georgia pharmacy journal - august 2014

August 2014VOLUME 36, ISSUE 8

Confronting Current Challenges Facing

Pharmacy

Q&Awith Linda Wiant, PharmD

Director of Pharmacy, Georgia Department of Community Health

Plus• Medicaid and Georgia DCH SHBP Begin Covering Flu Shots

The Georgia Pharmacy Association proudly sponsors Meadowbrook Insurance Group, Inc. for your workers’ compensation needs.

Editor: R. Scott Brunner, [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.

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August 2014

1The Georgia Pharmacy Journal

ContentsMessage from Bobby Moody ........................

Message from Scott Brunner ........................

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

Upcoming GPhA Events ................................

22

54

PharmPAC Investors ...................................18Continuing Education ...............................20GPhA Board of Directors .........................28

Industry News ...............................................12

Confronting Current Challenges Facing Pharmacy 8......................................................

New Members ...................................................7

Q&Awith Linda Wiant, PharmD Director of PharmacyGeorgia Department of Community Health

Flu Shots Now Covered By Medicaid 9.............................................................

The Georgia Pharmacy Journal2

From the GPhA President

This summer has flown by. Since the GPhA convention, your Execu-tive Committee has met twice and spent considerable time discussing, planning, and even dreaming a bit about the future of your association. We have set the calendar for most of the coming year and planned the fall region meeting schedule, which you’ll

read about elsewhere in this magazine. These meetings will serve as a “Meet The New EVP” tour. Scott plans to attend all 12 region meetings this fall, along with a couple of other members of the Executive Committee. I hope you’ll note the date for the meeting in your area and plan to come meet and hear from him. I think you’ll come away convinced that GPhA is headed in an exciting new direction focused on serving you better.

Some other items we’re working on:• Focusing on membership growth by creating an effec-

tive recruiting plan;• Working to better enunciate GPhA’s value proposition

for members – including realigning our print and online communications and developing materials that demonstrate the value we provide Georgia pharmacists;

• Developing a leadership development program to iden-tify and equip new future GPhA leaders;

• Looking at our internal operations and outreach initia-tives to assure that we have accurate records and processes for staying in touch with our members.

What else would you like to see from GPhA to make it a better association? If you have any ideas, e-mail me at [email protected], or you can reach Scott at [email protected]. We welcome all your thoughts to improve our association.

And be sure to read this month’s Journal carefully. In it, DCH’s Linda Wiant talks about the recent announcement that pharmacies can immunize Georgia Medicaid recipi-ents. This is a small but important step that step moves us closer to provider status, and I think you’ll enjoy the Q&A with Linda.

As payers see that pharmacists are able to provide health-care services, I believe that we will be given more opportu-nities like this. n

Bobby

Bobby MoodyPresident

When a person joins an asso-ciation, he or she does so based on an implicit promise, the expectation of not just a quid pro quo – I pay this, I get that – but also the expectation that the quo should exceed the value of the quid: I pay this, I get more than my money’s worth in return. It’s why we so often refer to your association

dues as an investment, not a payment. Investments grow. They appreciate in value. Payments, not so much.

Here at GPhA, my job as your EVP is to make sure we make good on that promise.

Keeping the promise means equipping and supporting your GPhA Board of Directors in charting a course toward the future that is compelling, and assuring that the organi-zation is accountable for the outcomes the Board identifies.

It means your GPhA staff team must be not only highly competent, but highly responsive to your needs and creative in delivering services that enhance your professionalism.

It means that our GPhA systems and programs must be state-of-the art, so that you’re not inconvenienced by clunky websites or frustrating registration processes or tedious CE courses or poorly planned meetings.

It means that GPhA is not only a trustworthy source for information about issues impacting Georgia pharmacists, but that the information is timely, incisive, and appropriate to your professional needs and your fast-paced lifestyle.

It means that the issues we embrace and advocate for inure to the benefit of the broadest swath of our members, not just one practice area or another.

And it means that the relationships we nurture help create a big-tent organization that speaks for all of Georgia pharmacy.

Promises are sacred things, things to be taken seriously. In coming months your GPhA Board of Directors, officers, and staff will be taking a hard look at how we do what we do for you. We’ll be reimagining and revamping our service platform to broaden our vision and serve you better.

So stay tuned. More quid for your quo is coming soon from GPhA.

That’s a promise. n

Scott

From the GPhA EVP

Scott Brunner, CAE EVP

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September 2014TBD .......................GPhA Committee Meetings

October 2014October 7 .............Region 2 MeetingOctober 8 .............Region 3 MeetingOctober 14 ...........Region 1 MeetingOctober 15 ...........Region 12 MeetingOctober 17-22 ......2014 Annual NCPA ConventionOctober 28 ...........Region 7 MeetingOctober 29 ...........Region 4 Meeting

November 2014November 5 .........Region 8 MeetingNovember 6 .........Region 6 MeetingNovember 12 .......Region 11 MeetingNovember 13 .......Region 10 MeetingNovember 18 .......Region 9 MeetingNovember 19 .......Region 5 Meeting

January 2015January 11 ............BOD and Committee Meetings January 12 ............Legislative Session Begins

February 2015February 4 ............Georgia Pharmacy Coalition DinnerFebruary 5 ............VIP Day

March 2015March 27-30 ........APhA Annual Meeting & Exposition

April 2015TBD .......................Spring Region Meetings

May 2015TBD .......................Spring Region Meetings

July 2015July 8 .....................BOD Meeting July 9-12 ...............140th GPhA Convention

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The Georgia Pharmacy Journal

M E M B E R N E W S

Buddy Carter, a long time member and supporter of GPhA legislative initia-tives, celebrates his victory in the US Congressional District 1 runoff. Carter now faces Democrat Brian Reese in the November 4 election.

Buddy Carter Wins US Congressional District 1 Republican Runoff

In a major victory for the pharma-cy profession, Buddy Carter, R.Ph, came out the winner in the July 22 Republican runoff for the 1st Congressional District. He received 53 percent of the vote.

“I’m deeply grateful for the support of my fellow pharmacists. The support they showed in standing with me in this race was absolutely essential to my victory to-night,” Carter stated.

Carter is owner of Carter’s Pharma-cy with locations in Pooler, Rincon, and Garden City and a graduate of the Uni-versity of Georgia School of Pharmacy.

A long-time GPhA member and sup-porter of its legislative initiatives, Carter moves on to face Democratic nominee Brian Reese in the upcoming November 4 election. If elected, Buddy would be the only serving US Congressman who is a pharmacist by profession.

He was first elected as a Georgia State Senator in the 2009 general election and serves Georgia’s 1st district – including Bryan County and portions of Chatham and Liberty counties. n

If you would like more information about Buddy Carter’s run for US Congress, visit www.buddycarterforcongress.com.

Barry Bryant Receives Cardinal Health’s Community Leadership Award

Cardinal Health has named Barry Bryant, owner of Barney’s Pharmacy in Augusta, GA, as the recipient of its Ken Wurster Community Leadership Award.

The award was presented at Cardinal’s annual Retail Business Conference in Washington, D.C., in July.

The award honors a retail indepen-

dent pharmacist who promotes the ideals of community pharmacy. It was created in honor of Tampa, Fla. independent pharmacist Ken Wurster, who passed away in 2008.

Independent pharmacists and Cardi-nal Health employees were encouraged to submit nominations for this award, and all nominees were judged on a vari-ety of criteria, including:

• Community leadership and involve-ment• Ability to inspire others, and

• Willingness to go above and beyond the day-to-day operations of a retail independent pharmacy to make their community a better place to live. Bryant is a longtime GPhA member

and is a graduate of the University of Georgia’s College of Pharmacy. Barney’s Pharmacy is an independently owned and operated full-service pharmacy that has been serving the South Augusta and Central Savannah River Areas for more than 50 years. n


M E M B E R N E W S

Bowles Awarded 2014 Bowl of Hygeia

The GPhA has selected Robert C. Bowles, Jr., as the recipient of the 2014 Bowl of Hygeia Award for outstand-ing communi-ty service. The Award was pre-sented at the GPhA Conven-tion President’s Reception and Banquet on June 28. The award is sponsored by the American Pharmacists As-sociation Foundation and the National Alliance of State Pharmacy Associations with support from Boehringer Ingel-heim.

In a statement Bowles thanked his family, friends, and community. “The opportunities that the wonderful people of Upson and surrounding counties af-forded me during my 38 years of prac-ticing pharmacy in Thomaston are the reason that I could have even been con-sidered for this award,” he said.

The Bowl of Hygeia is the most wide-ly recognized international symbol for the pharmacy profession and considered one of the profession’s most prestigious awards, recognizing pharmacists who possess outstanding records of civic leadership in their communities, and it encourages pharmacists to take active roles in their communities. n

Robert C. Bowles

Neville Named UGA College of Pharmacy Teacher of the Year

“I believe that good teachers make difficult things seem simple,” said Michael Neville, 2014 recipient of the Teacher of the Year award at the Uni-

Bridge Named for Bobby ParhamOn Thursday, July 10, the river

bridge on East Hancock Street and Ga. 24 in Milledgeville became officially known as the Bobby Parham Bridge. Pharmacist Parham served as a State Representative for 35 years before being elected to the board of the State Depart-ment of Transportation. For more than 50 years, he has also been serving middle Georgia as a pharmacist.

“Bobby is a true leader in Georgia,” said pharmacist and former state Senator Eddie Madden. “He was a mentor to me on how to serve as an elected official and as a pharmacist.”

