Georgia Pharmacy Journal - August 2014 by Georgia Pharmacy Association

August 2014 VOLUME 36, ISSUE 8

Q&A with Linda Wiant, PharmD Director of Pharmacy, Georgia Department of Community Health

Confronting Current Challenges Facing Pharmacy

Plus

â&#x20AC;˘ Medicaid and Georgia DCH SHBP Begin Covering Flu Shots

The Georgia Pharmacy Association proudly sponsors Meadowbrook Insurance Group, Inc. for your workersâ&#x20AC;&#x2122; compensation needs.

August 2014 Editor: R. Scott Brunner, CAE sbrunner@gpha.org

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 ARTWORK Those 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 sbrunner@gpha.org. SUBSCRIPTIONS AND CHANGE OF ADDRESS The 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. ADVERTISING Advertising copy deadline and rates are available upon request. All advertising and production orders should be sent to the GPhA headquarters at sbrunner@gpha.org.

GPhA Headquarters 50 Lenox Pointe, NE Atlanta, Georgia 30324 t 404-231-5074 f 404-237-8435

Contents

2 Message from Scott Brunner ........................ 2 Upcoming GPhA Events ................................ 4 Member News ................................................... 5 New Members ................................................... 7 Message from Bobby Moody ........................

Q&A with Linda Wiant, PharmD Director of Pharmacy Georgia Department of Community Health

Confronting Current Challenges Facing Pharmacy ...................................................... Flu Shots Now Covered By Medicaid .............................................................

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

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From the GPhA President

his summer has flown by. Since the GPhA convention, your Executive 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 Bobby Moody the coming year and planned the fall President 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 effective 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 identify and equip new future GPhA leaders; • Looking at our internal operations and outreach initiatives 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 coliseumpharmacy@gmail.com, or you can reach Scott at sbrunner@gpha.org. 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 recipients. 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 healthcare services, I believe that we will be given more opportunities like this. n

Bobby

From the GPhA EVP

hen a person joins an association, 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 Scott Brunner, CAE my money’s worth in return. It’s why EVP 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 organization 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

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Upcoming GPhA Events September 2014

TBD .......................GPhA Committee Meetings

October 2014

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

November 2014

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

January 2015

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

February 2015

February 4 ............Georgia Pharmacy Coalition Dinner February 5 ............VIP Day

March 2015

Mark Your

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

April 2015

TBD .......................Spring Region Meetings

May 2015

TBD .......................Spring Region Meetings

July 2015

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

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

M E M B E R

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Buddy Carter Wins US Congressional District 1 Republican Runoff

n a major victory for the pharmacy 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 tonight,” Carter stated. Carter is owner of Carter’s Pharmacy with locations in Pooler, Rincon, and Garden City and a graduate of the University of Georgia School of Pharmacy. A long-time GPhA member and supporter 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

ardinal 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-

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Buddy Carter, a long time member and supporter of GPhA legislative initiatives, celebrates his victory in the US Congressional District 1 runoff. Carter now faces Democrat Brian Reese in the November 4 election. 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 Cardinal Health employees were encouraged to submit nominations for this award, and all nominees were judged on a variety of criteria, including: • Community leadership and involvement • 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

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M E M B E R

Bowles Awarded 2014 Bowl of Hygeia

he GPhA has selected Robert C. Bowles, Jr., as the recipient of the 2014 Bowl of Hygeia Award for outstanding community service. The Award was presented at the GPhA Convention President’s Reception and Banquet on June 28. The award is sponsored by the American Robert C. Bowles Pharmacists Association Foundation and the National Alliance of State Pharmacy Associations with support from Boehringer Ingelheim. In a statement Bowles thanked his family, friends, and community. “The opportunities that the wonderful people of Upson and surrounding counties afforded me during my 38 years of practicing pharmacy in Thomaston are the reason that I could have even been considered for this award,” he said. The Bowl of Hygeia is the most widely 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

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-

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Got a Legislative Issue for Us?

s you may have already heard, GPhA is changing our process by which we create our 2015 legislative agenda. Despite the changes to the process, your input is still an important part of the process and we want to hear from you. If you have an issue that you believe should be considered by the Governmental Affairs Committee for possible inclusion on our legislative priorities for the 2015 session of the Georgia General Assembly, please email them to Andy Freeman at afreeman@gpha.org by August 27, 2014 along with any research or supporting documents that you may have. n versity of Georgia College of Pharmacy, about his teaching philosophy. “I get students to explain difficult topics 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 students 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 laboratory 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 environments. The award was presented in April. n

