Volume 35, Number 5 www.gpha.org
2012 GPhA Convention & Tradeshow July 7-11, 2012
A Gathering Place for Many Practices, One Profession
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FEATURE ARTICLES 6
Special Report: Combining Constitution and Bylaws
A Look at the 2012 Spring CPE Conference
Walgreens: “America’s Premiere Pharmacy Lives Up
to Its Image”
GPhA Member Jonathan Marquess Featured in USA
GPhA Crossword Puzzle
The Basics of Pharmacy Performance Measurement
Timeline for GPhA 2012 Elections
ACPE Announces Launch of CPE Monitor™
2012 New Practitioner Leadership Conference
Continuing Education for Pharmacists
8 10 12 13 16 31
GPhA News Pharm PAC Members Pharm PAC Contribution Form GPhA New Members GPhA Advocacy GPhA Board of Directors
2 Pharmacists Mutual Companies 13 Melvin M. Goldstein, P.C. 13 Logix, Inc. 17 EC Retail Studio 18 RxAllyTM 19 Meadowbrook Insurance Group 21 Michael T. Tarrant 32 UBS
Executive Vice President’s Editorial
View GPhA’s Calendar of Events at:
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2012 GPhA Convention & Tradeshow Hilton Head Marriott Resort & Spa Hilton Head Island, SC July 7 - 11, 2012
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PRESIDENTâ€™S MESSAGE L. Jack Dunn, Jr., R.Ph. President Georgia Pharmacy Association
2012 GPhA Convention & Tradeshow Many Practices, One Profession I hope everyone is doing well. The association is getting ready for the 2012 GPhA Convention in Hilton Head, South Carolina. Hilton Head is a popular location for many families all around the country. This is the first time our convention has been to Hilton Head in quite some time. The Marriott Hotel, which is on the beach, will be a beautiful setting for our association to offer continuing education, as well as some fun and laughter too. It is always good to meet new pharmacists and establish new ties at the convention. On the other side of the coin, it is good to see old friends that you may have not seen in quite some time. Regardless of the case, networking with pharmacists is very popular throughout the convention.
The GPhA convention is July 7- July 11 at the luxurious Marriott Hotel in Hilton Head, South Carolina. Reservations can be made by going to the GPhA website at www.gpha.org or calling the GPhA office at 404231-8100. Rooms are filling up fast so donâ€™t wait, make those reservations today! I hope to see everyone at Hilton Head so we can reconnect with the many friends that we have made throughout our profession. Thanks and hope to see you soon.
a We will conclude the election of new officers at the convention, with electronic balloting closing at noon on Tuesday, July 10, 2012. The General Sessions will address the latest in pharmacy practice and a glimpse of what the future holds. The Legislative Session on Monday will host a panel of Georgia State Legislators, the Georgia Board of Pharmacy and national leaders addressing state and federal legislative issues.
I know our convention liaison, Pam Marquess, has been working closely with the convention committee to provide pharmacists with continuing education for all settings of pharmacy. We will also have other activities such as golf, tennis or just laying around the pool or beach.
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Convention The Georgia Pharmacy Journal
EXECUTIVE VICE PRESIDENT’S EDITORIAL Jim Bracewell Executive Vice President / CEO Georgia Pharmacy Association
Who Has the Keys to Effective Advocacy for Pharmacy in Georgia? I checked GPhA Director of Government Affairs Andy Freeman’s pockets and he does not have them. I checked with Jeff Lurey, Cindy Shepherd, I even checked with Senator Buddy Carter, Representative Ron Stephens, Representative Butch Parrish and Representative Buddy Harden. No one had the keys, but each one told me who did have the keys. The keys to persuasive advocacy for pharmacy in Georgia are in the pockets of the over 10,000 licensed pharmacists in our state. Five Facts to consider since you have the keys:
1. 2. 3. 4. 5.
The equivalent of the population in the U.S. pass through our pharmacies each month. Pharmacists are among the most trusted healthcare professionals in America according to the Gallup Poll. Pharmacists are regarded as people of influence among their peers. This year, each Georgia State Senator and each Georgia State House of Representative is up for election. This year, each of our 14 U.S. Congressmen are up for election.
Are you going to open the doors or keep the keys in your pocket? No one can use your keys but you. If the keys are not used, the doors to improved healthcare and the pharmacy profession will remain locked away or worse yet the opportunities will be seized by alternate healthcare professionals who will use their keys to open the doors of advocacy. This legislative session was, by most accounts, one of GPhA’s most successful, but not because we passed all the legislation we wanted. We certainly wanted to pass the expanded immunization bill and did not, but our biggest successes were preventing legislation that would have greatly harmed the pharmacy profession in GA. Sometimes like a football game, your defense wins the game for you. We will be back in 2013 as we start a new biannual legislative session. All legislation is new. There are no carry over bills from 2012. Everyone must start again just like in a fall football season. It is a new day and a new opportunity for GPhA to make a difference. This spring you should get to know your State Representative and State Senator. Some will have election opposition, some will not, but all will want your vote. You are the key to our professional success. Those that do not vote and those that do not contribute money or time are the ones who keep the keys in their pocket and often later complain why nothing changes for the good of our profession. Use your keys! Open a few doors to new opportunities for GPhA and your career.
The Georgia Pharmacy Journal
GPhA SPECIAL REPORT
Dear GPhA Member: The Bylaws Committee continues to work to revise and update the Constitution and Bylaws of the Association. With the implementation of new laws and regulations governing internal controls for organizations many national nonprofit organizations are opting to utilize one governance document rather than a separate Constitution and Bylaws. The committee feels that our Association would also be served more effectively by utilizing a single governance document so we are recommending combining our Constitution and Bylaws. Close scrutiny of recommended changes to the governance documents of an organization is imperative to preserve the integrity of the organization. For this reason the leadership of the Association desires to solicit more participation from the membership prior to the amendment process. In order to provide an opportunity for membership feedback, the amendment recommendations will be provided to the membership in the follow manner: 1. Recommended amendments will be posted to the website (www.gpha.org) with notification provided in the GPhA Journal. Members will have an opportunity to provide feedback and input to the Bylaws Committee via the website prior to May 24, 2012. The committee will consider all comments prior to the final posting of the proposed amendments. 2. After the opportunity for membership input, notification of the proposed changes will be followed per our governance documents. (See Constitution and Bylaws amendment procedures printed below.) The committee recommendations are noted in the Bylaws utilizing the editing process with strikethroughs denoting deletions and underlining denoting additions. The recommended amendments include changes needed to keep our Bylaws current with our organizational needs as well as language needed to clarify inconsistencies and to integrate the Constitution and Bylaws into a single document. Proposed changes for the Bylaws will be presented at the first General Session of the 2012 annual meeting, referred to the Resolutions Committee for report, and will be voted upon at the Final General Session of the 2012 annual meeting. The process to consider the combination of the governance documents will require the proposal be read once at the 2012 annual meeting, and then it will be referred to the Board of Directors. If the Board supports the recommendation it will be presented to the membership for a vote at the 2013 annual meeting. If the proposal to combine both documents into a single document is not approved, the Association will continue to operate with two separate governance documents. We look forward to hearing your comments. Sincerely, John T. Sherrer Chairman Bylaws Committee
The Georgia Pharmacy Journal
GPhA SPECIAL REPORT
Constitution Amendments: Every proposition to alter or amend the constitution shall be submitted in writing to the Chairman of the Board of Directors and the Executive Vice President of the Association at least 30 days prior to the annual meeting and shall be signed by three active members of the Association. The proposed Amendment shall be read once at the annual meeting and referred to the Board of Directors. The Board shall bring the proposed amendment, along with a written recommendation, to a vote at the next annual meeting; upon receiving the vote of three-fourths of the members present, it shall become a part of the constitution. Bylaws Amendment: Every proposition to alter or amend these bylaws shall be submitted to the active membership at least 30 days prior to the annual meeting, and shall be presented at the first General Session of the annual meeting, referred to the Resolutions Committee for report, and shall be voted upon at the Final General Session of the same annual meeting. Upon receiving a two-thirds majority vote of the active members present and voting, the amendment shall become a part of these bylaws.
