ADVOCACY: What is it?
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contents The Facts about Advocacy
Jim Bracewellâ€™s Column
The Advocacy Bucket List
How a Bill Becomes a Law
GPhA News Briefs
Welcome New Members
Southeastern PRN Conference
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T he facts
a d vo ca c y In 1869, a newspaper correspondent described a monster in the Capitol building in Washington, DC: â€œWinding in and out through the long, devious basement passage, crawling through the corridors, trailing its slimy length from gallery to committee room, at last it lies stretch at full length on the floor of Congress--this dazzling reptile, this huge, scaly serpent of the lobby.â€?
Throughout the history of advocacy and lobbying, no description is more vivid than this portrayal of those who act on behalf of others “to petition the Government for a redress of grievances.” (Yes, this is actual language from the First Amendment to the Constitution.) Although the term ‘lobbying’ often has negative connotations, the framers of the Constitution recognized that citizens must be free to make appeals to those who govern and who make policies, laws and regulations that affect the citizenry. Obviously, most citizens are not physically located at the seat of government, may not know how government works and are busy doing things other than lobbying. For those reasons, when they need help in making their petitions, they retain representatives who can more effectively seek remedy on their behalf. While the words advocacy and lobbying are often used interchangeably, GPhA uses the term advocacy. Advocacy is broader--although it certainly reflects the fundamental concept of redress, it’s not only delivering our message to members of the Georgia State Legislature, it’s also engaging regulators at the Georgia Board of Pharmacy and communicating through industry and consumer media the importance of protecting the profession of pharmacy. It’s a ‘war’ on multiple fronts. We’re advocating for the continued vibrancy of pharmacists and pharmacies, and that goes beyond lobbying. Advocacy also includes an enormous amount of time spent on educating key audiences, including providing information on the good public service work that our members do, providing quality healthcare advice for their patients. Relationships and credibility Engagement, education and political brand-building as part of advocacy are lengthy processes based on relationships and credibility. GPhA has done a remarkable job in building credibility with the Georgia State Leglslators as well as the Board of Pharmacy and we will continue to foster relationships as we prepare for the 2013 legislative session. By Amy DeFaveri 55
Robert Hatton GPhA President
EC Kicks Off the New Year
The GPhA Executive Committee gathered for its annual meeting at Lake Hartwell July 26-29th to plan the 2012-2013 year. This was the first gathering of the new slate of officers and perhaps the most important meeting of the year. Hosted by former State Senator Eddie Madden and his wife Linda, the location was condusive to strategic planning and team building. The success of any organization, large or small, depends greatly upon collaboration. Bringing our new leadership team together in a non-work setting developed team morale, established trust, strengthened our inter-group relationships, created unity and reinforced the importance of setting and attaining goals, and highlighted those key elements that turn a loosely bound group of individuals into a dynamic and inspired executive committee. The atmosphere of team building exercises encouraged a deeper comfort level among the executive committee, which allowed us to discuss more deeply held ideas about the organization and how to reach its goals for the upcoming year. Following this program, our Executive Vice President sequestered us in a meeting room for two and half days of powerful discussions and action planning for 2011-2012. we had a great time. After a morning of golf and an evening devoted to fishing, the committee got down to work, spending the next two days in hibernation as we worked through a very busy agenda. The EC also hosted the Southeastern officers convention in Savannah, GA, August 11-13th. The three day meeting welcomed executive committees from thirteen states and I am happy to report that your leadership gave them a weekend they wonâ€™t soon forget. We discussed issues important to all of us and had roundtable discussions regarding areas of need specific to each state. We strengthened all of our organizations by learning what had worked in different areas and sharing ideas. Through the very hard work of Jim Bracewell, we were able to secure funding from several organizations, including wholesalers, to offset the cost of the weekend and decrease the financial burden to GPhA. Now itâ€™s only nine weeks after the convention and things are already full speed ahead for your leadership. This year is going to be busy for everyone involved. There will be a great deal of legislative discussion as well as changes within the organization itself as we focus on membership. Thanks for your continuing commitment to the GPhA and always know that your hard work is appreciated. And as always, please let your leadership hear about important issues that we need to address. Thanks!
Jim Bracewell Executive Vice President & CEO
Is Government Broken?
Why Whining and Moaning Don’t Work
It is fall and football season is here again. On Monday morning, there will be a ton of whining and moaning by many of the teams that lost their games over the weekend. Coach Lou Holtz often said, the guy that complains most about how the ball bounces is likely the one who fumbled it. The people who complain that government is broken may well be the ones who are not registered to vote. They probably have not taken the time to know who their legislator is or where he or she lives. They may never have considered contributing to the election campaign of a candidate. If they are a pharmacist, I wonder if they have ever invited their legislator to our VIP Day Breakfast. Is representative government broken or are we the electorate, the voters, broken? Have we fallen prey to the political rhetoric in the media that says the government of the people is really broken? And we are helpless, only able to whine and moan about our elected officials? NO! Our form of government is not broken. We are the envy of nearly every country in the world. In Third World countries, people risk their very lives to vote, yet, in America, it is too much trouble to register and carry a valid ID. Your association has actively supported pharmacists for public office and today we have more pharmacists in our state legislature than in any other state in the union. Yes, we have more than Texas, more than California and more than New York. We are not broken. The only time I fear that pharmacists fumble the ball is when I have a legislator say “I just never hear from pharmacists back home in my district.” As pharmacist professionals, you are one of the most trusted members of your community and one of the greatest local influence leaders. Unshackle your influence; get involved in the political process. GPhA’s VIP Day – your Voice In Pharmacy Day at the state capitol – is Thursday, February 14, 2013. Today is the right time to invite your representative to join us for breakfast at the Train Depot across the street from the capitol on VIP Day. Don’t find yourself at the end of the next legislative session, whining and moaning that state government is broken. It is not broken if we do our part. Fix state government; fix the future of pharmacy’s role in healthcare in Georgia by getting involved in advocacy at GPhA. Where will you be on the morning of Thursday, February 14, 2013? I hope you are with us at GPhA’s VIP Day at the capitol, having breakfast with your state legislator and advocating with us on how to fix healthcare in Georgia.
Your Advocacy Bucket List In addition to the other items on your bucket list, you can help protect your profession by doing the following: •
Make sure you renew your GPhA member-
ship. Visit your profile at gpha.org. • Meet with your state senator or representative in your district as well as candidates for office, to educate them about pertinent issues affecting GPhA members. • Support candidates who share GPhA’s philosophy of protecting the profession of pharmacy. • Make your voice heard when legislators or regulators propose new rules that affect your profession and impact your ability to provide improved healthcare to your patients. • Attend VIP Day at the Georgia State Capitol in Atlanta, GA, February 14, 2012. • Participate in GPhA activities and help influence the decisions being made. • Rally your pharmacist colleagues to assist with GPhA’s advocacy efforts. • Monitor Pharm-O-Gram advocacy updates and participate in the ‘calls to action’ by communicating with the appropriate officials through letters, emails and phone calls.