Representative Parham has been pre-viously honored by GPhA as the only re-cipient of a lifetime membership award. GPhA’s outstanding legislator award is also being changed to the “Bobby Par-ham Outstanding Legislator Award” to honor this Georgia pharmacy legend. n

Got a Legislative Issue for Us?As you may have already

heard, GPhA is changing our pro-cess by which we create our 2015 legislative agenda. Despite the changes to the process, your input is still an important part of the pro-cess and we want to hear from you.

If you have an issue that you be-lieve should be considered by the Governmental Affairs Committee for possible inclusion on our legis-lative priorities for the 2015 session of the Georgia General Assembly, please email them to Andy Freeman at [email protected] by August 27, 2014 along with any research or supporting documents that you may have. n

GPhA Government Affairs Committee Chair Mike McGee and Director of Government Affairs Andy Freeman present Bobby Par-ham with a plaque commemorating the naming of the “Bob-by Parham Legisla-tive Award”

versity of Georgia College of Pharmacy, about his teaching philosophy.

“I get students to explain difficult top-ics in their own words and I try to do the same thing when I teach them. Whether I’m teaching in a large lecture hall or in small groups in the skills lab I want stu-dents to be able to think on their feet.

“I intentionally set students up to struggle with some exercises so that they can flounder, feel unsure, and learn from their mistakes,” Neville added. In 2008

he joined the college faculty and began coordinating the pharmacy care labo-ratory portion of the skills lab courses. In the classroom, Neville likes to give students the opportunity to practice and use their skills in simulated practice en-vironments. The award was presented in April. n

M E M B E R N E W S


Brunner Joins GPhA as Executive Vice President

Strategic success is powered by a handful of essential qualities. “We must have a firm foundation, be inclusive, be focused, be highly competent and high-performing, be polished, be out-ward-looking, and be nimble. These qualities define a successful associa-tion”, said Scott Brunner in remarks at the opening session of the GPhA Con-vention in June.

Brunner began work as GPhA’s new Executive Vice President on July 14. He brings 25 years of experience in associ-ation management and a track record of demonstrated success as a strategist, communicator, and innovator.

He has worked with both state and national associations and comes to GPhA after serving eight years as CEO of the 30,000-member Virginia Associ-ation of Realtors in Richmond.

Among Scott’s accomplishments is the creation of a leadership devel-opment initiative that became a national mod-el for equipping volunteer associ-ation leaders. He also conceived and guided a number of suc-cessful political

advocacy and member outreach initia-tives, and grew the political action com-mittees of the two associations he led to be among the largest and most effective PACs in those states.

Scott is a graduate of the University of Montevallo and holds a master’s de-gree in political science from Auburn University in Montgomery. He also holds the prestigious Certified Associa-tion Executive (CAE) designation. n

He can be reached at [email protected]

Scott Brunner, CAE

WELCOME New Members

Active Pharmacists Matthew Clifton - Moultrie, GAChinwe Mbonu - Atlanta, GA Ayn Piquant - Riverdale, GACimone Forbes - Dacula, GA

StudentsRachel Schnorr - UGA


The Georgia Pharmacy Association is the collective voice of the pharmacy profession, aggressively advocating for the profession in the shaping of pub-lic policy, encouraging ethical health care practices, advancing educational

leadership while ensuring the profession’s future is economically prosperous.

The members of GPhA would like to welcome all our new members and encourage them to take advantage of all the benefits membership offers.


L I N D A W I A N T

IN BRIEF: Name: Linda Wiant Title: DCH Director of PharmacyYears with DCH: 3 as of August 1, 2014Previous Positions: • Clinical Account Manager, Federal Programs, Xerox• Product Manager, Gold Standard (an Elsevier Company)• Director, Business Development & Professional Services, Prudent Rx• Director, Clinical Services (State Programs), ACS, Inc. (now Xerox)Hometown: Corpus Christi, TexasPharmacy Degree: Mercer University, PharmD., Residency at University Medical Center, Jacksonville FL, (now Shands Jacksonville)Interests/Hobbies: Cooking, reading, gardening, hiking, and kayakingInteresting Fact: My dad graduated from pharmacy school exactly 40 years before me. And from the same school.

Q&Awith

Linda Wiant, PharmD Director of Pharmacy,

Georgia Department of Community Health

L I N D A W I A N T


Q: Tell us about the Georgia Department of Community Health and where your work fits in DCH’s mission. How would you describe your role there?

A: The mission of the DCH is to provide Georgians with access to afford-able, quality health care through effec-tive planning, purchasing and oversight.We are dedicated to a healthy Georgia.

My role here at DCH is multi-faceted. There are the day-to-day challenges of keeping the pharmacy department run-ning and paying claims and handling issues that arise; thankfully, I have a great staff of pharmacists and program specialists working in the pharmacy unit. At a higher level, I see my role as being one that sets direction, balancing the need to be fiscally responsible and good stewards of the State’s money with the need to be responsive to provider concerns and providing a benefit that helps keep our members healthy.

Q: What made you decide to focus your pharmacy career in state government?

A: It was a natural fit when the position opened up. I had extensive experience in the PBM industry and understood claims processing and pre-ferred drug lists and auditing and I also had an understanding of Medicaid pharmacy programs from previous po-sitions. When the position came open, I was very interested because to me it was a dream job – it pulled together all of my previous experience and after all, there are only a few of these positions in

the country, so I decided the time was right to move into state government. I looked forward to bringing my private sector background together with public service.

Q: What are some challenges you see confronting the practice of pharmacy, and how is DCH focused on those challenges?

A: The practice of pharmacy in Georgia is changing very quickly. I see the challenge of specialty pharmaceu-ticals being one of the biggest on the horizon, and that horizon isn’t too far in the future. For GPhA members, the challenge will be how to manage these patients and continue to participate in providing these new, and often expen-sive, drug therapies. For us as a payer and a steward of the people’s money, the challenges are going to be many in-

cluding:• Anticipating and managing the im-pact to state budgets, and• Insuring that these expensive ther-apies, which can cost thousands of dollars a year, are benefiting patients. I think the biggest challenge for

both your providers and DCH is figur-ing out how to make sure these medi-cations are best used and how to make sure they are cost effective. I believe that will include intensively managing these patients to reduce side effects and insuring that patients are adherent to their therapies. If we purchase these medications but patients can’t or won’t use them, then we have wasted oppor-tunities and funds. And of course esca-lating costs of both brand and generic medications continue to be of concern to us all.

The other challenges, of course, are keeping up with changing regulations,

DCH announced in July that pharmacists can now be reimbursed for immunizations under Medicaid. Below, we talk to Director of Pharmacy Linda Wiant about that announcement and her work at DCH.

Confronting Current Challenges Facing Pharmacy

Flu Shots Now Covered by Medicaid The Georgia Department of Community Health (DCH) has announced

that flu shots can now be covered through Medicaid, insuring proper pro-vider reimbursement for these pharmacy services. For-profit providers should complete the “For-Profit Pharmacy MFN Form” and not-for-profit providers should complete the “Not-For-Profit Pharmacy MFN Form” available on the GPhA website at www.gpha.org. The Forms may also be downloaded from www.mmis.georgia.gov → Provider Information → Forms → Reporting Form for MFN Rates.

You may fax your form to Pharmacy Services at 1-877-567-8001, or mail it to the following address:Department of Community HealthPharmacy Services 2 Peachtree Street, N.W. 37th FloorAtlanta, Georgia 30303


L I N D A W I A N T

especially at the Federal level, that im-pact us all, such as changes to the 340B program or additional Affordable Care Act requirements.

Finally, communicating changes to our provider community is always a challenge. We strive to keep the asso-ciation aware of major changes, and we regularly publish banner messages on our portal at www.mmis.georgia.gov. We also encourage providers to sign up for our electronic newsletter, DCH-i, at dch.georgia.gov/dch-i. We are always very appreciative of the support we re-ceive from GPhA in helping to “spread the word” to their membership about important new initiatives or changes.

Q: You recently announced that pharmacists will now be allowed to administer and be compensated for flu vaccines under Medicaid. This is welcome news for Georgia pharmacists. Can you share some background on this issue?

A: This is an initiative we’ve had in the works since I came on board. We needed to make some changes to our sys-tem to accommodate claims from phar-macies through our fiscal agent’s system – the HP MMIS system. Of course, the

CMOs have accepted claims for immu-nizations for some time now. We are hopeful that this will increase our im-munization rates for adults in the state of Georgia, saving lives and reducing med-ical expenses not only for our members, but for the community as well.

Q: So how it will it work?

A: For Medicaid Fee-for-Service claims, pharmacists will use an 837P transaction to transmit a professional claim for the vaccine and an administra-tion fee. Pharmacists will need to enroll with an EDI vendor to transmit claims if they haven’t already done so. Many pharmacists already use this transaction to bill claims to other payers.

Q: Is there any special training pharmacists will need to participate?

A: DCH does not require any spe-cial training. Pharmacists are expected to follow any applicable laws and regu-lations around training, protocols, and record-keeping.

Q: How will DCH be commu-nicating this news to the pharmacy community?

A: DCH has had several discus-sions with various pharmacy associa-tions to notify them of the change. We also posted banner messages on our website and provided the banner mes-sage to not only the associations for dis-tribution to their membership but also to our PBM, Catamaran, who sent out an e-blast to their distribution list. The in-formation will also be published in our October edition of the pharmacy provid-er manual.

Q: Is there a different process for submitting claims through traditional Medicaid and CMOs?

A: The CMOs use the NCPDP standard transaction for immunization claims while Medicaid uses the ASC X12N version 5010 transaction standard for medical claims for processing flu vac-cine claims.

Q: How do you see this decision impacting healthcare in Georgia?

A: What we hope for is an im-provement in healthcare outcomes and an increase in immunization rates for our Georgia members. And that increase in immunization rates in our adult pop-ulation will hopefully increase commu-nity immunity as well.