A Look at the 2012 Spring CPE Conference GPhA held the 2012 Spring CPE Conference at the Georgia Tech Hotel & Conference Center on Saturday, April 21. Six hours of ACPE approved CE was provided along with a successful networking event, a proper venue and great food. The Conference brought together 57 GPhA member pharmacists, six GPhA Past Presidents, five GPhA Elected Executive Committee Members, four GPhA Region Presidents from Region 7, 8, 9, 10, and GPhA Past President and State Representative Buddy Harden. GPhA member and conference participant, Arthur Tribble, R.Ph. of NC, said that he’ll be on the lookout for the next event. “I thoroughly enjoyed every minute and have told other pharmacists about it and they want to be included next time. The full day of CE is so great. That way I can concentrate on just the CE and relax and enjoy it.“ Jannifer Johnson, Pharm.D. and Anabelle Keohane, Pharm.D., who also attended the meeting, couldn’t agree more.
The Georgia Pharmacy Journal
Walgreens: “America’s Premiere Pharmacy Lives Up to Its Image”1 by Lowell J. Anderson, DSc, FAPhA tion business. The company’s stock is down 30% since they announced the disagreement in June. That is a lot of money—so even the investor community might understand.
This is a pat on the back for Walgreens for its public and professional leadership. It is not about Express Scripts (ESI)— ESI is just doing what PBMs normally do. Walgreens has chosen to reject the contract offered by Express Scripts and removed itself from the Express Scripts network by January 1, 2012. I have no idea what the dollars are in the negotiation. It really doesn’t matter to me, because it is not so much the why as it is the how. Walgreens effectively told the world that there was a reimbursement even they could not accept. They have managed to save some contracts because of the relationships and contracts with employers. By the time this is printed they may have even have come to terms with ESI. In the meantime, it will have caused concern or inconvenienced a lot of Walgreens customers. But those several millions might just get a feel for the economic facts of life in the prescrip-
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I know that contrary to conventional wisdom, chains do reject contracts for a variety of reasons. We rarely hear of these rejections because it is good business to keep contract negotiations close. They usually do not broadcast these decisions to either the public or broadly to the profession. Pharmacists in independent practice understand that they have little bargaining clout when it comes to negotiating contracts with pharmacy-benefit managers and managed-care organizations. In spite of the often-repeated assertions by these organizations that contracts are negotiated, the independents are usually told to “take it or leave it,” should they try to negotiate. More often than not, to “leave it” is not an option for the independent and smaller chains. The chains, however, may negotiate with some degree of success because the PBMs and MCOs need their distribution channels; and one negotiation may result in several thousand outlets. I suspect that many of the chain/PBM contracts have even kept pace with the rising costs of dispensing even if not fully recovering dispensing costs. Certainly that is not the case with independents, where (in Minnesota) there is a whole generation of pharmacists
who have not experienced the thrill of having a PBM increase a dispensing fee. As partial justification for its action, Walgreens cites pharmacy services that are currently not compensated. With growth in prescription drug sales slowing, Walgreens and other major retail pharmacy chains hope to boost revenue by offering new health-care services. In addition to filling prescriptions, they now help patients manage their medications. For example, Walgreens pharmacists advise customers on appropriate doses and try to switch them to cheaper generic alternatives when possible. “Our product is not a pill; our product is a health outcome,” says Walgreens Chief Executive Greg Wasson. Express Scripts’ response thus far: A pill’s a pill, and Walgreens doesn’t deserve more money than other pharmacies for telling patients how to take them. If Express Scripts did agree to pay more, Walgreens would become its most expensive pharmacy, raising client costs “for essentially doing the same thing as everyone else,” says spokesman Brian Henry.2 Re-read that Express Script response— it is telling! Mr . Henry’s assertion that “A pill’s a pill” clearly reflects a philosophy that a prescription medication is merely a product that requires distribution. Evidently ESI has little
GPhA NEWS corporate concern about whether or not the “pill” achieves the desired outcome—the outcome that its employer customer is paying for. On the plus side, Mr. Henry does recognize that “everyone else” does provide information. Of course they don’t pay “everyone else” either. I imagine that this was a much-researched decision by Walgreens as there are very real costs and market considerations. I have no doubt that Walgreens assessment was that signing the offered contract would not be a financially responsible and defensible decision. Ultimately, they must answer to the Walgreens’ stockholders. Mr. Wasson, Walgreens CEO, said in an analyst conference call: “The terms Express Scripts offered us, including rates that were below the industry average cost to provide the prescription, were not in the best interest of our company, our customers, our employees or our shareholders .”3 ESI is in a sticky spot here also. If it does agree to a contract with Walgreens that assigns a value for what “everyone does for free” it will provide an opportunity for other pharmacy providers to seek similar treatment that recognizes the value of pharmacists’ services in their next contracts. Corporate courage—sometimes hard to distinguish from tough negotiating, but still courage—is a rarely seen attri- bute today. I think that the pharmacists of America should support the courage of Walgreens. When
the Express Script member transfers a prescription because of this contract disagreement, the receiving pharmacist should talk to the member about the importance of compensation for valuable services and compliment Walgreens for its courage. And also how their employer and its PBM have chosen to not pay for these services. The Walgreens pharmacists, I hope, do likewise when their patients ask about the contract. Walgreens, by some estimates, may lose 10% of prescription volume over this. Are the independents and other chains prepared to take a stand with similar costs? Our history is that we do not. And, of course, that is why the fee schedules are what they are. When pharmacy owners and managers read these contracts it should be with the same question that Mr. Wasson addressed: are these contracts “in the best interest of our company, our customers, our employees or our shareholders”?
for Leading Healthcare Change, University of Minnesota and co-editor of the International Pharmacy Journal. He is a Remington Medalist. 1 Walgreens Web site 2 “Walgreens seeks payment for customer counseling in Express Scripts battle”, The Wall Street Journal, 25 October 2011 3 Medill Reports, Shaina Humphries, 15 November 2011
Reprinted by permission of the Minnesota Pharmacy Association, Minnesota Journal (Winter 2012)
Personally, I commend Walgreens for its actions—both for rejecting a contract that was not in its interests or the interests of the customers it serves, and even more important, for bringing the issue to the professional, public and investor communities. Lowell J. Anderson, D.Sc., FAPhA, practiced in community pharmacy for most of his career. He is a former president of MPhA, Mn Board of Pharmacy and APhA. In addition he has held positions in the Accrediting Council on Pharmacy Education, National Association of Board of Pharmacy and the United States Pharmacopeia. Currently he is Co-director of the Center
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Pharm PAC Members
GPhA is leading the way in influencing pharmacy-related legislation in Georgia.
($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
($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 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.
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Houston Lee Rogers, Pharm.D., CDM Tim Short, R.Ph. Benjamin Lake Stanley, Pharm.D. Danny Toth, R.Ph. Christopher Thurmond, Pharm.D. Tommy Whitworth, R.Ph., CDM
($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 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. Michael T. Tarrant
($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. Sukhmani Kaur Sarao, Pharm.D. David J. Simpson, R.Ph. James N. Thomas, R.Ph. William H. Turner, R.Ph. Flynn W. Warren, M.S., R.Ph. Walter Alan White, R.Ph. William T. Wolfe, R.Ph.
($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. 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 Storey, III, R.Ph. Archie Thompson, Jr., R.Ph. Carrie-Anne Wilson Sharon B. Zerillo, R.Ph.
Pharm PAC Members (continued from previous page) Members
(No minimum pledge) John J. Anderson, Sr., R.Ph. Thomas Bagby Garner, Jr., R.Ph. Fred W. Barber, R.Ph. Mark T. Barnes, R.Ph. Henry Cobb, III, R.Ph., CDM 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 Joel Andrew Hill, R.Ph. Carey B. Jones, R.Ph. Susan M Kane, R.Ph. Emily Kraus Carroll Mack Lowrey, R.Ph. Tracie Lunde, Pharm.D. Ralph K. Marett, R.Ph.,M.S. Tom E. Menighan, R.Ph., MBA, ScD, FAPhA Darby R. Norman, R.Ph.
Christopher Brown Painter, R.Ph. Whitney B. Pickette, R.Ph. Victor Serafy, R.Ph. Negin Sovaidi Charles Iverson Storey III, R.Ph. James E. Stowe, R.Ph. James R. Strickland, R.Ph. Celia M. Taylor, Pharm.D. Leonard E. Templeton, R.Ph. 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 Pharm PAC supporters.
