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Call or e-mail TODAY to schedule a time to discuss your health insurance needs.
Trevor Miller – Director of Insurance Services 404.419.8107 or email at tmiller@gpha.org Georgia Pharmacy Association Members Take Advantage of Premium Discounts Up to 30% on Individual Disability Insurance Have you protected your most valuable asset? Many people realize the need to insure personal belongings like cars and homes, but often they neglect to insure what provides their lifestyle and financial well-being - their income! The risk of disability exists and the financial impact of a long-term disability (90 days or more) can have a devastating impact on individuals, families and businesses. During the course of your career, you are 3½ times more likely to be injured and need disability coverage than you are to die. (Health Insurance Association of America, 2000) As a member of the Georgia Pharmacy Association, you can help protect your most valuable asset and receive premium discounts up to 30% on high-quality Individual Disability Income Insurance from Principal Life Insurance Company.
For more information visit www.gphainsurance.com. * Association Program subject to state approval. Policy forms HH 750, HH 702, HH 703. This is a general summary only. Additional guidelines apply. Disability insurance has limitations and exclusions. For costs and details of coverage, contact your Principal Life financial representative.
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2010 GPhA Convention, June 26-30, 2010 Embassy Suites & Conference Center at Kingston Plantation Myrtle Beach, SC FEATURE ARTICLES
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Departments 10 Alaska CE at Sea 12 Pharmacy-Based Immunization Programs 16 GPhA New Members 19 GPhA Members in the News 20 Pharm PAC Contribution Card 21 Spring Region Meeting Information 22 Call for Awards Nominations 31 GPhA Board of Directors
GPhA Strategic Plan January 2010 Advertisers
South University APhA-ASP Chapter
GPhA Government Affairs Legislative Update
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New CPE Requirement
CPE Opportunity: USP’s Role in Patient Safety
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The Insurance Trust Principal Financial Group Georgia’s Own Credit Union Pharmacists Mutual Companies Logix, Inc. Michael T. Tarrant Pharmacy Technician Certification Board Study Guide UGA Alumni Dinner PQC AIP Spring Meeting Georgia Campus - Philadelphia College of Osteopathic Medicine Toliver & Gainer Melvin M. Goldstein, P.C. The Insurance Trust
COLUMNS
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President’s Message Editorial
For an up-to-date calendar of events, log onto
www.gpha.org.
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March 2010
PRESIDENT’S MESSAGE Eddie M. Madden, R.Ph. GPhA President
Road Map for the Future n 1991, I was President of Elbert County Chamber of Commerce. We undertook a strategic planning process to determine where the leadership of Elbert County believed the county should go to achieve economic development. As with most strategic planning, the process involved a two day commitment.
The rest is history. Richard B. Russell State Park and home to Arrowhead Point Golf Course is now one of the two most attended parks in the State of Georgia. Arrowhead Point is recognized nationally as one of the best public golf courses. A recent feasibility study outlined the need for a lodge to support the park’s growing popularity. The strategic plan is still viable and moving forward.
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At the end of the process, Lake Richard Russell, a U.S. Corps of Engineers managed lake on the Savannah River bordering South Carolina, was identified as our greatest resource. This lake is restricted from development by a 300 foot buffer zone around the lake. Portions of the lake have designated recreational areas that were turned over to the State of Georgia and South Carolina for their state’s development.
Needless to say, I believe in the effectiveness of a strategic plan to the success of an organization or goal. When I attended the National Association of State Pharmacy Association’s leadership conference in the spring of last year, the moderator asked the various states about their strategic plan. Several had one, but many, including Georgia did not.
Elbert County’s strategic plan was to develop a state golf course and lodge to lure development within the county. Our plan was in place and the leadership of Elbert County now had a road map to guide the decisions which would promote Elbert County’s economic growth.
With the support of the Association’s executive committee, a strategic planning meeting was scheduled. In November of last year, a group of leaders within GPhA met for a two day strategic plan. This session was moderated by David Miller, Professional Relations Director with Merck. Dave used a unique method to achieve our strategic plan but at the end of a day and a half of hard work, Georgia Pharmacy Association’s Road Map to the Future was developed. At the January Board of Director’s meeting, the board adopted the GPhA’s Strategic Plan and set a goal of increasing membership by 20 percent or 300 members by 2015.
I was elected to the Georgia Senate and one of my platforms for office in 1993 was to pursue economic development for the six rural counties that I represented. In 1995, I urged Governor Zell Miller to come to Elbert County to fly over the designated park lands on Lake Russell to view the potential sites for a State Park and future golf course. After the Governor’s visit, he placed funding for a feasibility study for the park and golf course in the 1996 state budget.
The Georgia Pharmacy Journal
While one might think there would be a host of issues that would be in the strategic plan, it boiled down to just two basic items, Membership and Governmental Advocacy. These are the two vital reasons our Association exists.
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Within these two are many other issues that are important to our Association’s success. The work of the committee delineated strategic directives for the achievement of our strategic plan. These can be seen in this JOURNAL on the next page and online at www.gpha.org. Beyond these directives, the committee also outlined numerous agenda items that have been presented to the Board of Directors for a successful implementation of the plan.
Our Association is a well respected body in the Georgia General Assembly. Our elected legislators and governmental leaders have to run for election or re-election on a regular basis. Their political future depends on financial support for their campaigns. Pharm PAC must become a more prominent contributor in these campaigns in order to stand with other more dominant associations within our State.
Our Association has lost 131 licensed pharmacists since 2006. Our strategic plan is designed to achieve a 20 percent increase in licensed pharmacists by 2015 which amounts to 300 new members. To achieve this goal, our Association has to commit the time, resources, and collective efforts of the entire Board of Directors. That would require each Board member recruiting three pharmacists per year.
When our Board of Directors meets and discusses issues of the Association, the issue will be posed, how does it affect our goal to increase membership or how does it improve our efforts at governmental advocacy. Our Association must stay focused with its resources and efforts to achieve our strategic plan! Our leadership now has a road map to the future.
GPhA Strategic Plan January 2010 Association Membership Membership in the Georgia Pharmacy Association will increase by *20 percent (300 pharmacists) by 2015. Strategy Directive I: Educate members about the ease of joining, making membership joining or renewing as easy as possible. Strategic Directive II: Develop and enhance new communication and recruitment tools to reach potential new members. Strategic Directive III: Identify and offer membership benefits that are specific to the needs of non-members. Strategic Directive IV: Increase and expand the types of membership categories with unique benefits for each.
Advocacy- Government Affairs Advocacy will be recognized at the premier service of the association Strategic Directive I: Advocate for key practice issues that affect pharmacists on a daily basis. Strategy Directive II: Grow the GPhA Pharm PAC to a comparable level with other Georgia healthcare providers’ political action committees. Strategy Directive III: Educate GA legislators about the value of pharmacists and pharmacy in health care reform. Strategic Directive IV: Educate pharmacists on legislative issues to foster their involvement and understanding of why political advocacy is important to the profession. * Total licensed pharmacist membership
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Member Benefit: Mention that you are a GPhA member and you receive $5 to open your first account at Georgia’s Own Credit Union.
