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* This is not a claims claim ms reporting site. You cannot electronically ally report a claim to us. To report a claim, call 800.247.5930. 247.5930. ** Compensated endorsement. Not all products available a in every state. The Pharmacists Pharmacissts Life is licensed in the District of allll states except AK, FL, HI, MA, ME, NH, NJ, NY and VT. Check with your Columbia and al representative or the company for details on coverages and carriers.


14

Departments

Armon Neel Helps Seniors on AARP Website FEATURE ARTICLES

7 10 16 21 24

BlueCross BlueShield Insurance Information Pharmacist Senator Buddy Carter Gets Committee Chairmanship Pharmacy Time Capsules: 2011 (Fourth Quarter) Pharmacists in Action: The Pharmacist and the Budget

10 11 12 15 17 18 23 30 30

GPhA Website Goes Mobile GPhA Mentorship Program Pharm PAC Contributors Pharm PAC Contribution Card GPhA New Members GPhA Convention Save the Date USPS Magazine Statistics GPhA Board of Directors Masthead

Advertisers 2 5 10 11 13 13 17 19 20 23 32

Pharmacists Mutual Companies GPhA Career Center Financial Network Associates Frances Cullen, P.C. Logix, Inc. Melvin Goldstein, P.C. Barbara Cole, Attorney at Law AIP GPhA Workers’ Compensation Pharmacy Quality Commitment UBS

CPE Opportunity: New Drugs: Benlysta, Daliresp & Edarbi

COLUMNS

4 6

President’s Message

For an up-to-date calendar of events, log onto

Editorial

The Georgia Pharmacy Journal

www.gpha.org. 3

October 2011


PRESIDENT’S MESSAGE L. Jack Dunn, Jr., R.Ph. GPhA President

Standing Committees Standing Tall for Your Future

ast month in the September JOURNAL we discussed taking action in GPhA by taking small steps and not standing still.

All pharmacists must make an effort to get involved with your local, regional, state and national professional organizations to help us keep our profession prosperous and our ability to meet and exceed our patients’ expectations by providing quality and timely patient care.

L

Recently the committees on third party, governmental affairs, student affairs, public relations and continuing education met at Mercer University. Through the leadership of Scott Meeks, Christina Gonzalez, Traci Lundi, Eddie Madden and Renee Adamson, the standing committees came together to interject new ideas for GPhA. The third party committee brought to the attention of our association the modified changes on the PBM bill. This bill now gives the insurance commissioner the ability to look at unfair practices presented by the PBMs. In order for the insurance commissioner to view the complaints submitted by the pharmacies or patients, the third party committee must devise a complaint form. This form will be standardized, so all complaints going to the insurance commissioner would aid in a quicker response to pharmacy or patient. One example of a complaint filed could be problems associated with the availability of specialized drugs. Patients on specialized drugs must purchase them only from a specific source approved by the PBM. These PBMs are gouging patients with unbearable pricing. This complaint could be added to the devised form and sent to the insurance commissioner. We, as pharmacists, must be the patient’s advocate and protect them from the unfair practices of the PBMs. This idea is one of many brought to the attention of GPhA by the standing committees.

The Georgia Pharmacy Journal

4

October 2011


SUPPORTING PHARMACISTS. ADVANCING CAREERS. Find the best jobs and highly qualified pharmacists Georgia has to offer.

ONLINE CAREER CENTER www.gpha.org/jobs


EXECUTIVE VICE PRESIDENT’S EDITORIAL Jim Bracewell Executive Vice President / CEO

The Advocacy of Today Shapes the Laws of Tomorrow Thursday morning on February 9, 2012, so it is pretty easy for them to say yes to your invitation. You will be a hero to him or her if you do this and plan to attend with your fellow pharmacy advocates for a great day at VIP Day.

ost of us are familiar with the commercial where the guy slaps his forehead and says, “I should have had a V8.”

M

When we are faced with a new law or regulation that is detrimental to the pharmacy profession it is at that time we slap our forehead and remember we should have been active in our advocacy for pharmacy long before the law or regulation was considered. It is truly a challenge to begin to advocate for a position after the proverbial “horse has left the barn.”

Tell Andy about your contact and invitation. Andy and his GPhA associates will follow up with the legislator to be sure it is on their calendar and we will send reminders right up to the day before the event. If in 2012 you find a new law or a new regulation that would have been so much better if the people writing it had heard from you then you will know that today is your “V8” moment. The advocacy of today will shape the laws or regulation of 2012. GPhA is here to help you have input into the future of your practice. The ball is in your court. Do not miss another opportunity to be the professional pharmacist you really want to be.

In October, the 2012 legislative session seems far away into next year, but it is really now less than 90 days before your professional scope of practice is in the hands of a well-meaning but often ill-informed legislature. So when should you make that relationship with your state representative and your state senator? Today, not tomorrow, you need to reach out to them in a personal manner and let them know who you are, where you practice and that you are an advocate for your patients and the profession of pharmacy. You likely will be surprised at how well you are received by them.

Do not hesitate to contact Andy Freeman at afreeman@gpha.org or 404-819-8118. He is your advocacy career coach and he is good at what he does.

You are halfway there to being a great advocate for your profession. Every advocate needs a coach; a person who will help with details, research issues, and supply you with talking points or perhaps join you in a visit with your legislator. Let me introduce you to Advocacy Coach, Andy Freeman, our Director of Government Affairs at GPhA. Now would be a great time to invite your legislator to our GPhA VIP Day event on Thursday, February 9, 2012, at the Georgia Train Depot. Your legislator is not as busy this fall and they have not yet made plans for that The Georgia Pharmacy Journal

6

October 2011


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Blue Cross and Blue Shield of Georgia Medical Plans

You will have the option to enroll in one of the following four (4) medical plans:  Open Access Point of Service (OA POS) – The plan provides benefits both in and out of network. The plan does not require a referral to see a specialist who participates in the BCBS Open Access network.  Health Savings Account (HSA) – This plan provides you with the flexibility to use a health care provider either in or out of the network without a referral. Medical Plan Highlights

OA POS

OA POS

OA POS

HSA

Medical deductible – In network

$500

$1,500

$1,000

$3,000

$1,500

$4,500

$2,500

$5,000

Medical deductible – Out of network

$1,000

$3,000

$1,000

$3,000

$1,500

$4,500

$5,000

$10,000

Out-of-pocket maximum – In network

$1,000

$3,000

$1,000

$3,000

$1,000

$3,000

$5,000

$10,000

Out-of-pocket maximum – Out of network

$4,000

$12,000

$4,000

$12,000

$4,000

$12,000

$10,000

$20,000

Primary care physician visit

$25 copay Ded. waived

$40 copay Ded. waived

$40 copay Ded. waived

40% Ded. waived

$0 Ded. waived

40% after ded.

Specialist visits

$35 copay Ded. waived

$50 copay Ded. waived

$50 copay Ded. waived

40% Ded. waived

20% Ded. waived

40% after ded.

Coinsurance

20% after deductible

20% after deductible

20% after deductible

40% Ded. waived

20% Ded. waived

40% after ded.

Emergency room

$100 copay Ded. waived

$100 copay Ded. waived

$100 copay Ded. waived

$100 copay Ded. waived

20% Ded. waived

40% after ded.

Generic

$15 copay

$15 copay

Ded. then 40%

Ded. then 20%

Ded. then 40%

Ded. then 40%

$15 copay

Ded. then 40%

Blue Cross and Blue Shield of Georgia Dental Plans

Dental coverage Calendar year deductible Single

$50

Family

$150

Deductible applies to

Type II and III

Coinsurance

GAD\1-hda\ebpg\Clients\GA Pharmacy Association\GA Pharm Assoc NL attachment 2011_2

Preventive services (Type I)

100%

Basic Services (Type II)

80%

Major Services (Type III)

50%

Periodontics and Endodontics

80%

Annual maximum

$1,000

Out of network usual and customary

90%


Do you want more information on the Blue Cross Blue Shield GPhA Plans?

Blue Cross and Blue Shield of Georgia Medical Plans

You will have the option to enroll in one of the following four (4) medical plans: ƒ Open Access Point of Service (OA POS) – The plan provides benefits both in and out of network. The plan does not require a referral to see a specialist who participates in the BCBS Open Access network. ƒ Health Savings Account (HSA) – This plan provides you with the flexibility to use a health care provider eitherdo in or out of thefor network without a referral. Who I contact information? Medical Email Plan Ruth Highlights

Ann McGeheeOAatPOS rmcgehee@gpha.org orOA callPOS on her direct line at 404-419-8104 OA POS

HSA

Medical deductible $500 $1,500 $1,000 $1,500 $2,500 “The responses from our currently insured groups have been$3,000 overwhelmingly positive.$4,500 This plan in many respects$5,000 mirrors – In network

the plan of the Georgia Dental Association that has long been a successful plan for dentists across Georgia. I am proud the $1,000 $3,000 $1,000 $3,000 $1,500 $4,500 $5,000 $10,000 GPhA was able to put together such a quality offering for the pharmacists and pharmacies of our association,” said$1,000 GPhA Executive Vice President the president$5,000 of Blue Cross Blue $3,000 $1,000 Jim Bracewell. $3,000 “Morgan $1,000Kendrick, $3,000 $10,000 Out-of-pocket maximum Shield and I serve on the board of the Georgia Healthcare Information Exchange. Morgan is a leader in healthcare and its – In network future in our state.” Medical deductible of – leadership Out of network

$4,000 Out-of-pocket maximum – Who Out of will network administer the

$12,000

$4,000

$12,000

$4,000

$12,000

$10,000

$20,000

plan for us?

Primary care physician visit

$25 copay Ded. waived

$40 copay Ded. waived

$40 copay Ded. waived

40% Ded. waived

$0 Ded. waived

40% after ded.

Specialist visits

$35 copay Ded. waived

$50 copay Ded. waived

$50 copay Ded. waived

40% Ded. waived

20% Ded. waived

40% after ded.

20% after

40%

20% Ded.

40% after

$15 copay

Ded. then 40%

Ded. then 20%

Ded. then 40%

Georgia Pharmaceutical Services, GPhA wholly owned subsidiary and insurance agency will provide the administration for the plan as they have in the past for The Insurance Trust.

