• Activity Date
• Participation Expiration Date
• Target Audience Statement
• Accreditiation Statement and Credit Designation
• Commercial Support
• Statement of Need
• Faculty Credentials and Disclosure Information
• General Learning Objectives
• Method of Participation
• Evaluation Method
• Hardware/Software Requirements
• Participant Support

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October 20, 2008

Participation Expiration Date

October 20, 2009

This activity is intended for transplant physicians, nurses, pharmacists, and certified case managers with an interest in liver transplantation.

Physician:
Lippincott Continuing Medical Education Institute, Inc. is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education to physicians.

Lippincott Continuing Medical Education Institute, Inc. designates this educational activity for a maximum of 2 AMA PRA Category 1 Credit(s)™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Nurse:
Lippincott Williams & Wilkins is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.

LWW is also an approved provider of continuing nursing education by the American Association of Critical-Care Nurses #00012278 (CERP category A), California CEP 11749, District of Columbia, Florida #FBN2454, and Iowa #75. LWW home study activities are classified for Texas nursing continuing education requirements as Type 1.

Lippincott Williams & Wilkins will award 3.0 contact hours for this continuing education activity. Expiration Date: October 31, 2009.

Pharmacist:
Lippincott Continuing Medical Education Institute, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

This program is designated for a maximum of 2 contact hours (0.2 CEUs). ACPE Universal Program Number 431-000-08-009-H01-P has been assigned to this program. Expiration Date: October 20, 2009.

Certified Case Manager:
This Continuing Education (CE) activity is provided by Lippincott Williams & Wilkins and has been preapproved by the Commission for Case Management Certification (CCMC) for 2 clock hours. CCM clock hours are based on a 60-minute hour. The CE is approved for meeting the requirements for certification renewal.

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Commercial Support

This CE activity has been supported by an independent educational grant from Astellas Pharma US, Inc.

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Statement of Need

Given the considerable advances in the field of organ transplantation, as well as enhancing patient safety in transplantation, the target audience of transplant physicians/surgeons, pharmacists, transplant nurses, and certified case managers in the field of transplantation has a need for such information to increase knowledge, improve competency and better their patient care. This publication provides timely and useful information from leading researchers and experts presented at the 2008 Joint International Congress of the ILTS, ELITA & LICAGE to help the target audience stay abreast of the latest knowledge in this important area, and apply that new knowledge in a way that would improve their care of patients.

Liver transplants in the U.S. in 2005 totaled approximately 6,000. The waiting list candidates (active and inactive) for livers has increased. Specific details on liver transplants are cited below (data obtained from the 2006 OPTN/SRTR Annual Report).

Liver Transplantation

• The number of liver transplants performed yearly has slowly and steadily increased over the last 10 years, reaching 6,441 procedures in 2005;
• The number of living donor liver transplants performed rose steadily from 1996 to 2001, when it peaked at 519; since 2003 there have been approximately 320 such procedures performed each year;
• The continual increase in the size of the waiting list for a liver transplant, which peaked in 2001, was interrupted in 2002 by the implementation of the allocation system based on the Model for End-stage Liver Disease and Pediatric End-stage Liver Disease (MELD/PELD).

During the first quarter of 2007, there were a total of 6,799 documented transplants; during that same quarter there were only 3,478 donors. According to the United Network for Organ Sharing,1 there are over 96,000 candidates on waiting lists for organ transplantation: approximately 66,200 for kidneys, 17,500 for livers, 2,500 for pancreas or combined kidney/pancreas transplants, 3,200 for hearts or heart/lung transplants, and 3,000 for lung transplants.²

Key outcomes after liver transplantation include a) survival of transplant recipients and b) the function of transplanted grafts. Graft survival rates are lower than patient survival rates because patients may survive a graft failure receiving a second transplant or with an alternative therapy. There are numerous published studies and reports regarding organ donor issues, surgical procedures, changes in immunosuppression regimens, risk factors for graft survival, and graft rejections.^3-7 However, additional investigations are needed to provide healthcare professionals with practical applications of research on solid organ transplantation and to develop new pharmacological agents to minimize organ rejection^8,9 and provide better patient care.

