Interactive Professor -- Intrathecal Drug Therapy for Chronic Pain

Intrathecal Drug Delivery for

CHRONIC PAIN Evolving Best-Practice Strategies to Maximize Efficacy and Safety

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

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

Intrathecal Drug Delivery for CHRONIC PAIN Evolving Best-Practice Strategies to Maximize Efficacy and Safety

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FACULTY

JASON E. POPE, MD, DABPM, FIPP President Summit Pain Alliance Santa Rosa, California

Dr. Pope is the President of Summit Pain Alliance in Santa Rosa, California. He serves the North American Neuromodulation Society (NANS) as a Directorat-Large, Membership Committee Chair, Advocacy and Policy Committee Co-Chair, and Annual Meeting Co-Chair for the upcoming 2017 meeting. He is also the Co-Chair for the Special Interest Group in Neuromodulation for the American Society of Regional Anesthesia and Pain Medicine (ASRA).

Further, he is the Committee Chair for CME and Education for the International Neuromodulation Society (INS), working to improve global exposure to pain treatment and neuromodulation techniques.

Dr. Pope completed his undergraduate studies in chemistry at Purdue University in West Lafayette, Indiana, his doctor of medicine at Indiana University School of Medicine in Indianapolis, his Anesthesiology Residency at Vanderbilt University Medical Center in Nashville, Tennessee, and his Fellowship in Pain Medicine at the Cleveland Clinic in Ohio. Following Fellowship, he advocated for pain care access and therapy as a congressional fellow to a member of the House of Representatives Energy and Commerce Subcommittee on Health.

Focused on education, Dr. Pope is centered on improving outcomes and safety.

He is extensively published in peer-reviewed journals, and has authored many chapters, textbooks, and atlases, and presented at regional, national, and international meetings. Working foundationally on comprehensive workshops for fellows, residents, and physicians in practice, both domestically and internationally, Dr. Pope and his colleagues are working toward an improved neuromodulation space.

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TARGET AUDIENCE This educational activity is targeted to an audience of pain management nurses and other providers involved in managing patients who are candidates for intrathecal analgesic drug delivery.

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 (FDA) has approved 2 analgesics—ziconotide and morphine—as intrathecal medications for patients with severe chronic pain.5,6 Nevertheless, 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).7 Using a unique case-based educational format, this Interactive Professor™ program will review the latest published evidence and practical guidance on appropriate candidates for intrathecal drug delivery, FDA-approved intrathecal analgesics, and monitoring patients over time for analgesia, functional outcomes, and treatment-emergent adverse effects.

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. Kim P, Grigsby E, Deer T, et al. Effectiveness and safety of intrathecal ziconotide as the first agent in pump for adult patients with severe chronic pain. Presented at the 22nd Annual Napa Pain Conference; August 27-29, 2015; Napa, CA. 7. 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.

Intrathecal Drug Delivery for CHRONIC PAIN Evolving Best-Practice Strategies to Maximize Efficacy and Safety

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EDUCATIONAL OBJECTIVES Upon completion of this activity, participants will be better prepared to: • Identify patients with severe chronic pain who are candidates for intrathecal drug delivery • Discuss the clinical profiles, prescribing considerations, and latest clinical trial data for analgesics that have been approved by the FDA for intrathecal drug delivery • Monitor patients receiving intrathecal drug therapy for efficacy, functional gains, and treatment-emergent adverse events

FACULTY FINANCIAL DISCLOSURE STATEMENT The faculty reported the following financial relationships or relationships to products or devices he or his spouse/life partner has with commercial interests related to the content of this CME activity: Jason E. Pope, MD, DABPM, FIPP Flowonix Medical Inc.; Jazz Pharmaceuticals plc; Medtronic

ACCREDITATION Greater Kansas City Chapter of the American Society for Pain Management Nursing is approved as a provider of continuing nursing education by the Kansas State Board of Nursing. This course offering has been submitted for approval for nursing contact hours applicable for RN, LPN, LMHT relicensure.

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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Intrathecal Drug Delivery for CHRONIC PAIN Evolving Best-Practice Strategies to Maximize Efficacy and Safety

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Intrathecal Drug Delivery for CHRONIC PAIN Evolving Best-Practice Strategies to Maximize Efficacy and Safety

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Intrathecal Drug Delivery for CHRONIC PAIN Evolving Best-Practice Strategies to Maximize Efficacy and Safety

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

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 Pain Prager J, et al. Neuromodulation. 2014;17(4):354-372. »» http://www.ncbi.nlm.nih.gov/pubmed/24446870

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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.ncbi.nlm.nih.gov/pubmed/19668287

A Predictive Model for Intrathecal Opioid Dose Escalation for Chronic Non-Cancer Pain Duarte RV, et al. Pain Physician. 2012;15(5):363-369. »» http://www.ncbi.nlm.nih.gov/pubmed/22996848

Care and management of intrathecal and epidural catheters.

Du Pen A. J Infus Nurs. 2005;28(6):377-381. »» www.ncbi.nlm.nih.gov/pubmed/16304495

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

Androgen Deficiency in Long-term Intrathecal Opioid Administration Kim CH, et al. Pain Physician. 2014;17(4):E543-E548. »» http://www.ncbi.nlm.nih.gov/pubmed/25054405

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-for-intrathecaldrug-de-peer-reviewed-article-JPR

Intrathecal Drug Delivery for CHRONIC PAIN Evolving Best-Practice Strategies to Maximize Efficacy and Safety

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 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

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-management-ofchronic-pain-reco-peer-reviewed-article-JPR

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NOTES

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