Q: What other projects are you currently working on that might impact Georgia pharmacists?

A: Most of our other projects are more operational in nature, certainly nothing as exciting as the flu vaccine program. We are exploring some chang-es to our prior authorization program to see if we can automate more of that process and we continually evaluate our PA limits to adjust to changes in the marketplace; this change, if we are able to implement it, would actually be trans-parent, and perhaps even invisible, to providers as we would hope to decrease the need for providers to actually call to

Wiant has a great staff of pharmacists and program specialists who help address the challenges of keeping the pharmacy department running, including paying claims. Here she meets with DCH Clinical Pharmacist Gillette Gray.

L I N D A W I A N T

receive an authorization. That’s one ex-ample of a change where we are trying to reduce the provider’s administrative burden. Of course, ICD-10, while not as impactful on pharmacist’s work as it is on other providers, continues to be an important initiative. We plan to be ready for external testing ICD-10 by October 1, 2014, even though the federally mandat-ed go-live date has been pushed back to October 1, 2015. We also know that the requirement that all prescription claims have an enrolled provider has been dif-ficult to implement for prescriptions written by residents, and we continue to evaluate changes that we can make to simplify that program and improve it. Hopefully we’ll have an update on changes to that policy soon.

Q: You pursued a career in phar-macy. What was your Plan B? What work do you think you’d be doing today if you hadn’t chosen pharmacy?

A: Actually, pharmacy was my plan B! I have a B.S. in Marketing with a minor in Humanities as my undergrad-uate experience. After several years of working in direct mail and other mar-keting fields, I decided to find a career that was more challenging and satisfying on a personal level.

My dad was a pharmacist and I knew what he did every day and it seemed like a good career choice. Our careers have been very different, but his work defi-nitely influenced my choices. n

The Georgia Department of Commu-nity Health (DCH) is one of Georgia’s four health agencies serving the state’s growing population. Serving as the lead agency for Medicaid and also over-seeing the State Health Benefit Plan (SHBP), Healthcare Facility Regulation and Health Information Technology in Georgia, DCH’s programs provide access to health care services for one in four Georgians. For more information go to dch.georgia.gov or call 404-656-4507.

Wiant’s job carries much responsibility. On the lighter side, she has quite a collec-tion of rubber duckies.


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

Neighborhood Pharmacies: An Untapped Resource

Community pharmacists can dra-matically help their patients stick to their prescription regimens, according to a new study led by researchers at the Uni-versity of Pittsburgh School of Pharma-cy. The findings suggest also that greater adherence to medications can lead to a reduction in emergency room visits and hospital admissions, thereby lowering health care costs for a variety of chronic conditions.

About 70 percent of all Medicare pa-tients get their prescriptions filled at neighborhood drug stores, but pharma-cists can do more for patients than just prepare medications, said lead inves-tigator Janice Pringle, Ph.D., associate professor and director of the Program Evaluation and Research Unit (PERU) at Pitt’s School of Pharmacy. She noted their training, knowledge and commu-nity accessibility perhaps makes them the ideal health professionals to help people learn how and why to take their

Initial License Applications Now Available OnlineThe Georgia Board of Pharmacy

has begun offering a new online ser-vice: the ability to submit an initial ap-plication for licensure for pharmacists, pharmacy interns, and pharmacy tech-nicians. Applicants for pharmacist li-censure, pharmacy intern licensure, and pharmacy technician registration can submit their applications online: gadch.mylicense.com/eGov/. To determine their eligibility for licensure or regis-tration, persons interested in applying should consult the laws, rules, and regu-lations of the Board, which are available under the “Laws, Policies, and Rules” section of the Board website. n

medications.“This untapped resource could be

harnessed and used to improve public health and reduce overall health care costs,” Dr. Pringle noted. “If people took their medications as prescribed, diabe-tes would not evolve and worsen, blood pressure would normalize, cholesterol would be reduced dramatically, and the risk for severe health problems, such as heart attack or stroke, would be reduced. Patients would live longer and probably enjoy a higher quality of life.”

“The cost savings demonstrated by the Pennsylvania Project should draw the attention of many payers to the value of leveraging pharmacists in the communi-

ty where their members live to improve health and wellness and reduce overall health care costs,” said study co-author Jesse McCullough, Pharm.D., director of field clinical services at Rite Aid Corp. “This is another area where the value of the pharmacist to the health care system is demonstrated.”

High quality medical care is a ‘team sport’ involving physicians and other providers, nurses, care managers, health plans and well trained pharmacists. Im-proving medication adherence rates im-proves quality, public health and saves money, and this study demonstrates the value pharmacists can add. n

Data Breach In the Pharmacy: What Does the Latest Leak Mean for Your Pharmacy?

What could be the largest data breach identified to date involves 4.5 billion username and password combinations from large industry leaders, small businesses, and even personal websites.

The breach’s wide reach has the potential to compromise pharmacy websites and user accounts, and pharmacists may need to take steps to check their site’s security.

According to Hold Security, the cybersecurity firm identifying the breach, those responsible used a combination of tactics to amass the data. The group’s tactics initially included purchasing databases with the infor-mation from other hackers, a press release from the company states. The group later switched their tactics. The group began using a botnet network – a group of malware infected computers controlled by a criminal group – to identify vulnerabilities in Structured Query Language (SQL), a pro-gramming language used for many database systems – including those that organize product or customer data for various websites. The hackers then used those vulnerabilities to steal identification credentials, including e-mail and password pairs, from the websites.

Although certain credentials might be repeated or invalid, the sheer number of username and password combinations represents a potential open door for systems and accounts.

“4.5 billion credentials seems like an impossible number, but just think of how many sites require you to register your e-mail address and, let’s face it, almost everyone re-uses their passwords,” the release stated.

Hold Securities recommends checking whether websites are susceptible to SQL-injection attacks. For pharmacies that control their own websites, this may necessitate a call to the website designer or hosting service. Local independent contracting firms can also offer information security services, and pharmacists should look for firms with certified experts. Common cer-tifications include Certified Software Lifecycle Professionals (CSSLP), and GIAC-Certified Web Application Defender (GWEB). n



Make Contact NowOn “Any Willing Pharmacy”

The National Community Pharmacists Association is calling on its members and state partners to contact their individual mem-bers of Congress regarding Part D preferred network exclusions and the need to support H.R.4577. This legislation would address preferred networks and allow any willing pharmacy in a medically underserved area to participate in a network if it accepts the same contract terms and conditions.

H.R. 4577 was introduced in early May by Reps. Morgan Grif-fith (R-Va.) and Peter Welch (D-Vt.). A total of 59 representatives have signed on to co-sponsor the bill. In order to get the bill to the floor for a vote, we need even more co-sponsors and we hope that all GPhA members can assist NCPA in achieving more co-sponsors on this important legislation.

If you have a relationship with any representative please contact them today and request their support. n

WHO Projects Ebola Vaccine Will Be Ready for 2015Several treatments for hemorrhagic

fever are in different stages of develop-ment.

As mobilization efforts for the devel-opment of an Ebola treatment contin-ue in response to the outbreak in West Africa, the World Health Organization (WHO) is confident that a vaccine for the virus will be ready for public use at some point in 2015.

With clinical trials ongoing for one

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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

Ebola treatment and set to begin for an-other, a WHO representative told French radio broadcaster RFI that a vaccine within the next year is a realistic goal. The latest figures on the crisis released by WHO place the estimated death toll at nearly 1000, with more than 1700 con-firmed and suspected cases.

“We have evaluated this vaccine can-didate in preclinical studies and we are now discussing with regulators advanc-ing it to a phase I clinical trial program later this year,” read a statement on the GSK website. “Clinical development for a new vaccine is a long, complex process, often lasting 10 or more years. It is diffi-cult to accelerate this process because of the many important steps that a candi-date vaccine must go through to ensure that it is safe and effective.”

If the vaccine is found to be safe, the trial will move to the next phase to test whether the vaccine produces protec-tive antibodies to fight the virus,” the NIH said in a press release. “This testing could begin as early as January. Opti-mistically, the vaccine could be available about a year after that for people at high-est risk for exposure to Ebola, such as health care workers.”

WHO is also set to conduct an ethical meeting this month to discuss the use of ZMapp, an experimental drug that showed promising results after being

administered in Ebola-stricken Ameri-can relief workers Dr. Kent Brantly and Nancy Writebol. n

NCPA Expresses Support for Legislation

The National Community Phar-macists Association (NCPA) expressed its support of a bill intended to help re-duce prescription drug abuse in a July 28, 2014 letter to the US House of Rep-resentatives.

The bill, dubbed the Ensuring Patient Access and Effective Drug Enforcement Act of 2014, aims to improve enforce-ment efforts for prescription drug diver-sion and abuse.

According to B. Douglas Hoey, RPh, MBA, chief executive officer of the NCPA, the bill balances improved en-forcement efforts with patient access through a collaborative discussion be-tween key players. Those players include drug manufacturers, wholesalers, com-munity pharmacies, and federal en-forcement and oversight agencies.

A provision within the bill would al-low pharmacists to submit a corrective action plan prior to the Drug Enforce-ment Agency revoking or suspending a license. n


Georgia DCH SHBP Begins Covering Flu Shots

Beginning August 15 the Geor-gia Department of Community Health State Health Benefit Plan (SHBP) will begin covering flu vaccines for members at in-net-work retail pharmacies. Please email Terracer Earnest, R.Ph at Express Scripts with any questions, [email protected]. If you need assistance processing a claim contact the Express Scripts pharmacy help desk at 800-824-0898 or 800-922-1557. n

NCPA Responds to PCMA’s Medication Synchronization Opposition

The National Community Phar-macists Association (NCPA) recently responded to the Pharmaceutical Care Management Association’s (PCMA) June 19th memo, which circulated arguments against medication synchronization.

