legislative issues will GPhA be working on in 2012-13? What position will GPhA take on these issues?

A.

Broadening our immunization protocol that we tried to do last year and ran up against a buzz saw will be a high priority. The other thing is that we want to try to come out from under the Secretary of State’s office and be autonomous. If I laid my cards out I’d try to come out from under the Secretary of State’s office first. I

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think you’re going to find after last years’ battle the Secretary of State, he knows that we’re formidable because of the number of pharmacists serving in the House and the one in the Senate. I believe that getting out from under them might be possible, but we have to determine the cost of political capital. We’ll have to wait and see what the price is. I do think that is going to be our top priority. And then there’s going to be things that come along where we have no advanced warning. Someone drops a bill and we’re like what in the world is that? And it’s usually something that’s going to stop some regulatory action that snuck in on top of a Georgia Power bill somewhere.

Q. What publications, websites, social media and television programs do you rely upon for healthcare/pharmacy-related news?

A. I glance at most all the free ones that come to the store, Drugstore News, Pharmacy Times, other retail publications; I get a little bit of news from all of them. I read about mergers and acquisitions particularly in the retail market. I knew that Rite Aid was buying Eckerd’s before employees did. Most of my information comes from being on the EC. I now look at different things that are more political. I read more about what’s coming out on legislation. I get a lot from the GPhA Pharmacy New Flash

Q. What hobbies and recreational activities do you pursue when you’re not running the Medicine Shoppe Pharmacy and helping lead GPhA?

A. You know, if I didn’t have children my life be very different! I’m very involved with what my kids are involved in. My oldest is very busy with band. She’s a drum major and we’re also busy looking at colleges. My 9-year old is in soccer so we are a soccer mom and dad. And my middle one is in band as well. On a personal level, I’m very involved in my local church; I’m a member of the board of trustees and the choir. I stay pretty busy. I also play trumpet-- it’s not a subtle instrument. I played in high school, not in college, but I play a lot with our church. Back when I had a life, I did a lot of woodworking. I’m not much into sports, but of course I’m a Bulldog fan.

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GPhA News

GPhA New 2012-13 Board of Directors GPhA extends a hearty welcome and nod of thanks to the following volunteers and yet-to-be-named volunteers for 2012-13. GPhA First Vice President to be elected at annual meeting GPhA Second Vice President to be elected at annual meeting Hugh Chancy, At Large Liza Chapman, At Large Keith Herist, At Large Josh Kinsey, At Large Tracie Lundie, At Large Eddie Madden, At Large Jonathan Marquess, At Large At Large At Large Region 2 Region 4 Region 6 Region 8 Region 10 Region 12 ACP Chair to be elected at annual meeting AEP Chair to be elected at annual meeting AHP Chair to be elected at annual meeting AIP Chair to be elected APT Chair to be elected ASA Chair to be elected at annual meeting John Sherrer, GA Pharmacy Foundation Chair Michael Farmer, Insurance Trust Chair Bill Prather, GA Board of Pharmacy President Ken Jozefczyk, GA Society of Healthsystems Pharmacists, President To be appointed, Mercer Dean’s Representative To be appointed, South Dean’s Representative To be appointed, UGA Dean’s Representative To be appointed, Mercer ASP Representative To be appointed, South ASP Representative To be appointed, UGA ASP Representative

The Georgia Pharmacy Journal  20

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continuing education for pharmacists Volume XXX, No. 5

New Cancer Drugs: Adcetris, Xalkori, and Zelboraf 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 Wuest have no relevant financial relationships to disclose.

Goal. The goal of this lesson is to provide information on brentuximab vedotin (Adcetris™), crizotinib (Xalkori®), and vemurafenib (Zelboraf®). Objectives. At the completion of

this activity, the participant will be able to: 1. recognize the new drugs by generic name, trade name and chemical name when relevant; 2. identify the indication, pharmacologic action and clinical application for each drug; 3. choose important therapeutic uses for the drugs and their applications in specified pathologies; 4. demonstrate an understanding of adverse effects and toxicity; warnings, precautions and contraindications; and significant drug-drug interactions for these drugs; and 5. select important information to convey to patients and/or their caregivers. Drugs discussed within this lesson are new molecular entity compounds (Table 1) indicated to treat a variety of cancers. The lesson provides an introduction to the new drugs and is not intended to extend beyond a brief overview of the topic. The reader is, therefore, urged to consult the products’ Prescribing

Gossel

Wuest

Information leaflet or Medication Guide, and other published reference sources for detailed descriptions.

