Volume 35, Number 6
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Content/Features Departments
feature articles 7
9 10 12 13 14 31
GPhA Advocacy Update from Washington, D.C.
8
AIP Convention Events
11
Bruce Broadrick in Action as Former PharmPAC
GPhA Advocacy Pharm PAC Members Pharm PAC Contribution Form GPhA New Members GPhA News GPhA Board of Directors
Chairman
Advertisers
14
Bruce Broadrick: Family Man, Getting Ready to Run,
Candidate, GA State House of Representatives District 4
15
Exploring the Nearest Faraway Place
16
137th GPhA Convention: We’ve Got a Seat Reserved
Just for You
16
Sid Anderson Summer Internship Award
20
Election Voting
20
Update Your Online Member Profile
21
13th Annual Carlton Henderson Memorial Golf
Tournament Form
22
ARE YOUR PRESCRIPTIONS KILLING YOU?, by
author and GPhA member Armon Neel, Jr.,
Pharm.D., CGP
23
Continuing Education Article
2 Pharmacists Mutual Companies 13 Melvin M. Goldstein, P.C. 13 Logix, Inc. 17 EC Retail Studio 18 RxAllyTM 19 Meadowbrook Insurance Group 22 Michael T. Tarrant 32 UBS
columns 4
President’s Message
6
Executive Vice President’s Editorial
2012 GPhA Convention & Tradeshow Hilton Head Marriott Resort & Spa Hilton Head Island, SC July 7 - 11, 2012
View GPhA’s Calendar of Events at: www.gpha.org
The Georgia Pharmacy Journal
3
June 2012
President’s message L. Jack Dunn, Jr., R.Ph. President Georgia Pharmacy Association
Boy, what an unbelievable year it has been for me as president of GPHA.
A
Shepherd and Jim Bracewell to plan for the next legislative session. This year, since qualifying for state representatives and senators began on May 23, we took an extra step. We had a special meeting in conjunction with our May Executive Committee meeting to get a jump start on our planning for this year. Our standard legislative workshop will take place on Friday, August 23, 2012.
s I reflect on this last year, I cannot believe it is almost over. I have been privileged to travel across the United States on the behalf of GPhA. Our association has received a lot of respect from many organizations such as the National Community Pharmacy Association, the American Pharmacists Association and the many state pharmacy associations. I have so many people to thank as president of this great organization.
I want to remind you that GPhA not only works to support great legislation to advance pharmacy, we work equally as hard to defeat legislation that is harmful to pharmacy. Case in point: a bill was introduced that would lump the Board of Pharmacy in with hairdressers, electricians and plumbers. While those are all honorable professions, they have nothing in common with a highly regulated healthcare profession like pharmacy. This bill was defeated largely in part to the strong advocacy efforts of the Georgia Pharmacy Association and its outreach in the General Assembly.
Beginning with the man at top of this organization, our CEO, Jim Bracewell, is a true ambassador for pharmacy. As I have traveled from state to state, Jim Bracewell’s name is always brought up as one of the top leaders in the profession of pharmacy. Thank you, Jim, for the relationships you have developed over the years to make our association prosper. I would also like to thank the Executive Committee for the vital input they provided over the past four years. I served with Presidents Sharon Sherrer, Robert Bowles, Eddie Madden and Dale Coker, and current Executive Committee members Robert Hatton, Pam Marquess and Bobby Moody. In 2010, President Eddie Madden led the development of a GPhA strategic plan for advocacy and membership. Today, the executive committee reviews that plan every month and tracks how our organization’s progress in reaching our goals.
For GPhA to further enhance its legislative program, we must have a strong Pharm PAC, of which Chairman Eddie Madden is an excellent leader. Eddie, a former State Senator, knows the ins and outs of the legislative process. He has constantly reminded us we must have sufficient money in our political action committee program for our advocacy program to work. Under his guidance, we have increased our fundraising for next year’s legislative session. Thank you, Eddie Madden, for keeping our focus on this valuable program.
Our advocacy program has had another banner year. Under the guidance of Andy Freeman and Government Affairs Chairman Eddie Madden, they developed effective lobbying efforts to advance pharmacy. Each year we gather with GSHP, the Board of Pharmacy, the GPhA Executive Committee, our pharmacist legislators, and our staff of Andy Freeman, Jeff Lurey, Cindy
The Georgia Pharmacy Journal
While I am talking about the legislative process, let’s remember the great VIP Legislative Day this past February 9, 2012. The event began with music provided by Ruby Red’s Dixie Land
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June 2012
Band. Insurance Commissioner Ralph Hudgens, Attorney General Sam Olens and State Representative Tom Weldon, our GPhA Legislator of the Year, addressed over 300 attendees at the event. This year’s VIP Day had the largest pharmacist participation in its history. It roused our spirits to see the steps in the capitol rotunda overflowing with pharmacists and students of pharmacy. There were so many pharmacists that we had members extending up both sides of the corridor to the second floor. It was very impressive to see everyone come together and speak up for their profession. I would also like to thank another important committee in our organization for its hard work this year. The Bylaws Committee had a lot to consider and put many hours of thought in their 2011-2012 yearly report. As the world constantly changes, the bylaws must be reviewed on a consistent basis. John Sherrer, Sharon Sherrer, Andy Rogers, Susan Miller and David Gamadanis spent countless hours addressing those changes. As a result, our constitutions and bylaws will be updated so our organization can adapt to the future. Another important entity of our association is the Georgia Pharmacy Foundation. The Foundation, through the leadership of Chairman John Sherrer and its board, has funded scholarships for deserving students of pharmacy across our state. At the annual convention each year, the Foundation raises money for scholarships through the Carlton Henderson Golf Tournament. In the spring, the Foundation puts together an annual New Practitioners Leadership Conference for pharmacists in their first ten years of practice. This past year, 17 young pharmacists came together at Lake Lanier Island for this program. These 17 people were
The Georgia Pharmacy Journal
tasked to look at the GPHA website and to help identify new measures of communicating with other young pharmacists. This program constantly identifies young people who have leadership potential with the Georgia Pharmacy Association. As a result of this program, many executive committee members, region presidents, and academy chairs have come out of this program. Thanks again, John, for your outstanding leadership of the Georgia Pharmacy Foundation.
presidency has been a blessing because I have so many friends who have lifted and guided me through this incredible journey. Some four years ago at the spring regional meeting, four of my friends came up to me to ask me to think about running for second vice president of GPHA. Bill Prather, Tim Short, Dale Coker and Robert Bowles are the members that encouraged me to pursue my lifelong dream to be President of an organization of this
Our annual convention and tradeshow in 2011 was a credit to the leadership of President Dale Coker, and this year we will seek to have an equally productive meeting and provide some exceptional continuing education. We have invited Rear Admiral Scott Giberson as our keynote speaker on Sunday, July 8. Scott is recognized for his work on the recent position paper issued by Surgeon General Regena Benjamin identifying the future role of pharmacist in the nation’s healthcare. I am looking forward to seeing each of you at the Marriott Hotel on Hilton Head Island, SC next month.
magnitude. Thanks to these four men for
While attending fall regional meetings last year, many association members asked the Executive Committee to consider a meeting with more continuing education programs. The Executive Committee decided to offer a super-regional meeting in Atlanta this past spring, which provided continuing education to pharmacists throughout the state. This program was well received by the pharmacists in attendance. It will be looked at thoroughly by the Executive Committee, the GPhA Board and the Region Presidents to consider what will best serve all the members of the association in all areas of the state.
many friends and learned so much while
In closing, this past year has been a lot of fun and a lot of work. Every day of my
will never forget this moment.
