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2010-2011 GPhA Presidentâ€™s Inaugural Address
14 GPhA New Members 31 GPhA Board of Directors
Advertisers FEATURE ARTICLES
11 12 13 17 18 19 21
2010 Legislative Session Recap APhA Immunization Program Congratulations to the University of Georgia Graduates
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The Insurance Trust Principal Financial Group Melvin M. Goldstein, P.C. Logix, Inc. AIP Michael T. Tarrant Design Plus Store Fixtures, Inc. Pharmacists Mutual Companies GPhA Workers Compensation Toliver & Gainer The Insurance Trust
Why Kroger Pharmacist Marsha Kapiloff Backs Pharm PAC
Congratulations to the Mercer University Graduates Congratulations to the South University Graduates CPE Opportunity: New Drug Update 2010
Presidentâ€™s Message Editorial
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PRESIDENTâ€™S MESSAGE Dale M. Coker, R.Ph., FIACP GPhA President
2010-2011 Inaugural Address
irst, I would like to thank you for allowing me the opportunity to serve as your next president. I have had the privilege of serving with some outstanding leaders of our profession on the Executive Committee the past three years. This Executive Committee has a lot of experience from which to draw. I have learned so much from my predecessors. Eddie M. Madden, R.Ph., has given me a better understanding of the political process. Robert C. Bowles, Jr,. R.Ph., CDM, CFts, has taught me that you have to learn to ask the right questions, and in Sharon M. Sherrer, Pharm.D., CDM, I was able to observe first hand her passion and love for her profession and for this association.
without you. You have been like a brother to me. You will always be in my heart.
Lastly, I would like to thank my family. My mom and dad could not be at the Convention, but I want to thank them for laying a solid foundation of principles and work ethic that has made such a profound impact on all their children. Their value system and love of family has now been extended to three generations. Now, I want to recognize my immediate family. My daughter, Laura Coker, who many of you already know, just finished her third year of pharmacy school at Mercer University and is now doing her rotations.
I would also like to thank Jim Bracewell for his leadership, both on the state and national level. The thing I admire most about Jim is the way he has raised the bar for transparency in our organization. I look forward to serving with Jack Dunn Jr., R.Ph., Robert M. Hatton, Pharm.D., and our new Second Vice President and hope I can be the mentor to them as our past presidents have been for me.
Scott will be entering his third year at the University of Georgia this fall and is currently counseling at a Christian summer camp in Dahlonega. He was able to get a 24-hour furlough in order to attend my inauguration. What a blessing you two have been in my life. Watching both of you mature into the people you have become is the greatest reward a parent can have. I am so proud of both of you!
I could not have committed to do what I have done over the past three years without a great pharmacy staff. They have carried the load when Iâ€™ve been away on association business without missing a beat. So, thanks Kathy, Chris, Hollie, Kelly, David, John, Gigi, and Sarah. I sincerely appreciate their dedication and hard work. I would also like to thank Devera Moeller who helped to make a smooth transition when we opened our compounding pharmacy. And a special thanks to my long time friend and former business partner, Larry Wilson, who was diagnosed with liver cancer just over two years ago. Larry, I could not have realized my dream
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And last, but certainly not least, I would like to thank my wife, Susan. We will be celebrating our thirty-fourth wedding anniversary in August. When I have needed support, you have always been right there. When I decided to start my own business, even though you probably thought I was crazy, you stood by me, and supported me, literally. Then when I went two years without a paycheck, you had reason to believe I was crazy, but you never complained and always had encouraging words. Thank you, honey, for always being there for me and always loving me. I would certainly not be where I am today without you. I love you.
treatment with drugs. The question mark represents the role of pharmacy in the future. How will we position ourselves to take advantage of the opportunities that will be afforded to us in health care reform and the new age of pharmaceuticals? Will we be ready, or will many of us dispense ourselves out of existence?
From my all time favorite movie came this question, â€œMama, whatâ€™s my destiny?â€? In the grand scheme of things, Forrest Gump wanted to know where he fit in. As we begin a new chapter of health care in this country, we as a profession will need to find our place. Where will we fit in? So, here, I will ask the questions of our profession and our association, â€œWhat is the destiny of our profession and our association?â€? And, on a more personal note, â€œWhat are we, individually, willing to do to help shape that destiny?â€? I have chosen the theme â€œPharmacy Forward: Dispensing Destinyâ€? for my year as president.
The dispensing function has more or less defined the pharmacistâ€™s role in health care. If there is any doubt about this, just watch the evening news when a pharmacist is interviewed (in Atlanta, of course, that would be Ira Katz, R.Ph.). What does the camera man always zoom in on? Thatâ€™s right, the pharmacist counting pills from a counting tray.
The graphic for the theme on the cover of this issue of the Journal depicts the past and present of our profession. The scales and the show globe represent the roots of our profession, which was compounding, something that is near and dear to my heart. Compounding is an art that we almost lost through neglect, and is something we must strive to maintain and defend, as it is our very heritage. The DNA strand represents the future of pharmacy and pharmaceuticals. This depiction shows the DNA strand overlapping the mortar & pestle. As compounding has always represented individualized care, I believe that as more and more drugs are genetically engineered, there will once again be a greater emphasis on individual approach to
The word â€œdispenseâ€? can have a couple of different meanings. The one we are familiar with in our profession is â€œto prepare and give out.â€? But to â€œdispense withâ€? means â€œto forgo or manage without.â€? It is my belief that the future of our profession hinges on our willingness to â€œdispense with, or manage without,â€? the traditional dispensing function. We must move pharmacy forward by championing the ideal of dispensing our knowledge and our service instead of dispensing a product. As we look to that future of our profession, it is wise to take a step back and look at where we are now, but also where weâ€™ve been.
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Friedrich Nietzche said â€œThe most fundamental form of human stupidity is forgetting what we were trying to do in the first place.â€?
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Well, what was this association trying to do in the first place? You need not go any further than our website to find out. Just click on history and here is what you will find:
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â€œIn the summer of 1875, a concerned group of Georgia pharmacists sent a notice to all the pharmacists of the state, requesting them to assemble in Macon on October 20, 1875:
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â€œ...to consider the organization of a pharmaceutical association, binding each other with closer ties of friendship and to promote interest in the junior members of the fraternity and exciting the spirit of emulation and ambition; the interchange and dissemination of scientific researches; the framing of laws to be enacted that will result not only in the protection of the profession but the public in general.â€?
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at the Convention, but are we engaging them throughout the year? And how do we keep student members engaged once they graduate? How are we using the latest in technology to keep them engaged? Kelly McLendon is to be commended for her work in engaging students and new practicing pharmacists through avenues such as an electronic Journal option and Facebook. Personally, I was very reluctant at first, but with the help of my children, I took the giant step of signing up for Facebook.
The first thing I would like to ask “How are we ‘...a concerned group of Georgia pharmacists?’” Our pharmacist legislators and our lobbyists talk about grassroots efforts all the time. This is where it all begins. As pharmacists we must be concerned about decisions that affect the future of our profession. I remember when Jim Bracewell called me just over three years ago to encourage me to run for Second Vice President of GPhA. I told him that I was concerned that as a compounding pharmacist, my issues in the profession would not reflect the vast majority of our membership. Jim reminded me of the one thing I did have that would serve me well in representing this association. That one thing is passion for the profession. Concern and passion for the direction of our profession is what we must have to ensure our future.
One of the very first messages I got once I had some pictures posted with my family, was a message from a young man who said, “Parents, they’re taking over Facebook.” What a welcome into the brave new world of Facebooking. For me personally, one of the most rewarding aspects of being on the Executive Committee, has been participating in the New Practitioner’s Leadership Conference each year. We need to continue to place more and more emphasis in recognizing and grooming potential leaders in our profession.
How would we assess ourselves in carrying out the organizational objectives of our association? First, how have we done with “...binding each other with closer ties of friendship?” For me, this has been the most rewarding aspect in my association with GPhA. It is the one thing that stands out as I have met and talked with pharmacists around the state over these past three years. What about our membership? Are we offering networking opportunities that are effective in today’s world, both socially and professionally?