Bridge Named for Bobby Parham

n 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 Department 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 previously honored by GPhA as the only recipient of a lifetime membership award. GPhA’s outstanding legislator award is also being changed to the “Bobby Parham Outstanding Legislator Award” to honor this Georgia pharmacy legend. n GPhA Government Affairs Committee Chair Mike McGee and Director of Government Affairs Andy Freeman present Bobby Parham with a plaque commemorating the naming of the “Bobby Parham Legislative Award”

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M E M B E R

Brunner Joins GPhA as Executive Vice President

trategic 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 outward-looking, and be nimble. These qualities define a successful association”, said Scott Brunner in remarks at the opening session of the GPhA Convention in June. Brunner began work as GPhA’s new Executive Vice President on July 14. He brings 25 years of experience in association 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 Association of Realtors in Richmond. Among Scott’s accomplishments is the creation of a leadership development initiative that became a national model for equipping volunteer association leaders. He also conceived and guided a number of sucScott Brunner, CAE cessful political advocacy and member outreach initiatives, and grew the political action committees 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 degree in political science from Auburn University in Montgomery. He also holds the prestigious Certified Association Executive (CAE) designation. n He can be reached at sbrunner@gpha.org

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WELCOME

New Members Active Pharmacists Matthew Clifton - Moultrie, GA Chinwe Mbonu - Atlanta, GA Ayn Piquant - Riverdale, GA Cimone Forbes - Dacula, GA Students Rachel Schnorr - UGA The Georgia Pharmacy Association is the collective voice of the pharmacy profession, aggressively advocating for the profession in the shaping of public 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.

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

L I N D A

W I A N T

Q&A with Linda Wiant, PharmD

Director of Pharmacy, Georgia Department of Community Health

IN BRIEF: Name: Linda Wiant Title: DCH Director of Pharmacy Years with DCH: 3 as of August 1, 2014 Previous 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, Texas Pharmacy Degree: Mercer University, PharmD., Residency at University Medical Center, Jacksonville FL, (now Shands Jacksonville) Interests/Hobbies: Cooking, reading, gardening, hiking, and kayaking Interesting Fact: My dad graduated from pharmacy school exactly 40 years before me. And from the same school.

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L I N D A

W I A N T

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 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?

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.

The mission of the DCH is to provide Georgians with access to affordable, quality health care through effective 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 running 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.

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

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

It was a natural fit when the position opened up. I had extensive experience in the PBM industry and understood claims processing and preferred drug lists and auditing and I also had an understanding of Medicaid pharmacy programs from previous positions. 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

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Q: A:

The practice of pharmacy in Georgia is changing very quickly. I see the challenge of specialty pharmaceuticals 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 expensive, 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 impact to state budgets, and • Insuring that these expensive therapies, which can cost thousands of dollars a year, are benefiting patients. I think the biggest challenge for both your providers and DCH is figuring out how to make sure these medications 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 opportunities and funds. And of course escalating 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,

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 provider 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 Health Pharmacy Services 2 Peachtree Street, N.W. 37th Floor Atlanta, Georgia 30303

L I N D A

especially at the Federal level, that impact 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 association 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 receive from GPhA in helping to “spread the word” to their membership about important new initiatives or changes.

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?

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

W I A N T

CMOs have accepted claims for immunizations for some time now. We are hopeful that this will increase our immunization rates for adults in the state of Georgia, saving lives and reducing medical expenses not only for our members, but for the community as well.

Q: A:

So how it will it work?

For Medicaid Fee-for-Service claims, pharmacists will use an 837P transaction to transmit a professional claim for the vaccine and an administration 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: A:

Is there any special training pharmacists will need to participate? DCH does not require any special training. Pharmacists are expected to follow any applicable laws and regulations around training, protocols, and record-keeping.

How will DCH be communicating this news to the pharmacy community?

DCH has had several discussions with various pharmacy associations to notify them of the change. We also posted banner messages on our website and provided the banner message to not only the associations for distribution to their membership but also to our PBM, Catamaran, who sent out an e-blast to their distribution list. The information will also be published in our October edition of the pharmacy provider manual.