Who are the board members of Georgia Pharmaceutical Services, Inc.? Coinsurance

20% after

Generic

$15 copay

20% after

deductible deductible waived ded. The board of directors of the GPhS are electeddeductible by the GPhA board of directors and theDed. current boardwaived is made up of Robert Bowles, room Dale Coker, Eddie Madden, Pam$100 Marquess, Bobby Moody, 20% and Ded. Sharon40% Sherrer. Emergency $100 Jack copayDunn, Robert Hatton, $100 copay copay $100 copay after Ded. waived waived Ded. waived Ded. waived ded. Executive Vice President Jim Bracewell servesDed. as the secretary in an ex-officio non-voting position. waived Ded. then 40%

$15 copay

Ded. then 40%

New Health Insurance Benefit From GPhA Plan Facts BlueEffective CrossOctober and Blue Shield ofCross Georgia Dental 1, 2011, Blue & Blue ShieldPlans of Georgia will be GPhA’s Plan Administrator. Dental coverage

Calendar Members of the GPhA health care plan will have four plans to choose from. year deductible

Dental will be included. Guaranteed rates through December 31, 2012.

The Georgia Pharmacy Journal

GAD\1-hda\ebpg\Clients\GA Pharmacy Association\GA Pharm Assoc NL attachment 2011_2

Single

$50

Family

$150

Deductible applies to

Type II and III

Coinsurance

9

Preventive services (Type I)

100%

Basic Services (Type II)

80%

Major Services (Type III)

50%

Periodontics and Endodontics

80%

Annual maximum

$1,000

Out of network usual and customary

90%

October 2011


Member News

Pharmacist Senator Buddy Carter Gets Committee Chairmanship By Tom Crawford | Published: October 5, 2011 in THE GEORGIA REPORT With the recent resignations of two state senators, Sen. Buddy Carter, R.Ph., (R-Pooler) and Sen. Charlie Bethel (R-Dalton) have been given committee chairmanships by the Senate’s Committee on Assignments. Carter, a Chatham County pharmacist, is the new chairman of the Senate’s Higher Education Committee. He replaces Jim Butterworth, who left the Senate to become Georgia’s adjutant general. Bethel, an attorney and a first-term legislator, is the new chairman of the Reapportionment Committee, replacing Mitch Seabaugh. Gov. Nathan Deal two days ago appointed Seabaugh as the deputy state treasurer. “Their individual talents and expertise in these areas are a great benefit to the General Assembly and the citizens of Georgia,� Senate President Pro Tem Tommie Williams (R-Lyons) said. “Senator Carter’s long career in public service has proven he can lead on difficult issues,� Senate Majority Leader Chip Rogers (RWoodstock) said. “Senator Bethel has proven to be one of the most knowledgeable members of the General Assembly on the legal and political issues involved in redistricting.�

GPhA Website Goes Mobile In an effort to better serve our members who utilize mobile devices, GPhA has created a mobile friendly website. To visit this site go to gpha.mobi. The image you see to the left is what the mobile site looks like to the mobile user. We hope you enjoy this new service.

I can answer your

QUESTIONS ABOUT TAXES & FINANCIAL PLANNING Join us for THIRD THURSDAY CONFERENCE CALLS Dial our complimentary conference line on the third Thursday of Sept., Oct. & Nov. from 4:00 to 4:30pm: (800) 391-1709 PIN 582280 Compliments of

MICHAEL T. TARRANT Financial Network Associates 1117 Perimeter Center West, Suite N-307 "UMBOUB ("t '/"QMBOOFSTDPNtNJLF!'/"QMBOOFSTDPN

An Independent Financial Planner since 1992 Focusing on Pharmacy since 2002 Securities, certain advisory services and insurance products are offered UISPVHI*/7&45'JOBODJBM$PSQPSBUJPO */7&45 t.FNCFS FINRA/SIPC, a federally registered Investment Advisor, and affiliated JOTVSBODFBHFODJFT*/7&45JTOPUBĂŻMJBUFEXJUI'JOBODJBM/FUXPSL Associates, Inc. INVEST does not provide tax or legal advice. Other BEWJTPSZTFSWJDFTNBZCFPĂŞFSFEUISPVHI'JOBODJBM/FUXPSL"TTPDJBUFT  *OD BSFHJTUFSFEJOWFTUNFOUBEWJTPSJBE

The Georgia Pharmacy Journal

10

October 2011


GPhA MEMBER BENEFIT

New GPhA Member Benefit: Be a Mentor, Get a Mentor Be a Mentor As a Mentor, you will share your knowledge with a pharmacy professional in a similar discipline in your region. In doing so, you will make an impact on the career path of an individual at the beginning of a career or at a crossroads. Based upon your responses to the questionnaire that follows, we will match you up with a Mentee that fits your needs. Mentor Criteria: •

Your address

Your years of experience

Your field of experience

To be a mentor got to GPhA and click “Be a Mentor, Find a Mentor” at the bottom of the Member Benefits Page.

Get a Mentor The “Be a Mentor, Find a Mentor” program is designed to help pharmacy professionals learn and grow in their profession, in addition to helping executives at any level increase their skill set by signing up for a Mentor. As a Mentee, you will be have an opportunity to gain knowledge and experience from pharmacy professionals that help guide your career. Based upon your responses to the questionnaire that follows, we will match you up with a Mentor that fits your needs. Your license is

Mentee Criteria: •

Your address

Your years of experience

Your current practice area

Your desired practice area

your livelihood. Protect it!

To be a mentor or mentee go to www.gpha.org and click “Be a Mentor, Find a Mentor” at the bottom of the Member Benefits Page.

Frances Cullen PC Professional Licensing Attorney (404) 806-6771 6771 phone (404) 806-7319 fax www.francullen.com Practice devoted solely to the representation of licensed professionals Over 20 years of experience with licensed professionals, Georgia Boards, GDNA & DEA Former Assista tant nt District Attorney Former Assistant Attorney General Criminal & License Defense

The Georgia Pharmacy Journal

11

October 2011


Current Pharm PAC Members Titanium Level ($2400 minimum pledge) T.M. Bridges, 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. William A Murray, 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. William G. Cagle, R.Ph. Hugh M. Chancy, R.Ph. Keith E. Chapman, R.Ph. Dale M. Coker, R.Ph., FIACP John Ashley Dukes, R.Ph. Patrick Dunham Jack Dunn, Jr. R.Ph. Neal Florence, R.Ph. Andy Freeman Martin T. Grizzard, R.Ph. John Hansford, 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. McCarthey, R.Ph. Drew Miller, R.Ph., CDM Laird Miller, R.Ph. Cynthia K. Moon Jay Mosley, R.Ph. Allen Partridge, R.Ph. Houston Lee Rogers, Pharm.D., CDM Tim Short, R.Ph. Christopher R. Thurmond, Pharm.D. Danny Toth, R.Ph. Tommy Whitworth, R.Ph., CDM

Earl Marbut, R.Ph. 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. Flynn W. Warren, M.S., R.Ph. William T. Wolfe, R.Ph.

Gold Level ($600 minimum pledge) James Bartling, Pharm.D., ADC, CACII Larry Batten, R.Ph. Liza G. Chapman, Pharm.D. Mahlon Davidson, R.Ph., CDM James Gordon Elrod, R.Ph. Kevin M. Florence, Pharm.D. Robert B. Moody, R.Ph. Sherri S. Moody, Pharm.D. Jeffrey Grady Richardson, R.Ph. Andy Rogers, R.Ph. Daniel C. Royal, Jr., R.Ph. Michael T. Tarrant

Bronze Level ($150 minimum pledge) Monica M. Ali-Warren, R.Ph. Fred W. Barber, R.Ph. John R. Bowen, R.Ph. Ben Cravey, 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. Amy S. Galloway, R.Ph. Ed Kalvelage John D. Kalvelage Steve D. Kalvelage Marsha C. Kapiloff, R.Ph. Joshua D. Kinsey, Pharm.D. Brenton Lake, R.Ph. 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.

Silver Level ($300 minimum pledge) Renee D. Adamson, Pharm.D. Chandler M. Conner, Pharm.D. Terry Dunn, R.Ph. Marshall L. Frost, Pharm.D. Johnathan Wyndell Hamrick, Pharm.D. James E. Jordan, Pharm.D. Willie O. Latch, R.Ph. W. Lon Lewis, R.Ph. Kalen Porter Manasco, Pharm.D.

If you made a gift or pledge to Pharm PAC in the last 12 months and your name does not appear above, please contact Andy Freeman at afreeman@gpha.org or 404-419-8118. Donations made to Pharm PAC are not considered charitable donations and are not tax deductible. The Georgia Pharmacy Journal

12

October 2011


Pharm PAC Contributors’ List Continued Mary P. Meredith, R.Ph. Rose Pinkstaff, R.Ph. Leslie Ernest Ponder, R.Ph. Kristy Lanford Pucylowski, Pharm.D. 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.

William D. Whitaker, R.Ph. Elizabeth Williams, R.Ph. Jonathon Williams, Pharm.D.

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

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

William Moye, R.Ph. Darby R. Norman, R.Ph. Christopher Brown Painter, R.Ph. Steve Gordon Perry, R.Ph. Whitney B. Pickett, R.Ph. Michael Roland Reagan, R.Ph. James L. Riggs, R.Ph. 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. Erica Lynn Veasley, R.Ph.

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October 2011


MEMBER NEWS

Armon Neel Helps Seniors on AARP Website By Ray Lightner Reprinted with additions from THE GRIFFIN DAILY NEWs

A Griffin pharmacist is showing doctors and patients that seniors may be overmedicated. Armon J. Neel, Jr., Pharm.D. is a certified geriatric pharmacist and consultant who evaluates the medications people are taking to determine if they are taking the right medications and doses. Neel consults with nursing homes and individual patients. This is something he has done for more than 40 years. It started as a suggestion from a friend but grew out of the way he started his practice, back in 1963. Neel’s father owned Neel’s Pharmacy, but Neel didn’t want to just fill prescriptions. So just two years out of pharmacy school, Neel opened an apothecary shop in Griffin across from the outpatient center, where he consulted with patients about medications and filled prescriptions.

He now visits nursing homes and hospitals five to six days a month. He goes over charts, talks with patients and provides recommendations. “I go in and match the drug chemistry to the patient’s chemistry,” Neel said.

He stopped filling prescriptions in 1977 and opened an institutional pharmaceutical consulting business, which he later sold in 2000 when he retired.

For a positive outcome, he said, “you have to balance things out together.”

“That lasted about three weeks,” Neel said. “I didn’t like being retired at all.”

He said, “As we get older, our chemistry changes and the muscle mass is affected. A lot of physicians don’t understand that.”