How would our association be assessed on “...exciting the spirit of emulation and ambition?” Now, I’m sure most of you bright pharmacy students going for your doctorate degree know what “emulation” means. As for me, being just an ordinary R.Ph., I had to look it up. Webster’s defines “emulation” as “ambition or endeavor to equal or excel others.” And I will repeat that… “...ambition or endeavor to equal or excel others.”
At this time last year, President Eddie Madden had the foresight to begin the process for a five year strategic plan for our association. Last October, pharmacists representing every facet of pharmacy and pharmacy school students came together to form the framework for a strategic plan. The plan was adopted by our Board of Directors in January of this year. There are two key elements of the plan, membership and advocacy.
One of GPhA’s tag lines is “A tradition of excellence.” As I have traveled around the country to meet with representatives of other state associations, in comparison, we truly do excel in many areas including leadership, membership, political involvement, but the pursuit of excellence never ends. Once it does, the Georgia Pharmacy Association begins to die. The pursuit of excellence requires a team effort, avoiding factions that separate and divide.
It was decided that we must begin by engaging our membership and proving the value of membership in GPhA. Strategic directives were identified to attain a twenty percent increase in our membership over five years. This year, the Executive Committee will be developing a strategic plan scorecard to evaluate and improve the plan to achieve our goal.
In some states, the independent pharmacies have formed their own associations. And in others, there is little cooperation between the hospital pharmacists associations and the state associations. In Georgia, the Academy of Independent Pharmacy stands in 100 percent support of the parent organization. I applaud the leadership of AIP for their diligence in adopting new by-laws in accordance with the mission of GPhA. Also, GPhA and GSHP have made great strides in the past few years to work together for the common good of our profession and our patients.
Let’s take a look at the next organizational objective. How would we assess where we are with “...promoting interest in the junior members of the fraternity?” There are roughly 76 students at the Convention who have been sponsored by many of you in this room. I think we have done an exceptional job in promoting student participation
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positioned to provide critical care in the event of a local or national public health disaster. Jean Sumner, M.D., immediate past president of the Medical Board, commented that pharmacists are the most over educated and underutilized health care professionals in the state. Over-educated and under-utilized: isn’t that a stigma that we would rather not have associated with our proud profession? Well, getting out front in responding to a public health disaster could go a long way toward doing just that.
As far as our individual members, how have we done to equal or excel others? The list is a long one indeed. Eddie Madden was recently honored with APhA’s Hubert Humphrey award. John T. Sherrer, R.Ph., is Second Vice President of the National Community Pharmacists Association. Hugh M. Chancy, R.Ph., was named NCPA’s pharmacist of the year in 2009, and was recently inducted as Fifth Vice President of NCPA, and Jonathan G. Marquess, Pharm.D., CDE, CPT, is a candidate for APhA’s Board of Trustees.
And lastly, how have we done with “...the framing of laws to be enacted that will result not only in the protection of the profession but the public in general.” Again, referring to the five year strategic plan being implemented this year, the two major initiatives identified were membership and advocacy. The political cry, “get into politics, or get out of pharmacy” applies more now than ever before. We must remain on the offensive to protect and preserve our profession but we must also be on the defensive. Sometimes our greatest successes are the bills that never become laws. They say that in football, defense wins games. The same can be said about the legislative process. This is part of the planning each year, to develop a defensive posture against legislation that would be detrimental to the profession of pharmacy.
I hesitated to name names, for fear of leaving someone out, but the list of leaders in our profession, in our pharmacy schools, in our legislature, and in our communities and local governments is truly impressive. All of you need to be commended for your dedication and service. How about “...interchange and dissemination of scientific researches?” How would we assess where we are? We now have continuing pharmacy education requirements that they didn’t have in 1875, yet those pharmacists were interested in sharing information and staying current in their practices. I believe this is the greatest opportunity for growth in our association. Are we providing timely continuing pharmacy education geared to the needs of the different practice settings? Should there be a requirement for live C.P.E.? Should we seek greater involvement from the pharmacy schools to publish research articles in our Journal? Should we redefine the purpose of our Region Meetings to include more C.P.E.? All questions that I will be seeking answers for during the coming year.
We have had some huge successes the past two years. Two of the biggest were passing legislation giving us legal authority to administer flu vaccines under protocol and most recently, requiring Pharmacy Benefit Managers to register with the Insurance Commissioner. As big as these successes were, neither got us where we need to be, but as Stuart Griffin has often told us about strategy: sometimes we have to take what we can get in the legislature to get a foot in the door and start with a solid foundation. Now that the door has been opened, we can build on the foundation to the ultimate goal of administering any vaccination without protocol and PBM transparency. This strategy has served us well in the past two legislative sessions, and I believe it will continue to serve us well as we stay the course.
We will continue to explore continuing pharmacy education opportunities in some fun and exciting venues, such as a Colorado ski trip which was offered in January and the upcoming Alaskan Cruise in August. There is still time to sign up. I hope many of you will join us. I hope you will also take advantage of the many continuing pharmacy education opportunities we will be offering in the future. We want GPhA to be “The Source” for continuing pharmacy education for our membership.
As I have contemplated the current state of our profession and my question about the destiny of pharmacy in Georgia, I see a lot of positives. Many of them I have already mentioned. We are highly respected across the country as a dynamic and innovative association. We have a lot going for us, but we can’t rest on our laurels.
I applaud the action of our State Board of Pharmacy in requiring three hours of disaster preparedness continuing education. This came about largely as a result of the Georgia Composite Medical Board and the Georgia Division of Public Health recognizing the importance of pharmacists as valuable members of the health care team who are
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As much as many of us love the traditions of our association, we can’t continue with the attitude that we have to do things a certain way because that’s the tradition, and that’s the way it was always done. Sometimes holding onto tradition can keep us from changing with the times. I am a firm believer that tradition and change can peacefully coexist.
that perception. We have opportunities offered us through avenues such as MTM. It is time for pharmacy reimbursement to be based on patient care performance and outcomes. With health care reform, like it or not, we will be challenged to perform. We must take advantage of these opportunities if we want to change the perception of our profession from the dispensing mode to the professional health care provider mode.
One of the major challenges we face as an organization is to continually seek out and engage those who are apathetic toward issues that affect the future of our profession, or who are just too busy to care.
A new generation of pharmacists is coming out of pharmacy schools equipped for pharmacy care services. Our pharmacy schools have done an outstanding job of preparing our future pharmacists through study, experiential learning, and service to the community. As employers, we must ensure that these bright young pharmacists are given the opportunity to display their skills in providing pharmacy care services.
Arnold Toynbee said, “Apathy can be overcome by enthusiasm, and enthusiasm can only be aroused by two things: first, an ideal, which takes the imagination by storm, and second, a definite intelligible plan for carrying that ideal into practice.”
Albert Schweitzer said, “I don’t know what your destiny will be, but one thing I know: the only ones among you who will be really happy are those who will have sought and found how to serve.”
The two key words here are ideal and plan. I believe the ideal is for pharmacists to be recognized, both professionally and financially, for the services we provide to our patients, rather than the products we dispense.
It has been the mindset of pharmacists for many generations, to serve their patients and their communities.
So what is our plan for achieving this ideal? Our association has undertaken a strategic plan that emphasizes advocacy for our profession. We need a strong PAC, an organized grassroots effort and effective lobbying to effect the changes to put our ideal into practice. Such was the case in passing of the Safe Medications Practice Act, a bill which was introduced by Rep. Ron Stephens, R.Ph., in the House, carried by Sen. E.L. “Buddy” Carter, R.Ph., in the Senate, and championed by Burnis D. Breland, B.S., FASHP, M.S., Pharm.D.
To quote from my favorite book, the Holy Bible, Proverbs 17:11 says “A merry heart doeth good, like a medicine.” True fulfillment in our profession comes from serving our patients and their needs. I would like to close with another quote from Albert Schweitzer. “An optimist is a person who sees a green light everywhere, while a pessimist sees only the red stoplight... the truly wise person is colorblind.” May we all be colorblind in our pursuit to move pharmacy forward as we Dispense Our Destiny.
