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Life insu insurance urance solutio solutions ons fr from om Thee Pharmacistss Life Insuranc ce Company. Company. Insurance For F o r more m ore information, inf o r mat io n, contact co nt ac t your y ou r local lo cal representative: re p re s e n t a t i v e :
Hutton H utton Madden Madden 800.247.5930 8 00.247.5930 eext. xt . 77149 149 6678.714.9198 78.714.9198 www.phmic.com w w w.p h mi c. co m *
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* This is not a claims claim ms reporting site. You cannot electronically ally report a claim to us. To report a claim, call 800.247.5930. 247.5930. ** Compensated endorsement. Not all products available a in every state. The Pharmacists Pharmacissts Life is licensed in the District of allll states except AK, FL, HI, MA, ME, NH, NJ, NY and VT. Check with your Columbia and al representative or the company for details on coverages and carriers.
22
Departments
Health Mart Healthy Living Tour Visits Georgia Pharmacies
16 10 15 30
GPhA New Members Pharm PAC Contributors Pharm PAC Contribution Card GPhA Board of Directors
FEATURE ARTICLES
7 13 12 14 18 24
Advertisers
BlueCross BlueShield Insurance Information New GPhA Member Benefit: Be a Mentor, Get a Mentor Athens Student Pharmacist, Kyle Burcher Honored as Future Pharmacist of the Year
2 5 12 11 11 16 17 19 20 21 23 32
Pharmacists Mutual Companies GPhA Career Center Financial Network Associates Logix, Inc. Melvin Goldstein, P.C. Barbara Cole, Attorney at Law PACE Alliance AIP GPhA Workers’ Compensation NCPA Convention Information Pharmacy Quality Commitment UBS
GPhA Legislative Update 2012 Convention Save the Date CPE Opportunity: New Drugs: Halaven, Natroba and Viibryd
COLUMNS
4 6
President’s Message Editorial
The Georgia Pharmacy Journal
For an up-to-date calendar of events, log onto
www.gpha.org. 3
September 2011
PRESIDENT’S MESSAGE L. Jack Dunn, Jr., R.Ph. GPhA President
Be Not Afraid of Growing Slowly; Be Afraid of Standing Still
ome two months ago while at the executive committee retreat in Hartwell I informed the executive committee that we were going to implement two programs for the association. These programs involve two simple steps and planning for a better year in 2011-12. With the recent trip of the Board of Directors to Jekyll Island, I believe these programs started off with a big step for our association. On Friday, members of the executive committee gave a brief description on the staff of GPhA. I believe this was very important for the new members of the board of directors, as they now know how to communicate with staff of GPhA.
communications with region members I believe that this will only make the presidency of the regions and academy chairs a more productive unit in the involvement in GPhA growth.
S
Saturday morning Kelly McLendon gave a presentation about the GPhA website. She went through the process on how to navigate through the website. Kelly went into detail on locating members as well as finding members benefits. She also gave insight on how to find the GPhA calendar on the website. If you are looking for your representative and your senator it is located on the website as well. I was amazed how much easier it was to navigate after hearing Kelly’s presentation. On Saturday afternoon with the guidance of Renee Adamson, president of the 3rd Region and Pam Marquess, a past president of the 7th region, the region presidents were introduced to requirements for region president. With involvement from all members there was an open forum for information for each office. Guidelines were established for each member to carry out throughout the year. From helping with the regions meetings to The Georgia Pharmacy Journal
4
September 2011
SUPPORTING PHARMACISTS. ADVANCING CAREERS. Find the best jobs and highly qualified pharmacists Georgia has to offer.
ONLINE CAREER CENTER www.gpha.org/jobs
EXECUTIVE VICE PRESIDENT’S EDITORIAL Jim Bracewell Executive Vice President / CEO
New Enhanced GPhA Membership Benefits this Fall Griggs, GPhA’s Director of Finance and Administration, directly at 404-419-8119 or via email at dgriggs@gpha.org. Dan can put you in touch with Harris Gignilliat with UBS to take advantage of these special discounted rates. Save money and improve your investment options, not a bad idea for this year.
hile your stocks may have declined in value, your investment in your GPhA membership has grown in value. Maybe congress ought to be talking to the GPhA leadership.
W
GPhA has added three significantly enhanced membership benefits this membership year. #1 Blue Cross Blue Shield insurance is now available at GPhA Association group rates as of October 1, 2011
#3 Personal financial planning and investment services membership group rates
GPhA has long been a resource for quality and cost efficient health insurance benefits for its member groups. Now employee groups can get that benefit via an agreement between GPhA and Blue Cross/Blue Shield which is one of the premiere providers of insurance in our state.
If you are like me you know very little about personal financial planning. As a member of GPhA you can get a professional review or professional assistance in preparing your personalize financial plan for your future. If you are very smart and have already done that you are exceptional. Would you like to get a second opinion on your plan at no cost to you? I did and I learned a lot had changed in the last few years and that I was not taking advantage of all that was available to me. As a GPhA member, your membership now entitles you to a no cost to you comprehensive financial plan review or plan development. You have no obligation to make any changes and no pressure. UBS does not sell insurance. UBS does not sell stock. UBS sells financial management services for a fee not a commission. You can purchase advice, not products. Jeff Lurey, Dan Griggs and several members of the GPhA Board have taken advantage of this great membership benefit. See the back page of this Journal for more information.
See the additional information on pages 7 & 9, or contact Ruth Ann McGehee at GPhA for a complete brochure and information package. Ruth Ann can be reached directly at 404-419-8104 or via email at rmcgehee@gpha.org. In today’s uncertain health care insurance market, taking advantage of this significantly enhanced program provided through your GPhA membership can be a very wise move for all to consider. #2 Administrative Management of 401ks at GPhA, a group discounted rate If you are an employer or your employer provides your team with a 401K benefit you can now do so at a cost you may never have thought was available. After more than a year of due diligence research GPhA was able to reduce the administrative cost of the Association’s 401K by almost 50% and at the same time significantly improve our investment opportunities for our team. Now you too, as a GPhA member, can avail yourself of this group discounted rate for 401K services.
Your association has become very selective about new membership benefits. We want to add value to your membership investment, not a bunch of coupons and tickets. We heard your feedback and acted accordingly. We think you will be pleased with these three new benefits of membership.
If you would like some basic information contact Dan
The Georgia Pharmacy Journal
6
September 2011
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Blue Cross and Blue Shield of Georgia Medical Plans
You will have the option to enroll in one of the following four (4) medical plans: Open Access Point of Service (OA POS) – The plan provides benefits both in and out of network. The plan does not require a referral to see a specialist who participates in the BCBS Open Access network. Health Savings Account (HSA) – This plan provides you with the flexibility to use a health care provider either in or out of the network without a referral. Medical Plan Highlights
OA POS
OA POS
OA POS
HSA
Medical deductible – In network
$500
$1,500
$1,000
$3,000
$1,500
$4,500
$2,500
$5,000
Medical deductible – Out of network
$1,000
$3,000
$1,000
$3,000
$1,500
$4,500
$5,000
$10,000
Out-of-pocket maximum – In network
$1,000
$3,000
$1,000
$3,000
$1,000
$3,000
$5,000
$10,000
Out-of-pocket maximum – Out of network
$4,000
$12,000
$4,000
$12,000
$4,000
$12,000
$10,000
$20,000
Primary care physician visit
$25 copay Ded. waived
$40 copay Ded. waived
$40 copay Ded. waived
40% Ded. waived
$0 Ded. waived
40% after ded.
Specialist visits
$35 copay Ded. waived
$50 copay Ded. waived
$50 copay Ded. waived
40% Ded. waived
20% Ded. waived
40% after ded.