By Amy DeFaveri
Georgia Governor Nathan Deal
Andy Freeman Director of Government Affairs
How a Bill Becomes a Law in Georgia
When I was growing up, I loved cartoons; every Saturday morning, you could find me on the sofa, eating a bowl of cereal and watching Bugs Bunny. I also loved the School House Rock programs that ran between cartoons, I’m often asked how a bill becomes a law and I am often tempted to break out into the classic lyrics of “I’m just a bill. Yes, I’m only a bill. And I’m sitting here on Capitol Hill….”, I usually refrain from doing so (and for that you are welcome). especially the “I’m just a Bill” episode. Many people don’t know how a bill becomes a law here in Georgia so, with some help from the Carl Vinson Institute of the University of Georgia, here is how it happens. I hope you will find the following information valuable. • The legislator sees the need for a new law or changes in an existing law and decides to introduce a bill. This is also where GPhA’s legislative team educates a legislator on what legislation is needed. • The legislator goes to the Office of Legislative Council. There, an attorney advises him/her on legal issues and drafts a bill. • One legislative day after filing, the bill is formally introduced. In chamber, the bill’s title is read during the period of 1st reading.
• Immediately after 1st reading, the presiding officer assigns the bill to a standing committee which, for most of GPhA’s legislation, is the Health and Human Services Committee.
• Once the presiding officer calls the bill up from the Rules Calendar, the Clerk reads the bill’s title (3rd reading). The bill is now ready for floor debate, amendments, and voting.
• In the House only, on the next legislative day, the Clerk reads the bill’s title (2nd reading) in chamber, although the actual bill is now in committee. In the Senate, 2nd reading comes after the bill is reported to be favorable from the committee.
• After debate, the main question is called and members vote. If the bill is approved by the majority of the total membership of that house, it is sent on to the other house.
• The bill is considered by the committee. Its author and other legislators may testify; GPhA’s legislative team and sometimes our members are often there to provide testimony. • The bill is reported favorably by the committee and returned to the Clerk or Secretary. • The Clerk or Secretary prepares a General Calendar of bills favorably reported by the committees. Starting with the 10th day of session in the House (15th day in the Senate), the Rules Committee meets and prepares a Rules Calendar for the next day’s floor consideration from bills on the General Calendar. During that period, the presiding officer calls up bills from this calendar for floor action; this continues over the last 30 days of the session in the House (25 days in the Senate) .
• If the second house passes the bill, it is returned to the house where it was introduced. If the changes are accepted, moves on to #12. If the first house rejects the changes and the second house persists, a conference committee may be appointed. If committee report is accepted by both houses, it then moves on to #12. • The bill is sent to the Governor (if requested) immediately. Otherwise, all bills are sent to the Governor following adjournment sine die (meaning “without assigning a day for a further meeting or hearing”). • If the governor signs the bill or does nothing, it becomes law. Governor may veto the bill; an override of that veto requires agreement by two-thirds of the members of each house. • The Act becomes effective the following July 1, unless a different effective date is provided in the act.
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Thank You to All PharmPAC Supporters Recent contributors are highlighted in bold blue. The information provided below is effective as of September 1, 2012
Diamond Level $4,800 minimum pledge Cynthia K. Moon Titanium Level $2,400 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. Ted M. Hunt, 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. Loren B. Pierce, R.Ph. Fred F. Sharpe, R.Ph. Jeff Sikes, R.Ph. Dean Stone, R.Ph., CDM Platinum Level $1,200 minimum pledge Ralph W. Balchin, R.Ph. Robert Bowles, Jr., R.Ph., CDM, Cfts Jim R. Bracewell 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. George B. Launius, R.Ph. Brandall S. Lovvorn, Pharm.D. Eddie M. Madden, R.Ph. 10 10
Jonathan Marquess, Pharm.D., CDE, CPT Pam Marquess, Pharm.D. Kenneth A. McCarthy, R.Ph. Drew Miller, R.Ph., CDM Laird Miller, R.Ph. Jay Mosley, R.Ph. 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 William F. Brewster, R.Ph. Bruce L. Broadrick, Sr., R.Ph. Liza G. Chapman, Pharm.D. Craig W. Cocke, R.Ph. J. Ernie Culpepper, R.Ph. Mahlon Davidson, R.Ph., CDM Kevin M. Florence, Pharm.D. Kerry A. Griffin, R.Ph. James Jordan, Pharm.D. Marsha C. Kapiloff, R.Ph. Earl W. Marbut, R.Ph. John W. McKinnon, Jr., 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. John Thomas Sherrer, R.Ph. Sharon Mills Sherrer, Pharm.D. Michael T. Tarrant Henry Dallas Wilson, III, Pharm.D. Silver Level $300 minimum pledge Renee D. Adamson, Pharm.D.
Ed Stevens Dozier, R.Ph. Terry Dunn, R.Ph. Charles Alan Earnest, R.Ph. Marshall L. Frost, Pharm.D. Johnathan Wyndell Hamrick, Pharm.D. James A. Harris, Jr., R.Ph. Michael O. Iteogu, Pharm.D. Joshua D. Kinsey, Pharm.D. Willie O. Latch, R.Ph. Kalen Porter Manasco, Pharm.D. 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. Kristy Lanford Pucylowski, Pharm.D. Ola Reffell, R.Ph. Edward Franklin Reynolds, R.Ph. Sukhmani Kaur Sarao, Pharm.D. David J. Simpson, R.Ph. James N. Thomas, R.Ph. Archie R. Thompson, Jr., R.Ph. Alex S. Tucker, Pharm.D. William H. Turner, R.Ph. Flynn W. Warren, M.S., R.Ph. Walter Alan White, R.Ph. Charles W. Wilson, Jr., R.Ph. Steve Wilson, Pharm.D. William T. Wolfe, R.Ph. Sharon Zerillo, R.Ph. Bronze Level $150 minimum pledge Sylvia Ann Davis Adams,R.Ph. Monica M. Ali-Warren, R.Ph. Julie Wickman Bierster, Pharm.D. Nicholas O. Bland, Pharm.D. Lance P. Boles, R.Ph. Michael A. Crooks, Pharm.D. William Crowley, R.Ph. Rabun E. Deckle, Pharm.D. Helen DuBiner, Pharm.D. Charles Alan Earnest, R.Ph. Vaspar Eddings, R.Ph.
Randall W. Ellison, R.Ph. Mary Ashley Faulk, Pharm.D. Amanda R. Gaddy, R.Ph. Charles C. Gass, R.Ph. Winton C. Harris, Jr., R.Ph. Lura Elizabeth Jarrett, Pharm.D. Ed Kalvelage John D. Kalvelage Steve D. Kalvelage Anabelle D. Keohane, Pharm.D. Brenton Lake, R.Ph. Allison L. Layne, C.Ph.T. William E. Lee, R.Ph. Michael Lewis, Pharm.D. Ashley Sherwood London Tracie D. Lunde, Pharm.D. Max A. Mason, R.Ph. Amanda McCall, Pharm.D. Susan W. McLeer, R.Ph. Sheila D. Miller, R.Ph. Natalie Nielsen Amanda Rose Paisley, Pharm.D. Rose Pinkstaff, R.Ph. Sara W. Reece Pharm.D., BC-ADM, CDE Leonard Franklin Reynolds, R.Ph. Don K. Richie, R.Ph. Laurence Neil Ryan, Pharm.D. Benjamin Lake Stanley, Pharm.D.
Dana E. Strickland, R.Ph. Charles Storey, III, R.Ph. Archie Thompson, Jr., R.Ph. William C. Thompson, R.Ph. Carrie-Anne Wilson Max Wilson Sharon B. Zerillo, R.Ph. Christy Zwygart, Pharm.D. Members No minimum pledge John J. Anderson, Sr., R.Ph. Robert C. Ault, R.Ph. Mary S. Bates, R.Ph. Thomas Bagby Garner, Jr., R.Ph. Fred W. Barber, R.Ph. Lucinda F. Burroughs, R.Ph. Henry Cobb, III, R.Ph., CDM Jean N. Courson, R.Ph. Guy Anderson Cox, R.Ph. Carleton C. Crabill, R.Ph. Wendy A. Dorminey, Pharm.D., CDM Benjamin Keith Dupree, Sr., R.Ph James Fetterman, Jr., Pharm.D. Charles A. Fulmer, R.Ph. Thomas Bagby Garner Jr., R.Ph. Kimberly Dawn Grubbs, R.Ph. Christopher Gurley, Pharm.D. Fred C. Gurley, R.Ph.