He started back seeing patients and opened a consulting business with a website, medicationexpert.com.

Getting doctors to listen sometimes is the hard part, he said. “It’s fun,” he said. “It’s my golf. When I get a new patient, it’s like teeing up a drive.”

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“What I do, I know well and I’m willing to share with a physician,” he said.

14

October 2011


Some of his patients end up going to another physician because the original physician won’t listen.

the-pharmacist column on the AARP website as AARP’s first geriatric pharmacist consultant. The site first ran a story on Neel in 2004 and has recently updated and rerun the story to introduce the ask-the-pharmacist column.

“A lot do and fare a lot better,” Neel said. As the baby boomers continue to age, Neel said, geriatric treatment will continue to grow as a field.

Neel will work on the column with Bill Hogan, an AARP producer with whom he has co-authored an upcoming book, ARE YOUR PRESCRIPTIONS KILLING YOU? HOW TO PREVENT DANGEROUS INTERACTIONS, AVOID DEADLY SIDE EFFECTS, AND BE HEALTHIER WITH FEWER DRUGS, to be published next year by Atria Books, a division of Simon & Schuster.

“There’s about 10,000 of us out there that do this,” he said. “The new paradigm for the 21st century is patient care, something I started 34 years ago.”

As a former president of GPhA, Dr. Neel has served as faculty for the GPhA convention and has been theonrecipient continued page 16

Because of his work, Neel was recently selected for an ask-

Join Pharm PAC Today! Pharm PAC is GPhA's Political Action Committee, providing the resources for the association to lobby and advocate on behalf pharmacy. GPhA leads the way in influencing pharmacyrelated legislation in Georgia. There are two ways in which to become a member. Once you have completed this form please mail it to Pharm PAC, 50 Lenox Pointe, NE, Atlanta, GA 30324.

Name: __________________________________________________ Address: _________________________________________________ Phone#: _________________________________________________ Email Address: ____________________________________________ Circle the Level in which you would like to participate with a monthly contribution: Titanium ($200/month)

Platinum ($100/month) Gold ($50/month)

Silver ($25/month)

Bronze ($12.50/month)

or If you wish to make a one time contribution write the amount you wish to contribute here: ______________________________________ If you are making a monthly contribution you will be contacted for additional information to set up your monthly contribution. If you are making a one time payment please mail your check in with your form.

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October 2011


Service Award.

of both the Bowl of Hygeia and the Innovative Pharmacy Practice Award as well as GPhA's Meritorious Service. He has served the patients of the state of Georgia for more than 50 years.

Along with chairing numerous committees on national and state levels, he has written many articles published in professional journals and presented various papers on long term care, Alzheimer’s disease, treatment of depression, anxiety, and dementia in the elderly, and performed numerous outcomes research studies relating to specific drug therapies.

As a result of Neel’s dedication and achievement, he has been recognized by his peers many times. Awards include: 1992 recipient of the George F. Archambault Award, consultant pharmacy’s highest honor; 1993 Innovative Pharmacy Practice Award from National Council of State Pharm. Association. Executives (Dupont-Pharmacia); 1973 A.H. Robins Bowl of Hygeia Award; President, Georgia Pharmaceutical Association; Phi Delta Chi “Pharmacist of the Year” Award; WSB 750 Award; NARD Awards of Merit in 1969-70-71-72-73-74; Profile of Career in Pharmacy in THE CONSULTANT PHARMACIST JOURNAL, Award of Appreciation, Georgia Association Nurses in Long Term Care; and Georgia Pharmacy Association Meritorious

Armon is married to June Chambers Neel. They have two sons and six grandchildren. Armon’s hobbies are pharmacy, computers and fishing. In 1989, the Neel family celebrated 100 years in pharmacy. Armon represents the fifth generation of Neel pharmacists. To visit the AARP Ask the Pharmacist section go to www.aarp.org/health and click “Experts”.

Pharmacy Time Capsules: 2011 (Fourth Quarter) number of new and refill prescriptions filled per year was 15,100 according to the Lilly Digest.

1986—Twenty-five years ago: * Food and Drug Administration approval of the first monoclonal antibody drug, Muronomab-CD3 (also known as Orthoclone OKT3), for treatment of transplant rejection

1936—Seventy-five Years Ago: *Johnstown, PA was hit with a devastating flood on St. Patrick’s Day. Initial reports were that 27 out of 34 drug stores were destroyed. Pharmacists and manufacturers rushed aid to the city to assure that essential medicines were available.

*Total health care expenses for a population of approximately 244 million were approximately $477 billion. *Average prescription price was $14.36 and the average number of new and refill prescriptions filled per year was 29,100 according to the Lilly Digest.

1886—One hundred twenty-five years ago: *The Brooklyn College of Pharmacy was formed in 1886. Renamed, it is now the Arnold and Marie Schwartz College of Pharmacy and Health Sciences of Long Island University.

1961—Fifty Years Ago: *Pharmacist Donald Hedgpeth and the Northern California Pharmaceutical Association indicted for violation of the Sherman Anti-trust Act for the development of a pricing schedule that incorporated a professional fee.

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. Membership offers the satisfaction of helping continue this work on behalf of pharmacy, and brings five or more historical publications to your door each year. To learn more, check out: www.aihp.org

*Amitriptyline HCl (Elavil) was introduced in the US by Merck Sharp & Dohme *Total health care expenses for a population of approximately 189 million were approximately $29 billion. *Average prescription price was $3.25 and the average

The Georgia Pharmacy Journal

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October 2011


GPhA MEMBER NEWS

Welcome to GPhA! The following is a list of new members who have joined Georgia’s premier professional pharmacy association! If you or someone you know would like to join GPhA go to www.gpha.org and click “Join” under the GPhA logo. Cory Swymer, Athens Kelly Lynn Thornbur, Calhoun

Individual Pharmacist Members Hanny S. Hassan, Hinesville Carol Ludwig, Dublin Sheila D. Miller, R.Ph., Grayson Carbert Moye, Pharm.D., Pelham Susan Lynn Synclair, Sharpsburg

Pharmacy Technician Members Corey L. Lofton, Villa Rica Rachel M. Lofton, Powder Springs Samantha T. Rhines, Mableton

Joint Pharmacist Members Aaliyah Khatib Mallard, Pharm.D., Atlanta Kendrick Ka’Juan Mallard, Pharm.D., Atlanta

New Graduate Pharmacist Members

BARBARA COLE ATTORNEY AT LAW, LLC 539 Green Street, NW Gainesville, GA 30501 678-971-9088 email bcoleattorney@gmail.com www.barbaracoleattorney.com

Arnaud Chevallie, Atlanta Theresa Dorsey, Pharm.D., Norcross Jonathan Lee, Pharm.D., Ph.D., Augusta Terica S. Johnson, Pharm.D., Savannah Ross Daniel Rainey, Pharm.D., Savannah

Pharmacy School Student Members Brianna Brown, Buford Sarah Kathryn Daniel, Evans Nathan Greenfield, Suwanee Kara Hartman, Augusta Ben Hudson, Sylvester Meredith Goodson McCloud, Augusta Wesley Douglas McKenzie, Marietta Hieu Ngoc Phan, Suwanee Lenard Starks, Berkeley Lake The Georgia Pharmacy Journal

All Aspects of Representation of Health Care Professionals Licensure Medicare Administrative Medicaid Criminal Bankruptcy Compliance State Bar Health Law Section Former Chief Magistrate Judge 17

October 2011


Please save the date for our 137th Annual Convention! Georgia Pharmacy Association 137th Annual Convention Hilton Head Marriott Resort & Spa Hilton Head Island, SC July 7-11, 2012 The Georgia Pharmacy Journal

18

October 2011


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Pharmacists in Action hubonpolicyandadvocacy Regulatory scorecard: What is happening now! Requests for information for which comment periods have closed: ; CDC: Draft document from the National Institute for Occupational Safety and Health with proposed additions and deletions to the hazardous drug list for 2012 ; FDA: Proposed research exploring the nature of including information about a disease and promotional information about a specific drug treatment in the same advertising piece ; FDA: Draft guidance on how the agency intends to apply its regulatory authorities to select medical software applications intended for use on mobile platforms Etc.: ; FDA: A public workshop regarding the approach of the Center for Drug Evaluation and Research to addressing drug shortages was held September 26. ; CMS: Medicare Part D open enrollment for patients to change plans for next year starts October 15 and ends December 7—earlier than in previous years. ; FDA: A public meeting will be held October 24 to discuss proposed recommendations released September 1 for the Prescription Drug User Fee Act (PDUFA V) reauthorization. ; For a complete list of all the issues and regulations being monitored and acted on by APhA, access the Government Affairs section of pharmacist.com. Also, print readers of the Hub should know that hyperlinks to pharmacist.com, Federal Register notices, and other useful websites can be accessed in the online version of the Hub, located at www.pharmacytoday.org.

The pharmacist and the budget hat does the recent debt ceiling

W deal, known as the Budget Control Act of 2011, mean for pharmacy? How can pharmacists influence the 12 Members of Congress on the new Joint Select Committee on Deficit Reduction, commonly referred to as the super committee? Staff from the APhA Government Affairs team and outside advisor SNR Denton, a major law firm in Washington, DC, discussed these questions with APhA Advocacy Key Contact (AAKC) members during an August 30 conference call with 179 participants. The political context for the debt ceiling deal dates back to the November 2010 election, Mark W. Weller, JD, SNR Denton Partner, said on the call. More than 80 freshman Republicans came to Congress with two key goals: They wanted to change the way Washington works, and they wanted to reduce the cost of government to the taxpayers. The debate about the rising federal debt ceiling was an opportunity for them to do just that, Weller said. He added that the debt ceiling increase usually happens with little fanfare and that many people claim the crisis was manufactured. Debt ceiling The debt ceiling deal has two main components: raising the debt ceiling so the federal government doesn’t default, and deficit reduction by the super committee on an aggressive timetable, John R. Feore III, JD, SNR Denton Associate, said on the call. The debt ceiling is being raised in a couple of phases. First, there’s an immediate $400 billion increase, with an additional $500 billion increase in the next 6 months, starting August 2. Depending on what happens with the super committee and Congress, another increase of $1.2 trillion to $1.5 trillion can occur. For

Timeline Feore described the timetable for the super committee to produce actual legislative language that can be scored by the Congressional Budget Office (CBO) and on which at least 7 of the 12 super committee members agree. The first two meetings were held September 8 and September 13. The super committee has to agree to a package that accomplishes the $1.2 trillion to $1.5 trillion in cuts by November 23, the day before Thanksgiving. If the super committee approves this package, it needs to transmit the CBO budget score, the legislative text, and a summary of the provisions to Congress and President Barack Obama by December 2. Committees in the U.S. House of Representatives and Senate can debate the package until December 9, at which point it goes to the full House and Senate floors for votes. The House and Senate need only a simple majority to pass the bill, which cannot be amended or filibustered, by December 23. Sequester If the super committee doesn’t produce a legislative package that reduces the deficit by $1.2 trillion or the bill doesn’t become law by January 15, the “sequeswww.pharmacytoday.org

26 PHARMACY TODAYsOCTOBER 2011

The Georgia Pharmacy Journal

deficit reduction, the super committee is charged with producing $1.5 trillion in cuts, with a de facto goal of $1.2 trillion, over the next 10 years beginning in fiscal year 2012. The debt ceiling deal already includes a cap on discretionary spending for $917 billion in deficit reduction over 10 years, making reaching agreement on these cuts much more difficult, according to Brian Gallagher, BSPharm, JD, APhA Senior Vice President of Government Affairs.

