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Thank you for a Wonderful 2010 GPhA Convention! 9ROXPH 1XPEHU ZZZ JSKD RUJ

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The Georgia Pharmacy Journal

August 2010

Departments

GPhA Honors Members During Convention

Jack Dunn Thank You Note GPhA New Members GPhA Member News GPhA Board of Directors

Advertisers

fEATUrE ArTICLES

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Pharm PAC Enrollment: Pledge Year 2010-2011 Pharm PAC Board of Directors New Pharmacy School Set to Open August 11 NCPA Convention and Trade Exposition Information

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The Insurance Trust Principal Financial Group PharmAssist Recovery Network Melvin M. Goldstein, P.C. AIP Pharmacists Mutual Companies Logix, Inc. Michael T. Tarrant Design Plus Store Fixtures, Inc. GPhA Workers Compensation Toliver & Gainer The Insurance Trust

Medication Adherence Fact Sheet CPE Opportunity: Medications for the Treatment of Nicotine Addiction

COLUMnS

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Presidentâ&#x20AC;&#x2122;s Message Editorial

For an up-to-date calendar of events, log onto

www.gpha.org.

The Georgia Pharmacy Journal

August 2010

PrESIDEnT’S MESSAGE Dale M. Coker, R.Ph., FIACP GPhA President

What Makes the Great Ones Great?

his year’s convention in Myrtle Beach, S.C., had its share of highlights. For entertainment, you could not have been disappointed by the performance of hypnotist Kevin Lepine and cast. The best part was the comments of the spectators after the show, such as, “Were they acting as fools because they were really hypnotized, or were they just acting?” The only way to know is to participate in the show, so this coward will never know.

Payton, the late, great John Wooden, and many others. Among his most memorable stories was the one about Warrick Dunn’s in-prison visit with the inmate who shot and killed his mother, in order to forgive him. Warrick Dunn learned the same lesson about forgiveness that Dr. Matthews had spoken about earlier in the morning.

Through his many years of interviewing and writing about great players and coaches, Yaeger compiled a list of sixteen characteristics of greatness. They are broken down into four categories: How they think, How they prepare, How they work, and How they live. In summary, those who have achieved greatness hate to lose more than they love to win, and they don’t go it alone; they understand the value of association; they are positive thinkers, they hope for the best, but prepare for all possibilities; they are the ultimate teammate; they know how and when to adjust their game plan and they are not afraid to take a risk; and most importantly, they live their lives with character, embracing the idea of being a role model.

Speaking of entertainment, who could forget the awesome performance of Tangee Renee and Club Visage at the President’s Banquet? There was also spirited competition to appeal to the competitors among us. The pharmacy schools from Mercer and South had a strong showing in the OTC bowl, while my alma mater from over in Athens had, shall we say, an off day (this made it easier to root for Mercer, since my daughter was a participant). The Brown Bag Competition made its debut, and I’m sure will be a mainstay in future conventions. There were also inspirational moments, most notably the sermon on forgiveness that Dr. Ted Matthews gave at the Sunday morning Interfaith Sunrise Service. At the same service, we enjoyed a virtuoso performance from classical guitarist Sarah Hatton, daughter of Candidate for First Vice President, Robert Hatton.

Some of the positive comments made about our association at the convention gave me reason to take a look at the characteristics of greatness and how they might apply to the Georgia Pharmacy Association. Ken Couch from Smith Drug, Jack Devours from McKesson and Joe Harmison from NCPA all commented about the strength of our association and our convention in comparison to others they had visited recently. Of course, being better than underachievers does not qualify us for greatness, but I think we have the right team in place to achieve it.

If motivation is what you were looking for, then you received a double measure from speaker Don Yaeger. His message was “What Makes the Great Ones Great?” Don has spent many years with some of the top names in professional sports, including Michael Jordan, Walter The Georgia Pharmacy Journal

August 2010

A carefully thought out five year strategic plan has been put into place. I pledge to our membership that it will not sit on a desk and collect dust this coming year. Some aspects of the plan are already being implemented, and we will put into place methods to measure its success. So, in order to achieve greatness for our association, here is the formula: convince fellow pharmacists who are not GPhA members to understand the value of association, stay positive, work as a team, prepare as a team, be willing to adjust the game plan, be willing to take risks, abide by the golden rule and live lives of character. All of this will equal Greatness for GPhA!

PharmAssist Recovery Network The PharmAssist Network continues to provide advocacy, intervention and assistance to the impaired practitioners, students and technicians in the state. If you or anyone you know needs assistance, please call the hotline number:

We would like to thank Purdue Pharma for providing GPhA a grant for the convention. This acknowledgment did not make it into the convention program booklet.

PharmAssist Hotline Number (24 hours / 7 days a week) 404-362-8185 (All calls are confidential)

Thank you for your thoughts...

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Dear Colleagues, Thank you for your thoughtfulness during this time of sorrow. Terryâ&#x20AC;&#x2122;s dad, Carl Waddell, was a person who had affected many people with his laughter and smile. The phone calls, emails, and text messages were greatly appreciated. The family would also like to thank those who have contributed to the American Heart Association, and the Diabetes or Cancer Societies. I told Carl half the state of Georgia was praying for him, and that brought a smile to his face. It also gave the family a couple of extra days to spend with him so we could cherish those moments.

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On behalf of the family, thank you again for your thoughtfulness and I am looking forward to seeing you in the next couple of months. Sincerely,

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Pharm PAC Enrollment Pledge Year 2010-2011

Titanium Level

Gold Level

Bronze Level

($2400 minimum pledge)

($600 minimum pledge)

($150 minimum pledge)

Michael Farmer Jeffrey L. Lurey Robert A. Ledbetter Jonathan and Pam Marquess Marvin O. McCord Judson L. Mullican Mark L. Parris

Platinum Level ($1200 minimum pledge)

Robert C. Bowles Bruce L. Broadrick Hugh M. Chancy Dale Coker Billy Conley Martin Grizzard Robert M. Hatton Alan M. Jones Ira Katz Harold M. Kemp Brandall Lovvorn Eddie Madden Scott Meeks Drew Miller Jay Mosley Tim Short

James W. Bartling Liza G. Chapman Mahlon Davidson Neal Florence Amy Galloway Marsha C. Kapiloff Bobby Moody Sherri S. Moody Robert Anderson Rogers Daniel C. Royal Thomas H. Whitworth

Oatts Drug Company Monica M. Ali-Warren Lance P. Boles Mike Crooks Charles Alan Earnest Amanda R. Gaddy Fadeke Jafojo William E. Lee William J. McLeer Sharon B. Zerillo

Silver Level

(no minimum pledge)

($300 minimum pledge)

Renee Adamson Marshall L. Frost Michael O. Iteogu Willie O. Latch Kenneth A. McCarthy Kalen Beauchamp Porter Edward Franklin Reynolds Michael T. Tarrant Flynn W. Warren

Members Michaelâ&#x20AC;&#x2122;s Pharmacy Claude W. Bates Chad J. Brown Max C. Brown Lucinda F. Burroughs Waymon M. Cannon Jean N. Courson Carleton C. Crabill Alton D. Greenway J. Clarence Jackson Leonard Franklin Reynolds Victor Serafy William D. Whitaker

If you are interested in making a pledge to Pharm PAC and your name does not appear above, call Kelly McLendon at 404-419-8116 or Ursula Hamilton at 404-419-8115. Donations made the Pharm PAC are not considered charitable donations and are not tax deductible. The Georgia Pharmacy Journal

August 2010

EXECUTIVE VICE PrESIDEnT’S EDITOrIAL Jim Bracewell Executive Vice President / CEO

“I Back”

“Pharm PAC”

f you were at our recent 135th Georgia Pharmacy Association Annual Meeting and Convention in Myrtle Beach, South Carolina, and you are not familiar with this phrase “I Back Pharm PAC” you may have been on the beach too much.

block of professional reimbursement. Pharmacy will be at the policy table. Pharmacy will be on the decision tree. Pharmacy will seize the day for better heath care for Georgians through the professional management of the patient’s prescription drug therapy.

If I say “Go Dawgs” or if I say “Roll Tide” most people in the Southeast know immediately what I am talking about and a certain number of people among us will also experience a solid heart throb.

Pharmacy has begun a new day in advocating for the profession. Pharmacy has a new Pharm PAC. I hope the next time someone says to you “I Back,” that without hesitation you will say “Pharm PAC.” It will be a rewarding experience.

