April GPhA Journal 2012 by Georgia Pharmacy Association

The Official Publication of the Georgia Pharmacy Association

April 2012

Spring CPE Conference in Atlanta GPhA consolidates regional meetings and weâ&#x20AC;&#x2122;re opening the door for you to be there...page 4

Volume 34, Number 4 www.gpha.org April 2012 Journal 8.indd 1

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CONTENT/FEATURES Departments

FEATURE ARTICLES 5

Spring Forward with Our New CPE Conference

Be one in a Million HeartsTM

GPhA 2012 Awards Selection

Georgia Pharmacy Association 137th Annual Conference

2012 Georgia General Assembly Wrap-Up

2012 Legislation Followed by GPhA

Timeline for GPhA 2012 Elections

Become a Pharmacy Based Immunizer

CE for Pharmacists: Restless Leg Syndrome

6 10 12 13 20 31

GPhA News Pharm PAC Members Pharm PAC Contribution Form GPhA Member News GPhA Pharmacy News GPhA Board of Directors

Advertisers 2 9 13 13 18 19 20 32

Pharmacists Mutual Companies EC Retail Studio Melvin M. Goldstein, P.C. Logix, Inc. RxAllyTM Meadowbrook Insurance Group Michael T. Tarrant UBS

Management 30

CE Quiz

COLUMNS

ive: 4

President’s Message

Executive Vice President’s Editorial

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

www.gpha.org

Georgia Pharmacy Association 137th Annual Convention Hilton Head Marriott Resort & Spa Hilton Head Island, SC July 7 - 11, 2012

o report

istrict of with your

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PRESIDENT’S MESSAGE L. Jack Dunn, Jr., R.Ph. President Georgia Pharmacy Association

Spring CPE Conference in Atlanta ‘When one door of happiness closes...’ hosting the April meeting. This does not preclude the Region from having other meetings and GPhA will always be there to promote and handle registration.

ast year, while attending fall region meetings, the Executive Committee began hearing ideas about improving our region meetings that are typically held annually in October and April. We learned that very few Regions hold additional meetings and these are the only two times the members in the Region come together. Region presidents cite the reduction in the number of meetings to the inability to obtain sponsorships for the meetings. Restrictions have been placed on drug companies prohibiting them from paying for a meal accompanied by a CPE presentation.

Will we see you on April 21, 2012 at the Spring CPE Conference in Atlanta? I hope you will talk to your Region officers about your ideas for growing and improving your region meetings. Your ideas provide inspiration and growth for our association. The GPhA staff and the Executive Committee are here to support the programs you provide for your region. As Helen Keller stated, ‘When one door of happiness closes, another opens’. Please open the door to your profession and be active in your association. HOPE TO SEE YOU IN ATLANTA ON APRIL 21.

On several occasions, association members asked if GPhA would have a Spring Region CPE in Atlanta which would provide a good setting for networking, increased opportunities for continuing education and discussion about new ideas for change in our profession. The region presidents could incorporate their region meeting with the Spring Region CPE and bring association members up to date on legal changes and other activities on the horizon for our profession. It has always been a policy of GPhA to provide the association with two region meetings each year. One meeting would be in the spring prior to the convention and another region meeting would be held in the fall. As I stated earlier, after our fall region meetings, the Executive Committee decided to take this option to the region presidents for their input.

When one door of happiness closes, another opens; but often we look so long at the closed door that we do not see the one which has been opened for us. Helen Keller US blind & deaf educator (1880 - 1968)

In January of 2012, at the GPhA Board Meeting, the idea of a convocation meeting of all Regions for this spring was discussed and approved as a one-time trial that would give the region presidents relief from

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Spring forward with our new Spring CPE Conference Saturday, April 21, 2012 - 8AM - 5PM

In an effort to improve our CPE offerings, GPhA worked alongside Region Presidents to put a "new twist" on Spring Region Meetings. We hope that you will join us for this amazing CPE event at the Georgia Tech Hotel and Conference Center!

Hotel Room Rate: $109/night + applicable taxes This unique opportunity provides a total of 6 CPE hours over the course of one day. CPE Topics include:

   

Attendees of this conference will be able to: 

Gain new knowledge that can be applied to everyday pharmacy best practices.



Review the current state of numerous state and national pieces of legislation that affect the practice of pharmacy.

. .

t e .

r )

Federal and State Legislative Update Medication Therapy Management New Drug Update Law Update

Reservations must be made on or before Thursday, March 22, 2012 After this date, reservation requests will be handled on a space and rate available basis. To make your reservation at the Georgia Tech Hotel & Conference Center, please call their Reservations department at: 404-838-2100 or 1-800-706-2899 and ask for the special "Georgia Pharmacy Association" rate. For your convenience, the hotel's main line is: 404-347-9440.

Activity Types: Knowledge Target Audience: Pharmacists and Pharmacist Technicians Registration Fee: $99 for Members; $150 for Potential Members Total CPE Contact Hours: 6 CPE Verification Process: Sign-in sheets and evaluations will be provided at each individual CPE opportunity. Both sheets must be legible, fully complete and turned in in order to receive CPE credit. No partial credits are offered as attendees must be present for the entire length of each CPE program. Statements of credit will be emailed within 6 weeks.

Consider bringing the family and taking advantage of a number of special discounts to Atlanta area attractions secured especially for attendees of this innovative conference. More details to come! Any Questions? If you have any questions about the conference, please contact Sarah Bigorowski at sbigorowski@gpha.org or 404-419-8126.

Additional information may be viewed by visiting the complete schedule located at www.gpha.org.

800 Spring Street, NW| Atlanta, GA 30308 www.gatechhotel.com

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GPHA NEWS Former GPhA President Jonathan Marquess and wife Pam Marquess, First Vice President of GPhA, join Jack Dunn, GPhA President, at the head of the table. EVP Jim Bracewell is seated next to Robert Hatton, GPhA President-Elect, with Rick Marasco, GPhA member and APhA CPE presenter. All take a break to enjoy some of New Orleansâ&#x20AC;&#x2122; fine food.

GPhA President, Jack Dunn, congratulates GPhA Member Monali N. Majmudar, Pharm.D., who received an Honorable Mention for the 2011 APhA Immunization Champion Award. GPhA EVP Jim Bracewell is pictured on the right.

GPhA President Jack Dunn poses with several students who attended the APhA Annual Meeting in New Orleans.

GPhA Delegates Carol Ludwig, Ken Eiland, 12th Region President, Bill Hopkins, Region President, and Pam Marquess, GPhA First Vice President, are pictured at the APhA House of Delegates. Not pictured is GPhA President Jack Dunn, also a delegate to

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GPHA NEWS GPhA President Jack Dunn has fun with some of the entertainers at the APhA Exhibit Hall.

APhA Trustee and former GPhA President Jonathan Marquess speaks to the GA Reception at the APhA Annual Meeting.

The Georgia reception at the APhA Annual Meeting had a record turn out.

GPhA President Jack Dunn poses with two GPhA winners of APhA Awards: Monali N. Majmudar, Pharm.D., winner of an Honorable Mention for the 2011 APhA Immunization Champion Award, and Dean Ted Matthews of Mercer University, winner of the APhA Outstanding Dean Award.

