Georgia Pharmacy Journal by Georgia Pharmacy Association

The Official Publication of the Georgia Pharmacy Association

February 2012

Special Focus on Drug Abuse

Volume 34, Number 2 www.gpha.org

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Content/Features Departments

feature articles

Special Focus on Drug Abuse:

8 Drug Abuse within the Profession

9 Protect Yourself from Rogue Pain Clinics

10 DEA Places Carisoprodol in Schedule IV 5

We Hope to See You on the Slopes!

12 Regions Bank Reverses Mandatory Mail Order Decision

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Important Pharmacy Legislation

Pharmacy-Based Immunization Delivery Program

24 CPE Opportunity - New Drugs: Arcapta, Brilinta & Xarelto

columns 4

President’s Message

Editorial

5 GPhA News 7 GPhA Awards Nomination Form 8 Georgia Board of Pharmacy News 9 GDNA Pharmacy News 12 AIP Member News 13 D. Steve Wilson Announcement 13 GPhA Member News 16 Pharm PAC Members 18 Pharm PAC Contribution Form 19 GPhA Legislative News 20 Pharmacy Time Capsules 30 GPhA Board of Directors 30 Masthead

2 Pharmacists Mutual Companies 5 Financial Network Associates 5 Melvin M. Goldstein, P.C. 11 Frances Cullen 13 GPhA Convention Information 15 Barbara Cole, Attorney at Law 15 Logix, Inc. 17 EC Retail Studio 21 GPhA Workers’ Compensation 22 AIP 32 UBS

Find GPhA’s up-to-date Calendar of Events at:

www.gpha.org

The Georgia Pharmacy Journal

February 2012

President’s message L. Jack Dunn, Jr., R.Ph. President Georgia Pharmacy Association

“Gear-Up” for the Legislative General Assembly

FL coaches use a number of “one –liners” to get their players and coaches mentally ready for upcoming championship games, including:

I want to share some additional news regarding professional development. In January your GPhA executive committee, at their own personal expense, attended an educational program sponsored by the Colorado Pharmacy Association. The program provided 15 hours of Continuing Pharmacy Education (CPE) credits along with the opportunity to ski and enjoy the majestic Rocky Mountains. The executive committee felt it was important to explore new opportunities for pharmacists to acquire CPE and have the ability to share ideas with pharmacists from other states.

“Attitude is a choice” “See challenges as opportunities” “Humility comes before honor” “Only worry about what you can control” “Have the proper state of mind” “Adversity is inevitable—so be prepared to see it as an opportunity to get better” “If you think you can…you can”

Motivational one-liners can also be used in our profession to give pharmacists an incentive to get ready for the legislature’s General Assembly. February is the month when pharmacists must get involved in the legislative process. This means getting to know the senators and representatives in your district. As a pharmacist, you can talk to your senators and representatives so they are informed about which laws would help or hinder our profession. Here are several ways for you to review proposed laws that are related to our profession: 1) read the monthly Georgia Pharmacy Journal; 2) visit GPhA’s website at www.gpha.org; 3) read your weekly Pharm-O-Gram email, GPhA’s government affairs e-newsletter, distributed every Friday; and 4) call Andy Freeman, GPhA’s director of government affairs, at (404) 419-8118. Andy can give you information about current events as they arise throughout the General Assembly. As these one-liners state, “challenges are opportunities and adversity is an opportunity to get better,” so pharmacists must get ready for this General Assembly. Please stay focused on the political process and up-todate on the laws as they pertain to your profession.

The Georgia Pharmacy Journal

Make your reservation and be ready to take advantage of a great four-day trip to ski and get your CPE in Vail, Colorado, in January 2013.

Above left to right: Jack Dunn; Robert Hatton; Kimberly Hatton; Jonathan Marquess; Pam Marquess; and Eddie Madden. Right: Eddie Madden.

February 2012

G P H A NE W s Robert Hatton GPhA President Elect Georgia Pharmacy Association

We Hope to See You on the Slopes!

n January 8-11, 2012, friends and members of the Georgia Pharmacy Association (GPhA) went to Beaver Creek, Colorado to stay at the Westin Riverfront Resort and Spa to participate in the 20th Annual Continuing Pharmacy Education (CPE) and Ski Conference sponsored by the Colorado Pharmacists Society and co-sponsored by GPhA. Some people have attended for many years, while for a few it was our first visit.

Your financial plan may need another look.

The sessions provided information to our pharmacy professionals and they enjoyed skiing and the beautiful Rocky Mountain scenery. At GPhA, we find attending and supporting other states’ association events allows us to develop fresh ideas that help us provide new and exciting benefits to our members. More information and an early registration form for the 2013 Colorado CPE program are available at www.copharm.org.

Melvin M. Goldstein, P.C. A T T O R N E___ Y AT

248 Roswell Street Marietta, Georgia 30060

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LAW

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n Private practitioner with an emphasis on representing healthcare professionals in administrative cases as well as other legal matters n Former Assistant Attorney General for the State of Georgia and Counsel for professional licensing boards including the Georgia Board of Pharmacy and the Georgia Drugs and Narcotics Agency n Former Administrative Law Judge for the Office of State Administrative Hearings

February 2012

E X E C UTI V E V I C E P RESIDENT ’ S EDITORIAL Jim Bracewell Executive Vice President / CEO Georgia Pharmacy Association

Let There Be Light!

n incandescent light bulb is only about 10% efficient? That is right—it gives out more heat than light.

Like many of you, I have been replacing my incandescent light bulbs with efficient fluorescent bulbs whenever I have the opportunity. Likewise, our current challenge is to replace our “incandescent” grassroots pharmacy advocates with energy efficient “fluorescent” advocates—members who will provide information that their legislators need. This information is available to you from your association and its government affairs department, specifically through Andy Freeman, our director of government affairs, at (404) 419-8118 or afreeman@gpha.org.

Amory Lovins of the Rocky Mountain Institute calculated that replacing a 75-watt incandescent light bulb with an 18-watt compact fluorescent (that gives the same amount of light) would, over the lifespan of the new bulb, prevent the emission of about one ton of carbon dioxide and eight kilograms of sulphur dioxide into the atmosphere, plus give you huge savings on electricity costs, and the compact fluorescent will last more than 10 times longer. Even so, you will find that incandescent light bulbs are very popular and seen in almost every grid-connected house in America.

Another great way to stay informed is to read the GPhA Pharm-O-Gram, a weekly emailed news publication that outlines the most pertinent pharmacy issues currently under consideration by the legislature. If you are not receiving the GPhA Pharm-O-Gram, simply email Kelly McLendon at kmclendon@gpha.org to be added to the email list.

So why is your Executive Vice President sharing information with you regarding efficient lighting? Because, I see a strong parallel between the wasteful incandescent light bulb and the inefficient efforts of some of our most energized members when it comes to grassroots advocacy.

Pharmacy needs you to be more proactive than ever in order to create the future for the pharmacy profession that you want—for the sake of your career and for your pharmacy practice.

All too often our members become more focused on using their energy to create heat on their legislator rather than on using their efforts to create light that might truly educate our legislators about important pharmacy issues.

Decide today to be an efficient advocate for your profession. Become an efficient “fluorescent” advocate and no longer waste time and energy creating more heat than light by not investing in educating our legislators prior to a vote.

Legislators are much more receptive to constituents who seek to educate them on issues, rather than constituents who simply pressure legislators to vote their way. Elected representatives are faced with a huge quantity of bills each year, often seeing more than 2,000 in a given legislative session. Therefore they are anxious for their supporters to provide them with factual information they can rely upon. With your advocacy efforts you can help representatives take a positive position on the important issues facing pharmacists in Georgia.

The Georgia Pharmacy Journal

Let there be pharmacy light—and more of it.

February 2012

Last call for GPhA awards nominations...

The Georgia Pharmacy Association’s Awards Committee invites you to submit nominations for the following awards. Nominations will be received by the Awards Committee and one individual will be selected for presentation of each award at GPhA’s 137th Annual Convention at the Hilton Head Marriott Resort & Spa on Hilton Head Island in July 2012. Bowl of Hygeia Award

Recognized as the most prestigious award in pharmacy, the Bowl of Hygeia Award is presented annually by GPhA and all state pharmacy associations. Selection Criteria: 1) Nominee must be a licensed Georgia pharmacist; 2) Award is not made posthumously; 3) Nominee is not a previous recipient of the Award; 4) Nominee is not currently serving nor has served within the immediate past two years as an officer of GPhA (other than ex-officio capacity or its awards committee;) 5) Nominee has an outstanding record of service to the community which reflects well on the profession.

Distinguished Young Pharmacist Award

Created in 1987 to recognize the achievements of young pharmacists in the profession, this Award has quickly become one of GPhA’s most prized awards. The Award’s purpose is two-fold - to encourage new pharmacists to participate in association and community activities and to annually recognize an individual in each state for involvement in and dedication to the pharmacy profession. Selection Criteria: 1) Nominee must have received an entry degree in pharmacy less than ten years ago; 2) Nominee must be a licensed Georgia pharmacist; 3) Nominee must be a GPhA member in the year of selection; 4) Nominee must be actively engaged in pharmacy practice; 5) Nominee must have participated in pharmacy association programs or activities and community service projects.

Innovative Pharmacy Practice Award

This Award is presented annually to a practicing pharmacist who has demonstrated innovative pharmacy practice resulting in improved patient care. Selection Criteria: 1) Nominee must have demonstrated innovative pharmacy practice which has resulted in improved patient care; 2) Nominee must be a licensed Georgia pharmacist; 3) Nominee must be a member of the GPhA in the year of selection.

2012 Awards Nomination Form - Submission deadline is Monday, March 1, 2012. Bowl of Hygeia

Distinguished Young Pharmacist

Innovative Pharmacy Practice Award

(Complete one form per individual nomination.) Nominee’s Full Name _______________________________________________ Nickname ___________________ Home Address _________________________________________ City _______________ State _____ Zip ______ Practice Site __________________________________________________________________________________ Work Address __________________________________________ City _______________ State _____ Zip ______ College/School of Pharmacy _____________________________________________________________________ List of professional activities, state/national pharmacy organization affiliations, and/or local civic or church activities: ____________________________________________________________________________________________ ____________________________________________________________________________________________ Supporting information: _________________________________________________________________________ ____________________________________________________________________________________________ Submitted by (optional): _________________________________________________________________________ Submit completed form(s) by March 1, 2012 to: GPhA Awards Committee, 50 Lenox Pointe, Atlanta, GA 30324 or complete this form online at www.gpha.org.