Keith Herist, Pharm.D., AAHIVE, CPA William “Woody” Hunt, Jr., RPh Carey B. Jones, R.Ph. Susan M Kane, R.Ph. Emily Kraus Tracie Lunde, Pharm.D. Randall T. Maret, R.Ph. Ralph K. Marett, R.Ph.,M.S. Darby R. Norman, R.Ph. Christopher Brown Painter, R.Ph. Whitney B. Pickette, R.Ph. Terry Donald Shaw, Pharm.D. Negin Sovaidi Charles Iverson Storey III, R.Ph. James R. Strickland, R.Ph. Leonard E. Templeton, R.Ph. Carey Austin Vaughan, Pharm.D. Erica Lynn Vesley, R.Ph. William D. Whitaker, R.Ph. Jonathon Williams, Pharm.D. Rogers W. Wood, R.Ph.
To join PharmPAC, please visit our website at gpha.org. If you made a gift or pledge to PharmPAC in the last 12 months and your name does not appear on this list, please contact Andy Freeman at email@example.com or 404-419-8118. PharmPAC donations are not charitable donations and are not tax deductible. 11 11
2013 VIP Day February 14, 2013 Georgia Railroad Depot 65 Martin Luther King, Jr., Drive Atlanta, GA Mark Your Calendars Now!
GPhA News Briefs • Region Meetings this fall will be held on Tuesdays during the month of October. More information can be found in this issue of The Journal on page 18. • Pharmacy-Based Immunization Delivery Program, October 27, 2012, 8:00am - 6:00pm at PCOM School of Pharmacy, hosted by GPhA. • Mark your calendars now for VIP Day, February 14, 2013 and make your voice heard. • Social networking is a strategic part of our 2012-2013 membership development and communication plans. GPhA can now be found on Facebook. Like us on Facebook: http://www.facebook.com/pages/Georgia-Pharmacy-Association/205159479604880. • Team Up. Pressure Down. Coaching Patients to Take Control. This is a great opportunity to earn free CPE credits. To learn more about the free CPE webinar and to register, visit www.GoToCEI.org under “Of Interest”. • Save the date now for the 138th GPhA Convention at the Omni Amelia Island Resort, June 22-25, Amelia Island, Florida. • Stay up-to-date on all GPhA events, advocacy activities and member benefits by visiting gpha.org often.
Welcome New GPhA Members Active Pharmacist
Will Andersen, Pharm.D., Macon, GA Donna LaToya Carter, Pharm.D., Evans, GA James Melton Chafin, Pharm.D., Smyrna, GA Merian Robinson, R.PH., Augusta, GA Tonya N. Webb, R.Ph., Hampton, GA Christy Zwygart, Pharm.D., Smyrna, GA
1st Year Post-Graduate
Kyle Jeffrey Hampson, Pharm.D., Atlanta, GA
Arnold Edd Holland, Nashville, TN Austin Brown Lively, Carrollton, GA 1313
2012 Southeastern PRN Conference
November 11-13, 2012 Simpsonwood Conference Center, Norcross, GA (located just north of Atlanta) The Southeastern PRN Conference is presented annually by the Georgia Pharmacy Foundation and the Georgia PharmAssist Committee. All Pharmacists, Student Pharmacists and Pharmacy Technicians are encouraged to attend to learn about the many facets of addiction. This program will offer a wide range of topics of educational value to the pharmacy professional. Pharmacists and Technicians may have the opportunity to earn 10 contact hours of continuing education by attending both Saturday and Sunday programs. Students will receive a Certificate of Achievement at the conclusion of the Conference PLEASE TYPE OR PRINT CLEARLY Pharm.D. R.Ph. Student Tech Name____________________Name/Nickname for Badge____________________If Business, Name of Company___________________________________________ Address_____________________________________________________________________City________________________State_________Zip_________________ Phone: Work____________Home____________Cell__________FAX____________Email_______________________________________________________________ Mail Your Registration with Check/Money Order to: Georgia Pharmacy Foundation/SE PRN Conference, Attention: Regena Banks, 50 Lenox Pointe, NE, Atlanta, GA 30324
Or: Register on-line at www.gpha.org. Or: FAX your registration to 404-237-8435 or 404-364-5021, Attention: Regena Banks Payment Information: (Conference Registration, CPE, Meals and Hotel fees are all inclusive for those requiring overnight lodging.) Rates for Pharmacists, Students and Technicians include conference registration, lodging for 2 nights, all meals at Rollins Dining Room and breaks. Rates are per person. R.Ph. How many in room________ = $________ Student or Technician How many in room________= $________ Rates for Pharmacists: (Rates are per person)
# in Room 1 2 3 4
On or Before 10/1 $345 $270 per person $245 per person $230 per person
After 10/1 $370 $295 $270 $255
Rates for Students & Technicians: (Rates are per person)
1 $295 $320 2 $240 per person $265 3 $225 per person $250 4 $210 per person $235 If sharing a room, please print name(s) on a separate page and forward with Registration. Please make certain roommate forwards Registration Form and payment. Day Rates for Pharmacists, Students and Technicians who do not need overnight lodging include a 2-day conference registration, CPE, 4 meals (2 Saturday & 2 Sunday) and breaks. Day Rate: Pharmacist $________ Day Rate: Student / Technician $________ On or Before 10/1 After 10/1 Pharmacists $170 $195 Students/Technicians $120 $145 Spouse/Guest Rate for Weekend: This includes only lodging and all meals; No CPE: Spouse/Guest Rate for Lodging ONLY for Weekend, NO meals or CPE included: Spouse/Guest Name: _______________________________________________
CHECK/MONEY ORDER — Enclosed in the Amount of: $ __________ PLEASE CHARGE THE FOLLOWING CREDIT CARD (circle one): MasterCard VISA Discover AMEX (Please provide billing address if not same as above) Amount to be Charged $________ Credit Card #: _______________________________________________________ Security #__________Exp. Date_____________ Cardholder Signature: ___________________________________________________________________Today’s Date: _________ Name As It Appears On Card __________________________________________________________________________________ Credit Card Billing Address ____________________________________________________________________________________
Don’t miss out on the next 138th GPhA Convention Omni Amelia Island Plantation Resort June 22-25, 2013 It’s going to be a great convention!
PHARMACY BASED IMMUNIZATION DELIVERY PROGRAM
Become a Pharmacy Based Immunizer in Suwanee! Saturday, October 27, 2012 from 8am - 6pm A CERTIFICATE PROGRAM FOR PHARMACISTS HOSTED BY GPHA AT PCOM SCHOOL OF PHARMACY ______________________________________________________________________________ Delivery live training seminar, the final examinaPharmacy-Based Immunization Delivery is an tion, and the injection technique assessment. innovative and interactive practice-based Statements of Credit and Certificates will be issued educational program that provides pharmacists with within 4-6 weeks of APhA’s receipt of program the skills necessary to become primary sources for materials. vaccine advocacy, education, and administration. After completing the live training seminar, The program reviews the basics of immunology, participants will be able to: identifies legal and regulatory issues pharmacists Identify opportunities for pharmacists to must consider before starting an immunization become involved in immunization delivery. program, and focuses on practice implementation. Describe how vaccines evoke an immune This program is priced as follows: response and provide immunity. GPhA Members: $400 Identify the vaccines available on the U.S. market for each vaccine-preventable disease GPhA Student Members: $175 and classify each vaccine as live attenuated or All GPhA Potential Members: $495 inactivated. Faculty:
Evaluate a patient’s medical and immunization history and determine in the patient falls into the target groups for each vaccine based on the Advisory Committee for Immunization Practices (ACIP) recommendations.
