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2012 VIP Day at the Capitol Save-the-Date FEATURE ARTICLES
Kelly J. McLendon Receives GSAE - Emerging Leader Award
Board of Pharmacy President’s Message: But I Just Stepped Out for a Moment...
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NPLC Nomination Form GPhA New Members GPhA Website Tutorial Pharm PAC Contributors Pharm PAC Contribution Card Steve Wilson Thank You GPhA’s Academy of Employee Pharmacists Networking Dinner Program 22 2012 Award Nomination Form 30 GPhA Board of Directors 30 Masthead
GPhA Works with NCPA to Urge Investigation of Merger of Two of Largest Pharmacy Benefit Managers
NCPA Press Release: Senators Express Concern Over Express Scripts-Medco Pharmacy Merger
Merger Letter from Senators Chambliss and Isakson
GPhA is Advocating for You!
The 2011 Southeastern Pharmacists’ Recovery Networks Conference
CPE Opportunity: Horizant, Caprelsa, Yervoy, and Zyriga
Pharmacists Mutual Companies Logix, Inc. EC Retail Studio Barbara Cole, Attorney at Law Financial Network Associates Melvin M. Goldstein, P.C. GPhA Convention Information AIP GPhA Workers’ Compensation UBS
For an up-to-date calendar of events, log onto
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President’s Message Editorial
The Georgia Pharmacy Journal
PRESIDENT’S MESSAGE L. Jack Dunn, Jr., R.Ph. GPhA President
January is Here and the Legislative Process is Not Far Behind…
hree and a half years ago, I began my term serving on the Georgia Pharmacy Association (GPhA) executive committee. I knew learning the procedures required of the executive committee was going to be a lengthy educational process. During this time, Jim Bracewell, executive vice president & CEO of GPhA, introduced me and the other executive committee members to a new way of thinking.
The meeting was a success for both pharmacists and physicians. The discussions were informative and both sides left with a better understanding regarding the goals they wanted to achieve in the upcoming legislative session.
Thank you to Jim for having the foresight to see through the difficulties in establishing this important collaboration. The end result for our state will be improved patient care as both associations work together to see overall improvements.
Jim had a vision for what might be accomplished if the GPhA collaborated with the Medical Associaiton of Georgia on pending legislation. He imagined what might be possible if all pharmacy professionals in our state worked toward a common goal to improve patient care and to protect our industry from potentially detrimental legislation. The executive committee was in total agreement with Jim and was eager to move forward.
Let the legislative process begin…
Therefore, it was decided that a meeting of these organizations should be held each fall to consist of the CEO, the lobbyists, and two executive members from each association. The meeting would be strategically scheduled prior to the upcoming legislative session. Its agenda would allow participating associations to discuss pending legislation to find items that might be worked on together and, if there were opposing views, determine compromises that that would benefit all parties involved. On December 13, 2011, we held the third of what we hope will be many of such joint meetings. GPhA and the Medical Association of Georgia (MAG) met to discuss upcoming 2012 legislation. The lobbyist and CEO of each association conducted the meeting and executive members were on-hand to clarify any questions.
The Georgia Pharmacy Journal
Nominate a Georgia Future Pharmacy Leader The Georgia Pharmacy Foundation New Practitioner Leadership Conference will expose the attendee to the development of personal and professional leadership skills. This could be a decisive step in the leadership career of a young pharmacy professional. Three Top Desired Qualities of Nominees 1. Leadership potential 2. Active involvement in student activities and or professional organizations 3. Activity in community organizations Nominees may not have practiced more than 10 years in pharmacy. The 2012 class will not exceed 20 in total. Conference Location: Legacy Lodge & Conference Center Lake Lanier Islands, GA Conference Dates: April 13-15, 2012 If there is a person you would like to nominate, please complete the form below and return it by January 23, 2012.
Nomineeâ€™s Name: _________________________________________ Address: _______________________________________________ ______________________________________________________ Phone: ________________________________________________ Email: _________________________________________________ Nominatorâ€™s Name: ________________________________________ Address: _______________________________________________ ______________________________________________________ Phone: ________________________________________________ Email: _________________________________________________ Return to : Georgia Pharmacy Foundation 50 Lenox Pointe Atlanta, GA 30324 Or Fax (404) 237-8435 If you need additional information contact Regena Banks at (404) 419-8121 or email firstname.lastname@example.org. The Georgia Pharmacy Journal
EXECUTIVE VICE PRESIDENT’S EDITORIAL Jim Bracewell Executive Vice President / CEO
Sittin’ on Go!
green light tells us to “go” and a yellow light tells us to “slow down or prepare to stop”—right? All drivers know these traffic signals. They keep us driving safely on the right path.
My signal to you is that if you will not be at VIP Day— would you at least pause and write your state representative and your state senator? Tell them that although you will not be able to attend VIP Day for GPhA, you are vitally interested in having their support for our legislative agenda.
What signal are you giving to our legislators for 2012? Are you signaling, “GO forward at the maximum speed in order to improve the practice of pharmacy?” Or are you putting out signals that imply, “Don’t move forward?”
Remember, there is no such thing as a non-signal. Just like a traffic light, it is Red – Yellow – or Green. There is always a signal. So what will be your signal to our lawmakers this 2012? They will be waiting to get a signal from you about your passion for pharmacy.
I cannot imagine any pharmacist would tell GPhA and your GPhA government affairs team to let up, slow down, or stop moving forward on the important advocacy it does on your behalf.
You may find your legislator contact information on the GPhA website: www.gpha.org or you may contact Andy Freeman at email@example.com or (404) 819-8118. As Director of GPhA Government Affairs, Andy wants to help you send all the right signals to our legislators.
But that is the message you send if you cannot find four hours on one day in February to join your fellow pharmacists at our state capital for VIP Day for GPhA. I sincerely hope you will consider attending VIP Day on Thursday morning, February 9, 2012, to show your advocacy and support. Now, I am not trying to place guilt on any GPhA member who is not able to join us for VIP Day. However, I will point out that you if are not able to attend, you need to decide what you will be doing to counter signals you might be sending to the our legislators about the importance you place on advocacy for pharmacy in Georgia. It’s hard to believe, but we talk regularly to legislators who tell us they never hear from the pharmacists in their district back home.
The Georgia Pharmacy Journal
Kelly J. McLendon Receives GSAE—Emerging Leader Award and has been an active member of GSAE for two years. A graduate of Berry College with a Bachelor of Arts Communication, she has been with GPhA for more than five years and was director of communication at Emory University’s Candler School of Theology for more than two years. Kelly McLendon receiving the GSAE
eorgia Pharmacy Association (GPhA) is proud to announce that Kelly J. McLendon, director of public affairs—GPhA, received the Georgia Society of Association Executives’ (GSAE) Emerging Leader Award at that association’s monthly membership luncheon on December 14, 2011.
This prestigious award is presented annually to one deserving GSAE association executive who has ten years or less of experience working within associations and who has demonstrated exceptional leadership through service to GSAE, their own association and to their community. “Kelly is a vital member of our management team here at Georgia Pharmacy Association,” says Jim Bracewell, executive vice president & CEO of GPhA. “Her creative thinking and passion continue to make important contributions to the growth of our organization’s membership and overall communications.”
Emerging Leader Award from GSAE 2010 Chairman of the Board of Directors “Receiving the Emerging Leader Award from GSAE is a surprise and an honor,” says McLendon, “It is an honor that I hope I can continue to live up to throughout my years of service to the association world.”
McLendon is a 2011 graduate of GSAE’s Leadership Academy
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The Georgia Pharmacy Journal
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BOARD OF PHARMACY NEWS
Board of Pharmacy President’s Message: But I Just Stepped Out for a Moment... Bill Prather, R.Ph. President, Georgia Board of Pharmacy
Charge) and staff pharmacists need to make it clearly understood that any activity that requires “direct supervision” must cease until the pharmacist is “physically present in the prescription department” and in a position to “actually observe” the activity.
hat is meaning of the term “direct supervision” as it pertains to the preparation, compounding and dispensing of prescription drugs in Georgia Pharmacies?