To join Pharm PAC, complete the form on the next page and mail it in with your contribution. If you made a gift or pledge to Pharm PAC in the last 12 months and your name does not appear on this list, please contact Andy Freeman at email@example.com or 404-419-8118. Pharm PAC donations are not charitable donations and are not tax deductible.
GPhA MEMBER JONATHAN MARQUESS FEATURED IN USA TODAY SUPPLEMENT In the March 2012 MediaPlanet supplement to USA Today, GPhA Former President and APhA Trustee, Jonathan Marquess, Pharm.D., CDE, CPT, wrote a compelling article on the importance of customers developing a partnership with their pharmacist to optimize their diabetes care. “Diabetes education is certainly a passion of mine. Anyone involved in diabetes care and education is passionate about the disease and their patients,” said Marquess. “We see patients at the Pharmacy (and hold classes there), we also go into physician’s offices and see patients, and finally we go into employers to educate their employees on diabetes.” Who knew anyone in the medical profession still made house calls? Read Jonathan Marquess’ article online here: http://doc.mediaplanet.com/all_projects/7711.pdf.
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Join Pharmâ€ˆPAC Today!
GPhA is leading the way in influencing pharmacy-related legislation in Georgia
Pharm PAC is Georgia Pharmacy Associationâ€™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 Pharm PAC 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)
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: Pharm PAC, Georgia Pharmacy Association, 50 Lenox Pointe, NE, Atlanta, GA 30324
Thank you for supporting Pharm PAC. Your gift allows GPhA to continue to advocate for improvements within the pharmacy profession.
Welcome our new Pharm PAC members!
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GPhA NEW MEMBERS
Welcome New GPhA Members! GPhA is pleased to welcome the following new members:
Individual Pharmacist Members:
Pharmacy School-Student Members:
Dawn Haywood Weeks, Pharm.D. Monali N. Majmudar, Pharm.D. Kenric B. Ware, Pharm.D. Mia Avery, Pharm.D. Nicole Liza Caylor, Pharm.D. Young Chang, R.Ph. Rodney L. Casey, R.Ph. Richard M. Tomelevage, R.Ph.
Hayley Klein Adina Klima Daniel C. Wiley
Associate Members: Theotus Butler, R.Ph.
If you, or someone you know, would like to join GPhA, visit www.gpha.org.
Melvin M. Goldstein, P.C. A T T O R N E___ Y AT
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: The CPE lesson on Restless Legs Syndrome and Management that appeared in the April 2012 issue of The Journal reflected the incorrect expiration date on the quiz. The quiz page should reflect February 15, 2015 expiration date. Please contact Ohio Pharmacists Association at firstname.lastname@example.org.
n Former Administrative Law Judge for the Office of State Administrative Hearings
The Georgia Pharmacy Journal
GPhA PHARMACY CROSSWORD PUZZLE
1 Pill 5 It lowers cholesterol levels 9 Prescription filled by mail (2 words) 10 Connect 11 Smoking deposit 12 ___ the counter 13 Antibacterial (British spelling) 15 Consumed 16 Symbol for sodium 17 Pin down 19 Amount of medicine taken one at a time 22 Metal container 24 Tan___ acid 26 Reaction to a shot, sometimes 29 Part of the large intestine 30 Inflamed 31 Abnormal functioning of the body 32 Pain here may indicate heart trouble 35 Light metal, for short 37 Site of the fibia and tibula 38 Wedding vow (2 words) 39 Add as an additional element (2 words) 41 Government agency that approves medications 43 Cellphone storage card 44 Only OK (2 words) 45 Type of drug that can alleviate some infections
Down 1 Substance formed by the combination of two chemicals 2 Cost 3 Knowledgeable about (2 words) 4 Eliminate 5 Medicine in sweet liquid form 6 Itâ€™s used to moderate pain from headaches and reduce fever 7 Inserted through a vein 8 Non-brand name 13 Depressed 14 Dietersâ€™ units, abbr. 18 Passive introductions of a substance into a vein 20 Electro-photographic, abbr. 21 Healthful dietary supplement 23 Temperature controller, for short 25 Popular 27 Medical application in thick liquid form 28 Guy 31 IVs 32 Go higher 33 For example, abbr. 34 Very small amount 36 Catalogue 40 12 in old Rome 41 Kind of body tissue 42 Basics of a subject
If you would like to see the addition of crossword puzzles in future journals or have any comments, please email Amy DeFaveri at email@example.com.
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GPhA NEWS The Basics of Pharmacy Performance Measurement Donna West-Strum, RPh, PhD The University of Mississippi
Background Over the years, there have been many efforts to measure and improve health care quality through performance measures. Performance or quality measures, which are used to quantify the quality of a specific aspect of care, may be created based on evidence-based guidelines. Measures should be scientifically reliable, valid, interpretable and actionable, relevant and feasible. They are developed to enable a standard way for the specific aspect of care to be measured across practice settings; thereby allowing quality of care to be compared across providers as well as over time. For example, a performance measure was developed to assess if patients received beta-blocker therapy in the hospital after having a heart attack. As hospitals started using this measure, it was possible to develop a hospital-specific report card, showing which hospitals provided better care after a heart attack. In response, hospitals began to implement processes to ensure that patients who had a heart attack were given beta-blockers. People pay attention to what is measured; and hence, quality of care can be improved if it is measured and acted upon. Focus of Article This summary provides an overview of pharmacy performance measurement. Pharmacy quality is related to appropriateness of medication use and medication safety, including medication errors and adverse drug events. With the increased utilization and cost of medications, more attention to quality in pharmacy is warranted. Therefore, there is more attention to pharmacy performance measurement as a way to assess pharmacy quality. Health plans, insurers, employers, and other payers have great interest in pharmacy quality. These organizations are interested in measuring pharmacy quality for three important reasons: 1) to provide pharmacy quality reports to consumers to help them choose the highest quality of care, 2) to provide quality reports to prescription drug plans and pharmacies to encourage quality improvement, and 3) to develop pay-for-performance programs whereby health plans and providers with better quality scores will receive higher fees. Application Pharmacy performance measures being developed are related to appropriateness of drug use, safety of medication use, medication adherence, medication cost, and patient satisfaction with drug therapy. Examples of pharmacy performance measures include excessive dosing of oral diabetes medications, use of high-risk medications in the elderly, and adherence to chronic medications. Pharmacy performance measures allow payers and others to evaluate pharmacies and prescription drug plans on their performance of a specific, evidence-based aspect of care. As previously suggested, these measures may then stimulate quality improvement programs in prescription drug plans and pharmacies, be provided to consumers to help them select a prescription drug plan or pharmacy, or be used to develop pay-for-performance programs. Whatâ€™s In It For You? Pharmacists need to be aware of the pharmacy performance measures that are being developed and adopted, such as by the Centers for Medicare & Medicaid Services (CMS) for the Medicare Part D program. Pharmacists are encouraged to use the measures in their practice sites to drive quality improvement initiatives in the pharmacy. For example, pharmacists may decide to evaluate medication adherence of statins in their pharmacy. If the pharmacist finds that statin users do not continue to get refills, the pharmacist may want to develop some systematic interventions to improve medication adherence in the pharmacy. These performance measures provide an opportunity for the pharmacist to demonstrate the quality of the pharmacy services provided. Performance measure scores are related to the pharmacistâ€™s ability to improve medication use and not just dispense medications; thereby allowing the pharmacist to demonstrate the effectiveness of their pharmacy services. A pharmacy with higher ratings on performance measures may attract more patients or may be able to receive higher reimbursement rates through a pay-for-performance system. PQA and its role in pharmacy performance measurement PQA is the Pharmacy Quality Alliance, formed in 2006. Its mission is to improve the quality of medication management and use across health settings with the goal of improving patientsâ€™ health through a collaborative process to develop and implement performance measures and recognize examples of exceptional pharmacy quality. PQA is actively involved in developing pharmacy performance measurements. They have workgroups developing measures related to medication adherence, pain, overuse of medication, and MTM. Pharmacists should visit the PQA website (www.pqaalliance.org) to learn more about the pharmacy performance measures being developed. As measures are considered and developed, there is opportunity for pharmacists and the public to comment on the measures. PQA collaborates with various stakeholders to understand where performance measures are needed as well as how they can and will be used in the health care system. For example, CMS has adopted some of the PQA measures to use in their 5-Star rating system, related to measuring performance of Medicare Part D prescription drug plans and Medicare Advantage plans. These performance measures are then publicly reported by CMS as well as used in their value-based purchasing initiatives.