This bill codifies the importance of the pharmacist’s involvement in medication therapy management(MTM). This bill also codifies the importance of collaboration between the pharmacist, physician and other clinical practitioners in the institutional setting. Are we ready for such an ideal in the community pharmacy setting, where pharmacists would have greater involvement in health care decisions, such as ordering tests and interpreting test results, making appropriate dosage changes, and monitoring anti-coagulant therapy under protocol? How about a third class of drugs or limited prescriptive authority? How far do we want to expand our scope of practice? I believe that we have perpetuated the notion that we are dispensers of medication rather than providers of services. Now, more than ever before, we are in a position to change
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EXECUTIVE VICE PRESIDENT’S EDITORIAL Jim Bracewell Executive Vice President / CEO
“I Have Not Yet Begun to Fight.” ~John Paul Jones
have always been inspired by those words and the spirit of John Paul Jones. What a patriot. What a lover of America. What an inspiration to all of us as we celebrate our nation’s birthday this month.
What can you do to assure our continued success? You can become politically active. GPhA is determined not to let the government put pharmacy out of business. GPhA is determined not to let the unregulated practices of PBMs put pharmacy out of business. GPhA Pharm PAC is our source for ammunition for the guns of GPhA. Are you sending ammunition to GPhA for the fight? Are you a monthly contributing member to Pharm PAC? We can only fight for you with the ammunition you give us.
I respect Jones so much that I sought out and visited his tomb in the basement of the United States Naval Academy Chapel in Annapolis, Maryland. It is guarded 24/7 by an armed Marine. What honor and love they have for Jones. But, enough of my emotion driven comments on history. What I want to ask you, the pharmacists of the Georgia Pharmacy Association, is, “Have you yet begun to fight?”
Go to the GPhA website www.gpha.org today or call Kelly McLendon and 404-419-8116 and “Back Pharm PAC!” – Pharm PAC needs your help like you need GPhA’s help.
This year in our state we have a watershed event. A perfect storm if you will, that can change health care and more specifically pharmacy in our state for years to come. This year we elect a new Governor. This year we elect a new Insurance Commissioner. This year we elect a new Attorney General. This year there is a new beginning for pharmacy in Georgia. Like John Paul Jones, pharmacy has been out gunned by the bigger ships of Pharmacy Benefit Managers. Pharmacy has been out run by insurance companies. Pharmacy has too long been on the menu of health care reform rather than at the table. In this issue we rolled up our sleeves and like John Paul Jones, we took their ships. We passed six pro- pharmacy pieces of legislation. We helped elect a pharmacist to the Georgia Senate. We stopped all negative pharmacy legislation, and we “...have not yet begun to fight...” for pharmacy in our state. We are ready, more than ever, to challenge all those who challenge this profession.
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Doyouwanttoworkforan IndependentPharmacy? Doyouwanttoownyourown pharmacy?
CallJeffLurey,R.Ph. AIPDirector 404Ǧ419Ǧ8103 firstname.lastname@example.org
Upcoming AIP Events Save the Date:
AIP Fall Meeting Sunday, September 12, 2010 Macon Marriott & Centreplex, Macon, GA
2010 Legislative Sessions Recap any of you are wondering why GPhA is putting the legislative recap in the July Journal. Many of you remember how disappointed we were when the Governor decided to veto the PBM bill in May of last year that we worked so hard to pass. This year GPhA wanted to give the Governor ample time to sign our bills. GPhA appreciates the Governor’s positive response to all propharmacy legislation that was passed during the 2010 legislative session.
The Executive Vice President of GPhA. Jim Bracewell, mentioned the other day that he cannot remember a year in the history of GPhA, nor can he think of another state pharmacy association that has had such a run passing pro-pharmacy legislation as Georgia during the 20092010 legislative term. Below is a list of what GPhA Government Affairs has accomplished over the 2009-2010 legislative term. HB217 & HB1154 In 2009, GPhA passed HB217 that allowed pharmacists to administer the
influenza vaccine via injection through a physician protocol. During the 2010 session we came back and extended the protocol in HB1154 to allow influenza vaccine to be given via nasal administration (Flu-Mist). HB368 & SB353 HB368 and SB353 are the drug update bills that pass the General Assembly every session to update the drug schedules accordingly. This type of legislation doesn’t take much to pass, but we have had the ability to stop any anti pharmacy amendments that attempted to make their way onto these bills. SB195 As e-prescribing becomes more prevalent, there are certain things that are not consistent with the way Georgia code is written concerning prescribing in general. Two of these inconsistencies that dealt with a physician’s digital signature and the notation of “Brand Necessary” written digitally opposed to in the physicians own handwriting, have been fixed via SB195.
Stuart Griff in Director of Government Affairs HB361 HB361 was introduced during the 2009 Legislative Session by Rep. Ron Stephens. HB361 specifically focuses on pharmacy practiced in an institutional setting. The bill codifies the importance of the pharmacist’s involvement in medication therapy management. HB361 also codifies the importance of the collaboration between the pharmacist,
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physician and other clinical practitioners. Although the bill only pertains to pharmacists in an institutional setting, the bill is very important for the practice of pharmacy as a whole as it recognizes pharmacists as highly trained medication therapy experts and as vital components in the welfare of their patients. SB310 This year was a success with GPhA’s number one priority of PBM regulation finally passing the Georgia General Assembly. On June 2, 2010, the Governor signed this bill into law. SB310 becomes effective January 1, 2011, and requires all PBM entities that operate in the State of Georgia to be licensed through the Department of Insurance.
SB310 was used as a vehicle to pass legislation that reduced the barriers of entry for MEWA insurance plans. As you know, GPhA owns the only MEWA in the state of Georgia. The new language required all MEWAs to take part in joint and several liability. Although good for new MEWAs, joint and several liability would have damaged the financial structure of an existing MEWA. We successfully exempted the Georgia Pharmacy Association’s Insurance Trust from the joint and several liability language. Defense Many industries that operate government affairs programs know that at some point some other entity will introduce legislation to harm their industry in one way or another. The pharmacy
association is no different. Over the past two years there have been multiple pieces of legislation that would harm the way you practice pharmacy in Georgia. GPhA has a record of 100 percent in stopping legislation that would be harmful to the pharmacy industry. Now that we are heading into an election year, I hope all of you will get involved in helping pro-pharmacy candidates. Between AIP and the GPhA Pharm PAC, the Georgia Pharmacy Association will be giving over $330,000.00 in political contributions over the 2010 election cycle. We hope that the Georgia legislators will see how important the practice of pharmacy is to us and how we are willing to “put our money where our mouth is” in order to promote propharmacy legislation.
APhA Immunization Program Pharmacy Based Immunization Program was held on April 17, 2010, in Macon, GA. This is an innovative and interactive training program that teaches pharmacists the skills necessary to become a primary source for vaccine information and administration. The program teaches the basics of immunology and focuses on practice implementation and legal/regulatory issues. As part of the training the participants gave (and received) subcutaneous and intramuscular injections. Thirty-seven participants attended this program. Each participant was awarded a certificate of achievement, and a total of 20 hours of continuing education credit for successful completion of all components of the program.
The goals of the program were to: • Provide comprehensive immunization education and training. • Provide pharmacists with the knowledge, skills, and resources necessary to establish and promote a successful immunization service.
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• Teach pharmacists to identify at-risk patient populations needing immunizations. • Teach pharmacists to administer immunizations in compliance with legal and regulatory standards. Thanks to Daniel K. Forrister, Pharm.D., and Sukhmani K. Sarao, Pharm.D., who are Clinical Assistant Professors at the University of Georgia. Participants who attended the program: Genevieve McArthur Betts Amber D. Brandt Anita G. Browne Sherrie B. Collins, R.Ph. Kari M. Coody, Pharm.D. Herman Mike Davis Amy Elhamshary Khirsty Frizzell Carson W. Gleaton, Pharm.D. Cari Schroeder Happe, Pharm.D. Earl R. Henderson, Jr., R.Ph. Wayne M. Herndon Willene B. Hodges, R.Ph.
