georgia pharmacy journal - march 2014

March 2014VOLUME 36, ISSUE 3

We Came... We Listened... We Have a Voice!

VOICE IN PHARMACY DAYVIP DAY

Editor: Jim [email protected]

The Georgia Pharmacy Journal® (GPJ) is the official publication of the Georgia Pharmacy Association, Inc. (GPhA). Copyright © 2014, 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 ARTWORKThose 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 email [email protected].

SUBSCRIPTIONS AND CHANGE OF ADDRESSThe Georgia Pharmacy Journal® (GPJ) (ISSN 1075-6965) is distributed as a regular membership service, paid for through allocation of membership dues. Subscription rate for non-members is $50.00 per year domestic and $10.00 per single copy; international rates $65.00 per year and $20.00 single copy. Subscriptions are not available for non-GPhA member pharmacists licensed and practicing in Georgia.

The Georgia Pharmacy Journal® (GPJ) (ISSN 1075-6965) is published monthly by the GPhA, 50 Lenox Pointe, NE, Atlanta, GA 30324. Periodicals postage paid at Atlanta, GA and additional offices.

POSTMASTER: Send address changes to The Georgia Pharmacy Journal®, 50 Lenox Pointe, NE, Atlanta, GA 30324.

ADVERTISINGAdvertising copy deadline and rates are available upon request. All advertising and production orders should be sent to the GPhA headquarters at [email protected].

GPhA Headquarters50 Lenox Pointe, NE

Atlanta, Georgia 30324t 404-231-5074 f 404-237-8435

www.gpha.org

March 2014

1The Georgia Pharmacy Journal

ContentsMessage from Pamala Marquess .................

Message from Jim Bracewell .........................

Welcome New Members.................................

Member News ..................................................

24

75

8PharmPAC Supporters ................................18Continuing Education ...............................20GPhA Board of Directors .........................28

VOICE IN PHARMACY DAYVIP DAY

.............................................

We Came... We Listened...

We Have a Voice!

Pamala MarquessGPhA President

The Georgia Pharmacy Journal2

MESSAGE from Pamala Marquess

Georgia Champions

The Winter Olympics have been very exciting as we cheer on our American athletes. Our family has been faithful to watch nightly in expectation of the Amer-ican athletes bringing home the Gold! We specifically find ourselves focused on the Olympians from Georgia... our Hometown Stars. We are cheering for these Georgians, even though we did not know them before the Olympics. We felt connected to them because they represent us in a personal way.

This led me to thoughts of which Georgians represent us in the profession. I realize that we have more Georgia Champions of Pharmacy than I anticipated. We actually

have Georgia Pharmacists who are in the leadership of four National Pharmacy Organizations. Sharon Clackum will be installed as President of the American Society of Consultant Pharmacist(ASCP) in November. John Sherrer will be installed as President and Hugh Chancy will be installed to the Board of Directors, of the National Community Phar-macists Association(NCPA) in October. Jonathan Marquess is a current Trustee for the American Pharmacists Association(APhA), and Dale Coker is President-Elect of the International Academy of Compounding Pharmacists(IACP).

I know each of these pharmacists personally as do many of you. I applaud them for their commitment and dedication to our profession.

I am aware that each of these pharmacists did not become Champions in a day but only after many years of volunteer leadership, mentorship and perseverance. They have been involved on a local, state and national level and dedicated themselves to the advancement of the pharmacy profession. Their professional networks are broad and they represent Georgia around the globe as Champions but each of them at home are known for their ability to encourage others to get involved. Inspiring practitioners and pharmacy students about our profession and always looking to the future with a positive attitude. Many of you can connect with how they have influenced your profes-sional life.

Each of you is a Champion in your own way. Georgia is filled with Champions although I only recognized a few.

I believe 2014 will be a very exciting year to watch as we cheer on our Georgia Champions! n

Pamala S. MarquessPam

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“We actually have Georgia Pharmacists

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Jim Bracewell Executive Vice President

The Georgia Pharmacy Journal

If your rearview mirror is larger than your windshield I think you would agree you have a problem.

How well would you drive a car like that? How well could you tell where you are going? How well would you see the road ahead if you are so focused on the road behind?

Ask yourself a personal question. How much of your conversation and thoughts each day are about how good the practice of pharmacy used to be, rather than how great the practice of pharmacy is going to be?

At the Georgia Pharmacy Association our rearview mirror is so small we hardly have one to speak of. Our total focus is on how to improve the profession of pharmacy in our state. We strive each day to make Georgia the best state in the union to practice pharmacy.

When was the last time you attended a Region Meeting, GPhA Meeting or Annual Meet-ing? If you made time in your professional career to join with the members of GPhA at these

events, you would soon find that your rearview mirror will grow smaller while your windshield increases in size each day, with each attended meeting and each communication.

Can you see the road ahead with pharmacists being recognized as health-care providers by CMS?

Is your windshield wide enough to see pharmacists earning a fair market income from the services they provide rather than the number of prescriptions they dispense?

Pharmacy should never ever abandon the oversight of the pharmaceuticals they are licensed to dispense. If you are content with looking in the rearview mirror at a decade ago where dispensing a prescription was value enough to the healthcare system, then you will miss the evolution that is taking place in the pharmacy profession.

Last year at Voice In Pharmacy Day (VIP) 2013, our keynote speaker was Rear Admiral Scott Giberson of the US Public Health Service who delivered a message of the vision for the profession’s future. This year at Voice In Pharmacy Day 2014, Tom Menighan, RPh., Execu-tive Vice President of the American Pharmacists Association, laid out our course to secure that future.

The Georgia Pharmacy Association is uniquely equipped to legislatively address the need-ed changes with four pharmacists in the House of Representatives and Senator Buddy Carter in the Georgia State Senate. There are currently no pharmacists in the US Congress. What a shame! State Senator Carter is seeking to change that with his run for the US Congress from the First Congressional District of Georgia.

GPhA has a very large windshield through which to see the future of pharmacy. Come get in the front seat and help us travel the road to a great future in pharmacy. n

Jim

4

“Come get in the front seat and help us travel the road to a great future in pharmacy.”

Is Your Rearview Mirror Larger Than Your Windshield?


M E M B E R N E W S

Pharmacists representing four com-munity pharmacies in Speaker Repre-sentative David Ralston’s district invited the Speaker to have lunch with them in his hometown of Blue Ridge, Georgia.

Pharmacists Mark Parris, Amy Stan-dridge, John Thomas, Larry Broome and Bill Prather (not pictured) includ-ed GPhA Executive Vice President Jim Bracewell and GPhA Director of Gov-ernment Affairs Andy Freeman in their legislative discussion with the Speaker.

Mark Paris challenged his fellow com-munity pharmacists around the state to take their legislator to lunch and build a personal relationship with them for the good of the pharmacy profession. n

ATLANTA, GA –

The Mercer University College of Pharmacy recently earned the full 8-year accreditation status from the Accredi-tation Council for Pharmacy Education (ACPE). The status is the longest term achievable for a Doctor of Pharmacy pro-gram and extends until June 30, 2022.

An ACPE accreditation team con-ducted an on-campus site visit of Mercer College of Pharmacy in October 2013 and recently notified the college of its final evaluation. H.W. “Ted” Matthews, Ph.D., dean of the College of Pharmacy and senior vice president for health sci-ences, credits the accreditation renewal status to a faculty and staff who continue to work tirelessly for excellence in stu-dent-learning outcomes.

