Intrathecal Drug Delivery for

CHRONIC PAIN

Selecting Patients and Optimizing Long-term Outcomes

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

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

There is no registration fee for attending this commercially supported satellite symposium. Attendees are admitted on a first-come, first-served basis.

An official independent commercially supported satellite symposium held in conjunction with the American Academy of Pain Medicine’s 31st Annual Meeting and pre-meeting activities.

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

3Intrathecal Drug Delivery for CHRONIC PAINSelecting Patients and Optimizing Long-term Outcomes

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FACULTY

Timothy R. Deer, MD, DABPMPresident and Chief Executive Officer Center for Pain Relief, Inc. Charleston, West Virginia

Timothy Deer, MD, 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 completed 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 did his training in Internal Medicine, Anesthesiology, and Pain Medicine.

Over the past 13 years, Dr. Deer has held numerous appointments including the 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 activities, 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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TARGET AUDIENCEThis educational activity is targeted to an audience of pain specialists and other health care providers involved in the management of patients with chronic pain who are candidates for intrathecal drug delivery.

STATEMENT OF NEED/PROGRAM OVERVIEWChronic pain affects an estimated 100 million adults in the United States.1 Because of the diversity of patient background and of chronic pain conditions, mechanisms, and clinical manifestations, a large population of patients is unable to achieve adequate pain relief or attainable functional goals.2 When patients are refractory to conventional medical management, intrathecal delivery of analgesics may provide certain advantages. Over the last 3 decades, the more than 300,000 patients who have received implanted pumps for a variety of indications have helped establish intrathecal therapy as a safe and effective method of drug delivery.3,4 Two analgesic agents have been approved for intrathecal use by the US Food and Drug Administration: ziconotide and morphine.5 Nevertheless, intrathecal therapy may be underutilized owing to poor patient selection, safety concerns, and other systemic barriers.6 This Interactive Professor™ program will provide data and guidance on evaluating patients who are candidates for intrathecal drug delivery, initiating intrathecal therapy for chronic pain, and tailoring therapy to reflect ongoing monitoring.

REFERENCES1. Institute of Medicine. Relieving Pain in America: A Blueprint for Transforming Prevention, Care,

Education, and Research. 2011. http://iprcc.nih.gov/docs/032712 _ mtg _ presentations/IOM _ Pain _ Report _ 508comp.pdf

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; discussion 372.

5. Ver Donck A, Vranken JH, Puylaert M, Hayek S, Mekhail N, Van Zundert J. 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 OBJECTIVESUpon completion of this activity, participants will be better prepared to:

• Comprehensively evaluate patients with chronic pain who are candidates for intrathecal drug delivery

• Discuss the clinical profiles and prescribing considerations associated with intrathecally delivered analgesic medications, including ziconotide and morphine

• Initiate intrathecal therapy for chronic pain based on an individualized evaluation of potential benefits and risks, previous treatment responses, and an adequate therapeutic trial

• Tailor intrathecal drug therapy to reflect ongoing monitoring for efficacy and treatment-emergent adverse events

PHYSICIAN ACCREDITATION STATEMENTThis activity has been planned and implemented in accordance with the Essential Areas 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.

PHYSICIAN CREDIT DESIGNATIONGlobal Education Group designates this live activity for a maximum of 0.5 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

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

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DISCLOSURE OF CONFLICTS OF INTERESTGlobal 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. All identified conflicts of interest are thoroughly vetted by Global for fair balance, scientific objectivity of studies mentioned in the materials or used as the basis for content, and appropriateness of patient care recommendations.

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:

Timothy R. Deer, MD Grant/Research Support – Bioness Inc., Jazz Pharmaceuticals, Inc., Medtronic, Inc., Spinal Modulation Inc., St. Jude Medical, Inc.; Advisory Boards – Axonics Modulation Technologies, Inc., Bioness Inc., Flowonix Medical Inc., Jazz Pharmaceuticals, Inc., Medtronic, Inc., Nevro Corp., Spinal Modulation Inc., St. Jude Medical, Inc.; Speakers Bureau – Jazz Pharmaceuticals, Inc.; Consultant – Axonics Modulation Technologies, Inc., Bioness Inc., Ethos Pharmaceuticals, Inc., Flowonix Medical Inc., Mallinckrodt Pharmaceuticals, Medtronic, Inc., Nevro Corp., Spinal Modulation Inc., SpineThera, Inc., St. Jude Medical, Inc., Vertos Medical Inc.; Stock Options – Axonics Modulation Technologies, Inc., Bioness Inc., Ethos Pharmaceuticals, Inc., Nevro Corp., Spinal Modulation Inc., SpineThera, Inc., Vertos Medical Inc.

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:

Ashley Marostica, RN, MSN Nothing to disclose

Amanda Glazar, PhD Nothing to disclose

Andrea Funk Nothing to disclose

Jim Kappler, PhD Nothing to disclose

7Intrathecal Drug Delivery for CHRONIC PAINSelecting Patients and Optimizing Long-term Outcomes

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DISCLOSURE OF UNLABELED USEThis 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.

INSTRUCTIONS TO RECEIVE CREDITIn order to receive credit for this activity, the participant must submit a completed program evaluation form.

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

DISCLAIMERParticipants 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 PanelDeer TR, et al. Neuromodulation. 2012;15(5):420-435. » http://www.neurovations.com/wp-content/uploads/Polyanalgesic-Consensus-Panel-2012.pdf

Polyanalgesic Consensus Conference—2012: Recommendations for the Management of Pain by Intrathecal (Intraspinal) Drug Delivery: Report of an Interdisciplinary Expert PanelDeer 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 PainDeer TR, et al. Neuromodulation. 2012;15(5):467-482. » http://www.ncbi.nlm.nih.gov/pubmed/22849581

Polyanalgesic Consensus Conference—2012: Consensus on Diagnosis, Detection, and Treatment of Catheter-Tip Granulomas (Inflammatory Masses) 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 PainPrager J, et al. Neuromodulation. 2014;17(4):354-372. » http://onlinelibrary.wiley.com/doi/10.1111/ner.12146/epdf

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SUGGESTED READING

Mortality Associated With Implantation and Management of Intrathecal Opioid Drug Infusion Systems to Treat Noncancer PainCoffey 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 StudyDeer TR, et al. Pain Physician. 2009;12(4):E291-E296. » http://www.painphysicianjournal.com/2009/july/2009;12;E291-E296.pdf

A Predictive Model for Intrathecal Opioid Dose Escalation for Chronic Non-Cancer PainDuarte RV, et al. Pain Physician. 2012;15(5):363-369. » http://www.painphysicianjournal.com/2012/september/2012;15;363-369.pdf

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

Androgen Deficiency in Long-term Intrathecal Opioid AdministrationKim CH, et al. Pain Physician. 2014;17(4):E543-E548. » http://www.painphysicianjournal.com/2014/july/2014;17;E543-E548.pdf

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

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

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Long-term Intrathecal Ziconotide for Chronic Pain: an Open-Label StudyWebster 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 PumpWesemann 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

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

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NOTES

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NOTES

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