5
giving me the insight to believe in myself. I also want to thank those past presidents whom I called on for advice during the year. John Sherrer, Hugh Chancy, Richard Smith, Jonathan Marques, Eddie Madden, Robert Bowles and Sharon Sherrer were always a great help whenever I needed them. I also want to thank the Board of Directors, all the committee members, GPhA staff and the Executive Committee for their continued support in helping me lead this organization. I have made so traveling all across the state and country. Your association is highly thought of across the land and you have a highly talented executive committee going forward. It has been my pleasure to serve as your president. I will continue to be involved in GPhA because I know it is imperative to the success of our profession. It will be a pleasure to turn this organization over to a friend and highly dedicated pharmacist, Robert Hatton. God Bless you all. I
June 2012
Executive Vice President’s Editorial Jim Bracewell Executive Vice President / CEO Georgia Pharmacy Association
“Red,
White &
Bruce”
Do you like the way that phrase sounds? I loved it the first time I heard it, for several reasons. 1. 2. 3. 4. 5. 6. 7.
Bruce is a lifelong pharmacist Bruce is a longtime member of the Georgia Pharmacy Association Bruce is a former GPhA Region President Bruce is a former GPhA President Bruce is a former GPhA Pharm PAC Chairman Bruce is a long time contributor to the Georgia Pharmacy Foundation Bruce is willing to submit his name as a candidate for the GA House of Representatives
Bruce Broadrick is a pharmacist that has given so much back to his profession and his community. Now he is offering to give back to his state. While I am impressed by the number of people that turn out to risk their life to vote in Iraq, I am appalled at how few of my fellow Americans will even register to vote. I am saddened by how so few Georgia pharmacists will advocate with our elected officials to make the practice of pharmacy all it can be in our state. When an outstanding man like Bruce steps forward and says he’s willing to put his name, his time and his energy into serving his fellow citizens and pharmacists by running for state representative, I get really excited. It is no wonder I love the phrase “Red, White and Bruce.” Bruce needs you to WIN this political race to put him in the State House of Representatives. If you live in his House District 4 in Dalton, then you can vote for him, put yard signs up for him and work in his campaign. But what if you are not a registered voter in House District 4? What can you do? The easiest thing you can do is write a check right now to help him pay for the campaign. See this issue’s story on Bruce for his mailing address. You can also send me your name and volunteer to call to a pharmacist that is in House District 4 and ask them to vote for Bruce and to get their spouse, parents and neighbors to vote for Bruce. This effort is small, but it is important and it works.. It cost nothing but a little of your time. Bruce is ready to change his life to help us. What are you ready to do to help him win this race? The race is on. Winning is up to us. If you want a brighter future, now is your opportunity. There’s no better time than this. I am waiting to hear from you. The election is Tuesday, July 31st. There is no time to waste; today is the day for action. I am “Red, White & Bruce.” What color are you?
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June 2012
G P h A NE W S
“This year’s ADVOCACY visits to our Senators and Congressmen was one of the most productive in several years. They were sincerely interested in our views on improving the country’s healthcare. Pharmacy has many of the answers to our healthcare problems. We just need to tell our story, honestly and sincerely to our congressional leaders. We saw the results with their support of our bills in Congress.” Hugh Chancy, NCPA’s Vice President
In early May, hundreds of community pharmacists from around the country went to Washington, D.C. to attend NCPA’s annual legislative conference. Among the conference attendees were Hugh Chancy, GPhA 2nd Vice President Bobby Moody, John Sherrer, Sharon Sherrer, Larry Braden, GPhA Executive Vice President Jim Bracewell and GPhA Director of Government Affairs Andy Freeman.
L to R: Bobby Moody, Rep. Austin Scott, Hugh, Chancey, Jim Bracewell and Andy Freeman.
L to R: Andy Freeman, Bobby Moody, Rep. Sanford Bishop.
During the Legislative Conference attendeesheard from a bevy of congressional and federal officials during speeches and panel discussions. In addition there were panels on the Federal Trade Commission’s PBM-related decisions, efforts to combat pharmacy crimes and the challenges facing long-term care providers. GPhA members met with their Congressmen and Senators to get them to join the Congressional Pharmacy caucus and to cosign onto various pieces of Federal legislation. The legislation included the Pharmacy Competition and Consumer Choice Act (S. 1058/H.R. 1971), a bill would result in greater choice of pharmacies for consumers. It would also provide greater transparency of PBMS and create fair standards for PBM audits. GPhA members also discussed the Medicare Access to Diabetes Supplies Act (HR 1936), the Preserving Our Hometown Independent Pharmacies Act of 2011 (HR 1946) and other issues with their Congressmen and staff. Many Congressmen pledged their support to the legislation including Rep. Phil Gingrey, who co-signed onto HR 1971 last week due to our request, and Rep. Austin Scott, who has already co-signed onto all of these important pharmacy bills and agreed to write a letter to the Georgia Congressional delegation asking them to join him in signing these pro-pharmacy bills. Meeting with Georgia’s Congressional Delegation while they are in DC is important but it is also important to meet with them when they are in their District. I know that when Congressmen come home this year to ask for your vote that I can count on you to ask them for theirs on issues of importance to pharmacy.
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June 2012
AI P n e w s
GPhA’s 137h Annual Convention
July 7-11, 2012 Hilton Head Marriott Resort & Spa, Hilton Head, SC
AIP Convention Events Sunday-July 8, 2012
7:00am-7:45am Compounding Pharmacy Section Breakfast
For ALL AIP’s CPS Members—By Invitation Only
8:00am—9:00 am CE for Compounders
9:15 am—10:15 am AIP CE program
10:15 am—10:30 am Break
10:30am—11:30 am AIP CE Program
11:45 am—1:00 pm AIP Wholesaler Appreciation Luncheon & Business Meeting
Registration for Luncheon:
(For Planning Purposes Please Fill Out and Return )
Member’s Name:_______________________________________ Nickname________________________ Names of Staff/Guests: ___________________________________________________________________ Pharmacy Name:_______________________________________________________________________ Address:______________________________________________________________________________ ______________________________________________________________________________________
PLEASE FAX BACK TO (404) 237-8435
E-mail Address (Please Print):_____________________________________________________________
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June 2012
G P h A AD V O C A C Y Andy Freeman Director of Government Affairs Georgia Pharmacy Association
GPhA Member Bruce Broadrick: Candidate, GA State House of Representatives District 4 For many years, Bruce Broadrick focused on serving others. When he graduated in 1976 from the University of Georgia with a degree in pharmacy, he went back to Dalton and took over his dad’s business, Frank’s Pharmacy, which he sold in 2009. Bruce continues to practice pharmacy today as a staff pharmacist for Walgreens.
practice of pharmacy in delivering diabetes care to the patients of the GPhA project in the Dalton area. He has seen the improved health outcomes and reduced cost from the proper use of prescription drugs and the pharmacist management of the chronic diseases. Bruce will be an asset to state government in the House of Representatives.”