“I am extremely pleased that our ac-creditation was renewed for the longest period possible,” Matthews said. “This achievement was not a forgone conclu-

Grassroots Advocacy At Its Best

sion. It was made possible by the hard and diligent work of an entire college with a singular focus for excellence. And

words cannot adequately express my ap-preciation for the hard work of my facul-ty, staff and students.” n

Mercer College of Pharmacy Earns Full 8-Year Accreditation Renewal Status

M E M B E R N E W S


A CERTIFICATE TRAINING PROGRAM

The Pharmacist and Patient-Centered Diabetes Care Certificate Training Program is a newly revised, practice-based activity designed to equip pharmacists with the knowledge, skills, and confidence needed to provide effective, evidence-based diabetes care. Five self-study modules provide comprehensive instruction in current diabetes concepts and standards of care. The live seminar incorporates case studies and hands-on skills training focused on the situations most likely to be encountered—as well as the services most needed—in community and ambulatory care practice settings. Participants will gain experience evaluating and adjusting drug therapy regimens for patients with type 1 and type 2diabetes, counseling patients about lifestyle interventions, analyzing and interpreting self-monitoring of blood glucose results, and assessing the overall health status of patients to identify needed monitoring and interventions.

PROGRAM GOALS• Provide comprehensive instruction in current standards

of care for patients with diabetes.• Increase pharmacists’ confidence in serving as the drug

therapy expert on the diabetes health care team.• Refresh pharmacists’ knowledge of the pathophysiology

of diabetes and the acute and long‐term complications of the disease.

• Familiarize pharmacists with important concepts in nutrition, exercise, and weight control that contribute to optimal diabetes care.

• Offer hands-on training in diabetes-related devices and physical assessment skills relevant to optimal diabetes care. Describe ways in which pharmacists can keep abreast of new developments and take advantage of professional opportunities in diabetes care.

• Introduce pharmacists to the many varied ways in which they can help to improve health outcomes among patients with diabetes.

SEMINAR LEARNING OBJECTIVES• Evaluate the overall health status of patients with

diabetes in terms of recommended monitoring and interventions, and formulate strategies for closing gaps in care.

• Propose modifications to a patient’s drug therapy regimen rooted in evidence-based algorithms for diabetes management.

• Recommend dietary interventions to support optimal glycemic control and weight loss (when indicated) in patients with diabetes.

• Analyze and interpret a patient’s self-monitoring of blood glucose results and use the results to identify needed changes in the diabetes management plan.

• Demonstrate proper technique for measuring blood pressure, administering injections, obtaining fingerstick samples for blood glucose monitoring, operating blood glucose meters, and performing monofilament foot testing.

• Integrate the varied aspects of comprehensive diabetes care into efficient, sensitive, respectful pharmacist–patient interactions that support optimal patient self-management.

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The American Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

TOTAL CPE CREDIT: 23 HOURS (2.3 CEUs)For a complete list of learning objectives, faculty and

other CPE information, please visit www.pharmacist.com/ctp

New program offering for 2014! Special promotional rate of only $99!

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This program was developed by the American Pharmacists Association and is cosponsored by the American Association of Diabetes Educators. This offering is in partnership with the Georgia Pharmacy Association and supported by an independent educational grant from Novo Nordisk.

WELCOME

The Georgia Pharmacy Association strives to be the leading voice for pharmacy in the state of Georgia. We aggressively advocate for the profession by shaping public policy and scope of practice to enhance the value of pharmacy. We take pride in our presti-gious history and value our membership for its diversity in all practice settings as well as its dedication to health care. GPhA provides its members with the resources and support needed to advance our profession. As healthcare changes, so do job responsibilities and career tracks may be refocused. GPhA is your career develop-ment partner as you address your future in pharmacy. Professional networking, skills training and continuing pharmacy educa-tion are key benefits of your GPhA member-ship. Whether you are a recent Pharmacy school grad or an established pharmacist, there is a place for your voice at GPhA.

New Members

Have you considered GPhA’s new Sustaining Membership? ..........only $14.58 per month Never get another renewal notice! Visit gpha.org and sign up today!

50 Lenox Pointe, NE, Atlanta, GA 30324 | tf: 888.871.5590 | ph: 404.231.5074 | f: 404.237.8435 | www.gpha.org

THE GEORGIA PHARMACY ASSOCIATION

Your Voice in PharmacyPharmacists

Terry Barnes - Calhoun, GA

Rajesh Naik - Duluth, GA

Gregg Malmstrom - Gainesville, GA

James Darley - Valdosta, GA

Alicia Elam - Augusta, GA

Thao Nguyen - Norcross, GA

Region 1 Tuesday, April 15, 2014 - SavannahRegion 2 Tuesday, April 15, 2014 - TiftonRegion 8 Tuesday, April 15, 2014 - WaycrossRegion 3 Tuesday, April 22, 2014 - ColumbusRegion 6 Tuesday, April 22, 2014 - MaconRegion 12 Tuesday, April 22, 2014 - DublinRegion 9 Tuesday, April 29, 2014 - Blue RidgeRegion 10 Tuesday, April 29, 2014 - AthensRegion 11 Tuesday, April 29, 2014 - AugustaRegion 4 Thursday, May 1, 2014 - GriffinRegion 5 Thursday, May 1, 2014 - AtlantaRegion 7 Thursday, May 1, 2014 - Acworth

Nominations for 1st and 2nd VPs

Tuesday, February 25, 2014 (120 days prior to Convention) The Nominating Committee will meet to discuss proposals for 1st & 2nd VP nominees. At least one name for 1st VP and at least two names for 2nd VP.

Upcoming GPhA Officer Elections

Tuesday, March 25, 2014 (90 days prior to Convention) 1st & 2nd VP nominees must be sub-mitted to membership.

Friday, April 25, 2014 (60 days before Convention)Petitions for additional nominees must be submitted to EVP by 12NOON.

Ballots and Election

Monday, May 12, 2014 (45 days prior to the commencement of Convention) *Please note that the 45th day falls on Sunday the 11th - date is

moved to the next business day.Ballots must be sent to membership –

Election Opens

Monday, June 16, 2014 (10 days prior to the commencement of Convention) *Please note that the 10th day falls on Sunday the 15th – date is moved to the next business day. Paper ballots must be returned by this date.

Saturday, June 28, 2014Election closes at 2 PM.

Upcoming GPhA Region Meetings

The Georgia Pharmacy Journal8 9The Georgia Pharmacy Journal

We Came... We Listened... We Have a Voice!“It is important that you stay engaged with the political process.”

“Our star is rising and awareness is growing in our communities.”

Watch Governor Deal’s Welcome Message on YouTube.

The Georgia Pharmacy Association Channel

Watch Dr. Menighan’s Keynote on YouTube.

The Georgia Pharmacy Association Channel

Governor Nathan Deal Dr. Thomas Menighan

Pharmacy is one of the more important el-ements of the delivery of healthcare and the treatment of illness in this country.

Georgia’s Governor Nathan Deal lead of the GPhA VIP Day with an opening address that touched on this issue and others.

“We need you in the state of Georgia. We have a growing popula-tion. We have an aging population. All this leads to a very fruitful future for pharma-cy in Georgia”, said Deal.

One way we can make sure we do not take healthcare to the brink is to do a better job of in-cluding pharmacy in the treat-ment of illnesses and diseases. Advancement in pharmaceuti-cals is making some traditional medical treatments and surgi-cal procedures unnecessary.

Because of the evolution and continuing regulations facing pharmacy, pharmacy profes-sionals need to stay involved in the political process at the state and national level.

“It is important that you stay engaged with the political pro-cess”, says Deal. n

Thomas Menighan, CEO of the American Pharmacists Association, offered the keynote ad-dress to the record num-ber of pharmacists, stu-dents, and technicians gathered at the Capitol for VIP Day with a mes-sage promoting growth, advocacy, and teamwork.

“We must be united and focus on pharma-cist’s needs. Stakehold-ers must work together, especially in regards to

provider status. Together, we can do great things,” Menighan said.

Pharmacists are better trained and better armed today to go out and really make a difference in the delivery of healthcare. “Capacity is in place and we really do have something to offer”, Menighan added.