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GPHA NEWS

Be one in a Million Hearts™

Amanda Paisley, Pharm.D. Pharmacy Intern Georgia Pharmacy Association

n February 21, I joined Georgia Pharmacy Association President, Jack Dunn, and Executive Vice President, James Bracewell, for Grand Rounds at the Center for Disease Control and Prevention to discuss their exciting new initiative called Be one in a Million Hearts™.

Million Hearts™ is sponsored by Centers for Medicare and Medicaid Services (CMS), the Department of Health and Human Services (DHHS), CDC, and other public and private sponsors. The goal of the initiative is to prevent one million strokes and heart attacks in the next five years. In order to meet this goal, healthcare professionals are being asked to focus on the following ABCS: Appropriate aspirin therapy Blood pressure control Cholesterol management Smoking cessation There were a number of ideas introduced at the meeting that will help us to accomplish the goal of preventing one million heart attacks and strokes. One of the ideas was to have pharmacists help with titrating blood pressure and cholesterol medication. What a great opportunity this could be! In order for us to make this a reality, we need to show our support and abilities for this initiative.

Attendees at the Million Hearts™ meeting from left to right: John O’Brien, GPhA President Jack Dunn, Anna Cohen, FACC Executive Director Million Hearts™ Janet Wright, MD, Amanda Paisley and GPhA EVP Jim Bracewell.

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GPHA NEWS Some of the ways for pharmacists and student pharmacists to get involved include: 1) Sign the Million Hearts™ pledge at: http://millionhearts.hhs.gov/pharmacies.html 2) Talk with your patients about their risk for stroke and heart attack, and what they can do to prevent them 3) Contact your local pharmacy school’s chapter of APhA and offer your services as a supervisor for a blood pressure or cholesterol screening event 4) Keep track of your successes and interventions (ex: initiating prophylactic aspirin use in a diabetic patient, improving adherence to statin medications) Eventually the Million Hearts™ website will be open for the sharing of success stories as well. For more information, you can follow the Million Hearts™ Campaign online at http://millionhearts.hhs.gov; on Facebook at www.facebook.com/millionhearts and on Twitter at @MillionHeartsUS.

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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) Ralph W. Balchin, R.Ph. 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. 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.

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Allen Partridge, R.Ph. Houston Lee Rogers, Pharm.D., CDM Tim Short, R.Ph. Benjamin Lake Stanley, Pharm.D. Danny Toth, R.Ph. Christopher Thurmond, Pharm.D. Tommy Whitworth, R.Ph., CDM

Gold Level

($600 minimum pledge) James Bartling, Pharm.D., ADC, CACII Larry Batten, R.Ph. William F. Brewster, R.Ph. Bruce L. Broadrick, Sr., R.Ph. Liza G. Chapman, Pharm.D. J. Ernie Culpepper, R.Ph. Mahlon Davidson, R.Ph., CDM Kevin M. Florence, Pharm.D. Kerry A. Griffin, R.Ph. Earl W. Marbut, R.Ph. Robert B. Moody, R.Ph. Sherri S. Moody, Pharm.D. William A. Moye, R.Ph. Anthony Boyd Ray, 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. Sheri D. Mills, C.Ph.T. Albert B. Nichols, R.Ph. Richard Noell, R.Ph. Leslie Ernest Ponder, R.Ph. William Lee Prather, R.Ph.

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

Ola Reffell, R.Ph.

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

Bronze Level

($150 minimum pledge) Monica M. Ali-Warren, 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. Charles C. Gass, R.Ph. Ed Kalvelage John D. Kalvelage Steve D. Kalvelage Marsha C. Kapiloff, R.Ph. Brenton Lake, R.Ph. Allison L. Layne, C.Ph.T. William E. Lee, R.Ph. Michael Lewis, Pharm.D. Ashley Sherwood London Max A. Mason, R.Ph. Amanda McCall, Pharm.D. Susan W. McLeer, R.Ph. Mary P. Meredith, R.Ph. Amanda Rose Paisley, Pharm.D. 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. Don K. Richie, R.Ph. Laurence Neil Ryan, Pharm.D. Richard Brian Smith, R.Ph. Charles Storey, III, R.Ph. Archie Thompson, Jr., R.Ph. Carrie-Anne Wilson Sharon B. Zerillo, R.Ph.

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Pharm PAC Members Continued from previous page Members

(No minimum pledge) John J. Anderson, Sr., R.Ph. Fred W. Barber, R.Ph. Mark T. Barnes, R.Ph. Henry Cobb, III, R.Ph., CDM Carleton C. Crabill, R.Ph. Wendy A. Dorminey, Pharm.D., CDM Benjamin Keith Dupree, Sr., R.Ph David M. Eldridge, Pharm.D. James Fetterman, Jr., Pharm.D. Charles A. Fulmer, R.Ph. Thomas Bagby Garner Jr., R.Ph. Christina Gonzalez

Kimberly Dawn Grubbs, R.Ph. Christopher Gurley, Pharm.D.

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. Ralph K. Marett, R.Ph.,M.S. Roy W. McClendon, R.Ph.

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

Darby R. Norman, R.Ph.

Christopher Brown Painter, R.Ph. Whitney B. Pickette, R.Ph. Victor Serafy, R.Ph. Negin Sovaidi James E. Stowe, R.Ph. James R. Strickland, R.Ph. Celia M. Taylor, Pharm.D. Leonard E. Templeton, R.Ph. Erica Lynn Vesley, R.Ph. William D. Whitaker, R.Ph. Elizabeth Williams, R.Ph. Jonathon Williams, Pharm.D. Rogers W. Wood, 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.

GPhA 2012 Awards Selection The GPhA Council of Presidents are charged with selecting the award recipients each year for our annual meeting and convention. This year the Council of Presidents will be meeting on Saturday, April 21, 2012 following the Spring CPE Conference. Nominations have been contributed by members across the state for each award and the Committee will have their voice in making the 2012 selections. Following their annual spring meeting, the GPhA Executive Committee will host a dinner for the former presidents and their spouses as an expression of gratitude for their service to GPhA as members of the Awards Committee, and their invaluable input and guidance throughout 2011-12. Bentley Adams Jr. John Anderson Sr. James Bartling Robert Bowles Jr. Bruce Broadrick Sr. Hugh Chancy George Chapman Dale Coker W. Conley Jr. William Dunaway Michael Farmer John Glenn

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David Graves Alton Greenway Buddy Harden Jr. Harold Jones Daniel Land Frances Lipscomb Jeffrey Lurey Eddie Madden Jonathan Marquess Jim Martin Max Mason Michael McGee

Isaac Mills Jr. Armon Neel Jr. Michael Reagan Robert Rogers John Sherrer Sharon Sherrer Brice Sikes Richard Smith Dean Stone Danny Toth Flynn Warren Steve Wilson

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Join Pharm 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: Titanium ($200/month) Silver ($25/month)

Platinum ($100/month) Gold ($50/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! The Georgia Pharmacy Journal

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GPHA MEMBER NEWS

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

Individual Pharmacist Members:

Associate Members:

Pharmacy School-Student Members:

Pharmacy Technician Members:

Jennifer M. Bennett, Pharm.D. - Alpharetta

Joseph Coyne, R.Ph. – Zion, IL CKerry Glenn Ward, C.Ph.T. – Rincon Dana L. Baumgart, C.Ph.T. – Phenix City , AL

Charles Reid - Woodbury Whitney Reed - Conyers Sorour Khaleghian - Athens Sarah L. Peake - Marietta

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.