EXECUTIVE VICE PRESIDENT’S EDITORIAL Jim Bracewell Executive Vice President / CEO
Thank you Georgia Pharmacy Association
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n Sunday, January 31, 2010, the Georgia Pharmacy Association Board of Directors voted to approve a contract for me to serve as your Executive Vice President and CEO through August 31, 2014. I am delighted, excited and pleased to have this opportunity to continue to serve the pharmacists and pharmacy in Georgia in this role. Thank you.
out the balance of this decade is number one on our list. The Board also adopted a clear and unmistakable one page strategic plan that defines our five year future in two specific areas: 1) Membership in the Georgia Pharmacy Association will increased by 20 percent by 2015; and 2) Advocacy will be recognized at the premier service of the association.
I said, jokingly, that the only person more happy about the new contract than me was the banker holding the mortgage on the townhouse I recently purchased.
I want to close the article with again offering my sincere thank you for the privilege to work in this leadership position for one of the most respected professions in our nation and one that has a growing presence in the future of health care in our country and the one in Georgia that has volunteer leadership that is committed to a better future for pharmacy in our state.
This long term commitment by your Board of Directors provides GPhA a firm foundation for a future on which we can continue to recruit and develop a highly professional, respected and productive leadership team for the GPhA office.
Call me anytime GPhA can be of help to you. This fall the renewed commitment by the Academy of Independent Pharmacy to aggressively fund the GPhA political advocacy plans for the state and national levels in this election cycle year has the potential to yield excellent opportunities for an improved future for the profession of pharmacy for the balance of this decade in the state of Georgia. Your association now has a four member pharmacists’ legislative caucus in the Georgia General Assembly Rep. Ron Stephens, Rep. Butch Parrish, Rep. Buddy Harden and Sen. Buddy Carter. That group of dedicated pharmacists is a caucus that is the envy of most state pharmacy associations across the country. In these very tough economy times the members of the Georgia Pharmacy Association have much to be thankful for and the solid prospect for an improving the future for the practice of pharmacy in our state through
The Georgia Pharmacy Journal
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March 2010
GPhA Convention June 26-30, 2010 Embassy Suites & Conference Center at Kingston Plantation, Myrtle Beach, South Carolina Register Now at www.gpha.org. GPhA’s 2010 Convention will be held at the Kingston Plantation in June. This is a favorite venue of GPhA members. With direct access to the to the beach and beautiful accommodations, we are assured a relaxing and educational convention. GPhA early bird registration will be $295 for a GPhA member. Hotel rooms fill quickly so make your reservations now and plan to attend the 2010 Convention. Register online now at www.gpha.org.
2010 Convention Room Block Embassy Suites Hotel Oceanfront Suite – King Oceanview Suite
$234.00 $174.00
Embassy suites are two-rooms with in room microwave and refrigerator and rate includes a complimentary buffet breakfast and complimentary manager’s reception (5:30 – 7:30pm daily- based on single/double occupancy).
Brighton Tower Condo Two Bedroom Oceanview Three Bedroom Oceanview
$220.00 $262.00
Does not include complimentary buffet breakfast or reception The units are a typical condo set up with living room, dining, full kitchen and a patio area. Units are individually owned and will vary in decoration. Daily maid service includes only removing trash, vacuuming, making beds with existing linens and replacing bath linens.
Plantation Villa One Bedroom Resort view Two Bedroom Resort view
$164 $174
Villas have full living area and full kitchens. Does not include complimentary buffet breakfast or reception Daily maid service includes only removing trash, vacuuming, making beds with existing linens and replacing bath linens. Call for Reservations: 1-800-876-0010 - Tell reservations the Group Code: GPA
Change in Convention Format: Due to comments on the 2009 Convention Survey and input from the Convention Planning Committee and GPhA Executive Committee, it was decided from this input that attendees would welcome a change to the convention format to include an evening of free time. Taking these suggestions into consideration, there will be a change in the Sunday evening format. To allow this change, plans now are to have a heavy hors d’oeuvres reception in the Exhibit Hall on both Saturday and Sunday and not a dinner on Sunday evening. Then we have planned a coffee and dessert reception at approximately 9:30 p.m. on Sunday with plans for the return of Kevin Lepine the Hypnotist that has been such a hit at our convention on several occasions. That show is scheduled for 10:00 p.m. to 11:00 p.m.. So registrants will have an evening free to spend with family and friends plus get time to socialize. The Georgia Pharmacy Association is accredited by the Accreditation Council of Pharmacy Education as a provider of continuing pharmacy education. These activities are eligible for ACPE credit; see final CPE activity announcement for specific details as they become available on the GPhA website.
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As details become available they will be posted to the GPhA website at www.gpha.org. The Georgia Pharmacy Journal
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March 2010
PHARMACY SCHOOLS’ NEWS
South University APhA-ASP Chapter Update Rick Wilhoit and Charity Wilkerson
his is one APhA chapter that shows no hesitation in starting the New Year off with a bang. As a much needed and well-deserved Christmas break came to an end, fully reenergized chapter officers and members geared up for another exciting year.
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After an officers meeting to regroup thoughts for the New Year, our chapter started off things with a fundraiser, which we called “mental getaway basket” raffle. Our officers worked diligently contacting local merchants for possible donations and we ended with more than ever expected. The basket up for raffle included five restaurants gift cards, movie passes, and a gift certificate for a massage. This month we also held our patient counseling competition, which was a great success. Many pharmacy students came out to compete and show their clinical knowledge and skills. After a great competition where many shined, our chapter Historian, Charity Wilkerson, was chosen as the winner and will represent South University’s chapter in Washington, DC on March 13. Continuing the month, we were very thankful and honored to have Mr. Jim Bracewell, executive Vice President of GPhA, and Eric Durham, as guest speakers at our general meeting on January 27. During the meeting students and members were encouraged to attend VIP day at the capitol, informed about the upcoming chapter events, and given a chance to socialize with a free pizza lunch following the meeting. The meeting seems to have been a huge success, as we have 34 students currently scheduled to attend VIP day. We still have quite a bit more scheduled for this quarter, as we have a large health screening coming up that will give us a chance to work with patients to inform them about immunizations and heartburn, as well as screen them for blood pressure, BMI, and blood glucose for our Project Diabetes patient care project. This screening is being done at an event being held by the American Diabetes Association in conjunction with the Black Heritage Festival. It will be held at the Savannah Civic Center and it is expected to attract over 1,000 attendees. Lastly, we are proud to be holding a seminar for SUSOP students on Medication Therapy Management (MTM) on February 24. Elizabeth Miller, PharmD, will be joining us from Walgreens to put on this informational session, and we are very excited to have her! Our chapter started off with a bang and we plan to continue to work together to make this a very memorable year!