There is a medication use crisis in this country. We must include quality measures, standards, ac-creditation, and provider status for pharmacists.

Pharmacists want to be valued members of the healthcare team. “Our star is rising and awareness is growing in our communities,” Menighan said. “If we want the star to continue to rise, then we all need to be engaged and work together at the state and federal level.” n

The Georgia Pharmacy JournalThe Georgia Pharmacy Journal10

“You could not be in a better profession. You can help change lives.”

Lt. Governor Casey Cagle

We rely on a per-sonal relationship with our pharmacist. There’s no substitute for it,” said Lt. Governor Casey Ca-gle. “You could not pick a better career to be a part of because you have an opportunity to really change peoples lives,” he added.

Every year there are a number of issues before the legislature but rest assured there are a num-ber of legislators that are going to stand up for pharmacy in the state of Georgia. There is a great deal of respect for a profession that strives to make people’s lives better.

In addition, the profession of pharmacy has a strong and very vocal organization in the Georgia Pharmacy Association. GPhA is one of the top five nonprofit advo-cacy organizations in the state.

Cagle says one of his big initia-tives is fighting childhood obesity. “One out of every three children in the state of Georgia suffers from obesity and part of the solution includes the important role phar-macy plays in preventative care,” he added.

“We’re looking forward to a big year and we will always be here for you. Thank you for what you are doing for your communities, your profession, and your state,” Cagle said. n

Contact the Lt. Governor’s Office at 404-656-5030.

V O I C E I N P H A R M A C Y D A YV O I C E I N P H A R M A C Y D A Y

Corporate contributions and contributions by foreign nationals are prohibited. Individuals may contribute a maximum of $5,200 to the campaign- $2,600 for the primary election and $2,600 for the general election. PACS may contribute $10,000 to the campaign - $5,000 for the primary election and $5,000 for the general election. Federal law requires us to

use our best efforts to collect and report the name, mailing address, occupation, and name of employer of each individual whose aggregate contributions exceed $200 in an election cycle.

REAL SOLUTIONS. CONSERVATIVE PRINCIPLES.

There is not a singlePharmacist serving in Congress. It’s time to change that. Please support Buddy Carter R.Ph for Congress. buddycarterforcongress.com/donate/

With all of the major changes taking place in the health care industry, now more than ever, we pharmacists must have our voices heard.

SUPPORT BUDDY CARTER R.Ph FOR CONGRESS

PAID FOR BY BUDDY CARTER FOR CONGRESSCARLTON HODGES, TREASURER

V O I C E I N P H A R M A C Y D A Y


Professional LicensingMedicare and Medicaid

Fraud and ReimbursementCriminal Defense

Administrative LawHealthcare LawLegal Advice for

Licensed Professionals

WWW.FRANCULLEN.COM

(404) 806-6771 • [email protected]

Representing pharmacists and pharmacies before the Georgia Pharmacy Board, GDNA and DEA.

AREAS OF PRACTICE


“Folks... no one can represent us like one of us.”

Senator Buddy Carter

As a legislator and a pharmacist, no one knows the importance of having effective rep-resentation than State Senator Buddy Carter.

The pharmacy pro-fession is lucky to have five pharmacist legisla-tors on the state level. But there are no phar-macists representatives on the federal level, yet.

As a candidate for the U.S. Congress, 1st Congressional District of Georgia, Carter could become the first.

“Many of you will say that I don’t live in that district so I can’t do anything to help. That’s sim-ply not true,” Carter says. “You can have an impact,” he added. You can help with your voice by spreading the word and your dol-lars by donating to the campaign.

“This is not only a great oppor-tunity for me to represent the peo-ple of my district but also a great opportunity for the profession of pharmacy,” Carter added.

Some of you may say that you did not go into pharmacy to get involved in politics. But politics has a big impact on the profession and we have to fight for our pro-fession.

How can you have an impact? You can start by checking out the Buddy Carter for Congress web-site at www.buddycarterforcon-gress.com

Remember, “no one can repre-sent us like one of us.” n

V O I C E I N P H A R M A C Y D A YV O I C E I N P H A R M A C Y D A Y

Inspiring confidenceGPhA/UBS Wealth Management Program

We know pharmacists think about much more than prescriptions. You think about your future and retirement,

making the right financial decisions for your family, and helping your employees so their future looks confident too.

UBS provides GPhA with exclusive UBS benefits for the complexities of your life and pharmacy. Contact us today

and let us help you plan with confidence.

Harris Gignilliat, CIMA®, CRPS®

Vice President–Wealth ManagementInstitutional Consultant, Retirement Plan Consultant

404-760-3301 [email protected]

Wile Consulting GroupUBS Financial Services Inc.

3455 Peachtree Road NE, Suite 1700Atlanta, GA 30326

ubs.com/team/wile

We will not rest

As a firm providing wealth management services to clients, we offer both investment advisory and brokerage services. These services are separate and distinct, differ in material ways and are governed by different laws and separate contracts. For more information on the distinctions between our brokerage and investment advisory services, please speak with your Financial Advisor or visit our website at ubs.com/workingwithus.UBS Financial Services Inc., its affiliates and its employees are not in the business of providing tax or legal advice. Clients should seek advice based on their particular circumstances from an independent tax advisor. CIMA® is a registered certification mark of the Investment Management Consultants Association, Inc. in the United States of America and worldwide. Chartered Retirement Plans SpecialistSM and CRPS® are registered service marks of the College for Financial Planning®. ©UBS 2014. All rights reserved. UBS Financial Services Inc. is a subsidiary of UBS AG. Member FINRA/SIPC. 7.00_Ad_7.5x4.875_AX0220_WileConsultingGrp2 GphA

Imagine an organization worth tens of millions of dollars where the co-CEOs refuse to share financial information and guidance with the employees who would eventually take over management. Most would not expect the business to contin-ue its success once the CEOs step down as inevitably they must. Should we ex-pect anything different if that organiza-tion is a family?

Succession planning (for a business or a family) increases the opportunities for multigenerational success. So often in the world of finance we focus on the earning, investment, saving and spend-ing of money. UBS clients are now ex-pressing a far greater interest in learning more about expanding the succession planning process to include how best to prepare heirs and pass down values. Their definitions of “success” and “in-heritance” are expanding to include in-dividual happiness and family cohesive-ness.

Why have family meetings? A recent study revealed that high tax-

es and poor investment advice were not the reasons for intergenerational dissi-pation of wealth. The study found that 60 percent of the time it was a trust and communication breakdown among fam-ily members that plays the biggest role.1

Some families have achieved suc-cessful succession planning with an informal, unstructured process. For most, however, a more formal process is preferable (or even necessary). Family meetings can provide a safe, structured context for discussing these issues with descendents.

“Family meeting” is a commonly used phrase that defies formal definition. “Family” may include one or more gen-erations and may or may not include in-laws and domestic partners. “Meeting” can be in person or through an electron-

ic gathering. Although definition is diffi-cult, the phrase “family meeting” can be best described by the expectations and goals of each family member. Therefore, to succeed, disparate expectations and goals must be understood, unified and addressed.

The underlying purpose of family meetings is communication. Reasons and goals for the communication in-clude: • the transmission of purpose and values • education regarding financial matters • the strengthening of family bonds • accountability for actions of family members • share news, concerns, opportunities and challenges • sharing information and making shared decisions • model family leadership behaviors to younger family members.

As with all new endeavors, there can be a fear of the unknown and the issues that may arise. It is important for fami-lies to determine what goals they wish to achieve and keep the focus there.

