This activity is jointly provided by Global Education Group and Integritas Communications. This activity is supported by an educational grant from AstraZeneca.
ANTHONY J. Lembo, MD
FACULTY
FACULTY
Associate Professor of Medicine Harvard Medical School Director, GI Motility Laboratory Division of Gastroenterology Beth Israel Deaconess Medical Center Boston, Massachusetts
Dr. Anthony J. Lembo earned his bachelor’s degree in mathematics from Amherst College in Amherst, Massachusetts, and his medical degree from Tufts University School of Medicine in Boston, Massachusetts. He subsequently completed his Internal Medicine Internship and Residency as well as a Gastroenterology Fellowship at the University of California, Los Angeles (UCLA) Medical Center in Los Angeles, California. Following his fellowship he became a Clinical Instructor of Medicine at UCLA in 1996 and served as the CoDirector of the Functional Bowel Disorders and GI (gastrointestinal) Motility Center at UCLA Medical Center. In 1997, Dr. Lembo joined the faculty at Beth Israel Deaconess Medical Center (BIDMC) in Boston, Massachusetts. He serves as Director of the GI Motility Laboratory in the BIDMC Division of Gastroenterology and as an Associate Professor of Medicine at Harvard Medical School in Boston, Massachusetts. His research interests include functional bowel disorders, such as irritable bowel syndrome, chronic constipation, and dyspepsia, as well as the role of placebo in functional bowel disorders.
For additional CME activities log on to
3
MICHAEL J. Brennan, MD FACULTY
The Pain Center of Fairfield Fairfield, Connecticut Assistant Medical Director, Chronic Pain and Recovery Center Silver Hill Hospital New Canaan, Connecticut Senior Attending Physician, Department of Medicine Bridgeport Hospital Bridgeport, Connecticut
Dr. Michael J. Brennan received his medical degree at 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. After leaving Sloan-Kettering, Dr. Brennan became the medical director of the Rehabilitation Center of Fairfield County and Ahlbin Centers for Rehabilitation Medicine and chief of the section of physical medicine at Bridgeport Hospital in Bridgeport, Connecticut. He is currently an assistant medical director, Chronic Pain and Recovery Center at Silver Hill Hospital, a senior attending physician in the Department of Medicine at Bridgeport Hospital, a consulting physician at St. Vincent’s Hospital in Bridgeport, Connecticut, and a boardcertified physiatrist in private practice in Fairfield, Connecticut. Dr. Brennan is especially interested in the management of pain and disability in patients suffering from the acute and long-term effects of musculoskeletal diseases, neurologic 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, recognizing his commitment to the treatment of patients suffering from chronic pain.
4
APRIL M. Zehm, MD FACULTY
Instructor, Harvard Medical School Assistant in Medicine Division of Palliative Care Massachusetts General Hospital Boston, Massachusetts
Dr. April Zehm earned her bachelor of science in biomedical engineering and her medical degree from the University of Wisconsin–Madison. She completed her internship and residency in Internal Medicine at the University of Wisconsin Hospital & Clinics and then completed Harvard’s Interdisciplinary Palliative Care fellowship at Massachusetts General Hospital/Dana Farber Cancer Institute. Dr. Zehm is now a practicing palliative care physician at Massachusetts General Hospital, where she specializes in the care of the seriously ill, symptom management, patient and family communication, and end-of-life care. She is also an instructor at Harvard Medical School and works on curriculum development for a variety of teaching forums for medical students, residents, and fellows. Dr. Zehm is a proud member of the American Academy of Hospice and Palliative Medicine (AAHPM) and has presented at its annual assembly several times.
For additional CME activities log on to
5
TARGET AUDIENCE The educational design of this activity addresses the needs of palliative care clinicians who manage patients on opioid-based pain regimens.
PREAMBLE
STATEMENT of NEED/PROGRAM OVERVIEW As the United States population ages, an increasing number of individuals will suffer from significant pain as they approach end of life.1 Despite advances in our understanding of pain physiology and available treatment modalities, pain associated with life-threatening illnesses is often untreated or undertreated.2 This results in part from side effects of commonly prescribed analgesics. For example, opioids have long been the cornerstone treatment for pain associated with cancer or other terminal conditions.3,4 The most frequent side effect of prescription opioids is constipation, which ranks as the third most commonly reported symptom in palliative care.5,6 Unaddressed opioid-induced constipation (OIC) can have markedly deleterious effects on patient function and quality of life.7,8 With an overall goal of improving comprehensive pain management in patients receiving palliative care, this Evidence-Based Best Practices program will examine the pathophysiology of opioid-induced bowel dysfunction, prophylactic treatment regimens for OIC, assessment strategies to identify and monitor affected patients, and new therapeutic approaches that mitigate OIC effectively and safely.