Soon, I hope when you hear the words “I Back” you will instinctively respond “Pharm PAC” and if you are a pharmacist with a love for your profession you too will feel a solid heart throb. The new Pharm PAC has been born. It has new levels of support. It has a new level of enthusiasm. It has a large number of new members and it is only just over a month old. Do you want to know more about it? Go to the www.GPhA.org and read about it and join online or contact your Region PAC Board Member (see page 10). See the Pharm PAC enrollment form on the opposite page. Two-thousand-ten is a turning point for Georgia pharmacists to reclaim control of their profession. When pharmacy was inactive in politics, other entities stepped up and began to set the course for the profession, but that will not be the case in 2011. Pharmacy will no longer be the dish to be carved up on the heath care table. Pharmacy will no longer be on the PBM menus or the butcher’s The Georgia Pharmacy Journal

August 2010

Pharm PAC

Who are the GPhA Pharm PAC Board of Directors? Article IV, Section 4.31 There may be up to 15 Directors, 12 of whom shall be nominated by the GPhA’s region presidents, one from each region, and the others shall be the GPhA’s President-Elect, the GPhA’s Executive Vice President and the Chair of the Political Action Committee.

Chairman: Eddie Madden, 2010-2011 Vice Chairman: Tommy Whitworth, 2010-2011 GPhA President-Elect: Jack Dunn, 2010-2011 Secretary: EVP Jim Bracewell, Exoffico (non-voting)

Region One Dean Stone Metter, GA

Region Seven Jim McWilliams Temple, GA

Region Two Keith Dupree Leesburg, GA

Region Eight T. M. Bridges Hazlehurst, GA

Region Three Judson Mullican Midland, GA

Region Nine Mark Parris Blue Ridge, GA

Region Four Tommy Whitworth LaGrange, GA

Region Ten Stacy Dickens Watkinsville, GA

Region Five Mahlon Davidson Oxford, GA

Region Eleven Stewart Flanagin Augusta, GA

5 4

1 8

Region Twelve Region Six Robert Moody Mark Cooper Macon, GA Dublin, GA

The Georgia Pharmacy Journal

August 2010

fEATUrED ArTICLE

New Pharmacy School Set To Open August 11; 75 Students Enrolled tudents arrive for orientation August 11 and classes begin August 16 for the newest pharmacy school in Georgia. The announcement was made Wednesday, July 7, in a joint communication from PCOM President and Chief Executive Officer Matthew Schure, PhD, and Mark Okamoto, Pharm.D., Professor & Founding Dean of the Philadelphia College of Osteopathic Medicine, School of Pharmacy in Suwanee.

Southern states, and to creating new models of inter-professional collaboration between pharmacists and physicians.”

That announcement comes on the heels of written approval from the national pharmacy education accrediting body, following an April visit to the school and a comprehensive review of the educational structure, some of the planned clinical training sites and the facility.

“Notification of ACPE’s granting of pre-candidate status for our program comes as great news for our faculty and staff who have worked so hard to prepare our curriculum, identify preceptors and pharmacy training sites and establish our teaching labs,” said Dean Okamoto. “Students begin classes Aug 16 and we are all looking forward to meeting the needs of the charter class of 75 students. No stone will be left unturned to provide them with a first-rate pharmacy school experience and equip them with the education and understanding they need to take leadership roles in an ever-changing healthcare environment. Our faculty brings diverse backgrounds to the school, with experience in pharmacy education, pharmaceutical and clinical research, clinical practice, and administrative management,” he added. “Our students will be the beneficiaries of all they have to offer.”

Although the accrediting body, the Accreditation Council for Pharmacy Education (ACPE), has just formally granted the school pre-candidate accreditation (the first of three levels of accreditation), plans for the school have been underway for nearly two years. Applicant interviews have been conducted and 75 students have been selected for the inaugural class. President Schure expressed his delight at the ACPE ruling granting preaccreditation status and allowing the School of Pharmacy to proceed with enrolling the first class. “We look forward to welcoming our class in August, to educating much needed pharmacists for Georgia and the

Data from the “Final Report, Task Force on Health Professions Education, Findings and Recommendations June 2006” to the Board of Regents of the University System of Georgia, indicated the need for pharmacists in Georgia is second only to the need for nurses, according to Campus Executive Officer John Fleischmann, EdD, who was instrumental in the initiative to bring

the pharmacy school to the college’s Georgia campus. The proposed opening of the new school attracted a large number of students for the 75 available seats, and over three hundred applicants were invited to the Georgia campus for interviews. According to Dr. Okamoto, “The admissions team has worked diligently to recruit and admit students whom are talented, who have expressed passion for the profession and who we expect to excel, both academically and professionally.” Students in the four-year Doctor of Pharmacy program will be involved in classroom, lab and pharmacy experiences beginning in year one. Classroom and lab experiences continue throughout the first three years of the program, while the fourth academic year sends students to eight 5-week rotations in hospital practice, community practice, ambulatory care and medicine rotations along with four elective rotations in a variety of settings including pediatrics, cardiology, infectious diseases, nuclear pharmacy, psychiatry, and managed care, to name a few. Most of the entering students have a baccalaureate degree and some have graduate degrees, but some of the students are able to fulfill the prerequisite requirements in less time. Many of the charter class come from working professional backgrounds as pharmacy technicians. The application process for new classes enrolling for Continued on page 17

The Georgia Pharmacy Journal

August 2010

GPhA MEMBEr nEWS

GPhA Honors Members During Recent Convention very year, the Georgia Pharmacy Association recognizes the contributions of individual member-pharmacists. Most of these recognitions occur at the Annual Convention during the President’s Inaugural Banquet or during the general sessions that occur daily during the convention, and acknowledge the efforts of individual pharmacists in professional service, public service, and innovative pharmacy practice.

Presented by Hutton Madden of Pharmacists Mutual Companies, the Distinguished Young Pharmacist honoree this year was Joshua D. Kinsey, Pharm.D., of Cleveland. The leadership accomplishments of this young man are most commendable, including opening Cleveland Pharmacy and Gift, in Cleveland, Georgia.

Mrs. Linda Madden of Elberton, was presented with the Pharmacist’s Mate Award and the 2010 President’s Award. The Pharmacist’s Mate Award was presented by Sharon Sherrer, Pharm.D.. Sharon presented for Judy Bowles who was unable to attend the convention. The President’s Award was presented by Eddie Madden, r.Ph..

David Pope, r.Ph., was the recipient of the National Alliance of State Pharmacy Associations’ Innovative Pharmacy Practice Award. Ensuring patients receive the highest quality and most cost effective care David Pope has instituted outreach educational programs to patients and training programs to fellow pharmacists to encourage pharmacy care, at a new and productive level to provide quality healthcare to the citizens of Augusta and across the country. David’s work has been recognized nationally with feature articles in the AMERICAN PHARMACIST and other national publications. David has brought pride and recognition to himself and the profession of pharmacy in our State.

flynn Warren, r.Ph., of Athens, was awarded the Bowl of Hygeia, one of the most highly coveted recognitions in pharmacy. As a former GPhA President and Georgia Pharmacy Foundation Board Member, Flynn excels in community service, but has also been extremely active in service to the pharmacists of Georgia and the education of pharmacists.

The Georgia Pharmacy Journal

August 2010

Dale Coker , r.Ph., fIACP was honored with several awards during the convention including the NCPA Leadership Award, the Smith Drug Company Incoming President Award and the McKesson Leadership Award. And, on Tuesday evening he was installed as the 2010-2011 President of the Georgia Pharmacy Association, after which he gave a gracious Inaugural Address which was printed in the June JOURNAL.

Also, during the convention GPhA honored Marvin Mac McCord, r.Ph., of Atlanta as th Academy of Independent Pharmacy’s Pharmacist of the Year.

This year we have three GPhA members whom we honored at the convention for their 50 years of service. They are as follows: Eddie f. Daniel, r.Ph., of Smyrna Samuel Goldberg, r.Ph., of Atlanta rodger A. Miles, Sr., r.Ph., of Carrollton.

As a final thank you to Eddie Madden, 2009-2010 GPhA President, Dale Coker presented him with the Past President’s Pin, a gold and diamond pin that is given to every outgoing president as a token of appreciation for their time of service.

During the General Session on Tuesday, Sharon Zerillo, r.Ph., was honored with the Academy of Employee Pharmacists’ Pharmacist of the Year Award.

We appreciate the contributions of these honorees for their contributions to the practice of pharmacy.

Chris Thurmond, Pharm.D., of Athens, was awarded the Mal T. Anderson Outstanding Region President Award. The award symbolizes strong leadership skills and dedication to the profession of pharmacy. Chris was unable to attend the convention and be will presented the award at a later date.