The Georgia Pharmacy Journal
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Pharmacy-Based Immunization Programs: Two Opportunities for Training Saturday, April 17, 2010 (8:30 a.m. - 6:00 p.m.) Macon Centreplex Auditorium Coliseum & Convention Center 200 Coliseum Drive Macon, GA 31217
Friday, June 25, 2010 (8:30 a.m. - 6:00 p.m.) Embassy Suites & Conference Center at Kingston Plantation 9800 Queensway Blvd Myrtle Beach, SC 29572
Further details and registration online at www.gpha.org or you can register by calling Kelly McLendon at 404-419-8116. Member Type GPhA Non-Member GPhA Members Pharmacy School Student
Cost $495 $400 $175
Pharmacy-Based Immunization Delivery is an innovative and interactive training program that teaches pharmacists the skills necessary to become a primary source for vaccine information and administration. The program teaches the basics of immunology and focuses on practice implementation and legal/regulatory issues. Pharmacy-Based Immunization Delivery certificate training program is a Practice-based activity conducted in two parts – a self-study learning component and a live training seminar. A Certificate of Achievement will be awarded to participants who successfully complete all program components. Key learning objectives for the live training seminar: • 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. • Outline the target groups for vaccination based on the Advisory Committee for Immunization Practices recommendations. • Review patients’ medical and immunization histories and determine vaccine recommendations based on current immunization schedules. • Outline the steps involved in establishing a pharmacy-based immunization delivery program. • 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 and the emergency procedures for management of patients with adverse reactions to vaccination. • Describe the appropriate technique for administration of the live attenuated influenza vaccine. • Demonstrate appropriate intramuscular and subcutaneous injection technique for adult immunization. For a more complete list of program learning objectives, please go to APhA’s website, www.pharmacist.com/ctp. This is a Practice Based CPE Activity. The target audience for this Activity is Pharmacists. Continuing Pharmacy Education (CPE) Credit CPN: 202-0014: Expiration Date: 12/31/10 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 CEU). ACPE UAN: Live-202-999-09-001-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 credits (1.2 CEU). ACPE UAN: SS-202-999-09-002-H01-P The American Pharmacists Association and the Georgia Pharmacy Association are accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Pharmacy-Based Immunization Delivery: A Certificate Program for Pharmacists was developed by the American Pharmacists Association, and is supported in-part by an educational grant from VaxServe.
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March 2010
GPhA LEGISLATIVE UPDATE
GPhA Government Affairs Legislative Update Information current as of February 15, 2010. If you have any questions please email Stuart Griffin at sgriffin@gpha.org.
arve-Out Bills: SB56 and SB49
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Position - Oppose SB56 creates an electronic database that identifies those individuals purchasing certain medications used for the production of methamphetamine. During the last part of the 2009 Session this bill was used as a vehicle to try and pass immunosuppressant and epilepsy carveout language. SB49 provides for the same purpose, but only for immunosuppressant carve-out. Both bills require the pharmacist to notify the physician when a substitution is made for an immunosuppressant drug or epilepsy drug. E-Prescribing: SB195 Position - Support SB195 is the Secretary of State's bill that contains language that helps update e-prescribing. SB195 is important to pharmacy because it contains the language that will update the e-prescribing process. Currently when a doctor transmits a prescription electronically to a pharmacist who is not set up to receive electronic prescriptions, the transmission is automatically sent to the facsimile that is on file for that pharmacy. Current Georgia law does not recognize that electronic signature as valid. SB195 will recognize these prescriptions as valid prescriptions. PBM: SB310 Position - Support Although the bill has been introduced, we are continuing to wait on the Governor's office to give us the go ahead. The Governor is allowing us to work with his health advisor so we can make sure the bill will be as effective as we need it to be. Although we are anxious to get the bill passed, it is very important that the bill is sufficient for what it is intended for - to put an end to PBM abuses. We hope to be moving the bill as soon as possible. Flu-mist: SB367 Position - Support Medimmune, the company that manufactures Flu-Mist, will be seeking legislation to amend the current influenza protocol statute to add Flu-Mist. We will be supporting Medimmune any way we can. SB367 passed the Senate Health and Human Services Committee on February 11, 2010. Generic Labeling: HB194 Position - Oppose HB194 requires the pharmacist to put the name of the generic and brand name of a medication on the label when a substitution occurs with the exception of specialty packaged drugs and other drugs exempted by the Board of Pharmacy. Safe Medication Practice Act: HB361 continued on page 15
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Position - Support HB361 was introduced during the 2009 Legislative Session by Rep. Ron Stephens (R-Savannah). HB361 specifically focuses on pharmacy practiced in an institutional setting. The bill codifies the importance of the pharmacist's involvement in medication therapy management. HB361 also codifies the importance of the collaboration between the pharmacist, physician and other clinical practitioners. Although the bill only pertains to pharmacists in an institutional setting, the bill is very important for the practice of pharmacy as a whole as it recognizes pharmacists as highly trained medication therapy experts and as vital components in the welfare of their patients. Sharps: HB504 Position - Oppose HB504 requires the pharmacist to supply the patient with a sharps waste container to dispose of their sharps waste after use. GPhA is trying to find a non-legislative solution to this problem. We are hoping to meet with the sponsor of this bill to solve the issue next week. If you would like to receive weekly updates from GPhA via email call Kelly McLendon at 404-419-8116.
New Continuing Pharmacy Education Requirement The Georgia State Board of Pharmacy now requires 3 hours of disaster preparedness continuing education for all licensed pharmacists by December 31, 2010. This boardapproved course will provide an introduction to emergency preparedness as well as explore the principles of mass immunization and mass dispensing. The web-based version will launch March 1 and live programs will be available throughout the year including at the GPhA convention. Stay tuned to the JOURNAL and emails for additional opportunities and sign up requirements for this program.
University of Georgia College of Pharmacy Monday, June 28, 2010 at the Rioz Brazilian Steakhouse 2920 Hollywood Drive, Myrtle Beach, SC 7:30 p.m. I will attend the Alumni Dinner for alumni spouses and friends of University of Georgia College of Pharmacy. Please make ______ reservations at $35.00 per person. _______ Yes, I would like to sponsor ______ student(s) for the alumni dinner at $35.00 each. Name: ______________________________________________ Name of spouse and/or guest(s): Address: City:
Class/Year:
________________
_____________________________________________________
______________________________________________________________________
_____________________ State: ___________
Zip code:
_____________________
Work Phone: _________________________ Home Phone: __________________________ Mail registration form with check, payable to UGA Foundation, by Friday, June 25, 2010, to Sheila Roberson, College of Pharmacy Alumni Director, University of Georgia, College of Pharmacy, Athens, GA 30602. For more information please call 706.542.5303. The Georgia Pharmacy Journal
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GPHA MEMBER NEWS
Welcome to GPhA! The following is a list of new members who have joined Georgia’s premier professional pharmacy association! Joshua Pendley, Savannah Matthew James Phillips, Pharm.D., Powder Springs Kristy L. Pucylowski, Pharm.D., Woodstock Timothy Wayne Rice, Pharm.D., Atlanta Lindsey N. Sadosky, Marietta Kenneth G. Schneider, O.D., Toccoa Marranda Pitchford Smith, Atlanta Nicole Spehar, Savannah Stuart R. Tasman, Marietta Kevin Christopher Taylor, Suwanee Megan Elizabeth Tracy, Buchanan Matthew A. Williams, Rydal Alison Willingham, Pharm.D., Byromville
Hannah Athan, Pharm.D., Atlanta Kimberly Blair Baker, Evans Kevin L. Bierschenk Colton Blackmon, Tallapoosa John E. Bryan, Helena, AL Serwanna Flanagan Clarke, Pharm.D., Marietta Vy Tuong Doan, Pharm.D., Savannah Allyson Franks, Brunswick Ashley Nicole Hannings, Marietta Scott Hartzog, B.S., Donalsonville William Anthony Hawkins, Pharm.D., Athens Chris Hobson, O.D., Kennesaw Pamela Tatum Leffert, Pharm.D., Athens
If you or someone you know wishes to join the Georgia Pharmacy Association you need only visit www.gpha.org and click “Join” at the top of the page. You can pay by credit card and your membership begins immediately. If you have any questions please call Kelly McLendon at 404-419-8116. The Georgia Pharmacy Journal
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PARTNER INFORMATION
Attention Independent Pharmacy Owners ave you read the fine print in your third party contract lately?
