Clinical Issues in Chronic Pain: Consensus and Controversies for Responsible Opioid Prescribing

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

This activity is supported by an educational grant from Teva CNS. This satellite symposium is neither sponsored nor endorsed by PAINWeek. This program was planned in accordance with AANP CE Standards and Policies and AANP Commercial Support Standard.

This CME/CE activity complies with all requirements of the federal Physician Payment Sunshine Act and as such, this activity is eligible for Sunshine Act Reporting. Additional information is required to be collected from participants. If you are planning on participating in the meal, please indicate so on the evaluation and provide your NPI number.

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CME/MEDICAL COMMUNICATIONS INQUIRIES

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CHARLES E. Argoff, MD FACULTY

Professor of Neurology Albany Medical College Director, Comprehensive Pain Center Albany Medical Center Albany, New York

Dr. Charles E. Argoff is Professor of Neurology at Albany Medical College and Director of the Comprehensive Pain Center at Albany Medical Center in New York. He is a member of the American Academy of Neurology, the International Association for the Study of Pain, the American Academy of Pain Medicine, and the American Pain Society, among other professional organizations.

Dr. Argoff is one of the editors of the recently published textbook Raj’s Practical Management of Pain, Fourth Edition. Coauthor of Defeat Chronic Pain Now, a recently published book for people with chronic pain, he has also recently released the third edition of Pain Management Secrets.

Dr. Argoff received his medical degree from Northwestern University Medical School in Chicago, Illinois. He completed his medical internship in internal medicine and residency in neurology at Stony Brook University in New York and a fellowship in neurology at the National Institutes of Health in Bethesda, Maryland.

MICHAEL J. Brennan, MD Director, The Pain Center of Fairfield Fairfield, Connecticut Senior Attending Physician Department of Medicine, Physical Medicine, and Rehabilitation Bridgeport Hospital Bridgeport, Connecticut

Dr. Michael J. Brennan received his medical degree from the State University of New York Downstate Medical Center, and completed a residency in physical medicine and rehabilitation at the New York Hospital-Cornell University Medical Center, where he served as chief resident. While at New York Hospital, Dr. Brennan also served as chief resident at the International Center for the Disabled in New York City.

After completing his residency, Dr. Brennan was appointed to the faculty of New York Hospital and Cornell Medical College in the Department of Physical Medicine and Rehabilitation. He served as acting chief of the rehabilitation service in the Department of Neurology at Memorial Sloan-Kettering Cancer Center in New

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York. After leaving Sloan-Kettering, Dr. Brennan became the medical director of the Rehabilitation Center of Fairfield County and Ahlbin Rehabilitation Centers, in Bridgeport, Connecticut, and chief of the section of physical medicine at Bridgeport Hospital, also in Bridgeport, Connecticut. A board-certified physiatrist in private practice in Fairfield, Connecticut, he is a senior attending physician in the Department of Medicine at Bridgeport Hospital and a consulting physician at St. Vincent’s Hospital in Bridgeport, Connecticut.

Dr. Brennan has special interests in the management of pain as well as disability in patients suffering from the acute and long-term effects of musculoskeletal diseases, neurological disorders, and cancer and various cancer treatments. He has published over 30 scholarly articles, abstracts, and textbook chapters on the treatment of cancer- and noncancer-related disabilities including lymphedema and pain. He is a reviewer for several medical journals and has served as guest editor for the Journal of Musculoskeletal Rehabilitation and as online editor for Pain.com. Recently, Dr. Brennan was awarded the Dr. Elizabeth Narcessian Memorial Award from Kessler Institute for Rehabilitation in recognition of his commitment to the treatment of patients suffering from chronic pain.

JEFFREY A. Gudin, MD Moderator Clinical Instructor, Anesthesiology Mount Sinai University School of Medicine New York, New York Director, Pain Management and Palliative Care Englewood Hospital and Medical Center Englewood, New Jersey

Dr. Jeffrey A Gudin received his medical degree from Albany Medical College in Albany, New York. Following a transitional internship in surgery, medicine, and anesthesiology at St. Barnabas Medical Center in Livingston, New Jersey, he completed his residency in anesthesiology at the Yale University School of Medicine and his fellowship at the Yale Center for Pain Management, in New Haven, Connecticut. While in New Haven, Dr. Gudin also trained in addiction medicine and directed a substance abuse treatment center. For the last 12 years, Dr. Gudin has been the Director of Pain Management and Palliative Care at Englewood Hospital and Medical Center, a Mount Sinai University School of Medicine teaching affiliate in New Jersey. He remains active in teaching and research, and has lectured internationally on a variety of topics in pain management, palliative care, and addiction medicine.