The Georgia Pharmacy Journal

August 2010

GPHA MEMBEr nEWS

Welcome to GPhA! The following is a list of new members who have joined Georgia’s premier professional pharmacy association! Joshua Morgan, Atlanta Julie Norman, Pharm.D., McDonough Funmilayo A. Olawole, Stockbridge Sonny Rader, R.Ph., Snellville Elaine C. Reifinger, Pharm.D., Grovetown David H. Ritchie, O.D., Milledgeville Brent Rollins, Bogart William F. Starnes, Pharm.D., richmond Hill William David White, Pharm.D., Athens Stephen Brett Winslette, rome Gwendolyn Williams Young, R.Ph., Bleckley

Patrice H Butterfield, Ph.D., Savannah Steve Butts, R.Ph., LaGrange Tiffany Davis, Pharm.D., Sylvania Michael Hanichen, R.Ph., Atlanta Joshua Harvey, Cumming Scott Hill, Pharm.D., Charleston, SC Phillip Russell James, R.Ph., royston Babafunlola Kalejaiye, Pharm.D., Acworth Brent Lake, Pharm.D., Gainesville Jenifer Nichole Lord, C.Ph.T, Dudley Zachary Martin, R.Ph., Johns Creek

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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GPhA MEMBEr nEWS

Mercer University Honors Alumni at Annual Dinner of Cleveland Pharmacy and Gifts in Cleveland, is a strong advocate of the College and is active in the Georgia Pharmacy Association. The Young Alumni Award recognizes the accomplishments and commitment of an alumnus who has graduated within the past 10 years.

he College of Pharmacy and Health Sciences presented six awards to friends and alumni who have made significant contributions to the school during its annual Alumni Association Dinner on June 28 in Myrtle Beach, S.C., held in conjunction with the Georgia Pharmacy Association Convention. Dean H.W. “Ted” Matthews presented the awards.

The Carlton Henderson Award was presented to Eddie M. Madden, r.Ph., of Elberton, the president and founder of Madden Pharmacy in Elberton and a leader in the pharmacy profession in the state. He is a former state senator, served as president of the Georgia Pharmacy Association for 2008-2009 and is a former member of the Georgia State Board of Pharmacy, 2001-2006. The award is named in honor of Carlton Henderson, longtime Mercerian and great supporter of the College of Pharmacy and Health Sciences, and recognizes an individual who has contributed to the reputation and enhancement of the pharmaceutical profession in the state of Georgia.

The Alumni Meritorious Service Award was presented to G. Brian robinson, Pharm.D. ’93, of Conyers. Robinson is the Atlanta north pharmacy supervisor for Walgreens Co., where he has been a key advocate for the College. He is an active member of the College’s Board of Visitors and actively recruits pharmacy students for employment. The Alumni Meritorious Service Award honors an alumnus of the College who has served the profession of pharmacy and the Alumni Association in an outstanding manner. The Young Alumni Award was presented to Joshua D. Kinsey, Pharm.D. ’05, of Cleveland. Kinsey is the owner

GPhA Member Appointed to the Advisory Committee on Examinations ne new member has been appointed and three reappointed to serve on the 2010-2011 Advisory Committee on Examinations (ACE). This standing committee, established by NABP in 1912, was created to safeguard the integrity and validity of NABP examinations.

As of June 1, 2010, the following individuals are serving terms on ACE. As of press time, the position of Executive Committee liaison was pending.

2010-2011 ACE Members • Tom Houchens, London, KY (Chair) • Sara St. Angelo, Indianapolis, IN • Carl W. Aron*, Monroe, LA • David Todd Bess, Cane Ridge, TN • Michael Duteau, Baldwinsville, NY • Judy Gardner, Atlanta, GA • Arthur I. Jacknowitz, Morgantown, WV • Betty J. Dong**, San Francisco, CA (Ex Officio Member, one-year term) • Kevin O. Rynn**, Piscataway, NJ (Ex Officio Member, one-year term) • Richard Morrison**, Bothell, WA (Ex Officio Member, one-year term)

ACE oversees the development and administration of all of the Association’s examination and certification programs. ACE also considers policy matters, evaluates long-range planning strategies, and recommends appropriate action to the NABP Executive Committee. ACE typically convenes three to four times per year and consists of individuals who are affiliated members of NABP, including current active board of pharmacy members and administrative officers, individuals who have served within the last five years as a member or administrative officer of a board of pharmacy, and nonaffiliated individuals who are practicing pharmacists or serving as pharmacy school faculty. The Georgia Pharmacy Journal

* Indicates new member ** Indicates reappointed members

August 2010

Continued from page 11

the Fall 2011 semester for all schools of pharmacy has already begun. The centralized Pharmacy College Application Service (PharmCAS, www.pharmacas.org) began accepting applications on June 14, 2010, for the next year’s class. “PCOM has become a national leader in the preparation of physicians and other healthcare professionals,” according to Dr. Fleischmann. “Since the Georgia branch campus establishment in 2005, our southern campus focus has been on providing service by addressing the shortage of professionals who provide healthcare

in Georgia and throughout the South. The PCOM’s School of Pharmacy will play a significant role in addressing the critical shortage of pharmacists in Georgia and in the region. Support from the pharmacy profession is critical in the establishment of any new pharmacy school. Within Georgia, our reception by the profession could not have been better. Our school has been widely embraced by the pharmacy profession throughout the State of Georgia.” “The opening of the school of pharmacy,” according to Dr. Robert Cuzzolino, PCOM’s vice president for

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

planning and graduate programs, “is a major step in PCOMs growth as an institution offering a wide array of high-quality graduate and professional programs in health related fields, from medicine, physician assistant studies and biomedical science to psychology, forensic medicine, organizational leadership, and now pharmacy. With two classes having graduated with their medical degrees at the new Georgia branch campus, we are thrilled at again making a real difference in the health manpower needs of Georgia and the Southeast, now through addressing the shortage of pharmacists in the region. Our School of Pharmacy leadership is innovative, the faculty is enthusiastic about being part of this new endeavor, and we are committed to new approaches that also build on a 111year-old tradition of excellence in health care professional education,” he added. Georgia Campus - Philadelphia College of Osteopathic Medicine is a private, not-for-profit branch campus of Philadelphia College of Osteopathic Medicine, an osteopathic medical school built on an over one-hundredyear tradition of educational excellence. GA-PCOM offers the doctor of osteopathic medicine degree, the doctor of pharmacy degree and a certificate and master’s degree in biomedical science.

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.

Toliver and Gainer, LLP 942 Green Street, SW Conyers, GA 30012-5310 altoliver@aol.com 770.929.3100

GPhA / APhA Immunization Program Coming Soon. We are planning to have another immunization program. Please check the GPhA website for details once they have been finalized.

The Georgia Pharmacy Journal

August 2010

PHArMCY nEWS

Independent Community Pharmacists Will Meet. Learn. Succeed---at the 2010 NCPA Annual Convention and Trade Exposition he National Community Pharmacists Association (NCPA) will present the latest in pharmacy education, case studies, and real world, businessimpacting information for the independent community pharmacy industry at its 112th Annual Convention and Trade Exposition at the Pennsylvania Convention Center in Philadelphia, October 23-27, 2010.

sought-after motivational speaker. The closing night event headlines “Saturday Night Live” alum and screen star Jim Belushi & the Sacred Heart Band at World Café- City Live, a fabulous non-smoking music and entertainment venue.

For more information and to register, visit www.ncpanet.org

Questioning the wisdom of your financial plan?

“NCPA is committed to the success of community pharmacists by providing practical business solutions and by advocating for their best interests in legislative, regulatory, and legal arenas,” said NCPA President and Arlington, TX pharmacy owner Joseph H. Harmison, PD. “And for over 100 years, our convention programming and first-rate trade exposition continues to reflect those values.”

If so, this ad entitles you to:

A cup of coffee, and a second opinion.

The convention theme of Meet. Learn. Succeed. introduced last year, reflects the top goals of the meeting for the representatives of over 3,000 community pharmacies who attend each year. When surveyed, participants cited the benefits of networking with their peers; learning from experts in the industry and using that knowledge to sharpen their patient care skills and improve their pharmacy’s performance throughout the following year. Over 70 percent of those surveyed said what they learned during the Convention would “pay for the trip” when they returned to their stores.

You’re welcome to schedule a time to come in or talk via conference call about your financial goals and what your portfolio is intended to do for you and your family. I’ll review it with you and give you my opinion – without obligation. Either way, the coffee is on me.