Two sections of Title 26 of the Georgia State Code, which governs pharmacy practice, use the term “direct supervision.” Section (26-4-85 b) states that pharmacy interns must be under a pharmacist’s “direct supervision.” Section (26-4-88 c) states that a pharmacist “shall be physically present in the prescription area and actually observing the actions” of any intern, extern or registered technician assisting them in the preparation of prescriptions to be dispensed.
What reasons might be acceptable for a pharmacist to be absent from the prescription department? Can they go out to lunch, go out for a drink, go out to smoke, meet their girl/boyfriend in the parking lot, go down the street to check on other business or go home to make sure they did not leave anything turned on? All of these reasons and many more have been given to the Board to explain why a pharmacist was not present in the pharmacy. Only two legal methods allow for a pharmacy area to remain open in the absence of a pharmacist. They include the following: the pharmacist must (a) be able to secure the pharmacy department so no one has access to the drugs; or (b) have another pharmacist come on duty.
The Board of Pharmacy for the State of Georgia tries to apply common sense to our interpretation of “direct supervision.” We understand that pharmacists (as tough as we are) at times will be out of the prescription department, possibly for a bathroom visit or to answer a patient question. When this happens, the PIC (Pharmacist In
The terms “direct supervision”, “physically present” and “actually observe” are really pretty easy to define. Before you leave your pharmacy unattended to go to your deer-stand, feed your bird-dogs, cut your grass, rake your leaves, eat mom’s home-cookin’, or any other reason—ask yourself the question that was first posed by Harry Callihan (AKA Dirty Harry,) “DO YOU FEEL LUCKY?” Please do not hesitate to call the Board with any questions at (478) 207-2440. Bill Prather Vice President Georgia State Board of Pharmacy
The Georgia Pharmacy Journal
GPhA FIGHTS MEDCO/EXPRESS SCRIPTS MERGER
GPhA Works with NCPA to Urge Investigation of Merger of Two of Largest Pharmacy Benefit Managers Andy Freeman Director of Government Affairs Georgia Pharmacy Association
Media outlets across the country including the NEW YORK TIMES and the WALL STREET JOURNAL ran the following press release from NCPA on the proposed merger and our involvement on the issue. Please make the time to thank Senator Isakson at (202) 224-3643 and Senator Chambliss at (202) 224-3521 for their help on this issue of importance to pharmacists! See the letter on page 11. It is good to have friends like this in elected office that work with GPhA’s legislative team and with members like you when called upon.
s you are probably aware, two of the largest PBMs in the United States, Medco and Express Scripts, are proposing to merge their two companies. If this happens, the resulting company would control 60 percent of the country’s mail order business, well over half of the specialty drug marketplace and would control over 40 percent of the national prescription drug volume. Such a merger would not be good for pharmacists or patients.
By creating a PBM with unprecedented market power, the merged company would be able to limit consumer choice and pharmacy access, simply to line the pockets of Express Scripts-Medco's shareholders. The merged firm will have an increased incentive to force consumers to utilize their mail order business. Studies show that mail order businesses consistently dispense more costly brand-name drugs and fewer generics than retail pharmacies; therefore, ultimately raising drug costs. GPhA’s legislative team has been working with our Congressional Delegation and other elected officials for the last few months to address the concerns of Georgia pharmacists about this proposed merger. After many phone calls and emails between us and Georgia’s members of congress, our efforts paid off and Georgia became the only State to have both of its US Senators express their concerns to the Federal Trade Commission asking them to look into this merger because of the belief that if this merger is approved it will lead to less competition, reduced transparency and increased prescription drug prices for all Americans.
The Georgia Pharmacy Journal
GPhA FIGHTS MEDCO/EXPRESS SCRIPTS MERGER
NCPA Press Release: Senators Express Concern Over Express Scripts-Medco Pharmacy Merger Scripts/Medco Merger: Cost Savings for Consumers or More Profits for the Middlemen?” NCPA member Susan Sutter of Marshland Pharmacies in Wisconsin is scheduled to testify. In September, a House Judiciary Subcommittee held a separate hearing.
LEXANDRIA, Va. (Dec. 5, 2011) – In advance of a key Senate subcommittee hearing, three U.S. Senators have joined the growing ranks of consumer groups, lawmakers and employers questioning the proposed mega-merger of two of the three largest pharmacy benefit managers (PBMs) – Express Scripts and Medco Health Solutions, the National Community Pharmacists Association (NCPA) said today.
“We are very supportive of our Senators who urged the FTC to conduct a complete investigation of this merger which takes into account the potential - and expected harm to Georgia’s community pharmacists and their patients,” says Jim R. Bracewell, executive vice president of Georgia Pharmacy Association.
In a letter to Federal Trade Commission (FTC) Chairman Jon Leibowitz, US Senators Saxby Chambliss (R-Ga.), Johnny Isakson (R-Ga.) and Jerry Moran (RKan.), urged a “thorough and complete investigation” of the proposed union. They pointed to the dominance that the company, if combined, would have particularly in the specialty and mail order pharmacy markets and requested that the FTC “take into account what impact this proposed merger could have on consumers and patients, on taxpayers, on the government, and on pharmacies.”
With the Senators’ letter, now 27 members of Congress have voiced concerns about the merger. Their unrest is shared by a wide range of other public and private sector stakeholders. Recently, the American Antitrust Institute (AAI), the Small Business Majority and the Pennsylvania Pharmacy Council came out against the merger.
“We appreciate these Senators and all members of Congress who have taken a stand for patients by voicing their doubts about this merger,” said NCPA CEO B. Douglas Hoey, R.Ph., MBA. “This merger would reduce patient choice and access to pharmacy services and ultimately result in higher prescription drug costs. While these companies may talk a good game to regulators and in Congressional testimony, their actions suggest they are more concerned with rewarding Wall Street investors and lavish executive compensation than improving patient care or reducing costs. The latest example of this being the reported $83 million ‘golden parachute’ for five Medco executives, should the merger go through.”
In its letter to the FTC, the AAI argued, “The merger will likely cause anticompetitive harm in the provision of PBM services to the large plan sponsors market segment. Because of the large PBMs’ vertical integration and enhanced buyer power, the merger will also likely cause anticompetitive harm in the specialty pharmacy and mail order pharmacy market segments.” In addition, while the FTC continues to scrutinize the merger, at least 28 state attorneys general have formed a working group to conduct their own review.
Tomorrow, the U.S. Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights is scheduled to hold a hearing entitled, “The Express The Georgia Pharmacy Journal
GPhA FIGHTS MEDCO/EXPRESS SCRIPTS MERGER
The Georgia Pharmacy Journal
2012 VIP Day at the Georgia Freight Depot
Notice to all Pharmacists and Pharmacy Technicians: All members and potential members are welcome to attend. Register online today at www.gpha.org or by calling (404) 231-5074. When: Thursday, February 9, 2012 Where: The Georgia Railroad Freight Depot - Freight Room (Across from the Capitol Building) 65 Martin Luther King, Jr., Drive, SE Atlanta, Georgia 30334 Schedule of Events: *NOTE: This schedule is tentative. We will continue to update you as it becomes more permanent. 6:00 a.m.: Registration & Exhibit Hall Opens with Coffee 6:30 a.m.: GPhA Attendee Orientation 7:00 a.m.: Breakfast with Your Legislator(s) 8:00 a.m.: Presentation of GPhA Legislator of the Year Award & Closing Remarks 9:15 a.m.: Group Photo on the Capitol Steps 10:00 a.m.: Tour the Georgia Capitol Building Special GPhA Recognitions to be made by Georgia House and Senate Members Wear your white coat to make our presence more effective! Parking directions available online. If you have any questions, please contact Sarah Bigorowski at firstname.lastname@example.org or (404) 4188126.