Coinsurance
20% after deductible
20% after deductible
20% after deductible
40% Ded. waived
20% Ded. waived
40% after ded.
Emergency room
$100 copay Ded. waived
$100 copay Ded. waived
$100 copay Ded. waived
$100 copay Ded. waived
20% Ded. waived
40% after ded.
Generic
$15 copay
$15 copay
Ded. then 40%
Ded. then 20%
Ded. then 40%
Ded. then 40%
$15 copay
Ded. then 40%
Blue Cross and Blue Shield of Georgia Dental Plans
Dental coverage Calendar year deductible Single
$50
Family
$150
Deductible applies to
Type II and III
Coinsurance
GAD\1-hda\ebpg\Clients\GA Pharmacy Association\GA Pharm Assoc NL attachment 2011_2
Preventive services (Type I)
100%
Basic Services (Type II)
80%
Major Services (Type III)
50%
Periodontics and Endodontics
80%
Annual maximum
$1,000
Out of network usual and customary
90%
Do you want more information on the Blue Cross Blue Shield GPhA Plans?
Blue Cross and Blue Shield of Georgia Medical Plans
You will have the option to enroll in one of the following four (4) medical plans: Open Access Point of Service (OA POS) – The plan provides benefits both in and out of network. The plan does not require a referral to see a specialist who participates in the BCBS Open Access network. Health Savings Account (HSA) – This plan provides you with the flexibility to use a health care provider eitherdo in or out of thefor network without a referral. Who I contact information? Medical Email Plan Ruth Highlights
Ann McGeheeOAatPOS rmcgehee@gpha.org orOA callPOS on her direct line at 404-419-8104 OA POS
HSA
Medical deductible $500 $1,500 $1,000 $1,500 $2,500 “The responses from our currently insured groups have been$3,000 overwhelmingly positive.$4,500 This plan in many respects$5,000 mirrors – In network
the plan of the Georgia Dental Association that has long been a successful plan for dentists across Georgia. I am proud the
Medical deductible $1,000 $3,000 $1,000 $3,000 $1,500 $4,500 $5,000 $10,000 of GPhA was able to put together such a quality offering for the pharmacists and pharmacies of our association” – leadership Out of network
said GPhA Executive Vice President Jim Bracewell. Kendrick, the president of$3,000 Blue Cross Blue Shield and I serve $1,000 $3,000 $1,000 “Morgan $3,000 $1,000 $5,000 $10,000 Out-of-pocket maximum on the board of the Georgia Healthcare Information Exchange. Morgan is a leader in healthcare and its future in our – In network state.”
$4,000 Out-of-pocket maximum – Who Out of will network administer the
$12,000
$4,000
$12,000
$4,000
$12,000
$10,000
$20,000
plan for us?
Primary care physician visit
$25 copay Ded. waived
$40 copay Ded. waived
$40 copay Ded. waived
40% Ded. waived
$0 Ded. waived
40% after ded.
Specialist visits
$35 copay Ded. waived
$50 copay Ded. waived
$50 copay Ded. waived
40% Ded. waived
20% Ded. waived
40% after ded.
20% after
40%
20% Ded.
40% after
$15 copay
Ded. then 40%
Ded. then 20%
Ded. then 40%
Georgia Pharmaceutical Services, GPhA wholly owned subsidiary and insurance agency will provide the administration for the plan as they have in the past for The Insurance Trust.
Who are the board members of Georgia Pharmaceutical Services, Inc.? Coinsurance
20% after
Generic
$15 copay
20% after
deductible deductible waived ded. The board of directors of the GPhS are electeddeductible by the GPhA board of directors and theDed. current boardwaived is made up of Robert Bowles, room Dale Coker, Jack Dunn, Robert Hatton, Eddie Madden, Pam$100 Marquess, Bobby Moody,20% andDed. Sharon40% Sherrer. Emergency $100 copay $100 copay copay $100 copay after Ded. waived waived Ded. waived Ded. waived ded. Executive Vice President Jim Bracewell servesDed. as the secretary in an ex-officio non-voting position. waived Ded. then 40%
$15 copay
Ded. then 40%
New Health Insurance Benefit From GPhA Plan Facts BlueEffective CrossOctober and Blue Shield Georgia 1, 2011 BlueofCross & BlueDental Shield Plans of Georgia will be GPhA’s Plan Adminstrator Dental coverage
Calendar Members of the GPhA health care plan will have four plans to choose from year deductible
Dental will be included Guaranteed rates through December 31, 2012
The Georgia Pharmacy Journal
GAD\1-hda\ebpg\Clients\GA Pharmacy Association\GA Pharm Assoc NL attachment 2011_2
Single
$50
Family
$150
Deductible applies to
Type II and III
Coinsurance
9
Preventive services (Type I)
100%
Basic Services (Type II)
80%
Major Services (Type III)
50%
Periodontics and Endodontics
80%
Annual maximum
$1,000
Out of network usual and customary
90%
September 2011
Current Pharm PAC Members Titanium Level ($2400 minimum pledge) T.M. Bridges, 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. William A Murray, R.Ph. Mark Parris, Pharm.D. 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 John Ashley Dukes, R.Ph. Patrick Dunham Jack Dunn, Jr. R.Ph. Neal Florence, R.Ph. Andy Freeman Martin T. Grizzard, R.Ph. John Hansford, 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. McCarthey, 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. Christoher R. Thurmond, Pharm.D. Danny Toth, R.Ph.
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 James Gordon Elrod, R.Ph. Kevin M. Florence, Pharm.D. Robert B. Moody, R.Ph. Sherri S. Moody, Pharm.D. Jeffrey Grady Richardson, R.Ph. Andy Rogers, R.Ph. Daniel C. Royal, Jr., R.Ph. Michael T. Tarrant Tommy Whitworth, R.Ph., CDM Silver Level ($300 minimum pledge) Renee D. Adamson, Pharm.D. Chandler M. Conner, Pharm.D. Terry Dunn, R.Ph. Marshall L. Frost, Pharm.D. James E. Jordan, Pharm.D. John Kalvelage Willie O. Latch, R.Ph. W. Lon Lewis, R.Ph. Kalen Porter Manasco, Pharm.D. Earl Marbut, R.Ph.
Michael L. McGee, R.Ph. William J. McLeer, R.Ph. Albert B. Nichols, R.Ph. Richard Noell, R.Ph. Rose Pinkstaff, 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. Walter Alan White, 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. Ben Cravey, 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. Amy S. Galloway, R.Ph. Johnathan Wyndell Hamrick, Pharm.D. Ed Kalvelage Steve D. Kalvelage Marsha C. Kapiloff, R.Ph. Joshua D. Kinsey, Pharm.D. Brenton Lake, R.Ph. William E. Lee, R.Ph. Ashley Sherwood London Charles Robert Lott, R.Ph. Max A. Mason, R.Ph. Amanda McCall, Pharm.D. Susan W. McLeer, 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 afreeman@gpha.org or 404-419-8118. Donations made to Pharm PAC are not considered charitable donations and are not tax deductible. The Georgia Pharmacy Journal
10
September 2011
Pharm PAC Contributors’ List Continued Mary P. Meredith, R.Ph. Leslie Ernest Ponder, R.Ph. Kristy Lanford Pucylowski, Pharm.D. Leonard Franklin Reynolds, R.Ph. Richard Brian Smith, R.Ph. 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.
William D. Whitaker, R.Ph. Elizabeth Williams, R.Ph. Jonathon Williams, Pharm.D.