Michael T. Tarrant

The four-day convention will feature nearly 20 hours of continuing education credits on topics including marketing, merchandising, technology and profitable niches including long-term care, immunizations, compounding, and more. New formats this year will integrate the popular and topical government affairs forum into the Second General Session and add the fun-filled NCPA Foundation Silent Auction to the opening night celebration. New educational programming includes sessions on 340B, diabetes education reimbursement and the return of the popular all-day technology seminar.

Financial Network Associates 1117 Perimeter Center West, Suite N-307 Atlanta, GA 30338 • 770-350-2455 mike@fnaplanners.com www.fnaplanners.com i An Independent Financial Planner since 1992 Focusing on Pharmacy since 2002 i Securities, certain advisory services and insurance products are offered through INVEST Financial Corporation (INVEST), member FINRA/SIPC, a federally registered Investment Adviser, and affiliated insurance agencies. INVEST is not affiliated with Financial Network Associates, Inc. Other advisory services may be offered through Financial Network Associates, Inc., a registered investment adviser.

This year’s keynote speaker is former Olympic champion Bruce Jenner, a gold medalist in the decathlon and now a

The Georgia Pharmacy Journal

August 2010

PHArMACY nEWS

Medication Adherence Fact Sheet • We all know that medicines don't work when people don't take them. If we examine the causes of poor patient health, or even hospitalizations, often times it's due to the improper use of medications. The costs to our nation's health care system due to medication non-adherence are estimated to be over $290 billion dollars. We also know that pharmacists can play a vital role in medication adherence, in fact, pharmacists are uniquely qualified to fulfill that role. Find one new patient each day to talk to and educate about their medications. New England Healthcare Institute Research Brief. Thinking Outside the Pillbox:A System-wide approach to Improving Patient Medication Adherence for ChronicDisease 2009. www.nehi.net/uploads/full_report/pa_issue_brief__final.pdf. Accessed May 1, 2010.

• Working with patients to improve adherence to their medication therapy should be a core competency of every pharmacist. It's the foundation from which all patient care services should be built upon. As a profession, we should strive to make adherence services a standard of practice, something done routinely for all chronic care patients. 75% of patients do not take their medications as prescribed. Contact a patient who you know is overdue for their refill, and tomorrow, call two more. It's a simple and effective way to build relationships with your customers, and a process that will lead to better health outcomes. National Council on Patient Information and Education. Enhancing Prescription Medicine Adherence: A National Action Plan 2007. http://www.talkaboutrx.org/documents/enhancing_prescription_medicine_adherence.pdf Accessed May 1, 2010.

• Poor medication adherence, especially in those with chronic conditions such as cardiovascular, HIV, diabetes, and asthma can lead to problems such as unnecessary disease progression, complications, and reduced quality of life. Preventable deaths due to non-adherence are estimated to be at least 125,000 each year. Pharmacists should lead the way in educating patients about being adherent to their prescribed medication therapy, especially those with chronic medical illnesses. Adherence initiatives that pharmacists have lead have been shown to improve patient outcomes for those patients with various chronic conditions Vermeire, E., et al. Patient adherence to treatment: three decades of research. A comprehensive review. J Clin Pharm Ther. 2001 Oct;26(5):331-42.

• There are many special populations that are at high risk for medication non adherence. The elderly population is more likely to have long-term chronic illnesses and according to one study, people aged 75 years and older take an average of 7.9 drugs per day. Many of these patients are not taking their medications correctly. Pharmacists need to assure their patients understand the importance of being adherent by discussing their medications with them at each visit, offering them counseling and reminders of ways that they can remain adherent to their mediation regimen such as using a pill box or setting an alarm. Small reminders such as these can help lead the way in improving medication adherence. Marinker M, Blenkinsopp A, Bond C, et al. From Compliance to Concordance: Achieving Shared Goals in Medicine Taking. London, UK: Royal Pharmaceutical Society of Great Britain; 1997.

• Poor medication adherence costs this nation $290 billion dollars representing 13% of the total healthcare spend in this country. Find one new patient each day to talk to about their medications. New England Healthcare Institute Research Brief. Thinking Outside the Pillbox:A System-wide approach to Improving Patient Medication Adherence for ChronicDisease 2009. www.nehi.net/uploads/full_report/pa_issue_brief__final.pdf. Accessed May 1, 2010.

• Improper medication use costs our nation an estimated $290 billion annually in total direct and indirect health care costs. Pharmacists need to educate patients on medication adherence. New England Healthcare Institute Research Brief. Thinking Outside the Pillbox:A System-wide approach to Improving Patient Medication Adherence for ChronicDisease 2009. www.nehi.net/uploads/full_report/pa_issue_brief__final.pdf. Accessed May 1, 2010.

• 75% of patients do not take their medications as prescribed. Pharmacists should lead the way in assuring optimal medication use. National Council on Patient Information and Education. Enhancing Prescription Medicine Adherence: A National Action Plan 2007. http://www.talkaboutrx.org/documents/enhancing_prescription_medicine_adherence.pdf Accessed May 1, 2010. Continued on page 29

The Georgia Pharmacy Journal

August 2010

Continuing Education for Pharmacists Medications for the Treatment of Nicotine Addiction This CPE lesson was written by Nazifa Obaidi, 2010 Pharm.D. Candidate, University of Nebraska College of Pharmacy, who has no financial or conflict of interest disclosures.

Goals The goals of this lesson are to provide background information on the health impact of tobacco use, the incidence of nicotine use, and to review the pharmacotherapy for tobacco cessation.

Objectives At the conclusion of this lesson, successful participants should be able to: 1. recall the incidence of tobacco use; 2. describe the pharmacological profiles of tobacco cessation therapies; and 3. compare efficacy of treatment options.

Introduction Tobacco is the leading cause of preventable death in the world. The effects of tobacco kill 5.4 million people a year worldwide, which translates to an average of one person every six seconds, from lung cancer, heart disease and other illnesses.1 In Nebraska, from 2000 to 2004, an annual average of 2,274 deaths were attributable to smoking.2 According to the CDC, trends in adult smoking in the United States have been declining since the 1950s. Although 46 million American adults smoke cigarettes, 70% of smokers want to quit completely and 40% of smokers attempt to quit each year.3,4 In 2008, 18.4% of adult Nebraska residents were cigarette smokers. Even though the use of tobacco The Georgia Pharmacy Journal

products is decreasing in high-income countries, it is increasing globally.5

tobacco cessation and was approved by the FDA in 2006.

Current Therapy

Mechanism of Action. Varenicline is a partial agonist at α4-ß2α neuronal nicotinic acetylcholine receptors (nAChRs) which are believed to be the site where nicotine exerts its action. Varenicline stimulates lowlevel agonist activity and competitively inhibits binding of nicotine, therefore, decreases nicotine cravings and withdrawal symptoms. Nicotine increases dopamine levels in the nucleus accumbens and prefrontal cortex. During periods of abstinence from nicotine, cravings are stimulated by low dopamine levels in the mesolimbic system. If a patient relapses and uses tobacco, varenicline reduces the associated reward by occupying nicotine receptor sites.8,9

There are three general classes of FDA-approved drugs for tobacco cessation: partial nicotinic receptor agonists, psychotropics, and nicotine replacement therapy (NRT). Varenicline (Chantix®) is the only approved partial nicotinic receptor agonist. Bupropion sustained-release (Zyban®) is the only approved psychotrope available. NRT formulations consist of nicotine gum, transdermal patch, lozenge, nasal spray, and oral vapor inhaler. A sublingual tablet is another NRT formulation, but it is not available in the United States.6 According to The Clinical Practice Guidelines for Treating Tobacco Use and Dependence, published in the Journal of American Medical Association, all of the FDA-approved drugs for tobacco cessation are considered first line therapy.7 Factors such as clinician familiarity with the medications, contraindications in certain patients, patient preference, previous patient experience with specific agents, and patient characteristics such as history of depression, should be considered when deciding between specific first line therapies.7

Partial Nicotinic Receptor Angonists Varenicline (Chantix®) Chantix® is the newest medication developed for 20

Dosing/Administration. Varenicline should be titrated over one week with therapy maintained for 12 weeks. Treatment should begin 1 week prior to smoking quit date. Initiate with 0.5 mg daily on days 1 to 3, increase to 0.5 mg twice a day on days 4 to 7, and 1 mg twice a day on day 8 until end of treatment.9 For those not smoking at week 12, an additional 12 week course is recommended for relapse prevention.6,9 If treatment is unsuccessful, smoking cessation should be attempted again.9 For patients with a creatinine clearance (CrCl) ≤ 50 mL/min, titrate to a maximum dose of 0.5 mg twice a day. No dosage adjustments are required in hepatic impairment.8 August 2010