Bruce worked his way up through the leadership of GPhA and served as President from 1996-1997. He was recognized for his leadership in his community by GPhA in 1999 when he was selected as the recipient of for the Bowl of Hygeia Community Service Award. Bruce also served for 18 years as the Chairman of the PAC because he knew of the importance of pharmacy being involved in politics.
If you would like to contribute to his campaign, you may mail contributions to: Friends of Bruce Broadrick for the House PO Box 947 Dalton, GA 30722-0947
Besides serving in leadership capacities within GPhA and the pharmacy community, Bruce has also served in various civic groups as well as local and State Boards, including the Whitfield County Board of Health, of which he is currently the Chairman. On May 23 of this year, Bruce prepared to continue serving his community by running for the State House of Representatives District 4. If elected, he will be fifth pharmacist currently serving in the Georgia General Assembly. GPhA Executive Vice President Jim Bracewell stated “He is excited about the prospect of having a pharmacist of Broadrick’s practice background in the State House. Bruce brings the knowledge of hands on
The Georgia Pharmacy Journal
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June 2012
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 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.
The Georgia Pharmacy Journal
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
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 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 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
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Ola Reffell, R.Ph. Edward Franklin Reynolds, R.Ph. 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. Walter Alan White, 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. 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. William C. Thompson, R.Ph. Carrie-Anne Wilson Sharon B. Zerillo, R.Ph.
June 2012
PharmPAC 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. 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. Susan M Kane, 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.
Christopher Brown Painter, R.Ph. Whitney B. Pickette, R.Ph. Negin Sovaidi Charles Iverson Storey III, R.Ph. 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.
Bruce Broadrick in Action as Former PharmPAC Chairman Candidate, GA State House of Representatives District 4
Broadrick shows support of PharmPAC by sponsoring hole at convention golf tournament.
The Georgia Pharmacy Journal
L to R: Rep. Ron Stephens, Bruce Broadrick (former PAC Chairman), and former State Rep. and Pharmacist David Graves.
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June 2012
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 our new PharmPAC members!
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June 2012
G P h A NE W M e m b e r S
Welcome New GPhA Members! GPhA is pleased to welcome the following new members:
Individual Pharmacist Members: Catherine Bourg, Pharm.D. - Athens Fredrick H. Burlakoff, R.Ph. – Flowery Branch Debra Mullin, R.Ph. - Alpharetta Jerry E. Teal, R.Ph. - Carrollton First Year Active Pharmacist Member: Kristen Cartledge, Pharm.D. - Ringgold Paul S. Cubita, Pharm.D. - Savannah Jacob Hampton, Pharm.D. - Ringgold Jennifer C. Omenukor, Pharm.D.
Joint Active Pharmacist Members: Michelle Wimpey, Pharm.D. - Martinez Nicholas Wimpey, Pharm.D. - Martinez Pharmacy Technician Members: Pedro Almonte Valentin, C.Ph.T. - Columbus Student Members: Kacey L. Beck - Savannah LaShayna Ruffin Olojo - Atlanta Mallory Jarriel - Darien
Second Year Active Pharmacist Member: Cecilia Harvey, Pharm.D. – Warner Robins
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
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 n Former Administrative Law Judge for the Office of State Administrative Hearings
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June 2012
G P h A NE W S
Bruce Broadrick: Family man, getting ready to run Candidate, GA State House of Representatives District 4
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June 2012
G P h A NE W S
Exploring the Nearest Faraway Place GPhA reconnects with one of Georgia oldest hidden gems, Jekyll Island Last month the Jekyll Island Convention Center opened its doors for the first of many events to come. Held on a beautiful Saturday morning, the convention center was filled with excitement as graduates of Georgia Coastal College and their families celebrated one another’s achievements. Looking back, the significance of this inaugural event could not have been more fitting. It was clear the excited feelings and bright outlook for the future was shared not only amongst the young graduates but all of Jekyll Island as they embark on so many new adventures. Construction of the Jekyll Island Convention Center started in early 2011 and was completed this May. The oceanfront convention center boosts 78, 0000 square feet of flexible function space and can accommodate groups up to 4,000. The center is also expected to achieve Leed Silver Certification and has invested in a number of efficiency initiatives such as implementing a rainwater collection system, creating preferred parking for low emitting and energy efficient vehicles and more. The Jekyll Island Authority, Jekyll’s management division, has been spearheading the revitalization process and shares that the completion of the convention center is only the start. Soon the center will have 2 new neighbors, a 135-room Hyatt Place in 2013 and 200-room Westin opening in 2014. These properties will join the 7 additional properties located on the island; including the beautiful and historic Jekyll Island Club Hotel. A beach village is also scheduled to open in summer 2013 and will include a number of restaurants, shops and entertainment options. Jekyll Island Convention Center held a Ribbon Cutting Ceremony on May 20th with Governor Nathan Deal in attendance.The Convention Center also welcomed its first conference, Georgia Rural Water Association, May 1922, 2012. Are you as excited about the changes on Jekyll Island as we are? What are your thoughts on the new Convention Center? We’d love to hear from you!
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June 2012
GPhA news
Your seat is reserved for you here....
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5 Pharmacy Students Receive $25,000 for AIP’s Sid Anderson Summer Internship Award The Board of Directors of the Academy of Independent Pharmacy (AIP) announced at their Spring Meeting the 5 students who would each receive a $5000 scholarship for a 10 week summer internship at an AIP member’s pharmacy during the summer. The internship experience focuses on the “business side” of operating a pharmacy. It is the intent of the scholarship to foster the entrepreneurial spirit in pharmacy students that have a strong desire to pursue a career in independent pharmacy. The experience will teach the student how to run a business. This is the first year that AIP has awarded more than 2 scholarships. AIP Chairman Ira Katz remarked “The students that applied this year were all outstanding candidates. In fact, they were so good we decided to award all 5 of the students who applied.” Three of the students are from UGA and two are from Mercer. The names of the students and their preceptors are: Lou Woods (Mercer) – Concord Pharmacy Rebecca Wilson (Mercer) – East Marietta Drugs Cassie Hayes (UGA) – Hawthorne Drugs Amanda Young (UGA) – Horton’s Drug Store Zach Thellman (UGA) – Medical Park Pharmacy
A Letter From A Member
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Above: Lou Woods and Rebecca Wilson Below: Zach Thellman, Cassie Hayes and Amanda Young
G P h A NE W S
and here.
137th GPhA Convention
Hilton Head Island Marriott Resort & Spa Hilton Head, SC July 7-11, 2012
Register now! www.gpha.org
The Georgia Pharmacy Journal
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June 2012
o t r o w ck o H
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June 2012
GPhA News
Don’t Forget to Vote!