Members (no minimum pledge) John J. Anderson, Sr., R.Ph. Mark T. Barnes, R.Ph. Walter A. Clark, 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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Tom E. Menighan, R.Ph., MBA, ScD, FAPhA
Williams Moye, R.Ph. Darby R. Norman, R.Ph. Christoher Brown Painter, R.Ph. Steve Gordon Perry, R.Ph. Whitney B. Pickett, R.Ph. Michael Roland Reagan, R.Ph. James L. Riggs, R.Ph. Laurence Ryan, Pharm.D. Victor Serafy, R.Ph. James E. Stowe, R.Ph. James R. Stirckland, R.Ph. Celia M. Taylor, Pharm.D. Leonard E. Templeton, R.Ph. Heatwole C. Thomas, R.Ph. Erica Lynn Veasley, R.Ph.
The Georgia Pharmacy Journal
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September 2011
MEMBERS IN THE NEWS
Athens Student Pharmacist, Kyle Burcher Honored as Future Pharmacist of the Year yle Burcher, a student pharmacist at The University of Georgia College of Pharmacy was named Future Pharmacist of the Year Winner at the second annual Next-Generation Pharmacist awards, a national event hosted at the John F. Kennedy Presidential Library in Boston, Massachusetts on Aug. 29.
professionals,� said Tom Rhoads, CEO of Parata Systems. “It was a perfect fit to honor these recipients in a prominent innovation hub like Boston.�
K
For information about the Next-Generation Pharmacist program, please visit www.nextgenerationpharmacist.com and www.pharmacytimes.com, or follow the program on Facebook and Twitter.
The Next-Generation Pharmacist program was created by Parata Systems and Pharmacy Times to salute the future vision of pharmacy, and those professionals who are helping define that future by their innovative practices. The Next-Generation Pharmacist awards honored pharmacy professionals in 10 additional categories, selected from nearly 350 nominations received from 40 states and Guam. The 2011 winners represent a true cross-section of the pharmacy industry – from large chain retailers and independent pharmacies, to institutional facilities and long-term care operations.
I can answer your
QUESTIONS ABOUT TAXES & FINANCIAL PLANNING
A panel of esteemed judges, chaired by Pharmacy Times’ Editor-in-Chief, Fred M. Eckel, RPh, MS, evaluated candidates against the highest standards of the pharmacy profession including customer service and patient care, as well as how he or she relates to the specific category. The judges also reviewed how each nominee is contributing to the pharmacy profession as a whole.
Join us for THIRD THURSDAY CONFERENCE CALLS Dial our complimentary conference line on the third Thursday of Sept., Oct. & Nov. from 4:00 to 4:30pm: (800) 391-1709 PIN 582280
“All of the 2011 winners are more than deserving of recognition for their dedication and attentiveness to patient care,� said Eckel. “They truly embody the ideals of the Next-Generation Pharmacist program.�
Compliments of
MICHAEL T. TARRANT Financial Network Associates
Kyle Burcher, along with each category honoree is profiled on Pharmacy Times’ website, www.pharmacytimes.com, and spotlighted in the July and August issues of the publication.
1117 Perimeter Center West, Suite N-307 "UMBOUB (" t '/"QMBOOFST DPN t NJLF!'/"QMBOOFST DPN
An Independent Financial Planner since 1992 Focusing on Pharmacy since 2002 Securities, certain advisory services and insurance products are offered UISPVHI */7&45 'JOBODJBM $PSQPSBUJPO */7&45 t .FNCFS FINRA/SIPC, a federally registered Investment Advisor, and affiliated JOTVSBODF BHFODJFT */7&45 JT OPU BĂŻMJBUFE XJUI 'JOBODJBM /FUXPSL Associates, Inc. INVEST does not provide tax or legal advice. Other BEWJTPSZ TFSWJDFT NBZ CF PĂŞFSFE UISPVHI 'JOBODJBM /FUXPSL "TTPDJBUFT *OD B SFHJTUFSFE JOWFTUNFOU BEWJTPS J BE
“Now in its second year, the Next-Generation Pharmacist awards are bringing well-deserved recognition to the outstanding contributions of our dedicated pharmacy The Georgia Pharmacy Journal
12
September 2011
GPhA MEMBER BENEFIT
New GPhA Member Benefit: Be a Mentor, Get a Mentor Be a Mentor As a Mentor, you will share your knowledge with a pharmacy professional in a similar discipline in your region. In doing so, you will make an impact on the career path of an individual at the beginning of a career or at a crossroads. Based upon your responses to the questionnaire that follows, we will match you up with a Mentee that fits your needs. Mentor Criteria: •
Your address
•
Your years of experience
•
Your field of experience
To be a mentor got to GPhA and click “Be a Mentor, Find a Mentor” at the bottom of the Member Benefits Page.
Get a Mentor The “Be a Mentor, Find a Mentor” program is designed to help pharmacy professionals learn and grow in their profession, in addition to helping executives at any level increase their skill set by signing up for a Mentor. As a Mentee, you will be have an opportunity to gain knowledge and experience from pharmacy professionals that help guide your career. Based upon your responses to the questionnaire that follows, we will match you up with a Mentor that fits your needs. Mentee Criteria: •
Your address
•
Your years of experience
•
Your current practice area
•
Your desired practice area
To be a mentor or mentee go to www.gpha.org and click “Be a Mentor, Find a Mentor” at the bottom of the Member Benefits Page.
The Georgia Pharmacy Journal
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September 2011
MEMBER NEWS By Andy Freeman GPhA Government Affairs Director
GPhA Legislative Update hings have been busy recently for the Government Affairs team of GPhA. We have been meeting with elected officials to brief them on issues that are of importance to pharmacy and what can be done in the State or Federal government.
T
In early August Congressman Paul Broun stopped by Hodgson’s Pharmacy in Athens, to talk with GPhA member and Region 10 President Chris Thurmond, Pharm. D. Chris made Congressman Broun aware of federal efforts we support to curb some of the abuses of PBMs. More visits are being planned right now for every Georgia congressmen to visit Georgia pharmacies over the next few months.
GPhA 1st Vice President Pam Marquess poses at podium at the capitaol
First Vice-President Pam Marquess recently testified at a hearing of the House Health and Human Services Committee. She spoke about the problems of mail order and specialty drugs. Legislators listened intently to her testimony and asked how they could address the concerns she raised. We have also handed out campaign contributions thanks to the generous members of PharmPAC and began the
GPhA Executive Committee meet with Speaker David Ralston over issues that are of importance to GPhA members
process of educating legislative leaders on our issues for the 2012 legislative session. Recently Lieutenant Governor Casey Cagle stopped by the GPhA offices and the executive committee also had a meeting with Speaker David Ralston at the Capitol.
Region Region 10 President Chris Thurmond welcomes Congressman Paul Broun to his pharmacy
The Georgia Pharmacy Journal
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September 2011
President Jack Dunn and PharmPAC Chairman Eddie Madden meet with Lieutenant Governor Casey Cagle
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 pharmacyrelated 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)
Gold ($50/month)
Bronze ($12.50/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 pleas mail your check in with your form
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September 2011
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 Amy C. Grimsley, Pharm.D., Atlanta Robert Haynes, Pharm.D., Atlanta Carmen Zayas-Aiken, Pharm.D., Lawrenceville Jonathan Canterbury, Pharm.D., Kathleen Erin Steinberg, Pharm.D., Atlanta Megan B. Jacobs, Pharm.D., Warner Robins Eric Lee Mullins, Pharm.D., Gainesville Samantha Yawn Berry, Pharm.D., Hoschton Samuel W. Lokey, R.Ph., Ashburn Bryan Hazelton, R.Ph., Fayetteville Robert George Probst, Pharm.D., Acworth
BARBARA COLE ATTORNEY AT LAW, LLC 539 Green Street, NW Gainesville, GA 30501 678-971-9088 email bcoleattorney@gmail.com www.barbaracoleattorney.com
Pharmacy School Student Members William Brown, Duluth Linda Im, Augusta
New Graduate Pharmacist Members Daniel B. Purvis, Pharm.D., Adel Alecia R. Chatman, Pharm.D., Atlanta Megan C. Potts, Pharm.D., Oxford Amanda R. Paisley, Pharm.D., Atlanta Brittany N. McLeod, Pharm.D., Hawkinsville Cheryl Neely Bursmith, Pharm.D., Waleska
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All Aspects of Representation of Health Care Professionals Licensure Medicare Administrative Medicaid Criminal Bankruptcy Compliance State Bar Health Law Section Former Chief Magistrate Judge 16
September 2011
Run with the bulls. Don’t be content to watch from the sidelines. Pace Alliance offers you the chance to make your pharmacy a prosperous business, one that stays ahead of the game. We know what it takes to survive. After all, we have been running ahead of the bulls for 22 years. Plus, teaming up with Pace benefits Pharmacy all across Georgia. So stop watching from the sidelines. Join the group of your peers who want to control the destiny of their businesses in order to prosper. This is your chance to take the bull by the horns. Contact Pace Alliance today.