Review a patient case and determine patientspecific 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.
The purpose of this educational program is to:
Provide comprehensive 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
October 13-17, 2012 Register today at www.ncpanet.org
NCPA’s 114th Annual Convention and Trade Exposition San Diego Convention Center
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By Amy DeFaveri
Calling All Night Owls. We all know morning people are said to have a business advantage, but what about those night owls? They’ve got a competitive edge, too. Read about their productivity tips for the wee hours on Fast Company’s website at http://www. fastcompany.com/3000732/whatsuccessfulnightowlsgetdonebed. Is Having a Brain a Medical Condition? Check out the latest SharpBrains’ August 2012 e-newsletter at smartbrains.com., featuring multiple insightful perspectives on how emerging brain and cognitive science can be applied to improve education, clinical practice, productivity and daily living. google.com/apps. If your organization has fewer than 10 employees, Google Apps offers free email. It’s Gmail, except it goes to “@yourdomain” and it’s hosted by Google Inc. Each user can send emails to 10,000 recipients per day and send attachments up to 25 MB. Just Google it for more information. Do Numbers Have a Gender? To psychologists Galen V. Bodenhausen and James E. B. Wilkie, the meanings people ascribe to numbers can reveal much about our psychological biases, the way we learned math, and even how our brains cope with abstract concepts. http:// insight.kellogg.northwestern.edu/index.php/Kellogg/article/ are_numbers_gendered.
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Upcoming Fall Region Meetings Save the date and join us!
Dates: Tuesday, October 2
Region Meeting: Region 2 Meeting
Tuesday, October 2
Region 5 Meeting
Tuesday, October 2
Region 11 Meeting
Location: Springhill Country Club 5 Springhill Dr. Tifton, GA 31794 (229) 382-6745 Pappadeux Seafood Kitchen 5635 Jimmy Carter Blvd. Norcross, GA 30071 (770) 849-0600 TBD
Tuesday, October 9
Region 4 Meeting
Tuesday, October 9
Region 8 Meeting
Tuesday, October 9
Region 9 Meeting
Tuesday, October 23
Region 6 Meeting
Tuesday, October 23
Region 7 Meeting
Tuesday, October 23
Region 12 Meeting
Tuesday, October 30
Region 1 Meeting
Tuesday, October 30
Region 3 Meeting
St. Francis Hospital Conference Room 2122 Manchester Expressway Columbus, GA 31904
Ed Dozier 2nd Region President (229) 883-3746 email@example.com Julie Bierster 5th Region President (678) 516-6492 JulieWi@pcom.edu Ashley London 11th Region President (706) 945-1490 firstname.lastname@example.org Nicholas Bland 4th Region President (706) 713-0609 email@example.com Michael Lewis 8th Region President (912) 638-4829 firstname.lastname@example.org Kristy Pucylowski 9th Region President (678) 388-7044 email@example.com Sherri Moody 6th Region President (478) 471-8686 firstname.lastname@example.org Amanda McCall 7th Region President (865) 207-9736 email@example.com Ken Eiland 12th Region President (478) 275-8648 Kenton.firstname.lastname@example.org Christine Somers 1st Region President (912) 507-0822 email@example.com Renee Adamson 3rd Region President (706) 582-3167 firstname.lastname@example.org
GPhA Executive Vice President & CEO, Jim Bracewell, Wins Carlton Henderson Award James Bracewell has been an innovative and passionate advocate for the profession of pharmacy. His commitment to pharmacy began with his service as Associate Vice President of University Relations and Development at Mercer University in the 1980s. Working with then Mercer Pharmacy Dean Dick Gourley and then Associate Dean H.W. “Ted” Matthews, Mr. Bracewell led the growth in financial and non-financial support of Mercer’s College of Pharmacy and Health Sciences. In 1992, Mr. Bracewell joined the South Carolina Pharmacy Association as Executive Vice President and CEO of SCPhA, taking that Association to its current status as one of the significant state pharmacy associations in the country in terms of innovation, professional leadership and practice. In 2006, Mr. Bracewell returned to his home state of Georgia and continues to bring guidance and influence to the pharmacy profession by serving as the current Executive Vice President and CEO of the Georgia Pharmacy Association. Among his many accomplishments, Mr. Bracewell took a key leadership role in the founding of Commun I Care, a South Carolina statewide organization providing pharmaceutical care for the uninsured and working poor of that state. In 1998, he was named Volunteer of the Year for his leadership work on this nationally recognized project. In 2006-2007, Mr. Bracewell served as President of the National Alliance of State Pharmacy Associations. In addition to his leadership at GPhA, he currently serves as Chairman of the Board of Directors of PACE Alliance, the country’s largest national pharmaceutical purchasing cooperative, comprised of 19 states across the United States. Active in his own profession, Mr. Bracewell also served as President of the South Carolina Society of Association Executives and, in 2002, was named the South Carolina Association Executive of the Year. His enthusiasm for football is legendary, having worked with young athletes for years as a high school football referee, and he continues to use football stories to influence others toward individual achievements and as significant team players. About the Carlton Henderson Award The Carlton Henderson Award – named in honor of Carlton Henderson, longtime Mercerian and supporter of Mercer’s College of Pharmacy and Health Sciences – recognizes an individual who has contributed to the reputation and enhancement of the pharmaceutical profession in the state of Georgia.
Previous Carlton Henderson Award Recipients 2011 – D. Steven Wilson 2010 – Eddie M. Madden 2009 – Sharon M. Sherrer 2008 – Judy L. Gardner 2007 – William A. Atkins, Sr. 2006 – William L. Prather 2005 – Jeffrey L. Lurey 2004 – J. Ronald Stephens 2003 – Rick Allen 2002 – Len G. Phillipps 2001 – Oren H. Harden, Jr. 2000 – Eugene L. Argo 1999 – William A. “Bill” Atkins
1998 – George D. McFarland 1997 – Sheila A. Young 1996 – H.W. “Ted” Matthews 1995 – John T. Sherrer 1994 – Al Jowdy 1993 – Jason B. Brown 1992 – Geraldine S. Hankla 1991 – Oliver M. Littlejohn 1990 – W. Rodney Harbin 1989 – Harold B. Hodgson, Jr. 1988 – N. William Chism 1987 – Larry L. Braden
Melvin M. Goldstein, P.C. A T T O R N E___ Y AT
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 20 20
o t r o w c o k H
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continuing education for pharmacists Volume XXX, No. 7
The Metabolic Syndrome: Pharmacologic and Non-Pharmacologic 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
The Metabolic Syndrome
Dr. Thomas A. Gossel and Dr. J. Richard Wuest have no relevant financial relationships to disclose.