June & July GPhA 2012 Elections First Vice President & Second Vice President June 4, 2012 PAPER BALLOT DEADLINE Reminder emails will be sent out on a weekly basis to JUNE 25, 2012! GPhA members who have not voted. If you prefer to use a paper ballot for the election, June 25, 2012 call Tei Muhammad toll free at 888-871-5590 and she Deadline for all mail-in ballots. (All mailed ballots must will send you a ballot. Your paper ballot must be post be post-marked by this date.) marked no later than June 25, 2012 to be counted in this year’s election. July 10, 2012 Polls close at Noon. Conduct Tellers Committee Meeting. July 10, 2012 Installation of new officers.
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June 2012
GPhF News 13th Annual Carlton Henderson Memorial Golf Tournament Hilton Head Marriott Resort & Spa Palmetto Dunes Robert Trent Jones Golf Course Date: Monday, July 9, 2012 Tee Time: 1:00pm Lunch provided at 12:15pm at the Clubhouse Registrations limited to the first 100 participants Proceeds provide Scholarships to Student Pharacists
Since its inception, the Foundation has given many scholarships to student pharmacists. The Foundation Board of Directors is committeed to offering more scholarships to deserving students. In order to increase the number and value of the scholarships, the Foundation must raise additional funds. Please show your support by participating in the 13th Annual Carlton Henderson Memorial Golf Tournament. Thank you! John T. Sherrer, R.Ph., Foundation Chairman.
2010-11 Scholarship Recipients Regina Baird Scholarships Jill Augustine (Mercer) Deepa Patel (Mercer) Kyle Edwards (South) Ashley Wilkins (South) Chelsea Clark (UGA) Blessing Adelfila (UGA)
Neil Pruitt, Sr. Entrepreneurial Scholarships Austin Tull (Mercer) Kelly Hancock (South) Cassie Hayes (UGA)
Carlton Henderson Scholarships Sarah Baggett (Mercer) Brantley Thompson (South) Sarah Phillips( (UGA)
1st Place: UGA 2nd Place: South 3rd Place: Mercer
Brown Bag Patient Counseling Competition-ASP Chapters
Sponsorship Opportunities:
Friend of the Foundation $1,330 Hole Sponsorship $500 Beverage Cart $500 Lunch $500 Tee Gift (or 100 items for gift bag) $500 Awards $500 Ball $500 And more are available
Name:________________________________________________________________________________________________________ Company______________________________________________________________________________________________________ Address________________________________________________________________________________________________________ City ________________________________________________________________State_________________Zip__________________ Phone____________________Fax____________________Email_________________________________________________________
PAYMENT: Each player’s registration fee includes: 2 mulligans, greens fee, golf cart, warm-up range, lunch, drink tickets and bag handling at golf course. [ ] Individual Player - $220 [ ] Foursome - $880 [ ] Friend of the Foundation - $1,330 (includes foursome and Hole sponsorship, $50 savings) [ ] Sponsorship (identify which one)____________________________________________ If Sponsor, list name as it should appear on signage_________________________________ [ ] I cannot participate, but want to support the Foundation [501(c)(3)] and student pharmacists with a tax deductible gift as permitted by law to the Georgia Pharmacy Foundation Scholarship Fund. Enclosed is a check for $___________ or Bill my credit card for $___________ (AmEx Visa M/C Discover) Card #_________________________________________________________________________________Security #____________Exp. Date____________ Signature ______________________________________________________________________________ Today’s Date_____________________________ Name as Appears on Card _________________________________________________________________________________________________________ Card Billing Address __________________________________________________City__________________________State________ Zip_______________ (If different from address shown above) Please mail to: Georgia Pharmacy Foundation Golf Tournament 50 Lenox Pointe, NE, Atlanta, GA 30324
The Georgia Pharmacy Journal 21
June 2012
GPhA News
ARE YOUR PRESCRIPTIONS KILLING YOU?
How to Prevent Dangerous Interactions, Avoid Deadly Side Effects, and Be Healthier with Fewer Drugs by Armon Neel, Jr., Pharm.D., CGP and Bill Hogan
Prescription drugs are a leading cause of death in America, right behind heart disease, cancer, and stroke, despite
being widely trusted and defended by doctors. They kill an estimated 100,000 people a year and severely harm, to the point of requiring hospitalization, another 1.5 million. To make matters worse, the debilitating effects of prescription drugs are routinely misdiagnosed as disease symptoms or, in those most vulnerable, dismissed as natural signs of aging. People 65 and older account for more than a third of all reported adverse drug reactions.
“TOO MANY OLDER AMERICANS ARE BEING PRESCRIBED DRUGS THEIR BODIES CAN’T HANDLE, AND AS A RESULT THEY’RE GETTING SICK AND DYING SOONER THAN THEY SHOULD,”declares acclaimed pharmacist and trailblazing activist, Armon Neel, Jr., PharmD, CGP. His assertion is based on rigorous research into drug therapies and four
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The Georgia Pharmacy Journal 22
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June 2012
G P h A C ONTINUING EDU C ATION
continuing education for pharmacists Volume XXX, No. 4
FDA Safety Warnings and Prescribing Updates: Simvastatin, Acetaminophen, Ondansetron, and Dronedarone Mona T. Thompson, R.Ph., PharmD Dr. Thompson has no relevant financial relationships to disclose.
Goal. The goal of this lesson is to provide a review of significant U.S. Food and Drug Administration (FDA) safety warnings and associated prescribing updates that were recently issued regarding simvastatin, acetaminophen, ondansetron, and dronedarone. Objectives. At the completion of this activity, the participant will be able to: 1. demonstrate an understanding of the safety warnings and associated prescribing changes, if applicable, issued for each of the entities discussed; 2. determine the patient population at risk for adverse events in relation to the safety warnings for each of the entities discussed; and 3. identify fundamental patient counseling points secondary to the safety warnings and associated prescribing changes, if applicable, for the entities discussed.
