Intrathecal Drug Therapy for Chronic Pain

Improving Patient Selection and Maximizing Outcomes DECEMBER 11, 2015 | 6:00 am – 7:45 am Mandalay Bay Hotel & Casino | Islander A/F

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This activity is jointly provided by Global Education Group and Integritas Communications.

This activity is supported by an educational grant from Jazz Pharmaceuticals.

This program is not affiliated with NANS.

CME/MEDICAL COMMUNICATIONS INQUIRIES info@integritasgrp.com integritasgrp.com

RICHARD L.

FACULTY

FACULTY

Rauck, MD, FIPP Clinical Associate Professor Department of Anesthesiology Wake Forest University School of Medicine Winston-Salem, North Carolina

Dr. Richard L. Rauck is a pain management physician in Winston-Salem, North Carolina.

Dr. Rauck graduated from Wake Forest University in 1982, after receiving his BS from Davidson College in Davidson, North Carolina. He completed his residency in anesthesiology in 1985 at the University of Cincinnati College of Medicine in Cincinnati, Ohio. In 1986 he completed a Fellowship in Pain Control at University of Cincinnati College of Medicine in Cincinnati, Ohio. Dr. Rauck is board certified in Pain Medicine and Anesthesiology.

Dr. Rauck has a long and active history of publishing in peer-reviewed medical journals, speaking at many national and international professional meetings, and maintaining an active clinical practice in pain management. He has authored over 100 original articles.

Dr. Rauck practices pain management as President of Carolinas Pain Institute, which he founded, and is the medical director for the Center for Clinical Research, LLC, which he also founded.

Presently, he is an editorial reviewer for Anesthesiology, Neuromodulation, and Journal of Pain, and is on the editorial boards of Pain Practice and Neuromodulation. President of both Sceptor Pain Foundation, of which he is a founding member, and of the World Institute of Pain, Dr. Rauck further serves on the board of directors for the North American Neuromodulation Society. He also received the John J. Bonica award in 2013 through the American Society of Regional Anesthesia and Pain Medicine. He is part of many other well-known associations and committees, too numerous to mention here.

He continues as Clinical Associate Professor of the Department of Anesthesiology at Wake Forest University School of Medicine and is director of the fellowship program of this department. Dr. Rauck was elected by his peers to be included in Best Doctors in America速 1992- 2015.

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TIMOTHY R. FACULTY

Deer, MD, DABPM President and Chief Executive Officer Center for Pain Relief, Inc. Charleston, West Virginia

Dr. Timothy Deer was born and raised in Chesapeake, West Virginia. During the last decade, he has originated many ideas that have been incorporated into the mainstream of present day theory and practice of interventional pain management.

Dr. Deer received his medical school education at West Virginia University, where he was an Alpha Omega Alpha honor student at the top of his class. After medical school, Dr. Deer attended the University of Virginia School of Medicine, where he trained in Internal Medicine, Anesthesiology, and Pain Medicine.

Over the past 13 years, Dr. Deer has held numerous appointments, including that of Chairman of the American Society of Anesthesiologists’ committee on Pain Medicine. This 42,000–member group represents more pain clinicians than any other organized body. Dr. Deer has also been President of the West Virginia Society of Anesthesiologists, President of the West Virginia Society of Interventional Pain Physicians, and Representative to the Carrier Advisory Committee to Medicare for Ohio and West Virginia.

In addition to those positions. Dr. Deer is on the Board of Directors for the North American Neuromodulation Society. He is also on the editorial committees for the journals Neuromodulation, Pain Medicine, and Pain Physician.

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ERIC J.

FACULTY

Grigsby, MD, MBA CEO and President, Neurovations Founder and Medical Director Napa Pain Institute Napa, California

Dr. Eric J. Grigsby is the Founder and Medical Director of Napa Pain Institute in Napa, California. A board-certified Anesthesiologist and Pain Physician, he is among the world’s clinical leaders in the field of Targeted Drug Delivery and Neuromodulation. Dr. Grigsby also serves as the President and Chief Executive Officer of Neurovations, a Clinical Research and Consulting company specializing in pain and neurologic disease.