Pharmacokinetics. Varenicline is almost completely absorbed and has a high bioavailability after oral administration. Peak concentration occurs within 3 to 4 hours and steady state is attained after 4 days of multiple dosing. Metabolism of varenicline is minimal with 92% of the drug excreted unchanged in the urine. Food and time of day do not affect the concentration of varenicline.8,9 Adverse Effects. The most common adverse effect of varenicline is nausea (30% vs. 10% placebo in 1 mg twice a day and 16% vs. 11% placebo in 0.5 mg twice a day). Other common adverse effects include sleep disturbances (insomnia, abnormal/vivid dreams), headache and abdominal pain. Rare, but serious side effects, include Steven Johnson’s Syndrome and angioedema of the face, mouth, and neck.8,9 Drug Interactions. No clinically significant interactions have been reported with varenicline use.8 Contraindications/Precautions. Varenicline use should be avoided in patients with a known hypersensitivity to varenicline. Patients should discontinue varenicline and seek medical help if a skin rash appears with mucosal lesions. Use with caution in renal impairment since varenicline is substantially excreted by the kidneys and can increase toxicity (see dosing/administration). Safe and effective use has not been established in children and adolescents less than 18 years of age. Varenicline is not recommended in this patient population. In 2009, a black box warning label was added to varenicline outlining the serious The Georgia Pharmacy Journal

neuropsychiatric effects and advising patients to immediately report agitation, depressed mood, and atypical changes in behavior or thoughts of suicidal ideation.8,9 A cohort nested observational study in the United Kingdom (n = 80,660) was conducted to determine whether varenicline was associated with an increased risk of suicidal behavior. It was concluded that there was no clear evidence of an increased risk with varenicline compared with other smoking cessation therapies. The study had limited power so risk could not be ruled out.10 Advantages. Relief from nicotine cravings and symptoms of withdrawal are attributed to varenicline's unique mechanism of action. Based upon the efficacy demonstrated in clinical trials, patients who can tolerate this medication may be more likely to abstain from tobacco use as compared to other therapies.

Psychotropes Bupropion Sr (Zyban®) Bupropion SR, initially approved as an atypical anti-depressant, is the first nonnicotine agent FDA-approved in the treatment of tobacco dependence .11 Mechanism of Action. The exact mechanism of action of bupropion SR in tobacco cessation is unknown, but it is thought to be related to inhibition of noradrenergic or dopaminergic neuronal uptake in the mesolimbic system.8,12 It also appears to be a weak antagonist at nicotinic receptors.6 Bupropion SR decreases cravings for cigarettes and decreases symptoms of nicotine withdrawal.13 Dosing/Administration. Bupropion SR should be initiated 1 to 2 weeks prior to the chosen smoking quit-day. 21

If patients have not quit smoking after the 7th week of therapy, they are generally considered non-responsive to treatment with bupropion SR.8 As monotherapy or in combination with NTS, the patient should be instructed to initiate bupropion SR 150 mg daily for the first three days, then the dose should be 150 mg twice a day for the remainder of the treatment period (7 to 12 weeks) with doses at least 8 hours apart. Maximum daily dose should not exceed 300 mg/day.8 Combined therapy of Zyban®and nicotine transdermal system (NTS) received FDA approval in 1999.8,11 Patients should initiate bupropion SR 1 to 2 weeks before the scheduled quit-day and NTS should be initiated on the scheduled quit day. Bupropion SR should be continued for 7 to 12 weeks and most NTS can be continued for 8 to 20 weeks. Dose tapering is not necessary when discontinuing treatment with bupropion SR in smoking cessation.8,11 Pharmacokinetics. Bupropion SR is a racemic mixture with an oral bioavailability of around 5% to 20% in animal models. The oral bioavailability of bupropion SR has not yet been determined in humans. Peak plasma concentrations are obtained within 3 hours after administration of bupropion SR. Although food slightly affects absorption, it is not clinically significant.8,9 Adverse Effects. Common adverse effects from bupropion SR include insomnia which occurs in 30% to 40% of patients, and dry mouth which occurs in 10% of patients.7,8 Other possible adverse effects include nervousness/difficulty concentrating, August 2010

rash, constipation and seizures. The possibility of seizures is 1/1,000 or 0.1%.6,8 Drug Interactions. Although the combination of NTS and bupropion SR is utilized, it can cause a clinically significant increase in blood pressure and it is recommended to monitor blood pressure. Concurrent use of bupropion SR with drugs that decrease the seizure threshold such as anti-depressants, antipsychotics, cocaine, psychostimulants (e.g., amphetamine, dextroamphetamine and stimulant weight-loss medications), sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous theophylline, tramadol, and systemic corticosteroids, should be avoided altogether or used with caution.8,11 Contraindications/Precautions. Absolute contraindications to bupropion SR include seizure disorders, bulimia, anorexia, and concurrent administration with MAOI therapy. Issued in 2004, Bupropion SR contains a black box warning concerning the increased risk of suicidal ideation in pediatric and young adult patients.8 In 2009, another black box warning was issued outlining the serious neuropsychiatric effects of bupropion SR such as changes in behavior, agitation, hostility, depressed mood, and suicidal ideation in patients with and without previous psychiatric disorders. There is a possibility for exacerbation of psychiatric disorders such as schizophrenia when bupropion SR is utilized for smoking cessation.11 Advantages. Bupropion SR can delay and/or decrease the weight gain that is associated with smoking cessation. The Georgia Pharmacy Journal

It is also an effective treatment for smokers with a history of depression.6

Nicotine Replacement Therapy (NRT) The aim of NRT is to replace some of the nicotine from tobacco in order to reduce nicotine withdrawal symptoms and reduce the motivation to smoke. NRT provides an alternative source of reinforcement and cognitive effects compared to the nicotine from tobacco.6 A Cochrane Review found that 17% of smokers who had used nicotine replacement therapy successfully quit at follow-up versus 10% of smokers in the control group.14 The choice of a specific NRT is mostly determined by patient preference, adverse effects, and price.6 Patients should discontinue smoking and all other forms of tobacco when initiating NRT.8 Mechanism of Action. Nicotine has both stimulant and depressant actions and is classified as a stimulant of nicotinic receptors of autonomic ganglia. Inhaled nicotine is quickly absorbed into the bloodstream where it passes the blood brain barrier. Once in the brain, nicotine binds to nicotine receptors and stimulates release of neurotransmitters such as dopamine.15 When nicotine is administered in low sustained doses, it desensitizes nicotine receptors and acts like a nicotine receptor antagonist.8 Contraindications/Precautions. Nicotine has cardiovascular side effects which can cause peripheral vasoconstriction, tachycardia and elevated blood pressure. NRT should be used with caution in patients with underlying cardiovascular disease such as recent myocardial infarction (within the past 2 weeks), serious cardiac arrhythmias, and serious or 22

worsening angina.8 NRT products may be appropriate for use in these patients under medical supervision. Nicotine can delay the healing of ulcers and should be used with caution in active peptic ulcer disease. Nicotine is relatively contraindicated in patients with a history of esophagitis, hiatal hernia, or gastroesophageal reflux disease because these conditions can be exacerbated by nicotine's pharmacologic effects.8,9 Formulationspecific contraindications are listed separately, if applicable, under individual NRT products. Drug Interactions. Nicotine has been reported to enhance the cardiovascular effects of adenosine which may result in an increase in chest pain and heart rate and a decrease in blood pressure. NRT and tobacco products should be avoided prior to stress testing and studies where adenosine will be used. Through its neuro-endocrine effects, nicotine may increase cortisol and catecholamine levels and may potentiate the effects of adrenergic agonists and ergot alkaloids. Dosage adjustments may be needed if significant changes in nicotine levels occur.8,9 Tobacco induces CYP450 enzymes and can increase the metabolism of other drugs. When a patient discontinues smoking, even if utilizing NRT, concentrations of certain drugs such as caffeine, clozapine, oxazepam, olanzapine, pentazocine, phenothiazines, propoxyphene, propranolol (and possibly other betaadrenergic blockers), theophylline, tricyclic antidepressants, and warfarin, may be affected. A decreased dosage of these drugs may be required at the cessation of smoking.8,9 August 2010

Nicotine Transdermal Patch (Nicoderm CQ®, Habitrol®, ProStep®, Nicotrol®) Transdermal