In recent years, living donor liver transplantation (LDLT) has emerged as a viable surgical option for patients with end stage liver disease.¹⁰ LDLT is considered more technically demanding than standard cadaveric donor transplantation. Right lobe LDLT, in particular, involves one of the most complicated surgical procedures and has created controversy regarding the safety of the healthy donor.¹¹ Right lobe LDLT is a relatively novel procedure with a relatively short history. However, in the past decade, the number of right lobe LDLTs has increased, and the results are improving significantly with technical refinement and better experience.¹¹ The safety of the donor remains a primary concern.

During the past 20 years, a variety of immunosuppressive agents have greatly expanded the choice of therapies for transplant physicians and surgeons.¹² Although new therapies have provided many choices for effective immunosuppression regimens in transplantation, intensified immunosuppression has also led to more complications such as previously rare infections and malignancies.¹³ Malignancy is now one of the most significant cause of mortality in transplant recipients.¹⁴ Transplant patients are at elevated risk for a wide range of solid-organ tumor types in addition to skin cancers and posttransplant lymphoproliferative disorder (PTLD).¹⁴ The risk of oncogenesis after transplantation is believed to closely correlate with exposure to immunosuppression—both overall and cumulative.¹⁴ The prevention of malignancy depends on a delicate balance in immunosuppression between rejection and malignancy risk.¹⁴

To minimize the risk of malignancies, researchers are exploring the use of drug minimization regimens in the interim to improve safety while maintaining efficacy of the current agents. However, a number of issues remain unresolved regarding these regimens, such as the timing of withdrawal, the risks and benefits of total avoidance, and the use of concomitant therapies and induction.

Another therapeutic strategy that has increased significantly in the past decade is the use of induction therapy before transplantation.¹⁵ The advantages of this approach lie in its ability to attenuate the initial immune response, reduce the potential for acute rejection episodes, and allow a reduction of immunosuppression after transplantation. However, despite the benefits of induction therapy, questions remain regarding the efficacy of different agents as well as the long-term consequences of induction therapy.

An area of increasing concern is the recurrence of hepatitis C virus (HCV) disease after liver transplantation. After transplant, 100% of recipients will have HCV viral recurrence.16 More than half of recipients will have some kind of abnormal histology at one year.¹⁶ At 5 years after transplantation, about 25% of recipients are at risk for developing cirrhosis,¹⁷ and graft failure occurs in about 10%.¹⁶ In recent years, the frequency and severity of HCV disease after transplantation appears to be increasing.¹⁸ Recurrent HCV infection is now the most common cause for graft failure in HCV-positive recipients.¹⁶ These findings are particularly ominous given that, in most recipients, re-transplantation for recurrent HCV has significantly worse outcome than primary transplantation.¹⁸

In order to fulfill the evidence-based practice competency standards cited by the Institute of Medicine¹⁹,  as well as clinical guidelines issues by the American College of Cardiology/American Heart Association20, the European Society of Cardiology²¹, and the National Kidney Foundation¹⁶, transplant professionals must integrate best research with clinical expertise and patient values for optimum care, and participate in learning and research activities to the extent feasible in order to gain a more complete understanding of current and possible future treatments for patients with diseases requiring solid organ transplantation.^23-27 The overall goal of this CPE activity, in keeping with LCMEI’s CME Mission, is to  help physicians increase their knowledge of the topic area, which hopefully will lead to improved competency, adherence to established practice guidelines, and overall better management of their transplantation patients.