References: Pharmacy Quality Alliance website http://www.pqaalliance.org Warholak TL and Nau DP (editors) Quality and Safety in Pharmacy Practice. McGraw-Hill,New York, NY. 2010.
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GPhA ADVOCACY Andy Freeman Director of Government Affairs Georgia Pharmacy Association
“So, the Legislative Session is over Andy, what do you do now?”
“So the Legislative Session is over Andy, what do you do now?” That is a question I get asked every year as the Georgia General Assembly is gaveled to closure. I take some time to get caught up on office work, write a few articles for the Journal and raise money for PharmPAC. This year, I also spent a few days in Washington, D.C. meeting with congressional staff to get their support on Federal legislation of importance to the practice of pharmacy. The week following the end of the session, I flew up to DC to talk about three pieces of legislation that deal with PBM transparency and audits; HR 1946, HR 1971 and HR 4215. All three bills are similar to each other, but are in three different committees. The thought is by having different versions of the legislation in different committees it increases the odds of one of them passing. While in DC, I met with key staff from the offices of U.S. Senator Johnny Isakson and U.S. Senator Saxby Chambliss. I also met with staff from Congressmen Austin Scott’s, David Scott’s, Graves’, Bishop’s, Gingrey’s, Lewis’, Kingston’s, Price’s, Johnson’s and Barrow’s offices. Congressman Austin Scott and Johnson have already cosigned on bills HR 1946 and HR 1971 and are expected to add their names to HR 4215 soon. I am optimistic that many others from Georgia will be signing on too.
Most of the staff I met with mentioned how they enjoy meeting with their pharmacy constituents in the district but also when the come up with NCPA or APHA to Washington DC. NCPA’s Annual Conference on National Legislation is coming up on May 7–9 and I am already setting up appointments for our members that will be there to meet with their Congressman. By the time this goes to print, our members will have met with their legislators and I’ll provide an update in the June issue of the journal. Before leaving DC, I met with some of NCPA’s Government Affairs staff to see how we can help them with their federal legislation as well as how we can work together on the recently allowed merger of Express Scripts and Medco. Our meeting also included a discussion of an event that we will do jointly in the fall with NCPA. Representing the interests of Georgia Pharmacists through legislation and government affairs is a full time, year-round job. It is a rewarding and busy job that I enjoy doing for you whether it is in Atlanta or in our Nation’s Capitol.
One of the things I learned on this trip is that Congressman Austin Scott is working on his own PBM legislation to introduce next year. When Austin was a State Representative he had authored several pieces of legislation to regulate Pharmacy Benefit Managers. His staff says Austin wants to work on this issue in Congress and wants our help to make sure he comes up with the best bill he can.
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GPhA PHARMACY CROSSWORD PUZZLE
The Georgia Pharmacy Journal
o t r o w ck o H
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©2012 RxAlly, Inc. All rights reserved. RxAlly, the RxAlly logo, and other trademarks, service marks, and designs are registered or unregistered trademarks of RxAlly. May 3/12 The Georgia Pharmacy Journal 2012 18
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Timeline for GPhA 2012 Elections First Vice President & Second Vice President March 9, 2012 (no later than) Nominating Committee must meet no later than this date.
June 25, 2012 Deadline for all mail-in ballots. (All mailed ballots must be post-marked by this date.)
April 10, 2012 The First Vice President (at least one person) and Second Vice President (at least two people) nominations must be made.
July 5, 2012 Mailed ballots to be retrieved and secured. July 10, 2012 Polls close at Noon.
May 10, 2012 The petitions from additional nominees must be submitted to the Executive Vice President.
July 10, 2012 Conduct Tellers Committee Meeting.
May 14, 2012 The following data to be sent to the election service: 1) member last names/member ids/email addresses; and 2) candidate pictures/bios.
July 10, 2012 Installation of new officers.
May 14, 2012 Paper Ballot to be sent to the printer. May 18, 2012 Email sent to notify GPhA members of the log-in information that will be arriving in their email box on May 23, 2012 from the Association online Voting with a reminder to unblock GPhAâ€™s email address from SPAM. May 23, 2012 Log-in information to be emailed to GPhA members from the Association Online Voting.
PAPER BALLOT DEADLINE JUNE 25, 2012!
May 23, 2012 Paper ballots to be sent in the mail. May 25, 2012 The election opens. Association Online Voting will email GPhA members the link to the voting site. Once each member has voted, he/she will receive no further reminder emails.
If you prefer to use a paper ballot for the election, call Tei Muhammad toll free at 888-871-5590 and she will send you a ballot. Your paper ballot must be post marked no later than June 25, 2012 to be counted in this yearâ€™s election.
July 4, 2012 Reminder emails will be sent to GPhA members who have not voted on a weekly basis.
The Georgia Pharmacy Journal
GPhA NEWS ACPE Announces Launch of CPE Monitor™ Chicago, IL – Following a successful pilot program engaging 40 continuing pharmacy education (CPE) providers, the Accreditation Council for Pharmacy Education (ACPE) announced the launch of the new continuing pharmacy education tracking service, CPE Monitor. ACPE is working in partnership with the National Association of Boards of Pharmacy (NABP), to authenticate and store data for completed CPE units received by pharmacists and pharmacy technicians from ACPE-accredited providers.
About the Accreditation Council for Pharmacy Education (ACPE) Accreditation Council for Pharmacy Education (ACPE) is the national agency for the accreditation of professional degree programs in pharmacy and providers of continuing pharmacy education. The mission of the organization is to assure and advance excellence in education for the profession of pharmacy. ACPE is an autonomous and independent agency whose Board of Directors is derived through the American Association of Colleges of Pharmacy (AACP), the American Pharmacists Association (APhA), the National Association of Boards of Pharmacy (NABP), and the American Council on Education (ACE).
Dimitra V. Travlos, PharmD, BCPS, Assistant Executive Director and Director of the Continuing Pharmacy Education Provider Accreditation for ACPE, states that “this service will save time and expense for state boards of pharmacy, CPE providers, pharmacists, and pharmacy technicians by providing a centralized repository for continuing pharmacy education details. CPE Monitor will be helpful to the growing number of pharmacists and pharmacy technicians who are licensed in multiple states and may need to meet the varied CPE requirements of different state boards of pharmacy.” When CPE Monitor is fully implemented, providers will no longer need to issue electronic or printed statements of credit to their pharmacist and pharmacy technician participants. Instead, the tracking system will make CPE data for each participant available to the state boards of pharmacy where participants are licensed or registered. Implementation of the CPE tracking system will also eliminate the need for Annual Activity Update (AAU) reporting by the provider each year. Full implementation of CPE monitor by all CPE providers is expected by the end of 2012, and it is anticipated that the boards of pharmacy will be able to begin accessing their licensees’ CPE data by 2013. The CPE tracking system will create a direct link for sending CPE data from ACPE-accredited providers to ACPE and then to NABP, ensuring that all reported CPE units are officially verified by ACPE-accredited providers. Pharmacists and pharmacy technicians may obtain their NABP eProfile ID, the unique identification number to be required when registering for a CPE activity from an ACPE-accredited provider, by going to www.MyCPEmonitor.net.