1-888-200-0998 • www.pacealliance.com
Please save the date for our 137th Annual Convention! Georgia Pharmacy Association 137th Annual Convention Hilton Head Marriott Resort & Spa Hilton Head Island, SC July 7-11, 2012 The Georgia Pharmacy Journal
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September 2011
AIP Fall Meeting Sunday, October 23, 2011 Macon Marriott & Centreplex Macon, GA
ARE YOU COMING? LEARN TO IMPROVE YOUR BUSINE$$ 1. 3 hour CE course on Pharmacy Law for Certified Technicians and Registered Technicians (pharmacists may also attend for CE credit) 2. Multiple programs on business management A. How to evaluate your Pharmacy B. How to generate additional revenue outside the prescription department C. Financial planning and retirement plans 3. Afternoon business meeting (includes an update from the PBM Task Force and the GPhA Governmental Affairs team)
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 and get CE Join us for a continental breakfast and lunch Visit with our AIP partners during breaks and lunch
SHOW YOUR SUPPORT²ATTEND THIS <($5¶6 $,3 )$// 0((7,1*
Get Ready to Meet. Learn. Succeed. Registration is Now Open!
Selling a Pharmacy: The Community Pharmacist’s Roadmap to Meeting friends, learning from experts, and succeeding back home with new ideas and knowledge. These are the top reasons pharmacists tell us why they attend NCPA's Annual Convention and Trade Successful Transition Selling a Pharmacy: The Community Pharmacist’s Roadmap to Exposition. Join us October 8-12 this year in Nashville and we're sure you'll agree.
Successful Transition Saturda , October 8, 1 6:30 Welcome to Nashville
.m. Se arate re istration fee
In As the the heart of Nashville, the Gaylord Oprylandyou Resort and Convention Centerdaily is located on thethe banks owner of a community pharmacy important decisions regarding Saturda , October 8, 1 6:30 .m. Se arate remake istration fee of the Cumberland River. Centrally andthe close to everything, this staff resortand wona host the 2010 Toast of health of your patients and yourlocated business, well being of your of issues Music City, award, andinmany more. important You'll find everything you inside thatowner comeThe from your involvement the There comes adaily timeneed when youthe are As the of aTennessean community pharmacy youcommunity. make decisions regarding Opryland complex andand nearby. attractions right outside thestaff complex Grand Ole faced with another important decision – how when sell the business have health of your patients yourFeatured business, the welland being of to your and ainclude hostyou ofthe issues nurtured andyour grown. Opry (celebrating 86involvement years Octoberin7-8) the General Jackson Showboat Twelve that come from the and community. There comes a time cruise. when you are miles from Gaylord the Country Music Hall of Fame and Museum offers a visceral faced withOpryland, another important decision – how and when to sell the business youexperience. have This program is designed help you with process: nurtured andthe grown. Preserving evolving historytoand traditions of that country music to educating its audiences, this x arts Financial planning preparation for retirement international organization servesand fans, students, scholars, and the music industry. The collection is This program is designed to help you with that process: x Normalizing Your Books managed from this location, as it travels the 8,000 museums nationwide. Elvis, Hank Williams, and x Financial planning preparation forsale retirement xareSellers Checklist – The details of Gene Autry among the manyand inductees. A must see! x Normalizing Books x ContractsYour and the legalities Sellers ChecklistGuidelines – Programming The details sale x atAccounting for of Sale Sneak xPeek Educational x Contracts and theperspective legalities x The Bankers •The PBM Landscape: A Critical Update - Valuation x Accounting for Sale x Should IGuidelines do this myself or on Prices a broker Tools for Decision •In-Depth PBM Briefing: Generics First andrely MAC and–Reimbursement x The Bankers perspective Valuation x Ask the Experts Panel-You •340B Opportunity Knocks—Should Answer? x Should I do this myself or rely onGuide a broker – Tools for Decision •Opportunities in Diabetes: The Pharmacist's to Insulin Pumps and Training Your Patients All registrants recei ve a copy of “Selling Pharmacy: A A Ho w To Guide” ($90 value!) x Ask the Experts Panel •Opportunities in Long-Term Care •A Critical Guide to Audit Survival for the Community Pharmacy The first 50 registrants ill receive w “Selling 2 discount onAa Ho listing the NCPA All registrants recei ve a copy of A Difference w To on Guide” ($90site, value!) •Closing the Image Gap: Merchandising With5% aaPharmacy: Critical linking independent pharmacy owners preparing to sell, www.pharmacymatching.com, •Mastering Your Message: Crystal Communication of Your Pharmacy's Value existing owners lookingilltoreceive buy additional stores, and for the right The first in50 registrants 5% a to 2 discount on entrepreneurs aYour listing on thesearching NCPA •A Lesson 5-Star Leadership: 7wPrinciples Fully Engage Pharmacy Staff site, opportunity to become a pharmacy owner. linking independent pharmacy owners preparing to sell, www.pharmacymatching.com, existing owners looking to buy additional stores, and entrepreneurs searching for the right Registration NCPAowner. members: $225 Non-Members: $325 opportunity to becomefee: a pharmacy Register at Registration fee: today NCPAhttp://www.ncpanet.org/index.php/events/2011-convention members: $225 Non-Members: $325 For more information, contact the NCPA Convention Department at 1.800.544.7447 Register today http://www.ncpanet.org/index.php/events/2011-convention at For more information, contact the NCPA Convention Department at 1.800.544.7447 The Georgia Pharmacy Journal
21
September 2011
GPhA MEMBER NEWS
Health Mart Healthy Living Bus Visits East Marietta Pharmacy ealth Mart Healthy Living Tour celebrated community pharmacists in Georgia and feature free health screenings for all patients at the pharmacies they visited on August 13, 2011.
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growing diabetes epidemic—the disease affects approximately 25.8 million Americans. A 2009 report by the Georgia Department of Community Health estimates that one in seven Georgia adults are living with diabetes.
The Health Mart Healthy Living Tour was on the road to celebrate and recognize community pharmacists for the important role they play as trusted health care providers in their communities—helping to educate and counsel people managing diabetes. Aboard the Health Mart Healthy Living Tour’s 40-foot mobile screening unit, tour staff will offer FREE health screenings that include blood pressure, cholesterol, blood glucose and hemoglobin A1C tests.
Tour screeners will identify people at risk and encourage those with diabetes to manage their condition with help from Health Mart pharmacists, who advise on ways to reduce medication spending and better understand drug
Co-sponsored by Bayer Diabetes Care and Novo Nordisk, the Health Mart Healthy Living Tour is aiming to raise awareness of the
regimens and complications. For Health Mart pharmacists, the events are indicative of Health Mart's effort to help independent pharmacies attract new customers and maximize the value of existing customers through marketing support.