Cancer

Few words cause greater apprehension and fear than when an individual hears, “You have cancer.” But because of early detection and a steady stream of new and much improved therapies, many

cancers can now be managed and even “beaten.” The Pharmaceutical Research and Manufacturers of America report that nearly 900 drugs and vaccines are currently undergoing intensive evaluation to treat various cancers. This remarkable progress made in treating cancer has led to declines in cancer deaths. According to the National Cancer Institute, cancer deaths in the United States decreased 1.6 percent per year between 2001 and 2006. The number of cancer survivors in the United States increased from three million in 1971 to 11.7 million in 2007. Despite progress over the past decade, cancer remains the second leading cause of death by disease – one of every four deaths in the United States. Cancer is exceeded only by heart disease as a cause

Table 1 Selected new cancer drugs Generic (Proprietary Applicant/Sponsor/ Indication Name) Distributor

Dosage Form

Brentuximab vedotin (Adcetris™)

Seattle Genetics

Hodgkin lymphoma and systemic anaplastic large cell lymphoma

50 mg single-use vials

Crizotinib (Xalkori®)

Pfizer Labs

non-small cell lung cancer

200, 250 mg capsules

Vemurafenib (Zelboraf®)

Genentech USA

metastatic 240 mg melanoma with tablets BRAFV600E mutation


of death. In 2010, some 569,000 Americans died of cancer, amounting to more than 1,500 people a day. Men have a little less than a one-in-two lifetime risk of developing cancer; and for women, the risk is about one-in-three.

Adcetris (brentuximab vedotin)

Adcetris (AD-set-ris) is the first new treatment for Hodgkin lymphoma (Hodgkin’s disease) since 1977, and the first specifically indicated to treat systemic anaplastic large cell lymphoma (ALCL). Its effectiveness was evaluated in a single clinical trial involving 102 patients with Hodgkin lymphoma. In the single-arm trial, patients were treated only with Adcetris. The study’s primary endpoint was an objective response rate, the percentage of patients who experienced complete or partial cancer shrinkage or disappearance following treatment. Seventy-three percent of patients achieved either a complete or partial response to the treatment. On average, these patients responded to the therapy for 6.7 months. The drug’s effectiveness in patients with systemic ALCL was evaluated in a single clinical trial in 58 patients. In the single-arm trial, patients were treated with Adcetris alone. Similar to the Hodgkin lymphoma trial, the study’s primary endpoint was an objective response rate. For patients receiving Adcetris for ALCL, 86 percent experienced either a complete or partial response and responded on average for 12.8 months. Indications and Use. The new drug has two indications. The first is treatment of Hodgkin lymphoma after failure of an autologous stem cell transplant (ASCT), or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates. An autologous stem cell transplant uses a patient’s own bone marrow that is designed to repair damaged marrow after the use of high chemotherapy doses. Unfortunately, ASCT is only effec-

tive in half of such patients. The second indication is treatment of patients with systemic anaplastic (reversion of cells to a more primitive or undifferentiated form) large cell lymphoma following failure of at least one prior multi-agent chemotherapy regimen. Both indications are based on patients’ response rate. Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma. Over the past 50 years, the field of oncology has drawn valuable insights from the management of Hodgkin lymphoma, a cancer that starts in lymphocytes. One early lesson was that the primary treatment should be optimized to cure the largest proportion of patients because salvage therapies are often ineffective. It was observed that high-dose chemotherapy and autologous hematopoietic stem-cell transplantation could cure Hodgkin lymphoma that is resistant to primary chemotherapy. This observation offered hope for a cure to otherwise “doomed” patients. The American Cancer Society estimates that about 8,830 new cases of Hodgkin lymphoma occurred in the United States during 2011, 4,010 in females and 4,820 in men. These numbers have not changed much over the past few years. Because of advances in treatment, survival rates have improved substantially since the early 1970s. The one-year relative survival rate for all patients diagnosed with Hodgkin lymphoma is now about 92 percent, with five-year and 10-year rates about 85 percent and 81 percent, respectively. ALCL is a relatively rare form of non-Hodgkin lymphoma that arises from T-cells. There are two types of ALCL, systemic (that affects lymph nodes and other organs), and the cutaneous type, that affects mainly the skin. As curative approaches to early-stage and advanced-stage Hodgkin lymphoma emerged through the 1990s, investigators focused on maximizing cure rates by intensifying the initial treat-