The Georgia Pharmacy Journal
GPhA MEMBER NEWS
Welcome to GPhA! The following is a list of new members who have joined Georgia’s premier professional pharmacy association! If you or someone you know would like to join GPhA go to www.gpha.org and click “Join” under the GPhA logo. Individual Pharmacist Members
Pharmacy School Student Members
Randall Thornton, R.Ph., Roswell Shaun Dillavou, Pharm.D., Greenville, SC Janet Long Speckter, R.Ph., McDonough Anyasor Vincent Ehule, R.Ph., Riverdale Nancy E. Martin, R.Ph., Pine Mountain Brainard Winston Ordonez, R.Ph., Columbus
Lorraine Lee Milton, Athens Sarah Katherine Williford, Fayetteville, NC Joshua A. Meeks, Alpharetta Mindy Daniel, Augusta Jason Scott Bauer, Athens
BARBARA COLE ATTORNEY AT LAW, LLC 539 Green Street, NW Gainesville, GA 30501 678-971-9088 email email@example.com www.barbaracoleattorney.com
GPhA WEBSITE NEWS
GPhA Website Tutorial GPhA understands that not everyone has the same level of comfort on the Internet. As a result, GPhA has created an online tutorial on how to use the GPhA website. It features howto’s and tools that you might not be aware of. If you are interested in viewing the GPhA Website Tutorial go to www.gpha.org and click on “GPhA Website Orientation Video.” It takes a moment to load, but will start automatically.
All Aspects of Representation of Health Care Professionals Licensure Medicare Administrative Medicaid Criminal Bankruptcy Compliance State Bar Health Law Section Former Chief Magistrate Judge
We hope you enjoy this brief video, and learn about the tools available to you. The Georgia Pharmacy Journal
Current Pharm PAC Members 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) Barry M. Bilbro, R.Ph. Robert Bowles, Jr., R.Ph., CDM, Cfts Jim R. Bracewell Larry L. Braden, 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. J. Thomas Lindsey, R.Ph. Brandall S. Lovvorn, Pharm.D. Eddie M. Madden, R.Ph. Jonathan Marquess, Pharm.D., CDE, CPT Pam Marquess, Pharm.D.
Kenneth A. McCarthy, R.Ph. Drew Miller, R.Ph., CDM Laird Miller, R.Ph. Cynthia K. Moon Jay Mosley, R.Ph. Allen Partridge, R.Ph. Houston Lee Rogers, Pharm.D., CDM Tim Short, R.Ph. Danny Toth, R.Ph. Tommy Whitworth, R.Ph., CDM Gold Level ($600 minimum pledge) James Bartling, Pharm.D., ADC, CACII Larry Batten, R.Ph. Liza G. Chapman, Pharm.D. Mahlon Davidson, R.Ph., CDM Kevin M. Florence, Pharm.D. Robert B. Moody, R.Ph. Sherri S. Moody, Pharm.D. William A. Moye, R.Ph. Jeffrey Grady Richardson, R.Ph. Andy Rogers, R.Ph. Daniel C. Royal, Jr., R.Ph. Michael T. Tarrant Silver Level ($300 minimum pledge) Renee D. Adamson, Pharm.D. Terry Dunn, R.Ph. Marshall L. Frost, Pharm.D. Johnathan Wyndell Hamrick, Pharm.D. Michael O. Iteogu, Pharm.D. James E. Jordan, Pharm.D. Willie O. Latch, R.Ph. W. Lon Lewis, R.Ph. Kalen Porter Manasco, Pharm.D. Michael L. McGee, R.Ph. William J. McLeer, R.Ph. Albert B. Nichols, R.Ph. Richard Noell, R.Ph.
William Lee Prather, R.Ph. Sara W. Reece, Pharm.D., BC-ADM, CDE 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. Flynn W. Warren, M.S., R.Ph. William T. Wolfe, R.Ph. Bronze Level ($150 minimum pledge) Monica M. Ali-Warren, R.Ph. Fred W. Barber, R.Ph. John R. Bowen, R.Ph. Michael A. Crooks, Pharm.D. William Crowley, R.Ph. Charles Alan Earnest, R.Ph. Randall W. Ellison, R.Ph. Mary Ashley Faulk, Pharm.D. Amanda R. Gaddy, R.Ph. Ed Kalvelage John D. Kalvelage Steve D. Kalvelage Marsha C. Kapiloff, R.Ph. Joshua D. Kinsey, Pharm.D. Brenton Lake, R.Ph. William E. Lee, R.Ph. Michael Lewis, Pharm.D. Ashley Sherwood London Charles Robert Lott, R.Ph. Max A. Mason, R.Ph. Amanda McCall, Pharm.D. Susan W. McLeer, R.Ph. Mary P. Meredith, R.Ph. Rose Pinkstaff, R.Ph. Leslie Ernest Ponder, R.Ph. Kristy Lanford Pucylowski, Pharm.D. Leonard Franklin Reynolds, R.Ph. Laurence Neil Ryan, Pharm.D. Richard Brian Smith, R.Ph.
If you made a gift or pledge to Pharm PAC in the last 12 months and your name does not appear above, please contact Andy Freeman at firstname.lastname@example.org or (404) 419-8118. Donations made to Pharm PAC are not considered charitable donations and are not tax deductible. The Georgia Pharmacy Journal
Pharm PAC Contributorsâ€™ List Continued Charles Storey, III, R.Ph. Archie Thompson, Jr., R.Ph. Marion J. Wainright, R.Ph. Jackie White Carrie-Anne Wilson Steve Wilson, Pharm.D. Sharon B. Zerillo, R.Ph.
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Members (no minimum pledge) John J. Anderson, Sr., R.Ph. Mark T. Barnes, R.Ph. Henry Cobb, III, R.Ph., CDM Carleton C. Crabill, R.Ph. Wendy A. Dorminey, Pharm.D., CDM David M. Eldridge, Pharm.D. James Fetterman, Jr., Pharm.D. Charles C. Gass, R.Ph. Christina Gonzalez Christopher Gurley, Pharm.D. Ann R. Hansford, R.Ph. 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. Roy W. McClendon, R.Ph.
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Darby R. Norman, R.Ph. Christopher Brown Painter, R.Ph. Steve Gordon Perry, R.Ph. Victor Serafy, R.Ph. James E. Stowe, R.Ph. James R. Strickland, R.Ph. Celia M. Taylor, Pharm.D. Leonard E. Templeton, R.Ph. Heatwole C. Thomas, R.Ph. Erica Lynn Veasley, R.Ph. William D. Whitaker, R.Ph. Elizabeth Williams, R.Ph. Jonathon Williams, Pharm.D.
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The Georgia Pharmacy Journal
Join Pharm PAC Today! Pharm PAC is GPhA's Political Action Committee, providing the resources for the association to lobby and advocate on behalf pharmacy. GPhA leads the way in influencing pharmacy-related legislation in Georgia. There are two ways in which to become a member. Once you have completed this form please mail it to Pharm PAC, 50 Lenox Pointe, NE, Atlanta, GA 30324. Name: __________________________________________________ Address: _________________________________________________ Phone#: _________________________________________________ Email Address: ____________________________________________
Circle the Level in which you would like to participate with a monthly contribution:
Titanium ($200/month) Platinum ($100/month) Silver ($25/month)
Or If you wish to make a one time contribution write the amount you wish to contribute here: _____________________________________________ If you are making a monthly contribution you will be contacted for additional information to set up your monthly contribution. If you are making a one time payment please mail your check in with your form.