Table 2 Usage for nicotine Gum7,8 Weeks 1-6 7-9 10 - 12

patches were FDA-approved in November 1991 and are available OTC and with a prescription. Dosing/Administration. Transdermal patches are available in several different doses and deliver between 5 mg and 22 mg of nicotine over a 16 to 24-hour period.14 Patches should be applied intact to an area of clean, dry, hairless and non-irritated skin on the upper body or upper outer part of the arm. After applying the patch, it should be pressed firmly with palm of hand for about 10 seconds to ensure adherence.13 Habitrol® Nicoderm® and ProStep® brands should be worn for 24 hours and then removed and disposed of by folding the patch onto itself. Nicotrol® should be applied after waking and removed before bedtime. If they are applied correctly, patches are not affected by showering, swimming, or exercise.8,9 Pharmacokinetics. Nicotine is well absorbed through the skin. However, the extent of absorption is not known. In general, peak nicotine plasma concentrations occur within 4 to 12 hours after application of a patch with a continuous release of nicotine over 16 to 24 hours.6,8 Time to peak plasma concentrations vary within the

various transdermal products. Habitrol® concentrations peak within 5 to 6 hours after application of the patch, Nicoderm® in 4 hours, and ProStep® in 9 hours. Nicotine from a transdermal system has an elimination half-life of 3 to 4 hours.8,9

consistent nicotine levels delivered over a 24 hour period; thereby, resulting in fewer compliance issues.13 Patches are also relatively easy to use and conceal.

Adverse Effects. Among the most common side effects of the transdermal patch is mild skin irritation such as itching, burning, and tingling within the first hour at the placement site as well as insomnia.6,7 Other possible side effects include vivid dreams or sleep disturbances and headache.8

approved as an OTC product by the FDA in January 1984.

Contraindications/Precautions. Use of the nicotine patch may cause skin irritation in people with certain conditions such as eczema, psoriasis, or atopic dermatitis. Since some nicotine patches contain aluminum or other metals that can overheat and cause skin burns, they should be removed prior to MRI procedures.8 Advantages. One advantage of utilizing a transdermal patch is the

Table 1 Dosing for nicoDerm CQ® Transdermal Patch8 Light Smoker (≤10 cigarettes/day)

Heavy Smoker (>10 cigarettes/day)

14 mg for 6 weeks then 7 mg for 2 weeks

21 mg for 6 weeks then 14 mg for 2 weeks then 7 mg for 2 weeks

The Georgia Pharmacy Journal

Usage 1 piece every 1 to 2 hours 1 piece every 2 to 4 hours 1 piece every 4 to 8 hours

Nicotine Polacrilex Gum (Nicorette®) Nicorette® was

Dosing/Administration. Nicotine gum is available in 2 mg and 4 mg strengths and come in a variety of flavors including original, cinnamon, fruit, mint, and orange. For patients who smoke ≥25 cigarettes per day, the 4 mg strength gum is recommended with a maximum of 24 pieces per day.8,13 For patients who smoke <25 cigarettes per day, the 2 mg strength gum is recommended with a maximum of 24 pieces per day. Patients should chew the gum slowly until a tingling sensation or peppery taste occurs. In order to allow absorption of the nicotine from the oral mucosa, the gum should then be "parked" inside the mouth between the cheek and gum until the tingle or peppery taste fades. This process should be repeated for around 30 minutes and the gum should not be swallowed. It is recommended to use at least 9 pieces of gum per day for the first 6 weeks in order to improve the likelihood of quitting. Certain acidic foods and beverages like coffee, wine, juices and soft drinks, can reduce the effectiveness of nicotine August 2010

gum. Therefore, it is recommended to not eat or drink for 15 minutes prior to or while using nicotine gum.8,17 Pharmacokinetics. Peak nicotine plasma concentrations occur within 15 to 30 minutes after the start of chewing the gum. Adverse Effects. Common side effects from utilizing nicotine gum include mouth soreness, hiccups, dyspepsia, and jaw pain.6,7,8 Adverse effects that are associated with incorrect chewing technique such as chewing gum too rapidly and can cause excessive release of nicotine include light headedness, nausea and vomiting, and throat and mouth irritation. Contraindications/Precautions. It is best to avoid nicotine gum in patients with temporomandibular joint (TMJ) disease or mouth and throat inflammation. Use with caution in patients with certain dental work such as dentures since nicotine gum is stickier than regular chewing gum and may stick to dental work.8,9 Advantages. Nicotine gum is a short acting NRT that offers flexible dosing and is attainable without a prescription.

Nicotine Polacrilex Lozenge (Commit®) Nicotine lozenge (Commit®) was approved on October 31, 2002 by the FDA for smoking cessation. It contains buffering agents to enhance buccal absorption of the nicotine. Dosing/Administration. Nicotine lozenges are available in 2 mg and 4 mg strengths and come in sugar-free mint flavor. Dosing for the nicotine lozenge is based on the “time to first The Georgia Pharmacy Journal

cigarette” (TTFC) which is used as an indicator of nicotine addiction.18 People who smoke their first cigarette of the day within 30 minutes of waking should use the 4 mg lozenge and those who smoke their first cigarette after 30 minutes of waking require the 2 mg lozenge. One lozenge every 1 to 2 hours should be used for the first 6 weeks of treatment. Then, reduce to 1 lozenge every 2 to 4 hours for weeks 7 to 9 of treatment and 1 lozenge every 4 to 8 hours for weeks 10 to 12.8,9 The recommended duration of therapy is 12 weeks with a maximum of 20 lozenges per day. The lozenge should be placed inside the mouth and allowed to dissolve slowly over 20 to 30 minutes with occasional rotation to different areas of the mouth.13 It should not be chewed or swallowed. For maximal results, at least 9 lozenges should be used daily during the first 6 weeks. Certain acidic foods and beverages like coffee, wine, juices and soft drinks, can reduce the effectiveness of the nicotine lozenge. It is recommended not to eat or drink for 15 minutes prior to or while using nicotine lozenge.6,7 Pharmacokinetics. Nicotine from the lozenge is readily absorbed through the buccal mucosa. Systemic absorption is slower than from a cigarette or the inhaled and nasal NRTs. Although pharmacokinetic data is not available for the nicotine lozenge, one study found that nicotine lozenges delivered around 25% more nicotine than nicotine gum. This was because the lozenge dissolves completely whereas the gum may retain some nicotine.16,18 Adverse Effects. Common adverse effects associated with the nicotine lozenge include nausea, hiccups, 24

cough, heartburn, headache, flatulence, insomnia, and mouth and throat irritation.8,18 Contraindications/Precautions. No specific contraindications are reported for nicotine lozenge.8 Refer to general NRT contraindications/precautions. Advantages. It is claimed that the best indicator for nicotine dependence is TTFC, which is how lozenges are dosed, rather than the number of cigarettes smoked, which is how the gum is dosed.16 The lozenge offers another flexible dosing schedule that can be used in acute situations as a rescue medication for cravings. Also, there are no precautions reported in TMJ patients, as with the nicotine gum.18

Oral Inhaler (Nicotrol®) On May 5, 1997, the FDA-approved Nicotrol® inhaler, a prescription-only oral inhalation system. Dosing/Administration. Nicotrol® inhaler is available as a 10 mg/cartridge inhalation system with each cartridge delivering 4 mg of nicotine. The recommended initial dose is 24 to 64 mg (6 to 16 cartridges) per day for up to 12 weeks followed by a gradual reduction in dosage over a period 6 to 12 weeks.6 Use for more than 6 months is not recommended.7 Patients should be instructed to place a cartridge into the mouthpiece and then inhale into back of throat or puff in short breaths. The nicotine in each cartridge will be used up after about 20 minutes of active puffing. Once a cartridge is opened, it retains potency for 24 hours.8 Pharmacokinetics. After oral inhalation, nicotine is rapidly August 2010

absorbed through the respiratory tract and mucous membranes. Additionally, there is a slower oral absorption of nicotine through the buccal mucosa with peak nicotine plasma concentrations occurring within 15 minutes after inhalation.8,9 Adverse Effects. The most common adverse effects from the oral inhaler are mouth and throat irritation and cough.6 Other possible adverse effects include dyspepsia, hiccups, headache, and rhinitis.8 Advantages. The inhaler formulation mimics the hand-to-mouth motion and puffing behaviors of smoking and is useful as a behavioral coping mechanism.6,16

Pharmacokinetics. After nasal inhalation, nicotine is rapidly absorbed through the respiratory tract and mucous membranes. Peak nicotine plasma concentrations occur within 4 to15 minutes after nasal administration. Approximately 53% of a dose (2 sprays) reaches systemic circulation.8,9

of NRT, the authors of the Cochrane Review concluded that all forms combined of NRT increased chances of quitting smoking by 50% to 70% in heavy smokers who are highly motivated to quit.14 Quit rates were generally found to be similar in comparison trials of bupropion SR with NRT.6

Adverse Effects. Common adverse effects of the nicotine nasal spray are rhinitis, throat and nasal irritation, sneezing, headache, and cough. Side effects usually subside after 3 to 7 days with regular use.8,9

Varenicline has been shown to be superior over placebo and bupropion SR. One randomized controlled trial comparing varenicline versus bupropion or placebo, found 43.9% of participants on varenicline remained continuously abstinent from smoking compared to 17.6% in the placebo group and 29.8% in the bupropion SR group.12 The most common adverse event of varenicline reported in the trial was nausea with a frequency of 29.4%.8,12 Table 3 summarizes odds ratios for all pharmacotherapy agents for tobacco cessation.