John L. Lee, R.Ph. Arthur C. Lee Mariam Majidi Regina Maniquis, Pharm.D. Carey Martin, III Suzanne Martin Len McCook, R.Ph. W. Troy McCorkle, R.Ph. Valeria McIntyre, Pharm.D. Vimal Dinesh Parag, Pharm.D. Misty Jones Potts, R.Ph. Dwayne R. Ragan, R.Ph. Anthony Boyd Ray, R.Ph. Holly Walker Ritter Amanda T. Roberson, R.Ph. Paul Alex Sandstrom Jan Webb Satterfield, R.Ph. Dean Stone, R.Ph., CDM Krista D. Stone, R.Ph. William A. Strickland, R.Ph. Edwin Studstill, R.Ph. Tim Thompson, R.Ph. Kristopher Tidwell Austin Tull
PHARMACY SCHOOL NEWS
GPhA Congratulates University of Georgia College of Pharmacy 2010 Graduates Navid Reza Amlani Evan Darwin Anderson Mathur Husam Badr Megan Jeanette Baggett Ora Jessica Bailey Bishakha Bandyopadhyay Christi Creighton Bell Kimesh Bhana Lauren Rachel Biehle Amy Tarrer Blount Travis Elliot Board Caitlin Anne Bowers Robert Bowen Brady, Jr. Elizabeth Hutto Brown Laura Taylor Brown Lora K. Brown Katie Beth Campbell Weston Ryan Carter Christy Cathryn Cecil Jane Chang Ameen Hussain Chaudhry Seon Mee Chung Christopher Elton Coleman Margaret Haden Cottingham Samantha Kate Dempsey Caroline Carlisle Dennis Joseph Michael Dobry Sarah Elizabeth Davis Dorsey Abraham J. Duncan Leigh Anne Dye Kristin Dee-Dee Edwards Humphrey Nosayaba Ehigiator Amy Meredith Ellis Christine Leigh Elson Rola Mousa Franks Cristy Marie Gaddy Anna Harden Gassett Meghan Amy Gettis Miller Walton Gibbons Bailey Holland Guest Christopher Ryan Gurley Christopher Ryan Haire The Georgia Pharmacy Journal
Jennifer Nicole Hall Jamie Leighanne Harris Adriana Aneta Hasselbring Melissa Jean Herndon Quynh-Nhu H. Ho Justin Thomas Holland Roxanne Askins Hotz Jamie Leigh Huckaby Ikpeme I. Ikpeme Cecilia J. Inhulsen Temitayo Latifah Isola Katherine Leigh Jackson Lindsey Ann Jackson Melinda Edwina James Sherita Latoya James Christopher Zachary Johnson Natalie Dianne Johnson Heather Michelle Jones Jennifer Marie Jones Kimberly Ann Kaptain Heather Marie Kerstner Bryant Jerrell Knight Robert Dak Chi Ko Alina Maylene Kuo David Bishop Laist Jamie Diane Lake William Tyler Landers Kara Michelle Lavin Robert Cecil Luschen Yen Kim Mach Regina Bernadette Maniquis Merinda Barbara Mason Philip Tyler Mayotte Jonathan Courtney McKoy Katherine Ann McMichael Elaine Rachel Mebel Saleha Hina Mehmood Kimberly Anne Millward Ben Collier Moon Kristen Leigh Motlow Lisa Marie Murphy Elizabeth Lynn Myhrberg 13
Kayla Nicole Mylius Vidya Nair Kiet Tuan Ngo Olubusola Opeoluwa Oluyemi Matthew Scott Owens Manav B. Patel Manisha Patel Sunil P. Patel Emily Carroll Peck William Joseph Pendergrast Jay Allen Perdue Jina Helmey Perdue Andy Wild Perez Marissa Ann Peterson Elizabeth Kathryn Poirier Ross Daniel Rainey Elizabeth Engelmann Raven Timothy Wayne Rice Ashley Nicole Rochester Alexandre Rogalevitch Anthony Carlos Scott Megan Brittany Shaw Mansi Tushar Sheth Olufunke Jadesola Shittu Heather Diane Staton Carl Craig Stingel Rebecca Jean Hutchinson Stone Elizabeth Stark Strohsnitter Vincent Michael Strohsnitter Stephen Andrew Thomas Laura Elizabeth Thompson Maria Miller Thurston Kimberly Heather Toole Sarah Elizabeth Walker Lindsey Lee Warren Tyler Cole Whitaker William David White Sidwin Delnee Wilcox Angela Barry Williams William Burt Wrenn, III
GPHA MEMBER NEWS
Welcome to GPhA! The following is a list of new members who have joined Georgia’s premier professional pharmacy association! Jun Li, R.Ph., Dublin Melissa F. Luce, Pharm.D., Saint Simons Island James Reid Malone, R.Ph., CGP, Atlanta Marie McBryde, Lillington, NC Zachary McBryde, Pharm.D., Johns Creek Clementine Ebenye Nanje, Powder Springs Minh James Pham, Pharm.D., Chamblee Allene Pitts, Columbus Willa Xu Qiang, Pharm.D., Alpharetta Jonathan L. Sinyard, Pharm.D., Cordele
Jennifer Bass, Pharm.D., Smyrna James Brent Brown, O.D., Atlanta Blake Daniel, R.Ph., Griffin Scott Hill, Pharm.D., Charleston, SC Asmerom Mosazghi Hagos, Pharm.D., Lawrenceville Larry G. Holt, R.Ph., Cassville Jessica Ruth Humphries, Pharm.D., Atlanta Linus Amaechi Igbokwe, R.Ph., Lawrenceville Heather Michelle Jones, Pharm.D., Chatsworth Stanley Richard Lenchner, R.Ph., Marietta
If you or someone you know wishes to join the Georgia Pharmacy Association you need only visit www.gpha.org and click “Join” at the top of the page. You can pay by credit card and your membership begins immediately. If you have any questions please call Kelly McLendon at 404-419-8116.
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South Carolina 14
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*Dividends cannot be guaranteed; however, they have been returned uninterrupted since 1909. † Notice: This is not a claims reporting site. You cannot electronically report a claim to us. To report a claim, call 800-247-5930. Not all products available in every state. Pharmacists Mutual Insurance Company is not licensed in HI or FL. The Pharmacists Life Insurance Company is not licensed in AK, FL, HI, MA, ME, NH, NJ, NY or VT. Pro Advantage Services, Inc., d/b/a Pharmacists Insurance Agency (in CA) is not licensed in HI. Check with a representative or the company for details on coverages and carriers.
PHARM PAC NEWS
Why Kroger Pharmacist, Marsha C. Kapiloff, R.Ph., Backs Pharm PAC
Marsha C. Kapiloff, R.Ph. Kroger Pharmacist and Pharm PAC Contributor
Unfortunately politics is not free. I have been a contributor to Pharm PAC for many years and will continue to always support Pharm PAC. We are little fish fighting the sharks like insurance companies, Medicaid, PBMs, and drug manufacturers. We need to know that those in the legislature will know where we stand to protect the pharmacy community and our patients. Through the years we have seen the reductions in reimbursements from the state. Our reimbursements cannot be the first area of government cuts. With the economy the way it is we need Pharm PAC more than ever. This is a crucial year for elections. Many people are discouraged with the economy and want to change the current elected officials. This year sees many offices up for grab. I feel it is especially important to ensure we support those candidates who support pharmacy. With this in mind I made an additional contribution this year. I encourage every pharmacist that believes in our trusted profession to stretch this year and give Extra to Pharm PAC. This is why I back Pharm PAC.
have been employed with The Kroger Company since I graduated from the University of Georgia. I worked in the Atlanta metro area for ten years then moved to Macon, Georgia. I have mostly worked as a pharmacy manager, but currently I am a floater for middle Georgia. This allows me the freedom to teach fifth graders on Sunday at church.
As a child I observed my mother volunteering all the time on one committee or another. Hers was the example for me to follow. As a student at University of Georgia I became an active member of the Student Pharmacy Association. It was just natural for me to remain active in the Georgia Pharmacy Association after graduation. Each year I would take my vacation from work to attend the GPhA Conventions. By attending the business sessions I was able to see how the association worked for the profession, and I knew that I wanted to be an active participant. Since then I have served on most of the GPhA Standing Committees, as Region President, and on the Board of Directors for several years. One of the duties of the Region President is to seek new members. I realized very few chain pharmacists were members of GPhA at that time. My goal was to change that number. When I asked them why they were not members the overall response was because the association did nothing for them. So I asked questions like, “Do you want your job or do you want a mail order pharmacy to have your job?”