NCPA clarified that PCMA dissemi-nated extremely misguided information regarding medication synchronization legislation. PCMA claimed that such leg-islation is a “mandate” that would “cre-ate an administratively complex system” and “increase costs.” PCMA’s position echoes their arguments made in response to most pro-American small business and patient care legislation supported by NCPA. NCPA said that in actuality medication synchronization legislation simply provides patients with the option

How to Engage Tobacco UsersAs part of the Georgia Ask, Ad-

vise and Refer with Follow-up Program webinar series, the DPH invites you and members of your healthcare team to

Call for APhA Award NominationsThe APhA Awards and Honors

Program is the profession’s most com-prehensive recognition program. Help us identify the students, practitioners, scientists, and organizations most de-serving of recognition at the 2015 APhA Annual Meeting & Exposition in San Di-ego, California.

Visit pharmacist.com/awards for in-formation. Deadline: Sept. 1. n


Pharmacists & Healthcare Reform: APhA Video Series

To help pharmacists better under-stand the effects of Congress’ overhaul of the U.S. healthcare system, APhA, with support from Boehringer Ingelheim Pharmaceuticals, Inc., has launched a video series explaining The Patient Pro-tection and Affordable Care Act of 2010. Part 1: Healthcare Reform 101• A summary of the law itself.• Discussion of Congress’ goals in pass-ing the law.• Pharmacy stakeholders’ reactions to the law.• APhA’s role in shaping the law.Part 2: Opportunities for the Pharmacist• Medication Therapy Management.• Innovation in healthcare delivery systems.• Integrated care models.Part 3: The Impact of Politics• An update on court challenges.• Insight on the timeline.• What it may mean for pharmacists if the law is repealed.• Resources for pharmacists.Part 4: What Can You Do• Shares core messages that pharmacists can take to legislators.• Encourages participation at the state level.• Identifies resources for pharmacists to help them get involved. The videos can be viewed at pharmacist.com/pharmacists-health -care-reform-insights-and-opportunities-short-videos. n

Prediabetes Overview Is Now Available With CE

“Intervention in the Early Stag-es: An Overview of Prediabetes” is now available with CE offering to Georgia healthcare and public health profession-als statewide. Please feel free to share this Georgia Prediabetes webinar series up-date with colleagues, partners, clinical support team members as well as medi-cal, nursing and pharmacy students.

To access this archived webinar and

participate in modules from the brand new “Engaging Tobacco Users: Tips for Healthcare Providers and Public Health Professionals in Georgia” on-line in-teractive training. This online training features 4 modules designed to further support healthcare providers, clinical support professionals (including reg-istered pharmacists, registered nurses, certified diabetes educators) as well as public health professionals statewide.

To enroll please access webinar series #8 from the “Webinars and Trainings - Georgia AARds Program” link on the DPH website. n

obtain additional information on how to obtain CEs (Continuing Education) credits, please visit the “Webinar and Trainings” section from the “Diabetes Prevention and Control Program” web-page on the DPH (Department of Public Health) website at dph.georgia.gov/. n


to have the pharmacy coordinate all of their chronic or maintenance medica-tions to be filled on the same date each month, to facilitate greater adherence, and improve their health. NCPA made clear that this is not a one-size-fits-all mandate, but rather a shared clinical decision between the patient, prescriber, and the pharmacist. n

Discussion Continues on Consumer Drug Leaflets

The FDA has made some progress toward improving consumer informa-tion leaflets for prescription drugs.

The leaflets, also known as patient medication information (PMI), are gen-erally created from content developed by ASHP and other providers of drug in-formation. Pharmacies select the specif-ic content to include in PMI documents and the format in which the printed doc-uments appear.

Bryon Pearsall, director of FDA’s Di-vision of Medical Policy Programs, said the agency’s “current thinking” about PMI is that it should consist of one-page documents produced by drug manufac-turers and “based on content, format, and testing standards established in regulation and healthcare providers will have open online access. n

Vitamins and Supplements: What Do Patients Really Need? Patients are using OTC vitamins

and supplements more often than ever. Those very same patients need guidance in the OTC aisles, and pharmacists are OTC experts.

If pharmacists practice at the top of their licenses, they will integrate re-warding work conducted in OTC aisles by looking at each patient’s total phar-

macotherapy regimen including pre-scription medications, OTC products, and dietary supplements.

Most Americans aspire to eat well. They’d like to eat a well-balanced diet and they understand that diets rich in fruits and vegetables provide important vitamins, minerals, and fiber. The FDA recommends we ask patients these ques-tions:• Do you eat fewer than 2 meals per day? • Is your diet restricted? • Do you eat alone most of the time? • Without wanting to, have you lost or gained more than 10 pounds in the last 6 months? • Do you take 3 or more prescription or OTC medicines a day? • Do you have 3 or more drinks of alco-hol a day?

As pharmacists you should address the growing trends related to vitamins and supplements. Take a look at the latest research. It will help you use all pharma-cotherapy rationally and safely. n

F I N A N C I A L N E W S


Planning for college has become an integral part of one’s overall financial plan. In the past five years alone, average tuition and fees at public four-year col-leges increased by 27% beyond the pace of inflation between the 2007-08 and 2012-13 school years. UBS clients are now expressing a far greater interest in learning more about how best to prepare heirs and pass down values. Given the historical increases of college costs, fam-ilies with children are anticipating in-creased spending for college to continue into the future, and are actively looking for the best strategies to save.

How do 529s and other assets impact a student’s ability to receive financial aid?

Federal aid is needs-based, and the amount a student receives is calculated by taking the cost of attendance (includ-ing tuition, books, housing, etc.) and subtracting the Expected Family Contri-bution (EFC), which is the amount that the student and parents are expected to contribute towards college expenses.Cost of attendance – EFC = Needs-based financial aid (See EFC calculation table be-low)

Grandparent-owned 529 plans?Grandparents who are well positioned

to help fund college education for their

grandchildren can receive an addition-al benefit in contributing to 529 plans, which have the potential to reduce their estate tax liability. In providing a value for their grandchildren, grandparents can also retain control of their assets by funding a 529 plan, in lieu of funding a custodial account or gifting outright. Using the annual exclusion from gift tax can be an attractive option for those who would like to gift to their grandchildren without impacting their lifetime gift tax exemption amount.

Should I fully fund a 529 plan?When it comes to funding a 529 plan,

receiving the tax benefits is contingent upon the beneficiary attending a quali-fied higher education institution. With-drawals that do not fall within those rules will be subject to a 10% penalty on the earnings. Parents may be reasonably cautious when it comes to funding a 529 plan, in case the 529 plan becomes over-funded, or if the child does not attend college.

529 plans allow for flexibility in ben-

eficiary selection. The beneficiary can be changed to another member of the family of the same generation, including siblings and cousins, without incurring a tax consequence. A 529 plan for the oldest child of a family could be used to fund expenses of the younger children, mitigating the risk of either overfunding the 529 plan or of penalized withdrawals if the first child does not pursue higher education. In determining whether a 529 plan has sufficient funds or conversely, if it should receive additional contri-butions, the availability of 529 plan ac-counts for other beneficiaries can be an important factor.

If the family only has one child or one possible beneficiary, overfunding the 529 plan means the unused excess is subject to the penalty even if the beneficiary at-tends college. However, there is no age at which plan withdrawals are not per-mitted and there are many post-higher education and vocational institutions that are accredited for 529 plan funding. For example, whether or not the ben-eficiary goes to a traditional four-year

Education For Your Kids & Grandkids: Five Common 529 Questions

The following assets are not included: retirement funds, primary home equity, family-owned businesses, annuities, and insurance policies. Qualified distributions from a parent or student-owned 529 savings plan are federal tax-free, and are not considered income for financial aid applications under federal guidelines.

Income 22% to 47% of available incomeAssets up to 5.64% of assets4 - mutual funds - securities - bank accounts, CDs - parent-owned 529 plans - dependent student-owned 529 plans

50% of AGI over $6,1303 20% of assests held in student’s name

- UTMA/UGMA accounts - Minor Trusts - Savings Bonds

Parents Students

Projected four-year tuition and fees2 Total four-year cost Type of institution Enrolling in 2014 Enrolling in 2031 (18 yrs.) Private college $186,581 $427,647 Public college $95,948 $219,914

F I N A N C I A L N E W S

college, he/she may also decide to attend culinary school, or take advanced lan-guage courses. Any college, university, or post-secondary institution that is el-igible for federal aid is qualified for the 529 plan funding.

How does Gifting work with 529 plans?

Another consideration when funding a 529 plan is the gifting situation of the family. Contribution limits in a 529 plan are generous, and many investment pro-grams have lifetime contribution limits above $300,000 per beneficiary. Contri-butions to a 529 plan, however, are treat-ed as gifts from the donor to the bene-ficiary. This year, the $14,000 ($28,000 for a married couple) per-donee annual exclusion can be used towards 529 plan contributions.

529 plans also offer the unique 5-year election that allows a contribution of up to $70,000 ($140,000 for a married cou-ple), front-loading the annual exclusion for the following five years. This allows

the donor to fund the plan very quickly and maximize the income tax benefits afforded such accounts.

Which expenses are qualified distri-butions from a 529 plan?