Goal. The goal of this lesson is to provide information on treatment measures reported to benefit persons with the metabolic syndrome. Objectives. At the completion of
this activity, the participant will be able to: 1. select criteria that define the metabolic syndrome; 2. identify specific non-pharmacologic management of the metabolic syndrome; 3. recognize the pharmacologic classification of the drugs used and their therapeutic role in treating the metabolic syndrome; and 4. exhibit knowledge of information relative to the metabolic syndrome and its treatment to convey to patients and/or their caregivers. Coronary heart disease (CHD) is the leading cause of premature death in the United States, accounting for an estimated 680,000 deaths (one of every five deaths from all causes) each year. CHD is also the leading cause of permanent disability in the U.S. labor force. Approximately 12.6 million Americans are believed to have a positive diagnosis of CHD; many more millions remain unaware of their pathology. The prevalence of CHD in the U.S. is expected to
increase by 43 percent between 2000 and 2050, largely due to an aging population; CHD mortality is projected to increase by 2.6 times that rate. In a recent prospective study, subjects with the metabolic syndrome (MetS) were 4.2 times more likely to die of CHD than those without MetS. Persons with MetS also possess an increased risk for future ischemic stroke, and a much higher than normal risk for developing type 2 diabetes mellitus (T2DM). A major risk factor for CHD is elevated low-density lipoprotein cholesterol (LDL-C), the “bad cholesterol.” The Third Report of the U.S. National Cholesterol Education Program’s Adult Treatment Panel III (NCEP:ATP III) classifies blood levels of LDL-C as optimal (<100 mg/dL), near optimal/above optimal (100-129 mg/dL), borderline high (130-159 mg/dL), high (160-189 mg/dL) and very high (≥190 mg/dL). NCEP:ATP III also notes the direct correlation that exists between LDL-C levels and incidence of CHD.
Approximately one-fourth of the U.S. adult population experiences clinical symptoms of MetS, with a prevalence of about 7 percent among individuals in their 20s, to >40 percent among persons >60 years of age. Persons with MetS have a two- to three-fold increased risk for CHD, a similar risk for future ischemic stroke, and a much greater risk for developing future type 2 diabetes mellitus (T2DM). It has long been recognized that patients with diabetes are at significantly increased risk for developing CHD. Indeed, there is evidence that diabetic patients without a previous myocardial infarction (MI) have as high a risk for MI as non-diabetic patients with a previous MI. Furthermore, it has been shown that diabetes and prediabetic conditions are relatively common in patients with CHD. The more MetS criteria a patient experiences (discussed below), the greater the risk, which is increased by concomitant LDL-C elevation. Although NCEP:ATP III identified CHD as the major clinical outcome of MetS, most individuals with this syndrome have concomitant insulin resistance, which confers increased risk for T2DM. When diabetes becomes clinically apparent, CHD risk rises sharply. Beyond CHD and T2DM, individuals with MetS also are susceptible to other conditions such as polycystic ovary syndrome, fatty liver, cholesterol gallstones, asthma,
An alternate definition of MetS has been proposed by the InternationRisk Factor Defining Level Abdominal obesity2 (waist circumference) al Diabetes Men >102 cm (40 in) Federation Women >88 cm (35 in) (IDF). The Triglycerides ≥150 mg/dL criteria HDL-C are simiMen <40 mg/dL lar to the Women <50 mg/dL NCEP:ATP Blood Pressure ≥130/85 mmHg III definiFasting glucose ≥110 mg/dL tion, with HDL-C = High-density lipoprotein cholesterol. the prin1 The NCEP:ATP III criteria require ≥3 of the five risk factors. ciple differ2 Abdominal obesity is more highly correlated with metabolic risk factors ence being than is an elevated body mass index (BMI). The measurement of waist emphasis on circumference, therefore, is recommended to identify the body weight component of the metabolic syndrome. abdominal obesity, and threshold difference according to ethnicity. sleep disturbances, and some forms For example, for people of Euroof cancer. pean descent, the cutoff point for A significant challenge in waist circumference is 94 cm for prevention of MetS is the lack of men and 80 cm for women. Smaller a diagnostic test. To diagnose the waist circumferences are required syndrome, the clinician must rely for South Asians and Chinese (90 on clinical observation and a high cm men, 80 cm women), and Japa“index of suspicion.” Unfortunately, nese (90 cm men, 85 cm women). by the time signs are detected, the A minor difference between the damage often has been done. NCEP:ATP III and IDF definitions The NCEP:ATP III provides a of MetS is that IDF suggests the definition of MetS to aid in diaguse of an oral glucose tolerance nosis and treatment of patients test. In the United States, cliniat risk of CHD: The syndrome cians and researchers are more requires ≥3 of the five risk factors likely to use the NCEP:ATP III listed in Table 1. The World Health criteria. Organization (WHO), in turn, Two other characteristics of defines MetS as glucose intolerMetS are prothrombotic and proance, impaired glucose tolerance or inflammatory states. Both are diabetes; and/or insulin resistance, emerging risk factors that contribtogether with ≥2 of the following ute to CHD. risk factors: impaired glucose regulation or diabetes; insulin resisTreatment tance; increased arterial pressure Elevated LDL-C is closely associ≥140/90 mmHg; increased plasma ated with the atherogenic process. triglycerides (≥1.7 mM [150 mg/ Lowering LDL-C levels, therefore, dL]) and/or low high-density lipois critical in decreasing the risk of protein cholesterol (HDL-C) (<0.9 CHD. MetS then becomes a secondmM [35 mg/dL] in men, <1 mM [39 ary target of risk-reduction therapy mg/dL] in women); central obesity after LDL-C lowering has been (waist-to-hip ratio >0.90 in men, accomplished. >0.85 in women) and/or body mass Primary Target. The LDL-C index (BMI) >30 kg/m2; and microgoal may best be achieved in initialbuminuria. The term central ating therapeutic lifestyle changes obesity refers to the amount of fat (TLC). These changes include: in the waist area.
Table 1 The metabolic syndrome as defined by the National Cholesterol Education Program Adult Treatment Panel III (NCEP:ATP III) 1
•Reduced saturated fat (<7 percent of total calories) and cholesterol (<200 mg/day) intake. See Table 2 for the overall composition of a TLC diet. •Enhanced LDL-C lowering by increasing phytosterols (plant sterols) (2 g/day) and viscous (soluble) fiber (10 to 25 g/day) in the diet. •Weight loss •Increased physical activity. Some (most!) individuals will still require an LDL-C lowering drug such as a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (statin), bile acid sequestrant, nicotinic acid or a fibrate (gemfibrozil/Lopid, and others; fenofibrate/Trilipix, and others). When these drugs are used, attention to TLC should always be maintained and reinforced. The goal is that individuals at low risk for CHD should reach an LDL-C level of <100 mg/dL. Individuals at higher risk should strive for an LDL-C blood level even lower. Once this goal has been attained, attention can turn to modulating other risk factors, i.e., MetS criteria. Statins. The advent of statin use has made a significant impact in reducing CHD risk. Several early landmark trials demonstrated clearly that reducing LDL-C significantly lowers CHD morbidity and mortality. In these studies, statins reduced the incidence of major cardiovascular events by about 25 to 35 percent compared with placebo. Later trials have shown even greater benefit. Reduction in relative risk was seen across a wide range of patients, from those with average LDL-C levels without evidence of CHD, to CHD patients with high LDL-C and total cholesterol levels. These studies also show that a significant residual CHD risk of approximately 65 to 75 percent remains after LDL-C has been reduced by statin therapy. Therefore, additional therapeutic options should be explored.