Lawyer and Pharmacist Leroy Toliver, Pharm.D., R.Ph., J.D. • Professional Licensure Disciplinary Proceedings • Medicaid Recoupment Defense • Challenges in Medicaid Audits • OIG List Problems • SCX or Other Audits
“Do you want to be paid fairly for the prescriptions you dispense?” “Do you want to have to call the doctor every time you generically substitute a prescription?”
Leroy Toliver has been a Georgia Registered Pharmacist for 34 years. He has been a practicing attorney for 25 years and has represented numerous pharmacists and pharmacies in all types of cases. Collectively, he has saved his clients millions of dollars.
“Do you want to have to get a prior authorization on every Medicaid prescription?” The list went on and on. These pharmacists were unaware what GPhA did for them. I asked then GPhA President, David B. Graves, R.Ph., to consider an academy for the employed pharmacists so they would feel more included in GPhA. That became the Academy of Employee Pharmacists, now the largest membership academy in GPhA.
Toliver and Gainer, LLP 942 Green Street, SW Conyers, GA 30012-5310 firstname.lastname@example.org 770.929.3100
Our association has a duty to protect our profession. Many of us do not have the time or the expertise to lobby for our issues. That is where Pharm PAC shines. They are able to determine the issues and where each candidate stands on these issues.
The Georgia Pharmacy Journal
PHARMACY SCHOOL NEWS
GPhA Congratulates Mercer University College of Pharmacy and Health Sciences 2010 Graduates Pharm.D. Graduates Linsi E. Adams Terry Michael Aldridge Leena Amine Carrie L. Ashley Jennifer Rhea Ausenbaugh Justin D. Austin Allyson Marie Berg Shacey Lynn Bishop Brian Gregory Blanar Akosua Kumiwa Boateng Randi Lynette Bridges Ginger Sanders Brown Mary Katherine Brown Sarah Larae Brown Holly Elizabeth Cagle Laverne A. Cameron Melody Crystalle Castro Omolola Cole Charles Cordaro Honeylit Katje Cueco Jennifer Leigh Dawson Kara Ray DeBord Sarah Ahmed Desoky Ann Hoang Dinh Mark Anthony Dowell Matthew Forbes Duff Pierre-Alex Duvivier Justin Todd Eason Ebony N. Ervin Carolyn Ekwutosi Eze David Michael Farino Brannon Scott Flores Raena Colleen Garcia Kevin Wayne Garrett Andrea Rose Gauld Katherine Park Gillette Ria Lynn Gober Eric Jeffrey Goldstein Brandi Fannon Gregg April Faith Griner Asmerom Mosazghi Hagos Lyndrick Lee Hamilton Johnathan W. Hamrick
Stephanie Marie Nemyer Sally Elizabeth Neubauer Stephanie Nicole Nielsen Amy Elizabeth Noonkester Julie Reagan Norman Guillermo Enrique Nun'ez Mark Olanrewaju Ogunsusi Jeehoon John Oh Omotola M. Oluyide Stephen Obehi Osakue Jr. Shirish Kishor Parbhoo Avi Patel Biral V. Patel Dimple Patel Neelam Kishar Patel Purvish D. Patel Ashley Elizabeth Patrick Clint Douglas Patrick Benjamin Karl Pearson Hang T. Pham Minh James Pham My Quang Thi Pham Timothy Parris Pope Molly Coker Prentice Bobby Jermaine Price Paige Vickery Price Nisha Ashwini Rajasekaran Monali B. Rathod Aimee Craven Reinhard Tina Rezakhani Alexis Theresa Robinson Yeimi Yairel Rodriguez Amy Newman Rogers Melinda Dawn Rowland Thomas C. Rumph, III Christa Lynne Russie Momo X. Ruthsatz Adam Richard Schnepp Paul McCollum Schrimsher Lisa Lynn Soderlind Terry McGraw Staton Tristen LeAnne Staton John Adam Titak
Jancie S. Hatcher Janet Rose Martinez Tyler Clark Hickman Benjamin James Higley Patrick L. Holt Chase Mahon Hyer Megan Brock Jacobs Mark C. Jerris Anthony John Jacob Allen Jolly Jessica Lynn Jones Brandon M. Jump Jonathan Michael Kaup Shae Nicole Kennedy Saad Khan Kenneth B. Kicklighter, Jr. Michael Scott Kilpinen Molly Snyder Knowles Tekla Rahayu Kovash Glenda L. Kuhlmeier Ngoc My La Liana Ngoc Le Chloe Rebecca Hanson Melissa Litchfield Cayce Blake Mark Lord Mohamad N. Lotfi Adriene AubRay Lucas Salome Ligia Lulusa Joyce N. Ngugi Arthur Howard Mann Mandana Manouchehri Lindsey Erin Mansell Zachary Wesley Martin Abby Church Massengale Courtney Anne Mays Joseph Hilbert McCoy Sarah Elizabeth McCranie Jessica L. Miranda Dina M. Mokhtar Jason Dean Montegna Shannon Leigh Moskowitz Sheila Robin Nasre Peter Kamau Ndaraya Apryl Gloria Nelson
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Tom Vinh Tran April Dawn Tuttle Lida Murray Valentine Hillary Leigh Volsteadt Long M. Vu Jennifer Ann Walters-Senn Alysha Renee Warner Michael Seth Weinstein Michelle Renee Williams Susana M. Williams Trey P.H. Williams III Janna Lynn Wyatt Douglas Reid Wylie Vivian Yun-Thayer Ph.D. Sahitya Katikaneni Satya Surya Shankar Lanke Guohua Li Jyotsna Paturi
PHARMACY SCHOOL NEWS
GPhA Congratulates South University Pharmacy School 2010 Graduates Ashley Acosta Olubunmi Nikki Adeniyi Sveta Rashesh Amin Brandon Robert Bankieris David Logan Beasley Scott Kenric Behrens Jennifer Marie Berg Angelica Santiago Bontilao Richard Allen Brook Shuritheran Chinniah Dana Leigh Chiulli Brian Joseph Cohen Rebecca Lynn Crunelle Rebecca Phillips Cubbedge Daniel Alexander De Arazoza Pascale Marie-Christine Desplanque Joseph Leman Duke Stephanie Fong Nicole Marie Fowler Matthew John Fox Kristen Marie Francis Laura Francis Christina Maria Gomez Donya Dean Goodly Michael Grenon Andrea Whittnye Hamby Hanny Sayed Hassan Laura Lee Hillman Lauren Ellis Hogan Jeffrey David Hogg Pamela Peiwen Hung Terica Shellene Johnson Veronica Morton Kilpatrick Emilie Victoria Landreth Lauren Lantz Thaovy Nguyen Le Trucvy Nguyen Le Mitchell Ryan Lee Bryan Wade Lewis Aily Liem The Georgia Pharmacy Journal
Lindsey Michelle Lovvorn Kim Phuong Thi Ly Mariam Majidi Amanda Kay Mulherin James Wesley Murphy Josephine Wangari Ndingiu Duyvy Vu Nguyen Marissa Anne Nolan Desalegn Asihel Ogbamicael Uchechi Enyinnaya Okereke Emi Onuki Elizabeth Marie Owen Sheree Danielle Pack Nilesh Manokbhai Patel Nisha Narayan Patel Sonia Chandrakant Patel Blake Andrew Powell Jessica Louise Rodery Manav Saini Paul Alex Sandstrom Wendy Carol Satterwhite April Simmons Beth Amber Simpson Jonathan Ryan Slocum Jeffrey Wayne Smith Austin Snyder Christine ReneĂŠ Somers Barbara Senze Sona Manali Mihir Soni-Talsania Charity Williams Speed Justin Glenn Spinks Deja Marie Stephenson Julia Strickland Benjamin McBeen Thomason Emanuel Scott Thompson Kristopher Richard Tidwell Kimberly Dianne Tucker Joni Marie Vickers Douglas Thomas Wunderlich Brant Matthew Zauner 19
Continuing Education for Pharmacists New Drug Update 2010 Puja Patel, Pharm.D. is a PGY-1 Resident at Kaiser Permanente, Atlanta. She was the Drug Information Resident at Mercer University College of Pharmacy and Health Sciences at the time this article was written. David Farino, Pharm.D. and A smerom Hagos, Pharm.D. were fourth year pharmacy students at Mercer University College of Pharmacy and Health Sciences at the time this article was written. Lisa M. Lundquist, Pharm.D., BCPS is Assistant Dean for Administration and Clinical Associate Professor at Mercer University College of Pharmacy and Health Sciences.