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

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 vaccine claims.

Q: A:

How do you see this decision impacting healthcare in Georgia? What we hope for is an improvement in healthcare outcomes and an increase in immunization rates for our Georgia members. And that increase in immunization rates in our adult population will hopefully increase community immunity as well.

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

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. 10

Most of our other projects are more operational in nature, certainly nothing as exciting as the flu vaccine program. We are exploring some changes 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 transparent, and perhaps even invisible, to providers as we would hope to decrease the need for providers to actually call to

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receive an authorization. That’s one example 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 mandated 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 difficult 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.

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

W I A N T

Actually, pharmacy was my plan B! I have a B.S. in Marketing with a minor in Humanities as my undergraduate experience. After several years of working in direct mail and other marketing 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 definitely influenced my choices. n

The Georgia Department of Community 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 overseeing 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 collection of rubber duckies.

I N D U S T R Y

Initial License Applications Now Available Online

he Georgia Board of Pharmacy has begun offering a new online service: the ability to submit an initial application for licensure for pharmacists, pharmacy interns, and pharmacy technicians. Applicants for pharmacist licensure, pharmacy intern licensure, and pharmacy technician registration can submit their applications online: gadch. mylicense.com/eGov/. To determine their eligibility for licensure or registration, persons interested in applying should consult the laws, rules, and regulations of the Board, which are available under the “Laws, Policies, and Rules” section of the Board website. n

Neighborhood Pharmacies: An Untapped Resource

ommunity pharmacists can dramatically help their patients stick to their prescription regimens, according to a new study led by researchers at the University of Pittsburgh School of Pharmacy. 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 patients get their prescriptions filled at neighborhood drug stores, but pharmacists can do more for patients than just prepare medications, said lead investigator 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 community accessibility perhaps makes them the ideal health professionals to help people learn how and why to take their

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

hat 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 information 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 programming 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 certifications include Certified Software Lifecycle Professionals (CSSLP), and GIAC-Certified Web Application Defender (GWEB). 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, diabetes 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. Improving medication adherence rates improves quality, public health and saves money, and this study demonstrates the value pharmacists can add. n

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I N D U S T R Y

WHO Projects Ebola Vaccine Will Be Ready for 2015

everal treatments for hemorrhagic fever are in different stages of development. As mobilization efforts for the development of an Ebola treatment continue 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

Make Contact Now On “Any Willing Pharmacy”

he National Community Pharmacists Association is calling on its members and state partners to contact their individual members 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 Griffith (R-Va.) and Peter Welch (DVt.). 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

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Ebola treatment and set to begin for another, 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 confirmed and suspected cases. “We have evaluated this vaccine candidate in preclinical studies and we are now discussing with regulators advancing 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 difficult to accelerate this process because of the many important steps that a candidate 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 protective antibodies to fight the virus,” the NIH said in a press release. “This testing could begin as early as January. Optimistically, the vaccine could be available about a year after that for people at highest 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 American relief workers Dr. Kent Brantly and Nancy Writebol. n

NCPA Expresses Support for Legislation

he National Community Pharmacists Association (NCPA) expressed its support of a bill intended to help reduce prescription drug abuse in a July 28, 2014 letter to the US House of Representatives. The bill, dubbed the Ensuring Patient Access and Effective Drug Enforcement Act of 2014, aims to improve enforcement efforts for prescription drug diversion and abuse. According to B. Douglas Hoey, RPh, MBA, chief executive officer of the NCPA, the bill balances improved enforcement efforts with patient access through a collaborative discussion between key players. Those players include drug manufacturers, wholesalers, community pharmacies, and federal enforcement and oversight agencies. A provision within the bill would allow pharmacists to submit a corrective action plan prior to the Drug Enforcement Agency revoking or suspending a license. n

Representing pharmacists and pharmacies before the Georgia Pharmacy Board, GDNA and DEA. AREAS OF PRACTICE Professional Licensing Medicare and Medicaid Fraud and Reimbursement Criminal Defense

Administrative Law Healthcare Law Legal Advice for Licensed Professionals

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I N D U S T R Y

Pharmacists & Healthcare Reform: APhA Video Series

o help pharmacists better understand 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 Protection and Affordable Care Act of 2010. Part 1: Healthcare Reform 101 • A summary of the law itself. • Discussion of Congress’ goals in passing 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-andopportunities-short-videos. n