The Georgia Pharmacy Journal
Please save the date for our Georgia Pharmacy Association 137th Annual Convention! Hilton Head Marriott Resort & Spa, Hilton Head Island, SC July 7-11, 2012 GPhA Room Rates: Island View $199 Ocean View $219 Ocean Front $239 To make reservation, call (800) 228-9290, and mention that you are in the Georgia Pharmacy Association Room Block. The Georgia Pharmacy Journal
GPHA LEGISTLATIVE NEWS
GPhA is Advocating for You!
Andy Freeman Director of Government Affairs Georgia Pharmacy Association
he 2012 Legislative Session of the Georgia General Assembly is approaching us at blinding speed. It will start January 9 this year and continue on for 40 legislative days as prescribed by the State Constitution, which means it will be probably run through sometime next April.
The Georgia Pharmacy Association (GPhA) continues to represent its members on legislation that effects the industry of Pharmacy. Transportation funding and taxes figure to be prominently discussed by legislators this year. Also on their agenda will be legislation that benefits the practice of pharmacy in Georgia. GPhA will focus on two main legislative priorities for the 2012 Legislative History:
The Georgia Pharmacy Journal
Expanding Immunization Protocol: In 2009, the Georgia General Assembly passed HB217 that allowed pharmacists to administer influenza vaccinations under a protocol agreement with a local physician. This bill created greater access to the influenza vaccine for the general public and has utilized the pharmacist’s education and training in the area of vaccine administration. Although this effort has been very successful, many citizens still do not have access to a physician and many of these citizens go without other life-saving vaccinations that are not covered under the influenza protocol legislation passed under HB217. By allowing the physician to enter into a protocol agreement (as they currently do for influenza vaccines under HB217) that gives permission to the pharmacist to administer all CDC recognized vaccines to the physician’s patients will give the patient unfettered access to life-saving vaccinations. 18
Mail Order: Georgia is the only state that prohibits prescriptions from being mailed to patients from within Georgia. Unfortunately this doesn’t stop insurance companies from sending prescription drugs to their patients from outside the state. GPhA plans to introduce legislation next session that will mandate that any pharmacy that sends a prescription to a Georgian be licensed in Georgia. This will mean that they will have to follow the same regulations that you have to follow. We are also asking that mailed prescriptions have safeguards to protect the patients by requiring packages to include something like temperature strips. We are looking at allowing a form of “Central Fill” to be used in Georgia. This will allow Georgian Pharmacies the ability to buy drugs in bulk like the out-of-state mail houses are able to do. The prescriptions would be filled in a central location and delivered to local pharmacies. Pharmacists wouldn’t January 2012
have to stock the drugs and would receive a fee for counseling with patients for their medical therapy.
doctors that make it too easy for addicts to get the access that they crave.
In addition to these two main issues, GPhA is working to “loosen the iron fist” that Pharmacy Benefit Managers (PBM) have over pharmacies through their questionable auditing practices. We are working closely with the State Insurance Commissioner on this issue and will offer up legislation if he thinks he will need an increase in legislative authority. We are also working with the Attorney General on legislation to help combat the abuse of prescription drugs. During the last few years, focus has been on pharmacies as a control point to limiting access to those that abuse prescription drugs. The Attorney General is looking at ways to monitor
This year will be a busy one for Pharmacy down at the Gold Dome and your help will be greatly needed to pass legislation that will benefit Pharmacy, as well as to defeat legislation that undoubtedly will be introduced that are not good for you or your career. Please plan to be at the Capitol on February 9, for VIP Day and if you aren’t already a member, please consider joining Pharm PAC. Your involvement in VIP Day and Pharm PAC will go a long way in making our legislative agenda a reality.
GPhA's Academy of Employee Pharmacists Networking Dinner Program Thursday, February 16, 2012 (7:00 - 9:00 PM) Maggiano's Little Italy at Perimeter Mall 4400 Ashford Dunwoody Road Atlanta, GA 30346 This event is free and open to all GPhA Members. It is sponsored by Boehringer Ingelheim featuring a special guest speaker on "Innovative The Treament of COPD and How to Reduce Exacerbations." Registration for this event is online only so please go to www.gpha.org, where you will find the link to register under “Upcoming Events.” Seating is limited, so be sure to register early. If you have any questions about the venue call Maggiano's at (770) 804-3313. The Georgia Pharmacy Journal
AIP Spring Meeting Sunday, March 18, 2012 Macon Marriott & Centreplex Macon, GA
ARE YOU COMING?
xLEARN TO IMPROVE YOUR BUSINE$$
- ACOs & RxALLY xSPECIAL GUESTS xMEDICAID xAIP ELECTIONS x BRING YOUR STAFF AND NETWORK WITH YOUR COLLEAGUES 1. 2. 3. 4.
Come meet and network with fellow independent pharmacists Bring your staff to network with other technicians Join us for a continental breakfast and lunch Visit with our AIP partners during breaks and lunch
SHOW YOUR SUPPORTÂ²$77(1'7+,6<($5Â¶6$,3635,1*0((7,1* 5HJLVWUDWLRQ)RU3ODQQLQJ3XUSRVHV3OHDVH)LOO2XWDQG5HWXUQ
3/($6( )$; %$&.72
0HPEHUÂ¶V1DPHBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB1LFNQDPHBBBBBBBBBBBBBBBBBBBBBBBB Pharmacy Name:_______________________________________________________________________ Address:______________________________________________________________________________ E-mail Address (Please Print):_____________________________________________________________ Will you be joining us for lunch (12-1pm)? Yes_____ No_____; # of additional Staff/Guests:____________ Names of Staff/Guests: ___________________________________________________________________
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James Taylor 404-419-8173 email@example.com
Call for GPhA awards nominations... The GPhA Awards Committee is seeking nominations for the following awards which will be presented at the GPhA 137th Annual Convention in 2012. A brief description and criteria of each award is included below. Please select the award for which you would like to nominate someone and indicate their name on the form below. Deadline for submitting the completed nomination form is March 1, 2012. Nominations will be received by the Awards Committee and an individual will be selected for presentation of the Award at GPhA’s 137th Annual Convention at the Hilton Head Marriott Resort & Spa on Hilton Head Island.
Bowl of Hygeia Award Recognized as the most prestigious award in pharmacy, the Bowl of Hygeia is presented annually by GPhA and all state pharmacy associations. Selection Criteria: 1) The nominee must be a licensed Georgia pharmacist; 2) The Award is not made posthumously; 3) The nominee is not a previous recipient of the Award; 4) The nominee is not currently serving nor has served within the immediate past two years as an officer of GPhA other than ex-officio capacity or its awards committee; 5) The nominee has an outstanding record of service to the community which reflects will on the profession.
Distinguished Young Pharmacist Award Created in 1987 to recognize the achievements of young pharmacists in the profession, the Award has quickly become one of GPhA’s most prestigious awards. The purpose of the Award is two-fold: 1) The encourage new pharmacists to participate in association and community activities, and 2) To annually recognize an individual in each state for involvement in and dedication to the pharmacy profession. Selection Criteria: 1) The nominee must have received entry degree in pharmacy less than ten years ago; 2) Nominee must be a licensed Georgia pharmacist; 3) Nominee must be a GPhA member in the year of selection; 4) Nominee must be actively engaged in pharmacy practice; 5) Nominee must have participated in pharmacy association programs or activities and community service projects.
Innovative Pharmacy Practice Award This Award is presented annually to a practicing pharmacist who has demonstrated innovative pharmacy practice which has resulted in improved patient care. Selection Criteria: 1) The nominee must have demonstrated innovative pharmacy practice which has resulted in improved patient care; 2) Nominee must be a licensed Georgia pharmacist; 3) Nominee must be a member of the GPhA in the year of selection.
