Comprehensive Pain Management: Uncovering and Addressing Opioid-Induced Constipation

September 8, 2015 Brera Ballroom Level 3 The Cosmopolitan of Las Vegas Las Vegas, Nevada This activity is jointly provided by Global Education Group and Integritas Communications.

This activity is supported by an educational grant from AstraZeneca.

This program was planned in accordance with AANP CE Standards and Policies and AANP Commercial Support Standard. This satellite symposium is neither sponsored by nor endorsed by PAINWeek速.

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

FACULTY FACULTY

CHARLES E. Argoff, MD Professor of Neurology Albany Medical College Director, Comprehensive Pain Center Albany Medical Center Albany, New York

JEFFREY A. Gudin, MD 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

ANTHONY J. Lembo, MD Prerecorded 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 educational design of this activity addresses the needs of pain specialists and other health care providers involved in the treatment of patients with opioid-induced constipation (OIC).

PREAMBLE

STATEMENT OF NEED/PROGRAM OVERVIEW Although as many as half of patients on long-term opioid therapy experience symptoms of constipation, this common side effect is often not addressed by clinicians, leaving many individuals to suffer in silence.1,2 Unmanaged opioid-induced constipation can result in a number of medical complications, impair quality of life, and cause patients to skip doses of their opioid treatment.3 Do you know which of your patients is experiencing opioid-induced constipation? What strategies do you employ to help ease the symptoms of constipation in your opioid-treated patients? Join us for a practical and engaging discussion among experts in pain management and gastroenterology. During this Interactive Exchange™ program, faculty will share recommendations for efficiently assessing bowel patterns and prescribing both prophylactic and more intensive bowel regimens. The goal is to help pain-treating clinicians gain a deeper understanding of the effects of opioids on the gastrointestinal tract and effective strategies to alleviate constipation symptoms in patients on chronic opioid therapy.

REFERENCES 1. Cook SF, Lanza L, Zhou X, et al. Gastrointestinal side effects in chronic opioid users: results from a population-based survey. Aliment Pharmacol Ther. 2008;27(12):1224-1232.

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

3. Bell TJ, Panchal SJ, Miaskowski C, et al. The prevalence, severity, and impact of opioidinduced bowel dysfunction: results of a US and European Patient Survey (PROBE 1). 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 baseline bowel habits, risk factors for OIC development, and ongoing changes in bowel function in patients on long-term opioid therapy • Implement a prophylactic treatment plan to address OIC concurrent with the initiation of opioid therapy • Analyze current pharmacotherapies for OIC based on mechanisms of action and data on efficacy and safety

PREAMBLE

• Tailor treatment regimens for patients experiencing OIC according to symptom severity, past treatment responses, and patient preferences • Collaborate with PCPs and other providers to ensure that opioid-treated patients are routinely assessed for changes in bowel habits

PROGRAM AGENDA 12:00 pm – 12:05 pm Preactivity Questionnaire 12:05 pm – 12:20 pm Disease Management Primer 12:20 pm – 12:55 pm Case Series in Opioid-Induced Constipation 12:55 pm – 1:15 pm Choose-a-Case Collaboration 1:15 pm – 1:30 pm Postactivity Questionnaire 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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NURSING CONTINUING EDUCATION 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.

PREAMBLE

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 - 0530-9999-15-058-L01) 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 (which includes 0.5 hours of pharmacology).

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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INSTRUCTIONS TO RECEIVE CREDIT In order to receive credit for this activity, the participant must complete the application form upon completion of the program.

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

Global Education Group (Global) requires instructors, planners, managers and other individuals and their spouse/life partner 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 spouse/life partner have with commercial interests related to the content of this CME activity:

Charles E. Argoff, MD

Speakers Bureau for Allergan, Inc.; AstraZeneca plc; Depomed, Inc.; Iroko Pharmaceuticals, LLC; Janssen Pharmaceuticals, Inc.; Millennium Laboratories; and Xenoport, Inc. Grant/ Research Support from Endo Pharmaceuticals Inc., Forest Laboratories, and Eli Lilly and Company. Consultant/Independent Contractor to AstraZeneca plc; Depomed, Inc.; Endo Pharmaceuticals; Nektar Therapeutics; Pfizer Inc.; Xenoport, Inc.; and Zogenix, Inc. Stock Shareholder of Depomed, Inc. and Pfizer Inc. Royalties from Elsevier B.V.