Why not have family meetings? In one initial family meeting, Mother,

Father and advisors gathered to discuss various topics and develop a plan for future, broader meetings. The meeting began well but a tension soon grew be-tween the two spouses. The totally unex-pected issue that arose dealt with values pertaining to spending/saving money. Specifically, for years, Mother wished to remodel the kitchen in their home and Father refused to spend the money. Though peacefully resolved, unrelated issues can sidetrack a meeting and cause discomfort.

Experience shows that, just as there are some frequently cited reasons for having family meetings, there are some

common (mostly unspoken) reasons to avoid one. • “I don’t want my children to know about my financial wealth. It will ruin them.” • “I’ve sacrificed and worked hard for my wealth and I want to enjoy it. I don’t want to want to be judged and told by my children to ‘practice what I preach.’” • “I have trouble balancing my desire for discretion and privacy with the need to teach my heirs about money.” • “I don’t want to raise issues between my children and my new spouse.” • “It’s too much work.”

Some are unable to get past these ob-stacles and for them, family meetings are not a genuine option. Those that choose to proceed understand that the possi-ble benefits of such meetings justify the imagined risks.

The family meeting process Once the determination has been

made that the positive potential from a family meeting outweighs the negative, meeting planning can proceed. There is no “typical” process for family meetings. Each family’s meetings are as unique and complex as the families themselves. Ex-perience shows, however, that the great-est success is achieved by following this general format: • The head(s) of the family meet to de-velop and formalize the values and goals they wish to convey. • A large family meeting is called to communicate and refine those values and goals. The family then develops a governance model incorporating those values and goals to organize and manage ongoing meetings and future decision-making. • Ongoing meetings (possibly including spouses and young family members) are held to educate and put in action the values and goals.


I N D U S T R Y N E W SI N D U S T R Y N E W S

This general structure greatly increas-es the chance of developing financially savvy heirs with a ready source of infor-mation and community. It helps to build strong family ties and create a sense of support and system of accountability. All families govern themselves and reach decisions; the key difference for families whose wealth lasts for generations is that they do it by design. Regular, well-planned and well-run family meetings incorporating clear values, historical connectivity and non-family advisors and educators help open multi-genera-tional communication channels. They also encourage familial and financial accountability among successors. At its essence, the family meeting is a learn-ing opportunity for every generation attending. Participants learn not simply by listening, but also by watching the activities and behaviors of family lead-ership through organizing, running and appreciating the benefits of the family meeting. n

Family Meetings:Leaving your loved ones more than just money.

Key Takeaways

• For a family meeting to succeed, disparate expectations and goals must be understood, unified and addressed.

• There is no “typical” process for family meetings. Each family’s meetings are as unique and complex as the families themselves.

• Regular family meetings can result in a disciplined ap-proach to stewarding family wealth, educating successive generations and providing a foundation for expressing family values in each endeavor. It also creates a family tradition.

At UBS, we work to provide our family clients with the latest think-ing and best practices. For more information about family meetings including meeting topics or agendas, recurring issues, or advice and guidance implementing a family meeting strategy, please contact Wile Consulting Group at UBS.


Thanks to All Our Supporters Highlight denotes new and increased contributors.

NOTICE: Contact Andy Freeman, GPhA Director of Government Affairs, to update your sup-port or if any information is incorrect. [email protected] 404-419-8118

*Denotes a monthly sustaining PAC member. (Month/Year) Denotes most recent contribution.

19The Georgia Pharmacy Journal

PharmPac Board of Directors Eddie Madden, ChairmanDean Stone, Region 1Keith Dupree, Region 2Judson Mullican, Region 3Bill McLeer, Region 4Mahlon Davidson, Region 5Mike McGee, Region 6Jim McWilliams, Region 7T.M. Bridges, Region 9Mark Parris, Region 9Chris Thurmond, Region 10Stewart Flanagin, Region 11Henry Josey, Region 12Pam Marquess, Ex-OfficioJim Bracewell, Ex-Officio

Diamond Level$4,800 minimum pledge*Scott Meeks, R.Ph.*Fred Sharpe, R.Ph

Titanium Level$2,400 minimum pledge*Ralph Balchin, R.Ph. T.M. Bridges, R.Ph. 12/14*Ben Cravey, R.Ph.*Michael Farmer, R.Ph.*David Graves, R.Ph.*Raymond Hickman, R.Ph.*Robert Ledbetter, R.Ph.*Brandall Lovvorn, Pharm.D. *Marvin McCord, R.Ph.*Jeff Sikes, R.Ph.*Danny Smith, R.Ph.*Dean Stone, R.Ph.*Tommy Whitworth, R.Ph.

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21The Georgia Pharmacy JournalThe Georgia Pharmacy Journal20

Thomas A. Gossel, R.Ph., Ph.D., Professor Emeritus, Ohio Northern University, Ada, Ohio

continuing educat ion for pharmacists

New Drugs: Gazyva, Gilotr i f , Perjeta, and Tivicay

Volume XXXII, No. 1

Dr. Thomas A. Gossel has no relevant financial relationships to disclose.

Goal. The goal of this lesson is to provide information on afatinib (Gilotrif™), dolutegravir (Tivicay®), obinutuzumab (Gazyva™), and pertuzumab (Perjeta®).

Objectives. At the completion of this activity, the participant will be able to:

1. recognize signs and symp-toms, and key features of targeted pathologies including information on their prevalence in the popula-tion;

2. recognize important thera-peutic uses for the drugs and their applications in specified patholo-gies;

3. select the indication(s), pharmacologic action(s), clinical application(s), and mode of admin-istration for each drug;

4. demonstrate an understand-ing of adverse effects and toxicity, warnings, precautions, contraindi-cations, and significant drug-drug interactions reported for each agent; and

5. list important patient infor-mation to convey to patients and/or their caregivers.

The drugs discussed in this lesson are included in Table 1. Perjeta was first approved in 2012 with its indication upgraded in 2013. In each instance, the drugs provide important advances in therapy for their targeted uses. This lesson provides a brief introduction to the

drugs and is not meant to extend beyond an overview of the topic. The reader is, therefore, urged to consult the products’ full Prescrib-ing Information leaflet (package insert), Medication Guide when available, and other published ref-erence sources for detailed descrip-tions.

Afatinib (Gilotrif)Gilotrif (JEE-loh-trif) was the second drug approved in 2013 for patients with untreated meta-static non-small cell lung cancer (NSCLC). In May 2013, FDA approved Tarceva (erlotinib) for first-line treatment of patients with metastatic NSCLC. Its indication was approved concurrently with a companion diagnostic test to iden-tify patients whose tumors have epidermal growth factor receptor (EGFR) gene mutations. Gilotrif was approved in July 2013 concur-rently with the therascreen® EGFR RGQ PCR Kit, a companion diag-nostic test that helps determine if a patient’s lung cancer cells express EGFR mutations.

Novel targeted therapies that can be used along with standard chemotherapy regimens offer the potential to improve outcomes in patients with advanced cancer. Therapies directed to a specific signaling pathway are more selec-tive, with the potential of reduc-ing adverse effects compared with broad-acting chemotherapy agents alone.

Indications and Use. Gil-otrif is indicated for treatment of

patients with metastatic NSCLC whose tumors possess the EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. Safety and efficacy have not been established in patients whose tu-mors have other EGFR mutations.

Non-small Cell Lung Can-cer. An estimated 228,190 new cases of lung cancer are expected in 2013, accounting for about 14 percent of cancer diagnoses. The incidence has been declining in men over the past two decades, but has just recently begun to decrease in women. From 2005 to 2009, lung cancer incidence rates decreased by 1.9 percent per year in men and by 0.3 percent per year in women.

Lung cancer is the primary cause of death when compared with other cancers in both men and women. An estimated 159,480 deaths, accounting for about 27 percent of all cancer deaths, are expected to occur in 2013.