The educational design (print- and online-based, distance-learning activity) of this CE program will provide participants with the latest research on liver transplant procedures, outcomes, patient management, and graft survival directly from leading experts. The format and design of 2008 ILTS Meeting Highlights CME Report as a print- and online-based, distance-learning activity has previously proven to be a credible and well-liked vehicle for the continuing medical education of transplant physicians, pharmacists, transplant nurses, and certified case managers, and to help improve overall patient care²⁸. This is evidenced by the rising numbers of physicians participating in such activities over the last two years, as evidenced by data compiled by various accrediting organizations from its accredited providers.

This CE activity includes a CE quiz, which allows participants to test their skills and their knowledge of the material presented in the educational activity. The CME activity will contain an evaluation assessment questionnaire that provides participants’ with a means to assess the activity’s quality, fairness, and balance, whether participants have increased their knowledge of the subject matter as a result of participating in the CE activity and may use that new knowledge to change their practice behavior, and to suggest topics of educational need for future transplantation-related Meeting Highlights CME Reports.

References

1. United Network for Organ Sharing. Available at: http://www.optn.org.
2. Organ Procurement and Transplantation Network. Available at: http://www.optn.org/data.
3. Magee JC, et al. Am J Transplant 2007;7:1319-1326.
4. Punch JD, et al. Am J Transplant 2007;7:1327-1338.
5. Pomfret EA, et al. Am J Transplant 2007;7:1376-1389.
6. Garrity ER, et al. Am J Transplant 2007;7:1390-1401.
7. Wolfe, RA, et al. Am J Transplant 2007;7:1404-1411.
8. Gallon LG, et al. Transplantation 2007;83:1324-1329.
9. Bagley J, et al. Transplantation 2007;84(1 suppl):S38-41.
10. Mayo Clinic. http://www.mayoclinic.org/liver-transplant/livingdonortransplant.html.
11. Lo CM, et al. Ann Surg. Jul 2004;240(1):151-158.
12. Hirose R, et al. Semin Liver Dis. Aug 2006;26(3):201-210.
13. Vincenti F. J Am Soc Nephrol. Jul 2003;14(7):1940-1948.
14. Buell JF, et al. Transplantation. Oct 15 2005;80(2 Suppl):S254-264.
15. Chandraker A, et al. Clin J Am Soc Nephrol. May 2006;1(3):356-357.
16. Gane E. Liver Transpl. Nov 2003;9(11):S28-34.
17. Mukherjee S, et al. Gastroenterology. May 2008;134(6):1777-1788.
18. Cameron AM, et al. Ann Surg. Oct 2006;244(4):563-571.
19. Greiner AC, Knebel E eds. Health professions education: a bridge to quality. Institute of Medicine, Washington, DC: National Academies Press, Washington, DC; 2003.
20. Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. ACC/AHA 2005 Guidelines update for the diagnosis and management of chronic heart failure in the Adult American Heart Association. 2005 (Aug. 16).
21. European Society of Cardiology. Guidelines on the diagnosis and treatment of acute heart failure. 2005.
22. American Association for the Study of Liver Diseases. AASLD practice guidelines: evaluation of the patient for liver transplantation. 2004 (Oct. 26).
23. Kidney Diseases Improving Global Outcomes (KDIGO). KDIGO Clinical Practice Guidelines for the Kidney Transplant Recipient
24. Martin, JE. Am J Health Sys Pharm 2005; 62(16): 15-18.
25. Snell G, et al. Med J Australia 2006; 184(9): 428-429.
26. Avery, RK and Michaels, M. Am J Transplantation 2008 (Mar. 5).
27. Platt, JL. ScienceDaily 1998 (Sept. 22).
28. Kasiske, B, et al. Am J Transplantation 2004; 4(7): 13-53.

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Faculty Credentials and Disclosure Information

Editor-In-Chief
Arthur J. Matas, MD, Professor of Surgery and Director, Renal Transplant Program, University of Minnesota, Minneapolis, Minnesota.
(Dr. Matas was/is a recipient of research grants from Astellas, Bristol-Myers Squibb, Genzyme, Novartis, Roche, and Wyeth.)