How to Engage Tobacco Users

s part of the Georgia Ask, Advise and Refer with Follow-up Program webinar series, the DPH invites you and members of your healthcare team to

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Georgia DCH SHBP Begins Covering Flu Shots

eginning August 15 the Georgia Department of Community Health State Health Benefit Plan (SHBP) will begin covering flu vaccines for members at in-network retail pharmacies. Please email Terracer Earnest, R.Ph at Express Scripts with any questions, thearnest@express-scripts.com. If you need assistance processing a claim contact the Express Scripts pharmacy help desk at 800-8240898 or 800-922-1557. n participate in modules from the brand new “Engaging Tobacco Users: Tips for Healthcare Providers and Public Health Professionals in Georgia” on-line interactive training. This online training features 4 modules designed to further support healthcare providers, clinical support professionals (including registered 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

Prediabetes Overview Is Now Available With CE

“I

ntervention in the Early Stages: An Overview of Prediabetes” is now available with CE offering to Georgia healthcare and public health professionals statewide. Please feel free to share this Georgia Prediabetes webinar series update with colleagues, partners, clinical support team members as well as medical, nursing and pharmacy students. To access this archived webinar and

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” webpage on the DPH (Department of Public Health) website at dph.georgia.gov/. n

Call for APhA Award Nominations

he APhA Awards and Honors Program is the profession’s most comprehensive recognition program. Help us identify the students, practitioners, scientists, and organizations most deserving of recognition at the 2015 APhA Annual Meeting & Exposition in San Diego, California. Visit pharmacist.com/awards for information. Deadline: Sept. 1. n

NCPA Responds to PCMA’s Medication Synchronization Opposition

he National Community Pharmacists 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 disseminated extremely misguided information regarding medication synchronization legislation. PCMA claimed that such legislation is a “mandate” that would “create 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

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I N D U S T R Y

to have the pharmacy coordinate all of their chronic or maintenance medications 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

Vitamins and Supplements: What Do Patients Really Need?

atients 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 rewarding work conducted in OTC aisles by looking at each patient’s total phar-

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macotherapy regimen including prescription 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 questions: • 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 alcohol 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 pharmacotherapy rationally and safely. n

Discussion Continues on Consumer Drug Leaflets

he FDA has made some progress toward improving consumer information leaflets for prescription drugs. The leaflets, also known as patient medication information (PMI), are generally created from content developed by ASHP and other providers of drug information. Pharmacies select the specific content to include in PMI documents and the format in which the printed documents appear. Bryon Pearsall, director of FDA’s Division of Medical Policy Programs, said the agency’s “current thinking” about PMI is that it should consist of one-page documents produced by drug manufacturers and “based on content, format, and testing standards established in regulation and healthcare providers will have open online access. n

F I N A N C I A L

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Education For Your Kids & Grandkids: Five Common 529 Questions P

lanning 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 colleges 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, families with children are anticipating increased 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 (including tuition, books, housing, etc.) and subtracting the Expected Family Contribution (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 below)

Grandparent-owned 529 plans?

Grandparents who are well positioned to help fund college education for their

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 grandchildren can receive an additional 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 qualified higher education institution. Withdrawals 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 overfunded, or if the child does not attend college. 529 plans allow for flexibility in ben-

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

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 contributions, the availability of 529 plan accounts 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 attends college. However, there is no age at which plan withdrawals are not permitted and there are many post-higher education and vocational institutions that are accredited for 529 plan funding. For example, whether or not the beneficiary goes to a traditional four-year

Students 50% of AGI over $6,1303 20% of assests held in student’s name - UTMA/UGMA accounts - Minor Trusts - Savings Bonds

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.

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F I N A N C I A L college, he/she may also decide to attend culinary school, or take advanced language courses. Any college, university, or post-secondary institution that is eligible 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 programs have lifetime contribution limits above $300,000 per beneficiary. Contributions to a 529 plan, however, are treated as gifts from the donor to the beneficiary. 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 couple), front-loading the annual exclusion for the following five years. This allows

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

Which expenses are qualified distributions from a 529 plan?

