2014-10 Georgia Pharmacy Journal by Georgia Pharmacy Association

Inside: GPhA’s 2014 Election Guide

October/November 2014 VOLUME 36, ISSUE 9

Hydrocodone Moves to C-II Here’s what you need to know

Plus • New rules for mail order • GPhA members take national posts • Fall region meetings are here

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

October/November 2014 Editor: Andrew Kantor akantor@gpha.org

Cover Story Hydrocodone Moves to C-II

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

Unless otherwise noted, the entire contents of this publication is licensed under a Creative Commons Attribution-NonCommercialNoDerivatives 4.0 International License. You are free to distribute the content of the publication for non-commercial purposes, in whole or in part, so long as you give accurate and complete attribution, and you do not alter that content in any way (other than its formatting). Direct any questions to the editor at akantor@gpha.org. SUBSCRIPTIONS 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 akantor@gpha.org.

The DEA has classified hydrocodone as Schedule II, but what does that mean, and what steps do you have to take?

Find out. ...........................................................

Features

10 14 18 22

GPhA Leaders Help Lead National Pharmacy Associations ........................

GPhA’s 2014 Election Guide ..................................................

Governor Meets with GPhA Board ...................................................... Financial Planning: Begin Before the End .............................................

And More...

2 Fall region meeting calendar ................................................. 4 News briefs.................................................................................. 5 PharmPAC ..............................................................................19 Continuing Ed ...................................................................... 24 PostScript ............................................................................... 32 Messages from the president and CEO................................

GPhA Leadership Chair of the Board: .............................................. Pamala S. Marquess President: .................................................................... Robert B. Moody President-Elect: ............................................... Thomas H. Whitworth First Vice President: ....................................................... Lance P. Boles Second Vice President: ............................................ Liza G. Chapman Executive Vice President and CEO: ............. R. Scott Brunner, CAE

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

t 404-231-5074

f 404-237-8435

We’re on the Web at GPhA.org Our blog is at GPhABuzz.com

The Georgia Pharmacy Journal

From the President

From the EVP First and goal(s)

I’m looking forward

e had a great Board of Directors meeting in August, and I believe the entire board has a new sense of invigoration. GPhA’s job is to represent you and Bobby Moody your interests — in fact, the interests President of the entire pharmacy profession in Georgia. So we’re getting things in place to develop a new strategic plan that will set out our goals for the next several years… and how we’re going to get there. Part of that plan includes working to grow your association — to attract new members, and offer more for existing ones. We’re also launching something new to help develop the future of pharmacy in Georgia: LeadershipGPhA, a yearlong, invitation-only program to help train up-and-coming pharmacists to be leaders and mentors. (Read more about it on page 5.) We’re also ramping up our communications, keeping members informed about the issues affecting them as well as what GPhA is doing. (Hydrocodone moving to Schedule II is a great example.) So be on the lookout for the new GPhA website, a new daily news feed, more information on Facebook, Twitter, and LinkedIn, and more. Finally, a shout out to several GPhA members who will be taking on leadership roles in national organizations: Next month GPhA Past President John Sherrer will be inaugurated as the president of The National Community Pharmacy Association, and his son Thomas was named as president of the National Community Pharmacy Association Student Leadership Council. GPhA Past President Dale Coker will become the president of the International Academy of Compounding Pharmacists, and GPhA member Sharon Clackum will be inaugurated at the president of the American Society of Consultant Pharmacists. (Read more about all of them on page 10.) Please join me in congratulating each of these GPhA members for their national recognition of leadership — and have a great October! n Bobby Moody, RPh, owns Powells Bloomfield Pharmacy in Macon

Scott Brunner, CAE EVP

ecking away at this column as I watch Auburn struggle to hold off a scrappy Kansas State team, and the announcers keep talking about Coach Gus Malzahn’s game plan and how he’s making adjustments to it on the fly. (Adjust harder, Coach. This is

making me nervous!) Any team that wants to win has a game plan — a plan that’s specific enough to confront the challenges it expects to face, but not so rigid it can’t be adjusted as the situation changes. Associations need plans, too: road maps that help guide us from status quo to a new and better reality for our members. In August, your GPhA Board of Directors built a 12-month, five-point plan for addressing some challenges we face. Achieving these short-term goals will position us to address some longer-term challenges. 1. Enact an aggressive program of membership growth and retention, including investigating group dues incentives, to build our member base and influence. 2. Enhance the effectiveness of the GPhA Board of Directors. 3. Develop an ambitious new long-term strategic plans for GPhA and the Foundation. 4. Overhaul GPhA’s brand, with focus on elevating the member experience and overhauling communications vehicles and member touch points, as well as engaging sister organizations and “broadening the tent.” 5. Position GPhA as the voice for all pharmacy in Georgia by growing our political effectiveness through outreach, streamlined processes, effective legislative planning, and building our grassroots advocacy capacity. Like my Tigers, we may need to make adjustments along the way. But there’s no doubt our game plan is focused on you and your success. It’s first and goal(s), and you’ve got a 50-yard-line seat. Cheer loudly for us, okay? We can’t win without your support. n Scott Brunner is GPhA’s new executive vice president. And yes — forgive him — he’s an Auburn fan.

The Georgia Pharmacy Journal

Endorsed* by:

Our commitment to quality means you can rest easy. Pharmacists Mutual has been committed to the pharmacy profession for over a century. Since 1909, we’ve been insuring pharmacies and giving back to the profession through sponsorships and scholarships. Rated A (Excellent) by A.M. Best, Pharmacists Mutual is a trusted, knowledgeable company that understands your insurance needs. Our coverage is designed by pharmacists for pharmacists. So you can rest assured you have the most complete protection for your business, personal and professional insurance needs.

Learn more about Pharmacists Mutual’s solutions for you – contact your local field representative or call 800.247.5930:

www.phmic.com

PO Box 370 • Algona Iowa 50511

Seth Swanson

Hutton Madden, ChFC

800.247.5930 ext. 7128 850.688.3675

800.247.5930 ext. 7149 404.375.7209

Not licensed to sell all products in all states.

It’s time to connect and reconnect with the best of Georgia’s pharmacy professionals. These meetings are open to all Georgia pharmacists, pharmacy technicians, and pharmacy students. Find your region and see when and where your meeting is. Then go to GPhA.org/fall2014 to register. (You need to register so we know how many to expect for dinner.) Grab a friend and enjoy an evening of conversation with colleagues and other pharmacy pros from your region. Help set the agenda for your association — and for the profession in general.

Region 1 Tues, Oct 14th

Carey Hilliard’s 198 Pooler Pkwy., Pooler $10 for members / $15 for nonmembers / $5 for students 6:30 PM — Registration 7:00 PM — Presentation and dinner Speaker: Leroy Graham, MD, Georgia Pediatric Pulmonary Associates Sponsored by Meda Pharmaceuticals

Region 2 Tues., October 7

Sundown Farms Plantation 894 Mack Dekle Rd., Moultrie Free to all 6:30 PM Sponsored by Eli Lilly & Boehringer Ingelheim

Region 3 Weds., October 8

Midtown Medical Center Conference Room A 710 Center Street, Columbus Free to all 6:30 PM — Meet and greet 7:00 PM — Dinner and meeting Sponsored by Sanofi

Region 4 Weds., October 29

Franks at the Old Mill 1095 W. Hwy 54, Fayetteville Free for members / $10 for nonmembers

6:30 PM — Registration and cocktails 7:00 PM — Dinner Presenter: Kevin Newton from ATEB (patient management, communications, and adherence solutions)

Region 5 Weds., November 19 Location TBD

Region 6 Thurs, November 6

Tic Toc Room 408 Martin Luther King Jr. Blvd., Macon $10 for members / $15 for nonmembers 6:30 PM — Registration 7:00 PM — Dinner Sponsored by Sanofi

Region 7 Tuesday, October 28

Henry’s 4835 North Main Street, Acworth Free for everyone 7:00 PM — Dinner Sponsored by Sigma Tau

Region 8 Weds., November 5

Railroad Depot – Suite P 315 Plant Avenue, Waycross $15 for all 6:30 PM — Social 7:15 PM — Dinner Sponsored by Smith Drug Company and McKesson

Region 9 Tues, November 18

Woodbridge Restaurant 44 Chamber Street, Jasper Free for members. 6:30 PM — Registration 7:00 PM — Dinner Sponsored by the Law Offices of Stuart J. Oberman

Region 10 Thurs, November 13

Hilton Garden Inn 390 E. Washington Street, Athens $10 for members / $10 for nonmembers / $5 for students 6:30 PM — Social 7:00 PM — Dinner

Region 11 Weds., November 12 Location TBD

Region 12 Weds., October 15

Peter’s Place 1626 Veterans Blvd, Dublin $5 for all 6:30 PM — Social 7:00 PM — Dinner Sponsored by Biocodex Pharmaceuticals and AmerisourceBergen

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

T H E

N E W S

S E C T I O N

Renew your license early this year

For tomorrow’s pharmacist leaders:

LeadershipGPhA The Georgia Pharmacy Association debuted its new program for up-andcoming pharmacist leaders in the state: LeadershipGPhA. This prestigious year-long development course will work with a dozen hand-picked Georgia pharmacists — men and women on the front end of their careers — to polish their leadership and teamwork skills. At the end, they’ll be equipped to help shape the future of the pharmacy profession in Georgia, to help mentor other professionals, and to advance their own careers. LeadershipGPhA consists of four overnight retreats and two webinars, costs of which are covered by the $1,500 tuition, which also includes registration for the GPhA 2015 Convention. Selected students may pay the tuition themselves, or may arrange for tuition costs to be shared by their employer, wholesaler, or other party. If you know an informed, passionate, Georgia pharmacist who deserves to be recognized as an up-and-coming leader, urge that person to apply for

The Georgia Pharmacy Journal

admission into the inaugural class of LeadershipGPhA. (And if you’re that pharmacist, you should apply yourself.) To learn more about LeadershipGPhA or to apply for the program, visit GPhA.org/LeadershipGPhA.

It’s almost license-renewal time, and this year it’s critical that you get your application in as soon as possible. Here’s why: In 2015, Georgia is requiring out-of-state pharmacies who do business in Georgia to be licensed in the state. That means there is going to be a huge glut of applications coming in. If you wait till the last minute to get yours in, you run a serious risk of being caught in any backlog. Don’t take a chance. Go to gbp.georgia.gov/docu ments/renew-online and start your renewal today. (Still need continuing ed credits? Better hurry. Check out our CE course list at GPhA. org/continuing-education for a class near you.)