Dr. Grigsby graduated from Brown University in Providence, Rhode Island, with an undergraduate degree in Biology and Economics. He then completed medical school at Boston University School of Medicine in Massachusetts and residency training in Anesthesiology and Pain Medicine at the Mayo Clinic in Rochester, Minnesota. He received his Masters in Business Administration from Duke University in Durham, North Carolina.

At Neurovations, Dr. Grigsby and his team collaborate with leading scientists, industry leaders, and clinicians to help shorten the innovation cycle of new therapies for pain and neurologic diseases.

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TARGET AUDIENCE The educational design of this activity addresses the needs of interventional pain specialists and other allied healthcare professionals involved in the treatment of patients with severe chronic pain.

PREAMBLE

STATEMENT OF NEED/PROGRAM OVERVIEW An estimated 100 million adults in the United States suffer from at least 1 chronically painful condition.1 Complexities in the underlying pathophysiologic mechanisms and clinical manifestations result in a large number of patients for whom conventional management strategies fail to produce adequate pain relief or the desired functional gains.2 For some of these individuals, intrathecal delivery of analgesic medications can be a safe and effective treatment modality.3,4 The US Food and Drug Administration has approved 2 analgesics—ziconotide and morphine—as intrathecal medications for patients with severe chronic pain.5 Despite the availability of these agents, however, the use of intrathecal therapy for chronic pain is often suboptimal, in part owing to poor patient selection, systemic barriers, and safety concerns (eg, opioid-induced respiratory depression).6 Using an engaging educational format, this Interactive Exchange™ program will provide attendees with the latest published evidence and practical guidance on the evaluation of candidates for intrathecal drug delivery, the potential benefits and risks of various intrathecal analgesics, and the essential elements of initial and ongoing patient monitoring plans.

REFERENCES 1. National Research Council. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Institute of Medicine. Washingon DC: The National Academies Press; 2011.

2. Gatchel RJ, Peng YB, Peters ML, Fuchs PN, Turk DC. The biopsychosocial approach to chronic pain: scientific advances and future directions. Psychol Bull. 2007;133(4):581-624.

3. Onofrio BM, Yaksh TL, Arnold PG. Continuous low-dose intrathecal morphine administration in the treatment of chronic pain of malignant origin. Mayo Clin Proc. 1981;56(8):516-520.

4. Prager J, Deer T, Levy R, et al. Best practices for intrathecal drug delivery for pain. Neuromodulation .

2014;17(4):354-372.

5. Ver Donck A, Vranken JH, Puylaert M, et al. Intrathecal drug administration in chronic pain syndromes.

Pain Pract. 2014;14(5):461-476.

6. Coffey RJ, Owens ML, Broste SK, et al. Mortality associated with implantation and management of intrathecal opioid drug infusion systems to treat noncancer pain. Anesthesiology. 2009;111(4):881-891.

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EDUCATIONAL OBJECTIVES After completing this activity, the participant should be better able to: • Assess candidates for intrathecal therapy via comprehensive medical histories, physical examinations, accurate pain diagnoses, and psychological evaluations • Describe the clinical profiles, dosing strategies, and other prescribing considerations for analgesic medications approved for intrathecal delivery • Construct intrathecal regimens for chronic pain that reflect potential medication benefits and risks, guideline recommendations, previous treatment responses, and therapeutic trial results

PREAMBLE

• Tailor intrathecal drug therapy based on ongoing monitoring of analgesia, functional outcomes, and treatment-emergent adverse events

PROGRAM AGENDA 6:00 am – 6:15 am

Registration and Breakfast

6:15 am – 6:20 am

Faculty Introductions

6:20 am – 6:30 am Scientific Updates on Intrathecal Analgesics 6:30 am – 7:20 am Best Practices for Intrathecal Therapy in Patients

With Chronic Pain 7:20 am – 7:30 am

Choose-a-Case: Audience-Directed Learning

7:30 am – 7:45 am

Ask the Experts: Question and Answer Session

PHYSICIAN ACCREDITATION STATEMENT This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Global Education Group (Global) and Integritas Communications. Global is accredited by the ACCME to provide continuing medical education for physicians.