Advantages. More rapid delivery of nicotine is obtained through a nasal spray therefore providing faster relief of withdrawal symptoms.6,16

Nasal Inhaler (Nicotrol速 NS) Clinical Trials/Comparison Dosing/Administration. Nicotrol速 NS is a prescription-only aqueous One clinical trial indicates that the solution of nicotine available as a combination of bupropion SR with 10mg/mL nasal spray. The NTS results in abstinence rates of recommended dosage is 1 spray 51% at week 10 following a 4-week (containing 0.5 mg nicotine per quit program. However, one year spray) into each nostril 1 to 2 times after the target quit-date, the hourly as needed whenever the bupropion SR and NTS combination patient feels the need to smoke, with is not significantly better at a maximum of 10 sprays (5 doses) per maintaining abstinence than the use hour.6,7 For best results, patients of bupropion SR alone.19 Nicotine should use at least 16 sprays (8 doses) abstinence rates in clinical trials after daily for the first 6 to 8 weeks. 6 weeks of monotherapy with Therapy should be continued for up bupropion SR were 44.2% for to 3 months. Increased duration of bupropion SR 300 mg per day versus therapy does not improve outcomes 19% with placebo. At one year, the and safety of use greater than 6 abstinence rate was superior to 8 months has not been established. placebo for those patients receiving Instruct patients to prime the nasal bupropion SR at 300 mg per day or pump before the first use, then blow 150 mg per day, but not for the 100 nose, tilt head back slightly and insert mg per day dosage.8 tip of bottle into nostril as far as According to a 2004 Cochrane comfortable. Patients should breathe Review which included over 40,000 through the mouth and then actuate people, treatment with bupropion SR spray into nostril. doubled the quit rate compared with placebo.6,14 After reviewing 132 trials The Georgia Pharmacy Journal

Second Line Drugs Second line therapies such as clonidine, an antihypertensive, and nortriptyline, a tricyclic antidepressant, should be considered after treatment failure or in patients with contraindications to first-line agents.20 Neither nortriptyline nor clonidine has an FDA-approved indication for tobacco dependence treatment and each has an increased incidence of side effects versus firstline treatments. However, both clonidine and nortriptyline have been shown to be efficacious.17 Clonidine is available as a transdermal patch (Catapres速 TTS) and tablets. One dosage regimen for clonidine is 0.1 to 0.4 mg daily or 0.1 mg once weekly transdermally for 3 to 6 weeks. Treatment should begin 3 days prior to or on the quit day.8 Dose should be August 2010

Table 3 Odds ratios of abstinence with first- and second-line smoking cessation therapy6,14 Therapies first-line NRT: Gum Patch Inhaler Lazenge Nasal Spray Varenicline Bupropion SR Second-line Nortriptyline Clonidine tapered prior to discontinuation of medication to circumvent rebound hypertension. The most common adverse effects are dry mouth, dizziness, sedation, constipation, erythema, contact dermatitis, and postural hypotension.9

Odds ratio (95% CI/# of trials)

1.43 (1.33 to 1.53)/53 trials 1.66 (1.53 to 1.81)/41 trials 1.90 (1.36 to 2.67)/4 trials 2.00 (1.63 to 4.45)/6 trials 2.02 (1.49 to 2.73)/4 trials 3.85 (2.70 to 5.50/2 trials 2.06 (1.77 to 2.40)/19 trials

2.14 (1.49 to 3.06)/6 trials 1.89 (1.30-2.74)/6 trials abortion, and increased perinatal mortality. Studies in pregnant animals have shown adverse effects to the fetus from intravenous nicotine, including teratogenicity in rats and acidosis, hypercarbia, and hypotension in the rhesus monkey fetus. There have been no adequate, well-controlled studies in pregnant females. Smoking cessation therapy

should only be used in pregnancy if the potential benefits, such as an increase in likelihood of smoking cessation, outweigh the risks to the fetus. Spontaneous abortion has been reported in pregnant women on NRT. Nicotine patches, lozenges, inhalers, and nortriptyline are classified as FDA pregnancy category D, while nicotine gum, bupropion SR, varenicline, and clonidine are classified as FDA pregnancy category C.8,9

Pipeline NicVAX速 is a nicotine conjugate vaccine currently in phase II clinical trials which is designed as a smoking cessation aid as well as an aid to prevent relapses. NicVAX速 is a nicotine derivative that is chemically bound to a selected carrier protein. It is designed to cause the immune system to produce antibodies that bind to nicotine in the bloodstream and prevent it from entering the brain. By blocking the effects of nicotine, the end result is lack of the positive stimulus caused by nicotine. There have been positive and

Treatment with nortriptyline should begin 10 to 28 days prior to quit date at a dose of 25 mg daily. Gradually Table 4 titrate to 75 mg to 100 mg daily and Medication Guidelines21 continue therapy for 8 to 12 weeks. Dose should be tapered prior to Effective Medication Combination Medications Not Recommended discontinuation of medication. Common adverse effects associated Longterm (>14 weeks) nicotine patch Antidepressants other than bupropion with nortriptyline therapy are + other NRT (gum or spray) SR and nortriptyline sedation, dry mouth and Selective serotonin re-uptake inhibitors The nicotine patch + the nicotine inhaler constipation.6

Pregnancy

The nicotine patch + bupropion SR (Strength of Evidence = A)

Pregnant women should seek medical advice before initiating any smoking cessation pharmacotherapy. The negative effects of cigarette smoking on the fetus have been well established, including low birth weight, an increased risk of spontaneous The Georgia Pharmacy Journal

(SSRIs) Anxiolytics/benzodiazepines/betablockers Opioid antagonitsts/naltrexone Mecamylamine Extened use of medications

August 2010

promising results from phase I and phase II studies showing safety, tolerability and efficacy of NicVAXÂŽ.15

Conclusion Tobacco use is the most preventable cause of premature mortality and morbidity in the world. With the addition of bupropion SR and varenicline to the market, a variety of medication therapies are available for those who have decided to quit smoking, giving patients and physicians more flexibility in choosing an appropriate treatment option. Following the most recent smoking cessation guidelines, those who smoke 10 or more cigarettes per day should be encouraged to use first-line smoking cessation therapies such as NRT, bupropion SR, or varenicline (strength of evidence: A).20 If there are contraindications to first-line therapies, second-line therapies of

either clonidine or notriptyline can be used. Table 4 summarizes effective combination smoking cessation therapies as well as medications not recommended for the treatment of tobacco cessation.

pharmacists.