Dr. Gudin has dedicated his career to promoting education in pain management. He attends and has presented at the American Pain Society, the American Academy of Pain Management (AAPM), the American Academy of Physical Medicine and

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Dr. Gudin is recognized nationally as a leader in pain management. He is an experienced researcher, consultant, speaker, and speaker trainer. He has collaborated with numerous initiatives to enhance responsible prescribing and the safe use of opioid pain medications.

STEVEN P. Stanos, DO Medical Director, Swedish Pain Services Medical Director, Occupational Medicine Services Swedish Health Services and Swedish Medical Group Seattle, Washington

Dr. Steven P. Stanos is currently Medical Director of Pain Medicine Services and Medical Director of Occupational Medicine Services at Swedish Medical System in Seattle, Washington. At Swedish, he is also working to develop a pain rehabilitation continuum of care for the Swedish and the Providence Health System. From 2002 to 2014 Dr Stanos served as medical director of the Center for Pain Management at the Rehabilitation Institute of Chicago (RIC), as well as directing workers compensation medical services for the hospital system. While in Chicago, he was an Associate Professor in the Department of Physical Medicine and Rehabilitation and Assistant Program Director of the Multidisciplinary Pain Fellowship at Northwestern University Feinberg School of Medicine.

He is board certified in physical medicine and rehabilitation and pain medicine by the American Board of Pain Medicine and subspecialty boarded by the American Board of Anesthesia.

Dr. Stanos presently serves on the Board of Directors and as Treasurer of the American Academy of Pain Medicine and on the Board of Directors of the American Board of Pain Medicine. He is active with the American Academy of Physical Medicine and Rehabilitation, and has served as the co-chair of education for the Pain and Neuromuscular Council and as a panel member on the academy’s Opioid Risk Evaluation Mitigation Strategies (REMS) task force. He is active on a number of committees for the American Pain Society and the Midwest Pain Society, where he serves on the board of directors.

He is active with ongoing educational initiatives for primary care, pain medicine, and physical medicine specialists around the United States and abroad. Dr. Stanos has been involved in the development and publication of treatment guidelines related to rehabilitation approaches to low back pain and chronic pain and serves as a reviewer

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Rehabilitation, and many other national venues. Dr. Gudin serves as a consultant to state medical boards on challenging cases, as well as to industry on novel analgesic products and risk management associated with opioids. He recently presented at the 2012 AAPM Safe Opioid Prescribing Course.

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for pain and pain medicine and rehabilitation (PM&R)–related scientific journals. Dr Stanos has published numerous scientific articles and book chapters related to pain management. A Mayday Foundation Advocacy fellow in 2013, his advocacy project focuses on increasing awareness for multi- and inter-disciplinary pain care.

He has served on numerous FDA panels related to chronic pain management and opioid therapies and presently serves as a panel member on the Public Health Service Delivery and Reimbursement Working Group for the National Pain Strategy (NPS) Task Force. The NPS was tasked to make recommendations to the US Department of Health and Human Services related to improvement in pain assessment, management, and population-based service focusing on increasing coordinated, multidisciplinary care, pain research, and education.

Dr. Stanos received his BA in psychology from the University of Cincinnati and DO degree from Nova Southeastern University in Miami, FL. He completed an internship in the Department of Medicine at Chicago Osteopathic Hospitals & Medical Centers, a PM&R residency at the Rehabilitation Institute of Chicago, and a pain fellowship at the Northwestern University Feinberg School of Medicine.

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TARGET AUDIENCE The educational design of this activity addresses the needs of pain specialists, primary care providers, and other clinicians involved in opioid-based management of chronic pain.

Affecting an estimated 100 million adults in the United States, chronic pain is among the most common reasons that patients seek medical treatment.1 Prescription opioids are an established treatment option for functionally limiting chronic pain severe enough to require around-the-clock therapy.2-4 Indeed, opioids are the cornerstone of cancer pain treatment,2,3 and have gained acceptance—though not unqualified—for select patients with noncancer chronic pain.4 Unfortunately, increased opioid prescribing for patients in pain has been mirrored by higher rates of opioid abuse and overdose.4 For example, in recent years, prescription opioids have been linked to approximately three quarters of pharmaceutical overdose deaths in the United States.4,5 To ensure patient safety and meet regulatory requirements, clinicians must adopt responsible prescribing strategies, including assessing all patients for risks related to opioid pharmacology and potential aberrant drug use.4 Initial risk-stratification efforts must be accompanied by appropriate follow-up monitoring and meticulous documentation of clinical decision making. Even among pain management experts, recommendations for the individualization of opioidbased regimens, incorporation of urine drug testing, and potential roles of abusedeterrent opioid formulations continue to evolve.6-8 During this Clinical Issues™ program, an expert faculty panel will discuss and debate guideline recommendations and newly published data on long-term opioid therapy, while providing practical advice on the growing evidence pool, risk-mitigation strategies, and regulatory requirements.