One of the major benefits of using a 529 plan is the tax-free treatment of distributions when used for qualified higher 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 institution. For part-time students, qualification of certain expenses may depend on other factors such as whether the student is enrolled half-time or more, and the allowable amount set by the school’s budget. Qualified higher education expenses do not include insurance, sports and club activity fees, transportation costs, student loan repayments, and any technology or room and board costs exceeding the “cost of attendance” financial aid figure. Also, expenses for private school

at the pre-college level are never qualified. In 2013, the IRS expanded the definition of qualified expenses to include the cost of computer technology and related equipment. Computers and related services used for educational purposes can now be purchased with tax-free distributions from 529 plans. The expansion of qualified distributions from 529 plans to include technology expenses is an additional benefit to using a 529 plan as a savings vehicle for higher education. n At UBS, we work to provide our family clients with the latest thinking 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: 404-760-3000 or visit www.ubs.com/ team/wile.

Inspiring confidence GPhA/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. Wile Consulting Group UBS Financial Services Inc. 3455 Peachtree Road NE, Suite 1700 Atlanta, GA 30326 ubs.com/team/wile

Harris Gignilliat, CIMA®, CRPS® First Vice President–Wealth Management Senior Retirement Plan Consultant 404-760-3301 harris.gignilliat@ubs.com

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

Highlight denotes new and increased contributors.

Thanks to All Our 2014 Investors 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 pledge Fred 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. 18

*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. 6/15 J. 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 pledge James 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.T Michael 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. 11/14 Lance 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. The Georgia Pharmacy Journal

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“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 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. 6/15 Richard 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 pledge Anonymous 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 The Georgia Pharmacy Journal

*Rabun Dekle, R. Ph. John Drew, R.Ph. 6/15 Becky 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.Ph Don 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. 6/15 James Stowe, R.Ph. 12/14 *Dana Strickland, R.Ph. G.H. Thurmond, R.Ph. 11/14 *Tommy Tolbert, R. Ph.

Members

No minimum pledge Claude Bates, R.Ph. 6/15 Stuart Bradley, Pharm.D. 6/15 Winston Brock, R.Ph. 6/14

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

NOTICE: Contact Andy Freeman, GPhA Director of Government Affairs, to update your support or if any information is incorrect. afreeman@gpha.org 404-419-8118

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Eddie Madden, Chairman Dean Stone, Region 1 Keith Dupree, Region 2 Judson Mullican, Region 3 Bill McLeer, Region 4 Mahlon Davidson, Region 5 Mike McGee, Region 6 Jim McWilliams, Region 7 T.M. Bridges, Region 8 Mark Parris, Region 9 Chris Thurmond, Region 10 Stewart Flanagin, Region 11 Henry Josey, Region 12 Bobby Moody, Ex-Officio R. Scott Brunner, Ex-Officio

continuing education for pharmacists Volume XXXII, No. 5

Atypical Antipsychotics: Overview, Metabolic Abnormalities, and Newer Agents Mona T. Thompson, R.Ph., PharmD 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 regarding efficacy, tolerability, and adverse events of the most recently approved agents which are iloperidone (Fanapt速), asenapine (Saphris速), and lurasidone (Latuda速).

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 antipsychotics; 2. demonstrate an understanding of the role that second generation antipsychotics (SGAs), also known as atypical antipsychotics, play in the treatment of schizophrenia and bipolar disorder; 3. demonstrate an understanding of the SGA-induced metabolic abnormalities and their management; 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, antipsychotic agents are increasingly being 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 posttraumatic stress disorder. Antipsychotics are divided into two groups: first generation antipsychotics (FGAs) or typical antipsychotics; and second generation antipsychotics (SGAs), commonly referred to as atypical antipsychotics. The first generation antipsychotics were developed in the 1950s and include agents such as haloperidol, chlorpromazine, fluphenazine, thioridazine, thiothixene, and pimozide. These agents are effective in treating the positive symptoms of psychosis 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 effective doses, including dystonic reactions (sustained muscle contractions), drug-induced parkinsonism (characterized by tremors, postural instability, and rigidity), akathisia (inability to remain motionless),

and tardive dyskinesia (involuntary, 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), quetiapine (1997), ziprasidone (2001), aripiprazole (2002), paliperidone (2006), asenapine (2009), iloperidone (2009), and finally lurasidone (2010). While the pharmacologic properties, therapeutic effects, and adverse events vary between FGAs and SGAs, the most accepted distinction is that the newer, second generation antipsychotics tend to have a decreased risk of extrapyramidal 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 histaminergic receptors. The degree and selectivity of receptor inhibition varies between antipsychotic classes and agents which results in the differing side effect profiles that are observed. SGAs differ from