ment. With very high cure rates for limited-stage Hodgkin lymphoma available by the end of the century, researchers began to focus on reducing the intensiveness of the primary treatment. Just two cycles of the minimally toxic regimen of doxorubicin (Adriamycin, and others), bleomycin (Blenoxane), vinblastine, and dacarbazine (DTICDOME), followed by moderate-dose radiation, cured almost all patients while avoiding staging laparotomy, infertility, and leukemogenesis (induction, development or progression of leukemia). More to the point, properly selected patients could be cured with chemotherapy alone, completely eliminating the risks of radiation. Mechanism of Action. Brentuximab vedotin is an antibodydrug conjugate (ADC). This means that it consists of three components: the antibody specific for CD30, the microtubule disrupting agent (active portion) mono-methyl auristatin E (MMAE), and a protease linker that covalently attaches MMAE to CD30. It is believed that Adcetris binds with CD30-expressing cells, is rapidly internalized and transported to lysosomes, and the linker is selectively cleaved with release of MMAE. Binding of MMAE to tubulin (a small family of globular proteins that make up microtubules) within the cancerous cells disrupts their microtubule network, and subsequently induces cell cycle arrest and apoptosis (natural, programmed death) of the cells. Adverse Effects. The most common adverse reactions reported in premarketing studies (≥20 percent) were neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory tract infection, diarrhea, fever, rash, thrombocytopenia, coughing and vomiting. Warnings, Precautions and Contraindications. The following warnings and precautions are listed: • Peripheral neuropathy: Patients should be monitored for neuropathy, and dose modifications


instituted accordingly. • Infusion reactions: If an infusion reaction occurs, the infusion should be interrupted and appropriate medical management instituted. If anaphylaxis occurs, the infusion should be discontinued immediately and appropriate medical management measures initiated. • Neutropenia: Complete blood counts should be obtained prior to each dose of Adcetris. If Grade 3 or 4 neutropenia develops, the condition should be managed by dose delays, reductions or discontinuation. • Tumor Lysis Syndrome: Patients with rapidly proliferating tumors and high tumor burden are at risk of tumor lysis syndrome. These patients should be monitored closely and appropriate measures taken. • Stevens-Johnson syndrome: If Stevens-Johnson syndrome occurs, the drug should be discontinued and appropriate medical therapy provided. • Progressive Multifocal Leukoencephalopathy (PML): A fatal case of PML was reported in a patient who received four chemotherapy regimens prior to receiving Adcetris. • Use in pregnancy: Fetal harm can occur. Pregnant women should be advised of the potential hazard to their fetus. Brentuximab vedotin is contraindicated with concomitant use of bleomycin. Drug Interactions. MMAE is a substrate and inhibitor of CYP3A4/5. Patients who are receiving strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole) concomitantly with Adcetris should be closely monitored for adverse reactions. Rifampin, a potent CYP3A4 inducer, may enhance metabolism of MMAE. Dosage and Availability. The usual dose is 1.8 mg/kg administered only as an intravenous infusion over 30 minutes every

three weeks. Treatment should be continued until a maximum of 16 cycles, disease progression or unacceptable toxicity occur. The drug should not be mixed with, or administered as an infusion with, other medicinal products. Adcetris is supplied as a sterile, white to off-white preservativefree lyophilized cake or powder in individually-boxed single-use vials. Store Adcetris vials in a cool place (36 to 46° F), and in its original container to protect from light. Do not use after the expiration date on the label. Properly discard unused medication. Patient Information. Excerpts from the FDA-approved Patient Counseling Information are shown in Table 2.