2012 Awards Nomination Form Bowl of Hygeia
Distinguished Young Pharmacist
Innovative Pharmacy Practice Award
Nominee’s Full Name _______________________________________________ Nickname ___________________ Home Address _________________________________________ City _______________ State _____ Zip ______ Practice Site __________________________________________________________________________________ Work Address __________________________________________ City _______________ State _____ Zip ______ College/School of Pharmacy _____________________________________________________________________ List of professional activities, state/national pharmacy organization affiliations, and/or local civic church activities: ____________________________________________________________________________________________ ____________________________________________________________________________________________ Supporting information: _________________________________________________________________________ ____________________________________________________________________________________________ Submitted by (optional): _________________________________________________________________________ Submit this form completed by March 1, 2012 to: GPhA Awards Committee, 50 Lenox Pointe, Atlanta, GA 30324 or complete this form online at www.gpha.org.
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GEORGIA PHARMACY FOUNDATION NEWS
The 2011 Southeastern Pharmacists’ Recovery Networks Conference: Provided Valuable Learning & Networking Opportunities he Georgia Pharmacy Foundation and the Georgia PharmAssist Committee successfully hosted its 16th annual Southeastern Pharmacists’ Recovery Networks (PRN) Conference during the second weekend of November at the beautiful Simpsonwood Conference Center located in Norcross on the outskirts of Atlanta.
This annual Conference welcomes anyone wishing to learn more about the disease of addiction. Although the event is called the “Southeastern PRN Conference,” it continues to attract pharmaceutical professionals from across the country. A number of attendees return each year to acquire new and updated information. Comment cards show that many participants have no idea that such extensive information is available to help treat this disease. Throughout the Conference emotional stories of personal recovery, or the recovery of a friend, become an important aspect of the overall experience and this year was no exception. This intensive learning event attracts a number of pharmacy technicians, whom each receive Continuing Professional Education credits. Student pharmacists are also encouraged to attend to receive a certificate acknowledging their participation. In addition to pharmacy schools located in Georgia, the Auburn University
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Harrison School of Pharmacy at the University of South Alabama regularly sends a large group of student pharmacists and this year, for the first time, Sullivan University College of Pharmacy of Louisville, Kentucky, sent seven of its pharmacy school students. Each year the Conference program is enhanced and expanded with new, cutting-edge knowledge and information. This year’s two-day program featured well-known experts in the field of addiction. The Saturday presentations included: Merrill Norton, Pharm.D., D.Ph., ICCDP-D and Clinical Associate Professor at UGA, covering Pharmacology of the Streets 2011; Chip Abernathy, LPC, CAC and Program Coordinator for Recovering Professionals Services at Ridgeview Institute, discussing Professional Ethics: Avoiding Burnout; Kendall Weinberg, M.Ed., LPC and Director of MARR’s Women’s Recovery Center, presenting on Women and Addiction; and Steve Moore, LCSW, PIP, The Moore Institute, speaking on The Cycle of Addiction. Sunday’s expert presenters included Jim Seckman, MAC, CAC II, CCS and Clinical Director at MARR, covering Addiction and Spirituality and Tom House, President of Partnership for Professional Wellness/Professional Monitoring, presented on Drug Testing for Healthcare Professionals. The program concluded with a panel discussing state and national positions
on Pharmacists’ Recovery Networks. State panelists were: Jim Bartling— GA; Brian Fingerson—KY; Johnny Moore—VA: Mary Christine Parks— NC; Jim Powers & David Templeman—FL: Barry Williams— TN; and Mike Quigley – OH. Charlie Broussard presented on the national status. Special recognition for the event’s success must go to two dedicated volunteers, whom are both Georgia Pharmacy Association, Inc. pastpresidents, Jim Bartling, Pharm.D., ADC, CAC II, Intervention Coordinator of the Georgia PharmAssist Committee and Richard B. Smith, R.Ph., Chairman of the Georgia PharmAssist Committee. Sincere appreciation goes to Conference exhibitors and sponsors: Academy of Independent Pharmacy (AIP); Cornerstone of Recovery; MARR, Inc.; QuestHouse, Inc.; Ridgeview Institute; and UF Shands – Florida Recovery Center. Generous promotional support was provided by nationally-known PRN website www.usaprn.org and by a number of state PRN organizations that promote the Conference through their websites and publications. Be sure to watch for details regarding the 2012 Southeastern Pharmacists’ Recovery Networks Conference. You may check www.gpha.org for dates and location.
continuing education for pharmacists Volume XXIX, No. 10
New Drugs: Horizant, Caprelsa, Yervoy, and Zytiga 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 :XHVWKDYHQRUHOHYDQWÀQDQFLDOUHODWLRQships to disclose.
Goal. The goal of this lesson is to provide background information on abiraterone (Zytiga™), gabapentin enacarbil (Horizant™), ipilimumab (Yervoy™) and vandetanib (Caprelsa®). Objectives. At the conclusion of
this lesson, successful participants should be able to: 1. recognize the new drugs by generic name, trade name and chemical name when relevant; 2. identify the indication, pharmacologic action and clinical application for each drug; 3. choose important therapeutic uses for the drugs and their appliFDWLRQVLQVSHFLÀHGSDWKRORJLHV 4. demonstrate an understanding of adverse effects and toxicity, DQGVLJQLÀFDQWGUXJGUXJLQWHUDFtions for these drugs; and, 5. select important information to convey to patients and/or their caregivers. Drugs discussed within this lesson are new molecular entity compounds (Table 1) indicated for use in a variety of pathologies. The lesson provides an introduction to the new drugs and is not intended to extend beyond a brief overview of the topic. The products’ Prescribing ,QIRUPDWLRQOHDÁHWRUMedication Guide, and other published refer-
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ence sources should be consulted for detailed descriptions.
Prostate cancer is the second leading cause of cancer-related death in men in the United States and the rest of the developed world. The new drug is reported to prolong the
lives of men with late-stage prostate cancer who have received prior treatment and had few available therapeutic options. Indications and Use. Zytiga (zye-teé-ga) is indicated for use in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel (Taxotere). Prostate Cancer. Cancers occurring in hormone-sensitive tissues such as the breast and prostate are some of the most commonly diagnosed cancers in developed countries. In prostate cancer, the male androgen, testos-
Table 1 Selected new drugs for 2011 Generic (Proprietary Applicant/Sponsor/ Indication Dosage Form Name) Distributor Abiraterone (Zytiga) Centocor Ortho Metastatic cas250 mg Biotech Inc tration-resistant tablets prostate cancer Gabapentin enacarbil (Horizant)
Moderate-to-severe restless legs syndrome
600 mg tablets
Unresectable or metastatic melanoma
50 mg, 200 mg vials
AstraZeneca Pharmaceuticals LP
Symptomatic or progressive medullary thyroid cancer
100 mg, 300 mg tablets
terone, stimulates prostate tumors to grow. For the past 50 years, hormonal therapy with medical or surgical castration has, therefore, been the mainstay of initial systemic therapy for advanced prostate cancer. Luteinizing hormonereleasing hormone (LHRH) analogues (e.g.,Lupron, Eligard) that suppress testicular testosterone production are the most commonly XVHGGUXJVDVĂ€UVWOLQHKRUPRQH therapy. Androgen deprivation therapy that depletes circulating levels of testosterone is initially effective in the majority of men. Responses are transient, though, and most patients eventually have progressive disease despite low levels of circulating testosterone. At present, androgen deprivation therapy (ADT) remains the cornerstone of treatment for advanced or metastatic prostate cancer, and is beyond a doubt the most effective therapeutic option. Approximately 90 percent of paWLHQWVUHVSRQGWRFXUUHQWĂ€UVWOLQH ADT strategies of medical castration with an LHRH agonist (with or without an antiandrogen) or surgical castration. However, most patients experience disease progression within two to three years. Traditional secondary hormonal manipulations, such as antiandrogen withdrawal, or second-line antiandrogens, glucocorticoids, estrogens or ketoconazole, can be RIFOLQLFDOEHQHĂ€WLQVRPHSDWLHQWV after primary antiandrogen failure. Currently, median survival after failed initial ADT is approximately 18 months with fewer than 20 percent of patients surviving beyond three years. $ELUDWHURQHLVWKHĂ€UVWGUXJLQ its class to receive FDA approval to prevent production of tissue testicular androgens by castrationresistant prostate cancer that demonstrates meaningful extension of survival in patients with chemotherapy-resistant, castration-resistant prostate cancer. There are other drugs in clinical trials that have theoretical advantages over abiraterone.
