Persistent and Breakthrough Pain by Integritas Communications

Friday, May 2, 2014

6:00 am – 7:30 am Marquis Ballroom Center Anaheim Marriott, Anaheim, California This activity is co-provided by Global Education Group and Integritas Communications. This activity is supported by an educational grant from Teva CNS.

Meeting space has been assigned to provide a Satellite Symposium supported by Teva CNS via an educational grant during the Oncology Nursing Society’s (ONS) 39th Annual Congress, May 1-4, 2014 in Anaheim, California. The Oncology Nursing Society’s assignment of meeting space does not imply product endorsement nor does the Oncology Nursing Society assume any responsibility for the educational content of the symposium.

PERSISTENT and BREAKTHROUGH PAIN

SUGGESTED READING

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FACULTY

Individualizing Opioid Therapy for Fluctuating Cancer Pain

CME/MEDICAL COMMUNICATIONS INQUIRIES info@integritasgrp.com integritasgrp.com 2

FACULTY

Michelle I. Rhiner, RN-BC, MSN, GNP-BC, ACHPN, CCM Nurse Practitioner, Department of Palliative Medicine Instructor, Department of Family Medicine Loma Linda University School of Medicine Loma Linda, California Michelle I. Rhiner, RN-BC, MSN, GNP-BC, ACHPN, CCM, is the Nurse Practitioner in the Department of Palliative Medicine at Loma Linda University Medical Center in Loma Linda, California, and Faculty Instructor in the Department of Family Medicine at Loma Linda University School of Medicine. Ms. Rhiner is certified by the American Nurses Credentialing Center in Pain Management, as a Gerontological Nurse Practitioner in Hospice and Palliative Care by the National Board for Certification of Hospice and Palliative Nursing, and in Case Management by the Commission for Case Management Certification. Ms. Rhiner has served on numerous advisory panels for institutions that include the American Pain Foundation. She was a founding panel member for the National Comprehensive Cancer Networkâ&#x20AC;&#x2122;s Palliative Care Committee and is a charter member of the California Commission on Aging Task Force. Author of numerous papers on pain management, quality of life, and symptom palliation, Ms. Rhiner has been a coinvestigator for many clinical trials on the management of pain and other symptoms.

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PERSISTENT and BREAKTHROUGH PAIN

Individualizing Opioid Therapy for Fluctuating Cancer Pain

Neal E. Slatkin, MD, DABPM FACULTY

Vice-President Medical Services Chief Medical Officer Hospice of the Valley Palliative Care Center Silicon Valley San Jose, California

Neal Slatkin, MD, DABPM, is vice president of medical services and chief medical officer for the Palliative Care Center Silicon Valley and Hospice of the Valley in San Jose, California. Â As a pain management and palliative care physician, he oversees a team of hospice and palliative care physicians and guides the overall direction of all medical programs. Since 2007 he has been recognized by Castle-Connolly as one of America's Top Doctors in Cancer, acknowledging his work in the diagnosis and treatment of cancerrelated pain in adults and children. Dr. Slatkin has spoken at numerous national and international conferences on subjects related to palliative care, pain management, and hospice, and has published broadly in these fields. Before joining Hospice of the Valley in 2009, he was for many years the Director of the Department of Supportive Care, Pain and Palliative Medicine, and a professor in the Department of Neurology at City of Hope Cancer Center in Duarte, California, where he served as a neuro-oncologist and also a principal investigator for numerous clinical studies exploring new treatment options for pain and other symptoms arising from cancer and diabetes mellitus. Between 1995 and 2000 he served as the medical director of the National Parkinson's Foundation Clinical Center of Excellence at City of Hope Cancer Center and was also the founding chair of City of Hope's Institutional Bioethics Committee in 1991. He is a Diplomate of the American Board of Psychiatry and Neurology with subspecialty certifications in pain management and in hospice and palliative medicine, and a Diplomate of the American Board of Pain Medicine.