One of the major benefits of using a 529 plan is the tax-free treatment of dis-tributions when used for qualified high-er educational expenses. These qualified higher educational expenses include tuition, fees, books, room and board, and include the additional expense of a special needs student at an eligible insti-tution. For part-time students, qualifica-tion of certain expenses may depend on other factors such as whether the student is enrolled half-time or more, and the al-lowable amount set by the school’s bud-get. Qualified higher education expens-es do not include insurance, sports and club activity fees, transportation costs, student loan repayments, and any tech-nology or room and board costs exceed-ing the “cost of attendance” financial aid figure. Also, expenses for private school

at the pre-college level are never qual-ified.

In 2013, the IRS expanded the defi-nition of qualified expenses to include the cost of computer technology and related equipment. Computers and related services used for education-al purposes can now be purchased with tax-free distributions from 529 plans. The expansion of qualified dis-tributions from 529 plans to include technology expenses is an additional benefit to using a 529 plan as a savings vehicle for higher education. nAt UBS, we work to provide our fam-ily clients with the latest thinking and best practices. For more information about family meetings including meet-ing topics or agendas, recurring issues, or advice and guidance implementing a family meeting strategy, please con-tact Wile Consulting Group at UBS: 404-760-3000 or visit www.ubs.com/team/wile.

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, andhelping 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®

First Vice President–Wealth Management Senior 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

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

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G P h A P h a r m P A C

Thanks to All Our 2014 InvestorsHighlight denotes new and increased contributors.

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

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.

Platinum Level$1,200 minimum pledgeFred Barber, R.Ph 6/15 Barry Bilbro, R.Ph 6/15 Thomas Bryan, Jr. 12/14*Larry Braden, R.Ph.*William Cagle, R.Ph.*Hugh Chancy, R.Ph.*Keith Chapman, R.Ph.*Dale Coker, R.Ph.*Billy Conley, R.Ph.*Al Dixon Jr., R.Ph.*Ashley Dukes, R.Ph. Patrick Dunham, R.Ph. 3/15*Jack Dunn Jr., R.Ph. *Mike Faulk, R.Ph.

*Neal Florence, R.Ph.*Andy Freeman*Robert Hatton, Pharm.D.Ted Hunt, R.Ph.12/14 Marsha Kapiloff, R.Ph. 6/15*Ira Katz, R.Ph. George Launius, R.Ph. 6/15J. Thomas Lindsey, R.Ph. 4/15 Jeff Lurey, R.Ph. 12/14*Eddie Madden, R.Ph.*Jonathan Marquess, Pharm.D. *Pam Marquess, Pharm.D.*Kenneth McCarthy, R.Ph.*Ivey McCurdy, Pharm.D.*Drew Miller, R.Ph.*Laird Miller, R.Ph.*Jay Mosley, R.Ph.*Sujal Patel, Pharm.D.*Mark Parris, Pharm.D.*Allen Partridge, R.Ph.*Houston Rogers, Pharm.D. Tim Short, R.Ph. 10/14*Benjamin Stanley, Pharm.D.*Danny Toth, R.Ph.*Christopher Thurmond, Pharm.D.*Alex Tucker, Pharm.D.Henry Wilson, Pharm.D. 11/14

Gold Level $600 minimum pledgeJames Bartling, Pharm.D. 6/15 *William Brewster, R.Ph. *Bruce Broadrick, R.Ph*Liza Chapman, Pharm.D. Carter Clements. Pharm.D. 5/15 *Mahlon Davidson, R.Ph.*Angela DeLay, R.Ph.

*Keith Dupree, R.Ph*Stewart Flanagin, R.Ph.*Kevin Florence, Pharm.D.*Kerry Griffin, R.Ph.*Michael Iteogu, R.Ph.*Joshua Kinsey, Pharm.D.*Dan Kiser, R.Ph.*Allison Layne, C.Ph.TMichael McGee, R.Ph. 4/15*Sheila Miller, Pharm.D.*Robert Moody, R.Ph.*Sherri Moody, Pharm.D. Catherine Moon 6/15 Floyd Moon 6/15*William Moye, R.Ph.*Anthony Ray, R.Ph.*Jeffrey Richardson, R.Ph.*Andy Rogers, R.Ph. Daniel Royal, R.Ph. 5/15*Michael Tarrant*James Thomas, R.Ph.Zach Tomberlin, Pharm.D. 4/15*Mark White, R.Ph.*Charles Wilson Jr., R.Ph. *Sharon Zerillo, R.Ph

Silver Level$300 minimum pledge*Nelson Anglin, R.Ph. *Renee Adamson, Pharm.D.Larry Batten, R. Ph. 11/14Lance Boles, R.Ph. 8/14 Robert Cecil, R.Ph. 3/15 Chandler Conner, Pharm.D. 6/15*Ed Dozier, R.Ph.*Greg Drake, R.Ph.*Terry Dunn, R.Ph.


G P h A P h a r m P A C

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

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 8Mark Parris, Region 9Chris Thurmond, Region 10Stewart Flanagin, Region 11Henry Josey, Region 12Bobby Moody, Ex-OfficioR. Scott Brunner, Ex-Officio

Alan Earnest, R.Ph. 6/15*Marshall Frost, Pharm.D.*Amanda Gaddy, R.Ph.*Johnathan Hamrick, Pharm.D.*Willie Latch, R.Ph*Hilary Mbadugha, Pharm.D.*Kalen Manasco, Pharm.D. Max Mason, R.Ph. 3/15*William McLeer, R.Ph.*Sheri Mills, C.Ph.T.*Richard Noell, R.Ph. *Darby Norman, R.Ph.*Cynthia Piela, R.Ph.*Donald Piela, Jr. Pharm.D. Bill Prather, R.Ph. 6/15 *Kristy Pucylowski, Pharm.D.*Edward Reynolds, R.Ph.*Ashley Rickard, Pharm.D.*Brian Rickard, Pharm.D. Brian Scott, R.Ph. 5/15 John Sherrer, R.Ph. 6/15 Sharon Sherrer, Pharm.D. 6/15Richard Smith, R.Ph. 5/15 Archie Thompson, R.Ph. 6/15 *Austin Tull, Pharm.D.Flynn Warren, R.Ph. 6/15*William Wolfe, R.Ph.

Bronze Level$150 minimum pledgeAnonymous 6/15 Bonnie Ali-Warren, R.Ph. 6/15*Shane Bentley, Student *Nicholas Bland, Pharm.D. *Robert Bowles *Mike Crooks, Pharm.D. Mandy Davenport, R.Ph. 6/15

*Rabun Dekle, R. Ph. John Drew, R.Ph. 6/15Becky Hamilton, Pharm.D. 4/15*Larry Harkleroad, R.Ph.*Hannah Head, Pharm.D.*Amy Grimsley, Pharm.D.*Thomas Jeter, R.Ph. *Henry Josey, Pharm.D.*Brenton Lake, R.Ph.*Tracie Lunde, Pharm.D.*Michael Lewis, Pharm.D.*Susan McLeer, R.Ph.Judson Mullican, R.Ph. 11/14*Natalie Nielsen, R.Ph.*Mark Niday, R. Ph.*Don Richie, R.Ph. *Amanda Paisley, Pharm.D. Rose Pinkstaff, R.Ph. 1/15*Alex Pinkston IV, R.PhDon Richie, R.Ph. 11/14*Corey Rieck Carlos Rodriguez-Feo, R.Ph. 12/14*Laurence Ryan, Pharm.D.*Olivia Santoso, Pharm.D. Wade Scott, R.Ph. 5/15 Diane Sholes, R.Ph. 6/15 Krista Stone, R.Ph. 6/15James Stowe, R.Ph. 12/14*Dana Strickland, R.Ph.G.H. Thurmond, R.Ph. 11/14*Tommy Tolbert, R. Ph.

MembersNo minimum pledgeClaude Bates, R.Ph. 6/15 Stuart Bradley, Pharm.D. 6/15Winston Brock, R.Ph. 6/14

Kristin Brooks 6/15 James Darley, Pharm.D. 6/15Donley Dawson, Pharm.D. 12/14Martin Grizzard, R.Ph. 6/15 James Hayes, CPhT 7/15Lise Hennick, R.Ph. 2/15 Ralph Marett, R.Ph. 6/15Whitney Pickett, R.Ph. 11/14 Annya Plotkina 6/15 Kimmy Sanders, Pharm.D. 6/15 Terry Shaw, R.Ph. 6/15Jeff Smith, Pharm.D. 5/15John Thomas, R.Ph. 11/14Jonathon Williams R.Ph 8/14*denotes sustaining members

“What inspired me to contribute monthly to PharmPAC was not to be the first student pharmacist to do so, but to help GPhA to continue to be a strong force in the advancement of pharmacists and student pharmacists.”

- Shane Bentley, PharmPAC


Mona T. Thompson, R.Ph., PharmD

continuing educat ion for pharmacists

Atypical Antipsychotics: Overview, Metabolic Abnormali t ies , and Newer Agents

Volume XXXII, No. 5

Mona T. Thompson has no relevant financial relationships to disclose.

Goal. The goal of this lesson is to provide an overview of atypical antipsychotics that are commonly prescribed for schizophrenia and bipolar disorder; summarizing available comparative data re-garding efficacy, tolerability, and adverse events of the most re-cently approved agents which are iloperidone (Fanapt®), asenapine (Saphris®), and lurasidone (Latu-da®).

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

1. compare and contrast the effectiveness and side effects of the first and second generation anti-psychotics;

2. demonstrate an understand-ing of the role that second genera-tion antipsychotics (SGAs), also known as atypical antipsychotics, play in the treatment of schizo-phrenia and bipolar disorder;

3. demonstrate an understand-ing of the SGA-induced metabolic abnormalities and their manage-ment; and

4. recognize the indications, mechanisms of actions, dosages, common adverse events, warnings (including black box warnings), precautions, and counseling points of three recently approved SGAs.