21

October 2011


hubonpolicyandadvocacy hub onpolicyandadvocacy tter” er” ttakes akes eeffect, ffect, F Feore eore ssaid. aid. IIn n tthe he ssequesequestter, er,, tthe er he O Office ffice ooff M Management anagement aand nd B Bududgget et w will ill bbee ccharged harged w with ith iimplementing mplementing aacross-the-board cross-the-board cuts cuts iin nm most ost p programs, rograms, split sp lit between between d defense efense aand nd n nondefense, ondefense, ttoo rreach each tthe he $$1.2 1.2 ttrillion rillion ttarget. arget. F Further, urther, iiff Congress C ongress eenacts nacts cuts cuts tthat hat aare re aany ny lless ess tthan han tthe he ttarget arget ooff $1 $1.2 .2 ttrillion, rillion, tthe he au automatic tomatic ccuts uts u under nder tthe he ssequester equester w will il l m make ake u up p tthe he difference. d ifference. U Under nder tthe he ssequester, equester er,, M Medicare edicare ccan an bbee ccut ut bbyy u up p ttoo 22%, % , bbut ut ccuts uts m must ust bbee llimited imited provider Medicaid ttoo p rovider rreimbursement. eimbursement. M edicaid aand nd oother ther low-income low-income programs programs aare re eexempt xempt ffrom rom tthe he ccuts. uts. you’ve where ““So So yo you’ve ggot ot a ssituation ituation wh w here tthe he ssuper uper ccommittee ommittee iitself tself ccan an ccome ome ttogether ogether with package w ith a p ackage tthat hat eessentially ssentially rreduces educes Medicaid, M edicaid, cchanges hanges SSocial ocial SSecurity, ecurity, aand nd does few here Medid oes a ffe ew tthings hings h ere oorr tthere here ttoo M ediwhich ccare, are, vversus ersus tthe he ssequester, equester, wh w hich ccannot annot Medicare more Medttouch ouch M edicare [[by by m ore tthan han 22%], %], M edFeore noted. iicaid, caid, and and SSocial ocial SSecurity,” ecurity,” F eore n oted. people SSome ome p eople aare re cconcluding oncluding tthat hat tthe he ssuper uper committee committee fa ffailing ailing ttoo rreach each aagreegreement facing automatic would m ent and and ffa acing tthe he aau utomatic ccuts uts w ould bee bbetter deal may make. b etter tthan han aany ny d eal iitt m ay m ake. perspective published August IIn nap erspective p ublished A ugust 331 1 oon n tthe he New England Journal of Medicine website, “Fallback cuts or super-committee policy cconcoction: oncoction: Choosing Choosing health health ccare’s are’s p olicy poison,” former health advip oison,” a ffo ormer ssenior enior h ealth ccare are aad dvissor or ttoo President President B Bill ill C Clinton linton ffr from rom 11994 994 ttoo 2001 2 001 w wrote rote that that ““health health ccare are sstakeholders takeholders are beginning to conclude that any plan aagreed greed oon n bbyy tthe he ssuper uper ccommittee ommittee w would ould result in larger aggregate cuts and would h ave a ggreater reater n egative iimpact.” mpact.” have negative C onversely, Gallagher Gallagher told told Pharmacy Conversely, Today,, iiff tthe Today he ssuper uper ccommittee ommittee tthinks hinks p roprovviders iders ccan an aaccept ccept tthe he aautomatic utomatic ccuts, uts, iitt m ay may sstart tart w ith tthem hem aass a bbaseline. aseline. with

HUB ON P POLICY OLICY A AND ND A ADVOCACY DVOCACY

provides readers provides readers with practical information on political issues impor important tant to pharmacy pharmacy,, APhA’s APhA’ APhA ’s Government Government Af Affairs Affair fairs activities activities that are kkeeping eeping pharmacists pharmacists’’ important important role front and center with decision mak makers, ers, and simple ways w ays for pharmacists to follow and influence www.pharmacist.com the federal, state, and local processes that are

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S uper c ommittee Super committee T he 112 2m embers ooff tthe he ssuper uper ccomomThe members m ittee aare re sp lit eevenly venly bbetween etween tthe he H ouse mittee split House ooff R epresentatives aand nd tthe he SSenate enate aand nd Representatives bbetween et ween D emocrats and and R epublicans. Democrats Republicans. T hey aare re R eps. X avier B ecerra ((D-CA), D-CA), They Reps. Xavier Becerra JJames ames C lyburn ((D-SC), D-SC), C hris Va V an H ollen Clyburn Chris Van Hollen ((D-MD), D-MD), Dave Dave Camp Camp ((R-MI), R-MI), JJeb eb H enHenssarling arling ((R-TX), R-TX), aand nd F red U Up pton ((R-MI); R-MI); Fred Upton aand nd SSens. ens. JJon on K Ky yl ((R-AZ), R-A Z), R ob P Po ortman Kyl Rob Portman ((R-OH), R-OH), P at T oomey ((R-PA), R-PA), M ax B auPat Toomey Max Bauccus us ((D-MT), D-MT), John John K erry ((D-MA), D-M A), aand nd Kerry

“A p “A pharmacy harmacy ttour our iis s p probably robably tthe he m most os t powerful p ower ful wa way y tto o deliver d eliver the the message message off what o w ha t a p pharmacist h a r ma c i s t ccan an d o. S h ow y our do. Show your M ember o ong r e s s Member off C Congress tthe he a area rea tthat hat you you h ave set set aside aside for for have MTM M TM or h how ow y you ou cconsult onsult with wi th a p atient.” patient.” P atty Murray Murray ((D-WA). D-WA). H ensarling aand nd Patty Hensarling M urray aare re ccochairs. ochairs. Murray M aking p harmacy’s c a se Making pharmacy’s case ““A A llot ot ooff p eople aare re ggoing oing ttoo bbee p resspeople pressiing ng ttheir heir ccase ase aass ttoo w wh hy tthey hey sshouldn’t houldn’t bbee why ccut ut … aand nd w eed ttoo bbee u p tthere here m aking wee n need up making a ccase ase aabout bout w wh hat a ggood ood jjob ob m edications what medications d nd h ow ccatastrophic atastrophic iitt w ould bbee ttoo doo aand how would

defining the structure of a reformed American health care system. Send an e-mail message to APhA at pt@aphanet.org to offer suggestions com-for future content, ask questions, make com ments, or request permission to use or copy this issue issue.. © 20 2011 11 by the American Pharmacists Association. All rights reserved. P Printed rinted in U.S.A. U .S.A.

22

patients were made Galp atients iiff ccuts uts w wer ere m ade ttoo tthat,” hat,” G alMedicare, Medicllagher agher ssaid aid oon n tthe he ccall. all. M edicare, M edicChildren’s Health aaid, id, aand nd the the C hildren’s H ealth IInsurance nsurance Program P rogram aare re 221% 1% ooff tthe he fe ffederal ederal bbudget, udget, defense ffollowed ollowed bbyy d efense aand nd SSocial ocial SSecurity ecurity hee aadd added. aatt 220% 0 % eeach, ach, h dded. ““Now’s Now’s tthe he ttime ime uss ttoo rrealize meaningful ffor or aallll ooff u ealize tthat hat iiff m eaningful made, programs ccuts uts aare re ggoing oing ttoo bbee m ade, tthese hese p rograms have for discussion,” Gallagher h ave ttoo bbee up up ffo or d iscussion,” G allagher need allll sstand ttold old Today Today.. ““Pharmacists Pharmacists n eed ttoo aal tand up work profession.” u p aand nd w ork ffor or oour ur p rofession.” Too tthat pharmacists up T hat eend, nd, p harmacists ccan an sset et u pa pharmacy district meeting with p harmacy tour tour or or a d istrict m eeting w ith con-their Member of Congress or their con gressional staff, Abbie Laugtug, APhA Director of Government Affairs, said on pharmacy probably tthe he ccall. all. “A “A p harmacy ttour our iiss p robably tthe he most deliver message m ost powerful powerful way way ttoo d eliver tthe he m essage of what a pharmacist can do,” she said. “If you can get them into a pharmacy aand nd aactually ctually sshow how tthem hem tthe he aarea rea tthat hat yyou ou have set aside [for medication therapy management] how with m anagement] oorr ho w yyou ou cconsult onsult w ith a patient, p atient, they’re they’re going going ttoo rremember emember tthat.” hat.” Regarding district meetings, Members R egarding d istrict m eetings, M embers ooff Congress district and C ongress have have offices offices iin n ttheir heir d istrict aan nd pharmacists can arrange to visit them or ttheir heir sstaff. taff. from AAKC IIn n rresponse esponse to to qquestions uestions ffr rom A AA AKC members, pharmacists m embers, Gallagher Gallagher said sa saiid tthat hat p harmacists could talk to their Members of Congress to llobby obby tthose hose oon n tthe he ssuper uper ccommittee, ommittee, tthat hatt ha patient make difference, p atient ttestimonials estimonials m ake a bbig ig d ifference, and that APhA is working closely with pharmacy oother ther p harmacy oorganizations. rganizations. Govern-For AAKC members, the Govern ment Affairs prepared points m ent A Af ffairs tteam eam p repared ttalking alking p oints how up meetings. aand nd a cchecklist hecklist oon n ho w ttoo sset et u pm eetings. The posted www. T he ttalking alking points points aare re p osted oon nw ww ww. pharmacist.com. To join AAKC, APhA members www.pharmacist.com/ m embers can can visit vviisit w ww ww.pharmacist.com/ kkeycontact. eycontact. —Diana — Diana Yap Yap

OCTOBER 2011 sPHARMACY TODAY 27

October 2011


“We implemented PQC in our pharmacy four months ago – it was easy. I have noticed an enhanced effort from the staff to work together to avoid and eliminate quality-related events.” Pharmacy Quality Commitment® (PQC) is what you need! PQC is a continuous quality improvement (CQI) program that supports you in responding to issues with provider network contracts, Medicare Part D requirements under federal law, and mandates for CQI programs under state law. When PQC is implemented in your pharmacy, you will immediately improve your ability to assure quality and increase patient safety. Do you have a CQI program in place?