There are two major types of lung cancer: non-small cell and small cell. NSCLC arises in epithe-lial cells and is the most common type. Small cell lung cancer onsets in the nerve cells or hormone-pro-ducing cells of the lung. The term “small cell” refers to the size and shape of the cancer cells as seen under a microscope. It is important to distinguish NSCLC from small cell lung cancer because the two types are treated differently. About 85 percent of all lung cancers are NSCLC, making it the most com-mon type of lung cancer.

The discovery of the EGFR

Table 1Selected new drugs

Generic (Proprietary) Distributor Indication Dose* Dosage Form Most Common Med Guide±

Name Adverse Reactions

Afatinib Boehringer Metastatic non- 40 mg 20, 30, 40 mg diarrhea, rash/ No (Gilotrif) Ingelheim small cell lung once daily tablets dermatitis acneiform, cancer stomatitis, paronychia, dry skin, decreased appetite, pruritus

Dolutegravir Glaxo- HIV-1 infection 50 mg 50 mg insomnia, headache No (Tivicay) Smith- once or tablets Kline twice daily

Obinutuzumab Genentech Chronic 100 mg to 1000 mg/ infusion reactions, No (Gazyva) lymphocytic 1000 mg 40 mL neutropenia, thrombo- leukemia single-use cytopenia, anemia, vial pyrexia, cough, musculoskeletal disorder

Pertuzumab Genentech HER2-positive 840 mg IV 420 mg/ alopecia, diarrhea, No (Perjeta)§ breast cancer infusion 14 mL neutropenia, nausea, to start single-use vomiting, fatigue, rash, vial peripheral neuropathy, fatigue, anemia*Recommended dose for most patients±At the time of publication of this lesson§drug originally approved in 2012

mutations changed the standard approach to evaluating NSCLC and established a new paradigm of tu-mor genotyping in clinical practice. EGFR is a transmembrane sig-naling receptor that is frequently overexpressed in NSCLC and plays a central role in cancer growth and metastasis. Different forms of EGFR mutations, most frequently exon 19 deletions and the exon 21 point mutation L858R, occur in ap-proximately 50 percent of adeno-carcinomas in persons who have never smoked, but can be found in patients with NSCLC. EGFR muta-tions confer an oncogene-addicted biology to the cancer, meaning the cells are overly dependent on the EGFR pathway for survival. Therefore, selective inhibition of this pathway through tyrosine ki-nase inhibitors can lead to massive apoptosis (programmed, or natural cell death) and dramatic clinical responses.

Mechanism of Action. Afatinib covalently binds to the

kinase domains of EGFR (ErbB1), HER2 (ErbB2), and HER4 (ErbB4), and irreversibly inhibits tyrosine kinase autophosphorylation, result-ing in downregulation of a wide spectrum of cancer relevant ErbB signaling pathways, and thereby has the potential to be effective against a wide range of ErbB-de-pendent tumor types.

Efficacy and Safety. Safety and effectiveness were established in a clinical trial enrolling 345 subjects with metastatic NSCLC whose tumors harbored EGFR mutations. Participants were ran-domly assigned to receive Gilotrif or up to six cycles of the chemo-therapy drugs pemetrexed (Alimta) and cisplatin (Platinol). Individu-als receiving Gilotrif experienced a statistically significant delay in tumor growth (progression-free survival) compared to patients receiving chemotherapy. There was no statistically significant differ-ence in overall survival.

In preclinical trials, common

adverse reactions included diar-rhea, skin breakouts that resem-bled acne, dry skin, itching, inflam-mation of the mouth, skin infection around the nails (paronychia), decreased appetite and weight, inflammation of the bladder (cysti-tis), nose bleed, runny nose, fever, eye inflammation, and hypokale-mia. Serious side effects included severe diarrhea, severe rash, lung inflammation, and hepatotoxicity.

Warnings, Precautions and Contraindications. The following warnings and precautions are listed.

•Diarrhea: This may result in dehydration and renal failure. Withhold Gilotrif for severe and prolonged diarrhea not responsive to antidiarrheal agents.

•Bullous and exfoliative skin disorders: Discontinue for life-threatening cutaneous reactions. Withhold drug for severe and pro-longed cutaneous reactions.

•Interstitial lung disease (ILD): Withhold drug for acute onset or


Table 2Patient information for

Gilotrif*

Inform patients:•to take Gilotrif on an empty stom-ach at least one hour before or two hours after eating, and not to take a missed dose within 12 hours of the next dose;•to tell their doctor if they have kid-ney or liver disease, lung or breath-ing problems, a history of severe dry eye or any other eye problems, if they wear contact lenses, or have heart problems or other medical conditions;•to tell their doctor if they are preg-nant or plan to become pregnant, or are breastfeeding; and to use highly effective contraception;•to inform their doctor about all of the medicines they take;•to limit exposure to sunlight. Pa-tients should use a sunscreen and wear a hat and protective clothing if they need to be in the sun;•that diarrhea is common and may be severe. Get medical attention right away if diarrhea becomes severe or does not go away.

*A complete list of information is avail-able in the product’s package insert.

worsening of pulmonary symp-toms. Discontinue Gilotrif if ILD is diagnosed.

•Hepatotoxicity: Monitor with periodic liver testing. Withhold or discontinue drug for severe or worsening liver tests.

•Keratitis: Withhold Gilotrif for keratitis evaluation. Withhold or discontinue drug for confirmed ulcerative keratitis.

•Embryofetal toxicity: The drug can cause fetal harm. Advise females of the potential hazard to the fetus and to use highly effective contraception.

No contraindications are listed.

Drug Interactions. Co-admin-istration of a P-glycoprotein (P-gp) inhibitor (e.g., ritonavir, cyclospo-rine, ketoconazole, erythromycin, verapamil, and others) can increase afatinib exposure. Reduce the new drug’s dosage by 10 mg per day if not tolerated. Co-administration of chronic P-gp inducers (e.g., rifam-

picin, carbamazepine, phenytoin, phenobarbital, St. John’s Wort) orally can decrease afatinib expo-sure. Increase Gilotrif by 10 mg per day as tolerated.

Administration and Dosing. The recommended dose of afatinib is 40 mg once daily, taken at least one hour before or two hours after a meal. Missed doses should not be made up within 12 hours of the next dose. Gilotrif tablets are available in 20 mg, 30 mg, and 40 mg.

Patient Counseling Infor-mation. Specific points for counsel-ing are summarized in Table 2.

Dolutegravir (Tivicay)HIV-infected individuals require treatment regimens personalized to fit their condition and their needs. Approval of new drugs like Tivicay (TIV-eh-kay) that add to existing options for treating HIV infections remains a high priority for FDA.

Although the first-generation integrase inhibitors such as ralte-gravir (Isentress) and elvitegravir (one of the components of Stribid) are potent and well tolerated in treatment-naïve (never received HIV therapy) and treatment-expe-rienced adults with HIV, improved therapy options would benefit these patients. Raltegravir requires twice daily dosing and has variable pharmacokinetic characteristics. Elvitegravir must be taken with food and requires coadministration with a pharmacokinetic boosting agent, thus increasing the poten-tial for clinically significant drug interactions. Additionally, treat-ment-experienced patients who fail raltegravir-based or elvitegravir-based regimens commonly develop integrase inhibitor resistance. Cross-resistance between ralte-gravir and elvitegravir has been reported. Thus, development of new unboosted integrase inhibi-tors with once-daily dosing and an improved resistance profile, such as dolutegravir, is desirable.

Indications and Use. Tivi-cay is an HIV-1 integrase strand transfer inhibitor (INSTI) indicated for use in a broad population of

HIV-infected patients. It can be used to treat HIV-infected adults who are either treatment-naïve or treatment-experienced, including those who have been treated with other integrase strand transfer in-hibitors. The drug is also approved for children aged 12 years and older weighing at least 40 kg who are treatment-naïve or treatment-experienced but have not previ-ously taken other integrase strand transfer inhibitors.