The Georgia Pharmacy Journal 21
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GPhF NEWS 2012 New Practitioner Leadership Conference The Georgia Pharmacy Foundation announces the graduates of its 19th New Practitioner Leadership Conference recently held at Lake Lanier Islands. This annual conference is a unique opportunity available to Georgia pharmacy practitioners who have been in practice for ten years or less and have demonstrated leadership qualities. It is designed to provide the selected pharmacists with time together so their organizational skills can be enhanced and enable both personal and professional growth. Seventeen practitioners were chosen with a possible 20 being the maximum that can attend each year. Their practice settings include academia, hospital, independent and chain retail, government and insurance. We are pleased to announce that the 2012 selected candidates are:
Class of 2012 NPLC Graduates
Mia Avery, Pharm.D., of Atlanta Catherine Bourg, Pharm.D., of Athens Laura Coker, Pharm.D., of Atlanta Courtney Crawford, Pharm.D., of LaGrange Johnathan Hamrick, Pharm.D., of Atlanta Kendra Jenkins, Pharm.D., of Atlanta Cedric O. Knight, II, Pharm.D., of Fairburn Blake Lord, Pharm.D., of Canton Kendra Manigault, Pharm.D., of Atlanta
Natalie Nielsen, Pharm.D., of Smyrna Amanda Paisley, Pharm.D., of Atlanta Blake Powell, Pharm.D., of Tifton Turkesia Robertson-Jones, Pharm.D., of Atlanta Ben Ross, Pharm.D., of Statesboro Jackie Siers, Pharm.D., of Atlanta Nafesa Walters-Smith, Pharm.D., of Tucker Daniel Zeigler, Pharm.D., of Savannah
This conference was initiated by the Georgia Pharmacy Foundation, and has proven highly successful in developing leadership skills in this group of young practitioners. At the current time 43 percent of the members of the Georgia Pharmacy Association board of directors are graduates of this conference. The Saturday sessions are planned to develop leadership skills. For most of the 19 years of this conferenceâ€™s existence the Foundation has been very fortunate to have one of the premiere speakers on leadership conduct this class. Dave Miller, R.Ph., Executive Vice President & CEO of IACP, always delivers to the gratification and enjoyment of the
The Georgia Pharmacy Journal 22
GPhF NEWS candidates who can never believe they have just sat through five hours of instructions. This year’s Saturday schedule had added excitement. Thanks to negotiations with Lake Lanier, the attendees took part in a dinner cruise. However, there was a small interruption in the cruise and a fast return to the dock. One of the candidates, Blake Lord, needed to make a mad dash home...his wife, expecting their first child in ten days, went into labor. When Blake first received word, the boat was in the middle of the lake. He was offered the opportunity to swim ashore but being the caring people that pharmacists are they took pity and the captain reversed engines and hauled it back to shore. Fortunately, Blake’s home is only an hour away from Lake Lanier. Word was received Sunday morning that his daughter, Emery, was born that morning and all were doing well. On Sunday, the GPhA Executive Committee members met with the new practitioners and shared their knowledge, experiences and responsibilities of leadership. The young pharmacists were challenged to get involved in their profession’s leadership and to utilize their abilities to support pharmacy. During the weekend a number of the Graduates won prizes presented by the GPhA Executive Committee in recognition of their participation and completion of the “homework” assigned to them prior to their arrival. The assignment included reading “Race to Relevance” which was provided to them by GPhA. On Saturday the participants were divided into work groups and each group made a presentation during Sunday’s meeting regarding their thoughts on association management. They were also asked for their recommendations on how to improve the GPhA website. At the close of the Sunday session, the Graduates voted Johnathan Hamrick to be their Class President. Turkesia Robertson-Jones was the ecstatic winner of the free weekend at Lake Lanier Islands compliments of Legacy Lodge and Conference Center.
Congratulations Class of 2012! The Georgia Pharmacy Foundation sincerely thanks the following companies for their generous support:
• A. Hutton Madden Pharmacists Life Insurance Co. • APCI (American Pharmacy Cooperative, Inc.) • McKesson • Smith Drug Co.
The Georgia Pharmacy Journal
continuing education for pharmacists Volume XXX, No. 3
New Drugs: Nulojix, Potiga and Tradjenta 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 belatacept (Nulojix®), ezogabine (Potiga™), and linagliptin (Tradjenta™). Objectives. At the completion of
this activity, the participant will be able to: 1. identify the new drugs by generic name, trade name and chemical name when relevant; 2. select the indication(s), pharmacologic action(s) and clinical applications for each drug; 3. recognize important therapeutic uses for the drugs and their applications in specified pathologies; and 4. demonstrate an understanding of adverse effects and toxicity, significant drug-drug interactions, and patient counseling information for these drugs. Drugs discussed within this lesson are new molecular entity drugs (Table 1) indicated to treat a variety of afflictions. 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 Information leaflet or Medication Guide, and other published reference sources for detailed descriptions.
Nulojix® (noo-LOJ-jiks) is a new option for patients with a kidney transplant. Before its approval, it was evaluated in two openlabel, randomized, multicenter, controlled Phase 3 studies that enrolled more than 1,200 patients
and compared two dose regimens of the test drug with cyclosporine. These trials demonstrated that the recommended Nulojix® regimen is safe and effective for the prevention of acute organ rejection. Indications and Use. Belatacept is a more potent, second-generation modification of its parent compound abatacept (Orencia®). Abatacept is a biologic that has antagonistic action on CD80 and CD86, and is approved for treatment of autoimmune disease, specifically rheumatoid arthritis. CD80 and CD86 are glycoproteins associated with generation of the body’s inflammatory response. The finding that abatacept was not
Table 1 Selected new drugs Generic (Proprietary Applicant/Sponsor/ Indication Name) Distributor
Bristol-Myers Squibb Company
T-cell costimulation blocker for prophylaxis of organ rejection following kidney transplantation
Lyophilized powder for injection 250 mg/ vial
Potassium channel opener for adjunctive treatment of partial-onset seizures
50, 200, 300, 400 mg tablets
Boehringer Ingelheim DPP-4 inhibitor for Pharmaceuticals, Inc. adjunctive therapy and Eli Lilly and Co. in type 2 diabetes mellitus
5 mg tablets
appropriate for solid organ transplantation because of its relatively weak affinity led to development of a more effective agent. Belatacept was produced by substituting two amino acids on the abatacept molecule. This resulted in a 10-fold enhanced binding affinity to CD86 and a two-fold increase in CD80 binding affinity in comparison to abatacept. Nulojix® is a selective T-cell costimulation blocker indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant. The drug should be used along with basiliximab (Simulect®) induction, mycophenolate mofetil (CellCept®) and corticosteroids. It should only be used in persons who have antibodies indicating a previous Epstein-Barr virus (EBV) infection (see Warnings and Precautions). Moreover, efficacy has not been established for prophylaxis of organ rejection in transplanted organs other than the kidney. Kidney Transplantation. Organ failure is a common medical problem that results in extensive human and economic costs. Hundreds of thousands of individuals die each year from organ failure in the United States. Transplantation is the only recognized long-term treatment for organ failure and is one of the major medical advancements over the past 50 years. In addition to benefit to the patient, successful transplantation also impacts the world’s healthcare system directly. For example, compared with the cost of kidney dialysis, a successful kidney transplant saves more than $300,000 per patient over five years. At present, more than 89,000 patients are awaiting a kidney transplant in the United States. The major issue in organ transplantation between genetically non-identical patients is related to the recipient’s immune system, which would treat a transplanted kidney as a foreign (“non-self”) tissue and immediately reject it. Thus, having medications to suppress the immune system is es-
sential if organ transplantation is going to be successful. However, suppressing an individual’s immune system places that individual at increased risk of infection and cancer (especially skin cancer and lymphoma), in addition to the adverse effects of the medications. The primary indication for kidney transplantation is end-stage renal disease (ESRD), regardless of the primary cause. This is defined as a glomerular filtration rate of <15 mL/min/1.73m2. Common diseases that can lead to ESRD include malignant hypertension, infections, diabetes mellitus and focal segmental glomerulosclerosis. Familial (hereditary) causes include polycystic kidney disease, a number of inborn errors of metabolism and autoimmune conditions such as lupus erythematosus. Diabetes is the most common cause of kidney transplantation, accounting for approximately 25 percent of transplanted kidneys in the United States. Kidney transplantation saves lives. The typical patient will live 10 to 15 years longer with a kidney transplant than if maintained on dialysis. Increase in longevity is greater for younger patients, but even 75-year-old recipients (the oldest group for which there are data) gain four more years of life on average. Patients generally have more energy, a less restricted diet, and fewer complications with a kidney transplant than if they remain on conventional dialysis. Depending on its quality, the new kidney usually begins functioning immediately. A living donor kidney typically requires three to five days to reach normal functioning levels, while a deceased-donor (formerly referred to as a cadaveric donation) kidney may require seven to 15 days. The typical hospital stay is four to seven days. If complications arise, additional medications (e.g., diuretics) may be administered to aid in renal function. Introduction of the calcineurin inhibitors cyclosporine (Neoral®, Sandimmune®, and others) and