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Table 1 SGA adult dosing* and formulations for schizophrenia and bipolar disorder SGA Aripiprazole Asenapine Clozapine Iloperidone Lurasidone Olanzapine Paliperidone Paliperidone Quetiapine Quetiapine XR Risperidone Risperidone Ziprasidone

Schizophrenia Dosing** (Max) 10-15 mg/day (30 mg/day) 5-10 mg BID (20 mg/day) 300-400 mg/day (900 mg/day) 6-12 mg BID (24 mg/day) 40-160 mg/day (160 mg/day) 5-10 mg/day (10 mg/day) 3-12 mg/day (12 mg/day) 117-234 mg/month 150-750 mg/day (750 mg/day) 400-800 mg/day (800 mg/day) 4-16 mg/day 12.5-50 mg/2 weeks (50 mg) 20-100 mg BID (200 mg/day)

Bipolar Disorder Dosing (Max) 15 mg/day (30 mg/day) 5-10 mg BID (20 mg/day) N/A N/A 20-120 mg/day (120 mg/day) 10-15 mg/day N/A N/A 400-800 mg/day (800 mg/day) 400-800 mg/day (800 mg/day) 1-6 mg/day 12.5-50 mg/2 weeks (50 mg) 40-80 mg BID

Formulations tablet, ODT, oral solution, IM§ SL tablet (regular and cherry) tablet tablet tablet tablet, ODT, IM§ ER (extended release) tablet ER-IM tablet ER (extended release) tablet tablet, ODT, oral solution IM (long-acting injection) capsule, IM§

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

the first generation agents, as the serotonin 5-HT2 receptor binding can exceed their affinity for dopamine D2 receptors. This inhibition of 5-HT2 may be one justification for the lower risk of EPS. In general, SGAs are better tolerated 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 cardiovascular disease (CVD). Other noteworthy side effects, warnings, and precautions associated with SGAs include hyperprolactinemia, neuroleptic malignant syndrome, blood dyscrasias (leukopenia, neutropenia, and agranulocytosis). There are black box warnings with all the SGAs for increased risk of mortality when used to treat dementia-related psychosis in elderly patients. Iloperidone, 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 relevant QTc effect. Additionally, black box warnings for aripiprazole,

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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 intramuscular administration can be used in emergency situations, or for patients who have difficulty swallowing. Rapid-disintegrating formulations may be useful in patients suspected of “cheeking” or concealing 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 antipsychotics in the treatment of schizophrenia and bipolar disorder. Individual product information leaflets and up-to-date treatment recommendations should be referred to for more comprehensive guidance.

Atypical Antipsychotic Use in Schizophrenia

Schizophrenia is a complex disorder characterized by delusions, hallucinations, inappropriate affect, and impaired psychosocial functioning. 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; however, 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 categories: positive, negative, and cognitive. 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

must be individualized based on the patientâ&#x20AC;&#x2122;s past medication history, current symptoms and concomitant conditions. Additionally, recognizing the different phases of illness (acute, stabilization, and stable), guides treatment selection and drug dosing. Systematic reviews and meta-analyses have not strongly concluded that any of the antipsychotics are more effective than any other for acute schizophrenia, with the exception of clozapine. Therefore, the side effect and tolerability profile and cost effectiveness are utilized to make therapy selection. The Schizophrenia Patient Outcomes Research Team (PORT) recommended treating initial, acute episodes with antipsychotics other than clozapine or olanzapine, because both are associated with greater weight gain, insulin resistance, and dyslipidemia compared to the others. Additionally, Schizophrenia PORT recommended that first-episode patients receive antipsychotic doses in the lower half of the recommended dose range. The American Psychiatric Association recommends that second generation agents, with the exception of clozapine, should be considered for initial therapy in patients in the acute phase of schizophrenia. However, the guideline notes that, in some instances, first generation agents may be an appropriate 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 considered. A patient experiencing partial or no response to the first SGA should be trialed on a different second generation or a first generation antipsychotic. Patients not adequately responding after trials with at least two different SGAs may be initiated on clozapine monotherapy. 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 schizophrenics 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 hypotension, 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 available 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 monotherapy, other medications and adjuncts, such as electroconvulsive therapy (ECT), can be tried based on the physicianâ&#x20AC;&#x2122;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 unknown 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 comorbid 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 concurrent 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 impairment. Manic symptoms include grandiosity, fast speech, racing thoughts, and distractibility. Hypomania is a less severe form of mania that does not involve functional impairment. Some patients with severe episodes of mania or depression 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 bipolar 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 antipsychotic. This regimen is endorsed by multiple treatment guidelines. Numerous meta-analyses indicate that the combination of antipsychotics and lithium or valproate leads to an increase in rate of response (measured using mania rat-