Goal: The goal of this lesson is to
introduce new medications approved by the Food and Drug Administration (FDA) in 2010.
Liraglutide (lir a GLOO tide) is an acylated human Glucagon-Like Peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in adults with type 2 diabetes mellitus.
Objectives: For each newly approved medication, participants should be able to: 1. Define the mechanism of action 2. Identify the dosage forms and strengths 3. Recognize common dosing regimens 4. Define the efficacy endpoints associated with each medication 5. Describe common warnings and adverse drug reactions 6. Sufficiently counsel patients To date, the FDA has approved nine new medications in 2010: Victoza® (liraglutide), Actemra® (tocilizumab), Ampyra® (dalfampridine), Vpriv™ (velaglucerase alfa for injection), Xiaflex™ (collagenase clostridium histolyticum), Menveo® [meningococcal (Groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine], Prevnar 13™ [pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein)], Provenge® (sipuleucel-T), and Zortress® (everolimus).
The Georgia Pharmacy Journal
Liraglutide is safe and effective when used as a monotherapy agent but can also be used concomitantly when administered with insulin secretagogues.1
effective for glycemic control. After one week of receiving 0.6 mg per day, the patient’s dose can be increased to 1.8 mg.1 Liraglutide is advantageous because it does not require any renal or hepatic dosage adjustment and has once daily dosing. Efficacy A total of three trials were conducted to measure the efficacy of liraglutide. The primary endpoint in all trials was the change from baseline A1c at the end of the study period. Table 1 provides information regarding these trials.
Pharmacology Liraglutide activates the GLP-1 receptor in pancreatic beta cells. Activation causes an increase in intracellular cyclic AMP (cAMP) leading to insulin release in the presence of elevated glucose concentrations. The mechanism of blood glucose lowering also involves a delayed gastric emptying.
Warnings and Precautions Liraglutide has a black box warning for causing thyroid C-cell tumors. Studies have shown an incidence of thyroid C-cell tumors in rats; it is unknown whether liraglutide causes thyroid C cell tumors in humans.
Formulation Liraglutide exists as a solution for subcutaneous (SC) injection, prefilled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, or 1.8 mg.
Liraglutide is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN2).
Dosing All patients should receive a starting dose of 0.6 mg SC daily for one week. The 0.6 mg dose is intended to reduce gastrointestinal symptoms during initial titration, and is not
Adverse Reactions The following side effects have been reported to occur in >10% of patients: nausea (29%), diarrhea (17%), vomiting (11%), and constipation (10%). Hypoglycemia
has been reported in seven patients receiving liraglutide combination therapy in clinical trials (6 with sulfonylureas, 1 with metformin). Comments Liraglutide is a pregnancy category C medication. Byetta® (exenatide) is another FDA approved medication in this drug class. Exenatide is injected twice a day and is excreted renally. Liraglutide is degraded by endogenous peptides, which may be beneficial in patients with renal impairment. Liraglutide is more expensive than exenatide but patients may find the convenience of once daily injection worth the extra cost.
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Patient Counseling Advise patients to discontinue liraglutide and to contact their health care provider if persistent severe abdominal pain occurs. Patients should be instructed on the proper use of liraglutide as follows: • Do not share a liraglutide pen with another person, even if the needle is changed. Sharing of the pen between patients increases the risk of transmission of infection. • Liraglutide solution should be inspected prior to each injection, and the solution should be used only if it is clear, colorless, and contains no particles. • Liraglutide can be administered
once daily at any time and should be injected subcutaneously in the abdomen, thigh, or upper arm. • Before the initial use, liraglutide should be stored in a refrigerator. After the first use, the pen can be stored for 30 days at room temperature. Advise patients that the most common side effects of liraglutide are headache, nausea, and diarrhea. Nausea is most common when first starting liraglutide but decreases over time in the majority of patients and does not typically require discontinuation of liraglutide.
Actemra速 (tocilizumab) Tocilizumab (toe si LIZ oo mab) is an interleukin-6 (IL-6) receptor inhibitor for treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Tocilizumab may be used as monotherapy or concomitantly with methotrexate or other diseasemodifying antirheumatic drugs (DMARDs). It has not been studied, and should not be used, in combination with other biologic DMARDs because of the risk of increased toxicity. Examples of biologic DMARDs include: abatacept, tocilizumab, certolizumab, entanercept, adalimumab, anakinra, infliximab, golimumab, and rituximab.4 Pharmacology Tocilizumab is the first in the class of IL-6 inhibitors and binds specifically to both soluble and membrane-bound IL-6 receptors. Interleukins, a type of
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cytokines, are hormone-like molecules that regulate immune responses. In general, interleukins exert their effects by influencing gene activation that results in cellular activation, growth, and differentiation. Therefore interleukins have effects on the regulation of immune responses, such as inflammation, in rheumatoid arthritis. Tocilizumab can block interleukin-6 receptor leading to a decrease in immune responses.
Efficacy A total of three trials were conducted to measure the efficacy outcomes of tocilizumab. The primary end point for all three trials was the proportion of tocilizumab patients with a 20% improvement in RA signs and symptoms, such as tender or swollen joints and pain, according to American College of Rheumatology criteria (ACR20) response at week 24. Table 2 provides information regarding these trials.
Formulation Tocilizumab is supplied as an intravenous (IV) infusion solution at a concentration of 20 mg/ml. Strengths of 80 mg/4 ml, 200 mg/10 ml, and 400 mg/20 ml come in singleuse vials.
Warnings and Precautions Tocilizumab has a black box warning for the occurrence of serious infection leading to hospitalization or death for some patients. Patients should be monitored for the development of signs and symptoms of infection, including the possible development of tuberculosis (TB). If a patient is positive for TB, start the treatment for TB prior to starting tocilizumab. Tocilizumab should not be initiated in patients with an absolute neutrophil count (ANC) <200/mm3, platelet count <100,000/mm3, or alanine transaminase (ALT) or
Dosing The initial dose of 4 mg/kg IV every 4 weeks is recommended and may be increased to 8 mg/kg. Infusions should be diluted to 100 ml using 0.9% normal saline over the course of one hour; bolus or push infusions are not recommended.
aspartate aminotransferase (AST) levels 1.5 times above the upper normal limit. Adverse Reactions The most commonly reported adverse reactions occurring in ≥ 5% of patients were: upper respiratory tract infections (8%), nasopharyngitis (7%), headache (7%), hypertension (6%), and increased ALT levels (6%). Comments Tocilizumab is a pregnancy category C medication. Patient Counseling Inform patients to contact their health care provider immediately if he or she experiences symptoms of infection or severe abdominal pain.
Ampyra® (dalfampridine) Dalfampridine (dal FAM pri deen) is indicated to improve walking in patients with multiple sclerosis (MS).8 Pharmacology The full mechanism of action of dalfampridine is unknown; however, it is known to be a broad spectrum potassium channel blocker. Potassium channel blockers inhibit the efflux of potassium ions out of the cell allowing a greater concentration of potassium inside the cell. Blocking potassium channels essentially
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prolongs the duration of action potentials, which allow more electrical activity to occur in a cell. Deficiencies in potassium ions can lead to symptoms such as muscle cramps.
≥5% of patients were: urinary tract infections (12%), insomnia (9%), headache (7%), dizziness (7%), asthenia (7%), nausea (7%), back pain (5%), and balance disorder (5%).8
Formulation Dalfampridine is available as an extended release tablet.
Comments Dalfampridine is a pregnancy category C medication.
Dosing The maximum recommended dose of dalfampridine is one 10 mg tablet PO twice daily.
Patient Counseling Inform patients to discontinue the use of dalfampridine if they experience a seizure.
Efficacy A total of two trials were conducted to measure the efficacy of dalfampridine. The primary endpoint in both trials was walking speed (feet/second) using responder analysis. A responder was defined as a patient who showed faster walking speed for three out of four visits. Table 3 provides information regarding these trials.