Management of MetS
The most significant lifestyle characteristics associated with MetS include a diet high in calories along 25 25
with a high content of saturated fats, and a lack of physical exercise. Both behavioral patterns occur frequently in the general population, and are generally associated with above-average weight or obesity. Therefore, TLC should continue to stress weight reduction and physical activity after appropriate control of LDL-C. Weight Control. NCEP:ATP III recognizes overweight and obesity as the parameter most closely associated with MetS, and includes them as direct targets of intervention. Weight reduction, which is essentially a matter of achieving a sustained negative caloric balance, will enhance LDL lowering and reduce all of the risk factors that define MetS. Evidence abounds that even moderate weight loss (e.g., 5 percent of body weight) benefits patients with MetS by improving insulin action, thus lowering glucose and hemoglobin A1C (HbA1c) levels and often reducing doses of or the need for specific antidiabetic medications. Weight loss improves the cardiovascular risk profile by reducing blood pressure, triglycerides and cholesterol, as well as coagulation and antifibrinolytic and inflammatory markers. Studies have shown a 25 percent reduction in mortality among obese patients with T2DM who intentionally lost weight, with a weight loss of 9 to 13 kg being most protective. Caloric intake should be reduced by 100 to 1000 cal/day to produce a weight loss of 0.5 to 1 kg per week. The goal is to reduce body weight by about 7 to 10 percent over six to 12 months, followed by long-term behavior modification and maintenance of increased physical activity. Lifestyle changes, however, are notoriously difficult to achieve and maintain. Furthermore, there is some evidence that weight loss is more difficult to achieve in obese patients with diabetes than in obese individuals without diabetes. At this time, weight reduction drugs have not been particularly effective for treatment of obesity. In recent years, bariatric surgery has been used 26 26
Table 2 Recommended nutrient constituents of the TLC 1 diet Nutrient
Saturated fat2 Polyunsaturated fat Monounsaturated fat Total fat Carbohydrate3 Fiber Protein Cholesterol Total calories (energy)4
Less than 7% of total calories Up to 10% of total calories Up to 20% of total calories 25 to 35% of total calories 50 to 60% of total calories 20 to 30 g/day Approximately 15% of total calories Less than 200 mg/day Balance energy intake and expenditure to maintain desirable body weight/prevent weight gain
TLC = therapeutic lifestyle change Trans fatty acids are another LDL-raising fat that should be kept at a low intake. 3 Carbohydrate should be derived predominantly from foods rich in complex carbohydrates including grains, especially whole grains, fruits and vegetables. 4 Daily energy expenditure should include approximately 200 kcal/day of at least moderate physical activity. . 1 2
with varying success rates in treating patients with morbid obesity. Effectiveness and safety of bariatric surgery in patients with MetS has been quite encouraging with 95 percent of patients free of the syndrome one year after surgery. Mediterranean Diet. One very useful dietary program stresses adherence to a Mediterraneanstyle diet plan, which includes foods that are especially high in olive oil and nuts. This enriched diet reduces blood pressure, as well as fasting glucose and insulin secretion. In one three-month study, this diet modestly increased HDL-C levels while decreasing triglyceride levels when compared with a low-fat diet. Applied to patients with MetS who used the Mediterranean diet over a two-year period, decreased body weight and inflammatory markers were noted. In one study, subjects who adhered closely to this style of diet had a 20 percent lower risk of MetS. Healthy food choices, together with regular exercise and not smoking, reduce the risk of CHD, in part through anti-inflammatory mechanisms. The Mediterranean diet, therefore, appears to be a good choice, and is usually quite acceptable to patients. Its major disadvantage is that it does not aid in weight
reduction unless accompanied by decreased caloric intake and increased physical activity. Physical Activity. Physical inactivity is likewise an underlying risk factor for CHD. It augments the lipid and nonlipid risk factors of MetS and may enhance risk by impairing cardiovascular fitness and coronary blood flow. Regular physical activity lowers very low density lipoprotein (VLDL) levels, elevates HDL-C, and may contribute to lowering LDL-C levels. It can also reduce blood pressure, reduce insulin resistance, and favorably influence cardiovascular function. Healthcare providers, therefore, recommend that a program of regular physical activity becomes a routine component of the management plan for high serum cholesterol. Dyslipidemias. Elevated triglycerides and depressed HDL-C are independent risk factors for CHD. As stated earlier, the focus of CHD risk-reducing therapy should switch to modifying MetS once the LDL-C target has been achieved. Elevated Triglycerides. Factors that contribute to elevating triglycerides above normal include obesity and overweight, physical inactivity, cigarette smoking,
excess alcohol intake, high carbohydrate diets (>60 percent of energy intake), several diseases (e.g., T2DM, chronic renal failure, nephrotic syndrome), certain drugs (e.g., corticosteroids, estrogens, retinoids, high doses of β-adrenergic blocking agents), and genetic disorders (e.g., familial combined hyperlipidemia, familial hypertriglyceridemia, and familial dysbetalipoproteinemia). Elevated serum triglycerides are most often noted in persons with MetS, although secondary or genetic factors can elevate triglycerides. Triglyceride levels are considered to be normal (<150 mg/ dL), borderline-high (150-199 mg/ dL), high (200-499 mg/dL) and very high (≥500 mg/dL). It is suggested that elevated triglycerides are an independent CHD risk factor because some triglyceride-rich lipoproteins are atherogenic. The latter are partially degraded VLDL, commonly called remnant lipoproteins. VLDL cholesterol (VLDL-C) level is the most readily available measure of atherogenic remnant lipoproteins. VLDL-C can, therefore, be a target of cholesterol-lowering therapy. NCEP:ATP III identifies the sum of LDL-C and VLDL-C (termed nonHDL cholesterol [total cholesterol minus HDL-C]) as a secondary target of therapy in persons with elevated triglycerides (≥200 mg/ dL). The goal for non-HDL-C in persons with high serum triglycerides can be set at 30 mg/dL higher than that for LDL-C on the premise that a VLDL-C level ≤30 mg/dL is normal. Treatment of elevated triglycerides depends on the cause(s) of the elevation and its severity. The primary aim of therapy for all persons with elevated triglycerides is to achieve the target goal for LDLC. When triglycerides are borderline-high (150-199 mg/dL), emphasis should include weight reduction and increased physical activity. For high triglyceride (200-499 mg/ dL) levels, non-HDL-C becomes a secondary target of therapy. Drugs in the fibrate group re-
verse dyslipidemia associated with MetS. In the Diabetic Atherosclerosis Intervention Study (DAIS), a multinational angiographic study of men and women with T2DM, fenofibrate-treated individuals experienced a 10 percent decrease in LDL-C, a 6 percent increase in HDL-C, and a 30 percent reduction in plasma triglyceride levels. In addition to weight reduction and increased physical activity, drug therapy can be considered in persons at high risk for CHD to achieve the non-HDL-C goal. There are two approaches to drug therapy. First, the non-HDLC goal can be achieved by intensifying therapy with an LDL-C lowering drug (e.g., a statin). Second, nicotinic acid or a fibrate can be added to achieve the nonHDL-C goal by further lowering of VLDL-C. Combining a statin with a fibrate is particularly attractive, but carries increased risk for myopathy. This increase in risk with a statin plus fibrate has been particularly noted for the fibrate gemfibrozil. A higher risk from the combination could result from pharmacological interaction of gemfibrozil with the statin to produce higher concentrations of the statin in the blood. Recent studies suggest that fenofibrate combined with a statin is less likely to cause myopathy than is gemfibrozil. When triglycerides are very high (≥500 mg/ dL), the initial aim of therapy is to prevent acute pancreatitis. This requires very low fat diets (≤15 percent of caloric intake), weight reduction, increased physical activity, and usually triglyceride lowering pharmacotherapy (fibrate or nicotinic acid). The combination of statin with a low dose of nicotinic acid is an alternative to a statin plus fibrate. Although low doses of nicotinic acid can be tolerated by most patients with MetS, some patients find it difficult to take on a long-term basis. For patients with T2DM, nicotinic acid can raise glucose concentrations; but as long as the dose is kept relatively low, it does not produce substantial deterioration of glycemic control in