Simvastatin
Simvastatin is an HMG-CoA reductase inhibitor (“statin”) that was initially approved in 1991 as an adjunct to diet to reduce the levels of low-density lipoprotein (LDL) or “bad” cholesterol. It is marketed as Zocor® or in combination with ezetimibe as Vytorin® by Merck. Abbott markets Simcor® which contains simvastatin and extended release niacin. While simvastatin-
containing entity labeling has always carried a risk of muscle injury (myopathy), FDA issued a drug safety communication in June 2011 making several restrictions, contraindications, and dose limitations for simvastatin to reduce the risk of muscle injury based on the agency’s ongoing safety review of therapy with high-dose simvastatin. These recommendations are currently reflected in the updated product information leaflets for all products. In 2010 nearly 30 million prescriptions of simvastatin were dispensed from one generic manufacturer alone, ranking it 7th among the Top 200 medications dispensed. It addition, in 2010 it was estimated that more than two million Americans were prescribed what is now considered an unsafe dose of simvastatin. Among the studies that led to the new FDA recommendations was the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH). The study was a seven-year, randomized, double-blind clinical trial that compared the efficacy and safety of simvastatin 80mg to simvastatin 20mg, with or without vitamin B12 and folate in patients who had survived a myocardial infarction. In SEARCH, 53 patients (1 percent) in the 80mg group versus two (0.03 percent) in the 20mg group developed myopathy, which was defined as unexplained muscle weakness or pain with a serum creatine kinase (CK) greater than 10 times the upper normal limit. CK is a muscle enzyme which becomes elevated secondary
to muscle injury. Furthermore, 22 patients (0.4 percent) in the 80mg group versus zero patients in the 20mg group developed rhabdomyolysis. Rhabdomyolysis was defined as unexplained muscle weakness or pain with serum CK >40 times the upper normal limit. This adverse event can range in severity from asymptomatic elevation of muscle enzymes to life threatening electrolyte imbalances, acute renal failure, multi-organ failure syndrome, and death. The greatest risk of developing myopathy was observed in the first year of simvastatin 80mg daily therapy. In addition, an increased risk of myopathy was seen in patients taking simvastatin 80mg in combination with amiodarone. Secondary to SEARCH and other safety data, the revised recommendation states that the previous highest approved dose of simvastatin 80mg should only be used in patients who have been taking this dose for 12 months or more without evidence of myopathy. Patients already taking lower dosages of the drug should not be titrated to the 80mg dose. If additional LDL reduction is necessary, alternate therapy is recommended. Atorvastatin 40mg and rosuvastatin 10mg are effective in reducing LDL levels by 45 to 50 percent which is comparable to simvastatin 80mg. Table 1 compares the relative LDL-lowering efficacy of available statin agents at all doses. Myopathy is often the result of simvastatin used in combination with certain drugs including CYP3A4 inhibitors. Therefore,
Table 1 Relative LDL-lowering efficacy of statin agents** Atorvastatin Fluvastatin Pitavastatin 10 mg 20 mg 40 mg 80 mg
40 mg 80 mg
1 mg 2 mg 4 mg
Lovastatin Pravastatin Rosuvastatin
Simvastatin
20 mg 40 mg 80 mg
10 mg 20 mg 40 mg 80 mg
20 mg 40 mg 80 mg
**Adapted from FDA drug safety communication last updated December 15, 2011
the second part of the FDA safety communication resulted in a new simvastatin label with more stringent drug interaction and drug-drug dosing limits. Simvastatin is now contraindicated with itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, gemfibrozil, cyclosporine, and danazol. The 10mg dose should not be exceeded in patients taking verapamil or dil-
Table 2 Simvastatin Patient Safety Counseling Points • All patients starting simvastatincontaining entities should be advised of the risk of myopathy, and should be told to report promptly any unexplained muscle pain, tenderness, or weakness. • Patients using the 80mg dose should be informed of the greater risk of myopathy. • Patients should be informed that there are certain types of medications that should not be taken in combination with simvastatin, and urged to inform providers when a new medication is prescribed or when the dose of an existing medication is increased. • Patients should be advised to report any symptoms that may indicate liver injury such as fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. • Women of childbearing age must use an effective method of birth control to prevent pregnancy while using simvastatin. If they become pregnant, simvastatin therapy should be discontinued immediately. Women who are breastfeeding should not take simvastatin.
5 mg 10 mg 20 mg 40 mg
tiazem, while the 20mg dose should not be exceeded with amlodipine, amiodarone, or ranolazine. Also, large quantities of grapefruit juice should be avoided (>1 quart per day). It is important to note that several of these medications are prescribed together for the treatment of various cardiovascular-related diseases, and healthcare providers may need to adjust therapy to avoid drug interactions. Merck launched a new website, www.simvastatininfocenter.com, with information for patients about these changes. The simvastatin label continues to issue other contraindications, warnings, precautions, and monitoring recommendations that remain consistent and are worthy of review. Simvastatin is contraindicated in patients with active liver disease (or persistent unexplained elevated hepatic transaminase levels), women who are pregnant or may become pregnant (category X), and nursing mothers. Other predisposing factors for skeletal muscle effects (myopathy and rhabdomyolysis) include advanced age (>65), female gender, renal impairment, and uncontrolled hypothyroidism. Liver function tests (liver enzymes) should be obtained prior to initiation of therapy and semiannually for the first year. More frequent monitoring is warranted for patients with elevated transaminase levels until normalization occurs. Discontinuation should occur if ALT/AST is persistently >3 times the ULN (upper limit of normal). In addition to the drug interactions listed above, fibrate products and niacin (>1gm/day) may in-
% LDL-C Reduction -30% -38% -41% -47% -55% -63%
crease the risk of adverse skeletal muscle effects. Lastly, simvastatin prolongs INR when used in combination with warfarin, rendering frequent INR monitoring when initiating or altering therapy. The most common adverse events related to therapy are: upper respiratory infections, headache, abdominal pain, constipation, and nausea. Table 2 includes safety information for simvastatin to convey to patients.
Acetaminophen
Acetaminophen or paracetamol (N-acetyl-p-aminophenol or APAP) is the most widely used analgesic and antipyretic agent in the United States and the world. It is available over-the-counter (OTC) as a 325mg and 500mg immediate release tablet, and as a 650mg extended release preparation marketed for the treatment of arthritis. It is also available in several infant and children’s formulations consisting of chewable tablets, oral suspension and elixir, as well as a component of many OTC and prescription cold and analgesic combination products. Unfortunately, its commonality and comfort with use may have led to presumed safety among Americans who are either not aware of the maximum safety dose or who do not fully comprehend the extent of harm that is associated with exceeding the safe dose. Therefore, unintentional overdosing may occur in patients who are ingesting multiple acetaminophen-containing products. Acetaminophen is not always clearly labeled as an ingredient
and the abbreviation “APAP” is sometimes used on prescription labels for medications that contain a narcotic and acetaminophen. In addition, there are various strengths and concentrations of acetaminophen formulations that are marketed for infants and children which may lead to dosing errors. The American Association of Poison Control Centers reports that acetaminophen is one of the most common pharmaceuticals associated with both unintentional and intentional poisoning and toxicity. In the United States, acetaminophen toxicity is the most common cause of acute hepatic failure, and is the second most common cause of liver failure requiring transplantation. The pathophysiology of hepatocellular damage as a result of acetaminophen toxicity is based on the production of the toxic metabolite of acetaminophen called N-acetylp-benzoquinone imine (NAPQI). NAPQI has a short half-life and, once it’s conjugated with glutathione, is renally excreted. However, under conditions of an acute acetaminophen overdose or when the maximum dose is exceeded over a prolonged period of time, NAPQI is produced in excess of the available glutathione levels. Hence, NAPQI covalently binds to hepatocellular proteins initiating a cascade of oxidative damage, mitochondrial dysfunction, hepatocellular injury, and liver necrosis. Toxicity is associated with a single ingested dose of 150mg/kg or approximately 7 to 10 grams APAP in adults. Toxicity may occur at lower doses in circumstances of chronic alcohol use, diminished nutritional status, and viral illness with dehydration. When dosing recommendations are adhered to, the risk of hepatotoxicity is extremely small. Fortunately, N-acetylcysteine (NAC) is an available antidote. While it is maximally hepatoprotective when given within eight hours of an acute APAP ingestion, it has been shown to decrease mortality rates in late-presenting patients