Pharmacy Editor
Julie A. Golembiewski, PharmD, Clinical Associate Professor, Department of Pharmacy Practice, University of Illinois Medical Center at Chicago, Chicago, Illinois.
(Dr. Golembiewski was a recipient of research grants from Hospira, Inc.; was a consultant for Baxter and Organon; and was on the speakers bureau of Baxter.)

Nurse Editor
Kim D. Phillips, RN, BSN, CCTC, Education and Community Outreach Coordinator, Transplant Program, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.
(Ms. Phillips has disclosed that she has no significant relationships with, or financial interests in, any commercial organizations pertaining to this educational activity.)

Pharmacy Peer Reviewer
Peggy Bickham, PharmD, Assistant Director of Pharmacy, Specialty and Support Services, Clinical Assistant Professor, University of Illinois Medical Center, Chicago, Illinois.
(Dr. Bickham has disclosed that she has no significant relationships with, or financial interests in, any commercial organizations pertaining to this educational activity.)

Medical Writer
Mary C. Love, AMWA Medical Writer, Columbia, Maryland.
Ms. Love  has disclosed that she has no significant relationships with, or financial interests in, any commercial organizations pertaining to this educational activity.

Other Staff (LCMEI, WKH, Other)
Karen Innocent (Director of CE [Nursing]) has disclosed that her spouse is an employee of Merck & Co. All other persons in a position to control the content of this CME activity have disclosed that they have no financial relationships with, or financial interests in, any commercial companies pertaining to this educational activity.

Identification and Resolution of Conflicts of Interest
Lippincott CME Institute, Inc. has identified and resolved any faculty conflicts of interest regarding this educational activity.

Off-Label or Investigational Usage Discussion
Dr. Matas has disclosed the following:

rATG has not been approved by the US Food and Drug Administration for liver induction. Please consult product labeling for the approved usage of this drug.

Everolimus is not yet approved by the US Food and Drug Administration
Tacrolimus in combination with Mycophenolate mofetil is not yet approved by the US Food and Drug Administration

General Learning Objectives

After completing this CME activity, participants should be able to:

1. Discuss the current rationale, indications and safety implications for the use of live donor liver transplantation.
2. Identify the advantages and disadvantages of, minimizing the use of steroids and calcineurin inhibitors in transplantation.
   
3. Describe the role of antiviral therapy in reducing and managing the recurrence of hepatitis C infections in liver transplant patients.
4. Explain the link between transplantation and the risk of oncogenesis.
5. Identify risk factors that may potentially increase the risk of malignancy after transplantation.

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Method of Participation

PHYSICIAN
Print: To earn CME credit, a participant must read the activity content and complete the quiz and evaluation assessment questionnaire, answering at least 70% of the quiz questions correctly. Participants must make a photocopy of the completed answer form for their own files and send the original answer form to Lippincott Continuing Medical Education, Inc., (LCMEI), 770 Township Line Road, Suite 300, Yardley, PA 19067. Only the first entry will be considered for credit and must be received by LCMEI by October 20, 2009. Acknowledgment will be sent to the participant within 6 to 8 weeks of participation.

Online: To earn CME credit, a participant must review the CME Overview information, complete the online CE Pre-Test, read the activity content, and complete the online CME Quiz and Evaluation Assessment questionnaire, answering at least 70% of the quiz questions correctly. A participant must elect the best answer and place a check mark in the corresponding space on the answer screen. Upon completion, the subscriber clicks the "Send" button and submits the exam for grading. Upon achieving a passing score, participants are provided with a certificate .pdf to print out on their own computers.

NURSE
Print: To earn CE credit, a participant must read the activity content and complete the quiz and evaluation assessment questionnaire, answering at least 70% of the quiz questions correctly. Participants must mail the completed form to Lippincott Williams & Wilkins, CE Group, 2710 Yorktowne Blvd., Brick, NJ 08723. Your entry must be received by LWW by October 31, 2009. Upon passing, you will receive your CE certificate of earned contact hours and an answer key to review your results with 4 to 6 weeks. If you fail, you have the option of taking the test again. There is no fee for participation in this CE activity.