The Georgia Pharmacy Journal

February 2012

G e o r g i a B o a r d o f P h a r m a cy N e w s Bill Prather, R.Ph. President Georgia Board of Pharmacy

Drug Abuse within the Profession

rug abuse is a generic term that like “tax reform” rolls off the tongue like boiled okra or raw oysters, particularly during election time. We all talk about it and billions have been spent to combat it, study it and catalog its effects, mostly to no avail.

prescribed pain-relieving drugs and found they could not stop. But in many cases they just thought taking the drug would help them through a hard day and make them feel better. And guess what? It did. Some people can handle it, but many cannot. They soon find themselves taking not just one hydrocodone to help with having had a few too many beers the night before, but taking 30 or 40 tablets a day. It is particularly sad when we must deal with students or recent graduates who may see all their career, education and dreams go up in smoke, sometime literally. It seems that many students and younger pharmacists either do not fully appreciate the implications, or are unaware of the implications, of the use of Cannabis. As a schedule I narcotic, this drug is not acceptable as a form of recreation or treatment for any illness, as an inhalant, in this state or this country.

At the Georgia State Board of Pharmacy, we deal with drug abuse at two levels as it relates to our profession. First, we deal with drug abuse as it pertains to pharmacists and pharmacies that seem to cherish dollars more than ethics. Those individuals who prefer to make $8 or $9 per tablet filling bogus prescriptions (they may be legal, but are still bogus) with no regard for how the medication will be used or by whom. They are no better than back-alley, drug-pushers and we will treat them as harshly as the law allows. I am not speaking here of the pharmacist who is sometimes fooled by an excellent forgery or does his best to check out patients and prescriptions as most of our Georgia pharmacists do. I’m referring to the few who would steal the nickels off a dead man’s eyes and never think twice. Those who never give a thought to the fact that the tablets they dispense might be sold to teenagers in parking lots. Maybe the Good Lord will show them mercy, but if they are judged guilty—the Board of Pharmacy will not.

No matter your age, if you have a drug problem—get help. If you know someone who has a problem—get them help. Drug addiction (A.K.A. drug abuse) is like cancer and, if caught early, can many times be effectively treated and careers saved. I have seen it happen. The alternative can be much worse than the embarrassment of losing a license, going through drug rehab or appearing before the Board to plead for your license back. I know for a fact it can mean not only broken dreams, but broken hearts that occur at funerals. Do not let it happen. You are a pharmacist and you are too smart for that. Plus the Profession, and your patients, need you.

Do you know why most Georgia pharmacists lose their licenses? It is because they are taking the drugs instead of selling them via legal/ethical prescriptions. This brings us to the second group that the Board encounters. Each month we meet with at least three Georgia pharmacists who have become addicted to narcotics and/or alcohol. Sometimes they have excuses, such as an injury or accident in which they were

The Georgia Pharmacy Journal

If you know someone who needs assistance, call (404) 362-8185. The PharmAssist Hotline is available 24 hours a day, seven days a week. Your confidential call will be returned as quickly as possible.

February 2012

G DNA P H ARMA C Y NE W S C. Richard Allen, R.Ph. Director Georgia Drugs and Narcotics Agency

Protect Yourself from Rogue Pain Pill Clinics

nce again, the Falcons gave us whiplash. We didn’t know what to expect from one week to the next. Not many could have predicted what went on this last season. Me? I won’t even think about placing a bet on what could happen next season, so please don’t expect to read here that I’m making a wager—I’m not a gambling man. Give me a few rolls of coins at a Las Vegas casino and I’m quite content. But put some chips in my hand at a blackjack table and my forehead breaks out in beads of sweat. Thank goodness there was never a life or death reason to convince anyone that I can gamble.

excuses are no longer going to work. Similar excuses will no longer work for physicians either. This is because the DEA has finally given us at the Georgia Drugs and Narcotics Agency examples to explain the term “Corresponding Liability.” This term appears throughout the DEA rule book, and ours, and it is one that all pharmacists and physicians are responsible for knowing when they dispense and prescribe controlled substances. Of special note are the following definitions: • Failing to review patient drug histories or verify questionable prescriptions. • Filling forged prescriptions on a routine basis (see above.) • The quantity on a group of prescriptions is questionably excessive for healthy looking patients. • Most, if not all, patients who get prescriptions from the same doctor receive the same drugs and quantities. • Young healthy patients getting narcotics, muscle relaxers, and anti-anxiety drugs in large quantities. • Patients who travel great distances, visit a physician and then drive to out-of-the-way pharmacies to get prescriptions filled.

All of which leads me to the point of this article: rogue pain pill clinics and the practice of filling questionable prescriptions from questionable practitioners for questionable patients. Reckless filling of prescriptions is nothing more than a gamble—a huge gamble. Now, before you give the same old excuses that all of you know, such as… • “The doctor has a valid DEA registration and that’s good enough for me.” • “I verify some of the prescriptions, and it’s not my job to second guess what a physician prescribes.” • “Our volume of business is too great to screen all these pain prescriptions.” • “I’m not responsible for what my customer does with the drugs I dispense.” • “It sure is good money, and I need the business.” …you need to be aware of some new information.

If you are filling these types of prescriptions, please read and commit this information to memory. It is never a pleasant experience when a pharmacist places their license in jeopardy and it’s especially unpleasant for me whenever it happens to a pharmacist. But it happens and right now our state is overrun with these rogue pain clinics.

According to the Drug Enforcement Administration (DEA), as unveiled at a recent national meeting, these

Rogue clinics are those owned by non-physicians, run (continued on next page)

The Georgia Pharmacy Journal

February 2012

G DNA P h a r m a cy N e w s (continued from page 9) by questionable managers who hire their physicians off Craigslist, and other such questionable locations, require cash for appointments, see mostly patients from states other than Georgia, and on and on. There is an obscene amount of money being made because of rogue clinics – by the clinic, the physician writing the prescriptions and the pharmacist who fills them. The problems they have created are complicated for the health care professionals who take the gamble by getting involved with them. And when law enforcement and regulatory agencies get involved, the problems are really going to get complex and severe. Worst of all, patients in need of adequate pain medication who are being treated by traditional pain specialists are made to suffer the stigma of being seen in the same light as rogue pain clinic patients. They may end up not having their prescriptions filled and not getting adequate treatment. Far worse, the rogue clinic prescriptions are placing a drain on the quotas and quantities of narcotics available for every type of patient, including hospice patients and those in need of acute care after surgical procedures. The DEA definitions are timely and sorely needed in our fair state, because Georgia has become a battleground for prescription drug dealers. Our interstates have become known as the “Pill-Billy Highways.” People from surrounding states are being sent here by the carload to visit rogue pain clinics with financing supplied by drug dealers back home.

Lists of pharmacies that will fill rogue pain clinic prescriptions are passed from one dealer/clinic/patient/ customer to the next. Rogue pain clinic owners have a cell number for their customers to call to find out which pharmacies are filling their prescriptions. It goes on and on, deeper and sleazier than most pharmacists would ever imagine. The rogue pain clinics moved here because many states passed laws that tightly regulate that kind of business and quite literally ran the clinics out of their respective states. Georgia’s prescription drug monitoring program will most certainly be a tool for our health care professionals to use in rooting out these clinics. But until we can get the program up and running, we’re still the only state in the Southeast left standing without one. Our lack of regulations or laws to oversee these rogue clinics brings in droves of people to our state to take advantage of our pharmacists. It would be fantastic if most of you had no idea what I am talking about… but I’m afraid that is not the case. What would be better is if this article can reach those few of you who are players in this type of practice and it causes you to stop gambling and take yourself out of this toxic mix. Don’t let the lure of easy money cause you to put your license and your professionalism at risk. Leave gambling to the Las Vegas casinos with their black-jack tables and Texas Hold‘em tournaments. If you’re there, you might catch a glimpse of me over by the slot machines with those sweat beads on my forehead as I plop in five nickels at a time… while hoping our next football season is more positive.

DEA Places Carisoprodol in Schedule IV

he DEA has followed the lead of 17 states and announced a final rule to reschedule carisoprodol in Schedule IV, effective January 11, 2012. Pharmacies who are not in states that have already made carisoprodol a controlled substance will need to inventory their stocks of carisoprodol as of January 11, and prescriptions written for carisoprodol prior to

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January 11, 2012, will be valid after January 11 as long as they are not over six months old and have not been refilled five or more times. Producers and repackagers of carisoprodol must amend their labels to include “C-IV” by April 10, 2012, and carisoprodol containers produced prior to April 10, may be distributed until June 11, 2012. Pharmacies should not redistribute to other

February 2012

G DNA P H ARMA C Y NE W S registrants (except, presumably for reverse distribution or destruction) any non-conforming packaging after June 11, 2012.

willing to cede any jurisdictional or judgmental territory not otherwise explicitly limned by the Supreme Court in Gonzales v. Oregon (546 U.S. 543 (2006)). Instead, she found that the ALJ nevertheless allowed extensive testimony regarding the medical and scientific bases for placement in Schedule IV, and thus found the ALJ’s error not prejudicial. The Administrator’s detailed discussion of the ALJ’s error is found at pages 77333 through 77336. [Department of Justice, DEA, 21 CFR Part 3108, Doc. No. DEA-333. Schedules of Controlled Substances: Placement of Carisoprodol into Schedule IV. 76 Fed. Reg. 77,330, December 11, 2011]

The DEA first announced proposed rule-making on October 6, 2009, and received 17 comments, all but one in favor of placing carisoprodol in Schedule IV. The dissenting comment was filed by Meda Pharmaceuticals, Inc., which holds the rights to market the drug under the brand name, Soma®. Meda argued that the DEA’s “administrative record does not include substantial and reliable evidence of potential for abuse sufficient to warrant scheduling carisoprodol and … the proposal gives inadequate weight to the negative impact on patient care of scheduling carisoprodol.” Meda also petitioned for a hearing, which was granted by the DEA Administrator in March 2010. The Office of the Administrative Law Judges (ALJ) conducted hearings in July and August 2010.