April Hazard Vallerand, PhD, RN, FAAN FACULTY

Professor, College of Nursing Wayne State University Detroit, Michigan

April Hazard Vallerand, PhD, RN, FAAN, is currently the College of Nursing Alumni Professor in the College of Nursing at Wayne State University. She is also the Interim Associate Dean for Research and the Interim Director of the PhD Program. Her research interests are focused on the improvement and maintenance of functional status in patients with chronic pain and the identification and reduction of pain-related disparities. She is the Principal Investigator for a study titled, Improving Functional Status in African Americans with Cancer Pain, funded by the National Cancer Institute. Dr. Vallerand is a Fellow in the American Academy of Nursing. She lectures nationally on the management of pain and has published numerous articles on pain and pain control. Dr. Vallerand has also authored 5 books on pharmacology for nurses and other health care professionals, including Davis's Drug Guide for Nurses, which is in its 13th edition. Dr. Vallerand received her Bachelorâ&#x20AC;&#x2122;s Degree in Nursing from Mount St. Maryâ&#x20AC;&#x2122;s College in Los Angeles, California, her Master of Science in Nursing from California State University, Los Angeles, and her PhD in Nursing from the University of Pennsylvania, before completing a 3-year postdoctoral fellowship in Psychosocial Oncology at the University of Pennsylvania School of Nursing.

PERSISTENT and BREAKTHROUGH PAIN

Individualizing Opioid Therapy for Fluctuating Cancer Pain

AGENDA 6:00 am – 6:05 am Faculty Introductions 6:05 am – 6:25 am Meeting the Challenge of Cancer Pain Management 6:25 am – 6:50 am Breakthrough Cancer Pain: Assessment and

Differential Diagnosis

6:50 am – 7:15 am Tailoring Breakthrough Pain Management: Safe and

Effective Opioid Therapy

PREAMBLE

7:15 am – 7:30 am Concluding Comments and Q&A Session

TARGET AUDIENCE The educational design of this activity addresses the needs of oncology nurses and other health care professionals who collaboratively provide supportive care to patients with pain related to malignancy, anticancer surgery, chemotherapy, or radiation therapy.

EDUCATIONAL OBJECTIVES At the conclusion of this educational activity, participants should be better prepared to: • Describe the diagnostic criteria for BTP and clinical characteristics of various episode subtypes • Assess patients with cancer for transient increases in pain that compromise function or reduce quality of life • Tailor multimodal opioid-based regimens for cancer-related persistent pain and BTP to achieve adequate analgesia, reach functional goals, and minimize treatment-related risks • Comply with medical standards of care and Risk Evaluation and Mitigation Strategies when treating and monitoring patients who require prescription opioids for cancer pain • Educate patients with cancer pain about the safe use of prescription opioids, including transmucosal immediate-release fentanyl products

FEE INFORMATION There is no fee for this educational activity.

Cancer pain is prevalent and often inadequately treated.1,2 Affecting approximately one quarter of patients with newly diagnosed malignancy and more than three quarters of those with advanced cancer, pain is consistently reported as one of the most troubling cancer symptoms for patients and their families.1-4 Because pain is biopsychosocial in nature, it manifests clinically as a dynamic condition, with pain levels fluctuating over days, hours, and even minutes.5 Indeed, even when the persistent baseline component of cancer pain is generally controlled with an analgesic regimen, most patients will continue to experience short periods during the day when their pain spikes. Referred to as breakthrough pain (BTP), these transient episodes have been linked to increased physical disability, poor psychological status, and higher health care costs.3,6-8 In the oncology setting, the treatment of persistent and BTP frequently relies on opioid agonists.9,10 Implementing and tailoring opioid-based therapy require consideration of potential pain etiologies and patient-specific treatment goals and risks—a challenging task in the context of the myriad issues faced by the oncology health care team.10-12 Oncology nurses, in particular, often interact with patients throughout the continuum of cancer care, allowing them to identify untreated pain and advocate for affected individuals. This Evidence-Based Best Practices program will discuss comprehensive assessment and treatment approaches for cancer-related BTP, including Risk Evaluation and Mitigation Strategies associated with prescription opioids and patient-monitoring strategies to promote safe opioid use.