The Georgia Pharmacy Journal
22
September 2011
The tour visited East Marietta Drugs Health Mart Pharmacy, Mableton Health Mart Pharmacy, Moye's Health Mart Pharmacy, and Chip's Health Mart Pharmacy.
“We implemented PQC in our pharmacy four months ago – it was easy. I have noticed an enhanced effort from the staff to work together to avoid and eliminate quality-related events.” Pharmacy Quality Commitment® (PQC) is what you need! PQC is a continuous quality improvement (CQI) program that supports you in responding to issues with provider network contracts, Medicare Part D requirements under federal law, and mandates for CQI programs under state law. When PQC is implemented in your pharmacy, you will immediately improve your ability to assure quality and increase patient safety. Do you have a CQI program in place?
Call toll free (866) 365-7472 or go to www.pqc.net for more information. PQC is brought to you by your state pharmacy association.
The Georgia Pharmacy Journal
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September 2011
continuing education for pharmacists Volume XXIX, No. 7
New Drugs: Halaven, Natroba and Viibryd 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 :XHVW KDYH QR UHOHYDQW Ă&#x20AC;QDQFLDO UHODWLRQships to disclose.
Goal. The goal of this lesson is to provide information on eribulin (Halavenâ&#x201E;˘), spinosad (Natrobaâ&#x201E;˘), and vilazodone (Viibrydâ&#x201E;˘).
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Objectives. At the conclusion of
this lesson, successful participants should be able to: 1. identify the new drugs by generic name, trade name and chemical name when relevant; 2. select the indication(s), pharmacologic action(s) and clinical applications for each drug; 3. recognize important therapeutic uses for the drugs and their DSSOLFDWLRQV LQ VSHFLĂ&#x20AC;HG SDWKRORgies; and 4. demonstrate an understanding of adverse effects and toxicity, VLJQLĂ&#x20AC;FDQW GUXJ GUXJ LQWHUDFWLRQV and patient counseling information for these drugs.
Drugs discussed within this lesson are new molecular entity compounds (Table 1) indicated for treatment of 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 reader is, therefore, urged to consult each productâ&#x20AC;&#x2122;s Prescribing InformaWLRQ OHDĂ HW RU Medication Guide, and other references for detailed descriptions including outcomes
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of comparative clinical trials with similar drugs.
Halaven (Eribulin Mesylate)
Eribulin mesylate is a non-taxane L H XQOLNH SDFOLWD[HO VLPSOLĂ&#x20AC;HG synthetic analogue of halichondrin B, isolated from the rare marine sponge Halichondria okadai, and subsequently from several unrelated sponges belonging to the
Axinella family. Early experiments revealed potent anticancer activity in cell-based and animal models, but further work was limited by non-availability of the natural product. The U.S. National Cancer Institute provided funding to trawl-harvest one metric ton of the deepwater sponge that yielded 310 mg of halichondrin B to continue drug development. At approximately the same time, a synthetic chemistry laboratory succeeded in the total synthesis of halichondrin B following a process involving 90 chemical steps. Indications and Use. Halaven (HAL-ih-ven) is indicated for treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease.
Table 1 Selected new drugs in 2011 Generic (Proprietary Name)
Applicant/ Sponsor/ Distributor
Indication
Dosage Form
Eribulin (Halaven)
Eisai Inc
Microtubule inhibitor for treatment of metastatic breast cancer
Vials: 1 mg/2 mL for IV injection
Spinosad (Natroba)
ParaPRO and/ or Pernix Therapeutics, Inc
Pediculocide for treatment of head lice infestation
Suspension: 0.9% for topical application
Vilazodone (Viibryd)
Forest Pharmaceu- Antidepressant for ticals LLC treatment of major depressive disorder
24
Tablets:10, 20, 40 mg
September 2011
Prior therapy should have included an anthracycline (Adriamycin, and others) and a taxane (Taxol, and others) in either the adjuvant or metastatic setting. Metastatic Breast Cancer. Breast cancer is the most commonly diagnosed cancer and the second leading cause of cancer-related death in women in the United States. It is estimated that 207,090 women were diagnosed with breast cancer, and 39,840 women in this country died of breast cancer in 2010. Approximately 20 percent of patients with breast cancer will GHYHORS PHWDVWDVHV ZLWKLQ ÀYH years of their initial diagnosis. Despite recent improvements in the treatment of metastatic breast cancer, there is still no absolute standard of care for patients who have experienced failure of their initial therapy. Thus, the prognosis for patients with metastatic breast cancer remains poor, with D ÀYH \HDU VXUYLYDO UDWH RI RQO\ 26 percent in the United States. Death from breast cancer is usually a result of chemotherapy-resistant metastatic disease. Many patients become refractory to the standard agents and therefore fail to respond. Moreover, because anthracyclines and taxanes are increasingly used as adjuvant therapy, the number of patients previously exposed to these agents when they develop metastatic disease is increasing. The term metastatic describes a cancer that has spread from its original tumor site to distant organs. Metastatic breast cancer is the most advanced stage (Stage IV) of breast cancer. Cancer cells have spread beyond the breast and axillary (underarm) lymph nodes to other areas of the body where they continue to grow and multiply, thereby competing with healthy cells in these areas. Breast cancer has the potential to spread to almost any region of the body; the most common region being bone, followed by lung and liver. Treatment of metastatic breast cancer generally focuses on relieving a
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woman’s symptoms and extending her life. A primary diagnosis of Stage IV breast cancer may indicate rapid disease progression or that the cancer was present but not detected in the breast for some time. To help detect breast cancer in earlier stages when it is most curable, women should follow the guidelines for early detection established by the American Cancer Society, which include breast self-examinations, and annual clinical breast exams and mammography (the latter beginning at age 40 years). Mechanism of Action. In highly complex cells containing a nucleus (eukaryotic cells), microtubules are crucial for maintaining cell shape and function. They are also involved in movement of chromosomes during cellular division and the subsequent segregation of chromosomes into the two daughter cells. The crucial role for microtubules in cell division makes them an extremely suitable target for the development of chemotherapeutic drugs against the rapidly dividing tumor cells. Eribulin inhibits microtubule dynamics via a novel mechanism of action, which is thought to involve binding to a unique site on tubulin (a protein component of microtubules). This blocks the growth phase of microtubules without affecting the shortening phase, and sequesters tubulin into nonproductive aggregates. The drug causes irreversible mitotic block, which leads to cell cycle arrest, and ultimately, apoptosis (natural, or programmed death of normal cells) following prolonged mitotic blockage. Cancer cells are deadly because they are immortal, that is, they do not undergo apoptosis. They eventually kill the patient by depriving normal cells of their nutrition and space. Preclinical studies demonstrated eribulin activity in cell lines that are taxane resistant as a result of beta-tubulin mutations. In one study involving 508 patients who received the test drug and 254 the control, median survival with the test drug was
25
13.1 months versus 10.6 months for the control treatment. Adverse Effects. The most common adverse reactions (inciGHQFH SHUFHQW ZHUH QHXWURpenia, anemia, asthenia (loss of strength)/fatigue, alopecia, peripheral neuropathy, nausea and constipation. The most common serious adverse reactions were febrile neutropenia (4 percent) and neutropenia (2 percent). The most common adverse reaction resulting in discontinuation of the drug was peripheral neuropathy (5 percent). Warnings, Precautions and Contraindications. The following warnings and precautions are listed: Neutropenia. Peripheral blood cell counts should be monitored and the dose adjusted as appropriate. Peripheral neuropathy. Patients should be monitored for signs of neuropathy ( numbness, tingling and burning sensation in the hands and feet) and managed with dose delay and adjustment. Use in pregnancy. Fetal harm can occur when Halaven is administered to a pregnant woman. QT prolongation. Patients should be monitored for prolonged QT intervals in the presence of congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities. The new drug should be avoided in patients with congenital long QT syndrome. No contraindications are listed. Drug Interactions. Eribulin does not inhibit CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4 enzymes, so is not expected to alter the plasma concentration of drugs that are substrates of these enzymes. Likewise, no interaction is expected with permeability glycoprotein (P-gp) inhibitors. Dosage and Availability. The recommended dose in patients without hepatic or renal impairment is 1.4 mg/m2 administered LQWUDYHQRXVO\ RYHU WZR WR ÀYH PLQutes on Days 1 and 8 of a 21-day cycle. Doses should be reduced in
September 2011
Table 2 Counseling points for Halaven (eribulin)* This medicine is used to treat breast cancer that has spread to other parts of the body. 5HDG WKH 3DWLHQW ,QIRUPDWLRQ EHIRUH you start taking Halaven and each WLPH \RX JHW D UHÀOO 7HOO \RXU GRFWRU -if you have liver, kidney or heart problems. -if you have any signs of infection such as: fever (above 100.5° F), chills, cough, burning or pain when you urinate. -if you have numbness, tingling or burning in your hands or feet. -about all other prescription and nonprescription (OTC) medicines, vitamin/mineral supplements, natural products and herbal remedies you are taking. 3HULRGLF ODERUDWRU\ WHVWLQJ LV LPSRUtant with this medicine. Be sure to make all testing appointments. :20(1 1RWLI\ \RXU GRFWRU LI \RX become or intend to become pregnant, or breastfeed a child. +DODYHQ LV WR EH LQMHFWHG LQWR \RXU vein, in cycles of treatment, with the cycle lasting 21 days. You will receive an injection once a week for 2 weeks in a row with no injection the third week of each treatment cycle. *Excerpted from the FDA-approved Patient Information.