HIV Infections. The num-ber of individuals newly infected with HIV has declined, but it still remains a worldwide epidemic. Prevalence continues to rise with current estimates of 34 million peo-ple living with HIV or acquired im-munodeficiency syndrome (AIDS), up from 29.4 million in 2001, due to new infections as well as patients living longer. In 2011, 1.7 million people worldwide died of AIDS. Al-though the HIV mortality rate has decreased 80 percent since its peak in 1995, HIV was the sixth leading cause of death for persons aged 25 to 44 in 2009. Deaths have declined in part due to increased treatment options and utilization of highly ef-fective antiretroviral medications.

Mechanism of Action. HIV integrase is responsible for the transport and attachment of provi-ral DNA to host-cell chromosomes, allowing transcription of viral pro-teins and subsequent assembly of virus particles. Proviral integration involves two catalytic reactions: first, 3'-processing in the host-cell cytoplasm to prepare proviral stands for attachment; and second, strand transfer whereby proviral DNA is covalently linked to cellular DNA.

The HIV integrase enzyme coordinates insertion of viral DNA into the host chromosome. The two- metal binding class of integrase inhibitors target the binding of the divalent metal ions Mg2+ and Mn2+ to prevent the strand transfer step in the integration process, thereby inhibiting viral replication.

Efficacy and Safety. Safety and efficacy in adults were evalu-ated in 2,539 participants enrolled

in four clinical trials. Depending on the trial, participants were randomly assigned to receive dolutegravir, each in combination with other antiretroviral drugs, or Atripla, a fixed-dose combination of efavirenz, emtricitabine, and tenofovir. A fifth trial established pharmacokinetics, safety, and effi-cacy of Tivicay as part of treatment regimens for HIV-infected children aged 12 years and older weighing at least 40 kg who had previously not taken integrase strand transfer inhibitors.

Among the most common adverse reactions observed during clinical trials were difficulty sleep-ing and headache. Serious effects included hypersensitivity reactions and abnormal liver function in par-ticipants co-infected with hepatitis B and/or C.


•Hypersensitivity reactions including rash, constitutional findings, and sometimes organ dysfunction, including hepatotoxic-ity: Discontinue the drug and other suspect agents immediately if signs or symptoms of hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. Do not use in patients who have experi-enced a previous hypersensitivity reaction to Tivicay.

•Underlying hepatitis B or C: Appropriate laboratory monitoring for hepatotoxicity during therapy with Tivicay is recommended in patients with underlying hepatic disease such as hepatitis B or C.

•Redistribution/accumulation of body fat and immune reconstitu-tion syndrome: Effects have been noted in patients treated with com-bination antiretroviral therapy.

Coadministration with dofeti-lide (Tikosyn) is the only reported contraindication. Dolutegravir can interfere with the organic cat-ion transporter responsible for the active secretion of dofetilide into the renal tubules, which may ulti-mately increase patients’ risk for

serious and life-threatening events.Drug Interactions. Drugs

that are metabolic inducers may decrease the plasma concentrations of dolutegravir. The labeling states that the drug can be taken with-out regard to meals, but should be taken two hours before or six hours after consumption of cation-containing medications such as antacids or laxatives, sucralfate, oral iron supplements, oral calcium supplements, or buffered medica-tions. An extensive list of drugs that may alter plasma levels of Tivicay is provided in the product’s package insert and should be read in advance of dispensing the new drug.

Administration and Dos-ing. Dolutegravir’s half-life sup-ports once-daily dosing. Tivicay is, therefore, dosed 50 mg once daily in treatment-naïve or treatment-experienced INSTI-naïve patients. The dose is increased to 50 mg twice daily in treatment-naïve or treatment-experienced INSTI-naïve patients when given with the combination of efavirenz, fosam-prenavir/ritonavir, tipranavir/rito-navir, or rifampin. Doses of 50 mg twice daily are also recommended for patients INSTI-experienced with certain INSTI-associated re-sistance substitutions or clinically suspected INSTI resistance.

The dose for pediatric patients who are treatment-naïve or treat-ment-experienced INSTI-naïve, aged 12 years and older and weigh-ing at least 40 kg is 50 mg once daily. If efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, or rifampin are coadministered, the recommended dose is then 50 mg twice daily.

Tivicay is available in tablets containing 50 mg dolutegravir. Doses may be taken without regard to meals.

Patient Counseling Infor-mation. Specific points for counsel-ing are summarized in Table 3. It is estimated that to maintain viral load suppression in patients with HIV infection, a medication adher-ence rate of ≥95 percent may be required. Poor virologic and immu-

nologic responses to antiretrovirals leads to development of drug-resis-tant virus.

Obinutuzumab (Gazyva)Gazyva (gah-ZY-vuh) is the first drug with breakthrough therapy designation to receive FDA approv-al. This designation was granted soon after the biologic license ap-plication to support marketing ap-proval was submitted to FDA. FDA can designate a drug as break-through therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may of-fer a substantial improvement over available therapies for patients with serious or life-threatening diseases. FDA also granted Gazyva priority review because the drug


Tivicay*

Inform patients:•to contact their doctor right away if they develop a rash, or any symptom suggestive of a more serious reaction such as severe hypersensitivity;•to inform their doctor if they have hepatitis B or C, or any symptoms of other infection;•that redistribution or accumula-tion of body fat may occur in patients receiving antiretroviral therapy and that the cause and long-term health effects of these conditions are not known at this time;•that Tivicay is not a cure for HIV-1 infection and they may continue to experience illnesses associated with HIV-1 infection;•that they need to take all HIV medi-cines exactly as prescribed;•that they should avoid doing things that can spread HIV-1 infection to others;•to take a missed dose as soon as they remember. If they do not re-member until it is within four hours of the next dose, they should skip the missed dose and go back to the regular schedule. Patients should not double their next dose or take more than the prescribed dose.



demonstrated the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition. FDA also granted Gazyva orphan product designation.

Indications and Use. Gazyva is a CD20-directed cytolytic anti-body indicated for use combined with chlorambucil (Leukeran, etc.) for treatment of patients with pre-viously untreated chronic lympho-cytic leukemia (CLL).

Chronic Lymphocytic Leu-kemia. CLL is a blood and bone marrow disease that usually worsens slowly. According to the National Cancer Institute, 15,680 Americans will be diagnosed and 4,580 will die from the cancer in 2013. Almost 90 percent of leuke-mia cases occur in adults 20 years of age and over, among whom the most common type (38 percent) is CLL, with an incidence rate of six cases per 100,000 people per year. Median survival is highly vari-able, with some patients exhibiting benign tumor progression, while others develop aggressive disease with a survival less than two to three years.

Mechanism of Action. Obinu-tuzumab is a glycoengineered humanized monoclonal antibody that targets the CD20 antigen expressed on the surface of pre B- and mature B-lymphocytes. Upon binding to CD20, obinutuzumab mediates B-cell lysis through en-gagement of immune effector cells, by directly activating intracellular death signaling pathways, and/or activation of the complement cascade. The immune effector cell mechanisms include antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.

Efficacy and Safety. The drug’s approval was based on a study of 356 participants in a ran-domized, open-label, multicenter trial comparing obinutuzumab in combination with chlorambucil to chlorambucil alone in participants with previously untreated CLL. Participants receiving Gazyva in combination with chlorambucil

demonstrated significant improve-ment in progression free survival, with an average of 23 months compared to 11.1 months with chlo-rambucil alone.

The most common adverse effects observed in participants re-ceiving Gazyva in combination with chlorambucil were infusion-related reactions, a decrease in infection-fighting white blood cells (neutro-penia), a low level of platelets in the blood (thrombocytopenia), low red blood cells (anemia), pain in the muscle and bones, and fever.