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Pharmacy Quality Commitment offers an easy way for you to be in compliance with this requirement. It is easily implemented into your pharmacy’s daily routine and extensive toll free and online support is provided to get you started. PQC is a product offered by the Alliance for Patient Medication Safety (APMS), a federally listed Patient Safety Organization. APMS provides legal protection and confidentiality for submitted patient safety data and error reports. Go to www.pqc.net to find out more about the program and get in compliance today!
Pharmacies, in order to be compliant with CMS regulations and network contract requirements and avoid possible audit recoupments, must have a quality improvement program. Most third party contracts ask you to implement and maintain a verifiable, documented pharmacy quality assurance program – the wording varies from contract to contract: - a medication safe practices program - a utilization management and quality assurance program - establish an internal medication error identification program and a plan to reduce medication errors
This program is endorsed by the Georgia Pharmacy Association and the Academy of Independent Pharmacy. Contact GPhA’s Sid Anderson for additional information 404-419-8115
If you use a PSAO for third party contracting that does not eliminate your liability for non compliance with the contract terms.
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March 2010
GPHA MEMBERS IN THE NEWS Levis A. “Al” McConnell, III, of Milton, GA was sworn in on January 7, 2010, to the Georgia State Board of Pharmacy. McConnell is a pharmacy district manager for CVS/Caremark. He is a three-time recipient of the Area 8 Pharmacy Triple S Award, member of the Georgia Pharmacy Association and a mentor for the Emerging Leader Program. McConnell earned two bachelor degrees from the University of Georgia. He and his wife, Melinda, have two children.
Bruce L. Broadrick, R.Ph., CDM, was elected to the Northwest Georgia Healthcare Partnership Board, a consortium of business, healthcare and local political leaders working together to advance health in the community of Dalton. He is also serving as chairman of Dalton’s Board of Health. In Memoriam Joseph E. Whitaker, R.Ph., passed away on January 25, 2010, at the age of 59. Mr. Whitaker was the owner of Griffin Drug Company for 17 years.
Alex Tucker and his wife Jodie welcome Alex “Shane” Tucker, Jr., into this world. The baby, born, January 28, 2010, was 8 pounds and 10 ounces. All of them are healthy.
If you have an item that you would like included in the GPhA Members in the News section of The Georgia Pharmacy Journal please email the item of news to Kelly McLendon at kmclendon@gpha.org or fax it to her attention to 404-237-8435.
Hutton and Marian Madden have welcome their son, Colton, into this world. Colton was 8.58 pounds and 20.25 inches long. All are doing well. Colton is the grandson of Eddie and Linda Madden.
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Pharm PAC would like to encourage you to make a contribution today and help pharmacy look forward to a bright future in the state of Georgia.
Lawyer and Pharmacist Leroy Toliver, Pharm.D., R.Ph., J.D. • Professional Licensure Disciplinary Proceedings • Medicaid Recoupment Defense • Challenges in Medicaid Audits • OIG List Problems • SCX or Other Audits
Name: ________________________________ Address: _______________________________ _____________________________________ Phone Number: __________________________
Leroy Toliver has been a Georgia Registered Pharmacist for 34 years. He has been a practicing attorney for 25 years and has represented numerous pharmacists and pharmacies in all types of cases. Collectively, he has saved his clients millions of dollars.
Email Address: __________________________ Contribution: $__________________________ (Circle the Pledge Level to which you wish to belong.) $1 - $250 - Patriot $251 - $500 - Representative $501 - $1000 - Senator $1001+ - Governor’s Circle
Toliver and Gainer, LLP 942 Green Street, SW Conyers, GA 30012-5310 altoliver@aol.com 770.929.3100
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Sustainers Circle: When you check this box and provide valid credit card information you are making a 5 year commitment to make the same contribution for the next 5 years. Your credit card will automatically be charged annually on the date of your initial contribution. Contributions or gifts to Pharm PAC are not deductible as charitable contributions for Federal income tax purposes. Name on the Credit Card: _____________________________________ Credit Card Number: _____________________________________ CSV#: ________ Expiration Date: ____________ Signature: ______________________________ Contributions made to Pharm PAC are not tax deductible.
Detach this form and complete it and return it to:
Pharm PAC, 50 Lenox Pointe, NE Atlanta, GA 30324 You may also donate online. The Georgia Pharmacy Journal
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GPhA 2010 Spring Region Meetings New State Laws That Impact the Practice of Pharmacy 2010 Update Robert Bowles, R.Ph., CDM, CFts, Chairman of the Board Eddie Madden, R.Ph., President Dale Coker, R.Ph., President-Elect Jack Dunn, R.Ph., First Vice President Robert Hatton, Pharm.D., Second Vice President Jim Bracewell, Executive Vice President/CEO
Schedule of Spring 2010 Region Meetings For additional information and to RSVP go to www.gpha.org Region 1 Region 2 Region 3 Region 4 Region 5 Region 6 Region 7 Region 8 Region 9 Region 10 Region 11 Region 12
April 20, 2010, 6:30-9:00 p.m. April 15, 2010, 7:00-9:30 p.m. TBD April 15, 2010, 6:00-9:00 p.m. April 20, 2010, 6:00-8:30 p.m. April 27, 2010, 6:30-9:15 p.m. April 15, 2010, 6:00-9:00 p.m. April 13, 2010, 7:00-9:30 p.m. April 27, 2010, 6:30-9:00 p.m. April 13, 2010, 7:00-9:30 p.m. TBD April 27, 2010
Carey Hilliard’s, Savannah Stonebridge Country Club, Albany TBD Canongate, Peachtree City Mercer University, Atlanta Healy Point Country Club, Macon Civic Center, Cartersville Holiday Inn, Waycross The Woodbridge Inn, Jasper Redeemer Presbyterian, Athens TBD Page House B & B, Dublin
Heather DeBellis Tony Singletary John Drew Bill McLeer Shobhna Butler Bobby Moody Mike Crooks Larry Batten David Gamadanis Chris Thurmond Marshall Frost Ken Eiland
If you are not sure which region you are supposed to be in the new region webpages list the counties in each region and show a map. Just visit www.gpha.org and click on Region Webpages on the right side.