Call toll free (866) 365-7472 or go to www.pqc.net for more information. PQC is brought to you by your state pharmacy association.

The Georgia Pharmacy Journal

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October 2011


continuing education for pharmacists Volume XXIX, No. 8

New Drugs: Benlysta, Daliresp and Edarbi 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 :XHVWKDYHQRUHOHYDQWĂ€QDQFLDOUHODWLRQships to disclose.

Goal. The goal of this lesson is to provide information on azilsartan (Edarbi™), belimumab (BenlystaÂŽ), DQGURĂ XPLODVW 'DOLUHVSÂŒ  Objectives. At the conclusion of

this lesson, successful participants should be able to: 1. identify the new drugs by generic name, trade name and chemical name when relevant; 2. select the indication(s), pharmacologic action(s) and clinical applications for each drug; 3. recognize important therapeutic uses for the drugs and their DSSOLFDWLRQVLQVSHFLĂ€HGSDWKRORgies; and 4. demonstrate an understanding of adverse effects and toxicity, VLJQLĂ€FDQWGUXJGUXJLQWHUDFWLRQV and patient counseling information for these drugs.

'UXJVGLVFXVVHGZLWKLQWKLVOHVson are new molecular entity compounds (Table 1) indicated for treatment of a variety of pathologies. The lesson provides an introduction to the new drugs and is not intended to extend beyond a brief overview of the topic. The reader is, therefore, urged to consult each product’s Prescribing Information OHDà HWRUMedication Guide, and other published reference sources for detailed descriptions.

The Georgia Pharmacy Journal

)QUUGN

9WGUV

Azilsartan medoxomil (Edarbi)

Hypertension is often referred to as the “silent killerâ€? because it usually does not cause symptoms until it is well along in its course of destructive pathology. Observational studies have demonstrated that blood pressure levels are directly and strongly related to the relative risks of stroke, heart disease and kidney failure. Hypertension also remains inadequately controlled in many people diagnosed with the condition; thus, having a variety of treatment options is important. A new therapy, azilsartan (Edarbi) has been approved to treat essential hypertension. Indications and Use. Edarbi HK'$5EHH LVLQGLFDWHGIRUWKH treatment of hypertension, either alone or in combination with other antihypertensive agents. Most of the drug’s antihypertensive action RFFXUVZLWKLQWKHĂ€UVWWZRZHHNV RIGRVLQJ5HSRUWVIURPFOLQLFDO trials with azilsartan suggest that azilsartan 80 mg is more effective in reducing systolic blood pressure than the highest approved dose

24

of olmesartan (Benicar), which is considered by some researchers to be more effective than other drugs in the same pharmacologic class. Hypertension. Hypertension is the most common primary diagnosis in the United States, affecting an estimated 74.5 million individuals in this country alone. From the age of 50 and upward, Americans have a 90 percent chance of developing hypertension. 7KDWLVDVWDUWOLQJULVNIRUDPRGLĂ€able condition that strongly predisposes to heart disease, stroke and kidney failure. Most worrisome is that even with medical treatment that is successful in many cases, the prevalence of hypertension remains elevated particularly among African-Americans, despite much effort to educate Americans about the importance of healthy eating, physical activity, smoking cessaWLRQDQGDYRLGDQFHRIVPRNHĂ€OOHG environments. A wide variety of drugs representing numerous pharmacological classes are available to reduce EORRGSUHVVXUH'UXJVWKDWPRGXlate the renin-angiotensin-aldosterRQHV\VWHP 5$$6 DUHZLGHO\XVHG alone or in combination with other antihypertensive therapies because RIWKHLUHIĂ€FDF\7KLVLVFRXSOHG with one of the best adverse efIHFWSURĂ€OHV0RUHRYHUZLWKLQWKH 5$$6FODVVHVGUXJVWKDWLQKLELW the action of angiotensin II by binding directly to the angiotensin type 1 (AT1) receptor (angiotensin UHFHSWRUEORFNHUV>$5%V@ LQFOXG-

October 2011


Table 1 New drugs for 2011 Generic (Proprietary Name)

Applicant/ Sponsor/ Distributor

Indication

Dosage Form

Azilsartan (Edarbi)

Takeda Pharmaceuticals America

Angiotensin II receptor blocker for treatment of hypertension

tablets: 40, 80 mg

Belimumab  %HQO\VWD 

Human Genome 6FLHQFHV,QF

B-lymphocyte stimulator- Vials: 120 mg, VSHFLĂ€FLQKLELWRUIRUWUHDW PJ ment of active lupus erythematosus

5RĂ XPLODVW  'DOLUHVS 

)RUHVW3KDUPD FHXWLFDOV,QF

3KRVSKRGLHVWHUDVHW\SH 7DEOHWVPFJ LQKLELWRUWRUHGXFHWKH risk of chronic obstructive pulmonary disease exacerbations

ing azilsartan, are the best tolerated of all antihypertensive drug FODVVHV6RPH$5%VKDYHVKRZQ JUHDWHIĂ€FDF\LQUHGXFLQJPRUWDOLW\ in patients with heart failure and post-myocardial infarction, as well as slowing progression of diabetic QHSKURSDWK\'HVSLWHWKHDYDLODELOity of antihypertensive treatments, however, the disease remains inadequately controlled, with slightly less than half of the patients who receive treatment successfully achieving blood pressure goals. Mechanism of Action. Azilsartan medoxomil, which is also known as azilsartan kamedoxomil, is a prodrug that is hydrolyzed to azilsartan in the gastrointestinal tract during absorption. Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzymes (ACE, kinase II). Angiotensin II is the principal pressor agent of the 5$$6,WVHIIHFWVLQFOXGHYDVRFRQstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Azilsartan inhibits the vasoconstrictor and aldosteronesecreting effects of angiotensin II by selectively blocking angiotensin II binding to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is, therefore, inde-

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pendent of the pathway for angiotensin II synthesis. An AT2 receptor is also found in many tissues, but this receptor is not known to be associated with cardiovascular homeostasis. Azilsartan has more WKDQDIROGJUHDWHUDIĂ€QLW\ for the AT1 receptor than for the AT2 receptor. %ORFNDGHRIWKH5$$6ZLWK ACE inhibitors, that inhibit the biosynthesis of angiotensin II from angiotensin I, is widely used in treatment of hypertension. In contrast to ACE inhibitors that also inhibit the degradation of bradykinin, a reaction catalyzed by ACE, the new drug does not inhibit ACE and, therefore, it should not affect bradykinin levels. Whether this difference has clinical relevance is not yet known. Azilsartan does not bind to or block other receptors or ion channels known to be important in cardiovascular regulation. Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and angiotensin II circulating levels do not overcome the effect of azilsartan on blood pressure. Adverse Effects. In premarketing clinical trials, the most common adverse reaction in adults was diarrhea.

25

Warnings, Precautions and Contraindications. The following warnings and precautions are listed: ‡Fetal or neonatal exposure. When pregnancy is detected, Edarbi should be discontinued as soon as possible (a “Boxed WarnLQJÂľ 'UXJVWKDWDFWGLUHFWO\RQ the renin-angiotensin system can cause injury and death to the developing fetus. ‡Volume or salt depletion. These conditions should be corrected prior to administration of Edarbi. ‡Renal function. Patients with renal impairment should be monitored for renal function worsening. There are no contraindications listed. Drug Interactions. No cliniFDOO\VLJQLĂ€FDQWGUXJLQWHUDFWLRQV have been observed in studies of azilsartan medoxomil or azilsartan given with amlodipine, antacids, FKORUWKDOLGRQHGLJR[LQĂ XFRQazole, glyburide, ketoconazole, metformin, pioglitazone and warfarin. In volume-depleted elderly patients, including those on diuretic therapy, or who have compromised renal function, co-administration RIQRQVWHURLGDODQWLLQĂ DPPDWRU\ GUXJV 16$,'V ZLWKDQJLRWHQVLQ II receptor antagonists, including azilsartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Patients receiving azilsartan and 16$,'WKHUDS\VKRXOGEHPRQLtored periodically for renal function. Dosage and Availability. The recommended adult dose of Edarbi is 80 mg taken once daily. A starting dose of 40 mg for patients who are treated with high doses of diuretics should be considered. The drug may be administered with or without food, and with other antihypertensive agents. It is available in tablets containing 40 mg and 80 mg. The tablets should be dispensed and stored in their original container to protect from light and moisture. Patient Information. Ex-

October 2011


Table 2 Major counseling points for Edarbi (azilsartan) tablets* This medicine is used to treat high blood pressure. ‡5HDGWKH3DWLHQW,QIRUPDWLRQEHIRUH you start taking Edarbi and each WLPH\RXJHWDUHÀOO ‡7HOO\RXUGRFWRU -if you have abnormal body salt (electrolyte) levels in your body. -about all other prescription and nonprescription (OTC) medicines, vitamin/mineral supplements, natural products and herbal remedies you are taking. Especially tell your doctor if you are taking other medications to treat your high blood pressure or heart problems. ‡,I\RXIHHOIDLQWRUGL]]\OLHGRZQ and call your doctor right away. ‡:20(11RWLI\\RXUGRFWRULI\RX become or intend to become pregnant, or breastfeed a child. ‡(GDUELLVXVXDOO\WDNHQRQFHDGD\ at approximately the same time. It can be taken with or without food. ‡6WRUH(GDUELLQLWVRULJLQDOWLJKWO\ closed container, protected from moisWXUHDQGOLJKW'RQRWXVHDIWHUWKH expiration date on the label. Properly discard unused medication. ([FHUSWHGIURPWKH)'$DSSURYHG Patient Information

FHUSWVRI)'$DSSURYHG3DWLHQW Information are shown in Table 2.