most patients. Only after triglyceride levels have been lowered to <500 mg/dL should attention turn to LDL-C lowering to reduce risk for CHD. Low HDL-C. Low HDL-C is a strong independent predictor of CHD. Low HDL-C is defined as a level <40 mg/dL (men) and <50 mg/ dL (women). Low HDL-C levels may be caused by several factors, many of which are associated with insulin, i.e., elevated triglycerides, overweight and obesity, physical inactivity, and T2DM. Other causes include cigarette smoking, very high carbohydrate intake (>60 percent of calories), and certain drugs (e.g., β-adrenergic blocking agents, anabolic steroids, progestational agents). Although a number of clinical trials suggest that increasing HDL-C will reduce the risk for CHD, the evidence remains insufficient at present to specify a goal of therapy. NCEP:ATP III does not include a goal for increasing HDLC. Moreover, currently available drugs do not robustly raise HDL-C. Nonetheless, a low HDL-C level should receive attention and management according to the following sequence. In all individuals with low HDL-C, the primary target of therapy is to lower LDL-C. After the LDL-C goal has been met, emphasis should shift to weight reduction and increased physical activity (when MetS is present). When low HDL-C is associated with high triglycerides, secondary priority is directed toward achieving the non-HDL-C goal, as outlined above. Also, if triglycerides are <200 mg/ dL (isolated low HDL-C), drugs for HDL-C raising (fibrates or nicotinic acid) can be considered. However, treatment for isolated low HDL-C is mostly reserved for persons with CHD and CHD risk equivalents. The VA-HIT (Veterans Affairs HDL-Cholesterol Intervention Trial) was the first major clinical trial to demonstrate that reducing triglycerides and increasing HDLC without significantly affecting LDL-C significantly reduces cardiovascular events. The study enrolled 27 27
2,531 men with CHD and a mean HDL-C of 32 mg/dL, LDL-C of 111 mg/dL, and triglycerides of 160 mg/ dL, and randomly assigned them to receive gemfibrozil or placebo. At one year, mean HDL-C and triglyceride concentrations were 6 percent higher and 31 percent lower, respectively, in the gemfibrozil group than in the placebo group. LDL-C levels did not differ between groups. In the initial analysis, gemfibrozil reduced the risk of the primary endpoint (nonfatal MI or coronary death) by 22 percent relative to placebo after a median follow-up of 5.1 years. In a subsequent analysis, the benefit of gemfibrozil correlated most strongly with the improvement in HDL-C levels. The incidence of CHD events was unrelated to triglyceride or LDL-C levels. On further analysis, each 5-mg/dL increase in HDL-C was associated with 11 percent reduction in CHD events. Nearly half of the subjects in VA-HIT had either diabetes or hyperinsulinemia, and many were obese. In a subgroup analysis, a significant reduction in CHD risk was observed in patients with diabetes and/or hyperinsulinemia, but not in those without these conditions. Therefore, most of the clinical benefit noted in VA-HIT may be attributed to patients with low HDL-C, many of whom had MetS based on NCEP:ATP III criteria. Hypertension. Mild elevations of blood pressure can often be controlled with TLC, but if hypertension persists despite such efforts, antihypertensive drugs are usually necessary. Intensive treatment of hypertension has been shown to reduce the incidence of adverse cardiovascular events, with diabetic patients deriving most benefit. The NCEP:ATP III recommends that antihypertensive therapy be introduced early, and at much lower blood pressure (≥130/≥85 mmHg). Tight blood pressure control with either angiotensin-converting enzyme (ACE) inhibitors or β-adrenergic blocking agents is associated with reduced 28 28
incidence of microvascular and macrovascular complications in patients with diabetes. No particular agent has been identified as being preferable for hypertensive patients with MetS. Current data suggest that the benefits associated with antihypertensive therapy are largely due to their blood pressure-decreasing effect rather than drug type. However, it has recently been suggested that drugs that block the reninangiotensin system may prevent or delay development of diabetes and, thus, confer cardiovascular benefit. In the HOPE study (Heart Outcomes Prevention Evaluation), the ACE inhibitor ramipril (Altace and others) was studied to examine effectiveness in reducing macrovascular and microvascular effects in patients with diabetes. The study included 3,654 subjects with diabetes and 5,720 without the disease. In patients at high risk for cardiovascular events, treatment with ramipril reduced the rates of death, myocardial infarction, and stroke. Ramipril also reduced the new diagnoses of diabetes by 34 percent. The exact mechanism by which ramipril may prevent the development of diabetes is unknown. One possible mechanism is that the drug prevents the loss of potassium, which is essential for proper pancreatic β-cell function. Ramipril-induced vasodilation can improve blood perfusion of pancreas and muscular beds, enhancing beta-cell function and increasing insulin-mediated uptake by muscle. Or, it may increase bradykinin levels to a point whereby nitric oxide production is increased, along with insulin-mediated glucose uptake by the muscle. Insulin Resistance and Hyperglycemia. Lifestyle intervention is the initial approach to management of insulin resistance and hyperglycemia. Restricted diet and increased exercise can reduce the risk for conversion of impaired fasting glucose/impaired glucose tolerance to T2DM. Preliminary reports indicate that metformin (Glucophage and others) or thiazoli-
dinediones (pioglitazone/Actos and rosiglitazone/Avandia) also reduce risk for T2DM in persons with impaired fasting glucose or impaired glucose tolerance. Avandia is available in the United States, only on a restricted basis due to suspicion that it causes heart disease. At the same time, no controlled clinical trial evidence has demonstrated that these drugs will reduce the risk for cardiovascular events in patients with MetS. Moreover, neither metformin nor the thiazolidinediones are recommended solely for prevention of diabetes. Patients with T2DM who concomitantly exhibit other features of MetS are at particularly high risk for CHD. High priority should be given to treatment of dyslipidemia and hypertension. Glycemic control to an HbA1C of <7 percent will reduce microvascular complications and decrease risk for macrovascular disease as well. Antihypertensive and hypoglycemic drugs can modify insulin sensitivity and body weight. Metformin and thiazolidinediones improve insulin sensitivity, but have variable effect on body weight. Metformin reduces weight whereas thiazolidinediones can increase it. The increase in weight in patients treated with insulin secretagogues (sulfonylureas, repaglinide/Prandin or nateglinide/Starlix) and insulin results mostly from improved glycemic control and increases in caloric intake as a result of hypoglycemia. Except for nicotinic acid, lipid-altering drugs do not affect insulin sensitivity or weight, whereas the effect of antihypertensive drugs is more complex. β-Adrenergic blockers and thiazide diuretics may decrease insulin sensitivity, but less so at low doses. ACE inhibitors and angiotensin II receptor antagonists (losartan/Cozaar, etc.), on the other hand, have variable effects. ACE inhibitors and angiotensin II receptor antagonists seem to decrease the incidence of T2DM. Prothrombotic (Atherothrombotic) State. This is characterized by elevated fibrinogen, plasminogen activator inhibitor 1