with fulminant hepatic failure. NAC may be administered orally or intravenously. Among its several protective mechanisms, it is a precursor of glutathione and, thus, increases the concentration of glutathione available for the conjugation of NAPQI. In both 2009 and 2011, FDA announced required labeling changes for acetaminophen-containing products in an attempt to reduce the number of misadventures associated with its use. In April of 2009, FDA announced that it would require that by April 2010, the ingredient “acetaminophen” must be clearly identifiable on the packaging so that consumers can easily recognize the active ingredient for all OTC preparations. Second, all OTC labels now contain warnings that highlight the potential for liver toxicity and warn consumers against using more than the recommended dose of acetaminophen, using multiple products that contain acetaminophen, and for consuming moderate amounts of alcohol along with acetaminophen. In January 2011, FDA announced that it was asking manufacturers of oral prescription acetaminophen combination products (not intravenous) to limit the maximum amount of acetaminophen in these products to 325mg per tablet, capsule, or other dosage unit. FDA provides the rationale that by limiting the amount of acetaminophen in oral prescription products per dosage unit, patients will be less likely to overdose if they mistakenly ingest too many doses. Because all oral prescription products containing acetaminophen also contain an additional analgesic (most often an opioid) and because there are no data to indicate that taking more than 325mg of APAP per dosage unit provides more pain relief, this change is not expected to greatly reduce the pain management effectiveness of these drugs. The dosage limit will not affect the dosing directions for the same products. FDA is also requiring that a
new boxed warning on the risk of severe liver injury be added to all prescription products that contain acetaminophen. Boxed warnings are FDA’s most serious warnings. Drug companies were given three years, (until January 2014) to make the necessary changes to limit the amount of acetaminophen to 325mg per dosage unit. Alternatively, they may choose to withdraw the product from the market. However, because several of these products are already available in multiple strengths, including 325mg, FDA is not anticipating that this requirement will affect patient care or the options available for pain management. In addition, FDA is asking companies to add a new warning regarding severe allergic reactions, including anaphylaxis. While rare, swelling of the face, mouth and throat, difficulty breathing, itching, and rash have been reported with APAP use. It is important to note that at the time of writing this lesson, FDA had not made any additional changes to the dosing of OTC acetaminophen products. However in the fall of 2011, McNeil Consumer Healthcare (the manufacturer of Tylenol®) revised the Extra Strength Tylenol® label. It now contains new dosing instructions lowering the maximum daily dose for the single-ingredient pain reliever from eight tablets per day (4,000mg) to six tablets per day (3,000mg). The dosing interval has also changed from two tablets every four to six hours, to two tablets every six hours. The lower maximum dose is expected to be on the labeling of Regular Strength Tylenol® sometime in 2012. The company also states that they are working closely with other manufacturers of acetaminophen products to help ensure consistency in dosing instructions. There are significant changes to liquid acetaminophen marketed for infants which were announced by FDA in December 2011. An additional concentration (160mg/5ml) is now available made to coincide
Table 3 Acetaminophen Patient Safety Counseling Points • Advise patients to continue taking their prescription pain medicine as directed. There is no immediate danger to patients who take oral prescriptions containing greater than 325mg of acetaminophen. • Counsel patients who have multiple acetaminophen-containing prescriptions about the risk of severe liver injury associated with toxicity. • Inform patients of the new dosing instructions for Extra Strength Tylenol®. • The 160mg/5ml liquid acetaminophen marketed for infants may be packaged with an oral syringe instead of a dropper. Parents and caregivers should only use the device provided with the product to measure the dose. Do not mix and match dosing devices. • Advise patients that although rare, there have been reports of severe allergic reactions with acetaminophen including swelling of the face, mouth and throat, difficulty breathing, itching, or rash.
with the concentration found in Children’s Tylenol®. This represents another effort to minimize dosing errors for parents and caregivers. The previous infant concentrations of 80mg/ml and 80mg/0.8ml will continue to be available until supplies are depleted. The new 160mg/5ml infant acetaminophen may be packaged with an oral syringe versus a dropper. Therefore, healthcare providers must advise parents and caregivers to only use the device provided with the product purchased. It is important not to mix and match measuring devices from previous bottles. Finally, dosing instructions for children as young as six months will now be included on the label of Infants’ Tylenol® and Children’s Tylenol®. FDA has drafted a downloadable PDF that may be printed and distributed to the lay public detailing some of the recent changes
made in an effort to reduce the risk of accidental acetaminophen overdosing. The document can be found at: www.fda.gov/downloads/ ForConsumers/ConsumerUpdates/ UCM239891.pdf. Patient safety information is included in Table 3.
Ondansetron (Zofran)
Ondansetron was developed and marketed by GlaxoSmithKline under the trade name Zofran®, and was initially approved by FDA in 1991. It is an antiemetic agent in the selective 5-HT3 receptor antagonist class which works by blocking the action of serotonin, a natural substance that is linked with nausea and vomiting. Current FDA-approved indications include prevention of nausea and vomiting associated with moderately to highly emetogenic cancer chemotherapy, radiotherapy, prevention of postoperative nausea and vomiting (PONV), and treatment of PONV if no prophylactic dose of ondansetron was received. It is commonly used off-label for the treatment of hyperemesis gravidarum and nausea and vomiting associated with pregnancy. It is also used off-label for treatment of nausea and vomiting associated with chemotherapy, gastroenteritis, and other disorders associated with nausea and vomiting. Zofran® is widely used because it has been found to be effective in comparative studies, is available in several different formulations (tablet, oral disintegrating tablet, oral solution, and injection), is labeled as pregnancy risk factor B, and has a low incidence of drowsiness and sedation. These advantages make it ideal for outpatient use. It can be prescribed safely in children with viral gastroenteritis while phenothiazines (i.e., promethazine, prochlorperazine) are contraindicated in children less than two years of age. Ondansetron has also become more commonly used since coming off patent due to increased affordability. In September 2011, FDA issued a drug safety communication for ondansetron indicating that it may
be associated with abnormal heart rhythms. This was issued secondary to ongoing safety reviews and has led to interim changes to the drug label. In addition, GlaxoSmithKline is being required to conduct a thorough QT study to assess the potential for the drug to prolong the QT interval. These results are expected in the summer of 2012 and may result in additional labeling changes. A long QT interval results when myocardial repolarization does not work normally. It is defined as a QT interval >470ms for postpubertal males and >480ms for postpubertal females. The syndrome can be congenital or acquired (e.g., side effect of medication, hypokalemia, hypomagnesemia). Patients with a prolonged QT interval are at risk for an arrhythmia called Torsades de pointes which can cause cardiac arrest. This is a rare arrhythmia that occurs more often in hospitalized patients who have other risk factors discussed in this lesson. The Zofran® label already contains information about the potential for QT prolongation, but this revision represents a stronger warning. The new warning states that ondansetron should be avoided in patients with congenital QT prolongation since these patients are at risk for developing Torsades de pointes. In addition, it is now recommended to conduct electrocardiogram (ECG) monitoring in patients with electrolyte abnormalities (hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or in patients taking other medications that can lead to QT prolongation. According to FDA guidelines, drug-induced prolongation of more than 10ms suggests potential for clinically significant prolongation. Various studies have been conducted which examine the effect of ondansetron on the QT interval. All three studies cited by FDA in the safety announcement are associated with intravenous administration of ondansetron. In 2008, Charbit et al conducted a study
Table 4 Ondansetron Patient Safety Counseling Points • Advise patients to contact a healthcare provider if they experience signs and symptoms of an abnormal heart rate or rhythm, such as shortness of breath, dizziness, or fainting. • Patients with the greatest risk for developing arrhythmias associated with ondansetron use include those with congenital long QT syndrome; those taking diuretics which may predispose them to hypokalemia or hypomagnesemia; and those taking other medications that lead to QT prolongation.