This CME/CE activity complies with all requirements of the federal Physician Payment Sunshine Act. If a reportable event is associated with this activity, the accredited provider managing the program will provide the appropriate physician data to the Open Payments database.

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PHYSICIAN CREDIT DESIGNATION Global Education Group designates this live activity for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

GLOBAL CONTACT INFORMATION PREAMBLE

For information about the accreditation of this program, please contact Global at 303-395-1782 or inquire@globaleducationgroup.com.

INSTRUCTIONS TO RECEIVE CREDIT In order to receive credit for this activity, the participant must complete the program evaluation.

FEE INFORMATION & REFUND/ CANCELLATION POLICY There is no fee for this educational activity.

DISCLOSURE OF CONFLICTS OF INTEREST Global Education Group (Global) requires instructors, planners, managers, and other individuals and their spouses/life partners who are in a position to control the content of this activity to disclose any real or apparent conflict of interest they may have as related to the content of this activity.

The faculty reported the following financial relationships or relationships to products or devices they or their spouses/life partners have with commercial interests related to the content of this CME activity:

Richard L. Rauck, MD, FIPP

Consultant – Jazz Pharmaceuticals; Grant/ Research Support – Alfred Mann Foundation, Mallinckrodt Pharmaceuticals, Medtronic; Honoraria – Medtronic; Speakers Bureau – Jazz Pharmaceuticals

Timothy R. Deer, MD, DABPM

Advisory Board – Axonics Modulation Technologies, Inc., Bioness Inc., Flowonix Medical Inc., Jazz Pharmaceuticals, Medtronic, Nevro Corp., Spinal Modulation Inc., St. Jude Medical, Inc.; Consultant – Axonics Modulation Technologies, Inc., Bioness Inc., Ethos Pharmaceuticals, Inc., Flowonix Medical Inc., Mallinckrodt Pharmaceuticals, Medtronic, Nevro Corp., Spinal Modulation Inc., SpineThera, Inc., St. Jude Medical, Inc., Vertos Medical Inc.;

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Grant/Research Support – Bioness Inc., Jazz Pharmaceuticals, Medtronic, Spinal Modulation Inc., St. Jude Medical, Inc.; Speakers Bureau – Jazz Pharmaceuticals; Stock Options – Axonics Modulation Technologies, Inc., Bioness Inc., Ethos Pharmaceuticals, Inc., Nevro Corp., Spinal Modulation Inc., SpineThera, Inc., Vertos Medical Inc.

Eric J. Grigsby, MD, MBA

Consultant – Jazz Pharmaceuticals, Medallion Therapeutics, Inc., Medtronic; Grant/Research Support – Medtronic; Stock Shareholder – Medallion Therapeutics, Inc.

Amanda Glazar, PhD

Nothing to disclose

Andrea Funk

Nothing to disclose

Laura Gilsdorf

Nothing to disclose

Jim Kappler, PhD

Nothing to disclose

PREAMBLE

The planners and managers reported the following financial relationships or relationships to products or devices they or their spouses/life partners have with commercial interests related to the content of this CME activity:

DISCLOSURE OF UNLABELED USE This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. Global Education Group (Global) and Integritas Communications do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of any organization associated with this activity. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

DISCLAIMER Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management.

Any procedures, medications, or other courses of diagnosis or treatment discussed in this activity should not be used by clinicians without evaluation of patient conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

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GUIDELINES Polyanalgesic Consensus Conference—2012: Recommendations on Trialing for Intrathecal (Intraspinal) Drug Delivery: Report of an Interdisciplinary Expert Panel Deer TR, et al. Neuromodulation. 2012;15(5):420-435. »» http://www.ncbi.nlm.nih.gov/pubmed/22494357

Polyanalgesic Consensus Conference—2012: Recommendations for the Management of Pain

by Intrathecal (Intraspinal) Drug Delivery: Report of an Interdisciplinary Expert Panel Deer TR, et al. Neuromodulation. 2012;15(5):436-464. »» http://www.ncbi.nlm.nih.gov/pubmed/22748024

Polyanalgesic Consensus Conference—2012: Recommendations to Reduce Morbidity and Mortality in Intrathecal Drug Delivery in the Treatment of Chronic Pain Deer TR, et al. Neuromodulation. 2012;15(5):467-482. »» http://www.ncbi.nlm.nih.gov/pubmed/22849581