Reprinted with permission from the December 2011 issue of the ASPL Pharma Law e-News. For more information about ASPL, visit their web site at www.aspl.org.

The DEA’s 31-page Federal Register announcement discusses the ALJ’s recommendation in detail, and recounts government and petitioner arguments concerning the scope of a scheduling hearing, including the degree of deference that is required to be given to medical and scientific judgments made by the FDA. The ALJ considered eight statutory factors affecting a decision on a drug’s need to be controlled under the Act: (1) actual or potential liability for abuse; (2) scientific evidence of its pharmacological effect, if known; (3) the state of current scientific knowledge regarding the drug; (4) its history and current pattern of abuse; (5) the scope, duration, and significance of abuse; (6) the extent of risk, if any, to the public health; (7) its psychic or physiological dependence liability; and (8) whether the substance is an immediate precursor of a substance already controlled under the Act. The ALJ concluded that the record supported placing carisoprodol in Schedule IV, and the Administrator agreed with the ALJ’s recommendation. However, the Administrator devoted considerable discussion to what she considered an error by the ALJ, which was the ALJ’s conclusion that statute and prior jurisprudence made FDA’s scientific and medical decisions binding on the DEA and the ALJ. The Administrator was clearly not

The Georgia Pharmacy Journal

February 2012

AI P M e m b e r N e w s

Regions Bank Reverses Mandatory Mail Order Decision

am often asked, “Why should I be a member of GPhA/Association of Independent Pharmacy (AIP)?” There’s no simple answer, but here is an example that answers it better than I ever could.

mandatory mail order program. I don’t know how many of you fill prescriptions for employees at Regions Bank, but without our efforts these patients would have been forced to use mail order.

At a meeting in Gainesville, one of our GPhA/AIP members (Laird Miller) was asked a question regarding a recent decision made by Regions Bank which forced their employees to use a mandatory, mail order program. Laird called me to find out the details and this is what happened next:

This shows how GPhA/AIP helps the profession and everyone in it. Individually, you could never pull off such an effort. And it answers the question, “Why should I be a member of GPhA/AIP?” Jeff Lurey, R.Ph. AIP Director

1. I did some research and found that Regions Bank’s national headquarters are in Birmingham and they have numerous branches in the Southeast, Midwest, and Texas. 2. I contacted our pharmacy friends in those states along with the NCPA to form a coalition to try to reverse Regions Bank’s decision. 3. Our friends at APCI in Alabama responded very quickly as did NCPA. APCI is a client of Regions Bank, so they had some leverage to be able to set up a faceto-face meeting with Regions Bank CEO. NCPA also attended. 4. We sent our AIP members faxes and emails to rally the troops. I also wrote a very strongly worded letter to the Regions CEO blasting mail order pharmacy, focusing mainly on poor patient care and the negative economic effect on local communities of sending business out of state. 5. Many pharmacists in Georgia and Alabama also voiced their displeasure, especially members who were doing business with Regions Bank. As you can tell, it took quite an effort and a lot of time and resources to pull this together. Because of the efforts of GPhA/ AIP, APCI, and NCPA, we were able to get Regions Bank to discontinue their

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February 2012

GPHA Member News

D. Steve Wilson Completes Term on Georgia State Board of Pharmacy

s D. Steve Wilson rotates off the Georgia State Board of Pharmacy, the Georgia Pharmacy Association (GPhA) wishes to thank him for his many years of service to that organization.

Wilson is the owner of Carter’s Pharmacy in Smyrna, Georgia. He is a past GPhA president, D. Steve Wilson an active GPhA member, and has served in a number of capacities on the GPhA’s board of directors. He is a member and past president of the Smyrna Optimist Club and an adjunct associate professor at Mercer University.

Wilson earned an associate’s degree from Kennesaw College and a bachelor’s in pharmacy, doctoral degree in pharmacy and a master’s of business administration from Mercer University. He and his wife, Karen, live in Smyrna and have two children. “Serving on the Georgia State Board of Pharmacy, Wilson has been a positive representative for the Georgia pharmacy profession as a whole as well as for the Georgia Pharmacy Association,” says Jim Bracewell, executive vice president and CEO of GPhA. “We are grateful for the important role he has played in helping shape the future of pharmacy.”

Mark Your Calendars!

Georgia Pharmacy Association 137th Annual Convention

Hilton Head Marriott Resort & Spa Hilton Head Island, SC July 7 - 11, 2012

Call (800) 228-9290 today to make your reservation! Be sure to mention that you are part of the Georgia Pharmacy Association Room Block to receive our special room rates.

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February 2012

GPHA Member News

Welcome New GPhA Members! GPhA is pleased to welcome the following new GPhA members:

Individual Pharmacist Members:

Mikhil Joseph, Orange Park, FL Sungtaek Kim, Johns Creek Brittany Lawrence, Baxley Justin Lawson, Duluth Matthew Lee, Thunderbolt Andrew Lipham, Carrollton Meagan Logue, Dublin Tessa Low-a-chee, Savannah Kyley Makanani, Conyers Neerav Maniklal, Cordele Courtney Mathis, Dalton Rachel McAllister, Savannah Rebecca McKinnon, Pearson Alexis McLoon, Hazelhurst Blake Meeks, Byron Sam A. Mekkaoui, Duluth Joshua Miller, Athens Thomas Miller, Atanta Brandi Montgomery, Savannah Chase Moody, Dacula Amy Moreno, Pensacola, FL Melissa Mullis, Athens Susiana Mulyadi, Sugar Hill Veronica Munoz, El Paso, TX Kalie Murphy, Statesboro Katherine Mykytka, Atlanta Tiffani Nelson, Pheonix, AZ Lisa Ng, Savannah Khanh Nguyen, Lawrenceville Viet Nguyen, Loganville Nneka Okeke-Stubbs, Savannah Kingsley Onokalah, Acworth Kelli Ottum, Savannah Tia Oudinot, Savannah Dhruminkumar Patel, Savannah Jaymin Patel, Pineville, NC Kaushal Patel, Savannah Payal Patel, Snellville Sonali Patel, Savannah John Phillips, Atlanta Rachel Pitner, Marietta Elizabeth Pittman, Sandersville Amanda Plunkett, Douglasville

David Carver R.Ph., Smyrna

Pharmacy School-Student Members: Ade Subomi Adeyemo, Stone Mountain Shelby Allen, Statesboro Ricky Applewhite, Atlanta Jimena Baron, Atlanta Arit Bassey, Savannah Amanda Bauerle, Dayton, OH Caitlin Beale, Atlanta Traci Benedict, Acworth Robert Bentley, Summerville, SC Molly Bloodworth, Macon Chardiera Bonaby, Atlanta Tiffany Alana Boyd, Atlanta Ashley Bridges, Sandersville Amanda Brown, Port Orange, FL Helen Tyler Bryant, Atlanta Catherine Michelle Cameron, Arden, NC Mary Carpenter, Savannah Francois Cherestal, Snellville Brenna Clayton, Cumming Julia Coluccio, Atlanta Blair Curless, Roswell Khanh Dang, Atlanta Barrett Darley, Uvalda Brian Donahue, Hooksett, NH James Lee Dykes, Statham Edna Esumei, Marietta Sarah Evans, Savannah Michael Filipkowski, Ponte Vedra Beach, FL Jonathan Frazier, Barnesville Lesley Gordon, Duluth Sara Griffin, Atlanta Caio Guimaraes, Nolensville, TN Tekia Hamilton, Savannah Misty Hammontree, Savannah Anthony Hawkins, Athens Lori Hill, Melbourne, FL Jennifer Huddleston, Athens Annette Irizarry, Auburn Bianca Iv, Fleming Island, FL

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February 2012

GPHA Member News Pharmacy School-Student Members: (continued) Manoj Pradhan, Atlanta William Qian, Smyrna Ali Quraishi, Parsippany, NJ Sindhu Ravindran, Buford Rejeanne Richard, Hampton James Robinson, Atlanta Anne Salley, Atlanta Trent Sappe, Atlanta Amanda Schwarz, Savannah Sandra Shahinpour, Atlanta Ashley Sheridan, Savannah Danette Sipper, Braselton Christina Smith, Stockbridge Rebecca Smith, Athens

Monica Stephens, Savannah Kristen Swanson, Hartwell Hoa Tang, Atlanta Anne Thiong’o, Kennesaw Nhi Tran, Savannah Anastasia Triantafilloy, Savannah Panagiotis Triantafilloy, Savannah Cuong Tu, Savannah Kameron Tucker, Savannah Matthew Wallace, Cumming Angela Wampler, Warner Robins Ashley Wilkerson, Atlanta Kasey Willis, Crestview, FL Valerie Wilson, Savannah Sara Workman, Savannah Briana Worthy, Kathleen Megan Wright, Pooler

If you, or someone you know, would like to join GPhA, Georgia’s premier professional pharmacy association, go to www.gpha.org and click “Join” under the GPhA logo.