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

LAW

248 Roswell Street Marietta, Georgia 30060 Telephone 770/427-7004 Fax 770/426-9584 www.melvinmgoldstein.com

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

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

I Have a Great Opportunity

o, I am not about to try and sell you on investing in gold reserves or green industry stocks. I am going to remind you of the best investment in your professional career and pharmacy practice and urge you today to block out time on your calendar to attend the GPhA Annual Meeting and Convention to be held at the Marriott Resort & Spa on Hilton Head Island, S.C., July 7-11. Most of us readily affirm the value of our college degree or advanced studies. It is a statistical fact that over a work career a college graduate will earn one to one and one half million dollars more than if they had stopped their education at high school graduation. With this basic knowledge about the value of education, especially for a profession like pharmacy, one would think that anyone who wants to earn more, deliver improved care and service would prioritize their continuing professional development. At the GPhA office, we encourage our staff to invest in their continuing education. Dan attends classes on latest tax changes, Sarah attends meetings to learn the latest in meeting venues and Andy attends classes to learn about PAC regulations. I am sure that is what you would want your staff at GPhA to be doing. You want us to know the latest information. You want us trained well in the skills to do our job for you, but are you investing in yourself? The GPhA meeting in July is an opportunity to hear from some of the best thinkers and speakers about pharmacy and provide you the knowledge you need to be a part of the today’s health care team.

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What are you doing today to make absolutely sure that you are the Rx Expert of tomorrow, next year or the following year? One of my favorite stories is about the young Wall Street investor that buys a small farm in upstate Vermont. As winter is approaching the young investor finds himself with an axe, a chopping block and the need for several cords of firewood. As he worked in the midmorning sun, he is now developing a full sweat; he was experiencing some self-doubt about owning a farm. Just then, this crusty old neighbor farmer stopped to watch the young man chop wood. After a long spell of silence the old farmer suggested, “Son you might want to stop and sharpen that axe”, to which the irritated and frustrated young investor replied harshly, “Old man, you obliviously don’t see that I don’t have time to do something like that when I have all this wood to chop.“ July in Hilton Head is a great time to sharpen your axe and improve your pharmacy practice. You will learn a lot in the CE classes, you will learn a lot from the exhibit hall vendors, but most likely you will learn the most from a colleague of yours in GPhA. Go to the GPhA website and reserve your room today and enjoy some fun, fellowship and education with the best pharmacists in Georgia.

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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.

Georgia Pharmacy Association 137th Annual Convention Schedule At-a-Glance (preliminary) Saturday, July 7, 2012

Monday, July 9, 2012

Tuesday, July 10, 2012

Morning CPE Sessions 2011-2012 GPhA Board Meeting Afternoon CPE Sessions Exhibit Hall Open Pharm PAC Contributors Reception--By Invitation Only

AIP Compounding Pharmacy Section Breakfast - By Invitation Only Council of President’s Breakfast & Meeting - By Invitation Only Morning CPE Sessions SECOND GENERAL SESSION GA Pharmacy Foundation/Carlton Henderson Memorial Golf Tournament AEP Tennis Tournament Afternoon CPE Sessions

Morning CPE Sessions THIRD GENERAL SESSION Election Balloting Closes Afternoon CPE Sessions Tellers Committee Meeting Resolutions Committee Meeting President’s Reception President’s Inaugural Banquet & Officer Installation Dessert Reception & Dance _________________________________

_________________________________

Sunday, July 8, 2012 Interfaith Sunrise Service GA Pharmacy Coalition Breakfast By Invitation Only Morning CPE Sessions ASA Luncheon & Business Meeting AIP Luncheon ACP Luncheon & Business Meeting AEP Luncheon & Business Meeting AHP Luncheon & Business Meeting FIRST GENERAL SESSION Exhibit Hall Open

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_________________________________

Wednesday, July 11, 2012 FINAL GENERAL SESSION 2012-2013 GPhA Board of Directors Meeting Region Presidents Meeting

Please note this schedule is subject to change.

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GPHA NEWS

Andy Freeman Director of Government Affairs Georgia Pharmacy Association

SB2 mo com

2012 Georgia General Assembly Wrap-Up

he 2012 session of the Georgia General Assembly was a good session for GPhA and Pharmacy. We were able to pass most of our legislative agenda, but just as important we were also able to stop a lot of anti-pharmacy legislation. Some of the legislation we were able to stop were laws that would have made generic substitution of certain prescriptions difficult, legislation that would have put the Composite Medical Board in charge of determining Continuing Education requirements for some pharmacists and another proposal that would have made pharmacists responsible for reporting and investigating potential child abuse or neglect of customers that come into their pharmacy. Probably the most important legislation we killed was the Georgia Secretary of Stateâ&#x20AC;&#x2122;s proposal that would have put non-pharmacists in charge of licensure, investigating and penalizing of pharmacists. Our success at the Capitol comes not just through the lobbying team that GPhA has assembled, but also through the four pharmacists that are state legislators. Rep. Buddy Harden, Rep. Butch Parrish, Rep. Ron Stephens and Sen. Buddy Carter represent your profession well under the Gold Dome. GPhA is also very fortunate to have Eddie Madden, a former State Senator, to help develop and guide our legislative agenda. Just as important to our legislative program are people like Drew Miller, Jonathan Marquess, Liza Chapman and Mandy Reece who were willing to give their time to testify at the Capitol on various issues this session.

Also of importance are pharmacists like you that keep in constant communication throughout the session and the rest of the year with their legislators to ensure that they understand what issues the pharmacy industry faces every day as well as the 300+ pharmacists, students and friends that joined us at this yearâ&#x20AC;&#x2122;s VIP Day. Lastly, 2012 is an election year and we need to make sure that we are doing our part to have pharmacy friendly elected officials. We have several elected friends that have opposition that we need to help and there are some legislators that we need to help find opponents for. I hope that you will join me in becoming a member of PharmPAC if you are not already one. PharmPAC registration forms can be found in this issue or online at our website. Thanks again for all of your hard work. Together we can make 2013 another great year for pharmacists at the State Capitol.

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SB3 and

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SB4 care ing ing

SB4 the tion 222 give do n kill

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HB1 inad the

HB1 reco

HB1 Pha pas Past President and GPhA Govt. Affairs Chairman, Eddie Madden (center), advocated for GPhA issues with Senator Frank Ginn (left) and Lt. Governor Casey Cagle (right).