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ing scale) in a significantly shorter time period. The SGAs most studied in bipolar disorder include aripiprazole, olanzapine, quetiapine, and risperidone. Patients who do not respond to one medication combination 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 profile, 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 ziprasidone) 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 discontinuation 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 consists of combinations of at least two drugs, including a mood stabilizer, atypical antipsychotic, and antidepressant. Among atypical antipsychotics, 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 required for bipolar disorder.

Atypical Antipsychotic Metabolic Effects

SGAs can induce metabolic abnormalities that are associated with an increased risk of type 2 diabetes mellitus, metabolic syndrome, and cardiovascular disease. These metabolic changes include weight gain, hyperglycemia, and dyslipidemia. It is believed that individuals with schizophrenia and affective disorders have approximately a 1.5 to 2

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Table 2 Metabolic risks associated with atypical antipsychotics Drug Aripiprazole Asenapine Clozapine Iloperidone Lurasidone Olanzapine Paliperidone Quetiapine Risperidone Ziprasidone

Weight Gain – + +++ ++ – +++ ++ ++ ++ –

Diabetes low low* high mild* low* high mild moderate mild low

Lipid Profile low low* high mild* low* high mild moderate mild low

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

percent times higher prevalence of both obesity and diabetes compared to the general population. Patients with a first episode of schizophrenia who have not previously taken an antipsychotic agent appear to be the most vulnerable to these side effects. Characteristics of schizophrenic lifestyle, including sedentary behavior, may contribute. Because other major risk factors for diabetes were not controlled in past studies, it remains unclear whether the psychiatric condition, independent of other risk factors, accounts for the increased prevalence. Evidence suggests that personal, familial, or genetic factors also influence 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 phenothiazines. However, this side effect was somewhat ignored during the 1970s and 1980s as it was found to be minimal in the more potent FGAs. Since the introduction 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 suggests that the antipsychotics with the highest tendency to induce significant 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 druginduced weight gain may be a result of gene polymorphism. Evidence suggests that treatment 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. Variability in weight gain among the agents is summarized in Table 2. A meta-analysis of multiple studies on antipsychotics found that clozapine was associated with the greatest weight gain after 10 weeks of treatment, compared to ziprasidone which was linked to the least weight gain. Other studies have made this same conclusion, showing that clozapine and olanzapine 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 antipsychotic agent is entirely body weight

neutral, as the proportion of individuals who experience clinically relevant weight gain, traditionally defined as >7 percent of pretreatment weight, is greater with any agent versus placebo. Diabetes. Extensive reporting has documented the onset or exacerbation of diabetes following the initiation of SGAs. Large retrospective 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 hyperglycemia, 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 suggests 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 associated with the greatest risk of dyslipidemias, followed by quetiapine then risperidone. The dyslipidemic adverse effects of clozapine, olanzapine, 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 ziprasidone 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 paliperidone. The researchers concluded that preliminary data suggest that lurasidone is associated with the lowest weight gain potential. The reviewers stated that insufficient evidence is available to draw

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 routine 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. Metformin has shown the most success, although none of these drugs has enough evidence to recommend for broad clinical use.