with 16 healthy volunteers who received 1mg of droperidol, 4mg of ondansetron, 1mg droperidol plus 4mg ondansetron, or placebo intravenously in a crossover design. Droperidol is another effective antiemetic that earned a black box warning in 2001 for its potential for proarrhythmic events related to QT prolongation. Compared with placebo, both droperidol and ondansetron significantly prolonged the QT interval. The difference was 25 +/- 8ms after droperidol which was significantly greater than 17 +/- 10ms which was measured after ondansetron. The authors concluded that both droperidol and ondansetron either alone or in combination induced significantly marked QT interval prolongation when administered at usual doses. The authors also noted that none of the participants had QT exceeding the threshold known to increase an individual’s risk of Torsades de pointes. However, this study was conducted in healthy volunteers with no other risk factors for prolongation as there otherwise would be in postoperative patients. Although ondansetron appears to be less toxic than droperidol based on this study, it should still be administered with caution in patients with a prolonged QT interval. However, a study conducted in 2005 concluded that in the postoperative setting, a situation known to prolong the QT interval
due to lower body temperature and administration of anesthesia, both droperidol and ondansetron were associated with similar clinically relevant QT interval prolongation. Caution should be taken when ondansetron is administered to treat PONV. Another study conducted by Haferman et al found that when ondansetron was used in patients with cardiovascular disease with one or more risk factors for Torsades de pointes, ondansetron did significantly increase the QT interval for up to 120 minutes after administration. The authors concluded that patients at high risk for Torsades de pointes should receive telemetry (cardiac monitoring) while on ondansetron. Alternative antiemetics that can be used to reduce the risk of QT prolongation include the selective 5-HT3 receptor antagonist, palonosetron (marketed as Aloxi®), which has similar indications, or prochlorperazine, a phenothiazine, used for the general treatment of nausea and vomiting. Zofran® is dosed according to weight in children up to 4mg per dose. Children 12 years of age and older are dosed as adults. The adult dose is most commonly 4 to 8mg, but varies according to the indication. The most commonly reported side effects are headache, constipation, dizziness, malaise, or fatigue. Counseling information is included in Table 4.
Dronedarone (Multaq)
Dronedarone (Multaq®) is an antiarrhythmic agent approved to reduce the risk of hospitalization related to atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF. Paroxysmal AF is defined as two or more recurrent AF episodes that terminate spontaneously in less than seven days, and usually in less than 24 hours. Persistent AF is defined as AF that fails to self-terminate within seven days. Episodes of persistent AF often require pharmacologic or electri-
cal cardioversion to restore sinus rhythm. Dronedarone is prescribed for rhythm control (versus rate control) with a goal of reducing symptoms by decreasing frequency and duration of episodes, as well as the symptoms during recurrences. Since its launch in July 2009 by Sanofi Aventis and through October 2011, over 1.3 million prescriptions for Multaq® were dispensed to approximately 278,000 patients. Dronedarone is an analogue of amiodarone (Cordarone®) that lacks the iodine moiety. It was developed in hopes of better tolerability and fewer long term side effects in comparison to amiodarone. Thus far, studies have confirmed that it does have a safer extracardiac sideeffect profile and less cumulative toxicity, but it is also less effective in maintaining sinus rhythm (DIONYSOS clinical trial). In addition, dronedarone carries its own set of limitations and contraindications. In January 2011, FDA issued a safety announcement regarding severe liver injury associated with the use of dronedarone secondary to voluntary post-marketing reports. The case reports included hepatocellular liver injury, hepatic failure, and two cases of liver transplantation. The current Multaq® label states that it is contraindicated in patients with liver toxicity related to previous use of amiodarone and in patients with severe hepatic impairment. Patients are advised to report symptoms suggesting hepatic injury such as anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching. Healthcare professionals should also consider periodic laboratory monitoring of hepatic enzymes, especially during the first six months of therapy. In July 2011 and again in December 2011, FDA issued a drug safety communication regarding dronedarone and an increased risk of serious cardiovascular adverse effects when studied in patients with permanent AF. Permanent AF is defined as AF that lasts for
Table 5 Dronedarone (Multaq ® ) Patient Safety Counseling Points • Multaq® is not for persons with heart failure with symptoms which have recently worsened, or for persons with severe heart failure. Patients should call their doctor if they have signs or symptoms of heart failure including: shortness of breath or wheezing at rest; wheezing, chest tightness or coughing up frothy sputum at rest, nighttime or after minor exercise; trouble sleeping or waking up at night due to breathing problems; using more pillows to prop self up at night in order to breathe more easily; gaining more than 5 pounds quickly; or increasing swelling of feet or legs. • Multaq® is not for persons with permanent AF. Patients should call their doctor if they notice their pulse is irregular. • Advise patients to tell their doctor if they have signs or symptoms of liver problems: loss of appetite, nausea, vomiting; fever, feeling unwell, unusual tiredness; itching; yellowing of the skin or the whites of eyes; darkening of urine; or right upper quadrant stomach pain or discomfort. Patients who had liver problems after taking amiodarone should also avoid dronedarone. • Patients who are pregnant or breastfeeding should not take Multaq®. Patients who plan to become pregnant should talk to their physician and use effective birth control. • Warn patients about certain drugs that are contraindicated with dronedarone: nefazodone, ritonavir, ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, and cyclosporine. Also advise patients of the risk of a dangerous abnormal heart rhythm (Torsades de pointes) that can occur when taken with phenothiazines, tricyclic antidepressants, and class I or class III antiarrhythmics. • Advise patients to avoid grapefruit juice. • Emphasize to patients that it is important to continue antithrombotic treatment as prescribed by their physician while taking dronedarone.