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HB1 SB 2

GPHA NEWS

2012 Legislation Followed by GPhA SB288 – Immunizations; allow pharmacists to give immunizations with physician’s protocol. Allows Pharmacists and nurses to give more immunizations. Passed out of the Senate 43-7 but died in House Health and Human Services when the Chair refused to let it come up for a vote. SB346 - State Board of Pharmacy; prescription drugs by mail/other common carriers; Changes current state law to allow mail order from within the state with the same restrictions and patient safety precautions that Kaiser Permanente currently has. Also allows the Board of Pharmacy to develop rules to allow for a prescription to be filled at one pharmacy and sent to another pharmacy, which is commonly referred to as Central Fill. Language for the Board of Pharmacy to regulate remote entry access for hospital pharmacies was also added to the legislation. Passed out of the Senate and House and is on the Governor’s desk. SB370 - Controlled Substances; Schedule I and V controlled substance; “dangerous drug”; Annual drug update bill. Passed the Senate and House and has already been signed by the Governor into law. SB380 - Pharmacist and Pharmacies; change definition of security paper; State Board of Pharmacy; Fixes the problems regarding Prescription Pads that was inadvertently created with the passage of the Prescription Drug Monitoring legislation from last year. This bill will also allow for the licensing of pharmacies from other states that send prescriptions to Georgians. Georgia is one of the few states that do not currently license pharmacies in other sates. Passed the Senate but died on the floor of the House on the final legislative day. SB416 - Insurance Dept; authorize to develop exchange standards regarding electronic prior authorization drug requests with health care provider Allows for the national standards that are to be adopted by the National Council of Prescription Drug Programs governing electronic prior approvals of prescriptions to be the standard followed here in Georgia. Passed the Senate and House and is awaiting the Governor’s signature. SB445 - Secretary of State; create the position of director of professional licensing; provide powers, duties, and responsibilities This is the Secretary of State’s bill to reportedly streamline the process of getting professional licenses and renewals. Some of our main objections to the legislation are that it takes away the Pharmacy board’s authority to issue emergency schedule controlled substances (lines 2220-2223), authorizes the 7 member Consumer Board to reschedule dangerous drugs and controlled substances (lines 2275-2278), gives the SOS authority to inspect pharmacies (line 2228) instead of the POST certified licensed Pharmacists that work for GDNA. We do not like having the new Consumer Board appoint and control the GDNA Director (line 2394) either. GPhA successfully lobbied to kill this legislation along with some other groups. HB964 - The Pharmacy Audit Bill of Rights; recoupment pursuant to an audit under certain circumstances; Currently when a Pharmacy Benefit Manager audits a pharmacy, they can recoup the cost of the drug for simple clerical or record keeping errors. This legislation will correct this problem. Did not pass the House and is dead. HB972 - Georgia Pain Management Clinic Act; This is the Attorney General’s legislation to continue regulating Pill Mills in Georgia. Died on the last day of the session as the House did not have time to approve the changes made by the Senate. HB1069 - Pharmacists and pharmacies; revise definition of security paper Fixes the problems regarding Prescription Pads that was inadvertently created with the passage of the Prescription Drug Monitoring legislation from last year. Passed the House but died on the floor of the Senate the last day. HB1125 - The Pharmacy Audit Bill of Rights; recoupment pursuant to an audit under certain circumstances; Does not allow PBM’s to recoup the costs of drugs in an audit if there was a technical or error such as spelling errors, etc. Did not pass the House and is dead. HB1130 - Georgia State Board of Pharmacy; administratively attached to Department of Community Health; Moves the Board of Pharmacy out from underneath the Secretary of State and makes it an independent agency like the Composite Medical Board. Did not pass the House and is dead for this year. GPhA anticipates that this issue will be brought up again next year. HB1149 - Physicians; administration of vaccines by pharmacists or nurses pursuant to vaccine protocol agreements; House version of SB 288 which allows pharmacists to give any immunization. Did not pass the House and is dead.

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PHARMACY NEWS

Timeline for GPhA 2012 Elections:

First Vice President & Second Vice President March 9, 2012 (No later than.) Nominating Committee must meet no later than this date. April 10, 2012 The First Vice President (at least one person) and Second Vice President (at least two people) nominations must be made. May 10, 2012 The petitions from additional nominees must be submitted to the Executive Vice President. May 14, 2012 – The following data to be sent to the election service: 1) member last names/member ids/email addresses; and 2) candidate pictures/ bios. May 14, 2012 Paper Ballot to be sent to the printer. May 18, 2012 Email sent to notify GPhA members of the log-in information that will be arriving in their email box on May 23, 2012 from the Association online

Voting with a reminder to unblock GPhA’s email address from SPAM. May 23, 2012 Log-in information to be emailed to GPhA members from the Association Online Voting. May 23, 2012 Paper ballots to be sent in the mail May 25, 2012 The election opens. Association Online Voting will email GPhA members the link to the voting site. Once each member has voted, he/ she will receive no further reminder emails. July 4, 2012 Reminder emails will be sent to GPhA members who have not voted on a weekly basis. June 25, 2012 Deadline for all mail-in ballots. (All mailed ballots must be post-marked by this date.)

July 5, 2012 Mailed ballots to be retrieved and secured. July 10, 2012 Polls close at Noon. July 10, 2012 Conduct Tellers Committee Meeting.

July 10, 2012 Installation of new officers.

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Become a Pharmacy Based Immunizer Macon, Georgia Saturday, May 19, 2012 8:00am - 6:00pm

A CERTIFICATE PROGRAM FOR PHARMACISTS Hosted by GPHA at the Hilton Garden in

Macon / Mercer University

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 Faculty: Liza G. Chapman, Pharm.D. 2nd Faculty Member TBD 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. To earn a Certificate of Achievement, participants must complete all components of the program including the self-study, the self-study assessment, the Pharmacy-Based Immunization Delivery live training seminar, the final examination, and the injection technique assessment. Statements of Credit and Certificates will be issued within 4-6 weeks of APhA’s receipt of program materials. After completing the live training seminar, participants will be able to: • 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 vaccine-preventable 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. (continued on next page)

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(continued from previous page)

• Review a patient case and determine patient-specific vaccine recommendations based on the appropriate immunization schedule. • 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. 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 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. 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. If you have questions about this program please contact Sarah Bigorowski at sbigorowski@gpha.org or 404419-8126.

To register for this event please visit www.gpha.org.

continuing education for pharmacists Volume XXX, No. 2

Restless Legs Syndrome and Management 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 review restless legs syndrome, with emphasis on presenting key points of information to pass along to patients. Objectives. At the completion of

this activity, the participant will be able to: 1. demonstrate knowledge of restless legs syndrome including its causes and triggers, epidemiology and prevalence, pathogenesis, and clinical impressions; 2. explain the mechanism of action and major adverse events associated with the drugs used in treating restless legs syndrome; 3. select nonpharmacologic measures that are reported to modify symptoms of restless legs syndrome; and 4. demonstrate an understanding of information relative to restless legs syndrome to convey to patients and their caregivers.