firm conclusions about the metabolic effects of the newly approved SGAs. Table 2 summarizes the metabolic adverse events associated 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 Psychiatric Association, the American Association of Clinical Endocrinologists, and the North American Association for the Study of Obesity held a consensus development conference on the subject of antipsychotic drugs and obesity. At the time, the panel developed baseline and follow-up monitoring recommendations 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 circumference; blood pressure; fasting plasma glucose; and fasting lipid profile (Table 3). Nutritional counseling, as well as cognitive behavioral counseling, have been found to be effective in reducing antipsychotic induced weight gain. Health care providers, as well as patients,

Recently Approved Atypical Antipsychotics

Three of the most recently approved atypical antipsychotics, iloperidone, asenapine and lurasidone, 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 studies and less clinical experience. Iloperidone, marketed as Fanapt, was introduced in 2009 for the treatment of schizophrenia. It

Table 3 Monitoring protocol for patients on SGAs* Baseline

4 8 12 quarterly weeks weeks weeks

annually

personal/ family history

weight (BMI)

waist circumference

blood pressure

fasting plasma glucose

fasting lipid profile

X X

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

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is dosed at 12 to 24 mg daily, divided 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 dopamine D2 receptors. This variation in receptor affinity explains why iloperidone has been associated with dizziness and orthostatic hypotension. For this reason, dosing titration is recommended to begin at 1 mg twice daily, and increasing daily until the treatment dose is attained. Other receptor binding characteristics which may be important include a lower affinity to muscarinic receptors and histamine 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 increased medication errors. Comparison 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 iloperidone 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.

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Asenapine, marketed as Saphris, is indicated for the treatment 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 differs 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 administration. 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 receptors 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-related), 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 clinically 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 suggested 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 dosing 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 lurasidone. Administration with food greatly increases the absorption of lurasidone; therefore, it is recommended to be taken with food (at least 350 calories). Patients should be instructed to read the Medication Guide each time the prescription is filled. Administration with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole) and CYP3A4 inducers (e.g., rifampin, St. Johnâ&#x20AC;&#x2122;s wort, phenytoin, carbamazepine) is contraindicated. Dosing modifications are required in patients with moderate to severe renal and hepatic impairment. Similar to other SGAs, lurasidone possesses dopamine D2 and serotonin 5-HT2A antagonism. It also has potent-5HT7 antagonism which may provide cognition improvement. However, results from longer term trials are needed to determine the significance. It has low affinity to muscarinic, histamine H1, and alpha-1-adrenergic receptors. 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 summarized advantages of lurasidone as minimal weight gain (and possible best in class) with no clinically meaningful alterations in glucose,

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.

Conclusion

Antipsychotics are primarily indicated for the treatment of schizophrenia 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 differences between agents.

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

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 targeted to pharmacists in all practice settings.

Program 0129-0000-14-005-H01-P Release date: 5-15-14 Expiration date: 5-15-17

CE Hours: 1.5 (0.15 CEU)

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

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continuing education quiz

Please print.

Atypical Antipsychotics: Overview, Metabolic Abnormalities, and Newer Agents

Address_____________________________________________

1. Antipsychotics are indicated for treatment of all of the following EXCEPT: a. schizophrenia. c. obsessive-complusive disorder. 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 EXCEPT: 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 treatment of bipolar depression? a. Quetiapine c. Risperidone b. Clozapine d. Aripiprazole

Completely fill in the lettered box corresponding to your answer. 1. 2. 3. 4. 5.

[a] [a] [a] [a] [a]

[b] [b] [b] [b] [b]

[c] [c] [c] [c] [c]

[d] 6. [a] [d] 7. [a] [d] 8. [a] [d] 9. [a] [d] 10. [a]

[b] [b] [b] [b] [b]

[c] [c] [c] [c] [c]

[d] [d] [d] [d]

11. [a] 12. [a] 13. [a] 14. [a] 15. [a]

[b] [b] [b] [b] [b]

[c] [d] [c] [c] [c] [c]

 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  no 4. Did the program meet your educational/practice needs?  yes  no 5. How long did it take you to read this lesson and complete the quiz? ________________ 6. Comments/future topics welcome.

Program 0129-0000-14-005-H01-P 0.15 CEU

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City, State, Zip______________________________________ Email_______________________________________________ NABP e-Profile ID____________Birthdate_________

(MMDD)

Return quiz and payment (check or money order) to Correspondence Course, OPA, 2674 Federated Blvd, Columbus, OH 43235-4990

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 effect 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 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 opa@ohiopharmacists.org.

may 2014

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