Achieving Balance: Practical Management Strategies for Opioid-Induced Constipat

ACHIEVING BALANCE

Practical Management Strategies for Opioid-Induced Constipation This activity is jointly provided by Global Education Group and Integritas Communications.

This activity is supported by an educational grant from AstraZeneca.

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

ACHIEVING BALANCE

Practical Management Strategies for Opioid-Induced Constipation

FACULTY Jeffrey A. Gudin, MD Director, Pain Management and Palliative Care Englewood Hospital and Medical Center Englewood, New Jersey Clinical Instructor, Anesthesiology Icahn School of Medicine at Mount Sinai New York, New York

Anthony J. Lembo, MD Associate Professor of Medicine Director, GI Motility Laboratory Harvard Medical School Beth Israel Deaconess Medical Center Boston, Massachusetts

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TARGET AUDIENCE The Interactive Professor™ is intended to help primary care providers (PCPs), including physicians, physician assistants, nurse practitioners, and other allied healthcare professionals anticipate, assess, and comprehensively manage constipation in patients who are being treated with prescription opioids.

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 modalities, opioids are the cornerstone treatment for cancer pain and palliative care, and have gained increasing acceptance as an important therapeutic option for carefully selected patients with chronic noncancer pain.2,3 Outcomes with long-term opioid therapy, however, are often suboptimal—at times, because side effects from these prescription analgesics are poorly managed.4,5 For instance, although at least half of patients on long-term opioid therapy experience symptoms of constipation, this undesirable effect of opioids is often not identified or addressed by prescribing clinicians.6,7 Poorly managed opioid-induced constipation can result in a number of medical complications, impair quality of life, and lead to inadequate pain control if patients decided to skip opioid doses.8 This Interactive Professor™ program will review practical approaches to assessing bowel patterns in opioid-treated patients as well as prophylactic laxative regimens and FDA-approved agents for patients who experience opioid-induced constipation.

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

7. Coyne KS, LoCasale RJ, Datto CJ, et al. Clinicoecon Outcomes Res. 2014;6:269-281.

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

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EDUCATIONAL OBJECTIVES After completing this activity, the participant should be better able to: • Evaluate patients on chronic opioid therapy for bowel function and risk factors for OIC development • Compare the mechanisms of action and clinical profiles of current prescription medications for OIC • Construct evidence-based treatment regimens for patients with OIC that reflect bowel symptoms, prior treatment response, and patient preferences

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 0.50 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

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 an evaluation form at the conclusion of the program.

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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.

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 Speakers Bureau: AstraZeneca, Daiichi Sankyo Company, Limited, and Salix Pharmaceuticals Inc. Consultant: AstraZeneca, Daiichi Sankyo Company, Limited, and Salix Pharmaceuticals Inc. Anthony J. Lembo, MD Consultant: AstraZeneca plc; Ironwood Pharmaceuticals, Inc. Salix Pharmaceuticals, Inc. and Valeant Pharmaceuticals International, Inc. 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: Amanda Glazar, PhD

Nothing to disclose

Andrea Funk

Nothing to disclose

Laura Gilsdorf

Nothing to disclose

Rose O’Connor, 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 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.

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ACHIEVING BALANCE

Practical Management Strategies for Opioid-Induced Constipation

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Practical Management Strategies for Opioid-Induced Constipation

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Practical Management Strategies for Opioid-Induced Constipation

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ACHIEVING BALANCE

Practical Management Strategies for Opioid-Induced Constipation

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ACHIEVING BALANCE

Practical Management Strategies for Opioid-Induced Constipation

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ACHIEVING BALANCE

Practical Management Strategies for Opioid-Induced Constipation

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CLINICAL ASSESSMENT TOOLS Bowel Function Index (BFI) The BFI provides a numerical score for the prior 7 days based on ease of defecation, feeling of incomplete evacuation, and personal judgment of constipation. »» www.exchangecme.com/resourcePDF/chronicpain/ BowelFunctionIndex.pdf