hepatic or renal impairment. The drug is supplied in singleuse vials containing 1 mg/2 mL. Vials should be stored at 25° C (77° F), with excursions permitted to 15° to 30° C (59° to 86° F). Patient Information. Excerpts of FDA-approved Patient Information are shown in Table 2.
Natroba (Spinosad)
Spinosad is a relatively new insecticide derived from fermentation of a soil actinomycete bacterium, Saccharopolyspora spinosa, discovered in 1982 from soil in an abandoned rum distillery. Spinosad is a mixture of spinosyn A and spinosyn D in a ratio of approximately 5 to 1 (spinosyn A to spinosyn D). The in-
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secticide has been used on outdoor ornamentals, lawns, vegetables and fruit trees to control most insect pests. Spinosad is not acutely toxic to mammals and is nonhazardous by oral, dermal, ocular, and inhalational routes. In long-term mammalian studies, it did not cause tumors, neurotoxicity, embryotoxicity, or teratogenicity. Indications and Use. Natroba (Nah-TRO-buh) is a pediculocide indicated for topical treatment of head lice infestations in patients four years of age and older. Safety in pediatric patients below the age of four years has not been established. Caution should be exercised when the drug is used on a nursing mother. The product should be used in the context of an overall lice management program that includes washing or dry cleaning all recently worn clothing, towels and bed linens, and washing all personal care items such as hair brushes and combs. It is an effective, easy-to-use product, resolving most head lice infestations in about 10 minutes with just one application and no nit combing. If live head lice are seen one week VHYHQ GD\V DIWHU WKH ÀUVW DSSOLFDtion, Natroba should be used again. $ ÀQH WRRWK FRPE PD\ EH XVHG WR remove dead lice and nits from the hair and scalp, but combing is usually not required. Head Lice Infestation. Head lice are ectoparasitic (live on the surface of the host’s body) insects (Pediculus humanus capitis) that live in the hair of the scalp and neck. They are not usually found elsewhere on the body. Head lice infestation is common in the U.S. among children three to 12 years of age. The insect feeds on the blood of the host by piercing the skin of the scalp. A typical infestation may involve around 30 insects, but the range is wide. The full-grown insect is dark and small, 2 to 3 mm in length, about the size of a sesame seed. Lice cling to hair shafts with their claws. After mating, the female lays about six to eight eggs a day until death at around 30 days.
26
The eggs are yellow-white and are attached onto the hair shaft close to the scalp by a secretion from an adult louse, most often behind the ears and back of the neck since the skin there is a rich source of blood. The eggs typically take around seven to 10 days to hatch, with the empty egg shell (“nit”) remaining attached to the hair. Development of the newly hatched louse (nymph) into an adult takes six to 14 days. Head lice can neither hop nor Á\ WKH\ FUDZO 7KHUH DUH UHSRUWV that combing dry hair can build XS VXIÀFLHQW VWDWLF HOHFWULFLW\ WR physically eject an adult louse from an infested scalp. Transmission in most cases occurs by direct contact with the head of an infested individual; however, indirect spread through contact with personal belongings (e.g., combs, brushes, hats) of an infested individual is much less likely but may occur rarely. Lice removed with regular combs are likely to be injured or dead. A healthy louse is not likely to leave a healthy head unless there is a heavy infestation. Head lice infestation rarely leads to complications other than itching. Rarely, secondary infection of the scalp, including impetigo, may occur due to scratching the area. Some people experience a great deal of embarrassment, anxiety and distress due to their, or their children’s, infestation. Direct costs for various treatments and clinic visits are considerable. Indirect costs associated with time spent by school nurses and administrators, absenteeism from school and/or work, and lost wages and productivity of caregivers are also considerable as well. The annual combined direct and indirect costs of head lice in the United States is estimated to be $1 billion. One problem with insecticide lotions is development of resistance among lice, reported to be up to 82 percent for permethrin and 64 percent for malathion. These products may also be unacceptable to some people because of the risk of potential unwanted effects (e.g., skin
September 2011
Table 3 Counseling points for Natroba (spinosad)* This medicine is used to get rid of lice in scalp hair of children and adults. Â&#x2021;5HDG WKH 3DWLHQW ,QIRUPDWLRQ EHIRUH you start using Natroba. Â&#x2021;7HOO \RXU GRFWRU LI \RX KDYH DQ\ skin conditions or allergies. Â&#x2021;:20(1 7HOO \RXU GRFWRU LI \RX become or intend to become pregnant or are breastfeeding a child. Â&#x2021;:DVK \RXU KDQGV EHIRUH DQG DIWHU applying Natroba. Â&#x2021;6KDNH WKH ERWWOH ZHOO ULJKW EHIRUH use. Â&#x2021;)ROORZ WKH LQVWUXFWLRQV IRU XVH LQ the Patient Information carefully. Â&#x2021;$SSO\ WR GU\ KDLU GR QRW ZHW LW Â&#x2021;'R QRW VZDOORZ RU DOORZ 1DWURED WR get in the eyes. Â&#x2021;6WRUH WKLV SURGXFW LQ D GU\ SODFH DW room temperature. Â&#x2021;'R QRW XVH WKLV SURGXFW DIWHU WKH expiration date on the label. Properly discard unused medicine. *Excerpted from the FDA-approved Patient Information.
