Restoring Balance: Advances in the Management of Opioid-Induced Constipation

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

This activity is supported by an educational grant from AstraZeneca.

This event is not a part of the official AAFP Assembly. This activity has been reviewed and is accepted for up to 1.5 Prescribed credits by the American Academy of Family Physicians.

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

FACULTY FACULTY

Anthony J. Lembo, MD Prerecorded Associate Professor of Medicine Harvard Medical School Beth Israel Deaconess Medical Center Boston, Massachusetts

Jeffrey A. Gudin, MD Director Pain Management and Wellness Center Englewood Hospital and Medical Center Englewood, New Jersey

Bill H. McCarberg, MD Adjunct Assistant Clinical Professor University of California, San Diego Founder, Chronic Pain Management Program Kaiser Permanente San Diego Family Practitioner Neighborhood Health San Diego, California

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Advances in the Management of Opioid-Induced Constipation

TARGET AUDIENCE The educational design of this activity addresses the needs of family physicians involved in the treatment of patients with opioid-induced constipation (OIC).

PREAMBLE

STATEMENT OF NEED/PROGRAM OVERVIEW As many as 100 million adults in the United States suffer from chronic pain.1 Among the multitude of available treatment modalities, opioids are generally regarded as the cornerstone for cancer pain treatment and palliative care, and have gained increasing acceptance as an important therapeutic option for carefully selected patients with chronic noncancer pain.2,3 Yet the side effects of opioid therapy often create significant barriers to good patient outcomes.4,5 Constipation is the most common opioid-related adverse effect, affecting up to 50% of patients on long-term therapy.6-10 OIC is especially burdensome because—unlike for many other adverse effects of opioids— patients do not develop tolerance to treatment-related reductions in bowel motility and increases in gastrointestinal fluid absorption.5 Thus, clinicians who manage patients on opioid therapy must be prepared to integrate approaches that target adequate analgesia and reduce risks of aberrant prescription drug use with efforts to proactively consider and appropriately manage opioid-related side effects—most notably constipation. During this Interactive Exchange™ program, expert faculty will provide practical insights into structured evaluation of bowel habits, prophylactic bowel regimens, and newer pharmacologic approaches that antagonize opioid receptor activation in the gastrointestinal tract.

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

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

3. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Adult Cancer Pain. 2010;2010.

4. Daniell HW. Am J Med. 2007;120(9):e21.

5. McNicol E, Horowicz-Mehler N, Fisk RA, et al. J Pain. 2003;4(5):231-256.

6. Bell TJ, Panchal SJ, Miaskowski C, et al. Pain Med. 2009;10(1):35-42.

7. Cook SF, Lanza L, Zhou X, et al. Aliment Pharmacol Ther. 2008;27(12):1224-1232.

8. Panchal SJ, Muller-Schwefe P, Wurzelmann JI. Int J Clin Pract. 2007;61(7):1181-1187.

9. Villars P, Dodd M, West C, et al. J Pain Symptom Manage. 2007;33(1):67-77.

10. Benyamin R, Trescot AM, Datta S, et al. Pain Physician. 2008;11(suppl 2):S105-S120.

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EDUCATIONAL OBJECTIVES After completing this activity, the participant should be better able to: • Discuss the fundamentals of opioid pharmacology with an emphasis on clinical effects of opioid receptor activation in the gastrointestinal tract • Proactively implement plans to address OIC in patients who have been selected for long-term opioid therapy • Longitudinally assess opioid-treated patients for problematic bowel function

• Individualize multimodal bowel regimens based on the degree of symptoms, treatment responses, and patient preferences • Counsel patients who have been selected for chronic opioid therapy about the risks of OIC, dietary recommendations, and potential benefits and drawbacks of various treatment approaches

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 sponsorship of Global Education Group (Global) and Integritas Communications, LLC. 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.

AAFP ACCREDITATION STATEMENT This live activity, Restoring Balance: Advances in the Management of Opioid-Induced Constipation, with a beginning date of 10/21/2014, has been reviewed and is acceptable for up to 1.50 Prescribed credit(s) by the American Academy of Family Physicians. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

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PREAMBLE

• Describe the clinical profiles of current and emerging opioid receptor antagonists for the management of OIC

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Advances in the Management of Opioid-Induced Constipation

INSTRUCTIONS TO RECEIVE CREDIT In order to receive credit for this activity, the participant must complete the evaluation form and return it to a staff member at the end of the program.