Bristol Stool Form Scale This visual scale is used to help patients characterize their stool. It classifies the most commonly passed stool forms into 7 types. »» www.bladderandbowelfoundation.org/wp-content/uploads/2014/12/ BBF-Bristol-StoolChart.pdf

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 prior 2 weeks. »» www.proqolid.org/content/download/11747/176511/version/2/file/ PAC-SYM12-2.1- eng-US-review+copy.pdf

PATIENT RESOURCES Patient Conversation Guide This patient tool can be completed prior to the visit with the health care provider to guide a meaningful conversation about bowel habits and constipation symptoms. »» www.theacpa.org/uploads/ACPA-Opioid – Constipation – Chart-V4.pdf

Patient Education Handout This leaflet provides patients with approaches to mitigate opioid-induced constipation and includes a list of questions about constipation for patients to ask their doctors or clinics. »» www.acponline.org/patients–families/products/health –tips/oic – en.pdf

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PRACTICE GUIDELINES The Functional Gastrointestinal Disorders and the Rome III Process, 2006.

Drossman DA. Gastroenterology. 2006;130(5):1377-1390. »» www.ncbi.nlm.nih.gov/pubmed/16678553

Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain, 2009.

Chou R, et al. J Pain. 2009;10(2):113-130. »» www.ncbi.nlm.nih.gov/pmc/articles/PMC4043401/

VA/DoD Clinical Practice Guideline: Management of Opioid Therapy for Chronic Pain, 2010.

Department of Veterans Affairs, Department of Defense. »» www.healthquality.va.gov/guidelines/Pain/cot/COT _ 312 _ Full-er.pdf

OTHER RESOURCES Emerging treatments in neurogastroenterology: a multidisciplinary working group consensus statement on opioid-induced constipation.

Camilleri M, et al. Neurogastroenterol Motil. 2014;26:1386-1395. »» www.ncbi.nlm.nih.gov/pmc/articles/PMC4358801

Responsible Opioid Prescribing: A Clinician’s Guide. 2nd edition, revised and expanded.

Fishman SM. Washington, DC: Waterford Life Sciences; 2012. »» library.fsmb.org/cme/index.html

A Clinical Guide to Opioid Analgesia. 2nd edition.

Fine PG, Portenoy RK. New York, NY: Vendome Group, LLC; 2007. »» www.amazon.com/A-Clinical-Guide-Opioid-Analgesia/dp/1933692626#

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SUGGESTED READING Chronic opioid induced constipation in patients with nonmalignant pain: challenges and opportunities.

Nelson AD, Camilleri, M. Therapy Adv Gastroenterol. 2015;8(4):206-220.

The impact of opioid-induced constipation among chronic pain patients with sufficient laxative use.

LoCasale RJ, et al. Int J Clin Pract. 2015;Epub ahead of print.

Opioid-induced bowel dysfunction: epidemiology, pathophysiology, diagnosis, and initial therapeutic approach.

Dorn S, et al. Am J Gastroenterol. 2014;2(1):31-37.

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.

Constipation in people prescribed opioids.

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

The narcotic bowel syndrome: a recent update.

Drossman D, Szigethy E. Am J Gastroenterol. 2014;2(1):22-30.

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

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

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.

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A volunteer model for the comparison of laxatives in opioidrelated constipation.

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

Establishing “best practices� for opioid rotation: conclusions of an expert panel.

Fine PG, et al. J Pain Symptom Manage. 2009;38(3):418-425.

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

Chey WD, et al. N Engl J Med. 2014;370(25):2387-2396.

A randomized, placebo-controlled trial of lubiprostone for opioidinduced constipation in chronic noncancer pain.

Jamal MM, et al. Am J Gastroenterol. 2015;110(5):725-732.

Clinical evaluation of the efficacy of methylnaltrexone in resolving constipation induced by different opioid subtypes combined with laboratory analysis of immunomodulatory and antiangiogenic effects of methylnaltrexone.

Neefjes ECW, et al. BMC Palliative Care. 2014;13:42.

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