Barbara Cole

Attorney At Law, LLC

All Aspects of Representation of Health Care Professionals: Licensure Medicare Administrative Medicaid Criminal Bankruptcy Compliance State Bar Health Law Section Former Chief Magistrate Judge 539 Green Street, NW Gainesville, GA 30501 (678) 971-9088 bcoleattorney@gmail.com

www.barbaracoleattorney.com The Georgia Pharmacy Journal

February 2012

Pharm PAC Members

GPhA is leading the way in influencing pharmacy-related legislation in Georgia Titanium Level

($2400 minimum pledge) T.M. Bridges, R.Ph. Ben Cravey, R.Ph. Michael E. Farmer, R.Ph. David B. Graves, R.Ph. Raymond G Hickman, R.Ph. Robert A. Ledbetter, R.Ph. Jeffrey L. Lurey, R.Ph. Marvin O. McCord, R.Ph. Scott Meeks, R.Ph. Judson Mullican, R.Ph. Mark Parris, Pharm.D. Fred F. Sharpe, R.Ph. Jeff Sikes, R.Ph. Dean Stone, R.Ph., CDM

Platinum Level

($1200 minimum pledge) Barry M. Bilbro, R.Ph. Robert Bowles, Jr., R.Ph., CDM, Cfts Jim R. Bracewell Larry L. Braden, R.Ph. Thomas E. Bryan Jr., R.Ph. William G. Cagle, R.Ph. Hugh M. Chancy, R.Ph. Keith E. Chapman, R.Ph. Dale M. Coker, R.Ph., FIACP Jack Dunn, Jr. R.Ph. Neal Florence, R.Ph. Andy Freeman Martin T. Grizzard, R.Ph. Robert M. Hatton, Pharm.D. Ted Hunt, R.Ph. Alan M. Jones, R.Ph. Ira Katz, R.Ph. Hal M. Kemp, Pharm.D. J. Thomas Lindsey, R.Ph. Brandall S. Lovvorn, Pharm.D. Eddie M. Madden, R.Ph.

Jonathan Marquess, Pharm.D., CDE, CPT

Pam Marquess, Pharm.D. Kenneth A. McCarthy, R.Ph. Drew Miller, R.Ph., CDM Laird Miller, R.Ph. Cynthia K. Moon Jay Mosley, R.Ph. Allen Partridge, R.Ph.

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Houston Lee Rogers, Pharm.D., CDM Tim Short, R.Ph. Danny Toth, R.Ph. Tommy Whitworth, R.Ph., CDM

Gold Level

($600 minimum pledge) James Bartling, Pharm.D., ADC, CACII Larry Batten, R.Ph. Bruce L. Broadrick, Sr., R.Ph. Liza G. Chapman, Pharm.D. Mahlon Davidson, R.Ph., CDM Kevin M. Florence, Pharm.D. Kerry A. Griffin, R.Ph. Robert B. Moody, R.Ph. Sherri S. Moody, Pharm.D. William A. Moye, R.Ph. Jeffrey Grady Richardson, R.Ph. Andy Rogers, R.Ph. Daniel C. Royal, Jr., R.Ph. Michael T. Tarrant

Silver Level

($300 minimum pledge) Renee D. Adamson, Pharm.D. Ed Stevens Dozier, R.Ph. Terry Dunn, R.Ph. Marshall L. Frost, Pharm.D. Johnathan Wyndell Hamrick, Pharm.D. Michael O. Iteogu, Pharm.D. Willie O. Latch, R.Ph. W. Lon Lewis, R.Ph. Kalen Porter Manasco, Pharm.D. Michael L. McGee, R.Ph. William J. McLeer, R.Ph. Albert B. Nichols, R.Ph. Richard Noell, R.Ph. William Lee Prather, R.Ph.

Sara W. Reece, Pharm.D., BC-ADM, CDE

Edward Franklin Reynolds, R.Ph. Sukhmani Kaur Sarao, Pharm.D. David J. Simpson, R.Ph. James N. Thomas, R.Ph. Alex S, Tucker, Pharm.D. William H. Turner, R.Ph. Flynn W. Warren, M.S., R.Ph. William T. Wolfe, R.Ph.

Bronze Level

($150 minimum pledge) Monica M. Ali-Warren, R.Ph. Fred W. Barber, R.Ph. John R. Bowen, R.Ph. Michael A. Crooks, Pharm.D. William Crowley, R.Ph. Charles Alan Earnest, R.Ph. Randall W. Ellison, R.Ph. Mary Ashley Faulk, Pharm.D. Amanda R. Gaddy, R.Ph. Ed Kalvelage John D. Kalvelage Steve D. Kalvelage Marsha C. Kapiloff, R.Ph. Joshua D. Kinsey, Pharm.D. Brenton Lake, R.Ph. Allison L. Layne, C.Ph.T. William E. Lee, R.Ph. Michael Lewis, Pharm.D. Ashley Sherwood London Charles Robert Lott, R.Ph. Max A. Mason, R.Ph. Amanda McCall, Pharm.D. Susan W. McLeer, R.Ph. Mary P. Meredith, R.Ph. Rose Pinkstaff, R.Ph. Leslie Ernest Ponder, R.Ph. Kristy Lanford Pucylowski, Pharm.D.

Sara W. Reece Pharm.D., BC-ADM, CDE

Leonard Franklin Reynolds, R.Ph. Laurence Neil Ryan, Pharm.D. Richard Brian Smith, R.Ph. Charles Storey, III, R.Ph. Archie Thompson, Jr., R.Ph. Marion J. Wainright, R.Ph. Jackie White Carrie-Anne Wilson Steve Wilson, Pharm.D. Sharon B. Zerillo, R.Ph.

Members

(No minimum pledge) John J. Anderson, Sr., R.Ph. Mark T. Barnes, R.Ph. Henry Cobb, III, R.Ph., CDM

February 2012

Pharm PAC Members GContinued P h A LE G ISLATI V E Carleton C. Crabill, R.Ph. Wendy A. Dorminey, Pharm.D., CDM David M. Eldridge, Pharm.D. James Fetterman, Jr., Pharm.D. Charles C. Gass, R.Ph. Christina Gonzalez Christopher Gurley, Pharm.D. Ann R. Hansford, R.Ph. Keith Herist, Pharm.D., AAHIVE, CPA

Joel Andrew Hill, R.Ph.

Carey B. Jones, R.Ph. Susan M Kane, R.Ph. Emily Kraus Carroll Mack Lowrey, R.Ph. Tracie Lunde, Pharm.D. Roy W. McClendon, R.Ph.

NE W S

Victor Serafy, R.Ph. James E. Stowe, R.Ph. James R. Strickland, R.Ph. Celia M. Taylor, Pharm.D. Leonard E. Templeton, R.Ph. Heatwole C. Thomas, R.Ph. William D. Whitaker, R.Ph. Elizabeth Williams, R.Ph. Jonathon Williams, Pharm.D. Rogers W. Wood, R.Ph.

Tom Menighan, R.Ph., MBA, ScD, FAPhA

Darby R. Norman, R.Ph. Christopher Brown Painter, R.Ph. Steve Gordon Perry, R.Ph.

Thank you to all of our generous Pharm PAC supporters. To join Pharm PAC, see the form on the next page.

If you made a gift or pledge to Pharm PAC in the last 12 months and your name does not appear on this list, contact Andy Freeman at afreeman@gpha.org or (404) 419-8118. Pharm PAC donations are not charitable donations and are not tax deductible.

EC RETAIL STUDIO

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EC RETAIL STUDIO IS TURN-KEY SERVICE REDEFINED.

TARGETED DEPARTMENT FOCUS

GRAPHICS & SIGNAGE

FACILITY DESIGN

Do you want more production from your retail floor?

contact Marty Walker, 770.690.0023 x103

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February 2012

Join Pharmâ&#x20AC;&#x2C6;PAC Today!

GPhA is leading the way in influencing pharmacy-related legislation in Georgia

Pharm PAC is Georgia Pharmacy Associationâ&#x20AC;&#x2122;s Political Action Committee. Your generous donations help GPhA to be able to lobby and advocate on the behalf of Georgia pharmacy professionals.

You have two Pharm PAC membership options: 1) A Monthly Contribution: (Please complete the following.) Name: _________________________________________________________________________ Address: _______________________________________________________________________ Phone#: ________________________________________________________________________ Email Address: __________________________________________________________________

*You will be contacted for additional information to set up your monthly contribution.

Circle the level of monthly support you would like to provide: Platinum ($100/month) Gold ($50/month) Titanium ($200/month) Silver ($25/month)

Bronze ($12.50/month)

2) A One-Time Gift: To make a one-time contribution, simply write the amount you wish to contribute here: $_________ and mail your check with this completed form. To finalize your membership, complete and mail this form to: Pharm PAC, Georgia Pharmacy Association, 50 Lenox Pointe, NE, Atlanta, GA 30324 Thank you for supporting Pharm PAC. Your gift allows GPhA to continue to advocate for improvements within the pharmacy profession.

Welcome our new Pharm PAC members! Ed Stevens Dozier, R.Ph. Keith Nicholas Herist, Pharm.D., AAHIVE, CPA Rogers W. Wood, R. Ph. William H. Turner, Sr., R. Ph.

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February 2012

GPHA Legislative News Andy Freeman Director of Government Affairs Georgia Pharmacy Association

Important Pharmacy Legislation

ver the last couple of weeks, Congressman Hank Johnson and Congressman Austin Scott have signed onto some legislation called The Pharmacy Competition and Consumer Choice Act (H.R. 1971) that is being supported by the National Community Pharmacists Association and is of importance to pharmacists. This legislation would increase pharmacy benefit managers (PBM) transparency, provide protections from certain abusive and burdensome audit practices by PBM’s, and allow any willing pharmacy to participate in a network, as long as it is eligible to participate in a federal or state health plan. Congressman Scott also signed onto The Preserving Our Hometown Independent Pharmacies Act of 2011 (H.R. 1946.) This legislation will create a more competitive marketplace for pharmacy services by enhancing the ability of independent community pharmacies to negotiate with PBMs. Please take a moment and call these congressmen to thank them for their support of this pharmacy

legislation: Representative Hank Johnson at (202) 2251605 and Representative Austin Scott at (202) 2256531. While you have your phone out, please call the rest of Georgia’s Congressional Delegation (especially if they are your congressmen) to ask them to sign onto H.R. 1971 and H.R. 1946: Representative Jack Kingston (202) 225-5831 Representative Sanford Bishop (202) 225-3631 Representative Lynn Westmoreland (202) 225-5901 Representative John Lewis (202) 225-3801 Representative Tom Price (202) 225-4501 Representative Rob Woodall (202) 225-4272 Representative Tom Graves (202) 225-5211 Representative Paul Broun (202) 225-4101 Representative Phil Gingrey (202) 225-2931 Representative John Barrow (202) 225-2823 Representative David Scott (202)225-2939

Together we can change our laws and make pharmacy better!