Background Antipsychotic medications are

indicated for the treatment of schizophrenia, bipolar disorder, and in some cases major depressive disorders. In addition, antipsy-chotic agents are increasingly be-ing prescribed off-label for various other mental disorders including agitation in dementia, anxiety, obsessive-compulsive disorder, autism, developmental disorders, delirium, aggressive behavior, personality disorders, and post-traumatic stress disorder.

Antipsychotics are divided into two groups: first generation antipsychotics (FGAs) or typical antipsychotics; and second gen-eration antipsychotics (SGAs), commonly referred to as atypical antipsychotics. The first genera-tion antipsychotics were developed in the 1950s and include agents such as haloperidol, chlorproma-zine, fluphenazine, thioridazine, thiothixene, and pimozide. These agents are effective in treating the positive symptoms of psycho-sis such as hallucinations and delusions. However, FGAs do not adequately treat many of the other problematic aspects of psychiatric illness such as negative symptoms, cognitive impairment, and affective symptoms. They are also largely associated with extrapyramidal side effects (EPS) at clinically effec-tive doses, including dystonic reac-tions (sustained muscle contrac-tions), drug-induced parkinsonism (characterized by tremors, postural instability, and rigidity), akathisia (inability to remain motionless),

and tardive dyskinesia (involun-tary, repetitive body movements).

Overview of Second Generation Antipsychotics (SGAs) Second generation antipsychotics were developed in an effort to find more effective agents with fewer and more manageable side effects. The first of these was clozapine, which was clinically introduced in 1989. Since then, nine other oral atypical antipsychotics have been brought to market: risperidone (1993), olanzapine (1996), que-tiapine (1997), ziprasidone (2001), aripiprazole (2002), paliperidone (2006), asenapine (2009), iloperi-done (2009), and finally lurasidone (2010).

While the pharmacologic properties, therapeutic effects, and adverse events vary between FGAs and SGAs, the most accepted dis-tinction is that the newer, second generation antipsychotics tend to have a decreased risk of extrapy-ramidal side effects compared to FGAs. This is possibly due to their lower affinity for the dopamine 2, or D2 receptor. These agents predominantly work on dopamine and serotonin receptors in the central nervous system, as well as cholinergic, adrenergic, and his-taminergic receptors. The degree and selectivity of receptor inhibi-tion varies between antipsychotic classes and agents which results in the differing side effect profiles that are observed. SGAs differ from


the first generation agents, as the serotonin 5-HT2 receptor binding can exceed their affinity for dopa-mine D2 receptors. This inhibition of 5-HT2 may be one justification for the lower risk of EPS.

In general, SGAs are better tol-erated and many of them are more effective than the older agents at treating negative, cognitive, and affective symptoms associated with schizophrenia. Unfortunately, their use is associated with weight gain, diabetes, and an atherogenic lipid profile, all of which are risk factors for the development of cardiovascu-lar disease (CVD).

Other noteworthy side ef-fects, warnings, and precautions associated with SGAs include hyperprolactinemia, neuroleptic malignant syndrome, blood dyscra-sias (leukopenia, neutropenia, and agranulocytosis). There are black box warnings with all the SGAs for increased risk of mortality when used to treat dementia-related psy-chosis in elderly patients. Iloperi-done, quetiapine, and ziprasidone are associated with the highest risk for QTc prolongation; asenapine, clozapine, olanzapine, paliperidone, and risperidone exhibit this effect to a lesser degree. Aripiprazole and lurasidone have no clinically rele-vant QTc effect. Additionally, black box warnings for aripiprazole,

quetiapine, and lurasidone include increased suicidal thoughts and behaviors in children, adolescents and young adults. Understanding the varying degrees of severity of side effects is critical to selecting appropriate therapies for patients and maximizing adherence.

In addition to oral tablets, several antipsychotic medications are available in other formulations. Rapid-disintegrating tablets and liquid formulations for oral or in-tramuscular administration can be used in emergency situations, or for patients who have difficulty swal-lowing. Rapid-disintegrating formu-lations may be useful in patients suspected of “cheeking” or conceal-ing oral tablets in their mouths to later dispose of them. Long-acting injectable antipsychotic agents may be used in patients with repeated nonadherence to pharmacological treatment.

A summary of various dosing formulations and approved dosing ranges for each of the 10 SGAs is listed in Table 1. The next sections of this lesson will very broadly discuss the role of atypical antipsy-chotics in the treatment of schizo-phrenia and bipolar disorder. Indi-vidual product information leaflets and up-to-date treatment recom-mendations should be referred to for more comprehensive guidance.

Atypical Antipsychotic Use in Schizophrenia Schizophrenia is a complex disor-der characterized by delusions, hal-lucinations, inappropriate affect, and impaired psychosocial func-tioning. According to the Centers for Disease Control and Prevention (CDC), worldwide prevalence of schizophrenia ranges from 0.5 to 1 percent. This disorder affects men and women at equal rates; howev-er, the first episode usually occurs earlier in men (early twenties) than women (late twenties). Suicide is common in schizophrenic persons; approximately one third of patients with this disorder will attempt suicide, and one in 10 will succeed in taking their own lives.

Symptoms of schizophrenia are divided into three broad catego-ries: positive, negative, and cogni-tive. Positive symptoms consist of hallucinations, delusions, thought disorders (disorganized thinking), and movement disorders. Negative symptoms refer to disruptions of normal emotions and behaviors, and include flat affect and lack of pleasure in everyday life. Examples of cognitive symptoms include poor executive functioning and trouble focusing or paying attention.

Antipsychotics are first-line treatment for schizophrenia. The selection and use of antipsychotics

Table 1SGA adult dosing* and formulations for schizophrenia

and bipolar disorder

SGA Schizophrenia Bipolar Disorder Formulations Dosing** (Max) Dosing (Max) Aripiprazole 10-15 mg/day (30 mg/day) 15 mg/day (30 mg/day) tablet, ODT, oral solution, IM§ Asenapine 5-10 mg BID (20 mg/day) 5-10 mg BID (20 mg/day) SL tablet (regular and cherry)Clozapine 300-400 mg/day (900 mg/day) N/A tabletIloperidone 6-12 mg BID (24 mg/day) N/A tabletLurasidone 40-160 mg/day (160 mg/day) 20-120 mg/day (120 mg/day) tabletOlanzapine 5-10 mg/day (10 mg/day) 10-15 mg/day tablet, ODT, IM§

Paliperidone 3-12 mg/day (12 mg/day) N/A ER (extended release) tabletPaliperidone 117-234 mg/month N/A ER-IMQuetiapine 150-750 mg/day (750 mg/day) 400-800 mg/day (800 mg/day) tabletQuetiapine XR 400-800 mg/day (800 mg/day) 400-800 mg/day (800 mg/day) ER (extended release) tabletRisperidone 4-16 mg/day 1-6 mg/day tablet, ODT, oral solutionRisperidone 12.5-50 mg/2 weeks (50 mg) 12.5-50 mg/2 weeks (50 mg) IM (long-acting injection)Ziprasidone 20-100 mg BID (200 mg/day) 40-80 mg BID capsule, IM§

*From patient package inserts; **Acute phase dosing; §Indicated for agitation associated with schizophrenia and bipolar disorderODT: oral disintegrating tablet; IM: intramuscular; SL: sublingual tablet; ER-IM: extended-release intramuscular


must be individualized based on the patient’s past medication his-tory, current symptoms and con-comitant conditions. Additionally, recognizing the different phases of illness (acute, stabilization, and stable), guides treatment selec-tion and drug dosing. Systematic reviews and meta-analyses have not strongly concluded that any of the antipsychotics are more ef-fective than any other for acute schizophrenia, with the exception of clozapine. Therefore, the side ef-fect and tolerability profile and cost effectiveness are utilized to make therapy selection. The Schizophre-nia Patient Outcomes Research Team (PORT) recommended treat-ing initial, acute episodes with antipsychotics other than clozapine or olanzapine, because both are associated with greater weight gain, insulin resistance, and dys-lipidemia compared to the others. Additionally, Schizophrenia PORT recommended that first-episode patients receive antipsychotic doses in the lower half of the recommend-ed dose range.

The American Psychiatric Association recommends that second generation agents, with the exception of clozapine, should be considered for initial therapy in pa-tients in the acute phase of schizo-phrenia. However, the guideline notes that, in some instances, first generation agents may be an ap-propriate first-line option. Debate over the relative advantages and disadvantages of first and second generation agents continues. As older second generation drugs come off patent and newer drugs (e.g., asenapine, iloperidone, lurasidone, and paliperidone) are marketed, cost effectiveness should be consid-ered.

A patient experiencing partial or no response to the first SGA should be trialed on a different sec-ond generation or a first generation antipsychotic. Patients not ade-quately responding after trials with at least two different SGAs may be initiated on clozapine monothera-py. Clozapine is generally reserved for refractory cases, although it

can be considered sooner if the patient has a history of suicidality, violence, or co-morbid substance abuse. Treatment-resistant schizo-phrenics have been shown to have greater rates of improvement with the use of clozapine compared to many other antipsychotic options. However, clozapine use is reserved due to its black box warnings (i.e., agranulocytosis, orthostatic hypo-tension, seizure, myocarditis and cardiomyopathy, and increased mortality in elderly patients with dementia-related psychosis). The most common potentially fatal adverse effect of clozapine is agranulocytosis. This occurs in approximately one percent of all patients using the drug. Because of this risk, clozapine is only avail-able through a REMS (Risk and Evaluation Mitigation Strategies) program, in which prescribers, patients and pharmacies must be enrolled. FDA requires baseline monitoring of white blood cell count and absolute neutrophil count, as well as monitoring throughout treatment. If the patient is still refractory after clozapine mono-therapy, other medications and adjuncts, such as electroconvulsive therapy (ECT), can be tried based on the physician’s experience.