REFERENCES 1. Cohen MZ, Easley MK, Ellis C, et al. Cancer pain management and the JCAHO’s pain standards: an institutional challenge. J Pain Symptom Manage. 2003;25(6):519-527. 2. Goudas LC, Bloch R, Gialeli-Goudas M, Lau J, Carr DB. The epidemiology of cancer pain. Cancer Invest. 2005;23(2):182-190. 3. Svendsen KB, Andersen S, Arnason S, et al. Breakthrough pain in malignant and non-malignant diseases: a review of prevalence, characteristics and mechanisms. Eur J Pain. 2005;9(2):195-206. 4. Bruera E, Kim HN. Cancer pain. JAMA. 2003;290(18):2476-2479. 5. 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. 6. Portenoy RK, Payne D, Jacobsen P. Breakthrough pain: characteristics and impact in patients with cancer pain. Pain. 1999;81(1-2):129-134. 7. Fortner BV, Okon TA, Portenoy RK. A survey of pain-related hospitalizations, emergency department visits, and physician office visits reported by cancer patients with and without history of breakthrough pain. J Pain. 2002;3(1):38-44. 8. Hwang SS, Chang VT, Kasimis B. Dynamic cancer pain management outcomes: the relationship between pain severity, pain relief, functional interference, satisfaction and global quality of life over time. J Pain Symptom Manage. 2002;23(3):190-200.

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PREAMBLE

STATEMENT OF NEED AND LEARNER’S GAP

PERSISTENT and BREAKTHROUGH PAIN

Individualizing Opioid Therapy for Fluctuating Cancer Pain

9. Nalamachu S, Hassman D, Wallace MS, Dumble S, Derrick R, Howell J. Long-term effectiveness and tolerability of sublingual fentanyl orally disintegrating tablet for the treatment of breakthrough cancer pain. Curr Med Res Opin. 2010;27(3):519-530. 10. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Adult Cancer Pain. Fort Washington, Pennsylvania; 2010. 11. Fine PG, Portenoy RK. A Clinical Guide to Opioid Analgesia. 2nd ed. New York: Vendome Group, LLC; 2007. 12. Starr TD, Rogak LJ, Passik SD. Substance abuse in cancer pain. Curr Pain Headache Rep. 2010;14(4):268-275.

NURSING CONTINUING EDUCATION PREAMBLE

Global Education Group is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s COA. This educational activity for 1.5 contact hours is provided by Global Education Group. Nurses should claim only the credit commensurate with the extent of their participation in the activity. For information about the accreditation of this program, please contact Global at 303-395-1782 or inquire@globaleducationgroup.com.

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. 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:

Name of Faculty or Presenter

Reported Financial Relationship

Michelle I. Rhiner, RN-BC, MSN, GNP-BC, ACHPN, CCM

Consultant/Independent contractor to INSYS Therapeutics Inc., and Speaker’s Bureau for Teva Pharmaceuticals, Inc.

Neal E. Slatkin, MD, DABPM

Consultant/Independent contractor to INSYS Therapeutics Inc.

April Hazard Vallerand, PhD, RN, FAAN

Consultant/Independent contractor to AcelRx Pharmaceuticals Inc., and Speaker’s Bureau for Teva Pharmaceuticals, Inc.

Name of Planner or Manager

Reported Financial Relationship

Ashley Marostica, RN, MSN

Nothing to disclose

Amanda Glazar, PhD

Nothing to disclose

Jim Kappler, PhD

Nothing to disclose

Stacey Hansen

Nothing to disclose

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 manufacturerâ&#x20AC;&#x2122;s product information, and comparison with recommendations of other authorities.