GPHA Website News

GPhA Website Tutorial

Not everyone has the same level of comfort on the Internet - so GPhA has an online tutorial to guide you through our website. This tutorial gives several “how-to” features as well as other helpful tools. To view the GPhA Website Tutorial go to www.gpha.org and click on “GPhA Website Orientation Video.” Note: it may have a moment’s delay, but will start automatically.

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February 2012

Pharmacy Time Capsules 1987—Twenty-five years ago: Nova Southeastern University’s College of Pharmacy admitted its first class thus becoming the first college of Pharmacy in south Florida. Fluoxetine (Prozac) approved for marketing as treatment for depression

1962—Fifty Years Ago: Kefauver-Harris bill passed in response to thalidomide tragedy. Bill required manufacturers to prove effectiveness as a condition of FDA approval. Hospital Pharmacy Residency accreditation standards leading to a rapid expansion of clinical training programs were first approved by American Society of Hospital Pharmacists.

1937—Seventy-five Years Ago: American Journal of Pharmaceutical Education (Lyman’s Journal) was launched by American Association of Colleges of Pharmacy with Dean Lyman of Nebraska serving as the founding editor. Cannabis sativa remains listed in the USP XI (official from 1936). The Marijuana Tax Act passed levying a fee on “every person who imports, manufactures, produces, compounds, sells, deals in, dispenses, prescribes, administers, or gives away marihuana.”

1912—One hundred Years Ago: Journal of the American Pharmaceutical Association launched in January 1912 with James Hartley Beal serving as the editor. Zada Mary Cooper (University of Iowa) was the first woman faculty member to attend an annual meeting of the American Association of Colleges of Pharmacy, (then American Conference of Pharmaceutical Faculties).

1887—One hundred twenty-five years ago: Florida Pharmacy Association formed in the Board of Trade Rooms in Jacksonville on June 8, 1887. Henry Robinson of Jacksonville was elected the first president.

By: Dennis B. Worthen Lloyd Scholar, Lloyd Library and Museum, Cincinnati, OH One of a series contributed by the American Institute of the History of Pharmacy, a unique non-profit society dedicated to assuring that the contributions of your profession endure as a part of America’s history. To learn more, check out: www.aihp.org.

The Georgia Pharmacy Journal

February 2012

For more information, contact: James Taylor (404) 419-8173 jtaylor@gpha.org The Georgia Pharmacy Journal

February 2012

AIP Spring Meeting Sunday, March 18, 2012 — Macon Marriott & Centreplex

ARE YOU COMING?

 LEARN TO IMPROVE YOUR BUSINE$$

- ACOs  SPECIAL GUESTS

1. Come meet and network with fellow independent pharmacists 2. Bring your staff to network with other technicians

 MEDICAID

3. Join us for a continental breakfast and lunch

 AIP ELECTIONS  BRING YOUR STAFF AND NETWORK

WITH YOUR COLLEAGUES

4. Visit with our AIP partners during breaks and lunch

Most Important Meeting In Years!!

SHOW YOUR SUPPORT—ATTEND THIS YEAR’S AIP SPRING MEETING Registration:

(For Planning Purposes Please Fill Out and Return )

Member’s Name:_______________________________________ Nickname________________________ Pharmacy Name:_______________________________________________________________________ Address:______________________________________________________________________________ E-mail Address (Please Print):_____________________________________________________________ Will you be joining us for lunch (12-1pm)? Yes_____ No_____; # of additional Staff/Guests:____________ Names of Staff/Guests: ___________________________________________________________________

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Please Fax Back to (404) 237-8435 February 2012

PHarmaCY-Based immuniZation deliVerY ProGram schedule. Saturday, February 25, 2012 from 8a.m. - 6p.m. •

A CERTIFICATE PROGRAM FOR PHARMACISTS -

HOSTED BY GPHA HELD AT PCOM SCHOOL OF PHARMACY – GA CAMPUS Pharmacy-Based Immunization Delivery is an innovative and interactive practice-based educational program that provides pharmacists with the skills necessary to become primary sources for vaccine advocacy, education, and administration. The program reviews the basics of immunology, identifies legal and regulatory issues pharmacists must consider before starting an immunization program, and focuses on practice implementation. This program is priced as follows: GPhA Members: $400 GPhA Student Members: $175 All GPhA Potential Members: $495 The purpose of this educational program is to: • • • •

Provide comprehensive immunization education and training Provide pharmacists with the knowledge, skills, and resources necessary to establish and promote a successful immunization service. Teach pharmacists to identify at-risk patient populations needing immunizations. Teach pharmacists to administer immunizations in compliance with legal and regulatory standards.

Pharmacy-Based Immunization Delivery is conducted in two parts: the self-study and the live training. A certificate of Achievement will be awarded to the participants who successfully complete all program components, including an evaluation form. Statements of Credit and Certificates will be issued within 4-6 weeks of APhA’s receipt of program materials. Key learning objectives for the live training seminar are: • • • •

•

Identify opportunities for pharmacists to become involved in immunization delivery. Describe how vaccines evoke an immune response and provide immunity. Identify the vaccines available on the U.S. market for each vaccinepreventable disease and classify each vaccine as live attenuated or inactivated. Evaluate a patient’s medical and immunization history and determine if the patient falls into the target groups for each vaccine based on the Advisory Committee for Immunization Practices (ACIP) recommendations. Review patients case and determine patient-specific vaccine recommendations based on the appropriate immunization

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• • • •

Discuss the legal, regulatory, and liability issues involved with pharmacy-based immunization programs. Describe the signs and symptoms of adverse reactions that can occur after vaccination Describe the emergency procedures for management of patients with adverse reactions to vaccination. List the steps for appropriate intranasal administration technique for the live attenuated influenza vaccine. Demonstrate appropriate intramuscular and subcutaneous injection technique for adult immunization.

For a complete list of learning objectives, please go to APhA’s website, www.pharmacist.com/ctp/immunization. Continuing Pharmacy Education (CPE) Credit: Release Date: 5/15/2011 Successful completion of the live seminar component involves passing the final exam with a grade of 70% or higher and demonstrating competency in 2 intramuscular and 1 subcutaneous injection. Successful completion of this component will result in 8.0 contact hours of continuing pharmacy education credit (0.80 CEUs). ACPE UAN: 202-999-11-135-L01-P Successful completion of the self study component involves passing the self-study assessment questions with a grade of 70% or higher and will result in 12.0 contact hours of continuing pharmacy education credit (1.2 CEUs). ACPE UAN: 202-999-11-136-H01-P Your course book will be sent to you via UPS no later than three weeks prior to the course provided that complete payment has been received by GPhA. No refunds are available for this course. However, substitutions may be made but a course book will not be issued to the new participant. The participant who is canceling is responsible for transmitting the course book to the substituted participant. GPhA reserves the right to cancel the seminar should an inadequate number of seats be filled by 9 days prior to the program. Pharmacy-Based Immunization Delivery: A Certificate Program for Pharmacists was developed by the American Pharmacists Association. For all APhA education and accreditation information please visit www.pharmacist.com/education.

If you have questions about this program please contact Sarah Bigorowski at sbigorowski@gpha.org or (404) 419-8126. The American Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

To register for this event, go to www.gpha.org. 23

February 2012

continuing education for pharmacists Volume XXIX, No. 11

New Drugs: Arcapta, Brilinta and Xarelto Thomas A. Gossel, R.Ph., Ph.D., Professor Emeritus, Ohio Northern University, Ada, Ohio and J. Richard Wuest, R.Ph., PharmD, Professor Emeritus, University of Cincinnati, Cincinnati, Ohio Dr. Thomas A. Gossel and Dr. J. Richard Wuest have no relevant financial relationships to disclose.

Goal. The goal of this lesson is to provide background information on indacaterol (Arcapta™), ticagrelor (Brilinta™), and rivaroxaban (Xarelto®). Objectives. At the conclusion of

this lesson, successful participants should be able to: 1. recognize the new drugs by generic name, trade name and chemical name when relevant; 2. identify the indication, pharmacologic action and clinical application for each drug; 3. choose important therapeutic uses for the drugs and their applications in specified pathologies; 4. demonstrate an understanding of adverse effects and toxicity, and significant drug-drug interactions for these drugs; and 5. select important information to convey to patients and/or their caregivers. Drugs discussed within this lesson are new molecular entity compounds (Table 1) indicated to treat a variety of afflictions. This lesson provides an introduction to the new drugs and is not intended to extend beyond a brief overview. The Prescribing Information leaflet or Medication Guide, and other published reference sources should be consulted for detailed descriptions.

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Gossel

Wuest

Indacaterol (Arcapta)

The safety and efficacy of Arcapta (ar-CAP-ta) Neohaler was demonstrated in six clinical trials that included 5,474 patients ages 40

years and older who had a clinical diagnosis of chronic obstructive pulmonary disease (COPD). The patients had a smoking history of at least one pack a day for 10 years and exhibited moderate-to-severe decreases in lung function. Indications and Use. Arcapta is a long-acting bronchodilator indicated for once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. Arcapta is NOT indicated to treat acute deteriorations of COPD or asthma. Chronic Obstructive Pulmo-

Table 1 Selected new drugs for 2011 Generic (Proprietary Applicant/Sponsor/ Indication Dosage Form Name) Distributor Indacaterol (Arcapta) Novartis Long-acting β275 mcg Pharmaceuticals adrenergic agonist capsules Corporation for maintenance for use in bronchodilator Neohaler treatment of chronic obstructive pulmonary disease Rivaroxaban (Xarelto)

Janssen Pharmaceuticals Inc.