Deer TR, et al. Neuromodulation. 2012;15(5):483-495. »» http://www.ncbi.nlm.nih.gov/pubmed/22494332

Best Practices for Intrathecal Drug Delivery for Pain Prager J, et al. Neuromodulation. 2014;17(4):354-372. »» http://onlinelibrary.wiley.com/doi/10.1111/ner.12146/epdf

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RESOURCE CENTER

Polyanalgesic Consensus Conference—2012: Consensus on Diagnosis, Detection, and Treatment of Catheter-Tip Granulomas (Inflammatory Masses)

SUGGESTED READING Mortality Associated With Implantation and Management of Intrathecal Opioid Drug Infusion Systems to Treat Noncancer Pain Coffey RJ, et al. Anesthesiology. 2009;111(4):881-891. »» http://anesthesiology.pubs.asahq.org/article.aspx?articleid=1932483

Intrathecal Ziconotide and Opioid Combination Therapy for Noncancer Pain: an Observational Study Deer TR, et al. Pain Physician. 2009;12(4):E291-E296. »» http://www.painphysicianjournal.com/2009/july/2009;12;E291-E296.pdf

Factors to Consider in the Choice of Intrathecal Drug in the Treatment of Neuropathic Pain Deer TR, Pope JE. Expert Rev Clin Pharmacol. 2015;8(5):507-510. »»http://www.tandfonline.com/doi/pdf/10.1586/17512433.2015.1060577

Prospective Study of 3-Year Follow-up of Low-Dose Intrathecal Opioids in the Management of Chronic Nonmalignant Pain Hamza M, et al. Pain Med. 2012;13(10):1304-1313. »» http://www.ncbi.nlm.nih.gov/pubmed/22845187

RESOURCE CENTER

Androgen Deficiency in Long-term Intrathecal Opioid Administration Kim CH, et al. Pain Physician. 2014;17(4):E543-E548. »» http://www.painphysicianjournal.com/current/ pdf?article=MjEzOQ%3D%3D&journal=83

Intrathecal Pharmacology Update: Novel Dosing Strategy for Intrathecal Monotherapy Ziconotide on Efficacy and Sustainability Pope JE, Deer TR. Neuromodulation. 2015;18(5):414-420. »»http://onlinelibrary.wiley.com/doi/10.1111/ner.12274/abstract

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Intrathecal Therapy: The Burden of Being Positioned as a Salvage Therapy Pope JE, et al. Pain Med. 2015;16(10):2036-2038. »» http://www.neuromodulation.org/Portals/0/ Final%20Drug%20Delivery%20for%20Patient.pdf

Practical Considerations and Patient Selection for Intrathecal Drug Delivery in the Management of Chronic Pain Saulino M, et al. J Pain Res. 2014;7:627-638. »» http://www.dovepress.com/practical-considerations-and-patient-selection-forintrathecal-drug-de-peer-reviewed-article-JPR

Safety and Efficacy of Intrathecal Ziconotide in the Management of Severe Chronic Pain Smith HS, Deer TR. Ther Clin Risk Manag. 2009;5(3):521-534. »» http://www.dovepress.com/safety-and-efficacy-of-intrathecal-ziconotide-in-themanagement-of-sev-peer-reviewed-article-TCRM

Long-term Intrathecal Ziconotide for Chronic Pain: an Open-Label Study Webster LR, et al. J Pain Symptom Manage. 2009;37(3):363-372. »» http://www.sciencedirect.com/science/article/pii/S088539240800376X

Clinical Accuracy and Safety Using the SynchroMed II Intrathecal Drug Infusion Pump

Programmable Intrathecal Pumps for the Management of Chronic Pain: Recommendations for Improved Efficiency Wilkes D. J Pain Res. 2014;7:571-577. »» http://www.dovepress.com/programmable-intrathecal-pumps-for-the-managementof-chronic-pain-reco-peer-reviewed-article-JPR

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RESOURCE CENTER

Wesemann K, et al. Reg Anesth Pain Med. 2014;39(4):341-346. »» http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4218763/pdf/aap-39-341.pdf

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