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:

PERSISTENT and BREAKTHROUGH PAIN

Individualizing Opioid Therapy for Fluctuating Cancer Pain

SLIDES

For additional CME activities log on to

PERSISTENT and BREAKTHROUGH PAIN

Individualizing Opioid Therapy for Fluctuating Cancer Pain

SLIDES

PERSISTENT and BREAKTHROUGH PAIN

Individualizing Opioid Therapy for Fluctuating Cancer Pain

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PERSISTENT and BREAKTHROUGH PAIN

Individualizing Opioid Therapy for Fluctuating Cancer Pain

SLIDES

PERSISTENT and BREAKTHROUGH PAIN

Individualizing Opioid Therapy for Fluctuating Cancer Pain

SLIDES

For additional CME activities log on to

PERSISTENT and BREAKTHROUGH PAIN

Individualizing Opioid Therapy for Fluctuating Cancer Pain

SLIDES

PERSISTENT and BREAKTHROUGH PAIN

Individualizing Opioid Therapy for Fluctuating Cancer Pain

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PERSISTENT and BREAKTHROUGH PAIN

Individualizing Opioid Therapy for Fluctuating Cancer Pain

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PERSISTENT and BREAKTHROUGH PAIN

Individualizing Opioid Therapy for Fluctuating Cancer Pain

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PERSISTENT and BREAKTHROUGH PAIN

Individualizing Opioid Therapy for Fluctuating Cancer Pain

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PERSISTENT and BREAKTHROUGH PAIN

Individualizing Opioid Therapy for Fluctuating Cancer Pain

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For additional CME activities log on to

PERSISTENT and BREAKTHROUGH PAIN

Individualizing Opioid Therapy for Fluctuating Cancer Pain

SLIDES

PERSISTENT and BREAKTHROUGH PAIN

Individualizing Opioid Therapy for Fluctuating Cancer Pain

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PERSISTENT and BREAKTHROUGH PAIN

Individualizing Opioid Therapy for Fluctuating Cancer Pain

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PERSISTENT and BREAKTHROUGH PAIN

Individualizing Opioid Therapy for Fluctuating Cancer Pain

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PERSISTENT and BREAKTHROUGH PAIN

Individualizing Opioid Therapy for Fluctuating Cancer Pain

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PERSISTENT and BREAKTHROUGH PAIN

Individualizing Opioid Therapy for Fluctuating Cancer Pain

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SUGGESTED READING LIST »» Persistent Pain and BTP Semi-Structured Questionnaire Brennan MJ, Bruckenthal P, Datta S, Gudin JA, Schottenstein DC. Preliminary development of a semistructured approach to persistent and breakthrough pain assessment. Paper presented at: PAINWeek; September 6-11, 2010; Las Vegas, NV.

»» 4 A’s Patient Reassessment Chart Note Adapted from Passik SD, Kirsh KL, Whitcomb L, et al. A new tool to assess and document pain outcomes in chronic pain patients receiving opioid therapy. Clin Ther. 2004;26(4):552-561.

»» Patient-Prescriber Agreement Form from the TIRF REMS Access Program For instructions on enrolling into the TIRF REMS Access program, please go towww.TIRFREMSaccess.com.

»» TIRF REMS Access Education Program Materials and Knowledge Assessment The TIRF REMS Access Education Program is designed to outline the key safety information critical for minimizing the risks of abuse, misuse, overdose, addiction, and serious complications associated with medication errors associated with TIRF medicines to ensure safe use.

»» TIRF REMS Access Program - Prescriber Enrollment Form For real-time processing of this enrollment form electronically, please go to www.TIRFREMSaccess.com and ‘Log In’ (if you have previously enrolled in a REMS program for one of the TIRF medicines) or ‘Create an Account’ to get started.