Thinking about buying or selling a pharmacy? Talk with Mike first. Mike understands the process and views it with your total financial plan in mind. He has helped many pharmacists successfully navigate the maze by choreographing your plan with attorneys, accountants, valuators, and bankers to help make the most of this potentially life-changing transaction. Mike can help you figure out what is prudent for you and if it makes sense in your financial plan.

FINANCIAL NETWORK ASSOCIATES, INC.

A Registered Investment Advisor

Michael T. Tarrant, CFP® - Vice President 1117 Perimeter Center West, Suite N-307 Atlanta, GA 30338

(770) 350-2455

mike@fnaplanners.com www.fnaplanners.com

Registered Representative of INVEST Financial Corporation, member FINRA/SIPC. INVEST and its affiliated insurance agencies offer securities, advisory services and certain insurance products and are not affiliated with Financial Network Associates, Inc.

T H E

N E W S

S E C T I O N

Board approves signature requirement for mail-order pharmacies .pharmacy domains are coming The National Association of Boards of Pharmacy has the rights to manage .pharmacy Internet domains, meaning if you want to own, say, http://andrew.pharmacy or http://yourlocal.pharmacy, you’ll need to register through NABP. It expects to allow pharmacies to register domains in the fourth quarter of 2014, but there will be rules. For example, you must be a licensed pharmacy that meets “all applicable regulatory standards” and “demonstrate good standing and compliance with the laws of the jurisdiction in which they are based, as well as in all jurisdictions in which they conduct business.” Oh, and don’t try to register someone else’s trademarked name. Pricing hasn’t been set.

The Georgia Board of Pharmacy has formally adopted new rules for mail-order pharmacies that wish to serve patients in Georgia. They will go into effect October 8, 2014. The new regulations require that out-of-state pharmacies obtain a “nonresident pharmacy permit” in order to ship prescription drugs into the state. They must also adhere to specific policies for delivery of medication, and even stricter ones for delivery of controlled substances. For example, if a medication requires temperature control, there has to be a way for the patient to see clearly whether those conditions were met during transport, and to notify the pharmacy if there is any problem with the medication. Under the new rules, a patient signature will now be required for delivery of Schedule II, III, IV, and V controlled substances; patients will also be allowed to designate another person to sign for them. If the package can’t be delivered or signed for, it cannot be left behind — it must be returned to the shipper’s facility (e.g., the local post office) and either held for pickup or, if the patient requests it, redelivered. If delivery of a controlled substance is in any way compromised, the pharmacy must either replace it via overnight delivery, or arrange for at least a seven-day supply from a local pharmacy. It is important to note these rules do not affect the current “traditional home delivery” service where a store employee delivers medications to a customer of the pharmacy. There are also a number of detailed administrative requirements, such as having someone available to provide consultation, keeping detailed records of instances when drugs aren’t delivered (or aren’t delivered on time), and maintain records of patient complaints. The Board has the details of the new regulations on its site at gbp.georgia.gov. someone available to provide consultation, keeping detailed records of instances when drugs aren’t delivered (or aren’t delivered on time), and maintain records of patient complaints. The Board has the details of the new regulations on its site at gbp.georgia.gov.

Electronic prescriptions might help reduce prescription-drug abuse As the federal government tries to fight the problem of prescription-drug abuse, one way it might do so is by switching to electronic prescriptions.

The Georgia Pharmacy Journal

T H E

N E W S

S E C T I O N

WELCOME

In 2010, a DEA rule (“Electronic Prescribing for Controlled Substances” or EPCS) allowed pharmacies to accept prescriptions for Schedule II-V controlled substances online. If that becomes more popular, it could help reduce prescription-drug abuse in a couple of ways. First, the lack of a paper script would reduce if not eliminate forged prescriptions. Second — and admittedly this has a bit of a Draconian/Big Brother vibe to it — it would allow pharmacies, the police, the government, or all three to track the use (and abuse) of medication and prevent “doctor shopping” by patients. But envisioning such a system and actually putting it into practice are two different things. According to e-prescription network SureScripts, only about half of pharmacies in the country can currently accept electronic prescriptions for controlled substances. Georgia trails the country — only between 11 and 20 percent of pharmacies here are equipped for EPCS, ranking us 41st in the nation. Another issue comes from the legislative side: Just because the DEA says that pharmacies can accept electronic prescriptions for controlled substances doesn’t mean the state law will allow it. (And the more restrictive of the two wins.) And there is, of course, the technical angle: Systems have to be secure, and there isn’t a single standard for handling health records, coding, or even how a doctor sends information to a pharmacy. (E-mail isn’t going to cut it.) But with prescription-drug abuse becoming either more of an issue or simply one we’re more aware of, you can expect initiatives like EPCS to start gaining ground.

The Georgia Pharmacy Journal

New Members Active Pharmacists Frank Killingsworth – Fort Valley Sofia Farah – Atlanta Spencer Tally – Cartersville Chad Potts – Dublin Joseph Cooley – Atlanta James White – Kennesaw April Hang – Norcross Russell Morris – Gainesville Associate The Bracewell Group – Atlanta 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.

T H E

Study: states allowing medical marijuana have fewer overdose deaths If a state has legalized medical marijuana, fewer people there overdose on painkillers — that’s according to a study by researchers at UPenn, the VA, the Albert Einstein College of Medicine, and Johns Hopkins. In fact, they found, opioid-overdose deaths decreased by an average of 20 percent a year after medical marijuana was legalized, then had dropped 25 percent in by two years, and were down by a third in the fifth and sixth years.

Remember: October is American Pharmacists Month 8

N E W S

S E C T I O N

Flu vaccine:

Two interesting notes from the CDC

As part of its ever-cheerful “Morbidity and Mortality Weekly Report,” the CDC has a couple of important notes about this year’s flu vaccine: one about live vs. inactived virus in children, and one about the timing of giving the vaccine to those 65 and older. Live vs. inactivated: While the inactivated virus appears to be more effective for adults, “several studies have demonstrated superior efficacy of LAIV [live virus] in children,” according to the CDC, especially those who have respiratory problems such as asthma. As for the older set: The CDC notes that two studies have found a “statistically significant decline” in vaccine effectiveness for those 65 and older after six months. That might mean delaying vaccination is a good idea — as long as those folks still get their shots.

Acetaminophen doesn’t help lower-back pain: study A new Australian study of more than 1,600 people found that acetaminophen does not help relieve lower back pain. In that study, published in The Lancet, researchers found that acetaminophen/Tylenol/paracetamol was no more effective than a placebo. Not only did patients taking it actually take longer to recover than those taking a placebo (17 days vs. 16 days), during those two-plus weeks they were in just as much pain.

Feds allow pharmacies to take back meds — will Georgia follow? Retail pharmacies are now allowed to collect unused medication, according to the DEA. Unfortunately, Georgia law still prohibits this. The DEA says pharmacies can now take back medications directly, by mail, or via receptacles. GPhA is working with the Georgia Board of Pharmacy to see whether Georgia law should be changed to match the new federal rule. You can get the details and keep up with developments at GPhA.org/ takeback.

The Georgia Pharmacy Journal

T H E

N E W S

S E C T I O N

GPhA at work

Your channel to Medicaid

It may seem small, but with help from several members of GPhA’s Academy of Independent Pharmacy, we were able to get Medicaid FFS to suspend the MAC on a particular formulation of sulfamethoxazole-trimethoprim. Yes, GPhA can do that — solving problems is what we do for our members.

Did you know?

When a large PBM violated the Georgia Audit Bill of Rights, GPhA worked with an attorney to help a small, rural pharmacy fight back — a fight it could never win alone.

Who signs?

Georgia law requires the attending physicians name be on the label, but CMS policy often requires using the name of the prescriber when billing — which could be a PA or NP. We’re working to change the law to allow using the PA/NP name on the prescription and label, rather than requiring the attending physician.

And more

Other issues we’re working on: MAC price-update legislation, making it easier to bill for flu shots for Medicaid patients, explaining Medicare Part D star ratings, and working on “any willing pharmacy” and provider status legislation at the national level. We’re busy — busy working for you.

Get ready for more naloxone scripts You may start receiving an increased volume of prescriptions for naloxone (Narcan) due to legal changes in 2014. The Medical Amnesty/Naloxone Law, which passed with overwhelming bi-partisan support, makes it easier to get access to naloxone, which can treat opiate overdoses.

M E M B E R

N E W S

Georgia Pharmacists to Lead National Associations Since our beginning, the Georgia Pharmacy Association has taken great pride in helping develop the leadership skills of our members. There is no one-size-fits all definition of what makes a good leader, but it’s apparent that these four GPhA members have what it takes.

“Being involved in GPhA has been a vital part of my pharmacy career. My early involvement provided me with a community of pharmacy mentors that enriched my development as a pharmacist.”

“GPhA is strong at advocating for pharmacists rights and has been very supportive on the state level.”

John T. Sherrer

Independent Pharmacy Owner Education: PharmD, Mercer College of Pharmacy GPhA Member Since 1977 Hometown: Marietta Incoming President, National Community Pharmacy Association

ohn attended his first NCPA convention as GPhA president-elect in 1987, and he has attended every convention since. He says both associations have helped him tremendously as an independent pharmacy owner, including offering networking and educational opportunities. John will have the honor of assuming the office of president of NCPA in October, and he hopes to use his position to help with issues such as fairness and standardization in MAC pricing — and he also would like to see pharmacists finally achieve provider status with CMS. “The advancement of pharmacy as a profession should be a concern for every pharmacist,” he says. “It is imperative for pharmacists to be involved in pharmacy associations and to be advocates in the legislative process. It is our responsibility to educate our elected representatives concerning the issues affecting pharmacy.”

Sharon Clackum

Clinical Pharmacist Education: PharmD, Mercer College of Pharmacy GPhA Member Since 1980 Hometown: Cumming Incoming President, American Society of Consultant Pharmacists

roviding optimal medication management. Improving healthcare outcomes for older people. Working toward achieving provider status. Helping everyone get access to pharmacy services — these are just a few of the issues Sharon is addressing as president of the American Society of Consultant Pharmacists. Sharon began her pharmacy career working as a pharmacist specializing in assisted-living and long-tern-care facilities, and she’s always been involved with

The Georgia Pharmacy Journal

M E M B E R

N E W S

ASCP. “At that time, the ASCP was the only professional organization specializing in that area,” Sharon explains. Today it’s expanded, and ASCP’s membership now includes not only pharmacists but other healthcare providers. The association is dedicated to providing medication management to seniors no matter where they reside.