REFERENCES 1. Institute of Medicine. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. 2011.

2. Swarm RA, Abernethy AP, Anghelescu DL, et al. National Comprehensive Cancer Network: Adult Cancer Pain. J Natl Compr Canc Netw. 2013;11(8):992-1022.

3. Portenoy RK. Treatment of cancer pain. Lancet. 2011;377(9784):2236-2247.

4. Chou R, Fanciullo GJ, Fine PG, et al. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009;10(2):113-130.

5. Warner M, Hedegaard H, Chen L-H. Trends in Drug-poisoning Deaths Involving Opioid Analgesics and Heroin: United States, 1999-2012. NCHS Health E-Stat. Atlanta, GA: Centers for Disease Control and Prevention/National Center for Health Statistics; 2014.

6. Peppin JF, Passik SD, Couto JE, et al. Recommendations for urine drug monitoring as a component of opioid therapy in the treatment of chronic pain. Pain Med. 2012;13(7):886-896.

7. Butler SF, Cassidy TA, Chilcoat H, et al. Abuse rates and routes of administration of reformulated extended-release oxycodone: initial findings from a sentinel surveillance sample of individuals assessed for substance abuse treatment. J Pain. 2013;14(4):351-358.

8. Simon K, Worthy SL, Barnes MC, Tarbell B. Abuse-deterrent formulations: transitioning the pharmaceutical market to improve public health and safety. Ther Adv Drug Saf. 2015;6(2):67-79.

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STATEMENT OF NEED/PROGRAM OVERVIEW

EDUCATIONAL OBJECTIVES After completing this activity, the participant should be better able to: • Assess candidates for chronic opioid therapy via comprehensive clinical interviews, reviews of the medical history, physical exam, and stratification of risks for drug misuse and abuse • Discuss the clinical profiles of current and emerging prescription opioid analgesics, including abuse-deterrent formulations

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• Initiate opioid trials for patients with functionally impairing chronic pain severe enough to require around-the-clock, long-term therapy • Tailor opioid-based regimens founded on evaluations of analgesia, functional goals, side effects, and risk evaluation and mitigation strategy (REMS)–compliant principles for patient monitoring and documentation • Engage in open dialogues with patients with chronic pain about actively participating in a care plan, adhering to the treatment regimen, and safely using prescription opioid analgesics

PROGRAM AGENDA 11:30 am –12:00 pm Registration, Meal, Preactivity Outcomes Assessment 12:00 pm –12:05 pm

F aculty Introductions

12:05 pm –12:30 pm

Identifying Candidates for Opioid Trials

12:30 pm –12:50 pm M itigation of Opioid Risks: Considering Abuse-Deterrent Formulations 12:50 pm –1:15 pm

hallenges in Chronic Opioid Therapy: C Addressing Aberrant Behavior

1:15 pm –1:30 pm

Postactivity Assessment and Question and Answer Session

PHYSICIAN ACCREDITATION STATEMENT This 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.

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.

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PHARMACIST ACCREDITATION STATEMENT Global Education Group is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

CREDIT DESIGNATION Global Education Group designates this continuing education activity for 1.5 contact hour(s) (0.15 CEUs) of the Accreditation Council for Pharmacy Education. (Universal Activity Number - 0530-9999-15-056-L01-P)

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This is a knowledge-based activity.

NURSE PRACTITIONER CONTINUING EDUCATION Global Education Group is approved as a provider of nurse practitioner continuing education by the American Association of Nurse Practitioners: AANP Provider Number 1101021. This program has been approved for 1.5 contact hours of continuing education. (0.5 Rx hours have been identified.)

GLOBAL CONTACT INFORMATION 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 form.

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. 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.

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The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME activity: Charles E. Argoff, MD Speakers Bureau: Allergan, Inc.; AstraZeneca plc; Depomed, Inc.; Iroko Pharmaceuticals, LLC; Janssen Pharmaceuticals, Inc.; Millennium Laboratories; and Xenoport, Inc. Grant/Research Support: Endo Pharmaceuticals Inc., Forest Laboratories, and Eli Lilly and Company. Consultant/Independent Contractor: AstraZeneca plc; Depomed, Inc.; Endo Pharmaceuticals; Nektar Therapeutics; Pfizer Inc.; Xenoport, Inc.; and Zogenix, Inc. Stock Shareholder: Depomed, Inc. and Pfizer Inc. Royalties from Elsevier B.V. Michael J. Brennan, MD Consultant: Purdue, Insys, Teva. Speakers Bureau: AstraZeneca, Cara, Depomed, Iroko, Johnson & Johnson, Kaleo, Pernix, Purdue, Teva, Zogenix. Stock Shareholder: Cara.