more than one year, and cardioversion either has not been attempted or has failed. The safety announcements are based on data from two clinical trials, the PALLAS trial and the ATHENA trial. In PALLAS, dronedarone was evaluated for its effectiveness in patients with permanent AF. The trial was terminated early because of a significantly higher number of cardiovascular events comprised of 43 hospitalizations for heart failure, 23 strokes, and 13 cases of sudden death. These events resulted in 25 deaths, which was double the rate compared to the placebo group. These results were then compared to the ATHENA trial to confirm that when used according to the label (non-permanent AF), patients did not have an increased risk of cardiovascular death, stroke, or heart failure. Thus the Multaq® label has been revised in accordance with the FDA safety communication which includes the following key points: dronedarone is contraindicated in patients with permanent AF; cardiac rhythm should be monitored every three months and if a patient is found to be in AF, dronedarone should be stopped or the patient should be cardioverted if clinically indicated; dronedarone should only be prescribed according to its indication; and patients prescribed dronedarone should receive appropriate antithrombotic therapy. Dronedarone’s role in treating atrial fibrillation is still yet to be fully understood. In the 2011 updated guidelines for the management of atrial fibrillation jointly issued by the American College of Cardiology Foundation and American Heart Association, the following recommendation was made: (Class IIa) Dronedarone is reasonable to decrease the need for hospitalization for cardiovascular events in patients with paroxysmal AF or after conversion of persistent AF. Dronedarone can be initiated during outpatient therapy. A second recommendation was also published stating the following: (Class III-Harm) Dronedarone
should not be administered to patients with class IV heart failure or patients who have had an episode of decompensated heart failure in the past four weeks, especially if they have depressed left ventricular function (left ventricular ejection fraction <35 percent). Multaq® is an option if a patient cannot tolerate amiodarone, or for patients who have an underlying condition such as pulmonary or thyroid disease which is a contraindication for amiodarone use. It may also be considered in younger patients due to the concern about the cumulative effects of amiodarone taken over a lifetime. Currently, there is not enough evidence to determine if it is effective in patients with resistant atrial fibrillation where multiple antiarrhythmics have failed to maintain sinus rhythm. Multaq®’s approved dosage is 400mg twice daily with meals. In addition to the previous warnings and contraindications discussed, dronedarone should not be given with other class I or class III antiarrhythmic drugs (amiodarone, flecainide, propafenone, quinidine, disopyramide, dofetilide, or sotolol) or strong inhibitors of CYP3A (ketoconazole, itraconazole, voriconazole, cyclosporine, telithromycin, clarithromycin, nefazodone, and ritonavir). Concomitant use with other drugs and herbals that prolong the QT interval and increase the risk of Torsades de pointes are also contraindicated. Dronedarone should also be avoided in patients with second or third degree atrioventricular (AV) block or sick sinus syndrome without a functioning pacemaker, bradycardia (<50bpm), QTc Bazett interval >500ms or PR interval >280ms, liver toxicity related to previous use of amiodarone, pregnancy (category X), and nursing mothers. When used in combination with potassium depleting diuretics, monitoring of potassium and magnesium levels is necessary to ensure that levels remain within the normal range throughout the durations of therapy with Multaq®.
The most common adverse reactions associated with therapy include diarrhea, nausea, abdominal pain, vomiting and asthenia. Patient safety counseling points are included in Table 5.
Summary
This lesson serves as a summary of recent significant FDA safety announcements that were issued for simvastatin, acetaminophen, ondansetron, and dronedarone along with relevant prescribing changes that a healthcare provider should be aware of. These medications can continue to be safely prescribed and dispensed according to the revised labeling. It is vital that pharmacists are aware of these safety announcements and apply them when indicated. Providers are encouraged to read the full revised product leaflet for full prescribing information, as well as the clinical trials referred to in this lesson.
The author, 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 0129-0000-12-004-H05-P Release date: 4-15-12 Expiration date: 4-15-15
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 0129-0000-12-004-H05-P 0.15 CEU
Name________________________________________________
FDA Safety Warnings and Prescribing Updates: Simvastatin, Acetaminophen, Ondansetron, and Dronedarone
Address_____________________________________________ City, State, Zip______________________________________ Email_______________________________________________ NABP e-Profile ID*__________________________________
1. In the SEARCH study, the greatest risk of developing myopathy with 80mg daily therapy of simvastatin was: a. immediate. c. in the third year. b. in the first year. d. beyond the fourth year.
*Obtain NABP e-Profile number at www.MyCPEmonitor.net.
Birthdate____________ (MMDD)
2. All of the following are contraindicated with simvastatin EXCEPT: a. ketoconazole. c. gemfibrozil. b. clarithromycin. d. amiodarone. 3. The dose of simvastatin not to be exceeded when taken with amlodipine is: a. 5mg. c. 20mg. b. 10mg. d. 40mg. 4. Patients taking simvastatin should be advised to report all of the following symptoms of liver injury EXCEPT: a. dizziness. c. anorexia. b. fatigue. d. dark urine. 5. In the U.S., acetaminophen toxicity is the most common cause of acute: a. heart failure. c. hepatic failure. b. respiratory failure. d. renal failure. 6. To decrease the potential for overdose, FDA asked manufacturers of oral prescription acetaminophen combination products to limit the amount of acetaminophen per tablet to: a. 325mg. b. 500mg. 7. How many years has FDA given acetaminophen product manufacturers to add a box warning on prescription product labeling concerning the risk of severe liver injury? a. 6 months c. 2 years b. 1 year d. 3 years
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] [b] [b] [b] [b]
[c] [d] [c] [c] [d] [c]
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.
Return quiz and payment (check or money order) to Correspondence Course, OPA, 2674 Federated Blvd, Columbus, OH 43235-4990
8. Healthcare providers must advise parents and caregivers administering liquid acetaminophen products to infants to use: a. the same household teaspoon with each dose. b. an infant dropper. c. an oral syringe. d. the device provided with the product. 9. Ondansetron is labeled as pregnancy risk factor: a. A. c. C. b. B. d. X. 10. Torsades de pointes is a type of arrhythmia associated with: a. a long QT interval. b. a short QT interval. 11. Patients at greatest risk for developing arrhythmias associated with ondansetron use include those with all of the following EXCEPT: a. taking diuretics predisposing to hypokalemia. b. taking diuretics predisposing to hypomagnesemia. c. taking medications leading to QT prolongation. d. a congenital short QT interval. 12. Dronedarone is approved for use in patients with a history of paroxysmal or persistent atrial fibrillation. a. True b. False 13. Compared to amiodarone, dronedarone has been shown to have all of the following properties EXCEPT: a. safer extracardiac side effects. b. less cumulative toxicity. c. increased effectiveness in maintaining sinus rhythm. 14. All of the following drugs are contraindicated with dronedarone EXCEPT: a. ritonavir. c. ketoconazole. b. azithromycin. d. cyclosporine. 15. In accordance with the FDA safety communication for dronedarone,: a. it is contraindicated in patients with paroxysmal AF. b. patients in AF should be monitored for cardiac arrhythmia every six months. c. patients should be receiving appropriate antithrombotic therapy.
To receive CE credit, your quiz must be postmarked no later than April 15, 2015. A passing grade of 80% must be attained. All quizzes received after July 1, 2012 will be uploaded to the CPE Monitor and a statement of credit will not be mailed. Send inquiries to opa@ohiopharmacists.org.
April 2012
2011 - 2012 GPhA BOARD OF DIRECTORS
The Georgia Pharmacy Journal
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June 2012
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