tacrolimus (Prograf®), along with development of antiproliferative agents such as mycophenolate mofetil and antibody induction agents, has resulted in vast improvements in acute rejection rates and short-term graft survival in patients receiving kidney transplants. (Calcineurin is a serine/ threonine protein phosphatase that participates in a number of cellular processes including signal transmission.) While this progress was hoped to lead to a corresponding improvement in long-term graft function, a recent analysis has shown a lack of improvement in the relative risk of graft failure for those transplanted in 1995 through 2000, despite a reduction in acute rejection rates of nearly 50 percent during that time. One explanation for this lack of improvement in long-term graft survival is the nephrotoxicity imparted by cyclosporine and other early drugs. This hypothesis is supported by histological data obtained from biopsies of kidney recipients over 10 years that identified chronic calcineurin inhibitor-induced nephrotoxicity in 50 percent of grafts at two years, and in 100 percent of grafts at 10 years post-transplant. Mechanism of Action. Belatacept is a selective T-cell (lymphocyte) costimulation blocker that binds to CD80 and CD86 sites on antigen-presenting cells, thus blocking CD28 mediated costimulation of T lymphocytes. In vitro, belatacept inhibits T lymphocyte proliferation and production of the cytokines interleukin-2, interferongamma, interleukin-4, and tumor necrosis factor-alpha. Activated T lymphocytes are the predominant mediators of immunologic rejection. Adverse Effects. Most common adverse reactions (≥20 percent on Nulojix® treatment) in pre-marketing clinical trials were anemia, diarrhea, urinary tract infection, peripheral edema, constipation, hypertension, fever, graft dysfunction, cough, nausea, vomiting, headache, hypokalemia, hyperkalemia and leukopenia. Warnings, Precautions and
Contraindications. The following warnings and precautions are listed. • Post-Transplant Lymphoproliferative Disorder (PTLD): There is an increased risk of PTLD, predominantly involving the CNS. Patients should be monitored for new or worsening neurological, cognitive and/or behavioral signs and symptoms. PTLD is a form of cancer where white blood cells grow out of control after an organ transplant. The risk of PTLD is higher for transplant patients who have never been exposed to EBV, the cause of mononucleosis. Transplant patients who have not been exposed to EBV have greater difficulty mounting an effective immune response to the virus, if they become infected with EBV after a transplant. Typically, they get exposed to the virus at the time of transplant, as it is carried in about 80 percent of donated organs. • Other malignancies: There is increased risk for malignancy with all immunosuppressants, appearing related to intensity and duration of use. • Progressive Multifocal Leukoencephalopathy (PML): There is increased risk and should be considered in the diagnosis of patients reporting new or worsening neurological, cognitive or behavioral signs and symptoms. • Other serious infections: Increased risk of bacterial, viral, fungal, and protozoal infections has been reported, including opportunistic infections and tuberculosis. Some infections have been fatal. Polyoma virus (various rare viruses of animals that can also infect humans)-associated nephropathy can lead to kidney graft loss; reduction in immunosuppression should be considered. Patients should be evaluated for tuberculosis and treatment initiated for latent infection prior to Nulojix® use. Cytomegalovirus and pneumocystis prophylaxis are recommended after transplantation. • Liver transplant: Use of belatacept is not recommended. • Immunizations: Use of live
vaccines during treatment is not recommended. The only contraindication is use in patients who are EBV seronegative or with unknown EBV serostatus. Drug Interactions. No formal drug interaction studies have been conducted. Dosage and Availability. Nulojix® is given in doses of 10 mg/kg on the day of surgery and Day 5; then 10 mg/kg at the end of Week 2, Week 4, Week 8 and Week 12 after transplantation. This is followed with 5 mg/kg the end of Week 16, and every four weeks (plus or minus three days) thereafter. Use of higher than recommended or more frequent dosing is not indicated due to increased risk of serious infections and malignancy. Nulojix® is intended for intravenous infusion only, administered over 30 minutes. The product is supplied as a lyophilized powder for injection containing 250 mg belatacept per vial. Patient Information. Excerpts from the FDA-approved Medication Guide are shown in Table 2.
FDA’s approval of ezogabine (also known as retigabine) was based on the outcome of three clinical trials involving more than 1,000 adults. These studies established that ezogabine reduced seizure frequency by about 30 to 40 percent in those who responded to the therapy. Overall, 25 percent of patients receiving ezogabine in those clinical trials discontinued treatment due to negative side effects compared with 11 percent of those who received the placebo. Indications and Use. Potiga™ (poo-TEE-ga) is the first neuronal potassium channel opener, indicated for adjunctive treatment of partial-onset seizures in patients aged 18 years and older. Partial-onset Seizures. There are many types of seizures. The two main categories are termed “partial-onset” and “generalized.” The former seizures typi-
Table 2 Major counseling points for Nulojix (belatacept) injection* This medicine is used to prevent transplant rejection in people who have received a kidney transplant. •Read the Medication Guide before you start receiving Nulojix and each time you get a refill. •Tell your doctor: -if you have been exposed to EpsteinBarr virus (EBV); -if you have a change in mood or your usual behavior, the way you walk or talk, vision, the amount of urine you make, or blood or burning on urination; decreased strength or weakness on one side of your body; fever, night sweats, or tiredness that does not go away; weight loss; swollen glands, flu or cold symptoms, or cough; vomiting or diarrhea; tenderness over your transplanted kidney; or new skin lesion or bump, or change in size or color of a mole; -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. •Nulojix® is for injection by intravenous infusion over 30 minutes. *Excerpted from the FDA-approved Medication Guide
cally occur in one area of the brain, whereas generalized seizures usually affect nerve cells throughout the brain. Partial-onset seizures may be classified as “simple” or “complex.” More than 60 percent of adults who have seizures experience them as partial-onset seizures. Simple partial-onset seizures do not cause a loss of awareness and the patient remains alert, but they may produce abnormal sensations, such as a funny feeling (an aura), an unpleasant smell or a body movement such as repetitive jerking of an
Table 3 Major counseling points for Potiga (ezogabine) tablets* This medicine is used with other medicines to treat partial-onset seizures. • Read the Medication Guide before you start taking Potiga™ and each time you get a refill. • Tell your doctor: -if you have trouble or pain with urinating; -if you have unusual or extreme changes in behavior or mood, or thoughts about suicide or dying; -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 Potiga™. • Use caution when driving and performing tasks that require alertness until you know how you react to Potiga. Alcoholic beverages and other sedating medicines can increase the side effects caused by Potiga. • This medicine has abuse potential. Do not take higher doses or take it longer than prescribed by your doctor. • Store this medicine in a secure place. • WOMEN: Notify your doctor if you become or intend to become pregnant, or are breastfeeding. • Take Potiga™ exactly as instructed. Do not change the dose or stop taking it without talking to your doctor. It can be taken with or without food. • Store Potiga™ at room temperature in its tightly closed container. Do not use after the expiration date on the label. Properly discard unused medicine. *Excerpted from the FDA-approved Medication Guide
arm. During a simple partial-onset seizure, the patient can answer questions and follow commands, and can recall what happened during the seizure. Complex partial-onset seizures can cause loss of awareness, confusion, staring, and certain movements like hand rubbing, lip smacking, arm positioning, or
uncontrolled shouting or swallowing. In a complex-partial-onset seizure, the patient may not be able to answer questions or follow commands, and often cannot recall what happened during part or all of the seizure. Complex partial-onset seizures can spread to both sides of the brain and are then known as complex partial seizures with secondary generalization. Partialonset seizures are highly resistant to pharmacotherapy, including combination regimens, in approximately one-third of cases. These individuals are often affected by comorbid disorders and are difficult to treat. Mechanism of Action. The mechanism by which ezogabine exerts its therapeutic effects has not been fully elucidated. What is known is that the drug is the first member of a new pharmacologic class. In vitro studies indicate that the drug enhances transmembrane potassium currents. Potassium channels regulate neuronal function such that an increase in conduction of potassium allows membrane hyperpolarization and decreases neuronal excitability. Although the mechanism of action is not firmly established, the drug may act as an anticonvulsant by reducing excitability through the stabilization of neuronal channels in an “open” position. In vitro studies suggest that the new drug may also exert therapeutic effects through augmentation of GABAmediated currents. Adverse Effects. The most common adverse reactions in premarketing clinical trials (incidence ≥4 percent and approximately twice that of placebo) were dizziness, somnolence, fatigue, confusional state, vertigo, tremor, abnormal coordination, double vision, disturbance in attention, memory impairment, muscular weakness, blurred vision, gait disturbance, difficulty in speaking, and balance disorder. Warnings, Precautions and Contraindications. The following warnings and precautions are listed. • Urinary retention: Patients
should be carefully monitored for urologic symptoms. • Neuropsychiatric symptoms: Patients should be monitored for confusional state, psychotic symptoms and hallucinations. • Dizziness and somnolence: Patients should be monitored for dizziness and somnolence. • QT prolongation: The QT interval should be monitored in patients taking concomitant medications known to increase the QT interval or with certain heart conditions. • Suicidal behavior and ideation: Patients should be monitored for suicidal thoughts or behaviors. There are no contraindications listed. Drug Interactions. Ezogabine plasma levels may be reduced by concomitant administration of phenytoin or carbamazepine. An increase in dosage of Potiga™ should be considered when adding phenytoin or carbamazepine. Digoxin levels may be increased due to ezogabine inhibiting its renal clearance. Alcohol increases systemic exposure to Potiga™. Patients should be advised of possible worsening of ezogabine’s general dose-related adverse reactions if they consume alcoholic beverages while taking the drug. Dosage and Availability. The initial dose should be 100 mg three times daily for 12 weeks, then titrated to the maintenance level by increasing the dosage at weekly intervals by no more than 150 mg per day. The optimal effective dosage is between 200 mg three times daily (600 mg/day), and 400 mg three times daily (1,200 mg/ day). In controlled clinical trials, 400 mg three times daily (1,200 mg/day) showed limited improvement compared to 300 mg three times daily (900 mg/day), with an increase in adverse reactions and discontinuations. Potiga™ may be taken with or without food. When discontinuing Potiga™, the dosage should be reduced gradually over a period of at least three weeks. Dosing adjustments are required for geriatric patients and persons with
moderate to severe renal or hepatic impairment. Potigaâ„˘ is supplied as tablets containing 50 mg, 200 mg, 300 mg and 400 mg ezogabine. Patient Information. Excerpts from the FDA-approved Medication Guide are shown in Table 3.