Dale Coker

Independent Pharmacy Owner (Compounding) Education: RPh, UGA School of Pharmacy GPhA Member Since 1993 Hometown: Woodstock Incoming President, International Academy of Compounding Pharmacists

ale first became involved with the International Academy of Compounding Pharmacists while attending its “Compounders on Capitol Hill” event in 2002. Since then he’s served on the IACP board of directors, its education committee, and he has chaired both its bylaws revision and governance policies review committees. Prior to becoming IACP president, Dale began working on developing a threeyear plan for the academy — a plan that was accomplished in July. His main objective as president is to grow the academy’s professional/consumer advocacy program and strengthen its grassroots efforts. “There are three major challenges we face as pharmacists including third party reimbursement, federal vs. state rights in regulating compounding, and fighting legislation that would prohibit the use of bulk chemicals in veterinary compounds,” Dale says. “Pharmacy associations are vehicles that help us address these issues.”

Thomas Sherrer

Intern, Poole’s Pharmacy Education: Student, Mercer College of Pharmacy GPhA Member Since 2011 Hometown: Marietta Incoming President, National Community Pharmacy Association Student Leadership Council

“I

first became aware of the GPhA and the National Community Pharmacy Association through my parents, John and Sharon Sherrer, who are both pharmacists,” says Thomas. “I attended several meetings and when I decided to attend pharmacy school I knew I wanted to be involved.” In addition to the many sleepless nights, long study sessions, and the burden of student debt required of pharmacy school, Thomas believes that many students are concerned about job opportunities. He also believes that being involved with associations and the networking opportunities they offer can help tackle these challenges. Now he’ll be working with the National Community Pharmacy Association’s Student Leadership Council on its missions to cultivate future community pharmacy leaders, reach out to pharmacy schools to plant the seeds of ownership, and helping to test new programs.

The Georgia Pharmacy Journal

“We owe it to ourselves and to our profession to be involved, to stay current on best practices as well as regulatory and legislative issues. Pharmacy associations are vehicles that help us address these issues.”

“Being involved in pharmacy associations has many benefits. Associations provide the opportunity to shape the profession. Through the various meetings, conventions, and interactions it is a great way to network.”

C O V E R

S T O R Y

Hydrocodone Moves to C-II Here’s what you need to know

s you know, the U.S. Drug En-

forcement Agency announced recently that hydrocodone combination products (HCPs) are being reclassified as a Schedule II drug. But the DEA isn’t making the change immediately. It’s phasing it in between now and April 8, 2015 in two steps, and that has raised a number of questions for Georgia pharmacists. After looking at the information from the DEA, speaking to the Georgia

The DEA has moved all hydrocodone products into Schedule II. That means you’ll need to make some changes.

Board of Pharmacy, and reading analysis from APhA, the American Society for Pharmacy Law, and others, we’ve put together this short guide to how the transition of HCPs from C-III to C-II will work.

The Georgia Pharmacy Journal

C O V E R

Prescriptions for any medication containing hydrocodone (hydrocodone combination products, or HCPs) can continue to be filled and refilled until April 8, 2015 if they were written before October 6, 2014. In fact, doctors may continue to issue those refillable scripts — for up to five refills (180 days) — through October 5, including orally or by fax. So nothing changes between now and October 5, 2014. However, “No prescription for HCPs issued on or after October 6, 2014 shall authorize any refills.” (Ergo, they’ll be limited to a 90-day supply.) Starting October 6, you cannot accept prescriptions for HCPs that allow for refills. You can continue to refill scripts received before then, but you must treat all hydrocodone products as if they are C-II for storage and security purposes. And there’s the rub, isn’t it? If your software is updated to treat HCPs as C-II, but you’re allowed to dispense it as C-III until April, how’s that going to work?

Answer: We don’t know. And if you convince your software to let you dispense hydrocodone products as C-III between October and April, how’s that going to look on an audit?

Answer: We don’t know. As Laird Miller of Gainesville, a member of the Georgia Board of Pharmacy told us, “The regulation has some real flaws in it [and] we have not seen anything we can do to correct them.” But that doesn’t mean the BoP isn’t trying —

The Georgia Pharmacy Journal

S T O R Y

it’s been working with both the DEA and the GDNA to try to work out a plan for the October-to-April transition. But right now, says Miller, there’s much about how to implement the reclassification that’s still up in the air. The next major change is six months later: Starting April 8, 2015, you may no longer refill prescriptions for HCPs, period. They are fully Schedule II. n

You may continue to dispense HCPs from commercial containers labeled C-II (as long as those containers were labeled before October 6) until your stock is depleted.

Why the change? According to Medicare/Medicaid expert Kip Piper, hospital stays involving opioid overuse just among adults jumped more than 150 percent from 1993 to 2012 — it’s become a major health concern affecting people across geographic and demographic lines. In fact, according to an August 2014 study by the Agency for Healthcare Research and Quality, “The rate of adult hospital inpatient stays related to opioid overuse increased, on average, by five percent annually.” And with Medicaid and Medicare each paying for about a third of those opioid-overdose hospital stays, the government (and taxpayers) are feeling the problem right in the pocketbook.

We’ll be keeping you updated on any changes and updates to this issue. Visit GPhA.org/hydrocodone for the latest information, as well as resources for you and your patients.

E L E C T I O N

G U I D E

GPhA’s

2014 Election Guide E

ach year, the PharmPAC Board of Directors meets to choose the slate of candidates it will support. The board examines voting records, gets input from members across the state, and interviews candidates. The candidates we endorse are selected by the PharmPAC Board of Directors — working pharmacists and pharmacy professionals like you. They look for the men and women with the platforms and voting records that show that they’re friends to pharmacy and pharmacists. Of course there are other issues you, and hopefully every voter, considers. But PharmPAC’s and GPhA’s job is to find the candidates who support the pharmacists of Georgia: Democrats, Republicans, or Independents. Pharmacy issues are the only issues we care about. Voting is a great responsibility, and we hope you’ll consider these endorsements — and your profession — when you face the ballot box.

The association works every day to help ensure that legislation passed in Georgia is the best possible for you and your business. Visit GPhA.org/PharmPAC to learn more about PharmPAC.

THE POLITICAL ACTION COMMITTEE OF THE GPhA

The Georgia Pharmacy Journal

E L E C T I O N

G U I D E

Statewide Endorsements For Governor:

Nathan Deal

For Lieutenant Governor:

Casey Cagle

Pharmacy’s Champions Georgia is fortunate to have four state legislators in the 2015 session who are also working pharmacists. We appreciate the way they represent the pharmacy profession.

Governor Deal is one of the most knowledgeable elected officials in Georgia on healthcare policy. This goes back to his days in Congress as the chair of the Health Subcommittee of Energy and Commerce. Not long after he was elected governor, he helped GPhA ensure that pharmacists were not penalized by PBMs when doctors didn’t use the correct prescription pads. Governor Deal has actively sought our input from our members and recently took the time to meet with both our executive committee and board of directors. For Attorney General:

Sam Olens

After the 2012 New England Compounding Center debacle, many state pharmacy associations braced themselves for attacks on all compounding pharmacies. In the 2013 legislative session in Georgia, Lieutenant Governor Cagle led the efforts to expand the compounding profession in Georgia.

Representative Bruce Broadrick (R) Dalton - District 4 • 404-656-0202 • bruce.broadrick@house.ga.gov

Representative Buddy Harden For Insurance Commissioner:

Ralph Hudgens

(R) Cordele - District 148 • 404-656-0188 • bharden@planttel.net

Representative Butch Parrish (R) Swainsboro - District 158 • 404-463-2247 • butch.parrish@house.ga.gov

Georgia was one of the last states to enact a prescription drug monitoring program. AG Olens supported us then and has continued using his office to educate Georgians on the problems of prescription drug abuse.

The Georgia Pharmacy Journal

One of the first acts of Commissioner Hudgens after he was first elected in 2010 was to create an advisory panel of pharmacists to keep him up to date on regulations that impact the practice of pharmacy. Commissioner Hudgens was also helpful in preventing PBMs from penalizing pharmacists when doctors were not using approved prescription pads.

Representative Ron Stephens (R) Savannah - District 164 • 404-656-5115 • quickrxdrugs@yahoo.com

E L E C T I O N

G U I D E

Local Endorsements What’s my district? To ﬁnd your legislative district and voting location, visit mvp.sos.ga.gov STATE REPRESENTATIVES

District 1: John Deffenbaugh District 3: Tom Weldon District 4: Bruce Broadrick District 5: John Meadows District 6: Tom Dickson District 7: David Ralston District 8: Stephen Allison District 9: Kevin Tanner District 10: Terry Rogers District 11: Rick Jasperse District 12: Eddie Lumsden District 13: Katie Dempsey District 14: Christian Coomer District 15: Paul Battles District 16: Trey Kelley District 17: Howard Maxwell District 18: Kevin Cooke District 19: Paulette Rakestraw Braddock District 20: Michael Caldwell District 21: Scot Turner District 22: Wes Cantrell District 23: Mandi Ballinger District 24: Mark Hamilton District 25: Mike Dudgeon District 26: Geoff Duncan District 27: Lee Hawkins District 28: Dan Gasaway District 29: Carl Rogers District 30: Emory West Dunahoo Jr. District 31: Tommy Benton District 32: Alan Powell District 33: Tom McCall District 34: Bert Reeves District 35: Ed Setzler

District 36: Earl Ehrhart District 37: Sam Teasley District 38: David Wilkerson District 39: Erica Thomas District 40: Rich Golick District 41: Michael Smith District 42: Stacey Evans District 44: Don Parsons District 45: Matt Dollar District 46: John Carson District 47: Jan Jones District 48: Harry Geisinger District 49: Chuck Martin Jr. District 50: Lynne Riley District 51: Wendell Willard District 52: Joe Wilkinson District 53: Sheila Jones District 54: Beth Beskin District 55: Tyrone Brooks District 56: “Able” Mable Thomas District 57: Pat Gardner District 58: Simone Bell District 59: Margaret Kaiser District 60: Keisha Sean Waites District 61: Roger Bruce District 62: Ladawn Blackett Jones District 63: Ronnie Mabra District 64: Virgil Fludd District 65: Sharon Beasley-Teague District 66: Kimberly Alexander District 67: Micah Gravley District 68: Dusty Hightower District 69: Randy Nix District 70: Lynn R. Smith District 71: David Stover District 72: Matt Ramsey District 73: John Yates District 74: Valencia Stovall District 75: Mike Glanton District 76: Sandra G. Scott District 77: Darryl Jordan District 78: Demetrius Douglas District 79: Tom Taylor District 80: Mike Jacobs District 81: Scott Holcomb District 82: Mary Margaret Oliver District 83: Howard Mosby District 84: Rahn Mayo