irritation, exacerbation of asthma). Mechanism of Action. The mode of insecticidal action is associated with stimulation of the insectâ&#x20AC;&#x2122;s nervous system. Spinosad alters the function of nicotinic acid and GABA-gated ion channels in a manner consistent with the observed neuronal excitation. Spinosad does not interact with known binding sites for other nicotinic or GABAergic insecticides. These data indicate that spinosad acts through a unique insecticidal mechanism. After a period of hyperexcitation, lice become paralyzed and die within one to two days after ingesting the substance. Adverse Effects. The most common adverse events (>1 percent) in premarketing clinical trials were application site erythema (redness) and ocular erythema. Spinosad is not systemically absorbed; however, its benzyl alcohol content may be. Warnings, Precautions and
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Contraindications. The following warnings and precautions are listed: Â&#x2021;Benzyl alcohol toxicity. Natroba should not be used on infants below the age of 6 months because of its potential for increased systemic absorption with serious adverse reactions and death. No contraindications or drug interactions are listed for the product. Dosage and Availability. The product should be applied to the dry scalp and hair using only the amount needed to cover the scalp and hair, up to 120 mL (one bottle). It should be rinsed off with warm water after 10 minutes; treatment may be repeated seven days after WKH Ă&#x20AC;UVW WUHDWPHQW LI OLYH OLFH DUH seen. The product should not be taken orally or be used on areas of the body other than the scalp or hair. Natroba is supplied as a topical suspension containing 9 mg spinosad per gram. The product should be stored at 25° C (77° F), with excursions to 15° to 30° C (59° to 86° F) permitted. Patient Information. Excerpts of FDA-approved Patient Information are shown in Table 3.
Viibryd (Vilazodone)
Limitations of current antidepressant medications include extensive inter-individual variability in response, delayed onset of effect, GLIĂ&#x20AC;FXOW\ LQ PDLQWDLQLQJ UHPLVVLRQ safety concerns and intolerable side effects. Intolerable adverse events are the primary reason for premature discontinuation of antidepressant medication in onethird of patients, especially early in treatment. The results from the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study established that different antidepressants exhibit similar HIĂ&#x20AC;FDF\ LQ WUHDWLQJ WKH RYHUDOO population of depressed patients, DOWKRXJK WKHUH ZHUH VLJQLĂ&#x20AC;FDQW GLIferences in tolerability. This study also demonstrated that augmentation with a second drug is a useful adjunct to treatment. Thus, there
27
is great need today for alternative treatment regimens that provide improved predictability of response and better tolerability, including less sexual dysfunction, than existing agents. Drugs active at the 5-HT1A receptor, such as vilazodone to be discussed subsequently, are approved for treatment of anxiety, have been shown to exert antidepressant activity, and may be useful for augmenting the response to other antidepressants. On the basis of its mechanism of action, vilazodone has the potential to provide a more rapid antidepressant effect. ,W DOVR KDV DQ DGYHUVH HYHQW SURĂ&#x20AC;OH characterized by good tolerability and lower risk of adverse events. Indications and Use. Viibryd 9ĹŤ EULG LV WKH Ă&#x20AC;UVW RI D QHZ FODVV of antidepressants, the indolalkylamines, indicated for treatment of adult patients with major depressive disorder (MDD), also FDOOHG PDMRU GHSUHVVLRQ (IĂ&#x20AC;FDF\ was established in two eight-week, placebo-controlled trials in adult patients with MDD. Major Depressive Disorder. Depression is a leading cause of disability, lost productivity, and health care expenditure. MDD is a chronic, often debilitating illness that contributes to functional impairment and increased morbidity and mortality. It is characterized by symptoms that interfere with an individualâ&#x20AC;&#x2122;s ability to work, sleep, study, eat and enjoy once-pleasurable activities. Episodes of major depression often recur throughout a personâ&#x20AC;&#x2122;s lifetime, although some may experience only a single occurrence. The National Comorbidity Survey Replication (2003) established that the 12-month prevalence of MDD in the United States was 6.7 percent, with 80 percent of respondents categorized as having moderate or severe depression. The incidence reported in another study for older adults reached 9 percent. Despite the burden of MDD, many patients remain untreated or are inadequately treated following diagnosis. In fact, there is little evidence available to guide the initial
September 2011
choice of therapy, and discontinuation and switching prescriptions are common. Mechanism of Action. The mechanism of antidepressant effect of vilazodone is not fully understood, but is believed to be related to its enhancement of central serotonergic activity through selective inhibition of serotonin reuptake. Vilazodone is also a partial agonist at serotonergic 5-HT1A receptors; however, the net result of this action on serotonergic transmission and its role in the drug’s antidepressant action are unknown. Adverse Effects. The most common adverse reactions (inciGHQFH SHUFHQW DQG DW OHDVW WZLFH the rate of placebo) are: diarrhea, nausea, vomiting and insomnia. In premarketing clinical trials, there was no single adverse reaction leading to discontinuation in >1 percent of the patients. Warnings, Precautions and Contraindications. The followings warnings and precautions are listed: Clinical worsening/suicide risk. Patients should be monitored for clinical worsening and suicidal thinking or behavior (suicidality), especially during the initial few months of therapy or at times of dose changes. It is not known whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance studies in adults with depression that the use of antidepressants can delay the recurrence of depression. Serotonin syndrome or neuroleptic malignant syndrome (NMS)like reactions. If NMS occurs with treatment, the drug should be discontinued and supportive treatment initiated. Seizures. Seizures can occur with treatment, so the new drug should be used with caution in patients with a seizure disorder. Abnormal bleeding. Treatment can increase the risk of bleeding. Caution is advised when used in association with nonsteroidal DQWL LQÁDPPDWRU\ GUXJV 16$,'V
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including aspirin, or other drugs that affect coagulation. Activation of mania/hypomania. Activation can occur with treatment. Patients should be screened for bipolar disorder. Discontinuation of Viibryd therapy. A gradual reduction in dose is recommended rather than an abrupt cessation. Hyponatremia. This can occur in association with the syndrome of inappropriate antidiuretic hormone secretion (SIADH). The new drug is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs), so it should not be used concurrently with an MAOI or within 14 days of stopping or starting an MAOI. Drug Interactions. Viibryd should not be used concomitantly or within 14 days of stopping or starting an MAOI. Based on its potential for serotonin toxicity, also known as the serotonin syndrome, caution is advised when the new drug is taken concurrently with other drugs that may affect the serotonergic neurotransmitter system (e.g., MAOIs, SSRIs, SNRIs, triptans, buspirone, tramadol and tryptophan products, etc.) . The Viibryd dose should be reduced to 20 mg when co-administered with strong CYP3A4 inhibitors. Concomitant use of Viibryd with CYP3A4 inducers can result in inadequate drug concentrations and may diminish effectiveness. The effect of CYP3A4 inducers on systemic exposure to vilazodone has not been evaluated. The risk of using Viibryd in combination with other CNS-active drugs has not been systematically evaluated. Consequently, Viibryd should be used with caution in combination with other CNS-active drugs. Since the new drug is highly bound to plasma protein (96 to 99 percent), its administration with other drugs that are highly protein bound may cause increased free concentrations of the other drug. Dosage and Availability. The recommended dose is 40 mg once daily. The drug should be titrated to this dose starting with initial ad-
28
Table 4 Counseling points for Viibryd (vilazodone)* This medicine is used to treat patients with major depressive disorder. 5HDG WKH Medication Guide before you start taking Viibryd and each WLPH \RX JHW D UHÀOO 7HOO \RXU GRFWRU -if you are taking an MAO inhibitor (medicine for depression or Parkinsonism). The Medication Guide that comes with Viibryd contains a list of other medicines that should not be taken with it. -if you have any thoughts of committing suicide or manic episodes. -if you develop agitation, hallucinations, coma or other changes in mental status; coordination problems, fast heartbeat; sweating or fever; nausea, vomiting or diarrhea; muscle stiffness or tightness. -if you have seizures or convulsions. -if you have any side effect that bothers you or that does not go away. -about all other prescription and nonprescription (OTC) medicines, vitamin/mineral supplements, natural products and herbal remedies you are taking. :20(1 7HOO \RXU GRFWRU LI \RX become or intend to become pregnant or breastfeed a child. 7DNH HDFK GRVH RI 9LLEU\G ZLWK IRRG 'R QRW GULYH RU RSHUDWH GDQJHUous machinery until you know how Viibryd affects you. Alcoholic beverages and other sedating medicines can increase the drowsiness caused by Viibryd. 'R QRW VWRS WDNLQJ 9LLEU\G ZLWKRXW ÀUVW WDONLQJ WR \RXU GRFWRU 6WRUH 9LLEU\G LQ LWV WLJKWO\ FORVHG container or blister pack at room temperature. Do not use after the expiration date on the label. Properly discard unused medicine. *Excerpted from the FDA-approved Medication Guide.
