Achieving Balance: Practical Management Strategies for Opioid-Induced Constipation

This activity is sponsored by

pmiCME

OCTOBER 14, 2015 OCTOBER 30, 2015 NOVEMBER 11, 2015 DECEMBER 9, 2015

Rosemont, Illinois Princeton, New Jersey Los Angeles, California Tampa, Florida

Educational partner This activity is supported by an educational grant from AstraZeneca

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

FACULTY* FACULTY

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

JAMES W. Atchison, DO Medical Director, Center for Pain Management Rehabilitation Institute of Chicago Chicago, IL

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

DARREN M. Brenner, MD Assistant Professor of Medicine and Surgery Northwestern Univeristy Feinberg School of Medicine Chicago, Illinois

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JEFFREY A. Gudin, MD FACULTY

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

BILL H. McCarberg, MD Adjunct Assistant Clinical Professor University of California, San Diego San Diego, California Elizabeth Hospice Neighborhood Healthcare Escondido, California

*Not all faculty members will present in all cities.

Faculty is subject to change, with additional faculty to be announced.

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TARGET AUDIENCE This activity is intended for primary care providers involved in the treatment and management of patients with opioid-induced constipation.

LEARNING OBJECTIVES Upon completion of the activity, participants should be better able to: •• Describe the effects of opioid receptor activation in the gastrointestinal tract

PREAMBLE

•• Evaluate patients on chronic opioid therapy for bowel function and risk factors for opioid-induced constipation (OIC) development •• Implement a prophylactic treatment plan to address OIC concurrent with the initiation of opioid therapy •• Compare the mechanisms of action and clinical profiles of current prescription medication for OIC •• Construct evidence-based treatment regimens for patients with OIC that reflect bowel symptoms, prior treatment response, and patient preferences •• Communicate with opioid-treated patients about treatment-emergent adverse events through open, patient-centered dialogue throughout the course of therapy

PMICME CLINICAL STAFF AND TUFTS HEALTH CARE INSTITUTE EXPERT REVIEWER FINANCIAL DISCLOSURE As a continuing medical education provider accredited by the ACCME, it is the policy of pmiCME to require any individual in a position to influence educational content to disclose the existence of any financial interest or other personal relationship with the manufacturer(s) of any commercial product(s). pmiCME clinical staff and Tufts Health Care Institute expert content reviewers have provided financial disclosure and have no conflicts of interest to resolve for each of the sessions related to this activity.

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CONFLICT OF INTEREST RESOLUTION STATEMENT

PREAMBLE

pmiCME requires all individuals in a position to influence educational content for pmiCME-certified CME activities to disclose relevant personal financial relationship(s) with commercial interests prior to contributing to the activity. pmiCME assesses disclosed relationships and follows a defined process to resolve real or implied conflicts to ensure, to the best of our ability, that all educational content is free of commercial bias. Financial disclosures are listed in this program and will also be announced prior to the start of each presentation and posted on www.pri-med.com.

OFF-LABEL/INVESTIGATIONAL DISCLOSURES During the course of their presentations, the faculty may mention uses of products that have not been approved in the United States for the indication(s) being discussed. All presenters are instructed to notify participants when they are discussing unapproved uses or investigational agents. In addition, specific slides will include notation of the off-label use or investigational agent being discussed. Views presented during this program related to unapproved uses of products are solely those of the presenter(s) and are not endorsed by pmiCME, DBC Pri-Med, LLC, or ACP.

ACCREDITATION STATEMENT pmiCME is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

DESIGNATION STATEMENT pmiCME designates this live activity for a maximum of 1.25 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

ACKNOWLEDGMENT OF COMMERCIAL SUPPORT This activity is supported by an educational grant from AstraZeneca.

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SLIDES

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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

Image

Image

Image Image Image

Image

Separate hard lumps, like nuts Sausage-shaped but lumpy Sausage-shaped Separate hard lumps, like nuts Separate 1but lumpy

Sausage-shaped but lumpy

hard lumps, like nuts

Sausage-shaped lumpy Like a sausage or but snake but with cracks on its surface Sausage-shaped lumpy Like a sausage 2 orbut snake but with cracks on Sausage-shaped but its lumpy Like a sausage or snake but with cracks on its surface surface Sausage-shaped lumpy Like a sausage orbut snake but with cracks on its surface sausage oron snake Like a sausage or snake Like but awith cracks its but 3 surface Like a sausage or snake, smooth andon soft with cracks its surface Like a sausage or snake but with cracks on its Like a sausage or snake, smooth and soft surface Like a sausage or snake, smooth and soft Like a sausage or snake but with cracks on its Like a sausage or snake, surface Like a sausage 4 or snake, smooth and soft

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

Fluffy pieces with ragged edges, a mushy stool

Fluffy pieces with 6 ragged edges, a mushy stool

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

Watery, no solid7 pieces

Watery, no solid pieces

Fluffy pieces with ragged edges, a mushy stool Watery, no solid pieces Fluffy pieces with ragged edges, a mushy stool

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.

Fluffy piecesLewis withSJ,ragged edges, mushy stool

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?

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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#

»» 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/pdf/nihms664356.pdf

»» 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 »» 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. »» 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.

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RESOURCE CENTER

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

»» 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.

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

RESOURCE CENTER

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

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