District 85: Karla Drenner District 86: Michele Henson District 87: Earnest “Coach” Williams District 88: Billy Mitchell District 89: Stacey Abrams District 90: Pam Stephenson District 91: Dee Dawkins-Haigler District 92: Tonya Anderson District 93: Dar’shun Kendrick District 94: Karen Bennett District 95: Tom Rice District 96: Pedro “Pete” Marin District 97: Brooks Coleman District 98: Michael Brown District 99: Hugh Floyd District 100: Dewey McClain District 101: Valerie Clark District 102: Buzz Brockway District 103: Timothy Barr District 104: Chuck Efstration District 105: Joyce Chandler District 106: Brett Harrell District 107: David Casas District 108: B.J. Pak District 109: Dale Rutledge District 110: Andy Welch District 111: Brian Strickland District 113: Pam Dickerson District 114: Tom Kirby District 115: Bruce Williamson District 116: Terry England District 117: Regina Quick District 118: Spencer Frye District 119: Chuck Williams District 120: Mickey Channell District 121: Barry Fleming District 122: Ben Harbin District 123: Barbara Sims District 124: Henry “Wayne” Howard District 125: Earnest Smith District 126: Gloria Frazier District 127: Brian Prince District 128: Mack Jackson District 129: Susan Holmes District 130: David Knight District 131: Johnnie L. Caldwell, Jr. District 132: Bob Trammell, Jr. District 133: John Pezold

The Georgia Pharmacy Journal

E L E C T I O N

District 134: Richard Smith District 135: Calvin Smyre District 136: Carolyn Hugley District 137: Debbie Buckner District 138: Mike Cheokas District 139: Patty Bentley District 140: Robert Dickey District 141: Allen Peake District 142: Nikki T. Randall District 143: James Beverly District 144: James “Bubber” Epps District 145: E. Culver “Rusty” Kidd District 146: Larry O’Neal District 147: Heath Clark District 148: Buddy Harden District 149: Jimmy Pruett District 150: Matt Hatchett District 151: Gerald Greene District 152: Ed Rynders District 154: Winfred Dukes District 155: Jay Roberts District 156: Greg Morris District 158: Butch Parrish District 159: Jon Burns District 160: Jan Tankersley District 161: Bill Hitchens District 162: Bob Bryant District 163: J. Craig Gordon District 164: Ron Stephens District 165: Mickey Stephens District 166: Jesse Petrea District 168: Al Williams District 169: Dominic Lariccia District 170: Penny Houston District 171: Jay Powell District 172: Sam Watson District 173: Darlene K. Taylor District 174: John Corbett District 175: Amy Carter District 176: Jason Shaw District 177: Dexter Sharper District 178: Chad Nimmer District 179: Alex Atwood

STATE SENATORS

District 1: Ben Watson District 2: Lester Jackson District 3: William Ligon Jr.

The Georgia Pharmacy Journal

G U I D E

District 4: Jack Hill District 5: Curt Thompson District 6: Hunter Hill District 7: Tyler Harper District 8: Ellis Black District 9: P. K. Martin District 10: Emanuel Jones District 11: Dean Burke District 12: Freddie Powell Sims District 13: Greg Kirk District 14: Bruce Thompson District 15: Ed Harbison District 17: Rick Jeffares District 18: John Kennedy District 19: Tommie Williams District 20: Ross Tolleson District 21: Brandon Beach District 23: Jesse Stone District 24: William (Bill) Jackson District 25: Burt Jones District 26: David Lucas, Sr. District 27: Michael Williams District 28: Mike Crane District 29: Josh McKoon District 30: Mike Dugan

District 31: Bill Heath District 32: Judson Hill District 33: Michael Rhett District 34: Valencia Seay District 35: Donzella James District 36: Nan Orrock District 37: Lindsey Tippins District 38: Horacena Tate District 39: Vincent Fort District 40: Fran Millar District 41: Steve Henson District 42: Elena Parent District 43: Ronald Ramsey, Sr. District 44: Gail Davenport District 45: Renee Unterman District 46: Bill Cowsert District 47: Frank Ginn District 49: Butch Miller District 50: John Wilkinson District 51: Steve Gooch District 52: Chuck Hufstetler District 53: Jeff Mullis District 54: Charlie Bethel District 55: Gloria Butler District 56: John Albers

GPhA’s 2015 LEGISLATIVE AGENDA Here’s a brief overview of the three major issues we’re working on for 2015. For details, visit GPhA.org/2015legislativeagenda. Allowing pharmacists to administer CDC-approved vaccines Vaccines are critical for Georgians’ health, and pharmacists should be allowed to administer them — as they are in 38 states. Making MAC pricing more transparent We want clarity in PBM’s pricing plans: What is on their MAC pricing lists and how are those prices determined? We also want an appeals process so pharmacists can contest a listed MAC price. Allowing actual prescribers’ names to be on labels We want Georgia law clarified to allow a prescriber’s name to be put on a bottle label, not necessarily the attending physician. (This agenda was pending approval from the Board of Directors at press time. Look for the details of our agenda in the next issue, and regular updates on GPhABuzz. com)

G O V E R N M E N T

A F F A I R S

Governor Deal Meets with GPhA Board

Before becoming governor, Nathan Deal was a U.S. Congressman, serving as chairman and ranking Republican on the Health Subcommittee on Energy and Commerce. That’s where he became aware of issues relating to the delivery of healthcare and pharmacy services.

Georgia Governor Nathan Deal addressed the GPhA Board of Direc-

tors a board meeting August 17. “The delivery of healthcare is going to continue to be an evolving issue, and the nature of the delivery of pharmacy services within the healthcare system is changing dramatically,” said the governor. The GPhA Board and Executive Committee were able to spend some time with Governor and Mrs. Deal to talk about bringing transparency and fairness to dealing with PBMs, working with the Board of Pharmacy, and immunizations — an issue that Mrs. Deal has focused on the last four years. “We have some work to do on that, on adult immunization rates,” said Governor Deal. “If it takes legislation, we look forward to working with you on that,” he promised. n

GPhA Chair Pamela Marquess (left) and GPhA President Bobby Moody (right) escort Governor Deal and his wife Sandra (center) as they arrive at the GPhA Board of Directors Meeting on August 17.

Tommy Whitworth, GPhA president-elect, and Governor Nathan Deal discuss a pharmacy issue one-on-one.

The Georgia Pharmacy Journal

THE POLITICAL ACTION COMMITTEE OF THE GPhA

Diamond Level Investors $4,800 minimum pledge

Scott Meeks, RPh

Fred Sharpe, RPh

Investing in PharmPAC is investing in your business. The Georgia Pharmacists Political Action Committee — PharmPAC — provides the resources for your association to lobby and advocate on behalf of pharmacy professionals across the state. GPhA works at the local, state, and even federal level, leading the way in influencing pharmacy-related legislation. Investors in PharmPAC understand the importance of this to their business, and they make financial commitments of support. As of August 31, 2014, the following pharmacists, pharmacy technicians, students, and others have joined GPhA’s PharmPAC.

Titanium Level Investors $2,400 minimum pledge

Ralph Balchin, T.M. Bridges, RPh (12/14) RPh

Ben Cravey, RPh

Michael Farmer, RPh

David Graves, RPh

Raymond Hickman, RPh

Robert Ledbetter, RPh

Brandall Lovvorn, RPh

Marvin McCord, RPh

Jeff Sikes, RPh

Danny Smith, RPh

Dean Stone, RPh

Tommy Whitworth, RPh

The Georgia Pharmacy Journal

Gold Level Investors $600 minimum pledge James Bartling, PharmD (6/15) William Brewster, RPh Bruce Broadrick, RPh Liza Chapman, PharmD Carter Clements. PharmD (5/15) Mahlon Davidson, RPh Angela DeLay, RPh Keith Dupree, RPh Stewart Flanagin, RPh Kevin Florence, PharmD Kerry Griffin, RPh Michael Iteogu, RPh Joshua Kinsey, PharmD Dan Kiser, RPh Allison Layne, CPhT Michael McGee, RPh (4/15)

Representative Bruce L. Broadrick, Sr.

Sheila Miller, PharmD

Silver Level Investors

Robert Moody, RPh

$300 minimum pledge

Sherri Moody, PharmD Catherine Moon (6/15)

Hilary Mbadugha, PharmD Kalen Manasco, PharmD Max Mason, RPh (3/15) William McLeer, RPh Sheri Mills, CPhT. Richard Noell, RPh Darby Norman, RPh *Cynthia Piela, RPh *Donald Piela, Jr. PharmD Bill Prather, RPh (6/15) *Kristy Pucylowski, PharmD *Edward Reynolds, RPh *Ashley Rickard, PharmD *Brian Rickard, PharmD Brian Scott, RPh (5/15) John Sherrer, RPh (6/15) Sharon Sherrer, PharmD (6/15) Richard Smith, RPh (5/15)

Nelson Anglin, RPh

Archie Thompson, RPh (6/15)

Renee Adamson, PharmD

*Austin Tull, PharmD

Larry Batten, RPh 11/14

Flynn Warren, RPh (6/15)

William Moye, RPh

Lance Boles, RPh (8/15)

*William Wolfe, RPh

Anthony Ray, RPh

Robert Cecil, RPh (3/15)

Jeffrey Richardson, RPh

Chandler Conner, PharmD (6/15)

Floyd Moon (6/15)

Andy Rogers, RPh Daniel Royal, RPh (5/15) Michael Tarrant James Thomas, RPh

Bronze Level Investors

Ed Dozier, RPh

$150 minimum pledge

Greg Drake, RPh

Anonymous (6/15)

Terry Dunn, RPh

Bonnie Ali-Warren, RPh (6/15)

Alan Earnest, RPh (6/15)

Shane Bentley, Student

Marshall Frost, PharmD

Nicholas Bland, PharmD

Mark White, RPh

Amanda Gaddy, RPh

Robert Bowles

Charles Wilson Jr., RPh

Johnathan Hamrick, PharmD

Mike Crooks, PharmD

Sharon Zerillo, RPh

Willie Latch, RPh

Zach Tomberlin, PharmD (4/15)

“I served on the PharmPAC Board and as chairman for many years. I have seen the progress that has been made through the legislative process with the strength of PharmPAC. We face many challenges in the profession. There are challenges that we can control through active participation in the legislative arena. PharmPAC aids to give us a voice at the table for positive change.”

Mandy Davenport, RPh (6/15) The Georgia Pharmacy Journal

Denotes a monthly sustaining PAC investor. Highlight denotes new or increased contribution.