Once the patient has entered the stable or maintenance phase, antipsychotic medication should be continued at the dose that was effective during the acute phase. This has shown to reduce the rate of relapse at one year. It is un-known what the ideal duration of maintenance therapy should be for stable patients, but some experts recommend treatment indefinitely. Patients with schizophrenia may also require treatment for comor-bid conditions, such as agitation, depression, anxiety, and substance abuse.

Antipsychotic Use in Bipolar Disorder Bipolar disorder, also known as manic depressive illness, is a mood disorder that is thought to be genetic, causing unusual shifts in mood, energy, activity levels, and

the inability to carry out day-to-day activities. The disease consists of episodes of mania or hypomania, as well as mixed episodes of concur-rent major depression and mania or hypomania.

A manic episode is defined as a period of at least one week (or any duration if hospitalization is necessary) of abnormality and persistently elevated, expansive, or irritable mood with functional im-pairment. Manic symptoms include grandiosity, fast speech, racing thoughts, and distractibility. Hypo-mania is a less severe form of ma-nia that does not involve functional impairment. Some patients with severe episodes of mania or depres-sion have psychotic symptoms such as hallucinations or delusions.

Among the multiple subtypes of this disease are bipolar I and bipolar II disorder, distinguishable by specific mood episodes. Bipolar I disorder is characterized by a manic episode with or without a major depressed or mixed episode (major depression concurrent with mania). The lifetime prevalence of bipolar I disorder is 0.4 to 1.6 percent, and occurs equally in men and women. Bipolar II disorder is characterized by at least one major depressive episode accompanied by at least one hypomanic episode, and occurs more frequently in women. The average age of the first manic episode is 21 years for both men and women.

Pharmacological therapy is essential for the stabilization and prevention of relapse for each of these types of bipolar disorder. Treatment of bipolar disorder is individualized based on type of bi-polar disorder, associated features, and severity and frequency of episodes. For patients with severe manic and mixed episodes, the mainstay of treatment consists of lithium or valproate plus an anti-psychotic. This regimen is endorsed by multiple treatment guidelines. Numerous meta-analyses indicate that the combination of antipsy-chotics and lithium or valproate leads to an increase in rate of re-sponse (measured using mania rat-


ing scale) in a significantly shorter time period.

The SGAs most studied in bipolar disorder include aripipra-zole, olanzapine, quetiapine, and risperidone. Patients who do not respond to one medication com-bination should be treated with a second combination. Similar to schizophrenia treatment, the choice of antipsychotic is based on past medication use outcomes, patient preference, side effect pro-file, comorbid conditions, and cost as head-to-head trials comparing antipsychotics in combination with lithium or valproate are lacking.

In patients with hypomania and mild to moderate manic and mixed episodes, monotherapy with SGAs (e.g., risperidone, olanzapine, aripiprazole, quetiapine, or zipra-sidone) is a reasonable option. In addition, a large meta-analysis of 68 randomized trials attempted to rank these agents by efficacy and by frequency of treatment discon-tinuation for any reason, including adverse effects or lack of efficacy. These rankings indicated that both risperidone and olanzapine were likely the most effective agents with the lowest dropout rate.

The pharmacological treatment of bipolar depression mostly con-sists of combinations of at least two drugs, including a mood stabilizer, atypical antipsychotic, and antide-pressant. Among atypical antipsy-chotics, quetiapine is recommended by most guidelines as first choice. Benzodiazepines may also be used for adjunct treatment of insomnia, agitation, or anxiety. Long term maintenance therapy is also re-quired for bipolar disorder.

Atypical Antipsychotic Metabolic Effects SGAs can induce metabolic abnor-malities that are associated with an increased risk of type 2 diabetes mellitus, metabolic syndrome, and cardiovascular disease. These met-abolic changes include weight gain, hyperglycemia, and dyslipidemia. It is believed that individuals with schizophrenia and affective disor-ders have approximately a 1.5 to 2

percent times higher prevalence of both obesity and diabetes compared to the general population. Patients with a first episode of schizophre-nia who have not previously taken an antipsychotic agent appear to be the most vulnerable to these side effects. Characteristics of schizo-phrenic lifestyle, including seden-tary behavior, may contribute. Be-cause other major risk factors for diabetes were not controlled in past studies, it remains unclear whether the psychiatric condition, indepen-dent of other risk factors, accounts for the increased prevalence. Evidence suggests that personal, familial, or genetic factors also in-fluence how much weight is gained. When coupled with high rates of smoking and physical inactivity in this population, the relative risk of CVD mortality is significantly greater in this population.

Weight Gain. Excessive weight gain during antipsychotic drug treatment was identified as early as 1958, and was mainly associated with low potency phe-nothiazines. However, this side effect was somewhat ignored dur-ing the 1970s and 1980s as it was found to be minimal in the more potent FGAs. Since the introduc-tion of atypical antipsychotics in the 1990s, however, the concern has been renewed. Weight gain has been estimated to affect between 15 to 72 percent of patients with schizophrenia.

The exact mechanism of this

process is controversial and not well understood. Yet, evidence sug-gests that the antipsychotics with the highest tendency to induce sig-nificant weight gain are also potent appetite stimulants. This may be due to the drugs’ interactions with peptides, steroid hormones, amino acids, and neurotransmitters. Atypical antipsychotic-induced weight gain may also arise from excessive fat deposition, coupled with reduced energy expenditure. Another assessment is that drug-induced weight gain may be a result of gene polymorphism.

Evidence suggests that treat-ment with SGAs in patients with schizophrenia can cause rapid weight gain in the first few months of therapy, that may or may not stabilize within a year. Vari-ability in weight gain among the agents is summarized in Table 2. A meta-analysis of multiple stud-ies on antipsychotics found that clozapine was associated with the greatest weight gain after 10 weeks of treatment, compared to ziprasi-done which was linked to the least weight gain. Other studies have made this same conclusion, show-ing that clozapine and olanzap-ine are associated with the most weight gain, and ziprasidone and aripiprazole with the least. Initial data indicate that lurasidone, a newer agent that will be discussed in more detail, is also benign in regards to weight gain. No antipsy-chotic agent is entirely body weight

Table 2Metabolic risks associated with atypical antipsychotics

Drug Weight Gain Diabetes Lipid Profile Aripiprazole – low low Asenapine + low* low*Clozapine +++ high highIloperidone ++ mild* mild*Lurasidone – low* low*Olanzapine +++ high high Paliperidone ++ mild mildQuetiapine ++ moderate moderate Risperidone ++ mild mildZiprasidone – low low

*Limited data Adapted from CNS Drugs. 2012; 26 (9) and Diabetes Care. 2004; 27 (2)


neutral, as the proportion of indi-viduals who experience clinically relevant weight gain, traditionally defined as >7 percent of pretreat-ment weight, is greater with any agent versus placebo.

Diabetes. Extensive report-ing has documented the onset or exacerbation of diabetes following the initiation of SGAs. Large retro-spective cohort studies have been conducted to report the estimated prevalence of diabetes in patients using SGAs. While these studies have limitations, undeviating data indicate that the risk is highest in patients treated with clozapine or olanzapine, compared with those on other antipsychotics. Quetiapine has a moderate risk of hypergly-cemia, followed by risperidone. It appears that aripiprazole and ziprasidone do not show an effect. The mechanism of this side effect is thought to be drug-induced insulin resistance, due to weight gain or a direct effect on insulin-sensitive tissues.

Dyslipidemia. Dyslipidemia is also a related consequence of SGA use. Recent evidence sug-gests that dyslipidemia is not only a consequence of weight gain, but may occur as a separate and direct adverse effect of SGA treatment. Clozapine and olanzapine are asso-ciated with the greatest risk of dys-lipidemias, followed by quetiapine then risperidone. The dyslipidemic adverse effects of clozapine, olan-zapine, and quetiapine manifest as abnormal elevations in serum triglyceride levels, total cholesterol, and low-density lipoprotein (LDL) cholesterol, and as a decrease in high-density lipoprotein (HDL) cholesterol. Aripiprazole and zipra-sidone present a low risk.

De Hert et al. completed a systematic review to determine the weight gain and metabolic adverse effects associated with asenapine, iloperidone, lurasidone, and pali-peridone. The researchers conclud-ed that preliminary data suggest that lurasidone is associated with the lowest weight gain potential. The reviewers stated that insuf-ficient evidence is available to draw

firm conclusions about the meta-bolic effects of the newly approved SGAs. Table 2 summarizes the metabolic adverse events associ-ated with each SGA, including the newest agents, utilizing limited available data.

Management of Metabolic Adverse Effects with SGAs In 2003, the American Diabetes Association, the American Psychi-atric Association, the American Association of Clinical Endocri-nologists, and the North American Association for the Study of Obe-sity held a consensus development conference on the subject of anti-psychotic drugs and obesity. At the time, the panel developed baseline and follow-up monitoring recom-mendations for patients in whom SGAs are prescribed. Baseline monitoring includes personal and family history of obesity, diabetes, dyslipidemia, hypertension, or cardiovascular disease; weight and height (to calculate BMI); waist cir-cumference; blood pressure; fasting plasma glucose; and fasting lipid profile (Table 3). Nutritional coun-seling, as well as cognitive behav-ioral counseling, have been found to be effective in reducing antipsy-chotic induced weight gain. Health care providers, as well as patients,

family members and caregivers, should be aware of the signs and symptoms of diabetes, including diabetic ketoacidosis (DKA), which can be life-threatening.