Factor Xa inhibitor 10 mg indicated for prophy- tablets laxis of deep vein thrombosis during knee or hip replacement surgery

Ticagrelor (Brilinta)

AstraZeneca LP

P2Y12 platelet inhib- 90 mg itor to reduce cardio- tablets vascular events in patients with acute coronary syndromes

February 2012

nary Disease. Approximately 12 million adults in the United States have COPD. The disease is one of the few chronic pathologies that have shown an increase in mortality in recent years. It is projected that by 2020, the incidence of COPD will increase from its current level as the fourth leading cause to the third most common cause of death worldwide. COPD is a serious pulmonary disease that makes breathing difficult. Symptoms can include breathlessness, chronic cough and excessive phlegm. Disease exacerbations have a profound effect on patients with COPD, resulting in poor health and high mortality. Exacerbation of COPD is generally defined as an event in the natural course of the disease characterized by a change in the patient’s baseline dyspnea (shortness of breath), cough and/or sputum that is beyond normal day-to-day variations, is acute in onset, and may warrant a change in regular medication. An exacerbation can last several weeks and result in lung function decline, increased risk of death, and may be associated with severe anxiety. COPD is often not diagnosed until the disease is very advanced because people do not know the early warning signs. Sometimes they think they are short of breath or less able to perform the tasks they are accustomed to because they are “just getting old.” But shortness of breath is never normal! The good news is that COPD can be found early and much can be done to treat and help manage the disease. The overall prevalence of COPD has increased more rapidly in women than in men. Chronic bronchitis affects twice as many women as men in the United States; however, the rate for emphysema development in women and men remains approximately equal. More women with COPD suffer from depression than men. Women with COPD experience significantly worse health-related quality of life for the same degree of severity of their disease

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compared with their male counterparts. Although the data are sparse, studies have shown that women with COPD have worse exercise performance than men with the same pathology. The major etiological factor in COPD in both men and women in developed countries is many years of heavy tobacco smoking during the asymptomatic, initial phase of the disease. Tobacco smoke contains reactive oxygen species (ROS) and numerous different chemical components, many of which cause toxic effects on the lung. Additionally, hydrogen sulfide is a potent antioxidant and vasorelaxant. ROS inflicts damage that can cause both immunosuppression and proinflammatory effects such as stimulation of phagocytosis. Despite the enormous global impact of COPD, no drug therapy has been shown to prevent disease progression or reduce mortality. However, medical researchers have shown greatly increased interest in COPD over the past few years. This attention to COPD has been linked to a better understanding of its cellular and molecular mechanisms and identification of novel targets for the discovery of new treatments. Current management guidelines recommend that patients with moderate or more severe COPD should receive treatment with one or more long-acting bronchodilators. Mechanism of Action. Inhaled indacaterol acts locally in the lung as a bronchodilator. Although β2-receptors are the predominant adrenergic receptors in bronchial smooth muscle and β1-receptors are the predominant receptors in the heart, there are also β2-adrenergic receptors in the heart that comprise 10 to 50 percent of the total adrenergic receptors. The pharmacologic effects of β2-adrenoceptor agonist drugs, including indacaterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes conversion of adenosine triphosphate (ATP) to cyclic-3’,5’adenosine monophosphate (cyclic

adenosine monophosphate; cyclicAMP; c-AMP). Increased c-AMP levels initiate relaxation of bronchial smooth muscle. In vitro studies have demonstrated that indacaterol has more than 24-fold greater agonist activity on β2-receptors compared to β1-receptors. Adverse Effects. In premarketing clinical trials, the most common adverse reactions (>2 percent and more common than placebo) were cough, oropharyngeal pain, nasopharyngitis, headache and nausea. Warnings, Precautions and Contraindications. The following warnings and precautions are listed: • Treatment with Arcapta should not be initiated in acutely deteriorating COPD patients. Acutely deteriorating COPD is a life-threatening condition; Arcapta has not been studied in these patients. • The drug should not be used for relief of acute symptoms. Concomitant short-acting β2-agonists can be used for acute relief. • The recommended dose should not be exceeded. Excessive use of Arcapta, or use in conjunction with other medications containing long-acting β2-agonists can result in clinically significant cardiovascular events and may be fatal. • Life-threatening paradoxical bronchospasm can occur. Arcapta should be discontinued immediately if this appears. • In patients with cardiovascular or convulsive disorders, thyrotoxicosis or sensitivity to sympathomimetic drugs, Arcapta should be used with caution. The only contraindication is for use in patients with asthma; the product is not indicated for treatment of asthma. Arcapta carries a boxed warning that long-acting β2-adrenergic agonists (LABA) increase the risk of asthma-related death. All LABA, including Arcapta, should not be used in patients with asthma, unless used with a long-term asthma control medication.

February 2012

Table 2 M aj or co uns el ing po ints for Arcapta (indacaterol) inhalation* Arcapta is used to control symptoms of chronic obstructive pulmonary disease (COPD) in adults. It is NOT for use in asthma. • Read the Medication Guide before you start using Arcapta and each time you get a refill. • Tell your doctor: -if you have asthma, diabetes, heart problems, high blood pressure, seizures, or thyroid problems; -if your breathing problems worsen or your rescue medicine does not work as well; -if you have fast or irregular heartbeat, increased blood pressure, chest pain, or high blood sugar; -about all other prescription and nonprescription (OTC) medicines, vitamin/mineral supplements, natural products and herbal remedies you are taking. • WOMEN: Notify your doctor if you become or intend to become pregnant, or are breastfeeding. • Arcapta is for inhalation only. Do NOT swallow the capsules. Ask your doctor or pharmacist if you are not sure how to use the Neohaler device. The usual dose is once a day, at about the same time of day. • Store Arcapta in a dry place. The capsules must be kept in the foil package until just before placing in the Neohaler. Do not use after the expiration date on the label. Properly discard unused medication. *Excerpted from the FDA-approved Medication Guide

Drug Interactions. Drugdrug interactions listed include: • Other adrenergic drugs: Arcapta may potentiate their effect and should be used with caution. • Xanthine derivatives, steroids, diuretics or non-potassiumsparing diuretics that may potentiate hypokalemia or ECG changes: use with caution. • MAO inhibitors, tricyclic antidepressants, and drugs that

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prolong the QTc interval: Arcapta may potentiate the effect on the cardiovascular system and should be used only with extreme caution. • Beta-adrenergic blockers: Arcapta may decrease effectiveness of these drugs and should be used with caution and only when medically necessary. Dosage and Availability. Arcapta is to be used only by oral inhalation, 75 mcg once daily. The capsules must not be swallowed as the intended effect on the lungs will not be obtained, and should only be used with the Neohaler device that is provided. When used correctly, bronchodilation begins within five minutes of inhalation with peak effects in two to four hours. When beginning therapy with Arcapta, patients who have been taking inhaled, short-acting β2-agonists on a regular basis (e.g., four times a day) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief of acute respiratory symptoms. No dose adjustment is warranted based on age, gender, weight or ethnic subgroup. The product is available as inhalation powder contained in a hard capsule holding 75 mcg of indacaterol. Each dispensing pack contains a box of 30 capsules (five blister cards containing six capsules each) and a Neohaler device. Patient Information. Excerpts from the FDA-approved Medication Guide are shown in Table 2.

Rivaroxaban (Xarelto)

The risk of venous thromboembolism (VTE) following arthroplasty (total hip or total knee replacement surgery) is high and can result in significant morbidity and mortality. More than 6000 patients having had hip or knee replacement surgery received rivaroxaban in clinical studies. Among patients undergoing knee replacement surgery, 9.7 percent of those treated with rivaroxaban experienced a VTE compared with 18.8 percent of patients who received enoxaparin

(Lovenox). In a study involving hip replacement surgery, 1.1 percent of patients who received rivaroxaban had a VTE compared with 3.9 percent of those who received enoxaparin. In another study of hip replacement patients, 2.0 percent of those treated with rivaroxaban had a VTE compared with 8.4 percent of those who received enoxaparin. Indications and Use. Xarelto (za-REL-toh) is a factor Xa inhibitor indicated for prophylaxis of deep vein thrombosis (DVT) which may lead to pulmonary embolism in patients undergoing knee or hip replacement surgery. Factor Xa is one of many substances involved in the formation of permanent clots. There are no data on the use of the International Normalized Ratio (INR) to monitor the dosage of rivaroxaban. Thromboembolic Disease. Arterial and venous thromboses remain the major cause of morbidity and mortality in the developed world. Arterial thrombosis has been directly associated with development of myocardial ischemia and stroke. Venous emboli, on the other hand, originate from deep vein thrombi in more than 95 percent of cases. These emboli are transported through the larger channels and generally pass through the right side of the heart and into the pulmonary vasculature where they form potentially fatal, pulmonary emboli. The estimated annual incidence of VTE approaches 200,000 cases per year in the United States. Among hospitalized patients, DVT occurs in 10 to 40 percent of patients undergoing medical or general surgical procedures. The incidence increases to 40 to 60 percent in persons undergoing major orthopedic surgery. Approximately 6 percent of persons with pulmonary embolism and 12 percent of those with DVT die within one month of diagnosis. At the present time, the standard treatment for acute VTE is limited to the use of low-molecularweight heparin that needs to be given subcutaneously. These drugs, which are often discontinued after

February 2012

discharge from the hospital, are cost-effective only when the patients or their caregivers can be taught to inject the drug at home with overlapping administration of a vitamin K antagonist (e.g., warfarin). This presents a substantial challenge to outpatient management, since treatment with warfarin requires regular laboratory monitoring (INR determination) and dose adjustment, and may be complicated by numerous drug and food interactions. After the first year, the annual risk of major bleeding associated with warfarin is 1 to 2 percent. Consequently, the balance between risk and benefit of continued warfarin therapy remains a subject of debate, despite the high long-term risks of recurrent venous thromboembolism. A practical solution to some of these issues could be to administer an oral anticoagulant such as Xarelto, that does not require laboratory monitoring, as a single agent for treatment of acute venous thromboembolism and for continued treatment. Mechanism of Action. Xarelto is an orally bioavailable factor Xa inhibitor that selectively and directly blocks the active site of factor Xa without the need for the cofactor anti-thrombin for activity. This distinguishes its mechanism of action from that of the indirect Xa inhibitors, such as the lowmolecular-weight heparins (e.g., the pentasaccharide fondaparinux [Arixtra]). Activation of factor X to factor Xa via the intrinsic and extrinsic pathways plays a central role in the cascade of blood coagulation. Direct thrombin inhibition impairs both the clotting cascade, and thrombin-induced platelet activation and aggregation. By inhibiting factor Xa, generation of thrombin from prothrombin is reduced. Besides, tissue factor-induced thrombin generation is inhibited. As a consequence, the prothrombin time increases with factor Xa inhibition in a dose-dependent fashion. Rivaroxaban is also being developed for prevention of recurrent DVT and for prevention of stroke