Background

Restless legs syndrome (RLS), also known as Ekbon’s syndrome, was named after Swedish neurologist/physician Karl Ekbon. In the mid-1940s, Ekbon described the condition as a common and distressing condition, but one that is readily treatable. Two to 15 percent of the general population of

Gossel

Wuest

the United States may experience RLS symptoms, although the exact prevalence may be much higher because it is generally held that many patients fail to discuss their symptoms with healthcare providers. Patients may believe their condition is too insignificant with which to bother their physician, or they may not recognize that RLS can be symptomatic of more serious pathology that requires physician intervention. A sensorimotor (both sensory and motor) neurologic movement disorder, RLS causes patients to experience an almost irresistible urge to move their legs. Usually worse during periods of inactivity or rest, walking or other physical activity involving the legs can usually alleviate the sensations. Often associated with a sleep complaint, the inability to rest can have a negative impact on the patient’s quality of life due to agitation, discomfort, frequent waking, chronic sleep deprivation and stress. These conditions, in turn, can negatively affect job performance, social activities, and family life. Disturbed sleep and inability

to tolerate sedentary activities can lead to a compromised ability to enjoy life, and serious problems maintaining relationships. RLS hardly receives the attention it deserves. It has attracted little attention in medical textbooks until recently. A study conducted jointly in the United States and Europe suggests that the condition is not only under-reported, but also greatly under-diagnosed and under-treated. A 1996 report described the outcome of a group of patients who delayed seeking medical help for many years, but even after they did receive help, accurate diagnosis frequently took a decade or more. The Restless Legs Syndrome Foundation has taken account of these observations and often reminds its constituency that RLS is “the most common disorder you have never heard of!” This lesson describes RLS, including its clinical features and medical management. It stresses information that will be useful not only to pharmacists, but also to patients who experience the condition.

Epidemiology and Prevalence

RLS can affect persons of any race or ethnic group, but it is more common in persons of Northern European descent. African Americans are affected significantly less often than Caucasians. Its prevalence is distinctly lower in Asian populations, ranging from 0.1 percent in

Table 1 Drugs reported to exacerbate RLS • Alcohol • Analgesics (NSAIDs, non-opioid) • Anesthetics (bupivacaine, mepivacaine) • Anticonvulsants (methsuximide, phenytoin, topiramate, zonisamide) • Antidepressants (mirtazapine, SSRIs, trazodone, tricyclics, venlafaxine) • Antihistamines (older) • Antipsychotics (clozapine, olanzapine, quetiapine, risperidone) • Beta-adrenergic blockers (pindolol) • Caffeine • Donepezil • Interferon-alfa/ pegylated interferon-alfa • Levothyroxine • Lithium • Methadone (withdrawal) • Metoclopramide • Nicotine • Sodium oxybate

Singapore to 4.6 percent in elderly Japanese. Epidemiological studies in the general population of the United States and Europe show widely different prevalence rates, probably related to the variety of experimental design. Prevalence of RLS among patients in primary care settings has also been estimated. Results from a large survey of primary care centers in Europe and the United States reported that overall, 11.1 percent of patients experienced any degree of RLS symptoms, while 9.6 percent reported symptoms at least once weekly. RLS has a variable age of onset with prevalence increasing with advancing age. It can also occur in children. Studies confirm that in patients with severe RLS, onethird to two-fifths experienced their first symptoms before age 20 years, although a precise diagnosis of RLS was made much later. Women are twice as likely as men to develop RLS.

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Etiology and Pathophysiology

Although RLS is a disorder of the central nervous system, it is not a psychophysiologic pathology; however, it may contribute to or be exacerbated by such conditions. RLS can generally be categorized into primary (idiopathic) and secondary forms. Primary RLS is not related to other identifiable abnormalities; secondary RLS is associated with an underlying pathology. When no specific cause can be identified for initiating RLS symptoms, it is considered a primary condition. It is thought that RLS may be due to dysfunction of dopamineproducing cells in the nigrostriatal areas of the brain. Pharmacologic studies have shown a dramatic improvement in RLS symptoms with administration of levodopa, the precursor of dopamine, or with dopaminergic agonists that act on dopamine receptors in the brain. Conversely, dopamine antagonists will worsen symptoms in patients with RLS. Advanced brain imaging has revealed decreased dopamine D2 receptor binding in the striatum of patients with RLS. Hypoactive dopaminergic neurotransmission in RLS has recently been demonstrated and study results suggest that both striatal and extrastriatal brain regions are involved. The high incidence (40 to 60 percent) of familial cases of RLS strongly suggests a genetic origin for primary RLS, especially if the condition onsets at an early age. Family and twin studies have proposed both autosomal-dominant as well as recessive modes of inheritance. Genetic studies suggest several chromosomal loci associated with RLS. At present, five loci have been mapped for RLS in single families, and three susceptibility loci have been identified in a genome-wide association study. Secondary causes of RLS are more common in persons who develop symptoms for the first time in later life; secondary RLS occurs in over 70 percent of persons with onset at age 65 years or more. It is important to rule out secondary RLS

when attempting to control symptoms. Secondary Causes. A number of secondary causes of RLS have been identified. For example, symptoms of RLS may be associated with iron deficiency. A patient’s iron stores may be deficient without causing anemia. Studies have shown that decreased iron stores (i.e., ferritin levels below 50 µg/L) can exacerbate RLS symptoms. Iron is an essential cofactor for tyrosine hydroxylase, the rate-limiting enzyme for dopamine synthesis. Animal studies demonstrate that iron deficiency is associated with hypofunction of dopamine D2 receptors that is corrected by iron replacement. The fact that the extent of iron deficiency correlates well with symptoms and that iron is an effective therapy, at least in iron-deficient patients, provide strong support for the role of iron deficiency in the pathogenesis of some patients with RLS. Physicians often order serum ferritin levels in patients with newly diagnosed RLS or RLS patients with a recent exacerbation of symptoms. Once iron levels are corrected (discussed subsequently), symptoms are reduced. RLS has been reported in persons with spinal cord and peripheral nerve lesions, and in patients with vertebral disc disease. The exact pathological mechanism remains unknown. RLS occurs in up to one-half of patients with end-stage renal failure. Symptoms may be especially bothersome during dialysis when the patient is in a forced resting position. Improvement in RLS symptoms has been shown after renal transplantation. One in five women experience symptoms during pregnancy, especially in their last trimester. Some women, in fact, report RLS for the first time during pregnancy. Symptoms can be severe, but usually subside within four weeks postpartum. RLS symptoms may be worsened or unmasked by a variety of medications (Table 1). As a group,

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Table 2 Terms patients may use when describing RLS symptoms Aching Flowing water Burning Numb Buzzing Painful Cramping Pulling Crawling Restless Creeping Searing Drawing Tense Electric current-like Tingling Gnawing Tugging Indescribable Uncomfortable Itching Feeling of worms or bugs crawling under my skin

antidepressants are the drugs most commonly implicated in secondary RLS with almost all classes reported to worsen symptoms. Persons with RLS who take one or more of the listed drugs are advised to discuss with their physician the possibility of changing medications to improve symptoms.