Tradjenta was demonstrated to be safe and effective for use in eight double-blind, placebo-controlled clinical studies involving about 3,800 people in the United States with type 2 diabetes mellitus. The studies showed improvement in blood glucose control compared with placebo. Its approval provides another treatment option for the millions of Americans with type 2 diabetes. It is effective when used alone or when added to existing treatment protocols. Indications and Use. Tradjentaâ„˘ (TRAD-gen-ta) is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The drug should not be used in patients with type 1 diabetes or for treatment of diabetic ketoacidosis, nor has it been studied for use in combination with insulin. Diabetes Mellitus Type 2. Progressive in nature, diabetes mellitus is a significant global health threat. With an estimated 246 million individuals affected worldwide in 2007, the number is projected to reach 380 million in 2025. In the United States, more than 1.5 million new cases are diagnosed each year, with 23.6 million adults (approximately 8 percent of the U.S. population) currently diagnosed with the disease, of which 90 to 95 percent is type 2. The American Diabetes Association has estimated that the annual healthcare cost of diabetes in the United States is $174 billion, with $116 billion attributed to direct medical expenditures and the remainder due to lost productivity. The economic burden resulting from diabetes is, in part, due to
the long-term microvascular (e.g., retinal, renal) and macrovascular (e.g., cardiac) complications of this disease. In addition to being the major cause of kidney failure and blindness, diabetes doubles to quadruples the risk of death from cardiovascular causes. The Incretin Effect. In 1902, researchers found that acid infused into the intestine stimulated secretion of juices through the pancreatic duct, even after nerves to the intestine were severed. Further studies led to the eventual conclusion that the nature of the signal to the pancreas was most likely due to chemical stimulation. This substance was subsequently named secretin. Numerous experiments followed to clarify the nature of secretin. Data suggested that food entering the gut led to secretion of a stimulant substance (secretin) into the blood that ultimately led to insulin secretion and lowering of blood glucose. In 1932, the term incretin was coined to refer to an extract from the intestinal mucosa that produced hypoglycemia without inducing exocrine secretion. However, the belief that incretins actually existed was still not proven until 1964. Researchers then showed that orally administered glucose evoked a greater insulin response than that following intravenous administration of a like amount of the carbohydrate. This observation suggested a major role for one or more intestinal mediators of insulin secretion that was referred to as the incretin effect. A significant advance in understanding diabetes management followed identification of two naturally occurring gastrointestinal insulinotropic (induce insulin secretion) hormones (the incretins): glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). These substances shared many common actions in the pancreas, but exerted distinct actions outside the pancreas. Blood levels of both hormones were shown to rise rapidly after nutrient intake, then fall pre-
cipitously thereafter as a result of rapid enzymatic degradation of the incretins. In patients with type 2 diabetes, the incretin effect of both hormones was greatly diminished, as shown by decreased secretion of GLP-1 and impaired insulinotropic action of GIP. This was believed to contribute to diabetic patientsâ€™ inability to adjust their insulin secretion to meet physiological needs. Recently, the incretin effect has been demonstrated to be responsible for up to 70 percent of insulin response to a glucose load. GLP-1 is a peptide expressed in pancreatic alpha-cells and intestinal L cells where it is stored in granules and released into the blood in response to a nutrient stimulus. L cells are located throughout the gastrointestinal tract and contain regulatory hormones and/or biogenic amines. GLP-1 helps maintain glucose homeostasis through actions on both alpha- and beta-cells. The primary physiological stimulus for secretion of GLP-1 is a fat- and/or carbohydrate-rich meal. Mixed meals or individual nutrients, including glucose and other sugars, sweeteners, fatty acids, amino acids and dietary fiber, also can stimulate GLP-1 secretion. Both GLP-1 and GIP are released within minutes following food ingestion. Because early studies showed that individuals with type 2 diabetes have a reduced response to GIP even at supraphysiologic (pharmacologic) plasma levels when compared with healthy individuals, GIP was determined to be a poor target of therapy in diabetic patients. On the other hand, GLP-1 significantly augments glucosedependent insulin secretion and is still insulinotropic in type 2 diabetes. Its infusion reduces glucose levels experimentally by increasing glucose-dependent insulin secretion in type 2 diabetic patients. Mimicking GLP-1 would, therefore, seem to be a logical means for treatment of type 2 diabetes. A major obstacle to using endogenous GLP-1 or GIP in management of type 2 diabetes is that
Table 4 Major counseling points for Tradjenta (linagliptin) tablets* This medicine is used as an adjunct to diet and exercise to lower blood sugar in adults with type 2 diabetes. • Read the Patient Information before you start taking Tradjenta™ and each time you get a refill. • Tell your doctor: -if you develop a rash; raised red patches on your skin (hives); or swelling of your face, lips, and throat that cause difficulty in breathing or swallowing. -about all other prescription and nonprescription (OTC) medicines (especially aspirin and decongestants), vitamin/mineral supplements, natural products and herbal remedies you are taking. The Patient Information has a list of medicines you should not take. • Follow instructions on proper blood glucose monitoring, diet plan and prescribed exercise program. • Periodic laboratory testing is important with this medicine. Be sure to make all testing appointments. • Tradjenta™ is taken once a day, at approximately the same time. It can be taken with or without food. • Store this medicine at room temperature in its tightly closed container. Do not use after the expiration date on the label. Properly discard unused medicine. *Excerpted from the FDA-approved Patient Information
they are rapidly degraded by the enzyme DPP-4. The biological halflife (t1/2) of GLP-1, for example, is a short one to 1.5 minutes. Continuous infusion of endogenous GLP-1 is both expensive and, because of its short t1/2, impractical for the large majority of patients with type 2 diabetes. Research has, therefore, focused on developing compounds to either mimic activities of GLP-1, or limit its turnover by inhibiting DPP-4. Because DPP-4 inhibition prevents the degradation of incretins, these compounds can elevate the beneficial effects of these regulatory peptides for type 2 diabetes mellitus. Decreased incretin levels
have, in fact, been reported for diabetic patients. DPP-4 inhibitors have been shown to alleviate this deficiency and reduce glucose and hemoglobin A1c (HbA1c) successfully. Because the stimulation of insulin secretion is glucose dependent, the risk of hypoglycemia is low for DPP-4 inhibitors, whereas hypoglycemia is one of the main disadvantages of sulfonylureas. DPP-4 inhibitors have successfully been used for treatment of type 2 diabetes since 2006. Sitagliptin (Januvia®) was approved in 2006 and saxagliptin (Onglyza™) in 2009. Mechanism of Action. Linagliptin is a novel, orally active, highly specific, and potent inhibitor of DPP-4, an enzyme that degrades the incretin hormones GLP-1 and GIP. Thus, linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin in a glucosedependent manner and decreasing the levels of glucagon in the circulation. Adverse Effects. Adverse events reported in ≥5 percent of patients treated with Tradjenta™, and more commonly than in patients treated with placebo included nasopharyngitis. Hypoglycemia was more commonly reported in patients treated with the combination of Tradjenta™ and sulfonylurea, compared with those treated with the combination of placebo and sulfonylurea. Pancreatitis was reported more often in patients randomized to linagliptin (one per 538 person-years, versus zero in 433 person-years for the comparator drug). Warnings, Precautions and Contraindications. The following warnings and precautions are listed. • Use with an insulin secretagogue (e.g., sulfonylurea): The clinician should consider lowering the dose of the insulin secretagogue to reduce the risk of hypoglycemia. • There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Tradjenta™ or any other
antidiabetic drug. The only contraindication to use is a history of hypersensitivity reactions to linagliptin, such as urticaria, angioedema or bronchial hyperactivity. Drug Interactions. The efficacy of Tradjenta™ may be reduced when administered in combination with a P-glycoprotein/CYP3A4 inducer (e.g., rifampin). Use of alternative treatments is strongly recommended. Dosage and Availability. The recommended dose is 5 mg once daily, taken with or without food. Tradjenta™ is available as tablets containing 5 mg linagliptin. Patient Information. Excerpts of the FDA-approved Patient Information are shown in Table 4.