ministration of 10 mg once daily for seven days, followed by 20 mg once daily for an additional seven days, and then increased to 40 mg once daily. The tablets should be taken with food. Administration without
September 2011
food can result in inadequate drug concentrations and may diminish HIIHFWLYHQHVV :KHQ GLVFRQWLQXing treatment, the dose should be UHGXFHG JUDGXDOO\ 'UXJ HIĂ&#x20AC;FDF\ has not been systematically studied beyond eight weeks. It is generally agreed that acute episodes of MDD require several months or longer of sustained pharmacologic therapy. Patients should be reassessed periodically to determine the need for maintenance treatment and the appropriate dose for treatment. Viibryd is available in tablets containing 10 mg, 20 mg and 40 mg of vilazodone. It is also available in a starter blister pack containing 30 tablets, seven each 10 and 20 mg, and 16 tablets 40 mg. Patient Information. Excerpts from the FDA-approved Medication Guide are shown in Table 4.
Overview and Summary
The new drugs discussed in this lesson were approved to treat a wide variety of conditions. They should offer renewed hope for the patients they are intended to treat.
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 0129-0000-11-007-H01-P Release date: 7-15-11 Expiration date: 7-15-14
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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September 2011
2011 - 2012 GPhA BOARD OF DIRECTORS
The Georgia Pharmacy Journal Editor:
Jim Bracewell jbracewell@gpha.org
Managing Editor & Designer:
Kelly McLendon kmclendon@gpha.org
The Georgia Pharmacy Journal® (GPJ) is the official publication of the Georgia Pharmacy Association, Inc. (GPhA). Copyright © 2011, Georgia Pharmacy Association, Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical including by photocopy, recording or information storage retrieval systems, without prior written permission from the publisher and managing editor. All views expressed in bylined articles are the opinions of the author and do not necessarily express the views or policies of the editors, officers or members of the Georgia Pharmacy Association.
ARTICLES AND ARTWORK Those who are interested in writing for this publication are encouraged to request the official GPJ Guidelines for Writers. Artists or photographers wishing to submit artwork for use on the cover should call, write or e-mail the editorial offices as listed above.
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ADVERTISING Advertising copy deadline and rates are available at www.gpha.org upon request. All advertising and production orders should be sent to the GPhA headquarters as listed above.
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Chairman of the Board President President-Elect First Vice President Second Vice President State At Large State At Large State At Large State At Large State At Large State At Large State At Large 1st Region President 2nd Region President 3rd Region President 4th Region President 5th Region President 6th Region President 7th Region President 8th Region President 9th Region President 10th Region President 11th Region President 12th Region President ACP Chairman AEP Representative AHP Chairman AIP Chairman APT Chairman ASA Chairman Foundation Chairman Insurance Trust Chairman Georgia State Board of Pharmacy Representative Georgia Society of Health Systems Pharmacists Mercer Faculty Representative South Faculty Representative UGA Faculty Rep. ASP Mercer University Rep. ASP South University Rep. ASP UGA Rep. Executive Vice President
Patricia Knowles
GPHA HEADQUARTERS 50 Lenox Pointe, NE Atlanta, Georgia 30324 Office: 404.231.5074 Fax: 404.237.8435
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September 2011
continuing education quiz
Please print.
Program 0129-0000-11-007-H01-P 0.15 CEU
Name________________________________________________ Address_____________________________________________
New Drugs: Halaven, Natroba and Viibryd
City, State, Zip______________________________________ Email_______________________________________________
1. Eribulin is isolated from a: a. marine sponge. c. Yerba species. b. medicinal plant. d. Yew tree.
Return quiz and payment (check or money order) to Correspondence Course, OPA, 2674 Federated Blvd, Columbus, OH 43235-4990
2. The most common region for breast cancer to spread is the: a. lung. c. bone. b. liver.
7. Natroba resolves most head lice infestations in about: a. 10 minutes. c. 60 minutes. b. 30 minutes. d. 90 minutes.
3. The guidelines of the American Cancer Society suggest that yearly mammography begin at age: a. 35 years. c. 45 years. b. 40 years. d. 50 years.
8. In a head lice infestation, the term nit refers to the: a. newly hatched louse. c. engorged adult. b. empty egg shell.
4. In eukaryotic cells, microtubules are crucial for maintaining: a. synthesis of lipoproteins. b. respiration and secretion. c. macrophage differentiation. d. cell shape and function.
9. Which of the following products should be shaken well right before use? a. Halaven c. Viibryd b. Natroba
5. Numbness, tingling and burning sensation in the hands and feet are signs of: a. allergic reaction. c. peripheral neuropathy. b. myocardial infarction.
10. The action of spinosad brings paralysis and death to lice after a period of: D K\SHUWHQVLRQ F K\SHUH[FLWDWLRQ b. hypersensitivity. d. hyperhydrosis.
6. Spinosad was discovered in the soil of an abandoned: a. coal mine. c. gravel pit. b. soybean farm. d. rum distillery.
11. Vilazodone is active at which of the following subtypes of 5-HT receptor? a. 1A c. 1C b. 1B d. 1D 12. Drugs that are agonists to 5-HT receptors are: a. adrenergic. c. dopaminergic. b. cholinergic. d. serotonergic.
&RPSOHWHO\ ÀOO LQ WKH OHWWHUHG ER[ FRUUHVSRQGLQJ WR your answer.
1. 2. 3. 4. 5.
[a] [a] [a] [a] [a]
[b] [b] [b] [b] [b]
[c] [d] 6. [a] [c] 7. [a] [c] [d] 8. [a] [c] [d] 9. [a] [c] 10. [a]
[b] [b] [b] [b] [b]
[c] [d] [c] [d] [c] [c] [c] [d]
11. [a] 12. [a] 13. [a] 14. [a] 15. [a]
[b] [b] [b] [b] [b]
13. The most common adverse effects of Viibryd include all of the following EXCEPT: a. diarrhea. c. nausea. b. drowsiness. d. vomiting.
[c] [d] [c] [d] [c] [d]
[c] [d]
14. Viibryd should be taken: a. with food. b. on an empty stomach.
I am enclosing $5 for this month’s quiz made payable to: Ohio Pharmacists Association.
15. The recommended daily dose for Viibryd is: a. 15 mg. c. 40 mg. b. 25 mg. d. 50 mg.
5DWH WKLV OHVVRQ ([FHOOHQW 3RRU
2. Did it meet each of its objectives? yes no If no, list any unmet_______________________________ 3. Was the content balanced and without commercial bias? yes no 4. Did the program meet your educational/practice needs? yes no 5. How long did it take you to read this lesson and complete the quiz? ________________ 6. Comments/future topics welcome.
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To receive CE credit, your quiz must be postmarked no later than July 15, 2014. A passing grade of 80% must be attained. CE statements of credit are mailed February, April, June, August, October, and December. Send inquiries to opa@ohiopharmacists.org.
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july 2011 2011 September
Georgia Pharmacy Association 50 Lenox Pointe, NE Atlanta, GA 30324
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