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Mechanism of Action. Abiraterone selectively and irreYHUVLEO\LQKLELWVÇ‚K\GUR[\ODVH C17,20-lyase (CYP17). This ratelimiting biosynthesis enzyme is expressed in testicular, adrenal, and prostatic tumor tissues and is required for androgen biosynthesis. CYP17 catalyzes two sequential and key reactions that block synthesis of androgens without FDXVLQJDGUHQDOLQVXIĂ€FLHQF\ conversion of pregnenolone and SURJHVWHURQHWRWKHLUÇ‚K\GUR[\ GHULYDWLYHVE\Ç‚K\GUR[\ODVH activity; and (2) the subsequent formation of dehydroepiandrosterone and androstenedione, respectively, by C17,20-lyase activity. Both dehydroepiandrosterone and androstenedione are androgens and are precursors of testosterone. Adverse Effects. The most FRPPRQDGYHUVHUHDFWLRQVÂ• percent) noted in pre-clinical trials were joint swelling or discomfort, hypokalemia, edema, muscle GLVFRPIRUWKRWĂ XVKHVGLDUUKHD urinary tract infection, cough, hypertension, arrhythmia, urinary frequency, nighttime urination (nocturia), dyspepsia and upper respiratory tract infection. Warnings, Precautions and Contraindications. The following warnings and precautions are listed: Â‡Mineralocorticoid excess. Zytiga should be used with caution in patients with a history of cardiovascular disease. Its safety in patients with LVEF <50 percent or NYHA Class III or IV heart failure is not established. Hypertension should be controlled and hypokalemia corrected before treatment. Blood pressure, serum SRWDVVLXPDQGV\PSWRPVRIĂ XLG retention should be monitored at least monthly. Â‡$GUHQRFRUWLFDOLQVXIĂ€FLHQF\. Symptoms and signs of adrenoFRUWLFDOLQVXIĂ€FLHQF\VKRXOGEH monitored. Increased dosage of corticosteroids may be indicated before, during and after stressful situations. Â‡Hepatotoxicity. Increases in liver enzymes have led to drug in-
WHUUXSWLRQGRVHPRGLĂ€FDWLRQDQG or discontinuation. Liver function should be monitored, and the drug PRGLĂ€HGLQWHUUXSWHGRUGLVFRQWLQued as recommended. Â‡Food effect. Zytiga must be taken on an empty stomach. Absorption of abiraterone increases up to 10-fold when the drug is taken with meals and toxicity may occur. No food should be consumed within at least two hours before the dose of Zytiga is taken or at least one hour after the dose is taken. A single contraindication is listed: women who are or may become pregnant! Drug Interactions. Zytiga is an inhibitor of the hepatic drugmetabolizing enzyme CYP2D6. Co-administration with CYP2D6 substrates that have a narrow therapeutic index (e.g., thioridazine) should be avoided. If an alternative treatment cannot be used, caution should be exercised and a dose reduction of the concomitant CYP2D6 substrate considered. Dosage and Availability. The recommended dose is 1,000 mg given orally once daily in combination with prednisone 5 mg given orally twice daily. Zytiga is available in tablets containing 250 mg abiraterone. Patient information. Excerpts from the FDA-approved Patient Information are shown in Table 2.
Gabapentin Enacarbil (Horizant)
+RUL]DQWKRULÄť]DQW ZDVSXUSRVHfully synthesized to mimic the chemical structure of the neuroWUDQVPLWWHUÇ„DPLQREXW\ULFDFLG (GABA). Gabapentin (Neurontin, and others) was approved in the early-90s for use as an adjunctive medication to control partial seizures. Horizant is a transported prodrug of gabapentin that is used for treatment of restless legs syndrome (RLS). After administration, gabapentin enacarbil is actively absorbed throughout the small and large intestine and rapidly hydrolyzed to gabapentin.
Table 2 Major counseling points for Zytiga (abiraterone) tablets* This medicine is used along with prednisone to treat castration-resistant prostate cancer that has spread to other parts of the body. 5HDGWKH3DWLHQW,QIRUPDWLRQEHfore starting to take Zytiga and each WLPH\RXJHWDUHÀOO 7HOO\RXUGRFWRU -if you have liver or adrenal gland problems; -if you have dizziness, fast heartbeats, headaches, confusion, muscle weakness, pain in your legs, swelling in your feet or hands; or feel faint or lightheaded. -about all other prescription and nonprescription (OTC) medicines, vitamin/mineral supplements, natural products and herbal remedies you are taking. 3HULRGLFODERUDWRU\WHVWLQJLVLPportant with this medicine. Be sure to make all testing appointments. :20(1=\WLJDLVQRWIRUXVHLQ women. Do not touch Zytiga tablets if you are or intend to become pregnant, or are breastfeeding. 6ZDOORZ=\WLJDZKROHZLWKZDWHU Take on an empty stomach. =\WLJDLVXVXDOO\WDNHQRQFHDGD\ and the prednisone is taken twice a day. Do not stop taking either mediFLQHZLWKRXWÀUVWFRQWDFWLQJ\RXU doctor. 6WRUH=\WLJDDWURRPWHPSHUDWXUH 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.
Indications and Use. The new drug is indicated for treatment of RLS in adults. It is not recommended for patients who are required to sleep during the daytime and remain awake at night. Horizant is not interchangeable with other gabapentin products because of differing pharmacokinetic SURÀOHV7KHVDPHGRVHRI+RUL]DQW results in different plasma concentrations of gabapentin relative to other gabapentin products.
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Restless Legs Syndrome. A sensorimotor (both sensory and motor) neurologic movement disorder, RLS causes patients to experience an almost irresistible urge to move their legs. Usually worse during periods of inactivity or rest, walking and other physical activity involving the legs can usually alleviate the sensations. Often associated with a sleep complaint, the inability to rest can have a negative impact on the patient’s quality of life due to agitation, discomfort, frequent waking, chronic sleep deprivation and stress. These conditions, in turn, can negatively affect job performance, social activities, and family life. A commonly held view holds that RLS may be due to dysfunction of dopamine-producing cells in the brain. Pharmacologic studies have shown a dramatic improvement in RLS symptoms with administration of levodopa, the precursor of dopamine, or with dopaminergic agonists that act on dopamine receptors in the brain. The dopamine agonists Mirapex and Requip are already approved for treating RLS. Conversely, dopamine antagonists will worsen symptoms in patients with RLS. Mechanism of Action. Gabapentin enacarbil is a prodrug of gabapentin; thus, its therapeutic actions in RLS are attributable to gabapentin. The precise mechaQLVPE\ZKLFKJDEDSHQWLQLVHIÀFDcious in RLS is unknown. Adverse Effects. The most FRPPRQDGYHUVHUHDFWLRQV percent and at least twice the rate of placebo) were somnolence/sedation and dizziness. Warnings, Precautions and Contraindications. The following warnings and precautions are listed: Driving impairment. Patients should not drive until they have JDLQHGVXIÀFLHQWH[SHULHQFHZLWK Horizant to assess whether it will impair their ability to drive. Somnolence/sedation and dizziness. The drug may impair the patient’s ability to operate complex machinery.