Inform patients that the tablets can be taken with or without food and should be taken whole; do not divide, crush, chew, or dissolve.
Warnings and Precautions The use of dalfampridine is contraindicated in patients with a history of seizures and/or moderate or severe renal impairment (CrCl ≤ 50 ml/min).8
Pharmacology Velaglucerase alfa catalyzes the hydrolysis of glucocerebroside, reducing the amount of accumulated glucocerebroside. Foam cells or "Gaucher cells" are formed from the accumulation of glucocerebroside caused by the enzymatic deficiency. The accumulation of Gaucher cells in the liver and spleen leads to
Adverse Reactions The most commonly reported adverse reactions that occurred in
Vpriv™ (velaglucerase alfa) Velaglucerase alfa (vel a GLOO ser ase AL fa) is indicated for long-term enzyme replacement therapy (ERT) for pediatric and adult patients with type 1 Gaucher disease.10
organomegaly. Presence of Gaucher cells in the bone marrow and spleen lead to clinically significant anemia and thrombocytopenia. Formulation Velaglucerase alfa is a lyophilized powder which requires reconstitution and dilution. Doses available are 200 units/vial and 400 units/vial. Dosing The recommended dose of velaglucerase alfa is 60 Units/kg administered every other week as a 60-minute intravenous infusion. Patients previously treated on imiglucerase can be switched over to velaglucerase alfa at that same dose. Velaglucerase alfa should be administered under the supervision of a healthcare professional. Efficacy A total of two trials were conducted to measure the efficacy of velaglucerase alfa. The primary
The Georgia Pharmacy Journal
endpoint was the mean change from baseline for hemoglobin concentration, platelet counts, liver and spleen volume in patients after treatment. Table 4 provides information regarding these trials. Adverse Reactions Infusion-related reaction (such as flushing, erythema, and tachycardia) was the most commonly observed adverse reaction in patients (53%) during clinical trials. Other commonly reported adverse reactions that occurred in ≥10% of patients were: headache (35%), upper respiratory tract infection (32%), dizziness (22%), back pain (17%), joint pain (15%), and asthenia (13%). Comments Velaglucerase alfa is a pregnancy category B medication Patient Counseling Patients should be informed that only a healthcare professional can
administer velaglucerase infusion, which typically takes up to 60 minutes. Advise patients that velaglucerase alfa may cause infusion-related reactions. Infusion-related reactions can usually be managed by slowing the infusion rate and treatment with medications such as antihistamines, antipyretics and/or corticosteroids.
Xiaflex™ (collagenase clostridium histolyticum) Collagenase clostridium histolyticum (KOL la je nase) is indicated in adults for the treatment of Dupuytren’s contracture with a palpable cord.11 Pharmacology Collagenases are proteinases that hydrolyze collagen resulting in lysis of collagen deposits. Injection of collagenase clostridium histolyticum into a Dupuytren’s cord, which is comprised mostly of collagen, may
result in enzymatic disruption of the cord. Formulation Collagenase clostridium histolyticum, supplied as a lyophilized powder, must be reconstituted with the provided diluent prior to use. Dosing The dose of collagenase clostridium histolyticum is 0.58 mg per injection into a palpable cord with a contracture of a metacarpophalangeal (MP) joint or a proximal interphalangeal (PIP) joint. Injections may be administered up to 3 times per cord at approximately 4week intervals. Collagenase clostridium histolyticum must be administered by a healthcare provider. Efficacy A total of two trials were conducted to measure the efficacy of collagenase clostridium histolyticum. The primary endpoint was the proportion of patients who achieved a reduction in contracture of the selected primary joint (MP or PIP). Table 5 compares the two trials.
The Georgia Pharmacy Journal
Adverse Reactions The most commonly reported adverse reactions that occurred in â‰Ľ25% of patients included: peripheral edema (73%), contusion (70%), injection site hemorrhage (38%), injection site reaction (35%), and pain in the treated extremity (35%). Comments Collagenase clostridium histolyticum is a pregnancy category B medication. Patient Counseling Advise parent or guardian to use OTC analgesics (i.e. acetaminophen, ibuprofen) for fever, pain, or discomfort at injection site and to notify health care provider if bothersome side effects last more than 24 hours.
MenveoÂŽ [meningococcal (Groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine] Meningococcal (me NIN joe kok al) oligosaccharide diphtheria conjugate vaccine is indicated in people 11 to 55 years old for active immunization to prevent invasive meningococcal disease caused by Neisseria
meningitidis serogroups A, C, Y and W-135.13 Pharmacology Vaccination leads to the production of bactericidal antibodies against serogroups A, C, Y and W-135. Formulation Meningococcal oligosaccharide diphtheria conjugate vaccine is available as a solution for injection and is stored in the refrigerator. It must be prepared for administration through reconstitution with a lyophilized vaccine component. Dosing The vaccine is administered as a single 0.5mL intramuscular injection. Observation for 15 minutes after administration is recommended in order to avoid syncope. Warnings and Precautions Meningococcal oligosaccharide diphtheria conjugate vaccine should not be administered to anybody with a bleeding disorder or receiving anticoagulant therapy, unless the potential benefit outweighs the risk of administration. Furthermore, there is a potential for an increased risk of
Guillain-Barré Syndrome (GBS) associated with the use of this vaccine. Adverse Reactions The most frequently occurring adverse events in all patients were pain at the injection site (41%), headache (30%), myalgia (18%), malaise (16%) and nausea (10%). Comments This vaccine is a pregnancy category B medication. Patient Counseling Advise parent or guardian to use OTC analgesics (i.e. acetaminophen, ibuprofen) for fever, pain, or discomfort at injection site and to notify health care provider if bothersome side effects last more than 24 hours.
Prevnar 13™ [pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein)] Pneumococcal 13-valent conjugate vaccine is indicated for active immunization for the prevention of invasive disease and otitis media caused by Streptococcus pneumoniae.14 Pharmacology Pneumococcal 13-valent conjugate vaccine produces antibodies through stimulation of T-cells. Protein carrierspecific T-cells provide the signals needed for maturation of the B-cell response and generation of B-cell memory. This type of response induces immune memory and elicits booster responses on re-exposure in infants and children to pneumococcal polysaccharides.
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Formulation This vaccine is available as a suspension and should be stored in the refrigerator.
discomfort at injection site and to notify health care provider if bothersome side effects last more than 24 hours.
Dosing The four-dose immunization series consists of a 0.5 ml intramuscular injection administered at 2, 4, 6, and 12-15 months of age. Preferred sites for injection are the thighs or upper arms in toddlers and children.
Warnings and Precautions Apnea following intramuscular vaccination has been observed in some infants born prematurely. Adverse Reactions Reactions occurring in greater than 1% of infants and toddlers included diarrhea, vomiting, and rash. Comments This vaccine is a pregnancy category C medication. Other vaccines found in the same class as this agent include Prevnar® and Synflorix™. Pneumococcal 13-valent conjugate vaccine is a 13-valent vaccine. This means it contains 13 serotypes to Streptococcus pneumoniae to which it provides immunity. The original Prevnar® is 7-valent, while Synflorix™ is a 10-valent vaccine. Patient Counseling Advise parent or guardian that vaccine provides protection against the 13 most common and serious pneumococcal infections in infants and toddlers but does not provide protection from other causes of bacterial infection. Advise parent or guardian to use OTC analgesics (i.e. acetaminophen, ibuprofen) for fever, pain, or
Sipuleucel-T (si pu LOO sel tee) is indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.15 Pharmacology Sipuleucel-T is classified as an autologous cellular immunotherapy. While the precise mechanism of action is unknown, sipuleucel-T induces an immune response targeted against prostatic acid phosphatase (PAP), an antigen expressed in most prostate cancers. Formulation Sipuleucel-T is available as an injection and should be prepared in 250 ml infusion bags. Dosing Each dose of sipuleucel-T contains at least 50 million autologous CD54+ cells. Sipuleucel-T is given as three doses IV (infused over 1 hour) at approximately 2-week intervals. Efficacy Two trials were conducted to measure the efficacy of sipuleucel-T. The primary endpoint was time to disease progression. All patients were also followed until death. Table 6 lists the results from this trial. Warnings and Precautions Acute infusion reactions may occur within 1 day of infusion; the incidence of severe reaction may be higher with the second infusion, while
the third infusion is associated with a decrease in the incidence of severe reactions. Adverse Reactions The following side effects have been reported to occur in >15% of patients: chills (53%), fatigue (41%), fever (31%), back pain (30%), nausea (22%), joint ache (20%), and headache (18%). Patient Counseling Remind patients that the recommended course of therapy for sipuleucel-T is 3 complete doses. Each infusion of sipuleucel-T is preceded by a leukapheresis procedure. Advise patients to report signs and symptoms of acute infusion reactions such as fever, chills, and fatigue. Patients can take acetaminophen and an antihistamine approximately 30 minutes prior to administration of sipuleucel-T to minimize acute infusion reactions. Encourage patients to tell their doctor if they are taking immunosuppressive agents.