Belimumab (Benlysta)

A new drug to treat lupus has been slow in coming. Prior to Benlysta, )'$ODVWDSSURYHGGUXJVWRWUHDW the condition in 1955: hydroxychloroquine (Plaquenil) and corticosteroids. Aspirin was approved to treat lupus in 1948. Indications and Use. Benlysta (ben-LIST-ah) is indicated for treatment of adults with active autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives and 16$,'V,WLVWKHĂ€UVWLQKLELWRU designed to target B-lymphocyte stimulator protein, which may reduce the number of abnormal

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B cells thought to be a problem LQOXSXV(IĂ€FDF\KDVQRWEHHQ evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Benlysta has not been studied in combination with other biologics or intravenous cyclophosphamide; therefore, its use is not recommended in those situations. Lupus. Lupus (systemic lupus erythematosus; SLE) is a complicated and heterogeneous autoimmune disorder that is associated with unpredictable exacerbations and remissions in many patients. Lupus often has multiple sites of organ involvement, and can be potentially fatal. The U.S. prevalence estimates for various types of lupus vary greatly, with some estimates as high as 1.5 million persons. The 1DWLRQDO$UWKULWLV'DWD:RUNJURXS reported in 2005 a more modest prevalence of 161,000 Americans ZLWKGHĂ€QLWH6/(DQG $PHULFDQVZLWKGHĂ€QLWHRUSUREable SLE. Lupus primarily affects women (>90 percent) compared to men and can occur at any age but is usually diagnosed in persons aged 15 to 45 years. It is three times more common in African Americans compared to other individuals, and occurs with a higher frequency in Hispanics, Asians, and American Indians as compared with Caucasians. The seriousness of the disease is evident in the 1.5 to three-fold greater risk of mortality compared with the general population and fact that, even in the developed world, 10 percent of patients, particularly those with renal involvement, will die within 10 years of diagnosis. 'XHWRDGHDUWKRIDSSURYHG therapies, the most appropriate treatment is oftentimes inadHTXDWHO\GHĂ€QHGDQGPD\HYHQEH FRQWURYHUVLDO'HVSLWHZHOODFFHSWHGHIĂ€FDF\ZLWKVRPHDJHQWVVXFK as cyclophosphamide (Cytoxan) and prednisone, as well as improvements in survival that are evident from many epidemiological studies, there are limitations to the existing pharmacologic management of lupus. These limitations are due

26

primarily to serious toxicity and tolerability issues. Nonetheless, it is generally believed that patients should be treated aggressively during periods of disease exacerbation to prevent irreversible consequences. At this time, the primary challenge is to develop treatments that control the pathological immune response without producing toxicity that adds to the already considerable burden of disease. It has become increasingly evident that B cell abnormalities may be fundamental to the onset and chronic continuance of lupus. Traditionally, B cell activity has been hypothesized to contribute to lupus through production of autoantibodies derived from these cells and plasma cells caused by a breakdown of immune tolerance. The mechanisms underlying immune intolerance remain in question. In addition to antibody production, B cells possess complex regulatory immune functions, including production of cytokines (substances VHFUHWHGE\VSHFLĂ€FFHOOVRIWKHLPmune system that serve to regulate immune processes) and ability to function as secondary antigenpresenting cells. To illustrate, B cells activate antigen-presenting or LQĂ DPPDWRU\FHOOV HJF\WRWR[LF7 cells, macrophages, natural killer cells and granulocytes). Moreover, the complement system activated via antigen or antibody complexes FDQLQLWLDWHLQĂ DPPDWLRQDQGFHOO death to target tissues and organs, leading to clinical symptomatology and end-organ destruction. A 285 amino acid protein called B-lymphocyte stimulator (BLyS) functions as a cell mediator and is part of the tumor necrosis factor superfamily. Expression of BLyS RFFXUVVSHFLĂ€FDOO\LQP\HORLGFHOO lines (i.e., dendritic cells, macrophages, monocytes and granulocyte colony-stimulating factor-activated neutrophils). In vivo, BLyS is present as membrane-bound and soluble forms. Soluble BLyS, the active form, is enzymatically cleaved from the cell membrane and binds with its receptors, which in turn inhibits apoptosis (natural, programmed

October 2011


cell death) and contributes to the proliferation and differentiation of B lymphocytes into immunoglobulin-producing plasma cells. SpeFLÀFDOO\LQOXSXVLQFUHDVHG%/\6 concentrations have often been correlated with increased disease activity. Mechanism of Action. Benlysta is a monoclonal antibody that acts by binding to the soluble form RI%/\6ZLWKKLJKDIÀQLW\,WLV WKXVD%/\6VSHFLÀFLQKLELWRUWKDW blocks the binding of soluble BLyS to its receptors in B cells. Benlysta does not bind B cells directly, but inhibits survival of B cells, including autoreactive B cells, and reduces differentiation of B cells into immunoglobulin-producing plasma cells. Adverse Effects. In premarketing clinical trials, the most common adverse reactions in the groups receiving Benlysta and placebo were serious infections, 6 percent and 5.2 percent respectively. Common adverse reactions •SHUFHQW LQFOLQLFDOWULDOVZHUH nausea, diarrhea, fever, nasopharyngitis, bronchitis, insomnia, pain in the extremities, depression, migraine and pharyngitis. Warnings, Precautions and Contraindications. The following warnings and precautions are listed: ‡Mortality. More deaths were reported with Benlysta than with placebo during clinical trials. ‡Serious infections. Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents, including Benlysta. The drug should be used with caution in patients with chronic infections, and therapy interrupted if patients develop a new infection during Benlysta treatment. ‡Hypersensitivity reactions including anaphylaxis. Serious reactions have been reported. Benlysta should be administered by healthcare providers prepared to manage anaphylaxis, and patients monitored during and after administration of Benlysta. ‡Depression.'HSUHVVLRQDQG

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suicidality have been reported in Benlysta studies. Patients should be instructed to contact their healthcare provider if they experience new or worsening depression, suicidal thoughts or other mood changes. ‡Immunization. Live vaccines should not be given for 30 days before, or concurrently with Benlysta. Previous anaphylaxis to belimumab is the only contraindication listed. Drug Interactions. Formal drug interaction studies have not been conducted with Benlysta. In clinical trials of patients with SLE, the drug was administered concomitantly with other therapies, including corticosteroids, antimalarials, immunomodulatory and immunosuppressive agents (including azathioprine, methotrexate and mycophenolate), angiotensin pathway antihypertensives, HMGCoA reductase inhibitors (statins), DQG16$,'VZLWKRXWHYLGHQFHRI a clinically meaningful effect of these concomitant medications on belimumab pharmacokinetics. The effect of belimumab on the pharmacokinetics of other drugs has not been evaluated. Dosage and Availability. Benlysta is supplied as a sterile, preservative-free lyophilized powder for reconstitution, dilution, and intravenous infusion provided in single-use glass vials with a latexIUHHUXEEHUVWRSSHUDQGDà LSRII seal. The product contains 120 mg belimumab in a 5-mL single-use vial, and 400 mg belimumab in a 20-mL, single-use vial. The recommended dosage regimen is 10 mg/kg at two-week interYDOVIRUWKHÀUVWWKUHHGRVHVDQGDW four-week intervals thereafter. The drug should be administered as an intravenous infusion only, over a period of one hour. Premedication for prophylaxis against infusion reactions and hypersensitivity reactions should be considered. The drug should not be given in the same intravenous line with other agents. No physical or biochemical compatibility studies have been conducted to evaluate the coadmin-

27

istration of Benlysta with other agents. Patient Information. ExFHUSWVIURPWKH)'$DSSURYHG Medication Guide are shown in Table 3.

Roflumilast 'DOLUHVS

5RĂ XPLODVWLVDPHPEHURIDQHZ drug class for the treatment of a form of chronic obstructive pulPRQDU\GLVHDVH &23' :LWK improved understanding in recent years of the distinct pathophysiRORJ\RI&23'QRYHOWDUJHWHG therapies can be developed. One such class of targeted medications LVWKHSKRVSKRGLHVWHUDVH 3'(  LQKLELWRUV5RĂ XPLODVW 'DOLUHVS  D3'(LQKLELWRULVQRZ)'$DSSURYHGIRUWUHDWPHQWRI&23' Indications and Uses.'DOLUHVS GDÄťOLUHVS LVLQGLFDWHGWR UHGXFHWKHULVNRI&23'Ă DUHXSV (exacerbations) or worsening of symptoms in patients with severe &23'DVVRFLDWHGZLWKFKURQLF bronchitis and a history of exacerbations. It is neither a bronchodilator nor indicated for relief of acute EURQFKRVSDVP5RĂ XPLODVWLVQRW intended to treat another form of &23'ZKLFKLQYROYHVSULPDU\ emphysema. Chronic Obstructive Pulmonary Disease.&23'LVDVHULRXV pulmonary disease with symptoms including breathlessness, chronic cough and excessive phlegm. An exacerbation may persist up to several weeks and result in lung function decline, severe anxiety and increased risk of death. According to the National Heart, Lung and Blood Institute, cigarette smoking LVWKHOHDGLQJFDXVHRI&23'LQWKH United States and most developed countries in the world. More than 12 million people in the United States are known to KDYH&23'DQGXSWRPLOOLRQ may have the disease and not know it. It causes serious long-term GLVDELOLW\DQGHDUO\GHDWK&23' ranks as the fourth leading cause of death in the United States. At this time there is no cure. &23'LVRIWHQQRWFRQĂ€UPHGXQWLO the disease is advanced because