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in patients with atrial fibrillation. It is the second oral anticoagulant approved by FDA within the past year. Dabigatran (Pradaxa), a direct thrombin inhibitor, won FDA approval in 2010 for prevention of stroke in patients with atrial fibrillation. It is not approved for DVT prophylaxis. Adverse Effects. The most common adverse reaction (>5 percent) noted in premarketing trials was hemorrhage. Warnings, Precautions and Contraindications. The following warnings and precautions are listed: • Risk of bleeding: Xarelto can cause serious and fatal bleeding. Signs and symptoms of blood loss should be promptly evaluated. •Pregnancy related hemorrhage: Xarelto should be used only with caution in pregnant women due to the potential for obstetric hemorrhage and/or emergent delivery. Signs and symptoms of blood loss should be promptly evaluated. Contraindications listed include hypersensitivity to Xarelto, and active major bleeding. Drug Interactions. The manufacturer lists the following interactions. • Combined P glycoprotein (Pgp) and strong CYP3A4 inhibitors (e.g., carbamazepine, phenytoin, rifampin, St. John’s Wort): Concomitant use should be avoided unless the lack of a significant interaction is proven. A Xarelto dose increase to 20 mg should be considered if these drugs must be coadministered. The 20 mg dose should be taken with food. • Combined P-gp and weak or moderate CYP3A4 inhibitors (e.g., erythromycin, azithromycin, diltiazem, verapamil, quinidine, ranolazine, dronedarone, amiodarone, and felodipine): Concomitant use in patients with renal impairment should be avoided unless the benefit outweighs the bleeding risk. • Combined P-gp and strong CYP3A4 inducers: Concomitant use should be avoided, or the healthcare provider should consider an increased dose.

• Anticoagulants (e.g., NSAIDs/aspirin): Concomitant use should be avoided. • Clopidogrel (Plavix): Concomitant use should be avoided unless the benefit outweighs the bleeding risk. Dosage and Availability. The recommended dose is 10 mg taken orally, once daily, with or without food. For patients with hip replacement surgery, a treatment duration of 35 days is recommended. For patients undergoing knee replacement surgery, a treatment duration of 12 days is recommended. If a dose of Xarelto is missed, the dose should be taken as soon as possible on the same day and continued on the following day with once-daily intake as recommended. Xarelto is available as film-coated tablets containing 10 mg rivaroxaban. Patient Information. Excerpts from the FDA-approved Patient Counseling Information are shown in Table 3.

Ticagrelor (Brilinta)

Brilinta (brih-LIN-tah) was approved to maintain blood flow to the heart to reduce the risk of a cardiovascular event. It was evaluated for safety and effectiveness in more than 10,000 patients, including more than 3,000 patients treated for more than one year. In clinical trials, ticagrelor was more effective than clopidogrel (Plavix) in preventing heart attack and death. That advantage was seen with aspirin maintenance doses of 75 to 100 mg daily. Indications and Use. Brilinta is a platelet inhibitor indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndromes (ACS). Brilinta has been shown to reduce the rate of a combined endpoint of cardiovascular death, myocardial infarction, or stroke compared to clopidogrel. The difference between treatments was driven by cardiovascular death and myocardial infarction with no difference in the rate or severity of stroke. Acute Coronary Syndromes. ACS are the most common cause of

February 2012

Table 3 M aj or co uns el ing po ints for Xarelto (rivaroxaban) tablets* Xarelto is used to help prevent blood clots from forming in patients after hip or knee replacement surgery. • Read the Patient Information before you start taking Xarelto and each time you get a refill. • Tell your doctor: -if you have had any unusual bleeding. -if you have tingling, numbness or muscle weakness, especially in your legs; unusual bleeding or bruising; new bleeding such as nose bleed, bleeding gums, blood in your urine or bowel movements, coughing up or vomiting blood; heavy bleeding from cuts or menstruation; dizziness or tiredness; pain, swelling or fluid leakage around your surgical incision. -about all other prescription and nonprescription (OTC) medicines, vitamin/mineral supplements, natural products and herbal remedies you are taking. • WOMEN: Notify your doctor if you become or intend to become pregnant, or are breastfeeding. • Xarelto is usually taken once a day around the same time, with or without food. • Store Xarelto at room temperature in its tightly closed container. Do not use after the expiration date on the label. Properly discard unused medication. *Excerpted from the FDA-approved Patient Counseling Information

death worldwide. The term refers to a spectrum of conditions that result from myocardial ischemia, and includes unstable angina and myocardial infarction. ACS may develop slowly over many years by the buildup of atherosclerotic plaque. ACS usually occur due to rupture of an atherosclerotic plaque with superimposed thrombotic occlusion of one or more coronary arteries. Plaque disruption is accompanied by resultant platelet activation and aggregation at the site of the rupture, and thrombosis

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that results in oxygen deprivation in myocardial tissue. Platelets thus play a critical role in initiation and propagation of thrombosis. Multiple pathways mediate platelet activation. Initial deposition and activation is accomplished by interaction of cell surface glycoprotein (GP) receptors with subendothelial matrix proteins including collagen and von Willebrand factor. These events lead to release of various soluble agonists by adherent platelets, which in turn stimulate recruitment and activation of circulating platelets to form a propagating thrombus. The key platelet agonist thromboxane A2 (TXA2), adenosine diphosphate (ADP) and thrombin bind to distinct G protein-coupled receptors on the platelet surface. Although these substances initiate signaling via distinct pathways, they all lead to multiple common events, including platelet degranulation and release of soluble agonists, platelet shape change, activation of the GP IIb/IIIa fibrinogen receptor, and ultimately platelet aggregation. Before approval of ticagrelor, available oral antiplatelet agents approved in ACS included aspirin, an irreversible inhibitor of cyclooxygenase 1-mediated TXA2 synthesis, and the P2Y 12 antagonists clopidogrel (Plavix) and prasugrel (Effient) that selectively and irreversibly bind to the P2Y 12 ADP receptor. Treatment with the combination of aspirin plus a P2Y 12 antagonist (i.e., clopidogrel) has demonstrated greater efficacy than either drug alone, and aspirin plus clopidogrel is considered the gold standard over single-agent therapy in blocking the platelet response. Patients receiving dual antiplatelet therapy remain at substantial risk of ischemic events because these agents do not interfere with all platelet activation pathways including the one mediated by thrombin. Moreover, because platelet activation initiated by TXA 2 and ADP is critical to hemostasis; aspirin and clopidogrel target these

pathways and are associated with increased bleeding risk. The substantial residual risk for ischemic events and increased propensity for bleeding with aspirin and clopidogrel highlight the need for novel therapeutic agents that can reduce cardiovascular events, ideally without increasing the risk for bleeding. Hemorrhage has emerged as a major adverse outcome in patients with ACS, and several trials have confirmed the association of bleeding with mortality. The influence of major bleeding on mortality seems equivalent to the effect of a myocardial infarction. Unlike clopidogrel and prasugrel, ticagrelor is a member of a new class of P2Y 12 antagonists (see Acute Coronary Syndromes) that bind reversibly. This provides flexibility to the patient, allowing more rapid recovery of platelet function after the drug is discontinued. More rapid recovery of platelet function may be a doubleedge sword, however, placing the noncompliant patient at risk of a thrombotic event at an earlier time point when therapy is interrupted. Studies have demonstrated greater antiplatelet effects of ticagrelor compared with clopidogrel and greater reversibility. The antiplatelet effects seen three days after discontinuation of ticagrelor are comparable with those seen five days after discontinuation of clopidogrel. Mechanism of Action. Ticagrelor and its major metabolite reversibly interact with the platelet ADP P2Y12 receptors to prevent ADP-induced platelet activation. Ticagrelor and its active metabolite are very similar pharmacokinetically and are approximately equipotent. Adverse Effects. The most common adverse reactions are bleeding (12 percent) and dyspnea (14 percent). Warnings, Precautions and Contraindications. The following warnings and precautions are listed: • As with other antiplatelet agents,

February 2012

Table 4 M aj or co uns el ing po ints for Brilinta (ticagrelor) tablets* Brilinta is used with aspirin (not more than 100 mg) to lower your chance of having a heart attack or dying from a heart attack or stroke. • Read the Medication Guide before you start taking Brilinta and each time you get a refill. • Tell your doctor: -if you have ever had bleeding problems in the past, recent injury or surgery or plan to have surgery or dental work, a history of stomach ulcers or colon polyps, or lung problems; -if you are bleeding now, have a history of bleeding in your brain, have severe liver problems; -if you have bleeding that is severe or that you cannot control; pink, red or brown urine; vomit blood or your vomit looks like “coffee grounds;” red or black bowel movements; coughing up blood or blood clots; -if you have new or unexpected shortness of breath when you are at rest, or when you are doing any activity; -about all other prescription and nonprescription (OTC) medicines, vitamin/mineral supplements, natural products and herbal remedies you are taking. Do not take more than 100 mg of aspirin a day. • WOMEN: Notify your doctor if you become or intend to become pregnant, or are breastfeeding. • Brilinta is usually taken at around the same time each day, with or without food. • Store Brilinta at room temperature in its tightly closed container. Do not use after the expiration date on the label. Properly discard unused medicine. *Excerpted from the FDA-approved Medication Guide

Brilinta increases the risk of bleeding. In general, risk factors for bleeding include older age, a history of bleeding disorders, performance of percutaneous invasive procedures and concomitant use of medications that increase the risk of bleeding (e.g., anticoagulant and

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fibrinolytic therapy, higher doses of aspirin, and chronic nonsteroidal anti-inflammatory drugs). • Moderate hepatic impairment: Risks versus benefits of treatment, noting the probable increase in exposure to ticagrelor should be considered. • Dyspnea: Dyspnea was reported more frequently with Brilinta (14 percent of patients) than with clopidogrel (8 percent of patients). Dyspnea resulting from Brilinta is self-limiting. Other causes should be ruled out. • Discontinuation of Brilinta: Premature discontinuation increases the risk of myocardial infarction, stent thrombosis, and death. Contraindications include a history of intracranial hemorrhage, active pathological bleeding and severe hepatic impairment. Drug Interactions. Ticagrelor is predominantly metabolized by CYP3A4, and to a lesser extent by CYP3A5. It is an inhibitor of CYP3A4/5 and P-gp. • Avoid use of strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir and telithromycin). • CYP3A inducers (e.g., rifampin, dexamethasone, phenytoin, carbamazepine and phenobarbital). • Aspirin: Use of Brilinta with aspirin maintenance doses above 100 mg reduced the effectiveness of Brilinta. • Digoxin: Because of inhibition of the P-gp transporter, digoxin levels should be monitored with initiation of or any change in Brilinta therapy. Dosage and Availability. The initial (loading) dose is 180 mg, followed with 90 mg twice daily. After an initial loading dose of aspirin (usually 325 mg), Brilinta should be used with a daily maintenance dose of aspirin of 75 to 100 mg. Brilinta is available as tablets containing 90 mg of ticagrelor. The tablets must be kept in the container they come in, and the tablets kept dry. Patient Information. Ex-

cerpts from the FDA-approved Medication Guide are shown in Table 4.