Xalkori (crizotinib)

Safety and effectiveness of Xalkori (zal-KOR-ee) were established in two multi-center, single-arm studies enrolling a total of 255 patients with late-stage anaplastic lymphoma kinase (ALK)-positive nonsmall cell lung cancer (NSCLC), the leading cause of cancer mortality worldwide. A small sample of lung cancer tissue from each patient was collected and tested for the ALK gene abnormality prior to study enrollment. The studies were designed to measure an objective response rate, the percentage of patients who experienced complete or partial cancer shrinkage. Most patients in the studies had received prior chemotherapy. In one study, the response rate was 50 percent with a median response duration of 42 weeks. In the other, the objective response rate was 61 percent with a median response duration of 48 weeks. Xalkori was approved with a companion diagnostic test, the Vysis ALK Break Apart FISH Probe Kit, that will help determine if a patient has the abnormal ALK gene. Indications and Use. Xalkori is indicated for treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is ALK-positive, as detected by the FDA-approved

Table 2 Major counseling points for Adcetris (brentuximab vedotin) injection* This medicine is used to treat patients with Hodgkin lymphoma and patients with systemic anaplastic large cell lymphoma. • Tell your doctor: -if you have numbness or tingling of your hands or feet or any muscle weakness; -if you have a fever of 100.5o F or greater or other evidence of potential infection such as chills, cough; or pain on urination develops; -if you experience signs and symptoms of infusion reactions including fever, chills, rash, or breathing problems within 24 hours of infusion of Adcetris; -about all other prescription and nonprescription (OTC) medicines, vitamin/mineral supplements, natural products and herbal remedies you are taking. • Periodic laboratory testing is important with this medicine. Be sure to make all testing appointments. • WOMEN: Notify your doctor if you become or intend to become pregnant, or are breastfeeding. • Adcetris is usually administered by intravenous infusion over 30 minutes every 3 weeks. *Excerpted from the FDAapproved Patient Counseling Information.

test named above. This indication is based on patient response rate. There are no data available at the time of writing this lesson demonstrating improvement in patientreported outcomes or survival with Xalkori. Non-small Cell Lung Cancer. About 85 to 90 percent of all lung cancers are non-small cell lung cancer. There are three primary subtypes of NSCLC: squamous cell (epidermoid) carcinoma, adenocarcinoma (glandular cancer) and large cell (undifferentiated) carcinoma. Other subtypes include adenosquamous carcinoma and sarcomatoid carcinoma. The chance that a man will develop lung cancer during his


lifetime is about 1-in-13; for a woman, the risk is about 1-in-16. These numbers include both smokers and non-smokers. For smokers, the risk is much higher. The American Cancer Society estimates that for lung cancer in the United States, about 221,130 new cases were diagnosed (115,060 among men and 106,070 among women) in 2011. There were also an estimated 156,940 deaths from lung cancer (85,600 among men and 71,340 among women), accounting for about 17 percent of all cancer deaths. Mechanism of Action. Crizotinib is an inhibitor of receptor tyrosine kinase enzymes, including ALK. Translocations can affect the ALK gene resulting in the expression of oncogenic fusion proteins. The formation of ALK fusion proteins results in activation and dysregulation of cellular genetic expression and signaling which can contribute to increased cell proliferation and survival in tumors expressing these proteins. Adverse Effects. The most common adverse reactions (≥25 percent) in premarketing clinical trials were vision disorders, nausea, diarrhea, vomiting, edema and constipation. Warnings, Precautions and Contraindications. The following warnings and precautions are listed: • Pneumonitis: Severe, lifethreatening or fatal, treatmentrelated pneumonitis (a condition of localized acute inflammation of the lung without gross toxemia) has been observed. Patients should be monitored for pulmonary symptoms indicative of pneumonitis and the drug permanently discontinued in patients diagnosed with treatment-related pneumonitis. • Hepatic laboratory abnormalities: Concurrent elevations in ALT and total bilirubin have been reported. Patients should be monitored monthly and as clinically indicated with more frequent testing in those with Grade 2 to 4 elevations, with the drug temporarily suspended, dose reduced or