Suicidal thoughts or behavior. Patients should be monitored for suicidal thoughts or behavior. The increased risk of suicidal thoughts or behavior may be seen as early as one week after starting drug treatment, and persist for the duration of treatment. +RUL]DQWLVQRWLQWHUFKDQJHable with other gabapentin products. There are no contraindications listed. Drug Interactions. Neither gabapentin enacarbil nor gabapentin are substrates, inhibitors or inducers of the major cytochrome P450 enzymes. Gabapentin enacarbil is neither a substrate nor an inhibitor of P-glycoprotein in vitro. Dosage and Availability. The recommended dose is 600 mg once daily taken with food at about 5 p.m. Doses of 1,200 mg once GDLO\SURYLGHVQRDGGLWLRQDOEHQHÀW compared with the 600-mg dose, but cause an increase in adverse reactions. If the dose is not taken at the recommended time, the next dose should be taken the following day as prescribed. Tablets are to be swallowed whole, and not cut, crushed or chewed. When discontinuing the drug, patients receiving the recommended dose of 600 mg daily can do so without tapering the dose. If higher than the recommended dose is being used, the dose should be reduced to 600 mg daily for one week prior to discontinuation to minimize the potential of withdrawal seizures. Horizant Extended-Release tablets contain 600 mg of gabapentin enacarbil. Patient Information. Excerpts from the FDA-approved Medication Guide are shown in Table 3.
Yervoy’s manufacturer is touting two important advantages for its QHZGUXJ LWLVWKHÀUVWDQGRQO\ approved therapy for unresectable or metastatic melanoma to demonVWUDWHDVLJQLÀFDQWLPSURYHPHQWLQ overall survival, and (2) it is also WKHÀUVW)'$DSSURYHGWKHUDS\IRU
Table 3 Major counseling points for Horizant (gabapentin enacarbil) extendedrelease tablets* This medicine is used to treat moderate-to-severe primary Restless Legs Syndrome (RLS). Â‡5HDGWKHMedication Guide before you start taking Horizant and each WLPH\RXJHWDUHĂ€OO Â‡7HOO\RXUGRFWRU -if you have suicidal thoughts. The Medication Guide has a list of symptoms to look for; -about all other prescription and nonprescription (OTC) medicines, vitamin/mineral supplements, natural products and herbal remedies you are taking. Do not take Neurontin, Gralise or other gabapentin products. Â‡8VHFDXWLRQZKHQGULYLQJDQG performing tasks that require alertness until you know how you react to Horizant. Â‡$OFRKROLFEHYHUDJHVDQGRWKHU sedating medicines can increase drowsiness. Â‡:20(11RWLI\\RXUGRFWRULI\RX become or intend to become pregnant, or breastfeed a child. Â‡+RUL]DQWLVXVXDOO\WDNHQRQFH daily with food at about 5:00 p.m. Swallow whole; do not cut, crush or chew the tablet. Â‡6WRUH+RUL]DQWDWURRPWHPSHUDture in its tightly closed container, protected from moisture. Do not use after the expiration date on the label. Properly discard unused medicine. *Excerpted from the FDA-approved Medication Guide.
unresectable or metastatic melanoma in more than a decade. Indications and Use. Yervoy (yur-voi) is indicated for treatment of unresectable or metastatic melanoma. Melanoma. Most discoveries in human cancer immunology originate from studies of melanoma. In the past three decades, much has been learned about the immunobiology of melanoma. As knowledge continues to expand, so does the potential therapeutic role of immunotherapy in augmenting
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the antitumor immune responses against melanoma. Metastatic melanoma is the most serious form of all skin cancer. Melanoma is responsible for more than 75 percent of all skin cancer deaths and is one of the most common of all cancers among young adults. Its incidence in the United States increased rapidly during the 1970s, growing at an annual rate of approximately 6 percent. At this point in time, it continues to increase at a rate of approximately 3 percent per year. In 1973, the incidence of melanoma was 5.7 per 100,000 population; by 2002, the incidence had increased to 17.2 per 100,000. Detected early, the prognosis for patients with melanoma is generally favorable, and surgical excision is often FXUDWLYH7KHĂ€YH\HDUVXUYLYDO rate is approximately 90 percent for patients with early melanoma and skin lesions <1.5 mm, and is progressively lower for patients with thicker lesions. By and large, increased response rates observed with combinations of chemotherapy and immunotherapy have not WUDQVODWHGLQWRVLJQLĂ€FDQWVXUYLYDO EHQHĂ€WV Mechanism of Action. CTLA-4 is part of the bodyâ€™s negative regulator of T-cell activation. Ipilimumab binds to CTLA-4 and blocks its interaction with its binding sites, CD80/CD86. Blockade of CTLA-4 augments T-cell activation and proliferation. The mechanism of action of ipilimumab in patients with melanoma is indirect, possibly through T-cell mediated anti-tumor immune responses. Adverse Effects. Most comPRQDGYHUVHUHDFWLRQVÂ•SHUFHQW are fatigue, diarrhea, pruritus, UDVKDQGLQĂ DPPDWLRQRIWKH colon. Warnings, Precautions and Contraindications. The following warnings and precautions are listed: Â‡Immune-mediated adverse reactions (a Boxed Warning). The drug should be permanently discontinued for severe reactions, and the dose withheld for moder-
ate immune-mediated adverse reactions until return to baseline, improvement to mid-severity, or complete resolution, and the patient is receiving less than 7.5 mg prednisone or equivalent per day. Systemic high-dose corticosteroids should be administered for severe, persistent, or recurring immunemediated reactions. For immunemediated hepatitis: liver function tests should be evaluated before each dose of Yervoy. For immunemediated endocrinopathies: thyroid function tests and clinical chemistries should be monitored prior to each dose. Patients should be evaluated at each visit for signs and symptoms of endocrinopathy, with hormone replacement therapy provided as needed. There are no contraindications reported. Drug Interactions. No formal drug-drug interaction studies have been conducted with Yervoy. Dosage and Availability. The recommended dose should be withheld for any moderate immune-mediated adverse reactions or for symptomatic endocrinopathy. Patients with complete or partial resolution of adverse reactions (Grade 0-1), and who are receiving less than 7.5 mg prednisone or equivalent per day, may resume Yervoy at a dose of 3 mg/kg every three weeks, until administration of all four planned doses or 16 ZHHNVIURPWKHĂ€UVWGRVHZKLFKever occurs earlier. Yervoy is supplied in singleuse vials containing 50 mg (5 mg/ mL) and 200 mg (5 mg/mL). Vials should not be shaken. The drug should not be mixed with, or administered as an infusion with, other medicinal products. The diluted drug should be administered over 90 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein-binding LQOLQHĂ€OWHU Patient Information. Excerpts from the FDA-approved Medication Guide are shown in Table 4.
Table 4 Major counseling points for Yervoy (ipilimumab) injection* This medicine is used to treat melanoma that has spread or cannot be surgically removed. 5HDGWKHMedication Guide before you start receiving Yervoy. 7HOO\RXUGRFWRU -if you have an active autoimmune disease such as ulcerative colitis, Crohn’s disease, or lupus; -if you have any of the symptoms of side effects that are listed in the Medication Guide; -about all other prescription and nonprescription (OTC) medicines, vitamin/mineral supplements, natural products and herbal remedies you are taking. 3HULRGLFODERUDWRU\WHVWLQJLVLPportant with this medicine. Be sure to make all testing appointments. :20(11RWLI\\RXUGRFWRULI\RX become or intend to become pregnant, or breastfeed a child. <HUYR\LVXVXDOO\DGPLQLVWHUHGE\ intravenous infusion (into a vein) over about 90 minutes, every 3 weeks for 4 doses. *Excerpted from the FDA-approved Medication Guide.