Rabun Dekle, RPh

Member Investors

John Drew, RPh (6/15)

No minimum pledge

Becky Hamilton, PharmD (4/15)

Claude Bates, RPh (6/15)

PharmPAC Board of Directors

Larry Harkleroad, RPh

Stuart Bradley, PharmD (6/15)

Hannah Head, PharmD

Winston Brock, RPh (6/14)

Amy Grimsley, PharmD

Kristin Brooks (6/15)

Thomas Jeter, RPh

James Darley, PharmD (6/15)

Henry Josey, PharmD

Donley Dawson, PharmD (12/14)

Brenton Lake, RPh

Eddie Madden, Chairman

Martin Grizzard, RPh (6/15)

Tracie Lunde, PharmD

James Hayes, CPhT (7/15)

Michael Lewis, PharmD

Lise Hennick, RPh (2/15)

Susan McLeer, RPh

Ralph Marett, RPh (6/15)

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

Judson Mullican, RPh (11/14)

Whitney Pickett, RPh (11/14)

Natalie Nielsen, RPh

Annya Plotkina (6/15)

Mark Niday, RPh

Kimmy Sanders, PharmD (6/15)

Don Richie, RPh

Terry Shaw, RPh (6/15)

Amanda Paisley, PharmD

Jeff Smith, PharmD (5/15)

Rose Pinkstaff, RPh (1/15)

John Thomas, RPh (11/14)

Alex Pinkston IV, RPh Don Richie, RPh (11/14) Corey Rieck Carlos Rodriguez-Feo, RPh (12/14) Laurence Ryan, PharmD Olivia Santoso, PharmD Wade Scott, RPh (5/15) Diane Sholes, RPh (6/15)

GPhAâ&#x20AC;&#x2122;s lobbying can only be as effective as the support behind it. The association works every day to help ensure that legislation passed in Georgia is the best possible for you and your business. Visit GPhA.org/PharmPAC to hear learn more about PharmPAC.

Krista Stone, RPh (6/15) James Stowe, RPh (12/14) Dana Strickland, RPh G.H. Thurmond, RPh (11/14) Tommy Tolbert, RPh

The Georgia Pharmacy Journal

THE POLITICAL ACTION COMMITTEE OF THE GPhA

Get invested today.

Visit GPhA.org/PharmPAC or contact Andy Freeman at afreeman@GPhA.org or (804) 264-5033

F I N A N C I A L

Begin Before the End:

Why Families Need to Have Inheritance Conversations Now T he traditional view of inheritance is changing. When parents include their children in their inheritance plans, families are much happier with the outcomes, with nine out of ten heirs being highly satisfied when they know the details ahead of time. And yet, neither benefactors nor heirs feel comfortable having this difficult conversation. This reluctance is driven by emotional barriers on both sides. Benefactors feel it’s not a pressing issue and want to avoid creating a sense of entitlement in their heirs. Heirs feel it is not appropriate to bring up their parents’ money and they don’t want to look greedy. But both sides agree: the responsibility lies with the parents to start the conversation.

it requires starting well before the end and including family members in the process. And benefactors are starting to recognize the importance of this issue, with about half saying they would like to discuss their inheritance plans more with their heirs. While most benefactors have a will, they have not engaged in inheritance planning with their heirs. Question: “Which of the following do you have, or have you done?” An up to date will: 83% Discussed plans with children: 54% Let heirs know about wealth: 34%

1. Inheritance is no longer about waiting until the end.

Heirs indicate that the biggest barrier that kept their family from discussing inheritance plans was that they just didn’t talk openly about financial issues. They also did not want to bring up the topic for fear of appearing greedy. Benefactors, regardless of age, tend to feel it’s not a pressing issue. They also worry about their children counting too much on the inheritance or developing a sense of entitlement. Three in four view it as highly important that their children use their inheritance wisely and don’t squander it. Benefactors feel strongly that they want the inheritance process to go as smoothly as possible. The vast majority consider it highly important that the transfer of assets to their heirs goes smoothly, and two out of three consider it highly important that there are no bad feelings among their heirs about the inheritance. While nobody wants to start the conversation, both sides agree it is gen-

Families frequently avoid discussing this thorny topic until it is too late to address unresolved matters, leading to dissatisfaction and disagreements among heirs. However, when benefactors begin inheritance planning early and include heirs in the process, it leads to fewer disagreements among heirs and everyone is more satisfied. Families are starting to change their traditional approach to inheritance planning. Most benefactors have an up-to-date will and about half claim to have discussed plans with their children. But they are reluctant to divulge too much information, with only half saying their heirs know where the wealth is, and only about a third having disclosed their wealth to their heirs. Yet, good inheritance planning is much more than having a static will;

2. Key barriers get in the way of open discussions on inheritance planning.

erally up to the benefactor to do so. When asked about what could help ease the barriers to inheritance plan discussions, each constituency favors the parents raising the issue. Ultimately, it’s the parents’ money and their decision about what to do with it, so it is also up to them to decide when and what to share with their heirs. Benefactors care deeply about having a smooth inheritance process. Question: “How important are the following to you?” The transfer of assets goes smoothly from me to my heirs: 84% There are no bad feelings among heirs over who got what or how much: 66%

3. Inheritance planning is only a part of the wealth transfer process. Increasingly, wealth transfer planning includes not only a will, but also giving while living, managing taxes and providing support for multiple generations. Most benefactors prefer to begin passing on wealth to their heirs while living, with four out of five providing financial support to their adult children for a variety of reasons, including financial need and a desire to see their children succeed. Benefactors often give with multiple generations in mind. Nearly half of grandparents say it’s highly important that their assets also support their grandchildren. And nearly a quarter of them plan to leave part of their wealth directly to grandchildren. This sentiment is already at work. The number one way parents offer financial support to their adult children is by putting money into college funds for the grandchildren.

The Georgia Pharmacy Journal

F I N A N C I A L

Benefactors prefer giving while living, rather than passing on wealth posthumously. Question: “Which of the following best describes how you would prefer to pass on wealth to your heirs?” Prefer to pass on wealth while living: 60% Prefer to pass wealth posthumously: 40%

4. Families are happier & more satisfied when parents include heirs in planning. While it may not be an easy conversation to have, talking about inheritance planning makes a huge impact among heirs. When heirs know the details of the inheritance ahead of time they are much more satisfied with the distribution process. However, when heirs do not know the details ahead of time, they are more than twice as likely to have disagree-

ments among themselves about the inheritance distribution. The situation is even worse when there is a known unresolved issue prior to a parent’s passing, such as who will get the house. In these cases, satisfaction plunges among heirs and the likelihood of disagreements about the inheritance distribution skyrockets from 11% to 82%. Sensitive topics may not be easy to resolve, but it will only get harder once the parent passes. Transparency and conclusiveness in inheritance planning yields satisfied heirs . Question: “How satisfied were you with the process for the distribution of your parents’ estate when they passed away?” If no unresolved topics: 85% Knew inheritance details: 89% Had unresolved topics: 37% Did not know inheritance details: 65%

Break the silence.

Ultimately, successfully managing inheritance requires families to overcome the awkward silence, so that they can engage in open dialogue and more comprehensive planning. As part of the GPhA/ UBS Wealth Management Program, UBS is readily available to help guide you in these difficult conversations. For more information or guidance about inheritance planning, please contact Wile Consulting Group at UBS: 404-760-3000 or visit our website at www.ubs.com/ team/wile.

Content provided as part of the GPhA/UBS Wealth Management Program.

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

7.00_Ad_7.5x4.875_AX0220_WileConsultingGrp2 GphA

continuing education for pharmacists Volume XXXII, No. 6

New Drugs: Aptiom, Imbruvica, Luzu, and Sovaldi Thomas A. Gossel, R.Ph., Ph.D., Professor Emeritus, Ohio Northern University, Ada, Ohio Dr. Thomas A. Gossel has no relevant financial relationships to disclose.

Goal. The goal of this lesson is to provide information on eslicarbazepine acetate (Aptiom®), ibrutinib (Imbruvica™), luliconazole (Luzu®) and sofosbuvir (Sovaldi™). Objectives. At the completion of

this activity, the participant will be able to: 1. recognize signs and symptoms, and key features of targeted pathologies including information on their prevalence; 2. recognize important therapeutic uses for the drugs and their applications in specified pathologies; 3. select the indication(s), pharmacologic action(s), clinical application(s), dosing regimens, route of administration, and availability of each drug; 4. demonstrate an understanding of adverse effects and toxicity, warnings, precautions, contraindications, and significant drug-drug interactions reported for each agent; and 5. list important counseling advice to convey to patients and/or their caregivers. The four new-molecular entity drugs discussed in this lesson are indicated to treat a variety of pathologies (Table 1). This lesson provides a brief introduction to the drugs, and is not intended to extend beyond an overview of the topic. The reader is, therefore,

urged to consult the products’ full prescribing information leaflet (package insert), Medication Guide when available, and other published sources for detailed descriptions.

Eslicarbazepine Acetate (Aptiom)

Antiepileptic drugs (AED) are the major therapeutic intervention for epilepsy. A sizeable number of people with epilepsy experience pharmacoresistant seizures or encounter significant adverse effects with existing AED treatment. This poor response to seizure control means that combination therapy is recommended, but about 20 to 30 percent of patients continue to have seizures despite treatment with more than one AED. Therefore, there remains a need for new, effective AEDs, particularly those that can be used safely as adjuncts to standard therapy, to further reduce seizure frequency. Although structurally distinct from carbamazepine (e.g., Carbatrol, Tegretol) and oxcarbazepine (e.g., Trileptal, Oxtellar XR), eslicarbazepine acetate is chemically related to these carboxamide derivatives. Indications and Use. Aptiom (ap-TEE-om) is indicated as adjunctive treatment of partial-onset seizures. Partial-Onset Seizures. Epilepsy is caused by abnormal or excessive activity in the brain’s nerve cells. Epilepsy is one of the most common neurological disorders and, according to the Centers

for Disease Control and Prevention, affects nearly 2.2 million people in the United States, and up to 60 million people worldwide. Approximately 200,000 new cases of seizures and epilepsy occur in the United States each year. Partialonset seizures are the most common type encountered in patients with epilepsy. The International League Against Epilepsy classifies the disorder into three main types: partial (focal), generalized, and unclassified. Partial-onset epilepsy is restricted to discrete areas of the cerebral cortex while generalized epilepsy occurs in diffuse regions of the brain simultaneously. Because of the focused nature of a partial seizure, only a specific area of the body is usually involved. Treatment of partial-onset seizures is challenging since approximately 60 percent of patients with partialonset seizures do not achieve seizure control with current AEDs. Seizures can cause a wide range of symptoms, including repetitive limb movements, unusual behavior and generalized convulsions with loss of consciousness. Seizures can have serious consequences, including physical injury and death. Mechanism of Action. Eslicarbazepine acetate is extensively converted to eslicarbazepine, which is considered to be responsible for therapeutic effects. The precise mechanism(s) by which eslicarbazepine exerts anticonvulsant activity is unknown, but is believed