For details about the Continuing Education Program at the Spring Region Meetings and to RSVP for this event visit www.gpha.org or call GPhA at 404.231.5074. The Georgia Pharmacy Association is accredited by the Accreditation Council of Pharmacy eduction as a provider of continuing pharmacy education. The Georgia Pharmacy Journal
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Call for awards nominations... The GPhA Awards Committee is seeking nominations for the following awards which will be presented at the GPhA 135th Annual Convention in 2010. A brief description and criteria of each award is noted below. Please select the award for which you would like to nominate someone and indicate their name on the form below. Deadline for submitting the completes nomination form is March 12, 2010. Nominations will be received by the Awards Committee and an individual will be selected for presentation of the Award at GPhA’s 135th Annual Convention at the Embassy Suites Conference Center, Myrtle Beach, SC.
Bowl of Hygeia Award (sponsored by Pfizer) Recognized as the most prestigious award in pharmacy, the Bowl of Hygeia is presented annually by GPhA and all state pharmacy associations. Selection Criteria: 1) The nominee must be a licensed Georgia Pharmacist; 2) The award is not made posthumously; 3) The nominee is not a previous recipient of the Award, 4) The nominee is not currently serving nor has served within the immediate past two years as an officer of GPhA other than ex-officio capacity or its awards committee; 5) The nominee has an outstanding record of service to the community which reflects well on the profession.
Distinguished Young Pharmacist Award (sponsored by Pharmacist Mutual) Created in 1987 to recognize the achievements of young pharmacists in the profession, the Award has quickly become one of GPhA’s most prestigious awards. The purpose of the Award is two-fold: 1) To encourage new pharmacists to participate in association and community activities, and 2) To annually recognize an individual in each state for involvement in and dedication to the pharmacy profession. Selection Criteria: 1) The nominee must have received entry degree in pharmacy less than ten years ago; 2) Nominees must be a licensed Georgia pharmacist; 3) Nominee must be a GPhA member in the year of selection; 4) Nominee must be actively engaged in pharmacy practice; 5) Nominee must have participated in pharmacy association programs or activities and community service projects.
Innovative Pharmacy Practice Award (sponsored by NASPA/GPhA) This Award is presented annually to a practicing pharmacist who has demonstrated innovative pharmacy practice which has resulted in improved patient care. Selection Criteria: 1) the nominee must have demonstrated innovative pharmacy practice which has resulted in improved patient care; 2) Nominee must be a licensed Georgia pharmacist; 3) Nominee must be a member of GPhA in the year of selection.
2010 Awards Nominations 2010 Bowl of Hygeia
Distinguished Young Pharmacist
Innovative Pharmacy Practice Award
Nominee’s Full Name _________________________________________________________________ Home Address ______________________________ City ______________ ST _______ Zip _________ Practice Site________________________________________________________________________ Work Address _______________________________ City ______________ ST _______ Zip _________ College/School of Pharmacy _____________________________________________________________ List of Professional activities, state /national pharmacy organization affiliations, and/or local civic and church activities _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ Supporting information (required) ________________________________________________________ _________________________________________________________________________________ Submitted by (optional): _______________________________________________________________ Submit this completed form by March 12, 2010, to GPhA Awards Committee, 50 Lenox Pointe, Atlanta, GA 30324. Complete this form online at www.gpha.org. The Georgia Pharmacy Journal
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Continuing Education for Pharmacists USP’s Role in Patient Safety This continuing education monograph is adapted from the United States Pharmacopeial Convention (USP) series of white papers prepared by the Council of the Convention (CoC) titled "Focus On: Future Directions for USP." The learning objectives and assessment questions were developed by National Alliance of State Pharmacy Association's (NASPA) Continuing Education Advisory Panel. No financial support was received for this activity. This activity may appear in other state pharmacy association journals.
Council of the Convention Section on the Quality of Patient Care Rita Munley Gallagher, Ph.D., R.N., Section Chair (American Nurses Association) Thomas R. Clark, R.Ph., M.H.S. (American Society of Consultant Pharmacists) Charles W. Maas, M.D., M.P.H. (California Medical Association) Stephen P. Spielberg, M.D. (Association of American Medical Colleges) As a volunteer-driven, practitionerGoals: The goals of this lesson are based, standards-setting organization, to review and be aware the current USP provides an important and unique methods used by various organizations pathway for practitioners to set to increase patient safety and those standards they use in daily life. USP is future potential opportunities for USP not itself a regulatory body and does to be involved in patient safety. not enforce its standards; however, conformity assessment bodies may Objectives: At the conclusion of recognize USP standards in ways that this lesson, successful participants enhance their value, impact, and at should be able to: times make them mandatory. 1. Describe current methods to increase Irrespective of their voluntary or patient safety mandatory character, standards provide 2. Describe future patient safety a safe harbor for practitioners and opportunities for USP support optimum health care outcomes.
Introduction: For the last four decades, the United States Pharmacopeial Convention (USP) has relied on spontaneous reporting information to support creation of safe medication use and quality of care standards in the United States Pharmacopeia (USP) and allied reports. For the most part, these are standards and supporting information that speak to how practitioners within healthcare systems should adjust their processes and practices to promote safe medication use. At times, USP product standards call for the adjustment of labels and labeling to reduce the likelihood of error.1
While beyond the scope of this white paper, USP acknowledges—and has always supported—the remarkable work of academia, the Institute of Medicine (IOM), highly involved standards- and conformity-assessment organizations (many of whom are Convention members), and many others who have worked tirelessly to develop information and provide evidence-based approaches to promote patient safety, safe medication use, and optimal quality care. Much of this effort culminated in the seminal reports of the IOM beginning in 1999 and follow-on activities in the IOM and elsewhere.
The Council of the Convention Section on the Quality of Patient Care presents this white paper as a means of reviewing USP’s prior efforts in this area and to encourage the Convention to consider future patient safety opportunities for USP.
USP’s Labeling and Nomenclature Responsibilities in Law: In the United States, under the Federal Food, Drug, and Cosmetic Act (FDCA), the United States Pharmacopeia (USP) and National Formulary (NF) are recognized as official compendia. A drug with a name recognized in USPNF must comply with compendial identity standards or risk being deemed adulterated, misbranded, or both. Drugs must also comply with compendial standards for strength, quality, and purity, unless they are labeled to show all respects in which the drug differs. These Federal requirements arise under the adulterated drugs provision of the FDCA at §501(b) as well as the misbranding provisions at §502. The role of nomenclature is particularly important, since the link to drugs “recognized in an official compendium” at §501(b) arises in the statutory provision that addresses the
For the most part, USP does not provide clinical practice standards, which are the responsibility of practitioner associations, state practice boards, and other certifying bodies.
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designation of drugs by “established names” at §502(e). As explained in 21 CFR §299.4, the Food and Drug Administration (FDA) has statutory authority to designate “official” or “established names,” yet it rarely does so. Instead, while continuing to review proprietary (brand) names as part of the drug approval process, FDA defers to USP’s Nomenclature Expert Committee in the Council of Experts and to the U.S. Adopted Names (USAN) Council, in which USP plays a key role, to provide established/nonproprietary drug product and drug substance names. Accordingly, the term “established name” means an article recognized in USP-NF (see FDCA §502(e)(3)), and drugs with such names must meet USP-NF standards for identity as well as (unless labeled otherwise) strength, quality, and purity. The FDA has extensive authority regarding the labeling of drugs, ranging from the package insert, dispensing, and containers, to advertising and promotional materials. The FDCA provides that a drug with a name recognized in an official compendium—including USP or NF— will be considered misbranded unless it is packaged and labeled as prescribed therein (FDCA §502(g)). Monograph requirements for packaging and labeling are noted in the USP-NF General Notices at 4.10 and are reflected in various monographs and General Chapters.