October 2011


Table 3 Major points for Benlysta (belimumab) injection* This medicine is used to treat patients with systemic lupus erythematosus (SLE). Â&#x2021;5HDGWKHMedication Guide before you start taking Benlysta and each WLPH\RXJHWDUHĂ&#x20AC;OO Â&#x2021;7HOO\RXUGRFWRU -if you develop signs or symptoms of an infection such as: fever, chills, pain or burning on urination, urinating often, bloody diarrhea or coughing up mucus. -if you have an allergic reaction: LQFOXGLQJZKHH]LQJGLIĂ&#x20AC;FXOW\EUHDWKing; swelling of the face, lips, mouth, tongue or throat; skin rash, redness or swelling. -about all other prescription and nonprescription (OTC) medicines, vitamin/mineral supplements, natural products and herbal remedies you are taking. The Medication Guide contains a list of other medicines you should not take. Â&#x2021;:20(11RWLI\\RXUGRFWRULI\RX become or intend to become pregnant or breastfeed a child. Â&#x2021;7HOO\RXUGRFWRULI\RXH[SHULHQFH new or worsening depression, suicidal thoughts or other mood changes. Â&#x2021;<RXVKRXOGQRWUHFHLYHOLYHYDFFLQHV while using Benlysta. Â&#x2021;$IWHUSUHSDUDWLRQ%HQO\VWDVKRXOG be injected by IV infusion. Â&#x2021;9LDOVVKRXOGEHUHIULJHUDWHG protected from light and kept in the original carton until use. They should not be used after the expiration date on the label. Unused medicine should be properly discarded. ([FHUSWHGIURPWKH)'$DSSURYHG Medication Guide

people do not recognize the early warning signs. Sometimes people believe they are short of breath or less able to perform tasks they are accustomed to doing because they are simply â&#x20AC;&#x153;out of shapeâ&#x20AC;? or just â&#x20AC;&#x153;growing older.â&#x20AC;? But, shortness of breath is never normal. The numEHURISHRSOHZKRGLHIURP&23'LV increasing. The good news is that &23'FDQEHGHWHFWHGHDUO\DQG there is much that can be done to help manage the disease. ,QIRUPDWLRQDERXW&23'FDQ

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EHFRQIXVLQJ&23'HQFRPSDVVHV two distinct but often related processes of chronic bronchitis and emphysema. Both conditions result in structural changes that limit airĂ RZ%URQFKLWLVLVDQLQĂ DPPDWRU\ condition of the large and small airways that results in enlargement of mucus glands, increased numbers of goblet cells (cells in the lining of bronchioles that accumulate mucus), and mucus hyperseFUHWLRQ'DOLUHVSLVLQGLFDWHGIRU treating bronchitis, not emphysema. The latter involves destruction of the lung parenchyma (functional cells as contrasted with connective tissue) with dilation and destruction of the respiratory bronchioles. 7KHUHIRUHIDFWVDQGĂ&#x20AC;JXUHVWKDW GHVFULEH&23'PXVWEHLQWHUSUHWHG carefully because they may refer to both chronic bronchitis and emphysema, or to only one or the other. 3'(LVWKHSUHGRPLQDQW phosphodiesterase enzyme that is expressed in neutrophils, T cells and macrophages, suggesting that GUXJVWKDWLQKLELW3'(PLJKWEH HIIHFWLYHLQFRQWUROOLQJLQĂ DPPDWLRQLQ&23',QFOLQLFDOWULDOV WKH3'(LQKLELWRUURĂ XPLODVW reduced the number of neutrophils and eosinophils in the sputum of SDWLHQWVZLWK&23'DQGLPSURYHG lung function in patients with PRGHUDWHWRVHYHUH&23' Mechanism of Action.5RĂ XPLODVWDQGLWVDFWLYHPHWDEROLWH URĂ XPLODVW1R[LGH DUHVHOHFWLYH LQKLELWRUVRI3'(5RĂ XPLODVWLV three times more potent than roĂ XPLODVW1R[LGH5RĂ XPLODVWDQG URĂ XPLODVW1R[LGHLQKLELWLRQRI 3'( DPDMRUF\FOLF¡¡DGHQRVLQHPRQRSKRVSKDWH>F\FOLF$03@ metabolizing enzyme in lung tissue) activity leads to accumulation of intracellular cyclic AMP. While WKHVSHFLĂ&#x20AC;FPHFKDQLVP V E\ZKLFK the new drug exerts its therapeutic DFWLRQLQ&23'SDWLHQWVLVXQFOHDU it is believed to be related to the effects of increased intracellular cyclic AMP in lung tissue. 5RĂ XPLODVWVXSSUHVVHVJHQHUDtion of tumor necrosis factor alpha, DNH\SURLQĂ DPPDWRU\F\WRNLQH,W suppresses a number of activities

28

related to neutrophils including oxygen free-radical production and adhesion to endothelial cells. The drug also attenuates proliferation DQGF\WRNLQHUHOHDVHIURP&' cells that may involve inhibition of intracellular signaling pathways. These pharmacologic properties LOOXVWUDWHWKHSRWHQWLDOIRUURĂ XPLODVWWRPRGLI\LQĂ DPPDWRU\UHsponses prevalent in disorders such DV&23' Adverse Effects. Most comPRQDGYHUVHUHDFWLRQV Â&#x2022;SHUFHQW  noted in premarketing clinical trials were diarrhea, weight decrease, nausea, headache, back pain, LQĂ XHQ]DLQVRPQLDGL]]LQHVVDQG decreased appetite. Warnings, Precautions and Contraindications. The following warnings and precautions are listed: Â&#x2021;Acute bronchospasm. The drug should not be used for relief of acute bronchospasm. Â&#x2021;Psychiatric events including suicidality. Patients, their caregivers and families should be advised to be alert for emergence or worsening of insomnia, anxiety, depression, suicidal thoughts or other mood changes, and if changes occur to contact the healthcare provider. 7KHULVNVDQGEHQHĂ&#x20AC;WVRIWUHDWPHQW ZLWK'DOLUHVSVKRXOGEHFDUHIXOO\ weighed in patients with a history of depression and/or suicidal thoughts or behavior. Â&#x2021;Weight decrease. The patientâ&#x20AC;&#x2122;s weight should be monitored regularly. If unexplained or clinically VLJQLĂ&#x20AC;FDQWZHLJKWORVVRFFXUV GLVFRQWLQXDWLRQRI'DOLUHVSVKRXOG be considered. Â&#x2021;Drug interactions. Use with strong cytochrome P450 enzyme inducers is not recommended. (See Drug Interactions below.) Moderate to severe liver impairment is the only contraindication listed. Drug Interactions. A major VWHSLQURĂ XPLODVWPHWDEROLVPLV WKH1R[LGDWLRQRIURĂ XPLODVWWR URĂ XPLODVW1R[LGHE\&<3$ DQG&<3$6WURQJF\WRFKURPH P450 enzyme inducers (e.g., rifampin, phenobarbital, carbam-

October 2011


Table 4 Major counseling points for Daliresp (roflumilast) tablets* This medicine is used in patients with severe chronic obstructive pulPRQDU\GLVHDVH &23' WRGHFUHDVH WKHQXPEHURIĂ DUHXSVRUWKHZRUVHQLQJRI&23'V\PSWRPV Â&#x2021;5HDGWKHMedication Guide before \RXVWDUWWDNLQJ'DOLUHVSDQGHDFK WLPH\RXJHWDUHĂ&#x20AC;OO Â&#x2021;7HOO\RXUGRFWRU -if you have liver problems. -if you develop mood or behavioral problems including: thoughts of suicide or dying, attempt to commit suicide, trouble sleeping, new or worse anxiety or depression, or acting on dangerous impulses. -if you notice that you are losing ZHLJKW<RXVKRXOGKDYH\RXUZHLJKW checked regularly by your doctor. -about all other prescription and nonprescription (OTC) medicines, vitamin/mineral supplements, natural products and herbal remedies you are taking. Â&#x2021;:20(11RWLI\\RXUGRFWRULI\RX become or intend to become pregnant, or breastfeed a child. Â&#x2021;7KHXVXDOGRVHIRU'DOLUHVSLVRQH tablet once a day at approximately WKHVDPHWLPH'RVHVFDQEHWDNHQ with or without food. Â&#x2021;6WRUH'DOLUHVSDWURRPWHPSHUDWXUH LQLWVWLJKWO\FORVHGFRQWDLQHU'R not use after the expiration date on the label. Properly discard unused medicine. ([FHUSWHGIURPWKH)'$DSSURYHG Medication Guide

azepine, phenytoin) decrease V\VWHPLFH[SRVXUHWRURĂ XPLODVW and may reduce its therapeutic effectiveness. Therefore, the use of strong cytochrome P450 inducers ZLWK'DOLUHVSLVQRWUHFRPPHQGHG &RDGPLQLVWUDWLRQRI'DOLUHVSZLWK &<3$LQKLELWRUV HJHU\WKURP\FLQNHWRFRQD]ROHĂ XYR[DPLQH enoxacin, cimetidine) that inhibit ERWK&<3$DQG&<3$VLPXOWDQHRXVO\PD\LQFUHDVHURĂ XPLODVW systemic activity and result in increased adverse reactions. The risks of such concurrent use should

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be weighed carefully against potenWLDOEHQHĂ&#x20AC;W Dosage and Availability. The recommended dosage for patients ZLWK&23'LVRQHPFJWDEOHW per day, with or without food. 'DOLUHVSLVVXSSOLHGDVWDEOHWV FRQWDLQLQJPFJURĂ XPLODVW Patient Information. ExFHUSWVIURPWKH)'$DSSURYHG Medication Guide are shown in Table 4.

Overview and Summary

The new drugs discussed in this lesson were approved to treat a wide variety of serious pathologies. They will likely offer renewed hope for the patients they are intended to treat.

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 0129-0000-11-008-H01-P 5HOHDVHGDWH Expiration date: 8-15-14

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.

29

October 2011


2011 - 2012 GPhA BOARD OF DIRECTORS

The Georgia Pharmacy Journal Editor:

Jim Bracewell jbracewell@gpha.org

Managing Editor & Designer:

Kelly McLendon kmclendon@gpha.org

The Georgia Pharmacy Journal® (GPJ) is the official publication of the Georgia Pharmacy Association, Inc. (GPhA). Copyright © 2011, 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 who are 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 the editorial offices as listed above.

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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 as listed above.

Name

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Patricia Knowles

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30

October 2011


continuing education quiz

Please print.

Program 0129-0000-11-008-H01-P 0.15 CEU

Name________________________________________________ Address_____________________________________________

New Drugs: Benlysta, Daliresp and Edarbi

City, State, Zip______________________________________ Email_______________________________________________

1. Observational studies have demonstrated that blood pressure levels are directly and strongly related to risk of all of the following conditions EXCEPT: a. heart disease. c. liver disease. b. kidney failure. d. stroke.

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

7. Lupus (SLE) occurs LEAST commonly in: a. African Americans. c. Asians. b. Caucasians. d. Hispanics.

2. The effects of angiotensin II include all of the following EXCEPT: a. vasoconstriction. b. cardiac stimulation. c. renal reabsorption of sodium. d. inhibition of aldosterone synthesis.