The Georgia Pharmacy Journal

Table 1 Selected new drugs Generic (Proprietary) Name

Distributor

Indication

Dose*

Dosage Form*

Most Common Side Effects

Eslicarbazepine acetate (Aptiom)

Sunovion Pharmaceuticals Inc.

adjunctive treatment of partial-onset seizures

800 mg once daily

200, 400, 600, 800 mg tablets

(>4%): dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, tremor

Yes

Ibrutinib (Imbruvica)

Pharmacyclics

mantle cell lymphoma

560 mg once daily

140 mg capsules

chronic lymphocytic leukemia

420 mg once daily

(>20%): thrombocytopenia, diarrhea, anemia, neutropenia, fatigue, vomiting, nausea, musculoskeletal pain, upper respiratory tract infection, bruising, dyspnea, constipation, abdominal pain, decreased appetite, peripheral edema, rash

1% topical cream

(<1%): application site reactions

400 mg tablets

(>20%): fatigue, headache§; fatigue, headache, nausea, insomnia, anemia#

Luliconazole (Luzu)

Sofosbuvir (Sovaldi)

Medicis (division of Valeant Pharmaceuticals)

interdigital tinea pedis

once daily for 2 weeks

tinea cruris tinea corporis

once daily for 1 week

Gilead Sciences

chronic hepatitis C infection

400 mg once daily

*Recommended dose for most patients § Sovaldi in combination with ribavirin

to involve inhibition of voltagegated sodium channels in rapidly firing neurons. This may make it more effective in persons who have failed other sodium channel blockers due to developing pharmacoresistance to them. Efficacy and Safety. Three clinical studies in which participants with partial-onset seizures were randomly assigned to receive eslicarbazepine acetate or placebo demonstrated that the drug is effective in reducing the frequency of seizures. The most common adverse effects reported by patients receiving the drug in these clinical trials included dizziness, drowsiness, nausea, headache, double-vision, vomiting, fatigue and loss of coordination. Like other antiepileptic drugs, Aptiom may cause suicidal thoughts or actions in a very small number of patients. Warnings, Precautions and

The Georgia Pharmacy Journal

Medication Guide±

Availability at the time of publication of this lesson Sovaldi in combination with ribavirin and peginterferon alfa

Contraindications. The following warnings and precautions are listed: •Suicidal behavior and ideation: Monitor for suicidal thoughts or behavior. •Serious dermatologic reactions: Monitor for dermatologic reactions and discontinue in case of serious dermatologic reactions. •Drug reaction with eosinophilia and systemic symptoms: Monitor for hypersensitivity. Discontinue if another cause cannot be established. •Anaphylactic reactions and angioedema: Monitor for breathing difficulties or swelling. Discontinue the drug if another cause cannot be established. •Hyponatremia (sodium <125 mEq/L): Monitor sodium levels in patients at risk or patients experiencing hyponatremia symptoms. Concurrent hypochloremia may also be present in patients with

hyponatremia. •Neurological adverse reactions: Monitor for dizziness, disturbance in gait and coordination, somnolence, fatigue, cognitive dysfunction, and visual changes. Use caution when driving or operating machinery. •Withdrawal of Aptiom: As with all antiepileptic drugs, withdraw Aptiom gradually and avoid abrupt discontinuation to minimize the risk of increased seizure frequency and status epilepticus. •Drug-induced liver injury: Discontinue Aptiom in patients with jaundice or evidence of significant liver injury. •Abnormal thyroid function tests: Dose-dependent decreases in T3 and T4 have been observed. Evaluate for clinical signs and symptoms of hypothyroidism. Hypersensitivity to eslicarbazepine acetate or oxcarbazepine is a contraindication to Aptiom.

Drug Interactions. Several considerations are listed: •Carbamazepine: May need dose adjustment for Aptiom or carbamazepine. •Phenytoin: Higher dosage of Aptiom may be necessary and dose adjustment may be needed for phenytoin based on clinical response and serum levels of phenytoin. •Phenobarbital or primidone: Higher dosage of Aptiom may be necessary. •Hormonal contraceptives: Aptiom may decrease the effectiveness of hormonal contraceptives. Females of reproductive potential should use additional or alternative non-hormonal birth control. Administration, Dosing, and Availability. Start treatment at 400 mg once daily. After one week, increase dosage to 800 mg once daily, which is the recommended maintenance dose. Some patients may benefit from the maximum recommended maintenance dosage of 1200 mg once daily, although this dosage is associated with an increase in adverse reactions. A maximum dose of 1200 mg daily should only be initiated after the patient has tolerated 800 mg daily for at least a week. For some patients, treatment may be initiated at 800 mg once daily, if the need for additional seizure reduction outweighs an increased risk of adverse reactions during initiation. A dose reduction is recommended in patients with moderate and severe renal impairment (i.e., creatinine clearance <50 mL/min). Aptiom is marketed as tablets containing 200 mg, 400 mg, 600 mg, and 800 mg of eslicarbazepine acetate. Patient Counseling Information. Specific points for patient counseling are summarized in Table 2.

Ibrutinib (Imbruvica)

Ibrutinib is the third drug approved to treat mantle cell lymphoma (MCL), following bortezomib (Velcade, 2006) and lenalidomide (Revlimid, 2013). FDA approved the drug under the agency’s ac-

celerated approval program. This permits FDA to approve a drug to treat a serious disease based on clinical trials showing that the drug has an effect on a surrogate endpoint, that is reasonably likely to predict a clinical benefit to patients. FDA granted orphanproduct designation because it is intended to treat a rare disease. Indications and Use. Imbruvica (im-BRU-vih-kuh) is indicated for treatment of patients with MCL who have received at least one prior therapy. This indication is based on overall response rate. Imbruvica’s indication was expanded in February of 2014 to include chronic lymphocytic leukemia (CLL). The dose for CLL is included in Table 1, but this indication will not be discussed further in this lesson. Mantle Cell Lymphoma. MCL is a rare, aggressive form of non-Hodgkin lymphoma and represents about 6 percent of all non-Hodgkin lymphoma cases in the United States. Many secondary genetic events contribute to tumor growth in MCL, including the loss of DNA damage-response capacity, activation of cell-survival pathways, and inhibition of apoptosis (natural or programmed cell death). Prognosis in MCL is the worst among all B cell lymphomas. Historically, MCL has been treated like most other forms of B cell nonHodgkin lymphoma, with regimens such as a combination of cyclophosphamide (e.g., Cytoxan), vincristine (e.g., Oncovin), doxorubicin (e.g., Adriamycin), and prednisone. However, early retrospective studies in the United States and Europe showed that MCL patients treated with such regimens had an overall survival of less than three years. In the United States, 2,900 new cases of MCL are diagnosed each year with a median age at diagnosis of 65. By the time the cancer is diagnosed, it usually has already spread to the lymph nodes, bone marrow, gastrointestinal tract, spleen, and other organs. Mechanism of Action. Ibrutinib is a small-molecule inhibitor of

Table 2 Patient counseling information for Aptiom* Inform patients: •to read the FDA-approved Medication Guide prior to taking Aptiom and to re-read it each time the prescription is refilled, and to take the drug exactly as prescribed; •that Aptiom may cause serious side effects including suicidal thoughts or behavior; potentially serious skin reactions including a rash, swelling of the face, eyes, lips, tongue, or difficulty in swallowing; liver disease; and neurological reactions including dizziness or vision problems, and to report any change from normal to their doctor at once; •that the drug may lower their blood level of sodium and to report symptoms such as nausea, tiredness or lack of energy, irritability, confusion, muscle weakness/spasms, or more frequent or severe seizures to their doctor; •that the drug may slow thinking or motor skills, so they should not drive or operate heavy machinery until they know how it affects them; •to not stop taking their medicine without consulting their doctor; •that female patients of childbearing age should use additional or alternative non-hormonal forms of contraception during treatment with Aptiom and for at least one month after treatment with Aptiom has been discontinued; •to tell their doctor about all medicines they are taking. They should ask their pharmacist if they are not sure; •to avoid giving Aptiom to other people even if they have similar symptoms. It may harm them. *A complete list of information is available in the product’s Medication Guide.

a cytoplasmic specific protein called Bruton’s tyrosine kinase (BTK) expressed in B cells and myeloid cells. The drug forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is a signaling molecule of the B-cell antigen receptor and cytokine receptor pathways. BTK’s role in signaling through the B-cell sur-

The Georgia Pharmacy Journal

Table 3 Patient counseling information for Imbruvica* Inform patients:

•to read the FDA-approved Patient Information leaflet; •of the possibility of bleeding, and to report any signs or symptoms (blood in stools or urine, prolonged or uncontrolled bleeding). Tell them that Imbruvica may need to be interrupted for medical or dental procedures; •of the possibility of serious infection, and to report any signs or symptoms (fever, chills) suggestive of infection; •of the possibility of renal toxicity and advise them to maintain adequate hydration; •that other malignancies have occurred in patients with MCL who have been treated with Imbruvica, including skin cancers and other carcinomas; •of the potential hazard to a fetus and to avoid becoming pregnant; •to take Imbruvica orally once daily according to their doctor’s instructions and that the capsules should be swallowed whole, without being opened, broken, or chewed, with a glass of water at approximately the same time each day; •that in the event of a missed daily dose of Imbruvica, it should be taken as soon as possible on the same day with a return to the normal schedule the following day, and that they should not take extra capsules to make up the missed dose; •of the common side effects associated with Imbruvica; •to inform their doctor of all medicines including prescription drugs and OTC products, vitamins, minerals, and herbal products they are taking; •that they may experience loose stools or diarrhea, and to contact their doctor if diarrhea persists.