Overview and Summary

Treatment of COPD, DVT and ACS are targeted with therapy involving the three new drugs presented in this lesson. Patients should receive benefit from the drugs when used correctly.

The authors, the Ohio Pharmacists Foundation and the Ohio Pharmacists Association disclaim any liability to you or your patients resulting from reliance solely upon the information contained herein. Bibliography for additional reading and inquiry is available upon request. This lesson is a knowledge-based CE activity and is targeted to pharmacists in all practice settings.

Program 0129-0000-11-011-H01-P Release date: 11-15-11 Expiration date: 11-15-14

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.

February 2012

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2011 - 2012 GPhA BOARD OF DIRECTORS Name Position

Editor: Jim Bracewell jbracewell@gpha.org

Dale Coker Chairman of the Board Jack Dunn President Robert Hatton President-Elect Pam Marquess First Vice President Bobby Moody Second Vice President Robert Bowles State At Large Hugh Chancy State At Large Keith Herist State At Large Eddie Madden State At Large Jonathan Marquess State At Large Tim Short State At Large Richard Smith State At Large Christine Somers 1st Region President Fred Sharpe 2nd Region President Renee Adamson 3rd Region President Amanda Gaddy 4th Region President Julie Bierster 5th Region President Ashley Faulk 6th Region President Amanda McCall 7th Region President Larry Batten 8th Region President Kristy Pucylowski 9th Region President Christopher Thurmond 10th Region President Ashley London 11th Region President Ken Eiland 12th Region President Thomas Jeter ACP Chairman Josh Kinsey AEP Chairman Sonny Rader AHP Chairman Ira Katz AIP Chairman Gail Lowney APT Chairman Christina Gonzalez ASA Chairman John T. Sherrer Foundation Chairman Michael Farmer Insurance Trust Chairman Bill Prather Georgia State Board of Pharmacy Representative Patricia Knowles Georgia Society of Health Systems Pharmacists Amy Grimsley Mercer Faculty Representative Rusty Fetterman South Faculty Representative Sukh Sarao UGA Faculty Rep. Negin Sovaidi ASP Mercer University Rep. Annie Tran ASP South University Rep. David Bray ASP UGA Rep. Jim Bracewell Executive Vice President

Managing Editor Kelly McLendon

kmclendon@gpha.org

Writer & Designer: Mary Larkin mlarkin@gpha.org The Georgia Pharmacy Journal® (GPJ) is the official publication of the Georgia Pharmacy Association, Inc. (GPhA). Copyright © 2012, Georgia Pharmacy Association, Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical including by photocopy, recording or information storage retrieval systems, without prior written permission from the publisher and managing editor. All views expressed in bylined articles are the opinions of the author and do not necessarily express the views or policies of the editors, officers or members of the Georgia Pharmacy Association.

Articles and Artwork

Those interested in writing for this publication are encouraged to request the official “GPJ Guidelines for Writers.” Artists or photographers wishing to submit artwork for use on the cover should call, write or e-mail kmclendon@gpha.org.

Subscriptions and Change of Address

The Georgia Pharmacy Journal® (GPJ) (ISSN 1075-6965) is distributed as a regular membership service, paid for through allocation of membership dues. Subscription rate for non-members is $50.00 per year domestic and $10.00 per single copy; international rates $65.00 per year and $20.00 single copy. Subscriptions are not available for non-GPhA member pharmacists licensed and practicing in Georgia. The Georgia Pharmacy Journal® (GPJ) (ISSN 1075-6965) is published monthly by the GPhA, 50 Lenox Pointe NE, Atlanta, GA 30324. Periodicals postage paid at Atlanta, GA and additional offices. POSTMASTER: Send address changes to The Georgia Pharmacy Journal®, 50 Lenox Pointe, NE, Atlanta, GA 30324.

Advertising

Advertising copy deadline and rates are available at www.gpha.org upon request. All advertising and production orders should be sent to the GPhA headquarters at kmclendon@gpha.org.

GPhA Headquarters

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Power Marketing: (678) 990-3618

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February 2012

con tinuin g education quiz

Please print. Name

New Drugs : Arcapta, Brilinta an d Xarelto

Address

1. Arcapta is effective for treating: a. acute asthma. c. chronic asthma. b. acute COPD. d. chronic COPD.

2. Arcapta is a: a. short-acting bronchodilator. b. short-acting corticosteroid. c. long-acting bronchodilator. d. long-acting corticosteroid.

Birthdate

City, State, Zip

NABP e-Profile ID*

*Obtain NABP e-Profile number at www.MyCPEmonitor.net.

(MMDD)

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

3. The overall prevalence of COPD has increased more rapidly in: a. men. b. women.

8. Xarelto is an inhibitor of factor a. Ta. c. Xa. b. Va. d. Za.

4. The pharmacologic effects of Arcapta are attributed to its being an adrenergic receptor: a. agonist. b. antagonist.

9. By inhibiting the factor referred to in question 8, the generation of thrombin from prothrombin is: a. increased. b. decreased.

5. Arcapta stimulates adenyl: a. cyclase. c. oxidase. b. glucuronidase. d. reductase.

10. The most common adverse reaction with Xarelto noted in clinical trials was: a. anaphylaxis. c. hemorrhage. b. dyspepsia. d. tachycardia.

6. The Medication Guide for Arcapta advises patients to tell their doctor if they have: a. allergic rhinitis. c. glaucoma. b. cystic fibrosis. d. heart problems.

11. The recommended dose for Xarelto is 10 mg: a. once a day. c. three times a day. b. twice a day. d. four times a day.

7. When beginning therapy with Arcapta, patients who have been taking an inhaled short-acting β2 -agonist on a regular basis should be advised to continue its regular use. a. True b. False

12. The key platelet agonist is thromboxane: a. G2. c. C2 . b. E2. d. A2 . 13. The gold-standard over single-agent therapy in blocking the platelet response in acute coronary syndrome is aspirin plus: a. ticagrelor. c. clopidogrel. b. prasugrel. d. warfarin.

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

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

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

[b] [c] [d] 11. [a] [b] 12. [a] [b] [c] [d]] 13. [a] [b] 14. [a] [b] [c] [d] 15. [a]

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

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

14. Brilinta and its major metabolite reversibly interact with the platelet ADP P2Y12 receptors to: a. increase platelet activation. b. decrease platelet activation.

[c] [d]

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

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Program 0129-0000-11-011-H01-P 0.15 CEU

15. Brilinta should be used with a daily maintenance dose of: a. aspirin. c. prednisone. b. clopidogrel. d. warfarin.

To receive CE credit, your quiz must be postmarked no later than November 15, 2014. A passing grade of 80% must be attained. CE statements of credit are mailed February, April, June, August, October, and December until the CPE Monitor Program is fully operational. Send inquiries to opa@ohiopharmacists.org.

November 2011 February 2012

Georgia Pharmacy Association 50 Lenox Pointe, NE Atlanta, GA 30324

Introducing the GPhA/UBS Wealth Management Program UBS has agreed to provide all members of the Georgia Pharmacy Association with exclusive access to financial services resources through the Wile Consulting Group. This new group relationship enables members to leverage the vast scale of products and services at UBS. With more than 100 years of financial services experience, The Wile Consulting Group at UBS has been recognized as one of Barron’s Top 1,000 Financial Advisors in the country. The Wile Consulting Group is the endorsed wealth management provider for the Georgia Dental Association and also PriceWaterhouseCoopers Southern Division. They will replicate these same offerings to the GPhA. Member benefits include – Complimentary financial planning (a $5k–10k value) – Brand new 401(k) retirement savings plan designed exclusively for GPhA members at a group discount rate – Advisory and investment program offered at group discount rate – Retirement planning guidance, including a retirement income replacement system – Lending capabilities with competitive interest rates – Free access to UBS global investment research

Harris Gignilliat, CRPS® Vice President–Investments 3455 Peachtree Road NE, Suite 1700 Atlanta, GA 30326 404-760-3301 harris.gignilliat@ubs.com ubs.com/team/wile

Chartered Retirement Plans SpecialistSM and CRPS® are registered service marks of the College for Financial Planning®. Neither UBS Financial Services Inc. nor any of its employees provides legal or tax advice. You should consult with your personal legal or tax advisor regarding your personal circumstances. 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, the Wile Consulting Group, or visit our website at ubs.com/workingwithus. Financial Planning services are provided in our capacity as a registered investment adviser. As a firm providing wealth management services to clients in the U.S., 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. Note to the User: FINRA (NASD) requires that the prospectus offer legend (the first paragraph below) be in a font size that is at least the same size as that used in the main text of the marketing piece and in a different print style, such as bold or italic type. Once this disclosure (the prospectus offer legend) is used in any public facing materials, the materials are subject to filing with FINRA (NASD) by a Series 24 Principal. UBS Financial Services Inc. is a subsidiary of UBS AG. ©2011 UBS Financial Services Inc. All rights reserved. Member SIPC. 7.00_8.5x8.75_AX0712_GigH.2