intrathecal drug delivery for chronic pain

Intrathecal Drug Delivery for

CHRONIC PAIN

The Role of Nurses in Optimizing Long-term Outcomes

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

CME/MEDICAL COMMUNICATIONS INQUIRIES [email protected]

3Intrathecal Drug Delivery for CHRONIC PAINThe Role of Nurses in Optimizing Long-term Outcomes

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FACULTY

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

Timothy Deer, MD, was born and raised in Chesapeake West Virginia, USA. Over the last decade, he has originated many ideas that have been incorporated into the mainstream 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 thirteen years, Dr. Deer has held numerous appointments including the Chairman of the American Society of Anesthesiologist committee on Pain Medicine. This forty two thousand-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 committee for the journals Neuromodulation, Pain Medicine and Pain Physician.

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Ashley G. Comer, NPThe Center for Pain Relief, Inc. Charleston, West Virginia

Ashley Comer is a Board Certified Nurse Practitioner, certified by the American Academy of Nurse Practitioners. Born and raised in Charleston, West Virginia, Ashley attended West Virginia State University Community and Technical College where she obtained her Associates Degree in Nursing. Continuing her education, she went on to receive her Bachelor of Science in Nursing from West Virginia University. Graduating with honors, she completed her Masters of Science in Nursing with Family Nurse Practitioner specialization from Walden University. Ashley has a background in orthopedics, critical care, and cardiac surgery. Prior to joining the Center for Pain Relief, she worked as a Registered Nurse in the Open Heart Recovery Unit at Charleston Area Medical Center and for a Cardiothoracic Surgeon.



TARGET AUDIENCEThis 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 OVERVIEWChronic pain affects an estimated 100 million adults in the United States.1 When pain is severe and refractory to conventional medical management, patients are often unable to achieve adequate pain relief, resulting in dire functional and psychosocial consequences.2 Some of these individuals are likely to benefit from the intrathecal delivery of analgesics. Over the past 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 relatively safe and effective method of drug delivery.3,4 Two analgesics have been approved by the US Food and Drug Administration for intrathecal delivery: ziconotide and morphine.5,6 Studies suggest that intrathecal therapy may be underutilized owing to poor patient selection, safety concerns, and other systemic barriers.7 This Interactive Professor™ program will provide guidance on evaluating patients who are candidates for intrathecal drug delivery, and tailoring this modality based on ongoing monitoring of efficacy and treatment-emergent adverse effects.

REFERENCES1. National Research Council. Relieving Pain in America: A Blueprint for Transforming Prevention,

Care, Education, and Research. Institute of Medicine. Washington, 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, Hayek S, Mekhail N, Van Zundert J. Intrathecal drug administration in chronic pain syndromes. Pain Pract. 2014;14(5):461-476.

6. Pope JE, Deer TR. Ziconotide: a clinical update and pharmacologic review. Expert Opin Pharmacother. 2013;14(7):957-966.

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.

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EDUCATIONAL OBJECTIVESUpon completion of this activity, participants will be better prepared to:

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

• Discuss the clinical profiles of intrathecally delivered analgesic medications, including ziconotide and morphine

• Monitor patients receiving intrathecal drug therapy for efficacy, functional gains, and treatment-emergent adverse events

• Assist in the long-term care of individuals with intrathecally treated chronic pain via patient education, iterative assessment, and proper techniques for ongoing device and drug maintenance

ACCREDITATIONGreater 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.

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

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.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 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://www.ncbi.nlm.nih.gov/pubmed/24446870



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

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.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 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.ncbi.nlm.nih.gov/pubmed/25054405

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

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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

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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intrathecal drug delivery for chronic pain

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