*A complete list of information is available in the product’s Patient Information leaflet.

face receptors results in activation of pathways necessary for B-cell trafficking, chemotaxis, and adhesion. Ibrutinib inhibits malignant B-cell proliferation and survival. Efficacy and Safety. Imbruvica’s approval for MCL was based on a study with 111 participants

The Georgia Pharmacy Journal

who had received at least one therapy, and were given Imbruvica daily until their disease progressed or adverse effects became intolerable. Results revealed that nearly 66 percent of participants experienced tumor shrinkage or disappearance after treatment. An improvement in survival or disease-related symptoms has not been established. The most common adverse effects reported for MCL were thrombocytopenia (low levels of platelets in the blood), diarrhea, neutropenia (decrease in infection-fighting white blood cells), anemia, fatigue, musculoskeletal pain, edema, upper respiratory infection, nausea, bruising, shortness of breath, constipation, rash, abdominal pain, vomiting, and decreased appetite. Other clinically significant adverse effects include bleeding, infections, kidney problems, and development of other types of cancers. The adverse reaction most frequently leading to treatment discontinuation with Imbruvica was subdural hematoma. Warnings, Precautions and Contraindications. The following warnings and precautions are listed: •Hemorrhage: Monitor for bleeding. The mechanism for bleeding events is not well understood. •Infections: Monitor patients for fever and infections and evaluate promptly. •Myelosuppression: Check complete blood counts monthly. •Serious and fatal renal toxicity: Monitor renal function and maintain hydration. •Second primary malignancies: Other malignancies have occurred in patients, including skin cancers, and other carcinomas. •Embryo-fetal toxicity: Ibrutinib can cause fetal harm. Advise women of the potential risk to a fetus and to avoid pregnancy while taking the drug. There are no contraindications listed. Drug Interactions. Imbrutinib is primarily metabolized by cytochrome P450 enzyme 3A. Avoid co-administration with strong

or moderate CYP3A inhibitors and consider alternative agents with less CYP3A inhibition. Concomitant use of strong CYP3A inhibitors taken chronically (e.g., ritonavir, indinavir, nelfinavir, saquinavir, boceprevir, telaprevir, nefazodone) is not recommended. For short-term use (seven days or less) of strong CYP3A inhibitors (e.g., antifungals and antibiotics), consider interrupting Imbruvica therapy until the CYP3A inhibitor is no longer needed. Reduce Imbruvica dose to 140 mg if a moderate CYP3A inhibitor (e.g., fluconazole, darunavir, erythromycin, diltiazem, atazanavir, aprepitant, amprenavir, fosamprevir, crizotinib, imatinib, verapamil, grapefruit products, and ciprofloxacin) must be used. Administration, Dosing, and Availability. Administer Imbruvica orally once daily, at approximately the same time each day. Swallow the capsules whole with water; do not open, break, or chew the capsules. The recommended dose for MCL is 560 mg orally once daily. If a dose of Imbruvica is not taken at the scheduled time, it can be taken as soon as possible on the same day, with a return to the normal schedule the following day. Extra capsules of the dose should not be taken to make up for the missed dose. The product is available as capsules containing 140 mg of ibrutinib. Patient Counseling Information. Specific points for patient counseling are summarized in Table 3.

Luliconazole (Luzu)

Luzu (LOO-zoo) cream is the first topical azole antifungal approved to treat tinea cruris (jock itch) and tinea corporis (ringworm) with a one-week, once-daily treatment regimen. All other currently approved treatments require two weeks of treatment. For interdigital tinea pedis (athlete’s foot between the toes), the treatment is once daily for two weeks. Luliconazole provides good efficacy and tolerability with a short duration of

treatment. The drug has been approved in Japan since 2005. Indications and Use. Luzu cream is an azole antifungal indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in patients 18 years of age and older. Tinea Infections. Superficial mycoses (fungal) infections are not fatal, but they can seriously interfere with a patient’s quality of life in view of the considerable discomfort such as itching and interference with sleep, and/or cosmetic deformity. These diseases are found worldwide and affect 20 to 25 percent of the world’s population. Dermatophytosis (tinea infection) is the most common infection among the superficial mycoses. According to an epidemiological survey of ambulatory visits in the United States, the incidences of dermatophytosis were as high as 23.2 percent, 20.4 percent, and 18.8 percent respectively, during 1995 to 2004. T. rubrum, an anthropophilic (preferring humans to other animals) fungus, is the most prevalent causative agent of dermatophytosis in developed countries. Its incidence has not changed in recent decades, although many antifungal drugs with potent action against this species have become available during this period. Mechanism of Action. Although the exact mechanism of action against dermatophytosis is unknown, luliconazole appears to inhibit fungal ergosterol synthesis by inhibiting the enzyme lanosterol demethylase. Inhibition of this enzyme’s activity by azole antifungals results in decreased amounts of ergosterol, a constituent of fungal cell membranes, and a corresponding accumulation of lanosterol. Efficacy and Safety. Approval was based on three pivotal U.S. trials that included 679 adults with either tinea pedis (two trials) or tinea cruris (one trial). For the two studies in tinea pedis with a treatment duration of two weeks,

the primary endpoint was defined as complete clearance four weeks post-treatment. In study #1, 26 percent of participants treated with luliconazole were completely cleared, compared with 2 percent of those treated with vehicle alone. In study #2, 14 percent of participants treated with luliconazole were completely cleared, compared with 2 percent of those treated with vehicle alone. In the tinea cruris trial, complete clearance was assessed three weeks post-treatment. After one week of treatment, 21 percent of patients treated with luliconazole were completely cleared, compared with only 4 percent of those treated with vehicle alone. The most common adverse events were mild application site reactions reported in less than 1 percent of subjects for both luliconazole and vehicle. Warnings, Precautions and Contraindications. There are no warnings, precautions or contraindications listed. Drug Interactions. The potential of luliconazole to inhibit cytochrome P450 enzymes (1A2, 2C9, 2C19, 2D6, and 3A4) was evaluated. When applied in therapeutic doses to patients with moderate to severe tinea cruris, luliconazole may inhibit the activity of CYP2C19 and CYP3A4. However, no in vivo trials have been conducted to assess the effect of luliconazole on other drugs that are substrates of CYP2C19 and CYP3A4. The drug is not expected to inhibit cytochromes 1A2, 2C9, or 2D6. The induction potential of luliconazole has not been evaluated. Administration, Dosing, and Availability. When treating interdigital tinea pedis, a thin layer of Luzu cream should be applied to the affected skin areas and to about one inch of the surrounding healthy skin, once daily for two weeks. When treating tinea cruris or tinea corporis, Luzu cream should be applied in the same manner as tinea pedis above, once daily for one week. Luzu cream contains 1 percent luliconazole. Patient Counseling Infor-

Table 4 Patient counseling information for Luzu* Inform patients: •to read the FDA-approved Patient Information leaflet; •that this medicine is for use on the skin only, and it should not be used on or near the eyes, mouth, or vagina; •to tell the doctor if they are pregnant or plan to become pregnant, and about all medicines including prescription drugs and OTC products, vitamins, minerals, and herbal supplements they are taking; •about possible side effects including skin irritation; •to use the medicine exactly as the doctor instructs, and to wash their hands after applying Luzu cream. *A complete list of information is available in the product’s Patient Information leaflet.

mation. Specific points for patient counseling are summarized in Table 4.

Sofosbuvir (Sovaldi)

Sovaldi (soh-VAHL-dee) is the second drug approved by FDA during the last part of 2013 to treat chronic hepatitis C virus (HCV) infection. The other drug was simeprevir (Olysio). Indications and Use. The drug is to be used as a component of a combination antiviral treatment regimen for chronic HCV infection. There are several different types of HCV infection. Depending on the type of HCV infection a person has, the treatment regimen could include Sovaldi and ribavirin (Copegus, Rebetol, & others) or Sovaldi, ribavirin, and peginterferon alfa (PEG-intron, Pegasys). Both ribavirin and peginterferon alfa are also used to treat HCV infection. If these other agents used in combination with Sovaldi are permanently discontinued, Sovaldi should also be discontinued. Sovaldi efficacy has been established in subjects with HCV genotype 1, 2, 3 or 4 infection, including those with hepatocellular carcinoma who are awaiting liver transplantation and those with HCV/HIV-1 co-infection.

The Georgia Pharmacy Journal

Table 5 Patient counseling information for Sovaldi* Inform patients: •to read the FDA-approved Patient Information leaflet; •that Sovaldi is used in combination with other antiviral medicines, and they should read the Medication Guides supplied with those other drugs. The drug should not be used alone; •that Sovaldi may cause birth defects or death in an unborn baby, so the drug should not be used during pregnancy or if a female plans to become pregnant. Females and males must use two effective forms of birth control during treatment, and for six months after treatment with Sovaldi; •to tell their doctor if they have liver problems or a liver transplant, kidney problems or if on dialysis, have HIV or any other medical conditions, or are breastfeeding or plan to breastfeed; •to tell the doctor about all medicines including prescription drugs and OTC products, vitamins, minerals, and herbal supplements they are taking; •to take Sovaldi exactly as the doctor prescribes, and to not stop taking it or change doses without telling their doctor; •to tell the doctor about any side effect that is bothersome or does not go away; •to keep Sovaldi in its original container and to not use if the seal over the bottle opening is broken or missing. *A complete list of information is available in the product’s Patient Information leaflet.

Before initiating treatment with Sovaldi, the following points should be considered: (1) monotherapy of Sovaldi is not recommended for treatment of chronic HCV; (2) treatment regimen and duration are dependent on both the viral genotype and patient population; and, (3) treatment response varies based on baseline host and viral factors. Hepatitis C. As many as 170 million persons are chronically infected with HCV worldwide, with more than 350,000 dying annually from liver disease caused by