Several recent studies have reported an increase in the incidence of thyroid cancer during the past decades in the United States and Canada. A new drug for treatment of a rare form of thyroid cancer has been approved. This form of thyroid cancer accounts for less than 8 percent of all thyroid cancers. Indications and Use. Caprelsa (kap-rel-sah) is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. Medullary Thyroid Cancer. Medullary thyroid cancer (MTC) is a malignancy of the parafollicular C cells of the thyroid. About 1000 new cases are diagnosed in the United States each year. MTC accounts for a disproportionate number of cancer-related deaths. MTC
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occurs in sporadic form (75 percent of occurrences) or hereditary form (25 percent of occurrences). The prognosis is generally favorable if the disease is treated at an early stage, with the 10-year survival rate being 70 to 80 percent. Tenyear survival rates are less than 50 percent in persons for whom the cancer has spread to other tissues in their body. The primary and only effective form of therapy for both forms of MTC is total thyroidectomy, with dissection of ipsilateral (same side) and central lymph nodes, extended in some cases to contralateral (opposite side) dissection. Many patients, especially those with a family history of MTC and who were operated on before tumor metastatic spread, are cured by this surgical intervention. However, some patients show persistent disease after primary surgery. Radiation therapy has a limited role in patients with advanced MTC, and conventional cytotoxic chemotherapy has not been proven to prolong survival. Dysregulation of protein kinases in cancer cells is extremely common. Thus, protein kinases are attractive targets for anticancer drugs, including small molecular inhibitors that usually act to block binding of ATP or substrate to the binding site of tyrosine kinase, and monoclonal antibodies that VSHFLÀFDOO\WDUJHWUHFHSWRUW\URVLQH kinases and their binding sites. Mechanism of Action. Vandetanib is a tyrosine kinase inhibitor. The drug inhibits endothelial cell migration, proliferation, survival and new blood vessel formation in in vitro models of angiogenesis. Angiogenesis is the formation of new blood vessels from the pre-existing microvasculature. When a tumor is growing, cells induce angiogenesis in order to recruit new blood supply. In the context of cancer, angiogenesis is the creation of a network of blood vessels that supplies tumors with essential nutrients and oxygen, and removes waste products. Vandetanib inhibits epidermal
growth factor receptor-dependent cell survival in vitro. In addition, it inhibits epidermal growth factor (EGF)-stimulated receptor tyrosine kinase phosphorylation in tumor cells and endothelial cells, and VEGF (vascular endothelial cell growth factor)-stimulated tyrosine kinase phosphorylation in endothelial cells. Adverse Effects. The most common adverse drug reactions (>20 percent) seen with vandetanib have been diarrhea, rash, acne, nausea, hypertension, headache, fatigue, decreased appetite and abdominal pain. The highest number of laboratory abnormalities (>20 percent) were decreased calcium and glucose, and increased ALT. Warnings, Precautions and Contraindications. The following warnings and precautions are listed: Prolonged QT interval, Torsades de pointes, and sudden death (a Boxed Warning). Electrocardiograms and levels of serum potassium, calcium, magnesium and thyroid stimulating hormone (TSH) should be monitored at baseline, at two to four weeks and eight to 12 weeks after starting treatment with vandetanib, every three months thereafter, and following each dose adjustment. The dose should be reduced as appropriate. Stevens-Johnson syndrome resulting in death. Severe skin reactions may prompt permanent discontinuation of vandetanib. Interstitial lung disease (ILD), resulting in death. Vandetanib administration should be interrupted and unexplained dyspnea, cough, or fever investigated. Appropriate measures should be taken for ILD. Ischemic cerebrovascular events. Hemorrhage, heart failure, diarrhea, hypothyroidism, hypertension and reversible posterior leukoencephalopathy syndrome (disorder of the brain’s white matter) have been observed. 9DQGHWDQLEFDQFDXVHIHWDO harm when administered to a pregnant woman. Women should be advised to avoid pregnancy while
Table 5 Major counseling points for Caprelsa (vandetanib) tablets* This medicine is used to treat medullary thyroid cancer that cannot be surgically removed or has spread to other parts of the body. Â‡5HDGWKHMedication Guide before you start taking vandetanib and each WLPH\RXJHWDUHĂ€OO Â‡7HOO\RXUGRFWRU -if you have irregular heartbeat (i.e., 47SURORQJDWLRQ IHHOIDLQWRUOLJKW headed; -if you have any of the side effects listed in the Medication Guide; -about all other prescription and nonprescription (OTC) medicines, vitamin/mineral supplements, natural products and herbal remedies you are taking. Especially tell your doctor if you are taking any heart medicine or St. Johnâ€™s wort. Â‡3HULRGLFODERUDWRU\WHVWLQJLVLPportant with this medicine. Be sure to make all testing appointments. Â‡8VHFDXWLRQZKHQGULYLQJDQGSHUforming tasks that require alertness. This medicine may make you feel tired, weak, or cause blurred vision. Â‡3KRWRVHQVLWLYLW\ZKLFKGHYHORSVDV exaggerated sunburn, occurs in some patients taking this medicine. Avoid excessive exposure to sunlight and ultraviolet light (tanning booths). Using a sunscreen (minimum SPF 15) and wearing protective clothing during normal exposure to sunlight may help prevent this from occurring. Â‡:20(11RWLI\\RXUGRFWRULI\RX become or intend to become pregnant, or breastfeed a child. Â‡9DQGHWDQLELVXVXDOO\WDNHQRQFHD day. It can be taken with or without food. Swallow whole; do not chew or crush the tablets. Avoid contact with the contents of the tablets. If you cannot swallow the tablets, there are instructions in the Medication Guide on how to disperse them in noncarbonated water. Â‡6WRUHYDQGHWDQLEDWURRPWHPSHUDture 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.
The Georgia Pharmacy Journal
receiving vandetanib and for four months following treatment. Â‡%HFDXVHRIULVNRI47SUR longation, Torsades de pointes and sudden death, vandetanib is available only through a restricted distribution program called the Caprelsa REMS Program. Only prescribers and pharmacies certiĂ€HGZLWKWKHSURJUDPDUHDEOHWR prescribe and dispense vandetanib. The only contraindication to use is in patients with congenital ORQJ47V\QGURPH Drug Interactions. Concomitant use of known strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) may reduce drug levels of vandetanib and should be avoided. Patients should also avoid taking St. Johnâ€™s Wort. No cliniFDOO\VLJQLĂ€FDQWGUXJLQWHUDFWLRQ was shown with vandetanib and the potent CYP3A4 inhibitor, itraconazole. Administration of vandetanib with agents that may prolong WKH47LQWHUYDOVKRXOGEHDYRLGHG Dosage and Availability. The recommended daily dose is 300 mg of vandetanib taken orally. Vandetanib treatment should be continued until patients are no ORQJHUEHQHĂ€WLQJIURPWUHDWPHQW or an unacceptable toxicity occurs. The tablets may be taken with or without food. If a patient misses a dose, the missed dose should not be taken if it is less than 12 hours before the next dose. The patient should skip the missed dose and resume therapy with their next regularly scheduled one. The tablets should not be crushed. If they cannot be swallowed whole, they can be dispersed in a glass with two ounces of noncarbonated water and stirred for approximately 10 minutes until the tablet is mostly dispersed. No other liquids should be used. The dispersion should be swallowed immediately. Any residues in the glass should be mixed again with an additional four ounces of noncarbonated water and swallowed. The dispersion can also be administered through a nasogastric or
gastrostomy tube. The product is available as tablets containing 100 mg and 300 mg of vandetanib. Patient Information. Excerpts from the FDA-approved Medication Guide are shown in Table 5.
Overview and Summary
Among the four new drugs listed in this lesson, three (Zytiga, Yervoy and Caprelsa) are indicated for cancer treatment. They, along with Horizant for restless legs synGURPHVKRXOGEHRIEHQHĂ€WWRPDQ\ patients.
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 0129-0000-11-010-H01-P Release date: 10-15-11 Expiration date: 10-15-14
CE Hours: 1.5 (0.15 CEU) The Ohio Pharmacists Foundation Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
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continuing education quiz
Program 0129-0000-11-010-H01-P 0.15 CEU
New Drugs: Horizant, Caprelsa, Yervoy, and Zytiga
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The Georgia Pharmacy Journal
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