Table 3 Summary of therapeutic goals and recommendations for treating the metabolic syndrome Abdominal obesity Goal: 10% weight loss first year, then continued weight loss or maintain weight Recommendation: caloric restriction, regular exercise, behavior modification Physical activity Goal: regular moderate-intensity physical activity Recommendation: 30- to 60-minute moderate-intensity exercise daily Atherogenic diet Goal: reduced intake of saturated fats, trans fats and cholesterol Recommendation: saturated fat, 7% of total calories; reduce trans fat; dietary cholesterol <200 mg daily; total fat 25-35% of total calories Cigarette smoking Goal and recommendation: complete smoking cessation LDL-C Goals: High-risk patients – LDL-C <100 mg/dL Therapeutic option – LDL-C <70 mg/dL Moderately high-risk patients – LDL-C <130 mg/dL Therapeutic option – LDL-C <100 mg/dL Moderate-risk patients – LDL-C <130 mg/dL Recommendations: High-risk patients – lifestyle therapies and LDL-C lowering drug to achieve recommended goal Moderately high-risk-patients – lifestyle therapies; add LDL-C lowering drug if needed to achieve recommended goal when baseline LDL-C ≥130 mg/dL Moderate-risk patients – lifestyle therapies; add LDL-C lowering drug if necessary to achieve recommended goal when baseline LDL-C ≥160 mg/dL High triglyceride or low HDL-C Goal: insufficient data to establish goal Recommendation: high-risk patients – consider adding fibrate (preferably fenofibrate) or nicotinic acid to LDL-lowering drug therapy Elevated blood pressure Goal: blood pressure <135/<85 mmHg. For diabetes or kidney disease: blood pressure <130/80 mmHg Recommendation: lifestyle therapies; add antihypertensive drug(s) when necessary to achieve goals Elevated glucose Goal: maintenance or reduction in fasting glucose if >100 mg/dL. Hemoglobin A1C < 7% for diabetes Recommendation: lifestyle therapies; add hypoglycemic agents as necessary to achieve goal for fasting glucose or hemoglobin A1C Prothrombotic state Goal: reduction of prothrombotic state Recommendation: high-risk patients – initiate low-dose aspirin; consider clopidogrel if aspirin is contraindicated; moderately high-risk patients – consider low-dose aspirin Proinflammatory state Recommendation: No specific therapies
Proinflammatory State. This can be identified by elevated cytokines such as tumor necrosis factor-alpha (TNFα) and interleukin 6, in addition to elevations in C-reactive protein (CRP) and fibrinogen. Elevated CRP is widely thought to be an indicator of a proinflammatory state and is associated with higher risk for both cardiovascular disease and T2DM. Lifestyle therapies, especially weight reduction, will reduce concentrations of this cytokine and, thus, can mitigate an underlying inflammatory state. No specific anti-inflammatory drugs are available to modify the proinflammatory state. However, several drugs used to treat other metabolic risk factors, statins, fibrates and thiazolidinediones, are reported to reduce concentrations of CRP. The drugs, however, cannot be recommended specifically to reduce a proinflammatory state independent of other risk factors.
Summary and Conclusions
Lowering of LDL-C is the primary goal of therapy when there is a risk of CHD. Treatment of MetS is then undertaken as a secondary means of lowering risk for both CHD and T2DM. A summary of the therapeutic goals and recommendations for treating MetS are listed in Table 3. 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.
Eckel RH, Grundy SM, Zimmet PZ. The metabolic syndrome. Lancet. 2005;365:1415-1428.
and possibly other coagulation factors. The only available treatment to attenuate an increased risk for arterial thrombosis in patients with T2DM is low-dose aspirin or other antiplatelet drugs such as clopidogrel (Plavix and others). These drugs are universally
recommended unless specifically contraindicated in patients with established cardiovascular disease. In persons with MetS, aspirin prophylaxis is a therapeutic option when the risk for cardiovascular events is judged to be relatively high.
Program 0129-0000-12-007-H01-P Release date: 7-15-12 Expiration date: 7-15-15 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.
continuing education quiz
Program 0129-0000-12-007-H01-P 0.15 CEU
The Metabolic Syndrome: Pharmacologic and Non-Pharmacologic Management
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1. Individuals with MetS possess a much higher than normal risk for developing which of the following? a. Type 2 diabetes mellitus c. Pulmonary disorders b. Liver failure d. Renal disease 2. The National Cholesterol Education Program’s Adult Treatment Panel III (NCEP:ATP III) classifies very high blood levels of LDL-C as: a. >100 mg/dL. c. >160 mg/dL. b. >130 mg/dL. d. >190 mg/dL. 3. MetS, as defined by NCEP:ATP III criteria, requires that the patient have: a. >2 of the 5 risk factors. c. >4 of the 5 risk factors. b. >3 of the 5 risk factors. d. all of the risk factors. 4. The term central obesity refers to the amount of fat in the patient’s: a. chest area. c. waist area. b. hip area. 5. The LDL-C goal may best be achieved in initiating therapeutic lifestyle changes (TLC) which include a reduced saturated fat intake of total calories: a. <5 percent. c. <10 percent. b. <7 percent. d. <14 percent. 6. The highest percent of caloric intake of the recommended nutritional constituents of the TLC diet is: a. polyunsaturated fat. c. monounsaturated fat. b. protein. d. carbohydrate. 7. The Mediterranean Diet reduces all of the following EXCEPT: a. blood pressure. c. HDL-C levels. b. fasting glucose. d. insulin secretion.
Completely fill in the lettered box corresponding to your answer. 1. 2. 3. 4. 5.
[a] [a] [a] [a] [a]
[b] [b] [b] [b] [b]
[c] [c] [c] [c] [c]
[d] [d] [d]
6. [a] 7. [a] 8. [a] 9. [a] [d] 10. [a]
[b] [b] [b] [b] [b]
[c] [d] [c] [d]
[c] [d] [c]
11. [a] 12. [a] 13. [a] 14. [a] 15. [a]
[b] [b] [c] [d] [b] [c] [d] [b] [c] [b]
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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8. Regular physical activity lowers VLDL levels, elevates HDL-C levels, and may contribute to lowering LDL-C levels. a. True b. False 9. Which of the following triglyceride levels is considered to be borderline-high? a. 50-99 mg/dL c. 150-199 mg/dL b. 100-149 mg/dL d. 200-299 mg/dL 10. The primary aim of therapy for all persons with elevated triglycerides is to achieve the target goal of: a. HDL-C. c. VLDL-C. b. LDL-C. 11. Recent studies suggest that therapy with which of the following, combined with a statin, is less likely to cause myopathy? a. Fenofibrate b. Gemfibrozil 12. All of the following are reported to cause low HDL-C levels EXCEPT: a. progestational agents. b. very high carbohydrate intake. c. cigarette smoking. d. alpha-adrenergic blockers. 13. In the HOPE study, which of the following drugs was studied to examine effectiveness in reducing macrovascular and microvascular effects in patients with diabetes? a. Moexipril b. Benazepril
c. Ramipril d. Enalapril
14. Which of the following lipid-altering drugs reportedly affects insulin sensitivity or weight for patients with diabetes? a. Fibrates c. Statins b. Nicotinic acid 15. Other than low-dose aspirin, which of the following is available treatment to attenuate an increased risk for arterial thrombosis in patients with diabetes? a. Clopidogrel b. Warfarin To receive CE credit, your quiz must be received no later than July 15, 2015. A passing grade of 80% must be attained. All quizzes received after July 1, 2012 will be uploaded to the CPE Monitor Program and a statement of credit will not be mailed. Send inquiries to email@example.com.
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