Follow-up monitoring is also recommended which includes rou-tine reassessment of weight and, initially, quarterly plasma glucose, lipid levels, and blood pressure checks. Many drugs have been studied to counteract the weight gain as well, including metformin, amantadine, and topiramate. Met-formin has shown the most success, although none of these drugs has enough evidence to recommend for broad clinical use.

Recently Approved Atypical AntipsychoticsThree of the most recently ap-proved atypical antipsychotics, iloperidone, asenapine and lur-asidone, have been added to the psychiatric armamentarium. These agents were developed with the hope of maintaining efficacy with improved adverse effect profiles and decreased cardiovascular risk. Collectively, these agents have been subject to fewer clinical stud-ies and less clinical experience.

Iloperidone, marketed as Fanapt, was introduced in 2009 for the treatment of schizophrenia. It

Table 3Monitoring protocol for patients on SGAs*

Baseline 4 8 12 quarterly annually weeks weeks weeks

personal/ X X family history weight (BMI) X X X X X waist X Xcircumference

blood pressure X X X

fasting plasma X X Xglucose

fasting lipid X Xprofile *Consensus Development Conference on Antipsychotic Drugs and Obesity and Diabetes. Diabetes Care, February 2004, vol. 27, no. 2, 596-601.


is dosed at 12 to 24 mg daily, di-vided in two doses without regard to meals. Its pharmacodynamic profile differs from other SGAs in that it has a relatively higher affinity for noradrenergic alpha 1 receptors, compared to affinity for serotonin 5-HT2A and dopa-mine D2 receptors. This variation in receptor affinity explains why iloperidone has been associated with dizziness and orthostatic hy-potension. For this reason, dosing titration is recommended to begin at 1 mg twice daily, and increas-ing daily until the treatment dose is attained. Other receptor bind-ing characteristics which may be important include a lower affinity to muscarinic receptors and hista-mine receptors, potentially leading to fewer anticholinergic side effects such as cognitive dysfunction and gastrointestinal disturbances, as well as less weight gain and sedation, respectively. Proof that these characteristics translate to relevancy in clinical practice is yet to be determined through clinical trials.

Iloperidone is considered low risk for causing extrapyramidal symptoms, and low to intermediate for adverse metabolic effects. The slow titration schedule makes it less ideal for a patient with acute exacerbations of schizophrenia, and may lead to longer hospital stays as a delay in symptom control may occur when compared to other antipsychotic agents. Also, the dose titration has the potential for in-creased medication errors. Compar-ison studies have indicated that its efficacy is similar to ziprasidone, and is not superior to the other atypical antipsychotics. Lastly, it possesses a risk for QTc interval prolongation.

In a clinical review of ilo-peridone conducted by Arif and Mitchell, the authors concluded that iloperidone may be a viable and safe option for the treatment of schizophrenia in patients who cannot tolerate the side effects of other agents. However, iloperidone lacks clear superiority over other antipsychotics.

Asenapine, marketed as Saphris, is indicated for the treat-ment of acute and maintenance phases of schizophrenia in adults. It is also approved as monotherapy or adjunct to lithium or valproate for the treatment of bipolar manic or mixed episodes in adults. It dif-fers from other oral antipsychotics as it is only available as an orally disintegrating tablet administered sublingually for absorption through oral mucosa. Patients should be instructed to place the tablet under the tongue and allow it to dissolve. The patient should not eat or drink for 10 minutes following admin-istration. The tablet should not be swallowed. If it is swallowed, its bioavailability is reduced to <2 percent. Note that this differs from olanzapine, risperidone, and aripiprazole oral disintegrating tablets which must be swallowed to be effective. Asenapine has a higher affinity to serotonin 5-HT2C, 5-HT2A, 5-HT7, 5-HT2B, 5-HT6, and dopamine D2 receptors. It also has a low affinity to muscarinic recep-tors predicting a possible lower risk for anticholinergic side effects. The indication-specific dosing of 5 to 10 mg twice daily may be reached quickly without titration. Because the elimination half-life is 24 hours, a once daily dosing trial was recently conducted. However, study results were not available at the time this lesson was written.

The single most common side effect experienced in trials was somnolence, which is usually transient and highest in the first week of treatment. Other common side effects include weight gain, dizziness, EPS (akathisia, dose-re-lated), and oral hypoesthesia. Oral hypoesthesia (numbness) or oral dysgeusia (distorted, altered, or unpleasant taste) is a unique side effect to asenapine. This SGA has minimal effect on the QTc interval, which is not expected to be clini-cally significant.

Stoner and Pace conducted a review of efficacy and safety profiles based on the findings from clinical trials in schizophrenia and bipolar disorder available through

November 2011. Their review sug-gested that asenapine is efficacious in the conditions for which it is indicated. While the safety profile was acceptable, metabolic and EPS-related adverse events were present.

Lurasidone, marketed as Latuda, was introduced in 2010 with FDA-approved indications for schizophrenia, and for depressive episodes associated with bipolar I disorder, as monotherapy and as adjunctive therapy with lithium or valproate. Indication specific dos-ing recommends a starting dose of 20 to 40 mg daily, with a maximum daily dose of 160 mg. Initial dose titration is not required with lur-asidone. Administration with food greatly increases the absorption of lurasidone; therefore, it is recom-mended to be taken with food (at least 350 calories). Patients should be instructed to read the Medica-tion Guide each time the prescrip-tion is filled.

Administration with strong CYP3A4 inhibitors (e.g., ketocon-azole, clarithromycin, ritonavir, voriconazole) and CYP3A4 in-ducers (e.g., rifampin, St. John’s wort, phenytoin, carbamazepine) is contraindicated. Dosing modi-fications are required in patients with moderate to severe renal and hepatic impairment.

Similar to other SGAs, lurasi-done possesses dopamine D2 and serotonin 5-HT2A antagonism. It also has potent-5HT7 antagonism which may provide cognition im-provement. However, results from longer term trials are needed to de-termine the significance. It has low affinity to muscarinic, histamine H1, and alpha-1-adrenergic recep-tors. Common side effects include somnolence, akathisia, nausea, and parkinsonism. Less commonly reported adverse effects were acute dystonia, agitation, anxiety, and dizziness.

In a review article conducted by Citrome, the author summa-rized advantages of lurasidone as minimal weight gain (and possible best in class) with no clinically meaningful alterations in glucose,


Program 0129-0000-14-005-H01-PRelease date: 5-15-14

Expiration date: 5-15-17CE Hours: 1.5 (0.15 CEU)

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

This lesson is a knowledge-based CE activity and is tar-geted 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.

lipids, prolactin, or QTc interval. Risbood et al. concluded that,

due to pricing and lack of evidence demonstrating a difference in efficacy when compared to other antipsychotics, its place in therapy may be behind available generic antipsychotics.

ConclusionAntipsychotics are primarily indi-cated for the treatment of schizo-phrenia and bipolar disease. Side effect profiles differ across classes and agents, and oftentimes dictate therapy. Pharmacists can help maximize patient outcomes with a thorough understanding of the dif-ferences between agents.

Acknowledgement: Courtney Johnson, ONU PharmD Candidate, for contributions to the lesson.


continuing educat ion quiz Atypical Antipsychotics: Overview, Metabolic Abnormali t ies , and Newer Agents

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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. Antipsychotics are indicated for treatment of all of the following EXCEPT: a. schizophrenia. c. obsessive-complusive disor-der. b. bipolar disporder. d. depression.

2. Which of the following drugs is a first generation antipsychotic (FGA)? a. Ziprasidone c. Paliperidone b. Olanzapine d. Haloperidol 3. Which of the following SGAs has no clinically relevant effect on QTc interval? a. Quetiapine c. Iloperidone b. Aripiprazole d. Asenapine

4. The Schizophrenia PORT recommends treating initial, acute episodes with any of the following EX-CEPT: a. olanzapine. c. lurasidone. b. risperidone. d. quetiapine. 5. At least how many different SGAs should be trialed before clozapine monotherapy may be initiated? a. None c. Three b. Two d. Four

6. Which of the following SGAs has a black box warning for fatal agranulocytosis? a. Quetiapine c. Clozapine b. Olanzapine d. Paliperidone

7. Which of the following atypical antipsychotics is recommended by most guidelines as first choice in treat-ment of bipolar depression? a. Quetiapine c. Risperidone b. Clozapine d. Aripiprazole

8. Which of the following SGAs is likely associated with the least effect on weight gain? a. Paliperidone c. Asenapine b. Iloperidone d. Ziprasidone

9. Which of the following pairs of SGAs is associated with the highest risk of hyperglycemia? a. Olanzapine and quetiapine b. Quetiapine and risperidone c. Risperidone and clozapine d. Clozapine and olanzapine

10. Data indicate that which of the following pairs of SGAs is associated with the lowest risk of dyslipidemias? a. Aripiprazole and ziprasidone b. Olanzapine and quetiapine c. Risperidone and paliperidone

11. Recommendations for baseline evaluation of patients initiated on SGA therapy include all of the following EXCEPT: a. weight and height. c. serum creatinine. b. fasting plasma glucose. d. waist circumference. 12. The product insert for which of the following SGAs recommends a slow daily titration schedule? a. Iloperidone c. Lurasidone b. Asenapine

13. Patients are instructed not to eat or drink for at least 10 minutes following administration of which of the following? a. Iloperidone c. Lurasidone b. Asenapine

14. Oral hypoesthesia or dysgeusia is a unique side ef-fect of which of the following SGAs? a. Iloperidone c. Lurasidone b. Asenapine

15. Food containing at least 350 calories is required with the administration of: a. iloperidone. c. lurasidone. b. asenapine.

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

may 2014

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