permanently discontinued. • QT interval prolongation: In patients who have a history of or predisposition for QTc prolongation, or who are taking medications that are known to prolong the QT interval, periodic monitoring with ECG and electrolytes should be considered. • ALK testing: Detection of ALK-positive NSCLC using an FDA-approved test, indicated for this use, is necessary for selection of patients for treatment with Xalkori. • Pregnancy: Xalkori can cause fetal harm when administered to a pregnant woman. There are no contraindications listed. Drug Interactions. Avoid concurrent use with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole), and strong CYP3A inducers (e.g., phenytoin, carbamazepine, rifampin, phenobarbital). Crizotinib’s aqueous solubility is pH dependent with higher pH resulting in lower solubility. Therefore, drugs that elevate the gastric pH (e.g., proton pump inhibitors, H2-blockers or antacids) may decrease the solubility of crizotinib and subsequently reduce its bioavailability. The drug is also an inhibitor of P-glycoprotein (Pgp). Therefore, crizotinib may have the potential to increase plasma concentrations of coadministered substrates of P-gp. In either case, formal studies have not been conducted. Dosage and Availability. The recommended dose and schedule is 250 mg orally twice daily with or without food. The capsules must be swallowed whole. If a dose is missed, the patient should take it as soon as possible, unless it is less than six hours until the next dose, in which case the patient should not take the missed dose. Patients should not take two doses at the same time to make up for a missed dose. Dosing interruption and/or dose reduction to 200 mg taken

orally twice daily may be required based on individual safety and tolerability, then reduced further to 250 mg taken once daily if further reduction is necessary. Xalkori is available as capsules containing 200 mg and 250 mg of crizotinib. Patient Information. Excerpts from the FDA-approved Patient Counseling Information are shown in Table 3.

Zelboraf (vemurafenib)

Zelboraf’s (ZEL-bor-raf) safety and effectiveness were established in a single international trial involving 675 patients with late-stage melanoma with the BRAFV600E mutation, explained below, who had not received prior therapy. Patients were assigned to receive either Zelboraf or dacarbazine, another anti-cancer therapy. The trial was designed to measure overall survival. The median survival of patients receiving Zelboraf had not been reached (77 percent still living) at the time of the drug’s approval, while the median survival for those who received dacarbazine was eight months (64 percent still living). FDA’s approval of the cobas® 4800 BRAF V600 Mutation Test was based on data from the clinical study that also evaluated the safety and effectiveness of Zelboraf. The first-of-a-kind test is a companion diagnostic that will help determine if a patient’s melanoma cells have the BRAFV600E mutation. Indications and Use. Zelboraf is indicated for treatment of patients with unresectable (cannot be removed surgically) or metastatic melanoma with BRAFV600E mutation. It is not recommended for use in patients with wild-type BRAF melanoma. Melanoma. Melanoma is an aggressive cancer for which there are few effective therapies. It is the most pathologic form of skin cancer, and the leading cause of death from skin cancer. The cancer begins in melanocytes found in the epidermis. Melanocytes produce the brown pigment called melanin. Melanin imparts the tan or brown


color to the skin and protects its deeper layers from some of the harmful effects of ultraviolet rays from the sun. Because the majority of these affected cells still produce melanin, melanoma tumors often appear brown or black. But this is not always the case, with melanoma sometimes also appearing pink, tan or even white. Melanoma most often starts on the trunk (chest or back) in men and on the legs in women, but it can appear in other places as well. Having dark skin lowers the risk of melanoma, but a person with dark skin can still get the cancer. The discovery of genetic changes that underlie melanoma formation now provides a strong framework to develop therapies that antagonize several key molecular steps that lead to the malignant behavior of melanoma. The most commonly mutated signal transduction in melanoma is referred to as v-raf murine sarcoma viral oncogene (gene that causes cells to mutate) homolog B1 (BRAF). BRAF is part of the mitogen-activated protein kinase (MAPK) pathway, an intracellular signaling cascade that is implicated in the malignant behavior of a number of different cancers. BRAF mutations are more common in melanoma than other types of cancer. In its early stages, melanoma can almost always be cured. But it is likely to spread to other parts of the body if not caught early. Once it disseminates to distant sites and visceral organs, melanoma is almost invariably incurable, with a median survival time of eight to nine months and a three-year survival rate of only 10 to 15 percent. Overall, the lifetime risk of getting melanoma is about one in 50 for Caucasians, one in 1,000 for African Americans and one in 200 for Hispanics. The American Cancer Society’s estimate for melanoma in the United States for 2011 included about 70,230 new cases, with about 8,790 deaths from the tumor. The cancer accounts for less than 5 percent of skin cancer cases, but it causes most skin cancer deaths.