Committee is concerned with nomenclature for dosage form monographs and other aspects of the language used in the prescription, dispensing, sale, or manufacture of drugs. The Committee works in a collaborative fashion with the USAN Council, and USP has committed to using the USAN as the title of a drug monograph for that substance. The Committee’s authority to develop official nonproprietary names is identified in section 502(e) of the FDCA. The section indicates that a drug is misbranded if its label does not include the “established name” of the drug and each ingredient. It further specifies that the established name of a drug or ingredient is the official title used for the drug or ingredient in an official compendium such as USP or NF, as long as the FDA has not designated an official name in accordance with section 508 of the FDCA. In early 2006, a federal appeals court decision confirmed that the nonproprietary names assigned by the USP Nomenclature Expert Committee take precedence over the names informally approved by the FDA during regulatory review. Taken together, the public-private partnerships created through Congressional authority have provided U.S. practitioners with coherent non-propriety drug substance and product names, and these good naming conventions promote safe medication use and quality of care. 2. Safe Medication Use Expert Committee
Current Activities: 1. The USP Nomenclature Expert Committee USP’s Nomenclature Expert Committee establishes nonproprietary names for drug substances, drug products, excipients, biologics, dietary supplements, and medical devices for humans and animals. It also promotes uniformity and consistency among the official titles in the USP and NF. The
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The Safe Medication Use Expert Committee (SMU EC) began its work in the 2000-2005 cycle and continued in the 2005-2010 cycle. The nineteen members of the 2005-2010 SMU EC were drawn from the professions of medicine, nursing, and pharmacy, and include representatives from academia, research, government, and consumer interest. In this cycle, the SMU EC has reviewed and analyzed medication error reports submitted to USP, and from
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those, the Committee established recommendations for revision and development of standards in USP–NF and made recommendations to the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) discussed later in this white paper. It also developed guidelines, recommendations, a General Chapter, and publications related to safe medication practices and patient safety. The SMU EC’s members provided support to USP’s two reporting programs—MEDMARX® and the Medication Error Reporting (MER) Program. The SMU EC’s focus has been on policy-level priorities for the safe use of medications and patient safety initiatives. Examples of initiatives appear below: 4Total Dose per Total Volume — The SMU EC developed crosscutting support for a requirement to change labeling to indicate total dose per total volume for parenteral packages of 100mL or less. The recommendation was based on errors in which health professionals mistakenly administered the entire vial content in error— published in Pharmacopeial Forum (PF) 31(4) [July-Aug 2005]: Strength and Total Volume for Single –and MultipleDose Injectable Drug Products. 4Neuromuscular Blocking Agents — An article, “Improving the safety of neuromuscular blocking agents: A statement from the USP Safe Medication Use Expert Committee” was published in the American Journal of Health-System Pharmacists, Vol 63, Jan 15, 2006. The work stimulated a new policy statement from the American Society of Health-System Pharmacists (ASHP) on the use of neuromuscular blocking agents. The publication of this article followed the standard instituted by USP that required the warning, “Warning – Paralyzing Agent,” on the closures of neuromuscular blocking agents.
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4Patient Safety Stakeholder Forum — A cross-disciplinary Patient Safety Stakeholder Forum was convened on October 11, 2006 to discern the need for the creation of a new USP publication: “Safe Medication Practices Compendium.” This forum was followed by a USP white paper, “Exploring a Strategic Proposal for the Concept of a Compendium of Safe Medication Practices.” It was eventually concluded that additional exploration was needed to develop such a compendium. 4“Error Avoidance Recommendations for Tubing Misconnections When Using a Luer-Tip Connector: A Statement by the USP Safe Medication Use Expert Committee” was published in the Joint Commission Journal on Quality and Patient Safety. May 2008. Volume 34, Number 5: pp. 293-296. 4Physical Environments that Promote Safe Medication Use — General Chapter <1066> Physical Environments that Promote Safe Medication Use was created to provide safe medication use standards for all health care settings. 4Guidelines or Standards for Computerized Prescription Order Entry and Other Technologies — The SMU EC is working with Dr. Andrew C. Seger and Dr. Gordon Schiff from Brigham and Women’s Hospital on an analysis of computerized prescription order entry (CPOE) errors from the MEDMARX® database to develop guidelines/standards. 4“High Alert Drugs by Location” is being drafted by the Medication Error Data Analysis Advisory Panel of the SMU EC. 4Health Literacy and Prescription Container Labeling ─ The Health Literacy and Prescription Container Labeling Advisory Panel of the SMU EC is working on recommendations for the development of standards regarding
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simplifying language; using explicit text to describe dosage/intervals, including purpose for use; organizing the label in a patient centered manner; improving readability; and including supplemental information. 4Standardized Intravenous Concentrations — The SMU EC completed analysis of a Standard Intravenous (IV) Concentrations survey of health system pharmacy directors in order to determine the standard drip and flush concentrations being used in their respective facilities for the treatment of neonates, pediatrics, and adults. The goal is to standardize product concentrations to help decrease medication errors. The SMU EC will recommend standard concentrations for ten High Alert Drugs as a follow-up to an IV SMU survey (and an IV Summit held at USP) and publish an article identifying standard IV concentrations for ten High Alert Drugs by patient type. 4Tall-Man Lettering — The SMU EC will publish an article based, in part, on a research survey titled “Tall Man”/ Enhanced Lettering for Medication Name Differentiation. The survey on Tall Man Lettering was conducted in an effort to better understand the current landscape regarding use of and experience with enhanced lettering as a safety tool. Based on the survey results, the USP Nomenclature Expert Committee will consider the advisability of developing standards. A significant number of responses (1,788) were received from pharmacists (60%), nurses (16%), and physicians (16%), with the remainder coming from pharmacy technicians, nurse practitioners, and other healthcare providers. Cooperation in disseminating the survey was obtained primarily from the American Society of Consultant Pharmacists, the ASHP, the Institute for Safe Medication Practices (ISMP), the Joint Commission, and the National Alliance of State Pharmacy Associations.