Jeffrey A. Gudin, MD Speakers Bureau: AstraZeneca plc; Depomed, Inc.; INSYS Therapeutics, Inc.; Iroko Pharmaceuticals, LLC; kaleo, Inc.; Purdue Pharma L.P.; Salix Pharmaceuticals, Inc.; Teva Pharmaceutical Industries Ltd.; and XenoPort, Inc. Grant/ Research support: Teva Pharmaceutical Industries Ltd. Consultant/Independent Contractor: AstraZeneca plc.; INSYS Therapeutics, Inc.; Iroko Pharmaceuticals LLC; Purdue Pharma L.P.; Salix Pharmaceuticals, Inc.; Teva Pharmaceutical Industries Ltd.; and Zogenix, Inc. Steven Stanos, DO Consultant/Independent Contractor: Analgesic Solutions, AstraZeneca plc; myMatrixx, Pfizer Inc., Purdue Pharma L.P..

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: Kristen Delisi

Nothing to disclose

Amanda Glazar, PhD

Nothing to disclose

Andrea Funk

Nothing to disclose

Laura Gilsdorf

Nothing to disclose

Jim Kappler, PhD

Nothing to disclose

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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.

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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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.

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CLINICAL TOOLS »» Brief Pain Inventory (Short Form) A multidimensional pain assessment instrument that can be used to characterize several aspects of a patient’s pain experience, the short form is also widely used for clinical trials and has been translated into multiple languages.

»» Opioid Risk Tool This five-question clinical interview or patient questionnaire helps stratify patients based on their risk for opioid-related misuse and abuse.

»» Current Opioid Misuse Measure (COMM) ® A 17-item assessment questionnaire, the COMM focuses on current behaviors and cognition rather than character and personality traits associated with risks for substance abuse.

»» Pain Assessment and Documentation Tool (PADT ™) Completed via clinician-directed interview, this instrument provides a consistent and structured method to document progress with opioid therapy over time.

GUIDELINES »» American Pain Society and American Academy of Pain Medicine: Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain

SUGGESTED READING

Chou R, Fanciullo GJ, Fine PG, et al. J Pain. 2009;10(2):113-130.

»» Department of Veterans Affairs and Department of Defense: Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain The Management of Opioid Therapy for Chronic Pain Working Group. Washington, DC: Department of Veterans Affairs, Department of Defense; 2010.

»» A Clinical Guide to Opioid Analgesia. 2nd edition Fine PG, Portenoy RK. New York, NY: Vendome Group, LLC; 2007.

»» Responsible Opioid Prescribing: A Clinician’s Guide. 2nd edition, revised and expanded Fishman SM. Washington, DC: Waterford Life Sciences; 2012.

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SUGGESTED READINGS »» Abuse rates and routes of administration of reformulated extended-release oxycodone: initial findings from a sentinel surveillance sample of individuals assessed for substance abuse treatment Butler SF, Cassidy TA, Chilcoat H, et al. J Pain. 2013;14(4):351-358.

»» Establishing “best practices” for opioid rotation: conclusions of an expert panel Fine PG, Portenoy RK. J Pain Symptom Manage. 2009;38(3):418-425.

»» Universal precautions in pain medicine: a rational approach to the treatment of chronic pain Gourlay DL, Heit HA, Almahrezi A. Pain Med. 2005;6(2):107-112.

»» Urine drug testing in pain medicine Heit HA, Gourlay DL. J Pain Symptom Manage. 2004;27(3):260-267.

»» Substance misuse treatment for high-risk chronic pain patients on opioid therapy: a randomized trial Jamison RN, Ross EL, Michna E, et al. Pain. 2010;150(3):390-400.

»» Assessment and treatment of abuse risk in opioid prescribing for chronic pain Jamison RN, Serraillier J, Michna E. Pain Res Treat. 2011;2011:941808.

»» Rates of opioid dispensing and overdose after introduction of abusedeterrent extended-release oxycodone and withdrawal of propoxyphene

SUGGESTED READING

Larochelle MR, Zhang F, Ross-Degnan D, Wharam JF. JAMA Intern Med. 2015;175(6):978-987.

»» Abuse-deterrent formulations: part 2: commercial products and proprietary technologies Mastropietro DJ, Omidian H. Expert Opin Pharmacother. 2015;16(3):305-323.

»» A review of abuse-deterrent opioids for chronic nonmalignant pain Moorman-Li R, Motycka CA, Inge LD, et al. P T. 2012;37(7):412-418.

»» Abuse-deterrent formulations, an evolving technology against the abuse and misuse of opioid analgesics Schaeffer T. J Med Toxicol. 2012;8(4):400-407.

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