Clinical Assessment

A diagnosis of RLS is based primarily on a careful patient history and detailed physical and neurological examination. There is no laboratory test that can affirm the presence of RLS. The patient’s physical examination is often normal, except for those who have symptomatology suggestive of a secondary form of RLS or a comorbid condition. Symptoms may be described by patients as ranging from mild to intolerable. Due to the subjective nature of the disorder, however, patients often experience difficulty in describing their symptoms. Oftentimes their sensation defies description (Table 2). Confirmation of RLS is not easy. A population study showed that a large number of patients do not seek medical aid because of their motor condition, but rather because of the consequences of their disorder such as insomnia or decreased quality of life. Most patients with RLS experience the feelings in their

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lower legs (calves); however the aggravating sensations may also occur any place in the legs or feet. They may also occur in the arms or elsewhere. The feelings seem to originate from deep within the limbs, rather than from the joints, or on the surface. The sensations are usually bilateral, but may occur in one leg, move from one leg to the other, or affect one leg more than the other. The pain is more of an ache rather than sharp, jabbing pain. Symptoms are generally worse in the evening and night, and less severe in the morning. Symptoms appear with rest, sitting or lying down. The more comfortable the patient is, the more likely it is that RLS symptoms will occur. The reverse is also true – the less comfortable the patient is, the less likely it is that symptoms will onset. As a result, some patients may prefer to sleep on a hard surface including the floor rather than in a comfortable bed. The condition should be distinguished from sleeprelated disorders of the legs. Periodic Limb Movements in Sleep. The presence of repetitive and highly stereotypic periodic limb movements in sleep (PLMS) supports, but does not confirm, a diagnosis of RLS. PLMS is also known as periodic limb movements and periodic limb movement disorder, and was formerly referred to as myoclonus. PLMS is noted as repetitive movements, typically in the lower limbs, that occur every 20 to 40 seconds. Symptoms can also occur in the arms. Hundreds of these involuntary, rhythmic muscular jerks in the lower limbs may occur, sometimes throughout the night. Affected persons are often not aware they are experiencing the movements. In a person with severe RLS, these involuntary kicking movements may also occur while awake. PLMS is common in older adults, even those without RLS, and doesn’t always disrupt sleep. Eighty percent of persons with RLS also experience PLMS, which correlates with RLS severity, but less than half of those with PLMS also have RLS.

Table 3 Criteria for diagnosis of RLS Diagnostic criteria* •Compelling urge to move the limbs, usually associated with paresthesias/ dysesthesias •Motor restlessness as noted in activities such as floor pacing and rubbing the legs •Symptoms present or worse during rest, with temporary relief by activities such as walking or stretching, at least as long as the activity continues •Symptoms worse in evening and at night than during the day, or occur only in the evening or night Supportive clinical features± •Sleep disturbance and daytime fatigue •Normal neurological examination in primary RLS •Involuntary, repetitive, periodic, jerking limb movements during sleep or while awake •Positive family history of RLS •Positive response to dopaminergic therapy Associated features§ •Natural clinical course: Onset age is variable, in patients with earlier onset (<50 years) the symptoms are insidious, while patients with later onset have a more aggressive course. RLS is usually a chronic disease with a progressive clinical course; in the mildest forms of RLS, the clinical course can be static or intermittent. •Sleep disturbances: disturbed sleep is usually associated with RLS. •Medical evaluation/Physical examination: physical and neurological examination is generally normal (except for secondary RLS). Medical evaluation should be addressed to identify possible causes for secondary RLS. *Minimal criteria for positive diagnosis of RLS ±Supportive clinical features common in RLS but not required for diagnosis §These features may provide additional information about the patient’s diagnosis

Essential Criteria that Confirm RLS. The International Restless Legs Syndrome Study Group in collaboration with the National Institutes of Health has established criteria for diagnosis of RLS

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(Table 3). Four essential criteria must be present to establish a positive diagnosis. A mnemonic to help remember these points is URGE: Urge to move, Rest induced, Gets better with activity, Evening and night accentuation. In the absence of the core clinical features of RLS, a positive diagnosis of RLS cannot be made, and other causes of PLMS or isolated periodic limb movement disorder must be considered. The relation between PLMS and RLS is unclear, but treatments used for RLS may also be effective in PLMS as well. The presence of supportive and associated clinical features as shown in Table 3 is not necessary for a positive diagnosis, but they are definitely helpful to the differential diagnosis. Differential Diagnosis. RLS should be differentiated from other conditions including: •Nocturnal Leg Cramps. These typically include painful, palpable, involuntary muscle contractions, often focal, with a sudden onset. Nocturnal leg cramps are usually unilateral. •Akathisia. This is a closely related disorder, described as a condition of motor restlessness, ranging from a sense of inner disquiet, to inability to sit or lie quietly or to sleep, with no sensory complaints. The restlessness is generalized and internal rather than localized to the limbs and associated with paresthesias. Akathisia often does not correlate with rest or time of day, and often results as a side effect of medication such as neuroleptics or other dopamine blocking agents. •Peripheral Neuropathy. This can cause leg symptoms that are different from RLS. Symptoms are usually neither associated with motor restlessness nor lessened by movement. The condition is not worse during the evening or nighttime. Sensory complaints include numbness, tingling or pain. Small fiber sensory neuropathies such as those seen in diabetes mellitus may be confused with RLS. Patients with neuropathies may have both neuropathic and RLS symptoms. •Vascular Disease. Conditions

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such as deep vein thrombosis can be confused with RLS.

RLS in Children

Although RLS is generally discussed as a disease of adults, over the past 20 years there has been increasing recognition that it also occurs in children. Adults with the diagnosis often retrospectively recall having had symptoms during their childhood. Case series have described children as young as 18 months of age with features of RLS. Diagnosing RLS in children is particularly difficult because clinicians rely heavily on the patient’s description of symptoms. Even for adults with RLS, an accurate description of its subjective symptoms may be difficult. Children may describe RLS symptoms differently than adults, using terms such as oowies, ouchies, tickle, spiders, twitchy, jerky, boo-boos, want to run, and a lot of energy in my legs. Or, children may have at least two of the following: sleep disturbance, a biological parent or sibling with RLS, or polysomnographic-documented PLMS. Determining RLS in children can be aided using the same four criteria as for adults (see Table 3). According to a recent survey of more than 10,000 families in the United States and the United Kingdom, RLS affects about 2 percent of children. A pediatric RLS prevalence of 5.9 percent was noted at one pediatric sleep disorders clinic. Another study found a prevalence of 1.3 percent in 12 pediatric practices, and another reported its occurrence in 6.1 percent of Canadian children ages 11 to 13 years. The U.S./U.K. study found a strong genetic component to RLS. More than 70 percent of children with RLS had at least one parent with the condition. There is also evidence suggesting that children with attention deficit hyperactivity disorder (ADHD) and a family history of RLS are at risk for more severe ADHD. Most children with RLS do not require pharmacologic treatment

and indeed, there are no FDAapproved drugs for use in children with RLS. Case histories and anecdotal reports suggest it is best to begin with good sleep hygiene measures, cognitive behavioral therapy and caffeine restriction (including restriction of caffeinated soft drinks). If these measures are ineffective, screening for anemia and checking the patient’s serum ferritin level makes sense. For children, elemental iron in doses of 3 mg/kg/day given for three months was shown to improve PLMS and clinical symptoms, but more data are needed to determine effectiveness in pediatric RLS. Dopaminergic drugs used “off-label” in children have been shown to improve RLS symptoms. In cases of associated ADHD, dopaminergics may benefit ADHD symptoms as well.