Mechanism of Action. Zelboraf is a potent inhibitor of some mutated forms of BRAF serine-threonine kinase, including BRAFV600E. It also inhibits other kinase enzymes. Some mutations in the BRAF gene, including V600E, result in constitutively activated BRAF proteins, which can cause cell proliferation in the absence of growth factors that would normally be required for proliferation. Adverse Effects. Most common adverse reactions (≥30 percent) during premarketing trials were arthralgia (joint pain), rash, alopecia, fatigue, photosensitivity reactions, nausea, itching and skin papilloma (benign tumors derived from epithelium). Warnings, Precautions and Contraindications. The following warnings and precautions are listed: • Cutaneous squamous cell carcinomas: In premarketing trials, these occurred in 24 percent of patients. Dermatologic evaluations should be performed prior to initiation of therapy and every two months while on therapy, and managed with excision and continued treatment without dose adjustment. • Serious hypersensitivity reactions: These, in addition to anaphylaxis, have been reported during and upon re-initiation of treatment. Zelboraf should be discontinued in patients who experience severe hypersensitivity reactions. • Severe dermatologic reactions: These, including StevensJohnson syndrome and toxic epidermal necrolysis, have been reported. Treatment in patients who experience severe dermatologic reactions should be discontinued. • QT prolongation: Electrocardiogram (ECG) and electrolytes should be monitored before treatment and after dose modification. Monitor ECGs at day 15, monthly during the first three months of treatment, every three months thereafter, or more often as clinically indicated. If the QTc exceeds 500 ms, the drug should be temporarily interrupted, electrolyte

Table 3 Major counseling points for Xalkori (crizotinib) capsules* This medicine is used to treat patients with locally advanced or metastatic non-small cell lung cancer. • Read the Patient Information leaflet before you start taking Xalkori and each time you get a refill. •Tell your doctor: -if you have any new or worsening symptoms of lung cancer, including trouble breathing or shortness of breath, cough with or without mucus, or fever. -if your skin or the whites of your eyes turn yellow; you feel tired; your urine turns dark or brown; you have nausea or vomiting, a decreased appetite, pain on the right side of your stomach; or you bleed or bruise more easily than normal. -about all other prescription and nonprescription (OTC) medicines, vitamin/mineral supplements, natural products and herbal remedies you are taking. The Patient Information leaflet has a list of medicines you should not take with Xalkori. • Periodic laboratory testing is important with Xalkori. Be sure to make all testing appointments. • WOMEN: Notify your doctor if you become or intend to become pregnant, or are breastfeeding. • Xalkori is usually taken twice a day with or without food. The manufacturer advises to avoid eating grapefruit or drinking grapefruit juice when taking Xalkori. • Nausea, diarrhea, vomiting and constipation may occur with Xalkori. Supportive care for treatment of these conditions may include nonprescription anti-emetic and/or antidiarrheal or laxative medications. • Use caution when driving or operating machinery if you experience blurred vision, dizziness, or tiredness while taking Xalkori. Report light flashes or floaters in your eyes to your doctor. • Store Xalkori at room temperature protected from heat. Do not use after the expiration date on the label. Properly discard unused medication. *Excerpted from the FDA-approved Patient Counseling Information.


Table 4 Major counseling points for Zelboraf (vemurafenib) tablets* This medicine is used to treat patients with unresectable or metastatic melanoma. • Read the Medication Guide before you start taking Zelboraf and each time you get a refill. • Tell your doctor: -if you have any skin changes including a new wart, skin sore or reddish bump that bleeds or does not heal, or change in size or color of a mole; -if you have trouble breathing or swallowing, throat tightness or hoarseness, fast heartbeat, blisters on your skin or in your mouth, peeling of your skin, or swelling of your face, lips or tongue; -about all other prescription and nonprescription (OTC) medicines, vitamin/mineral supplements, natural products and herbal remedies you are taking. The Medication Guide has a list of medicines you should not take with Zelboraf. • Periodic laboratory testing is important with this medicine. Be sure to make all testing appointments. • WOMEN: Notify your doctor if you become or intend to become pregnant, or are breastfeeding. • Zelboraf is usually taken twice a day in the morning and evening, about 12 hours apart, with or without food. Swallow the tablets whole with a glass of water. Do not chew or crush them. • Avoid excessive exposure to sunlight or tanning booths. When you go outside, wear clothes that protect your skin. Use a lip balm and broad-spectrum sunscreen with SPF 30 or higher. • Store Zelboraf at room temperature in its original tightly-closed container. Do not use after the expiration date on the label. Properly discard unused medication. *Excerpted from the FDA-approved Medication Guide.