Overview and Summary
This lesson describes three newlyapproved drugs to treat a variety of afflictions. The drugs should offer renewed hope to persons being treated for these disease states.
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 0129-0000-12-003-H01-P Release date: 3-15-12 Expiration date: 3-15-15
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 New Drugs: Nulojix, Potiga and Tradjenta 1. Belatacept is a more potent, second-generation modification of: a. abatacept. c. alanzacept. b. abetacept. d. alenzacept. 2. Compared to its parent compound, Nulojix® has a 10fold enhanced binding affinity to: a. CD82. c. CD86. b. CD84. d. CD88. 3. Nulojix® should only be used in persons who have antibodies indicating a previous infection with: a. herpes zoster virus. c. hepatitis C virus. b. Epstein-Barr virus. d. Guillain-Barré virus. 4. Patients receiving Nulojix® have an increased risk of infection and cancer, especially: a. kidney and lung. c. ovarian or prostate. b. liver and myeloma. d. skin and lymphoma. 5. Belatacept inhibits the production of interferon: a. alpha. c. delta. b. beta. d. gamma. 6. Post-Transplant Lymphoproliferative Disorder predominantly involves the: a. CNS. b. CVS. 7. There have been reports of increased risk of all of the following types of infections with the use of Nulojix® EXCEPT: a. fungal. c. spirochetal. b. protozoal. d. viral.
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] 6. [a] [d] 7. [a] [d] 8. [a] [d] 9. [a] [d] 10. [a]
[b] [b] [c] [d] [b] [c] [d] [b] [c] [d] [b]
11. [a] 12. [a] 13. [a] 14. [a] 15. [a]
[b] [c] [d] [b] [b] [b] [b] [c] [d]
I am enclosing $5 for this month’s quiz made payable to: Ohio Pharmacists Association. 1. Rate this lesson: (Excellent) 5 4 3 2 1 (Poor) 2. Did it meet each of its objectives? yes no If no, list any unmet_______________________________ 3. Was the content balanced and without commercial bias? yes 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.
Program 0129-0000-12-003-H01-P 0.15 CEU
Name________________________________________________ Address_____________________________________________ City, State, Zip______________________________________ Email_______________________________________________ NABP e-Profile ID*__________________________________ *Obtain NABP e-Profile number at www.MyCPEmonitor.net.
Return quiz and payment (check or money order) to Correspondence Course, OPA, 2674 Federated Blvd, Columbus, OH 43235-4990
8. Which of the following drugs require that a Medication Guide be dispensed with it? a. Potiga™ and Tradjenta™ b. Nulojix® and Potiga™ c. Tradjenta™ and Nulojix® d. Nulojix®, Potiga™ and Tradjenta™ 9. Potiga™ is the first opener of which of the following types of neuronal channels? a. Calcium c. Potassium b. Magnesium d. Sodium 10. Ezogabine acts as an anticonvulsant by reducing excitability through the stabilization of the neuronal channels above in a(n): a. closed position. b. open position. 11. The optimal effective daily dosage of Potiga™ is: a. 100-200 mg. c. 400-800 mg. b. 200-400 mg. d. 600-1200 mg. 12. Tradjenta™ is indicated for the treatment of type 2 diabetes. a. True b. False 13. The extract from the intestinal mucosa that produces hypoglycemia without inducing exocrine secretion is referred to as intrinsic factor. a. True b. False 14. GLP-1 is a peptide expressed in pancreatic: a. alpha cells. b. beta cells. 15. Linagliptin is a potent inhibitor of: a. DPP-1. c. DPP-3. b. DPP-2. d. DPP-4.
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2011 - 2012 GPhA BOARD OF DIRECTORS
The Georgia Pharmacy Journal
Dale Coker Chairman of the Board Jack Dunn President Robert Hatton President-Elect Pam Marquess First Vice President Bobby Moody Second Vice President Robert Bowles State At Large Hugh Chancy State At Large Keith Herist State At Large Eddie Madden State At Large Jonathan Marquess State At Large Tim Short State At Large Richard Smith State At Large Christine Somers 1st Region President Fred Sharpe 2nd Region President Renee Adamson 3rd Region President Amanda Gaddy 4th Region President Julie Bierster 5th Region President Ashley Faulk 6th Region President Amanda McCall 7th Region President 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 Sukh Sarao UGA Faculty Rep. Negin Sovaidi ASP Mercer University Rep. Annie Tran ASP South University Rep. David Bray ASP UGA Rep. Jim Bracewell Executive Vice President
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Introducing the GPhA/UBS Wealth Management Program UBS has agreed to provide all members of the Georgia Pharmacy Association with exclusive access to financial services resources through the Wile Consulting Group. This new group relationship enables members to leverage the vast scale of products and services at UBS. With more than 100 years of financial services experience, The Wile Consulting Group at UBS has been recognized as one of Barron’s Top 1,000 Financial Advisors in the country. The Wile Consulting Group is the endorsed wealth management provider for the Georgia Dental Association and also PriceWaterhouseCoopers Southern Division. They will replicate these same offerings to the GPhA. Member benefits include – Complimentary financial planning (a $5k–10k value) – Brand new 401(k) retirement savings plan designed exclusively for GPhA members at a group discount rate – Advisory and investment program offered at group discount rate – Retirement planning guidance, including a retirement income replacement system – Lending capabilities with competitive interest rates – Free access to UBS global investment research
Harris Gignilliat, CRPS® Vice President–Investments 3455 Peachtree Road NE, Suite 1700 Atlanta, GA 30326 404-760-3301 firstname.lastname@example.org ubs.com/team/wile
Chartered Retirement Plans SpecialistSM and CRPS® are registered service marks of the College for Financial Planning®. Neither UBS Financial Services Inc. nor any of its employees provides legal or tax advice. You should consult with your personal legal or tax advisor regarding your personal circumstances. As a firm providing wealth management services to clients, we offer both investment advisory and brokerage services. These services are separate and distinct, differ in material ways and are governed by different laws and separate contracts. For more information on the distinctions between our brokerage and investment advisory services, please speak with your Financial Advisor, the Wile Consulting Group, or visit our website at ubs.com/workingwithus. Financial Planning services are provided in our capacity as a registered investment adviser. As a firm providing wealth management services to clients in the U.S., we offer both investment advisory and brokerage services. These services are separate and distinct, differ in material ways and are governed by different laws and separate contracts. Note to the User: FINRA (NASD) requires that the prospectus offer legend (the first paragraph below) be in a font size that is at least the same size as that used in the main text of the marketing piece and in a different print style, such as bold or italic type. Once this disclosure (the prospectus offer legend) is used in any public facing materials, the materials are subject to filing with FINRA (NASD) by a Series 24 Principal. UBS Financial Services Inc. is a subsidiary of UBS AG. ©2011 UBS Financial Services Inc. All rights reserved. Member SIPC. 7.00_8.5x8.75_AX0712_GigH.2