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4Harmonization with WHO Label Standards for Vincristine and Other Vinca Alkaloids — Three component changes were recommended to reduce the chance of vincristine (and other vinca alkaloids) being administered by the intrathecal route (which is universally fatal). Through a reworded cautionary statement, the recommendation would change to overwrap alert labeling and add a cautionary statement on the cap and ferrule of the vial. (This proposal is currently under consideration by the Nomenclature Expert Committee.) 3. The National Coordinating Council for Medication Error Reporting and Prevention USP serves as the Secretariat for the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP/The Council), an independent body comprised of numerous national organizations. The Council was formed in 1995 through the efforts of its member associations and agencies to focus on ways to enhance patient safety through a coordinated approach and a systems based perspective. An interdisciplinary group of 15 organizations and agencies held its first meeting in July 1995. In the past 14 years, the Council has grown to 26 member organizations and two individual members. The five goals that continue to direct the Council’s activities are: 4Stimulate the development and use of reporting and evaluation systems by individual health care organizations; 4Stimulate reporting to a national system for review, analysis, and development of recommendations to reduce and ultimately prevent medication errors;
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4Examine and evaluate the causes of medication errors; 4Increase awareness of medication errors and methods of prevention throughout the health care system; and 4Recommend strategies for system modifications, practice standards and guidelines, and changes in packaging and labeling. Council Accomplishments—1995 to Present: 4Defined a “medication error” and encouraged all stakeholders to use this definition to provide a uniform basis for medication error reporting and analysis. 4Developed a medication error taxonomy, index and algorithm for categorizing medication errors 4Issued a statement on calculating medication error rates 4Promulgated recommendations for: 4Prescribing 4Labeling and packaging 4Dispensing 4Administration 4Verbal medication orders 4Standard bar codes on medication packages and containers 4Reducing medication errors in non-health care settings 4Reducing at-risk behaviors 4Bar coding labels to reduce medication errors 4Promoting safe use of drug suffixes 4Avoiding medication errors with drug samples The Council has had national and international impact through its multidisciplinary conferences on bar coding, drug nomenclature, and suffix use. Continuing activities and other accomplishments include:
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4Developing and disseminating standardized definitions for terms such as adverse drug event, adverse drug reaction, harm, preventable event;
Prior Activities: USP’s Reporting Programs to Support Standards:
4Establishing a dedicated Web site for organizations, government, and practitioners to reference The Council’s recommendations and other information;
1. Drug Product Problem Reporting Program
4Developing a solid oral dosage forms article for broad dissemination; 4Endorsing the ISMP Safety SelfAssessment for Community/Ambulatory Pharmacy; 4Establishing consumer information links to The Council’s Web site; 4Developing and disseminating a white paper on the use of bar codes; 4Signing on to a set of General Principles supporting legislation to uphold, as privileged, information submitted to error reporting programs (These General Principles were incorporated into the Patient Safety and Quality Improvement Act of 2005 that was signed into law on July 29, 2005.); 4Recognition with the 2007 American Pharmacists Association Foundation Pinnacle Award; and 4Receipt of the 2008 Eisenberg Award. In the coming years, The Council will continue to focus on key issues impacting the safe use of medications. With the help of new and enthusiastic member associations and agencies, The Council will address medication reconciliation as well as geriatric and long-term care issues. The members of The Council are recognized at www.nccmerp.org.
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Because of concern with the quality of drug products on the market, in 1971, the USP and the FDA co-founded the Drug Product Problem Reporting Program (DPPR). This was a national program in which health professionals voluntarily reported problems and defects experienced with drug products marketed in the United States. Often, product problems or defects had to do with inadequate packaging or labeling that could lead to errors or confusion on the part of health professionals. Other problems such as inclusion of foreign matter, suspected contamination, questionable potency, and “bioinequivalence” based on observed therapeutic response were also reported among the more than 100,000 observations gathered in DPPR. USP terminated the DPPR contract with the FDA in 1987, but continued a USP Drug Reporting Program until August 2000. 2. Medical Device and Laboratory Product Problem Reporting Program Together with the DPPR Program, USP operated the Medical Device and Laboratory Product Problem Reporting Program (PRP) under contract with the FDA Center for Devices and Radiological Health (CDRH). In this program, USP collected reports on defective medical devices and shared that information with both CDRH and the manufacturers involved in incidents. This program had a major impact on the use of breast implants, dental implants, and marijuana testing kits. It was the precursor to the FDA’s MedWatch program. This contract with the FDA was terminated in September 1995.
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3. Veterinary Reporting Program In 1994, USP established a Veterinary Reporting Program (VRP) to assist the FDA’s Center for Veterinary Medicine (CVM), the Environmental Protection Agency, and the Department of Agriculture in obtaining information about adverse events with veterinary products. Reports were shared with the appropriate government agency and with the manufacturers of the products involved in the reports. The program was terminated in April 2003. 4. Medication Error Reporting Program In 1991, USP established its first Medication Error Reporting Program (MER) in conjunction with the ISMP. MER was designed to obtain spontaneous reports both for the medicine itself and the system in which the medicine was prescribed, dispensed, administered, and used. Between 1991 and 2008, MER received more than 6,000 voluntary reports of actual and potential medication errors. MER identified errors in various health care delivery environments, including hospitals, nursing homes, physicians’ offices, pharmacies, emergency response vehicles, and home care. The reports documented that errors are multi-disciplinary and multi-factorial and that they may be made by experienced as well as inexperienced health professionals, support personnel, interns, students, and even patients and their caregivers. Medication errors can and regularly do occur anywhere along the continuum from prescribing to transcribing to dispensing and administration. The causes of errors may be attributed to human error, to product names or designs, and to the medication handling and delivery systems in which the products are used and in which individuals operate and interact. USP submitted MER reports to the FDA as a MedWatch partner, including adverse drug reactions that came to MER but were not evaluated.
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MER reports were also shared with the relevant manufacturers. Examples of important changes USP made to its standards as a result of MER reports appear below: 4Potassium Chloride — Reported deaths due to the accidental misadministration of concentrated Potassium Chloride Injection led to: 1) changing the official USP name to Potassium Chloride for Injection Concentrate to give more prominence to the need to dilute the product prior to use; 2) requiring that labels bear a boxed warning with the words “Concentrate: Must be Diluted Before Use;” 3) requiring that the cap must be black in color (the use of black caps is restricted to this drug product only); and 4) requiring that the cap must be imprinted in a contrasting color with the words “Must be Diluted.” 4Vincristine Sulfate — Reported deaths due to confusion and the resultant injection of the anticancer drug, Vincristine Sulfate for Injection, directly into the spine instead of the vein resulted in changes in the requirements for packaging by pharmacies and manufacturers preparing ready-to-use doses. Each dose, whether prepared by the manufacturer or the pharmacist, must now be wrapped in a covering labeled “FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES” and that covering may not be removed until the moment of injection. 4Amrinone/Amiodarone — Reported deaths due to the confusion of similar names Amrinone and Amiodarone led USP and the USAN Council to change the nonproprietary name and official title of Amrinone to Inamrinone. 4Neuromuscular Blocking Agents — Reported deaths due to the inadvertent mix-up of neuromuscular blocking agents (which paralyze the respiratory system) with other drugs led to
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recommended changes in standards for labeling and packaging of the therapeutic class of neuromuscular blocking agent products 5. MEDMARX® MEDMARX® was developed by USP in 1998 as an Internet-accessible, anonymous reporting program that enables hospitals to voluntarily report, track, and trend data, incorporating nationally standardized data elements (i.e., definitions and taxonomy). These standardized elements were drawn from the work of the MER Program, the FDA, NCC MERP, and the ASHP. MEDMARX® is structured to support an interdisciplinary, systems-approach to medication error reduction and fosters a non-punitive environment for reporting. USP created MEDMARX® with the intent to broaden the model to include other health care settings, e.g. long-term and ambulatory care settings, and to include other types of reporting such as medical error and adverse drug reactions. Hospitals are encouraged to use MEDMARX® as part of their internal quality improvement processes, thereby extending their “peer-review” to other hospitals in the program. Hospitals can review errors entered by other institutions in “real time” and also see any reported action taken by another institution in response to an error in an effort to avoid similar errors in the future. This feature affords institutions the opportunity to examine errors in a proactive manner. For example, the institution can review the error profile of a drug or class of drugs to determine if certain risk prevention measures or training programs should be established within the institution before a product is added to the institution’s formulary. If the error profile is significantly serious, a
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determination may be made not to stock the drug. MEDMARX® supports the performance improvement standards of the Joint Commission, which requires institutions to look outward at the experiences of others in order to reduce risk. USP transferred its reporting programs, MEDMARX® and MER, to Quantros and ISMP, respectively, in 2008. USP will continue to use data from these and other programs to enhance its standards-setting activities to promote patient safety and safe medication use. In the interest of public health and to assist practitioners and patients, USP has posted eight annual reports on its Web site free of charge, ensuring full access to this clinically important information.