abnormalities corrected, and cardiac risk factors for QT prolongation controlled. • Liver laboratory abnormali-

ties: Liver enzymes and bilirubin should be monitored before initiation of treatment and monthly during treatment, or as clinically indicated. • Photosensitivity: If this occurs, patients should be advised to avoid sun exposure while taking the drug. • Serious ophthalmologic reactions: Uveitis, iritis and retinal vein occlusion have been reported, and patients should be monitored routinely for ophthalmologic reactions. • New primary malignant melanomas: These should be managed with excision and treatment continued without dose modification. • Pregnancy: Zelboraf may cause fetal harm. Women should be advised of potential risk to the fetus. • BRAF testing: An FDA-approved test is required for selection of patients appropriate for Zelboraf therapy (i.e., confirmation of BRAFV600E mutation). The efficacy and safety of Zelboraf have not been studied in patients with wildtype BRAF melanoma. There are no contraindications for Zelboraf listed. Drug Interactions. Concomitant use of Zelboraf with agents that have a narrow therapeutic window and are metabolized by CYP3A4, CYP1A2 or CYP2D6 is not recommended. If coadministration cannot be avoided, caution should be exercised and a dose reduction of the concomitant CYP1A2 or CYP2D6 substrate drug considered. Zelboraf may increase exposure to concomitantly administered warfarin. Exercise caution and consider additional INR monitoring when Zelboraf is used concomitantly with warfarin. Dosage and Availability. The recommended dose is 960 mg (four tablets) twice daily. Doses should be administered approximately 12 hours apart with or without a meal, and continued until disease progression or unacceptable toxicity occurs. If a dose is missed, it can be taken up to four hours prior to the

next dose to maintain the twicedaily regimen. Both doses should not be taken at the same time. Tablets should be swallowed whole with a full glass of water. When dose reduction is recommended due to adverse drug reactions, etc., dose reductions resulting in a dose below 480 mg twice daily are not recommended. Zelboraf tablets are supplied in a strength of 240 mg of vemurafenib. Patient Information. Excerpts from the FDA-approved Medication Guide are shown in Table 4.

Overview and Summary

This lesson discusses three new drugs for treatment of cancer. The good news is that the future for patients with Hodgkin lymphoma, anaplastic large cell lymphoma, non-small cell lung cancer or a specific form of melanoma now have renewed hope for prolonged survival.

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.

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

Program 0129-0000-12-005-H01-P Release date: 5-15-12 Expiration date: 5-15-15

CE Hours: 1.5 (0.15 CEU) The Ohio Pharmacists Foundation Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.


continuing education quiz

Please print.

Program 0129-0000-12-005-H01-P 0.15 CEU

Name________________________________________________

New Cancer Drugs: Adcetris, Xalkori, and Zelboraf 1. Despite progress over the past decades, cancer remains the second leading cause of death by disease after: a. heart disease. c. kidney disease. b. infectious disease. d. liver disease. 2. A stem cell transplant that uses a patient’s own bone marrow is referred to as: a. anaplastic. c. monoclonal. b. autologous. d. myoblastic. 3. ALCL is a form of non-Hodgkin lymphoma that arises from: a. B-cells. c. T-cells. b. NK-cells.

Address_____________________________________________ City, State, Zip______________________________________ Email_______________________________________________ NABP e-Profile ID*__________________________________ *Obtain NABP e-Profile number at www.MyCPEmonitor.net.

Birthdate____________ (MMDD)

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

4. Natural, programmed death of cells is referred to as: a. nephrosis. c. biolysis. b. necrosis. d. apoptosis.

9. Patients receiving Xalkori should be advised to take the dose: a. only on an empty stomach. b. only with meals or a snack. c. either with or without food.

5. Which of the following is a potent CYP3A4 inducer? a. Indinavir c. Rifampin b. Ketoconazole d. Voriconazole

10. Melanoma begins in melanocytes found in the: a. bones. c. kidneys. b. epidermis. d. lungs.

6. Safety and effectiveness of Xalkori were established in studies of patients with anaplastic lymphoma:

11. The lifetime risk of getting melanoma is greatest in: a. Caucasians. c. Hispanics. b. African Americans.

a. kinase-positive cancer. b. lipase-positive cancer.

c. oxidase-positive cancer. d. reductase-positive cancer.