Online: To earn CE credit, a participant must review the CE Overview information, complete the online CPE Pre-Test, read the activity content, and complete the online CE Quiz and Evaluation Assessment questionnaire, answering at least 70% of the quiz questions correctly. A participant must elect the best answer and place a check mark in the corresponding space on the answer screen. Upon completion, the subscriber clicks the "Send" button and submits the exam for grading. Upon achieving a passing score, participants are provided with a certificate .pdf to print out on their own computers.

PHARMACIST
Online: To earn CPE credit, you must first read the CPE Overview information, complete the online CPE Pre-Test, read the designated CPE content, and complete the online CPE Post­-Test and Evaluation Assessment questionnaire, answering at least 70% of the quiz questions correctly. A participant must elect the best answer and place a check mark in the corresponding space on the answer screen. Upon completion, the subscriber clicks the "Send" button and submits the exam for grading. Upon achieving a passing score, participants are provided with a certificate .pdf to print out on their own computers. There is no fee or charge for this activity to participants.

CERTIFIED CASE MANAGER
Online: To earn CE credit, a participant must review the CE Overview information, complete the online CPE Pre-Test, read the activity content, and complete the online CE Quiz questionnaire, answering at least 70% of the quiz questions correctly. A participant must elect the best answer and place a check mark in the corresponding space on the answer screen. Upon completion, the subscriber clicks the "Send" button and submits the exam for grading. Upon achieving a passing score, participants are provided with a certificate .pdf to print out on their own computers.

PHYSICIAN
Eight evaluation assessment questions are included. These questions ensure that Lippincott CME Institute determines that each activity’s learning objectives have been met, that the activity was of educational value to the target audience and was unbiased, assess whether or not the CME activity has resulted in a change in physician practice behavior, and offer participants a method of feedback.

NURSE
Five evaluation assessment questions are included. These questions ensure that Lippincott Williams & Wilkins determines that each activity's learning objectives have been met, that the activity was of educational value to the target audience and was unbiased, and offer participants a method of feedback.

PHARMACIST
An evaluation assessment questionnaire is included. These questions ensure that Lippincott CME Institute determines that each activity's learning objectives have been met, that the activity was of educational value to the target audience and was unbiased, assess whether or not the CPE activity has resulted in a change in pharmacist practice behavior, and offer participants a method of feedback.

Privacy Policy (online)
Lippincott CME Institute, Inc. has created this privacy statement in order to demonstrate our firm commitment to the privacy of our customers. The following discloses our practices on gathering and disseminating information for this web site.

LCMEI, Inc. has security measures in place to protect the loss, misuse and alteration of the information under our control. LCMEI, Inc. does not share or sell any individual's contact information, financial information, or unique identifiers to any commercial supporter, advertiser or third party without the specific permission of the individual.

If you have any questions about this privacy statement, the practices of this site, or your dealings with this web site, you can contact:

Hardware/Software Requirements

Participants must have Internet access and the correct browser software (Internet Explorer version 5.5 and higher or Netscape 7.02 and higher). If your browser is not current, please click on the specific link below to download the appropriate software (free of charge), by visiting the Microsoft or Netscape web site. To maximize your viewing, we suggest that you set your monitor resolution to 1024 x 768 pixels. Site can viewed 800 x 600 pixels but frame scrolling will result.

Participant Support

CECity.com Technical Support
If you have any questions about your access to this CPE activity or problems with completing the post-test/evaluation, please contact support@cecity.com. Call CECity Toll-Free at 1-888-My-CECity (1-866-692-3248), Monday-Friday 9AM to 6PM EST

LCMEI, Inc. Online CME Support
If you have any content-related questions about the online CPE activities, please feel free to contact LCMEI, Inc. at 1-267-757-3531.

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