Treatment in Adults

There is no cure for primary RLS. Both nonpharmacologic measures and pharmacotherapy, however, are helpful in relieving symptoms in many patients. It is important to note that both severity and frequency of RLS are variable; therefore, nonpharmacologic therapies alone may be appropriate for milder forms of RLS and indeed, these measures should be considered first in all but the most severe cases. It is also important to note that many pharmacologic agents are used in an “off-label” basis. Successful treatment for secondary RLS requires treating the underlying cause. Goals of treatment are to prevent or relieve symptoms, increase the amount and improve the quality of sleep, and treat or correct any underlying condition that may trigger or worsen RLS. Lifestyle and Behavioral Changes. For those with mild-tomoderate symptoms, prevention is key to their control. In general, simple lifestyle changes that promote good health can play an important role in alleviating symptoms of RLS. The measures listed in Table 4 may help reduce the discomfort and excessive leg movements. The websites listed in Table

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Table 4 Nonpharmacologic management of RLS •Identify any underlying disorders and treat, if feasible •Eliminate precipitants of RLS -Drugs (see Table 1) -Common stimulants and depressants: caffeine, alcohol, nicotine •Practice good sleep hygiene -Establish regular sleep and wake times -Restrict bed to sleep and intimacy; remove TV, stereo -Avoid perturbing activities immediately before sleep -Avoid bright lights in late evening or night -Have a light snack before bedtime •Apply simple behavioral interventions -Brief walk before bedtime -Hot bath or cold shower -Massage limbs -Practice meditation and/or yoga -Avoid heavy meals within 3 hours of bedtime -Avoid excessive napping during daytime •Moderate exercise: neither inactivity nor unusual and excessive exercise •Weight management: healthy diet and adequate activity •Information and support: use websites and patient support groups (see Table 5)

5 provide valuable information that can be passed along to patients. Pharmacologic. Although nonpharmacologic strategies may work for some patients with milder symptoms, most individuals with mild-to-moderate symptoms will require medication to help make symptoms tolerable. Medical management of RLS is a rapidly developing field. Large-scale multicenter trials in RLS became common only since the beginning of the 21st century. To date, only three drugs have earned FDA approval for RLS: ropinirole (Requip®) in May 2005, pramipexole (Mirapex®) in November 2006 and gabapentin enacarbil (Horizant™) in April 2011. Since symptom severity varies greatly between patients, no single medication or combination of drugs will work predictably for all

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patients. Treatment must therefore be individualized. Selection of pharmacologic agents is influenced by a number of factors, including: •Patient Age. Benzodiazepines, for example, may cause cognitive impairment in elderly patients. •Symptom Severity. Patients with mild symptoms may elect to forgo using medications due to cost, adverse effects or other reasons. Others may benefit from a dopaminergic agent or a dopamine agonist. Severe symptoms may require a strong opioid. •Symptom Frequency. Persons with infrequent symptoms may benefit greatly from a single dose of medication given on an as-needed basis, such as an opioid or levodopa. •Pregnancy. Neither safety nor efficacy of medications for RLS has been assessed in clinical trials involving pregnant women. •Renal Failure. Most pharmacologic agents are generally safe in patients with renal failure, although dose frequency and quantity may be modified if the drugs are excreted via the kidney. Moreover, for dialysis patients, some medications are dialyzable (e.g., gabapentin) while others are not. Dopaminergic Agents. Discovery that levodopa was effective in RLS revolutionized its management. Every dopaminergic agent tested has been shown to be effective against RLS and PLMS. Levodopa/carbidopa (Sinemet®, and others) provides near-immediate relief from RLS. The response is so characteristic that a brief course of therapy may be considered in patients whose diagnosis of RLS is in doubt. Levodopa is also effective in hemodialysis patients with RLS. In general, the drug is very well tolerated. Levodopa-induced dyskinesias have not been reported in RLS patients. Two troublesome and common problems develop with prolonged use of levodopa, which limits the value of this otherwise almost ideal agent for RLS: rebound and augmentation. Rebound is an outcome of the drug’s short half-life; after

Table 5 Support groups for RLS •Restless Legs Syndrome Foundation www.rls.org •Worldwide Education and Awareness for Movement Disorders (WE MOVE) www.wemove.org •National Sleep Foundation www.sleepfoundation.org •National Institute of Neurological Disorders and Stroke (NINDS) www.ninds.nih.gov/disorders/ restless_legs/restless_legs.htm •National Heart, Lung and Blood Institute (NHLBI) www.nhlbi.nih.gov/health/dci/ Diseases/rls/rls.htm

a while, patients start to awaken early in the morning with recurrence of their RLS. Sustained-release formulations can delay onset of rebound until later in the morning, although the long-term efficacy of this approach remains unknown. Augmentation is more serious. It may shorten symptom-free periods at rest. Also, symptoms develop earlier in the day (morning or afternoon instead of evening or night) and may become more severe; and symptoms may develop in parts of the body that were not previously involved. Augmentation occurs in up to 80 percent of patients treated with levodopa as early as four weeks into treatment. Approximately one-third have sufficiently severe symptoms that warrant a change in therapy. The precise mechanisms contributing to augmentation are unknown. The need for higher doses of levodopa and development of more severe RLS may predict development of this complication. Levodopa is, therefore, no longer the treatment of choice for RLS, although it remains a therapy of choice for persons with only intermittently severe symptoms. Dopamine Receptor Agonists. These are now regarded as the first-line treatment for RLS.

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The non-ergot agonists ropinirole and pramipexole have been shown to benefit RLS in randomized controlled trials. There is no indication based on the numerous comparative clinical trials reported for the dopamine receptor agonists that efficacy of one agent is better than another. The drugs are chemically distinct from dopamine, but their mechanism of action in the central nervous system is similar to that of the endogenous neurotransmitter. Studies suggest that the drugs are well tolerated in patients with severe RLS who have failed other therapies and in those with augmentation. Augmentation and tolerance have been reported, although at a much lower incidence than seen with levodopa, and they seem more likely to occur in patients who previously developed similar problems with levodopa. Dose reduction may be required if augmentation or tolerance develop, but, unlike with levodopa, a change in medication is rarely needed. Several reports of unusual compulsive behaviors occurring in persons taking dopamine receptor agonists include pathological gambling and increased sexuality. Other Medications. The therapeutic effect of opioids is well known. Intermittent use of low-potency opioids or opioid receptor agonists, usually taken before bedtime, can be effective. Studies have shown positive short-term and long-term responses of various opioids. In severe disease, opioids may be considered a second-choice treatment after dopaminergic agents. There is a chance for dependence, and these drugs should be used with caution in persons with a history of addiction. Benzodiazepines or benzodiazepine receptor agonists, taken before sleep, may be useful. This is especially relevant if the patient has another cause of poor sleep in addition to RLS, such as psychophysiologic insomnia. Most data have been derived with clonazepam (Klonopin®, and others). Some investigators have shown this drug to be well toler-