As part of the health care team, pharmacists can provide tobacco cessation and prevention services. This increases quit rates and expands the pharmacistâ&#x20AC;&#x2122;s role in tobacco treatment. One recently published systematic review found evidence that suggests pharmacists are effective in helping smokers stop tobacco use.22 The next M&P continuing education lesson will focus on developing and implementing a smoking cessation program, and will provide guidelines on what topics should be addressed during each smoking cessation meetings between patients and the

references 1. 10 Facts About Tobacco and Second-Hand Smoke. World Health Organization (WHO). http://www.who.int/features/factfiles/tobacco/en/index.html. Accessed on November 12, 2009. 2. State Tobacco Activities Tracking and Evaluation (STATE) System [serial online]. Accessed on November 5, 2009. 3. Smoking Cessation. American Heart Association (AHA). http://www.americanheart.org/presenter.jhtml?identifier=4731. Accessed on November 15 2009. 4. Tobacco. Center for Disease Control (CDC). http://www.cdc.gov/tobacco/data_statistics/fact_sheets/fast_facts/index.htm; Accessed on November 15, 2009. 5. Tobacco Free Initiative. World Health Organization. http://www.who.int/tobacco/mpower/tobacco_facts/en/index.html. Accessed on November 16, 2009. 6. Nides, M. (2008). Update on pharmacologic options for smoking cessation treatment. The American Journal of Medicine, 121(4 Suppl 1), S20-31. 7. Fiore MC, Jaen MC, Baker TB, et al. Treating Tobacco Use and Dependence: 2008 Update. A Clinical Practice Guideline. Washington, DC: US Dept of Health and Human Services. Public Health Service; 2008. 8. Clinical Pharmacology [internet database]. Tampa, FL: Gold Standard Inc; 2009. http://www.clinicalpharmacology.com: Accessed November 16, 2009. 9. Micromedex Healthcare Series [internet database]. Version 5.1. Greenwood Village, Colo.: Thompson Healthcare: Accessed November 16, 2009. 10. Gunnell, D., Irvine, D., Wise, L., Davies, C., & Martin, R. M. (2009). Varenicline and suicidal behaviour: A cohort study based on data from the general practice research database. BMJ (Clinical Research Ed.), 339, b3805. 11. Zyban prescribing information. http://us.gsk.com/products/assets/us_zyban.pdf; Accessed November 5, 2009. 12. Jorenby, D. E., Hays, J. T., Rigotti, N. A., Azoulay, S., Watsky, E. J., Williams, K. E., et al. (2006). Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: A randomized controlled trial. JAMA : The Journal of the American Medical Association, 296(1), 56-63.

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August 2010

References continued... 13. Quit-smoking products: Boost your chance of quitting for good. MayoClinic. http://www.mayoclinic.com/health/quit-smokingproducts/MY00781/NSECTIONGROUP=2: Accessed November 20. 2009. 14. Stead, L. F., Perera, R., Bullen, C., Mant, D., & Lancaster, T. (2008). Nicotine replacement therapy for smoking cessation. Cochrane Database of Systematic Reviews (Online), (1)(1), CD000146. 15. NicVAX. NABI pharmaceuticals. http://www.nabi.com/pipeline/pipeline.php?id=3; November 2009. 16. Hajek, P., West, R., Foulds, J., Nilsson, F., Burrows, S., & Meadow, A. (1999). Randomized comparative trial of nicotine polacrilex, a transdermal patch, nasal spray, and an inhaler. Archives of Internal Medicine, 159(17), 2033-2038. 17. Smoking Cessation. Rakel: Textbook of Family Medicine, 7th ed. Copyright© 2007 Saunders, An Imprint of Elsevier. 18. Shiffman, S., Dresler, C. M., Hajek, P., Gilburt, S. J., Targett, D. A., & Strahs, K. R. (2002). Efficacy of a nicotine lozenge for smoking cessation. Archives of Internal Medicine, 162(11), 1267-1276. 19. Jorenby, D. E., Leischow, S. J., Nides, M. A., Rennard, S. I., Johnston, J. A., Hughes, A. R., et al. (1999). A controlled trial of sustained-release bupropion, a nicotine patch, or both for smoking cessation. The New England Journal of Medicine, 340(9), 685-691. 20. West, R., McNeill, A., & Raw, M. (2000). Smoking cessation guidelines for health professionals: An update. health education authority. Thorax, 55(12), 987-999. 21. Treating tobacco use and dependence: 2008 update. Rockville (MD): U.S. Department of Health and Human Services, Public Health Service; 2008 May. http://www.guideline.gov; Accessed on November 20, 2009. 22. Dent, L. A., Harris, K. J., & Noonan, C. W. (2007). Tobacco interventions delivered by pharmacists: A summary and systematic review. Pharmacotherapy, 27(7), 1040-1051.

Continued from page 19

• Preventable deaths due to non-adherence are estimated to be at least 125,000 each year. Pharmacists should lead the way in educating patients about being adherent to their prescribed medication therapy. Vermeire, E., et al. Patient adherence to treatment: three decades of research. A comprehensive review. J Clin Pharm Ther. 2001 Oct;26(5):331-42.

• According to one study, people aged 75 years and older take an average of 7.9 drugs per day. Assure your patients understand the importance of being adherent by discussing their medications with them at each visit. Marinker M, Blenkinsopp A, Bond C, et al. From Compliance to Concordance: Achieving Shared Goals in Medicine Taking. London, UK: Royal Pharmaceutical Society of Great Britain; 1997.

• With the increasing number of patients with chronic illnesses, there are increased numbers of prescription medications being prescribed. Those patients that are on multiple medications are more likely to miss doses and not take their medications properly. While the list of reasons for non-adherence is long, pharmacists are on a short-list of healthcare professionals that can make a significant impact on this health care crisis. Talk to these patients about ways in order to improve their medication adherence. • There are many stakeholders in the effort to improve medication adherence and everyone in the health care system has a role to play. Patients are non adherent to medications for a variety of reasons, and need to be educated continuously. Pharmacists, as the medication experts should be leading the way to ensuring optimal medication use. Being among the most accessible members of the health care team, pharmacists are in the position to conduct adherence interventions. • Patients on multiple medications are more likely to miss doses and not take their medications properly. Talk to these patients about ways in order to improve their medication adherence. • There are many stakeholders in the effort to improve medication adherence. Pharmacists, as the medication experts should lead the way to ensuring optimal medication use. • Everyone in the health care system has a role to play in improving prescription medication adherence. Pharmacists, as the medication experts should lead the way to ensuring optimal medication use.

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August 2010

Continuing Education for Pharmacists Quiz and Evaluation Medications for the Treatment of Nicotine Addition 1. What percent of adult Nebraska residents were cigarette smokers in 2008? a. 5.2% b. 12.5% c. 18.4% d. 40.6%

6. Which NRT formulation is not FDA-approved in the United States? a. Gum b. Lozenge c. Patch d. Sublingual tablet

2. All the following are considered first-line medications for tobacco cessation except: a. Bupropion SR b. Clonidine c. NRT d. Varenicline

7. Which of the following is true about the nicotine patch? a. The patch should be removed prior to showering b. The patch should be removed prior to MRIs c. The patch can be cut if needed d. The patch should be removed prior to exercise

3. The most common adverse effect of varenicline is: a. Arrythmias b. Constipation c. Drowsiness d. Nausea

8. Dosage of which drug should be adjusted when a patient discontinues smoking? a. Atorvoastatin b. Celecoxib c. Metformin d. Olanzapine

4. When should a patient be instructed to quit smoking when initiating bupropion SR? a. One to two days after b. One to two weeks after c. One to two months after d. It does not matter when the patient quits smoking

9. Nicotine gum, bupropion SR, varenicline, and clonidine are classified as FDA pregnancy category ___. a. A b. B c. C d. D

5. What nicotine gum dosage regimen should be initiated for a patient who smokes 20 cigarettes per day? a. 1 piece (2 mg) every 1 to 2 hours b. 1 piece (4 mg) every 1 to 2 hours c. 1 piece (2 mg) every 4 to 8 hours d. 1 piece (4 mg) every 4 to 8 hours

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10. (T/F) Currently, there is vaccine being studied for the treatment of tobacco dependence. a. True b. False

August 2010

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 by the Nebraska Pharmacists Association under UAN#128-000-10-017-H01-P Participants should not seek duplicate credit. This article in reprinted with permission from the Nebraska Pharmacists Association.

Medication for the Treatment of nicotine Addiction This lesson is a knowledge-based CPE activity and is targeted to pharmacists. GPhA code: J10-08 ACPE#: 0142-9999-10-008-H01-P Contact Hours: 1.5 (0.15 CEU) Release Date: 08/01/2010 Expiration Date: 08/01/2013 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.

A A A A A

B B B B B

C C C C C

D D D D D

6. A B C 7. A B C 8. A B C 9. A B C 10. A B

D D D D

Activity Evaluation: must be completed for credit Please rate the following items on a scale from 1 (poor) to 5 (excellent)as to how well the activity: 1. 2. 3. 4. 5. 6. 7. 8.

Met my educational needs: Relates to pharmacy practice: Achieves the stated learning objectives: Faculty presented the information: Teaching methods conveyed information: Post-test aided in assessing my grasp of the information: Avoided any bias or commercial bias: How long did it take to complete this activity?

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 _______________________

A passing grade of 70% is required for each examination. A person who fails the exam may resubmit the quiz only once at no additional charge. Please check here if you are indicating a change of address

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2010 - 2011 GPhA BOARD OF DIRECTORS

The Georgia Pharmacy Journal Editor:

Jim Bracewell jbracewell@gpha.org

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The Georgia Pharmacy Journal® (GPJ) is the official publication of the Georgia Pharmacy Association, Inc. (GPhA). Copyright © 2010, 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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