7. About 85 to 90 percent of all lung cancers are: a. non-large cell. b. non-small cell. 8. The mechanism of action of crizotinib involves expression of ALK fusion: a. antibodies. c. lipids. b. kinins. d. proteins.

Completely fill in the lettered box corresponding to your answer. 1. 2. 3. 4. 5.

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

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

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

[d] [d]

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

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

[c] [d]

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

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

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

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

 I am enclosing $5 for this month’s quiz made payable to: Ohio Pharmacists Association. 1. Rate this lesson: (Excellent) 5 4 3 2 1 (Poor) 2. Did it meet each of its objectives?  yes  no If no, list any unmet_______________________________ 3. Was the content balanced and without commercial bias?  yes  no 4. Did the program meet your educational/practice needs?  yes  no 5. How long did it take you to read this lesson and complete the quiz? ________________ 6. Comments/future topics welcome.

12. Stevens-Johnson syndrome is a severe: a. pulmonary reaction. b. cardiovascular reaction. c. hepatic reaction. d. dermatologic reaction. 13. The advice to “Use with caution when driving or operating machinery” is most appropriate for patients receiving: a. Adcetris. c. Zelboraf. b. Xalkori. 14. The advice “Avoid excessive exposure to sunlight or tanning booths” is most appropriate for patients receiving: a. Adcetris. c. Zelboraf. b. Xalkori. 15. The recommended dose for Zelboraf 240 mg tablets is: a. 1 tablet daily. b. 2 tablets four times a day. c. 3 tablets three times a day. d. 4 tablets twice daily.

To receive CE credit, your quiz must be received no later than May 15, 2015. A passing grade of 80% must be attained. All quizzes received after July 1, 2012 will be uploaded to the CPE Monitor Program and a statement of credit will not be mailed. Send inquiries to opa@ohiopharmacists.org.

May 2012


2011 - 2012 GPhA BOARD OF DIRECTORS

The Georgia Pharmacy Journal

Name

Dale Coker Chairman of the Board Jack Dunn President President-Elect Robert Hatton Pam Marquess First Vice President Bobby Moody Second Vice President State At Large Robert Bowles Hugh Chancy State At Large State At Large Keith Herist Eddie Madden State At Large State At Large Jonathan Marquess State At Large Tim Short Richard Smith State At Large Christine Somers 1st Region President 2nd Region President Fred Sharpe Renee Adamson 3rd Region President Amanda Gaddy 4th Region President Julie Bierster 5th Region President Ashley Faulk 6th Region President 7th Region President Amanda McCall Larry Batten 8th Region President Kristy Pucylowski 9th Region President Christopher Thurmond 10th Region President Ashley London 11th Region President Ken Eiland 12th Region President Thomas Jeter ACP Chairman Josh Kinsey AEP Chairman Sonny Rader AHP Chairman Ira Katz AIP Chairman Gail Lowney APT Chairman Christina Gonzalez ASA Chairman John T. Sherrer Foundation Chairman Michael Farmer Insurance Trust Chairman Bill Prather Georgia State Board of Pharmacy Representative Patricia Knowles Georgia Society of Health Systems Pharmacists Amy Grimsley Mercer Faculty Representative Rusty Fetterman South Faculty Representative UGA Faculty Rep. Sukh Sarao Negin Sovaidi ASP Mercer University Rep. Annie Tran ASP South University Rep. David Bray ASP UGA Rep. Jim Bracewell Executive Vice President

Editor Jim Bracewell jbracewell@gpha.org

Managing Editor Amy W. DeFaveri

adefaveri@gpha.org The Georgia Pharmacy Journal® (GPJ) is the official publication of the Georgia Pharmacy Association, Inc. (GPhA). Copyright © 2012, 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 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 email adefaveri@gpha.org.

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.

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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 at adefaveri@gpha.org.

GPhA Headquarters

50 Lenox Pointe, NE Atlanta, Georgia 30324 Office: 404-231-5074 Fax: 404-237-8435 

Power Marketing: 678-990-3618

www.gpha.org The Georgia Pharmacy Journal

Position

31

July 2012


Georgia Pharmacy Association 50 Lenox Pointe, NE Atlanta, GA 30324


July 2012 Journal