combination with reduced dose cyclosporine. Combination therapy should be initiated as soon as possible after kidney transplantation.16 Pharmacology Everolimus is a macrolide immunosuppressant and an m-TOR inhibitor. It reduces protein synthesis, cell proliferation, angiogenesis, hypoxia-inducible factor, and the expression of vascular endothelial growth factor (VEGF). With the inhibition of angiogenesis and VEGF, the growth of new blood vessels is inhibited. All of these activities aid in suppressing the bodyâ€™s immune system. Formulation Everolimus is available as a 0.25 mg, 0.5 mg, and 0.75 mg tablet. Dosing For renal transplantation, the initial dose is 0.75 mg PO twice daily in combination with reduced dose cyclosporine. Avoid the use of concomitant strong CYP3A4 inducers and/or inhibitors. The dose of everolimus should be reduced by half if moderate hepatic impairment (Child-Pugh Class B) exists.
ZortressÂŽ (everolimus) Everolimus (e ver OH li mus) is an immunosuppressant for prevention of kidney transplant rejection used in
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Efficacy One trial was conducted to measure the efficacy of everolimus. The
primary endpoint was efficacy failure, defined as treated biopsy-proven acute rejection, graft loss, death or loss to follow-up. Table 7 lists the results from this trial. Warnings and Precautions Everolimus has a black box warning for increased susceptibility to infection and thus the possible development of malignancies. If everolimus is being prescribed with cyclosporine, reduce doses of cyclosporine in order to reduce nephrotoxicity. An increased risk of kidney arterial and venous thrombosis has been reported, mostly within the first 30 days post transplantation. Adverse Reactions The following side effects have been reported to occur in > 30% of patients: stomatitis (44%), infections (37%), asthenia (33%), fatigue (31%), cough (30%), and diarrhea (30%). Comments Everolimus is a pregnancy category C medication. Drug levels of everolimus need to be monitored 4 to 5 days after any dosage change. The recommended therapeutic range is 3-8 ng/ml. Everolimus is also available as a 10mg
tablet (Afinitor®) and indicated for the treatment of advanced renal cell carcinoma. Afinitor® is dosed 10 mg PO once daily at the same time every day. Patient Counseling Advise patients to take everolimus whole; do not divide, crush, chew or dissolve. Everolimus can be taken with or without food. Patients should be instructed to not drink grapefruit juice or eat grapefruit during treatment. Recommend that mouthwashes and/or topical treatments that do not contain alcohol or peroxide should be used if mouth ulcers or sores develop. Advise patients to avoid the use of live vaccines and close contact with those who have received live vaccines. Advise women of childbearing potential that everolimus may cause fetal harm and to use an effective method of contraception during therapy and for 8 weeks after ending treatment.
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References 1. Victoza® [package insert]. Princeton, NJ: Novo Nordisk Inc.; Revised January 2010. 2. Garber A, Henry R, Ratner R, et al. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, paralleltreatment trial. Lancet. 2009;373(9662):47381. 3. Nauck M, Frid A, Hermansen K, et al. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: The LEAD (Liraglutide Effect and Action in Diabetes)-2 Study,” Diabetes Care. 2009;32(1):84-90. 4. Actemra® [package insert]. San Francisco, CA: Genentech Inc.; Issued January 2010. 5. Jones G, Sebba A, Gu J, et al. Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: The AMBITION study. Ann Rheum Dis. 2010;69:88–96. 6. Smolen JS, Beaulieu A, Rubbert-Roth A, et al. Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial. Lancet. 2008;371:987–97.
8. Ampyra®[package insert]. Hawthorne, NY: Acorda Therapeutics, Inc.; 2010. 9. Goodman AD, Brown TR, Krupp LB, et al. Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial. Lancet. 2009;373(9665):732-8. 10. Vpriv™ [package insert]. Wayne, PA: Shire Pharmaceuticals; 2010. 11. Xiaflex™ [package insert]. Malvern, PA: Auxilium Pharmaceuticals, Inc.; 2010. 12. Hurst LC, Badalamente MA, Hentz VR, et al. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med. 2009; 361(10):968-79. 13. Menveo®[package insert]. Basel, Switzerland: Novartis Vaccines and Diagnostics, Inc.; 2010. 14. Prevnar 13™ [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc.; Revised February, 2010. 15. Provenge®[package insert]. Seattle, WA: Dendreon Corporaton.; Unissued Date 16. Zortress®[package insert]. East Hanover, NJ: Novartis Pharmaceutical Co; 2010.
7. Emery P, Keystone E, Tony HP, et al. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trial. Ann Rheum Dis. 2008;67:1516–23.
Continuing Education for Pharmacists Quiz and Evaluation New Drug Update 2010 1. Dalfampridine is indicated for which of the following disease states? a. Tourette’s syndrome b. Multiple sclerosis c. Epilepsy d. Degenerative spine disorder
6. Liraglutide has a black box warning for: a. Increasing the risk for neurotoxicity b. Causing thyroid C-cell tumors c. Causing serious infection leading to hospitalization or death for some patients d. Increasing the risk of suicidal thinking and behavior
2. Tocilizumab has a black box warning for: a. Causing thyroid C-cell tumors b. Increasing the risk for severe liver injury and acute liver failure c. Causing serious infection leading to hospitalization or death d. Increasing the risk for GI perforation
7. Collagenase clostridium histolyticum injections may be given at approximately: a. 2-week intervals b. 4-week intervals c. 6-week intervals d. 8-week intervals
3. The pneumococcal 13-valent conjugate vaccine should be initiated at which of the following ages? a. 2, 4, 6, and 12-15 months b. 3, 6, 9, and 12 months c. 4 and 6 months d. 6 and 9 months
8. The use of meningococcal conjugate vaccine may be associated with an increased risk of: a. Guillain-Barré syndrome b. Kimura disease c. Chédiak–Higashi syndrome d. Kostmann syndrome 9. Which of the following is the mechanism of action for liraglutide? a. GLP-1 receptor agonist b. GLP-1 receptor antagonist c. GLP-2 receptor agonist d. GLP-2 receptor antagonist
4. Velaglucerase alfa is available as which of the following formulations? a. Extended release tablet b. Intravenous infusion c. Solution d. Lyophilized powder
10. When everolimus is prescribed with cyclosporine, the dose of cyclosporine should be: a. Increased b. Decreased c. Remain the same d. None of the above
5. Sipuleucel-T is indicated for the treatment of: a. Lung cancer b. Breast cancer c. Colon cancer d. Prostate cancer
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Journal CPE Answer Sheet The Georgia Pharmacy Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. No financial was received for this activity. This article was originally published in the Georgia Pharmacy Association under UAN# 0142-0000-10-007-H01-P. Participants should not seek duplicate credit.
New Drug Update 2010 This lesson is a knowledge-based CPE activity and is targeted to pharmacists. GPhA code: J10-07 ACPE#: 0142-0000-10-007-H01-P Contact Hours: 1.0 (0.10 CEU) Release Date: 07/01/2010 Expiration Date: 07/01/2013 1. Select one correct answer per question and circle the appropriate letter below using blue or black ink (no red ink or pencil.) 2. Members submit $4.00, Non-members must include $10.00 to cover the cost of grading and issuing statements of credit/ Please send check or money order only. Note: GPhA members will receive priority in processing CE. Statements of credit for GPhA members will be emailed or mailed within four weeks of receipt of the course quiz. 1. 2. 3. 4. 5.
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