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

PREAMBLE

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: Jeffrey Gudin, MD Consultant/Independent Contractor to Nektar Therapeutics; Speaker’s Bureau for AstraZeneca plc and Salix Pharmaceuticals, Inc. Anthony Lembo, MD Consultant/Independent Contractor to AstraZeneca plc, GlaxoSmithKline, Ironwood Pharmaceuticals, Inc., Prometheus Laboratories Inc., and Salix Pharmaceuticals, Inc.; Grant/Research Support from Prometheus Laboratories Inc. Bill McCarberg, MD Consultant/Independent Contractor to AstraZeneca plc, Collegium Pharmaceutical, Inc., Depomed, Inc., Inspirion Pharmaceuticals, LLC, Iroko Pharmaceuticals, LLC, Janssen Pharmaceuticals, Inc., KalÊo, Inc., Mallinckrodt Pharmaceuticals, Inc., Millennium Pharmaceuticals, Inc., Pfizer, Inc., Salix Pharmaceuticals, Inc.,Takeda Pharmaceuticals U.S.A., Inc., and Zogenix, Inc.; Stockholder of Biospecifics Technologies Corp., Galena Biopharma, Inc., Johnson & Johnson, Nektar Therapeutics, Protein Design Labs, Inc.

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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

Rose O’Connor, PhD

Nothing to disclose

PREAMBLE

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, LLC, 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 manufacturer’s product information, and comparison with recommendations of other authorities.

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

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CLINICAL TOOLS »» Bowel Function Index The BFI provides a numerical assessment score for prior 7 days based on ease of defecation, feeling of incomplete evacuation, and personal judgment of constipation.

»» Patient Assessment of Constipation (PAC-SYM) This 12-item questionnaire of patient-reported symptoms assesses 3 subscales of symptoms (bowel movements, rectal symptoms, and abdominal symptoms) over the 2 prior weeks.

»» Bristol Stool Form Scale This visual scale is used to classify the type of stools passed.

PATIENT EDUCATION TOOL

SUGGESTED READING

»» This patient education tool lists items that patients can do at home to help ease their opioid-induced constipation and includes a list of questions to ask the doctor or clinic about constipation.

GUIDELINES »» The functional gastrointestinal disorders and the Rome III process, 2006.

Drossman DA. Gastroenterology. 2006;130:1377-1390.

»» Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain.

Chou R, et al. Pain. 2009;10(2):113-130.

»» Clinical practice guidelines: Management of Opioid Therapy for Chronic Pain, 2010 Department of Veterans Affairs. VA/DOD Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain.

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OTHER RESOURCES »» 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.

SUGGESTED READING »» Constipation: evaluation and treatment of colonic and anorectal motility disorders.

Rao SS. Gastroenterol Clin North Am. 2009;38(3)687-711.

»» Opioid-induced constipation in patients with chronic noncancer pain in the USA, Canada, Germany, and the UK: descriptive analysis of baseline patient-reported outcomes and retrospective chart review.

Coyne KS, et al. Clinicoecon Outcomes Res. 2014;6:269-281.

»» Opioids in chronic non-cancer pain: systematic review of efficacy and safety.

Kalso E, et al. Pain. 2004;112(3):372-380.

»» Constipation in people prescribed opioids.

»» A multi-institutional study analyzing effect of prophylactic medication for prevention of opioid-induced gastrointestinal dysfunction.

Ishihara M, et al. Clin J Pain. 2012;28(5):373-381.

»» A volunteer model for the comparison of laxatives in opioid-related constipation.

Sykes NP. J Pain Symptom Manage. 1996;11(6):363-369.

»» A Randomized Study of Lubiprostone for Opioid-Induced Constipation in Patients with Chronic Noncancer Pain.

Cryer B, et al. Pain Med. 2014; Epublished ahead of print.

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SUGGESTED READING

Ahmedzai SH, Boland J. Clin Evid (Online). 2010;pii:2407.

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»» Naloxegol for opioid-induced constipation in patients with noncancer pain.

Chey WD, et al. N Engl J Med. 2014;370:2387-2396.

»» Patient preference with respect to QoL and reduction in opioid-induced constipation (OIC) after treatment with prolonged-release (PR) oxycodone/naloxone compared with previous analgesic therapy [PREFER study].

SUGGESTED READING

van Dongen VC, et al. Int J Clin Pract. 2014. Epublished ahead of print.

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NOTES

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Advances in the Management of Opioid-Induced Constipation

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