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ated in older patients; however, its long duration of action may result in more adverse effects, such as an unsteadiness leading to falls during the night and drowsiness or cognitive impairment in the morning. Antiepileptics including carbamazepine (Tegretol®, and others) and gabapentin (Neurontin®, and others), have been reported to be efficacious in treating RLS, but are not commonly used in clinical practice due to their high incidence of adverse effects. Antiepileptics may be effective in patients with RLS who also suffer from painful paresthesias or underlying neuropathy. The most recently approved drug for RLS, gabapentin enacarbil (Horizant™) is a prodrug of gabapentin and accordingly, its therapeutic effects in RLS are attributable to gabapentin. The management of RLS continues to evolve as new drugs become available. Cabergoline (Dostinex®, and others), a dopamine agonist, is of interest because of its long half-life (65 hours). This theoretically might produce less augmentation. Magnesium has been reported in a small open-label trial to be an effective therapy for RLS. Selecting the Best Treatment for a Particular Patient. This usually proceeds in a “hit or miss” manner. Drugs should be used at their lowest effective dose, and only when necessary should the dose be slowly titrated upward. Medication should be taken early enough to permit absorption and action before the onset of sleep. Divided doses may be needed, often provided with the evening meal and later at night. If the first drug does not work, then a second agent with a different mode of action should be substituted. Sometimes a combination of medications works better than any single agent. Iron Replacement in Secondary RLS. As noted earlier, a serum ferritin concentration below 45 to 50 µg/L has been associated with increased severity of RLS. A common treatment regimen

is 325 mg ferrous sulfate three times daily along with 100 to 200 mg vitamin C with each dose to enhance absorption. Oral iron can cause constipation and abdominal discomfort, and the dose may need to be reduced in some patients. Oral iron should ideally be taken on an empty stomach to enhance absorption. If gastrointestinal symptoms develop, it should be taken with food. Follow-up ferritin determinations are indicated, initially after three to four months and then every three to six months until the serum ferritin level is greater than 50 µg/L. Iron therapy can then be discontinued. For patients with severe iron deficiency (ferritin ≤10 µg/L) and oral iron intolerance, intravenously administered iron can be considered. Of note is that RLS does not always respond to an increasing serum ferritin concentration, even if it was low initially.

Prognosis

RLS is usually a lifelong condition that has no cure. Although it has a variable course, symptoms may gradually worsen with age, albeit more slowly for those with the primary form of RLS than for patients who also suffer from an associated medical condition. Nonetheless, current therapies can control RLS, minimizing symptoms and maximizing periods of restful sleep. Some patients experience remissions, periods during which symptoms decrease or disappear for days, weeks or months; however, symptoms usually reappear. A diagnosis of RLS that onsets during adulthood does not indicate the onset of another neurologic disease. Individuals with RLS secondary to an underlying condition may note resolution of symptoms when their underlying condition is treated. Medication, when needed, usually provides relief of symptoms.

Summary and Conclusions

RLS is a common but under-recognized disorder associated with discomfort in the legs that is hard to describe and a distressing urge to

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n s

move them. It increases in frequency with aging, but is also found in children. Sleep disruption in RLS may impact daytime functioning and quality of life. For patients with mild symptoms, no drug treatment may be necessary; nonpharmacologic measures may be all that is needed. In patients with moderate to severe, troublesome symptoms, a dopamine receptor agonist is the current treatment of choice, although it should be noted that there have been few satisfactory studies comparing different pharmacotherapies. If dopamine agonists are poorly tolerated or ineffective, levodopa may be a satisfactory option for many people, especially for those with intermittent symptoms, such as during a long trip or sitting through a boring lecture! It takes only 15 to 30 minutes to become effective, and augmentation is not a risk with intermittent use.

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.

e e.

Program 0129-0000-12-002-H01-P Release date: 2-15-12 Expiration date: 2-15-15

CE Hours: 1.5 (0.15 CEU)

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

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continuing education quiz

Please print.

Program 0129-0000-12-002-H01-P 0.15 CEU

Name________________________________________________

Restless Legs Syndrome and Management

Address_____________________________________________

1. Restless Legs Syndrome (RLS) is: a. a motor disorder. b. a sensory disorder. c. both a motor and a sensory disorder. d. neither a motor nor a sensory disorder.

City, State, Zip______________________________________ Email_______________________________________________ NABP e-Profile ID*__________________________________

2. RLS is more common in which of the following groups of people? a. African Americans c. Asian Americans b. Northern Europeans d. Southern Europeans

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

Birthdate____________ (MMDD)

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

3. RLS is NOT a psychophysiologic pathology. a. True b. False 4. An essential cofactor for tyrosine hydroxylase, the rate-limiting enzyme for dopamine synthesis, is: a. magnesium. c. calcium. b. iodine. d. iron.

9. Most children with RLS require pharmacologic treatment. a. True b. False

5. The group of drugs most commonly implicated in secondary RLS is the: a. antidepressants. c. antipsychotics. b. antiepileptics. d. antirheumatics. 6. Diagnosis of RLS can be easily determined by a specific laboratory test. a. True b. False

10. All of the following are considered to be good sleep hygiene management EXCEPT: a. avoid bright lights in late evening or night. b. establish regular sleep and wake times. c. avoid perturbing activities immediately before sleep. d. do not eat anything after the evening meal.

7. Periodic limb movement disorder was formerly referred to as: a. dyskinesia. c. myoclonus. b. intermittent claudication. d. Raynaud’s disorder.

11. All of the following drugs have been approved for treating RLS EXCEPT: a. gabapentin. c. quinine. b. pramipexole. d. ropinirole.

8. The condition characterized by symptoms that are usually neither associated with motor restlessness nor lessened by movement is: a. akathisia. b. intermittent claudication. c. nocturnal cramps. d. peripheral neuropathy.

12. Which of the following drugs is dialyzable? a. Gabapentin c. Quinine b. Pramipexole d. Ropinirole

Completely fill in the lettered box corresponding to your answer.

14. Which of the following is regarded as first-line treatment for RLS? a. Benzodiazepines b. Dopamine receptor agonists c. Dopaminergic agents d. Opioids

1. 2. 3. 4. 5.

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

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

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

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

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

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

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

13. The troublesome and common problem that develops with prolonged use of levodopa that is more serious is: a. augmentation. b. rebound.

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

15. Most data on the use of benzodiazepines to treat RLS have been derived with: a. alprazolam. c. clonazepam. b. chlordiazepoxide. d. diazepam.

 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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April 2012 Journal 8.indd 30

To receive CE credit, your quiz must be postmarked no later than February 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.

February 2012

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The Georgia Pharmacy Journal

2011 - 2012 GPhA BOARD OF DIRECTORS Name Position

Editor: Jim Bracewell

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

jbracewell@gpha.org

Managing Editor Amy W. DeFaveri

adefaveri@gpha.org Writer & Designer: Amy W. DeFaveri adefaveri@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.

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

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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 adefaveri@gpha.org.

GPhA HEADQUARTERS

50 Lenox Pointe, NE Atlanta, Georgia 30324 Office: (404) 231.5074 Fax: (404) 237.8435

Power Marketing: (678) 990-3618

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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

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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

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