8. B cells activate all of the following types of cells EXCEPT: a. erythrocytes. c. macrophages. b. granulocytes. d. natural killer cells.

3. The type of angiotensin (AT) receptor that azilsartan KDVWKHJUHDWHUDIÀQLW\IRULVWKH b. AT2. a. AT1.

9. Benlysta is a(n): a. immunosuppressive agent. c. leuteinizing hormone. b. interferon derivative. d. monoclonal antibody.

4. In contrast to ACE inhibitors, azilsartan: a. inhibits the degradation of bradykinin. b. should not inhibit degradation of bradykinin.

10. Benlysta: a. binds B cells directly. b. inhibits survival of B cells. 11. Benlysta is administered: a. intramuscularly. c. intravenously. b. orally. d. subcutaneously.

5. Patients receiving azilsartan and which of the following should be monitored periodically for renal function? a. ACEI. c. NSAID. b. BAB. d. PPI.

12. The type of phosphodiesterase that Daliresp inhibits is: a. PDE4. c. PDE2. b. PDE3. d. PDE1.

%HQO\VWDLVWKHÀUVWLQKLELWRUGHVLJQHGWRWDUJHWZKLFK stimulator protein? a. B-granulocyte c. B-erythrocyte b. B-leukocyte d. B-lymphocyte

3'(LVWKHSUHGRPLQDQW3'(WKDWLVH[SUHVVHGLQ all of the following cells EXCEPT: a. T cells. c. macrophages. b. neutrophils. d. erythrocytes.

&RPSOHWHO\ÀOOLQWKHOHWWHUHGER[FRUUHVSRQGLQJWR 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] [b] [b] [b] [b]

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

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

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

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

14. Patients taking Daliresp should tell their doctor if they are: a. gaining weight. b. losing weight.

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

[c] [d]

15. The recommended dosage of Daliresp is 500 mcg: a. once daily. c. three times a day. b. twice daily. d. four times a day.

‰ I am enclosing $5 for this month’s quiz made payable to: Ohio Pharmacists Association. 5DWHWKLVOHVVRQ ([FHOOHQW  3RRU

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.

The Georgia Pharmacy Journal

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

31

august2011 2011 October


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 UP ÏOBODJBMTFSWJDFTSFTPVSDFTUISPVHIUIF8JMF$POTVMUJOH(SPVQ5IJTOFXHSPVQSFMBUJPOTIJQ UPÏOBODJBMTFSWJDFTSFTPVSDFTUISPVHIUIF8JMF$POTVMUJOH(SPVQ5IJTOFXHSPVQSFMBUJPOTIJQ FOBCMFTNFNCFSTUPMFWFSBHFUIFWBTUTDBMFPGQSPEVDUTBOETFSWJDFTBU6#4 FOBCMFTNFNCFSTUPMFWFSBHFUIFWBTUTDBMFPGQSPEVDUTBOETFSWJDFTBU6#4 8JUINPSFUIBOZFBSTPGÏOBODJBMTFSWJDFTFYQFSJFODF 5IF8JMF$POTVMUJOH(SPVQBU6#4IBT 8JUINPSFUIBOZFBSTPGÏOBODJBMTFSWJDFTFYQFSJFODF 5IF8JMF$POTVMUJOH(SPVQBU6#4IBT been recognized as one of Barron’s5PQ 'JOBODJBM"EWJTPSTJOUIFDPVOUSZ5IF8JMF$POTVMUJOH Barron’ss5PQ 'JOBODJBM"EWJTPSTJOUIFDPVOUSZ5IF8JMF$POTVMUJOH Barron’ Group is the endorsed wealth management provider for the Georgia Dental Association and also 1SJDF8BUFSIPVTF$PPQFST4PVUIFSO%JWJTJPO5IFZXJMMSFQMJDBUFUIFTFTBNFPťFSJOHTUPUIF(1I" 1SJDF8BUFSIPVTF$PPQFST4PVUIFSO%JWJTJPO5IFZXJMMSFQMJDBUFUIFTFTBNFPťFSJOHTUPUIF(1I" .FNCFSCFOFlUTJODMVEF .FNCFSCFOFlUTJODMVEF $PNQMJNFOUBSZ ¾$ ÏOBODJBMQMBOOJOH BL¾LWBMVF

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Chartered Retir Chartered Retirement ement Plans SpecialistSM and CRPS® ar are e rregistered egistered service marks of the College for Financial Planning®. /FJUIFS6#4`'JOBODJBM4FSWJDFT`*ODOPSBOZPGJUTFNQMPZFFTQSPWJEFTMFHBMPSUBYBEWJDF:PVTIPVMEDPOTVMU /FJUIFS6#4`'JOBODJBM4FSWJDFT`*ODOPSBOZPGJUTFNQMPZFFTQSPWJEFTMFHBMPSUBYBEWJDF: PWJEFTMFHBMPSUBYBEWJDF:PVTIPVMEDPOTVMU PVTIPVMEDPOTVMU XJUIZPVSQFSTPOBMMFHBMPSUBYBEWJTPSSFHBSEJOHZPVSQFSTPOBMDJSDVNTUBODFT"TBŖSNQSPWJEJOHXFBMUINBOBHFNFOUTFSWJDFTUPDMJFOUT XFPšFSCPUIJOWFTUNFOUBEWJTPSZBOECSPLFSBHFTFSWJDFT5IFTFTFSWJDFTBSFTFQBSBUFBOE XJUIZPVSQFSTPOBMMFHBMPSUBYBEWJTPSSFHBSEJOHZPVSQFSTPOBMDJSDVNTUBODFT"TBŖSNQSPWJEJOHXFBMUINBOBHFNFOUTFSWJDFTUPDMJFOUT XFPšFSCPUIJOWFTUNFOUBEWJTPSZBOECSPLFSBHFTFSWJDFT5IFTFTFSWJDFTBSFTFQBSBUFBOE EJTUJODU EJšFSJONBUFSJBMXBZTBOEBS FHPWFSOFECZEJšFSFOUMBXTBOETFQBSBUFDPOUSBDUT'PSNPSFJOGPSNBUJPOPOUIFEJTUJODUJPOTCFUXFFOPVSCSPLFSBHFBOEJOWFTUNFOUBEWJTPSZTFSWJDFT QMFBTFTQFBLXJUIZPVS'JOBODJBM"EWJTPS S'JOBODJBM"EWJTPS  EJTUJODU EJšFSJONBUFSJBMXBZTBOEBSFHPWFSOFECZEJšFSFOUMBXTBOETFQBSBUFDPOUSBDUT'PSNPSFJOGPSNBUJPOPOUIFEJTUJODUJPOTCFUXFFOPVSCSPLFSBHFBOEJOWFTUNFOUBEWJTPSZTFSWJDFT QMFBTFTQFBLXJUIZPVS'JOBODJBM"EWJTPS  UIF8 JMF$POTVMUJOH(SPVQ PSWJTJUPVSXFCTJUFBUVCTDPNXPSLJOHXJUIVT'JOBODJBM1MBOOJOHTFSWJDFTBSFQSPWJEFEJOPVSDBQBDJUZBTBSFHJTUFSFEJOWFTUNFOUBEWJTFS"TBŖSNQSPWJEJOHXFBMUINBOBHFNFOUTFSWJDFTUPDMJFOUT UIF8JMF$POTVMUJOH(SPVQ PSWJTJUPVSXFCTJUFBUVCTDPNXPSLJOHXJUIVT'JOBODJBM1MBOOJOHTFSWJDFTBSFQSPWJEFEJOPVSDBQBDJUZBTBSFHJTUFSFEJOWFTUNFOUBEWJTFS"TBŖSNQSPWJEJOHXFBMUINBOBHFNFOUTFSWJDFTUPDMJFOUT JOUIF64 XFPšFSCPUIJOWFTUNFOUBEWJTPSZBOECS PLFSBHFTFSWJDFT5IFTFTFSWJDFTBSFTFQBSBUFBOEEJTUJODU EJšFSJONBUFSJBMXBZTBOEBSFHPWFSOFECZEJšFSFOUMBXTBOETFQBSBUFDPOUSBDUT/PUFUPUIF6TFS'*/3" /"4%  JOUIF64 XFPšFSCPUIJOWFTUNFOUBEWJTPSZBOECSPLFSBHFTFSWJDFT5IFTFTFSWJDFTBSFTFQBSBUFBOEEJTUJODU EJšFSJONBUFSJBMXBZTBOEBSFHPWFSOFECZEJšFSFOUMBXTBOETFQBSBUFDPOUSBDUT/PUFUPUIF6TFS'*/3" /"4%  SSFRVJSFTUIBUUIFQSPTQFDUVTPšFSMFHFOE UIFŖSTUQBSBHSBQICFMPX CFJOBGPOUTJ[FUIBUJTBUMFBTUUIFTBNFTJ[FBTUIBUVTFEJOUIFNBJOUFYUPGUIFNBSLFUJOHQJFDFBOEJOBEJšFSFOUQSJOUTUZMF TVDIBTCPMEPSJUBMJDUZQF0ODF FRVJSFTUIBUUIFQSPTQFDUVTPšFSMFHFOE UIFŖSTUQBSBHSBQICFMPX CFJOBGPOUTJ[FUIBUJTBUMFBTUUIFTBNFTJ[FBTUIBUVTFEJOUIFNBJOUFYUPGUIFNBSLFUJOHQJFDFBOEJOBEJšFSFOUQSJOUTUZMF TVDIBTCPMEPSJUBMJDUZQF0ODF UIJTEJTDMPTVS F UIFQSPTQFDUVTPšFSMFHFOE JTVTFEJOBOZQVCMJDGBDJOHNBUFSJBMT UIFNBUFSJBMTBSFTVCKFDUUPŖMJOHXJUI'*/3" /"4% CZB4FSJFT1SJODJQBMUBS Financial Services Inc. is a subsidiary of UBS AG. h6#4 UIJTEJTDMPTVSF UIFQSPTQFDUVTPšFSMFHFOE JTVTFEJOBOZQVCMJDGBDJOHNBUFSJBMT UIFNBUFSJBMTBSFTVCKFDUUPŖMJOHXJUI'*/3" /"4% CZB4FSJFT1SJODJQBMUBS h6#4 Financial Services Inc. All rights rreserved. eserved. Member SIPC. @Y@"9@(JH)

The Georgia Pharmacy Journal: October 2011  

Articles include Armon Neel, Buddy Carter and National Health Care Update

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