Jeffrey A. Gudin, MD

Speakers Bureau for 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 from Teva Pharmaceutical Industries Ltd. Consultant/Independent contractor to AstraZeneca plc.; INSYS Therapeutics, Inc.; Iroko Pharmaceuticals LLC; Purdue Pharma L.P.; Salix Pharmaceuticals, Inc.; Teva Pharmaceutical Industries Ltd.; and Zogenix, Inc.

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PREAMBLE

DISCLOSURE OF CONFLICTS OF INTEREST

Anthony J. Lembo, MD Consultant/Independent contractor to AstraZeneca plc; Ironwood Pharmaceuticals, Inc.; Prometheus Laboratories Inc.; and Salix Pharmaceuticals, Inc. Grant/Research Support from Prometheus Laboratories Inc.

PREAMBLE

The planners and managers 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:

Ashley Marostica, RN, MSN Amanda Glazar, PhD Andrea Funk Kristen Delisi Rose O’Connor, PhD

Nothing to disclose Nothing to disclose Nothing to disclose Nothing to Disclose 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 manufacturer’s product information, and comparison with recommendations of other authorities.

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Bristol Stool Form Scale Bristol Stool Description

Form Scale

Image

Bristol Stool Description

Form Scale

Image

Bristol Stool Form Scale

Bristol Stool Form Scale CLINICAL ASSESSMENT TOOLS Description

Description Separate hard lumps, like nuts

Bristol Stool Form Scale

Description Separate hard lumps, like nuts

Bristol StoolStool Form Scale Bristol Form Scale Description

Separate hard hard lumps, lumps, like like nuts nuts Separate

Description Separate hard lumps, like nuts Sausage-shaped but lumpy

Type

Description

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Image

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smooth and soft

Like a sausage or snake, smooth and soft

Soft blobs blobs with with clear-cut clear-cut edges edges Soft

Like a sausage or snake, smooth and soft Soft blobs with 5 clear-cut edges Soft blobs with clear-cut edges

Fluffy pieces with ragged edges edges, a mushy stool Soft blobs with clear-cut

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withWatery, permission Lewis SJ, Heaton KW, Scandinavian Journal of Gastroenterology, 1997; 32(9):920–924. nofrom solid pieces »» http://bowelcontrol.nih.gov/Bristol_Stool_Form_Scale_508.pdf Healthcare.

Heaton KW. ScandaJ Gastroenterol.

1997;32(9):920–924.

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nofrom solid pieces withWatery, permission Lewis SJ, Heaton KW, Scandinavian Journal of Gastroenterology, 1997; 32(9):920–924.

Healthcare.

nofrom solid pieces d withWatery, permission Lewis SJ, Heaton KW, Journal of Gastroenterology, 1997; 32(9):920–924.

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RESOURCE CENTER

Like a sausage or snake, smooth and soft Soft blobs with clear-cut edges

NOTES

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CLINICAL ASSESSMENT TOOLS Bowel Function Index Please answer the following three questions by making a mark on the line between 0 and 100. Please transfer the results to the open squares at the bottom of the page. Add the three results and divide by three.

Question 1 (Q1) How would you rate the ease of defecation during the last 7 days according to patient assessment?

0=Easy/no difficulty

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100=Severe difficulty

Question 2 (Q2) Does your patient feel that his/her bowel evacuation has been incomplete during the last 7 days?

0=Not at all

50

100=Very strongly

Question 3 (Q3) How would you judge your patient’s constipation throughout the last 7 days?

50

100=Very heavily constipated

RESOURCE CENTER

0=No constipation at all

Results Q1

Q2

+

Q3

+

Sum

=

Total

/3=

Adapted from Rentz AM, et al. J Med Econ. 2009;12(0):371-383.

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CLINICAL ASSESSMENT TOOLS »» 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 opioidinduced 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

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

Drossman DA. Gastroenterology. 2006;130(5):1377-1390.

RESOURCE CENTER

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. http://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

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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. www.amazon.com/A-Clinical-Guide-Opioid-Analgesia/dp/1933692626#

»» 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

SUGGESTED READING »» 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.

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.

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

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

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RESOURCE CENTER

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

»» 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 study of lubiprostone for opioid-induced constipation in patients with chronic noncancer pain.

Cryer B, et al. Pain Med. 2014;15(11):1825-1834.

»» 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.

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

RESOURCE CENTER

van Dongen VCPC, et al. Int J Clin Pract. 2014;68(11):1364-1375.

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