•Infusion reactions: Premedi-cate patients with a glucocorticoid, acetaminophen and antihistamine. Monitor patients closely during infusion. Interrupt or discontinue infusion for reactions.

•Tumor Lysis Syndrome: Anticipate tumor lysis syndrome. Premedicate with antihyperuri-cemics and adequate hydration, especially for patients with high tumor burden and/or high circu-lating lymphocytic count. Correct electrolyte abnormalities, provide supportive care, and monitor renal function and fluid balance.

•Neutropenia: Monitor for infection.

•Thrombocytopenia: Monitor platelet counts and for bleeding. Management of hemorrhage may require blood product support.

•Immunization: Do not admin-ister live virus vaccines prior to or during Gazyva treatment.

•A boxed warning advises that hepatitis B virus reactivation and progressive multifocal leukoen-cephalopathy can occur and may result in death.

No contraindications are listed.

Drug Interactions. No formal drug interaction studies have been conducted with Gazyva.

Administration and Dosing. The recommended dose begin-ning on Day 1 of cycle 1 is 100 mg infused intravenously over four hours. On Day 2 of cycle 1, the dose

is 900 mg, followed by 1000 mg for all subsequent doses. The complete recommended dosing schedule is outlined in the product’s package insert. Doses are administered dur-ing six treatment cycles each of 28 days duration. Do not administer as an intravenous push or bolus. Gazyva is available in single-use vials containing 1000 mg/40 mL (25 mg/mL) of obinutuzumab. The drug is stable at 2°C to 8°C (36°F to 46°F). Vials should be protected from light and should not be frozen or shaken.

Patient Counseling Infor-mation. Specific points for coun-seling are summarized in Table 4.

Pertuzumab (Perjeta)FDA granted accelerated approval in 2013 to Perjeta (per-JET-uh)


Gazyva*

Advise patients to seek immediate medical attention for any of the fol-lowing:•signs and symptoms of infusion reactions including dizziness, nausea, chills, fever, vomiting, diarrhea, breathing problems, and chest pain;•symptoms of tumor lysis syndrome including nausea, vomiting, diarrhea, and lethargy;•signs of infection including fever and cough;• symptoms of hepatitis including worsening fatigue or yellow discolor-ation of skin or eyes;•new or changes in neurological symptoms including confusion, dizzi-ness or loss of balance, difficulty talk-ing or walking, or vision problems.

Advise patients:•that periodic monitoring of blood counts is necessary;•to avoid vaccinations with live viral vaccines;•that those with a history of hepatitis B infection (based on the blood test) should be monitored and sometimes treated for their hepatitis;•(women) to use effective contracep-tion while receiving Gazyva and for 12 months following treatment.


as part of a complete treatment regimen for patients with early stage breast cancer before surgery (neoadjuvant setting). Surgery to remove tumors is usually the first step in treating most forms of cancer. Perjeta was previously approved in 2012 for treatment of patients with advanced or late-stage (metastatic) HER2-positive breast cancer. Note: This new indication makes Perjeta the first FDA-approved drug for the neoad-juvant treatment of breast cancer. It is believed that using cancer drugs earlier could help shrink tumors, making them easier to remove. Thus, patients could avoid a full mastectomy. Treating the cancer at its earliest stages could prevent tumors from returning later, though studies have not yet established that benefit. Cancer specialists already use a variety of chemotherapy drugs as initial treatment for cancer, but they are not formally approved for the use.

Perjeta’s new use is intended for patients with HER2-positive, locally advanced, inflammatory or early stage breast cancer who are at high risk of having their cancer return or metastasize, or of dying from the disease. It is to be used in combination with trastuzumab (Herceptin) and other chemothera-py prior to surgery and, depending upon the treatment regimen used, may be followed by chemotherapy after surgery. Almost 20 percent of breast cancers have increased amounts of the HER2 protein. By making effective therapies avail-able to high-risk patients in the earliest disease setting, cancer recurrences may be delayed or prevented.

Indications and Use. Perjeta is indicated for use in combination with trastuzumab and docetaxel (Taxotere) for treatment of patients with HER2-positive metastatic breast cancer who have not re-ceived prior anti-HER2 therapy or chemotherapy for metastatic disease. The drug is also approved for use in combination with trastu-zumab and docetaxel as neoadju-vant treatment of patients with

HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node-positive) as part of a complete treatment regimen for early breast cancer. This indica-tion is based on demonstration of an improvement in pathologic complete response rate (pCR). No data are available demonstrating improvement in event-free survival or overall survival. Pertuzumab is also being studied in patients with other types of cancer, includ-ing gastric carcinoma, colorectal cancer, and castration-resistant prostrate cancer. However, these are not labeled indications at the present time.

Breast Cancer. An estimated 232,340 new cases of invasive breast cancer were expected to be diagnosed among women in the United States during 2013. Ex-cluding cancers of the skin, breast cancer is the most frequently diag-nosed cancer in women. An esti-mated 39,620 breast cancer deaths were expected in 2013, ranking it second as a cause of cancer death in women, after lung cancer.

Mechanism of Action. Per-tuzumab targets the extracellular dimerization domain of the human epidermal growth factor receptor 2 protein (HER2) and, thereby, blocks ligand-dependent heterodi-merization of HER2 with other HER family members, including EGFR, HER3, and HER4. Conse-quently, pertuzumab inhibits in-tracellular signaling, which in turn can result in cell growth arrest and apoptosis. Moreover, pertuzumab mediates antibody-dependent cell-mediated cytotoxicity.

Efficacy and Safety. Acceler-ated approval of Perjeta was grant-ed based on a study designed to measure the compound’s pathologic complete response. This is defined as the absence of invasive cancer in the breast and lymph nodes, as an endpoint to support accelerated approval of a drug for neoadjuvant treatment of high-risk, early stage breast cancer. Four-hundred sev-enteen participants were randomly assigned to receive one of four

neoadjuvant treatment regimens: trastuzumab plus docetaxel, Per-jeta plus trastuzumab and docetax-el, Perjeta plus trastuzumab alone, or Perjeta plus docetaxel. About 39 percent of patients who received Perjeta plus trastuzumab and docetaxel achieved pCR, compared to approximately 21 percent of women who received trastuzumab plus docetaxel alone. A confirma-tory trial is underway in more than 4,800 participants with HER2-positive breast cancer who had prior breast cancer surgery and are at high risk of having their can-cer return. The trial will provide further data on efficacy, safety and long-term outcomes. Results are expected in 2016.

The most common adverse effects reported in participants receiving Perjeta plus trastuzumab and docetaxel were alopecia, diar-rhea, nausea and neutropenia. Other significant effects included decreased cardiac function, infu-sion-related reactions, hypersensi-tivity reactions, and anaphylaxis.

The drug’s safety as part of a doxorubicin (Adriamycin)-containing regimen has not been established. Its safety when admin-istered for greater than six cycles of early breast cancer has likewise not been established.

Warnings, Precautions and Contraindications. The follow-ing warnings and precautions are listed.

•Embryo-fetal toxicity: Fetal harm can occur when administered to a pregnant woman.

•Left ventricular dysfunction: Monitor left ventricular ejection fraction (LVEF) and withhold dos-ing as appropriate.

•Infusion-related reactions: Monitor for signs and symptoms. If a significant infusion-related reac-tion occurs, slow or interrupt the infusion and administer appropri-ate medical therapies.

•Hypersensitivity reactions/anaphylaxis: Monitor for signs and symptoms. If a severe reaction occurs, discontinue the infusion im-mediately and administer appro-priate medical therapy.