Future Opportunities: 1. Nomenclature, Safety, and Labeling Expert Committee for the 2010-2015 Cycle In the next cycle, a new expert committee—Nomenclature, Safety, and Labeling Expert Committee— will combine the work of the Nomenclature and Safe Medication Use Expert Committees from the 20052010 cycle. This new Expert Committee will build on the work of its predecessors by continuing to develop guidelines, recommendations, General Chapters, and publications related to safe medication practices and patient safety, as well as by linking these efforts to drug naming and the labeling of medications. Via Expert Panels, specific standards-setting activities can be addressed on a broad range of safe medication use and quality of care standards. 2. Institute of Medicine In 2007, the IOM published Preventing Medication Errors, a report by its Committee on Identifying and Preventing Medication Errors. The
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report called on USP to work with the FDA and others in several areas related to drug naming, labeling, and packaging. The IOM posited that there are many ways that basic information about a specific drug is communicated to providers and patients and identified some of the more obvious problems: Brand names and generic names that look or sound alike 4Different formulations of the same brand or generic drug 4Multiple abbreviations to represent the same concept 4Confusing word derivatives, abbreviations, and symbols 4Unclear dose concentration/strength designations 4Cluttered labeling—small fonts, poor typefaces, no background contrast, overemphasis on company logos 4Inadequate prominence of warnings and reminders 4Lack of standardized terminology The proposed IOM action plan focused on two overarching principles: 1) product naming, labeling, and packaging should be designed for the end user—the provider in the clinical environment and/or the consumer; and 2) safety should always take precedence over commercial interests. In addition, Recommendation #4 of the IOM report included USP in a list of organizations that should work together to address labeling, packaging, and the distribution of free samples.
Conclusion: Based on its nomenclature and labeling recognition in the FDCA and exhortations from the community, the need for USP’s involvement in standards to promote safe medication use and quality care is as strong as ever—and may increase in an era of health care crisis and reform. One of USP’s greatest strengths lies in its ability to convene a broad and diverse group of stakeholders around issues common to all, and USP can
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leverage this role by helping to advance standards related to medication safety that are beyond the scope of a single health profession or professional organization. For many years, USP has devoted substantial resources and energy to its safe medication use and quality of care standards-setting activities, but has struggled to find a sustainable financial and public health model for these activities. Convention Delegates must now ask: What is the appropriate role for USP in setting standards related to medication/patient safety, and how will this role be financially supported? The Council of the Convention Section on the Quality of Patient Care calls on the Convention membership to articulate ways in which a standards-setting body such as USP can continue its work based on USP’s historical contributions, unique capabilities, and current and possible future positions in law. A BOUT USP and NA SPA The United States Pharmacopeia (USP) is an official public standards–setting authority for all prescription and over–the–counter medicines and other health care products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. USP sets standards for the quality, purity, strength, and consistency of these products–critical to the public health. USP’s standards are recognized and used in more than 130 countries around the globe. These standards have helped to ensure public health throughout the world for close to 200 years. More information can be found at www.USP.org The National Alliance of State Pharmacy Associations (NASPA) promotes leadership, sharing, learning, and policy exchange among state pharmacy associations and pharmacy leaders nationwide, and provides education and advocacy to support pharmacists, patients, and communities working together to improve public health. NASPA was founded in 1927 as the National Council of State Pharmacy Association Executives (NCSPAE). More information can be found at www.naspa.us
Reprinted with permission. Copyright 2009, The United States Pharmacopeial Convention. All rights reserved.
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Continuing Education for Pharmacists Quiz and Evaluation USP’s Role in Patient Safety 1. An article with an “established name” must meet USPNF standards for which of the following a. Identity b. Strength c. Quality d. All of the above
7. Changes were recommended to reduce the chance of vincristine and other vinca alkaloids from being administered incorrectly. The correct route of administration is: a. intravenous b. intrathecal c. intramuscular d. intracranial
2. Which of the following works in collaboration with the USAN Council? a. USP Nomenclature Expert Committee b. Safe Medication Use Expert Committee c. National Coordinating Council for Medication Error Reporting and Prevention d. None of the above
8. Which of the following is true regarding the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP/The Council)? a. They defined a “medication error” and encouraged all stakeholders to use the definition b. The first group had 26 member organizations and 2 individual members c. The council examines medication errors but does not evaluate causes of those errors d. All of the above are true
3. Which of the following does USP serve as the Secretariat for? a. USP Nomenclature Expert Committee b. Safe Medication Use Expert Committee c. National Coordinating Council for Medication Error Reporting and Prevention d. None of the above
9. Which program was operated under contract with the FDA Center for Devices and Radiological Health (CDRH) a. Drug Product Problem Reporting Program b. Medical Device and Laboratory Product Problem Reporting Program c. Veterinary Reporting Program d. Medication Error Reporting Program
4. Which of the following developed guidelines, recommendations, a General Chapter, and publications related to safe medication practices and patient safety? a. USP Nomenclature Expert Committee b. Safe Medication Use Expert Committee c. National Coordinating Council for Medication Error Reporting and Prevention d. None of the above
10. Between 1991 and 2008, Medication Error Reporting Program (MER) received how many voluntary reports of actual and potential medication errors? a. Over 3,000 b. Over 4,000 c. Over 5,000 d. Over 6,000
5. How many members does the 2005-2010 Safe Medication Use Expert Committee have? a. 16 b. 17 c. 18 d. 19 6. Studies on which of the following were conducted in an effort to better understand the current landscape regarding use of an experience with enhanced lettering as a safety tool? a. Tall Man Lettering b. Harmonization c. Health Literacy and Prescription Container Labeling d. Standardized Intravenous Concentrations
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Journal CPE Answer Sheet The Georgia Pharmacy Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
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2009 - 2010 GPhA BOARD OF DIRECTORS
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The Georgia Pharmacy Journal® (GPJ) is the official publication of the Georgia Pharmacy Association, Inc. (GPhA). Copyright © 2010, 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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