The Georgia Pharmacy Journal

HCV. Estimates of the number of persons in the United States who are chronically infected range from 2.7 million to 5.2 million. For previously untreated cases of HCV genotype 1 infection, representing more than 70 percent of all cases of chronic HCV infection in the United States, the current standard of care is 12 to 32 weeks of an oral protease inhibitor, combined with 24 to 48 weeks of peginterferon alfa plus ribavirin, with the duration of therapy guided by the on-treatment response and the stage of hepatic fibrosis. For patients infected with HCV genotype 2 or 3, until Sovaldi was approved, no direct-acting antiviral drugs had been available. The virus causes inflammation of the liver that can lead to diminished liver function or failure. Most people infected with HCV are without symptoms of the disease until hepatic damage becomes apparent, which may take several years. Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections, or liver cancer. Mechanism of Action. Sovaldi is a direct-acting antiviral agent against HCV. It is an inhibitor of HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate, which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator. Efficacy and Safety. Effectiveness was evaluated in six clinical trials that consisted of 1,947 participants who had not previously received treatment for their disease (treatment-naïve) or had not responded to previous treatment (treatment-experienced), including participants co-infected with HCV and HIV. The trials were designed to measure whether HCV

was no longer detected in the blood at least 12 weeks after finishing treatment (sustained treatment virologic response), suggesting a participant’s HCV infection had been cured. Results from all clinical trials showed that a treatment regimen containing Sovaldi was effective in treating multiple types of HCV. Additionally, Sovaldi demonstrated efficacy in participants who could not tolerate or take an interferon-based treatment regimen, and in participants with liver cancer awaiting liver transplantation, addressing unmet medical needs in these populations. The most common adverse effects reported in clinical study participants treated with Sovaldi and ribavirin were fatigue and headache. In participants treated with Sovaldi, ribavirin, and peginterferon alfa, the most common adverse affects reported were fatigue, headache, nausea, insomnia, and anemia. Warnings, Precautions and Contraindications. The following warning/precaution is listed: •Pregnancy: Ribavirin may cause birth defects and fetal death, and animal studies have shown interferons have abortifacient effects; avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to initiating therapy, use at least two effective non-hormonal methods of contraception, and have monthly pregnancy tests. The following contraindications are listed: •When used in combination with peginterferon alfa/ribavirin or ribavirin alone, all contraindications to peginterferon alfa and/ or ribavirin also apply to Sovaldi combination therapy. •Because ribavirin may cause birth defects and fetal death, Sovaldi in combination with peginterferon alfa/ribavirin or ribavirin is contraindicated in pregnant women, and in men whose female partners are pregnant. Drug Interactions. Drugs that are potent intestinal P-

glycoprotein (P-gp) inducers (e.g., rifampin, St. John’s Wort) may significantly reduce plasma concentrations of sofosbuvir and, thus, lead to a reduced therapeutic effect. Rifampin and St. John’s Wort should not be used with Sovaldi. An extensive list of other drugs that may lead to potentially significant drug interactions with Sovaldi is included in the product’s prescribing information. Consult the full prescribing information prior to use for potential drug-drug interactions. Administration, Dosing, and Availability. The recommended dose of Sovaldi is one 400 mg tablet, taken orally, once daily with or without food for 12 to 24 weeks. Dose reduction with Sovaldi is not recommended. Sovaldi should be used in combination with ribavirin or with a combination of ribavirin and pegylated interferon. Used in combination with ribavirin, Sovaldi is recommended for up to 48 weeks or until the time of liver transplantation, whichever comes first, to prevent post-transplant HCV reinfection. The product is available as tablets containing 400 mg sofosbuvir. It should be dispensed in its original container. Patient Counseling Information. Specific points for patient counseling are summarized in Table 5.

Program 0129-0000-14-006-H01-P Release date: 6-15-14 Expiration date: 6-15-17

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.

Overview and Summary

The four new drugs are indicated to treat a wide variety of pathologies. In each case, the drugs have been shown to be effective and safe when used as directed. Each offers advantages over earlier treatments used to manage the respective disease states.

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.

The Georgia Pharmacy Journal

continuing education quiz

Please print.

Program 0129-0000-14-006-H01-P 0.15 CEU

Name________________________________________________

New Drugs: Aptiom, Imbruvica, Luzu and Sovaldi

Address_____________________________________________

1. What percentage of people with epilepsy continues to have seizures despite treatment with more than one antiepileptic drug? a. 5-10 c. 20-30 b. 10-20 d. 30-40

Email_______________________________________________

2. All of the following statements about Aptiom are true EXCEPT: a. its precise mechanism of action is unknown. b. it may cause suicidal thoughts and behavior. c. sodium levels should be monitored. d. taken with phenobarbital, a lower dose of Aptiom may be necessary.

4. All of the following are true statements about mantle cell lymphoma EXCEPT: a. it is a rare, aggressive form of non-Hodgkin lymphoma. b. it represents about 2 percent of all non-Hodgkin lymphoma. c. about 2,900 new cases are diagnosed in the U.S. each year. d. by the time it is diagnosed, it has usually spread to the lymph nodes. 5. Imbruvica is indicated for treatment of patients with mantle cell lymphoma who: a. are resistant to ribavirin and peginterferon alfa. b. have received at least one prior therapy. c. are free of serious systemic fungal infections. d. are six years of age and older. 6. The adverse reaction most frequently leading to treatment discontinuation with Imbruvica was: a. diarrhea. c. anemia. b. subdural hematoma. d. bruising. 7. All of the following are true statements about tinea infections EXCEPT: a. they are found worldwide. b. they may interfere with sleep. c. their incidence has increased since 2005. d. they are anthropophilic infections.

Completely fill in the lettered box corresponding to your answer. [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] [d]

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

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

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

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

3. The maximum daily recommended maintenance dose of Aptiom is: a. 200 mg. c. 1200 mg. b. 600 mg. d. 1500 mg.

1. 2. 3. 4. 5.

City, State, Zip______________________________________

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

 I am enclosing $5 for this month’s quiz made payable to: Ohio Pharmacists Association. 1. Rate this lesson: (Excellent) 5 4 3 2 1 (Poor) 2. Did it meet each of its objectives?  yes  no If no, list any unmet_______________________________ 3. Was the content balanced and without commercial bias?  yes  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.

8. Which of the following is appropriate patient advice for Luzu cream? a. Apply a thin layer to affected skin areas and to about one inch of the surrounding healthy skin. b. Squeeze one inch of cream onto the affected area only. c. Avoid exposure to sunlight, incandescent lights and excessive heat. d. Avoid concomitant use of cosmetic skin lightener ointments and creams. 9. All of the following statements are appropriate in counseling patients on Sovaldi EXCEPT: a. do not drive or operate heavy machinery while taking Sovaldi. b. take with or without food. c. store Sovaldi in its original container. d. it should not be used during pregnancy. 10. Which of the following drugs inhibits Bruton’s tyrosine kinase? a. Aptiom c. Luzu b. Imbruvica d. Sovaldi 11. Which of the following drugs was approved to be used in combination with ribavirin or ribavirin and peginterferon alfa? a. Aptiom c. Luzu b. Imbruvica d. Sovaldi 12. Which of the following drugs was approved with orphanproduct designation? a. Aptiom c. Luzu b. Imbruvica d. Sovaldi 13. Seventy percent of chronic hepatitis C virus infections in the U.S. are caused by which of the following HCV genotypes? a. 1 c. 3 b. 2 d. 4 14. All of the following drugs are taken orally EXCEPT: a. Aptiom. c. Luzu. b. Imbruvica. d. Sovaldi. 15. The label of which of the following drugs lists no warnings, precautions or contraindications? a. Aptiom c. Luzu b. Imbruvica d. Sovaldi

To receive CE credit, your quiz must be received no later than June 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.

june 2014

The Georgia Pharmacy Journal

P O S T S C R I P T

The more things change I

t’s always fun to look into the past — where we’re younger, healthier, have more hair (or less, depending on the situation), and when things were simpler and easier. Forty-someodd years ago, my pharmacist was Kenny and he owned Campus Drugs in Flushing (that’s N.Y.). We never called it “Campus Drugs” — it was “the drugstore.” Kenny wasn’t “the pharmacist,” he was simply “Kenny.” He gave my mother placebos to “cure” some ailment of my brother’s. He gave us Coke syrup to help with a stomachache. He even got my friend and me a bottle of Andrew Kantor Editor potassium nitrate for a, um, science project. Campus Drugs is gone now, as is Willie’s Hardware, the Paperbound Book Shop, and Met Food. Times change. Usually. I had taken a trip in the WABAC machine* — in this case, the bookshelves in the GPhA offices — to scout through issues of this very magazine from 25 years ago. I was looking for information on two of GPhA’s past presidents. Flipping through the issues from the early- and mid-’80s it was clear what had changed… and what hadn’t. Unchanged: A column wondering when the U.S. would join the rest of the world with a single-payer healthcare system, and whether that would be good for pharmacy. Changed: An ad from Marion Laboratories featured a Rolodex, while IBM’s implied that its FastClaim system was faster than a Saturn V rocket. Unchanged: Then-GPhA president Jim Martin worried about reimbursement rates from third parties. Changed: As an example, he wrote, “If the average prescription price is $16.50, then pharmacists are going to have to be reimbursed at least 35% gross profit or $5.78 to cover expenses…” Unchanged: An article talking about increasing diversity in pharmacy. Changed: It featured eight older men and two women, all white. Whoever sits at my desk in 2039 might look at this issue and laugh at our silly keyboards (what, no neural shunts?), member photos that only included humans, and the idea of actually holding a meeting in person. She might also nod her head thoughtfully at our worries about regulation, compensation, and whatever drug is being abused by kids. The more things change, after all, the more they remain the same. Except for the hair.

*Google it

The Georgia Pharmacy Journal

AIP

Fall Meeting

Sunday, October 26, 2014 Macon Marriott & Centreplex Macon, GA

Agenda

7:00am Registration and Continental Breakfast 8:00am Measuring Quality Performance Standards and the CMS STAR ratings system: Pharmacies Role Elliot Sogel, Ph.D., R.Ph., F.A.Ph.A. 9:00am Star Ratings 101 John A. Galdo, Pharm.D., BCPS, CGP 10:00am ATEB—Adherence Program (Non CE) 11:00am Network with Partners 12:00pm Lunch with special guest speakers Rep. Doug Collins and Sen. Buddy Carter 1:00pm Prescribe Wellness - Adherence Program (Non CE) 2:00pm Medicaid Update (flu shots) Linda Wiant, PharmD, Director of Pharmacy DCH 3:00pm Legislative Update Andy Freeman 4:00pm Adjourn

• CE Programs on “Star Ratings” • Medicaid and Legislative Updates • Network with Colleagues • Meet with Partners

Continental Breakfast & Lunch Provided!

SHOW YOUR SUPPORT! ATTEND THIS YEAR’S AIP FALL MEETING Registration: (For Planning Purposes Please Fill Out and Return this Form) Member’s Name:

Nickname:

Pharmacy Name: Address: E-mail Address (Please Print): Will you be joining us for lunch (12-1pm)? Yes Names of Staff/Guests:

# of additional Staff/Guests:

PLEASE FAX BACK TO (404) 237-8435

THE GEORGIA PHARMACY ASSOCIATION

50 Lenox Pointe, NE Atlanta, GA 30324

Do the math. Make your investment in PharmPAC today. And stay tuned. Weâ&#x20AC;&#x2122;ll be calling on you soon to enlist as a grassroots contact for your Georgia Legislator. Make an annual or monthly investment in PharmPAC. Contact Andy Freeman at afreeman@gpha.org to set up your investment today.

Diamond Level

$4800 or $400 a month

Titanium Level

$2400 or $200 a month

Platinum Level

$1200 or $100 a month

Gold Level

$600 or $50 a month

Silver Level

$300 or $25 a month

Bronze Level

$150 or $12.50 a month

THE POLITICAL ACTION COMMITTEE OF THE GPhA

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