27The Georgia Pharmacy Journal The Georgia Pharmacy Journal26

Program 0129-0000-14-001-H01-PRelease date: 1-15-14

Expiration date: 1-15-17CE Hours: 1.5 (0.15 CEU)

The author, the Ohio Pharmacists Founda-tion and the Ohio Pharmacists Association disclaim any liability to you or your patients resulting from reliance solely upon the infor-mation contained herein. Bibliography for additional reading and inquiry is available upon request.

This lesson is a knowledge-based CE activ-ity and is targeted to pharmacists in all practice settings.

The Ohio Pharmacists Foundation Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

•HER2 testing: Perform using FDA-approved tests by laboratories with demonstrated proficiency.

•A boxed warning advises about the potential for cardiomy-opathy and embryo-fetal toxicity.

Perjeta is contraindicated in patients with known hypersensitiv-ity to pertuzumab or to any of its excipients.

Drug Interactions. No drug interactions have been noted between pertuzumab and trastu-zumab, or between pertuzumab and docetaxel.

Administration and Dosing. The initial dose is 840 mg admin-istered as a 60-minute intravenous infusion, followed every three weeks thereafter by 420 mg given as a 30- to 60-minute intravenous infusion.

For metastatic breast cancer, pertuzumab, trastuzumab, and docetaxel should be administered by intravenous infusion every three weeks. For neoadjuvant use, they should be administered by intrave-nous infusion preoperatively every three weeks for three to six cycles. The drug is available in single-use vials containing 420 mg/14 mL per-tuzumab. Vials should be protected from light, and should not be frozen or shaken.


Perjeta* Advise:•pregnant women and females of reproductive potential that Perjeta exposure can result in fetal harm, including embryo-fetal death or birth defects;•females to use effective contracep-tion while receiving Perjeta and for six months following the last dose of the drug;•nursing mothers treated with Per-jeta to discontinue nursing or discon-tinue Perjeta, taking into account the importance of the drug to the mother;•women who are exposed to Perjeta during pregnancy to enroll in the MotHER Pregnancy Registry by con-tacting 1.800.690.6720.


Patient Counseling Infor-mation. Specific points of counsel-ing for Perjeta are summarized in Table 5.

Overview and Summary The diseases NSCLC, HIV, CLL, and breast cancer represent four pathologies that are potentially fatal. The new drugs described within this lesson offer renewed hope for extending the lifespans of millions of Americans afflicted by these conditions.

continuing educat ion quiz New Drugs: Gazyva, Gilotr i f , Perjeta, and Tivicay

Program 0129-0000-14-001-H01-P0.15 CEUPlease print.

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Completely fill in the lettered box corresponding to your answer.1. [a] [b] [c] [d] 6. [a] [b] [c] 11. [a] [b] [c] [d] 2. [a] [b] [c] [d] 7. [a] [b] [c] [d] 12. [a] [b] [c] [d] 3. [a] [b] [c] [d] 8. [a] [b] [c] [d] 13. [a] [b] [c] [d] 4. [a] [b] [c] [d] 9. [a] [b] [c] [d] 14. [a] [b] [c] [d] 5. [a] [b] [c] [d] 10. [a] [b] [c] [d] 15. [a] [b] [c] [d]

I am enclosing $5 for this month’s quiz made payable to: Ohio Pharmacists Association.

1. Rate this lesson: (Excellent) 5 4 3 2 1 (Poor)2. Did it meet each of its objectives? yes no If no, list any unmet_______________________________3. Was the content balanced and without commercial bias? yes no4. Did the program meet your educational/practice needs? yes no5. How long did it take you to read this lesson and complete the quiz? ________________ 6. Comments/future topics welcome.

1. Afatinib was approved to treat non-small cell lung cancer whose tumors possess which of the following? a. HER2 protein c. EGFR gene mutations b. CD20 antigens d. Topoisomerase II 2. The primary cause of cancer-related deaths is: a. breast cancer. c. lymphoma. b. lung cancer. d. leukemia.

3. All of the following are patient counseling points for Gilotrif EXCEPT: a. limit exposure to sunlight. b. fat redistribution may occur. c. diarrhea is common and may be severe. d. take on an empty stomach. 4. Dolutegravir is classed as a/an: a. tyrosine kinase inhibitor. b. blocker of heterodimerization of HER2 with other HER family members. c. humanized monoclonal antibody. d. integrase strand transfer inhibitor.

5. Dolutegravir can interfere with the active secretion of which of the following into renal tubules? a. Dofetilide c. Efavirenz b. Doxorubicin d. Rifampin

6. Dolutegravir is taken: a. on an empty stomach. b. with food/meals. c. without regard to meals. 7. Among the most common adverse reactions reported for Tivicay is: a. thrombocytopenia. c. headache. b. stomatitis. d. diarrhea.

8. Gazyva is indicated to be taken with: a. chlorambucil. c. trastuzumab. b. docetaxel. d. cisplatin.

9. The therapeutic use of obinutuzumab is to treat: a. HIV infection of the eye. b. chronic lymphocytic leukemia. c. non-small cell lung cancer. d. HER2-positive metastatic breast cancer.

10. The drug that received a new approval in 2013 for use in a neoadjuvant setting is: a. Gilotrif. c. Gazyva. b. Tivicay. d. Perjeta. 11. The drug used to treat patients with HER-positive metastatic breast cancer is: a. afatinib. c. obinutuzumab. b. dolutegravir. d. pertuzumab.

12. The drug with a boxed warning that advises about the potential for cardiomyopathy is: a. Gilotrif. c. Gazyva. b. Tivicay. d. Perjeta.

13. The drug that should be discontinued if interstitial lung disease is diagnosed is: a. Gilotrif. c. Gazyva. b. Tivicay. d. Perjeta.

14. Patients taking which of the following drugs should not receive live virus vaccines? a. Gilotrif c. Gazyva b. Tivicay d. Perjeta

15. Covalent binding to the kinase domains of EGFR to inhibit tyrosine kinase autophosphorylation is a mecha-nism of action for: a. afatinib. c. obinutuzumab. b. dolutegravir. d. pertuzumab.

To receive CE credit, your quiz must be received no later than Janu-ary 15, 2017. A passing grade of 80% must be attained. CE credit for successfully completed quizzes will be uploaded to the CPE Monitor. CE statements of credit will not be mailed, but can be printed from the CPE Monitor website. Send inquiries to [email protected].

january 2014

Name PositionRobert M. Hatton Chair of the BoardPamala S. Marquess PresidentRobert B. Moody President-ElectThomas H. Whitworth First Vice PresidentLance P. Boles Second Vice PresidentLiza Chapman State At LargeTerry Forshee State At LargeDavid Graves State At LargeJoshua D. Kinsey State At LargeEddie Madden State At LargeLaird Miller State At LargeChris Thurmond State At Large Krista Stone 1st Region PresidentEd S. Dozier 2nd Region PresidentRenee D. Adamson 3rd Region PresidentNicholas O. Bland 4th Region PresidentShelby Biagi 5th Region PresidentSherri S. Moody 6th Region PresidentTyler Mayotte 7th Region PresidentMichael Lewis 8th Region PresidentAmanda Westbrooks 9th Region President Flynn Warren 10th Region PresidentKalen Manasco 11th Region President Ken Von Eiland 12th Region PresidentTed Hunt ACP ChairSharon B. Zerillo AEP ChairJohn Drew AHP ChairDrew Miller AIP ChairMichelle Hunt APT ChairLeah Stowers ASA ChairJohn T. Sherrer Foundation ChairAl McConnell Board of Pharmacy ChairMegan Freeman GSHP PresidentAmy C. Grimsley Mercer Faculty RepresentativeRusty Fetterman South Faculty RepresentativeLindsey Welch UGA Faculty RepresentativeTyler Bryant ASP, Mercer University Tiffany Galloway ASP, South University Jessica Kupstas ASP, UGA Jim Bracewell Executive Vice President

2013-2014 Board of Directors


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