REFERENCES 1. Robinson CL. Health Prog. 2007;88(1):48-53. 2. Deandrea S, et al. Prevalence of undertreatment in cancer pain. A review of published literature. Ann Oncol. 2008;19(12):1985-1991. 3. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology: Adult Cancer Pain. Version 2.2016. 4. American Geriatrics Society Panel on Pharmacological Management of Persistent Pain in Older Persons. J Am Geriatr Soc. 2009;57(8):1331-1346. 5. Coyne KS, et al. Clinicoecon Outcomes Res. 2014;6:269-281. 6. Gatti A, Sabato AF. Clin Drug Investig. 2012;32(5):293-301. 7. Holzer P. Expert Opin Investig Drugs. 2007;16(2):181-194. 8. Rao SS. Gastroenterol Clin North Am. 2007;36(3):687-711.
6
EDUCATIONAL OBJECTIVES After completing this activity, the participant should be better able to: • Evaluate baseline and ongoing bowel function in palliative care patients who need opioid-based pain management • Describe the mechanisms of action, published evidence, and prescribing considerations for FDA-approved medications in the treatment of OIC • Incorporate prophylactic bowel regimens and newer OIC therapies into comprehensive palliative care plans
PHYSICIAN ACCREDITATION STATEMENT This activity has been planned and implemented in accordance with the accreditation requirements 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 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
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 1.0 contact hour is provided by Global Education Group. Nurses should claim only the credit commensurate with the extent of their participation in the activity.
NURSE PRACTITIONER CONTINUING EDUCATION Global Education Group is accredited by the American Association of Nurse Practitioners as an approved provider of nurse practitioner continuing education. Provider number: 110121. This activity is accredited for 1.0 contact hour which includes 0.1 hour of pharmacology. Activity ID #2306L. This activity was planned in accordance with AANP CE Standards and Policies.
For additional CME activities log on to
7
PREAMBLE
• Communicate with opioid-treated palliative care patients and their caregivers to facilitate bowel assessment efforts and shared decision-making about OIC treatment options
GLOBAL CONTACT INFORMATION For information about the accreditation of this program, please contact Global at 303-395-1782 or cme@globaleducationgroup.com.
INSTRUCTIONS to RECEIVE CREDIT In order to receive credit for this activity, the participant must complete the program evaluation.
PREAMBLE
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: Anthony J. Lembo, MD Consultant/Independent Contractor: Alkermes plc, Ardelyx, Inc., Forest Laboratories, Inc., Ironwood Pharmaceuticals, Inc., Prometheus Laboratories Inc., Salix Pharmaceuticals, Inc.; Grant/Research Support: Prometheus Laboratories Inc. Michael J. Brennan, MD Consultant/Independent Contractor: AstraZeneca, Cara Therapeutics Inc., Collegium Pharmaceutical Inc., Depomed, Inc., Progenics Pharmaceuticals, Inc., Purdue Pharma L.P., Teva Pharmaceuticals USA Inc.; Honoraria: AstraZeneca, Collegium Pharmaceutical Inc., Depomed, Inc., Progenics Pharmaceuticals, Inc., Purdue Pharma L.P., Teva Pharmaceuticals USA Inc.; Stockholder: Cara Therapeutics Inc. April M. Zehm, MD
8
Nothing to disclose
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
Andrea Funk
Nothing to disclose
Laura Gildsdorf
Nothing to disclose
Ashley Marostica, RN, MSN Nothing to disclose Rose O’Connor, PhD
Nothing to disclose
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.
For additional CME activities log on to
9
PREAMBLE
DISCLOSURE OF UNLABELED USE
SLIDES
10
SLIDES
For additional CME activities log on to
11
SLIDES
12
SLIDES
For additional CME activities log on to
13
SLIDES
14
SLIDES
For additional CME activities log on to
15
SLIDES
16
SLIDES
For additional CME activities log on to
17
SLIDES
18
SLIDES
For additional CME activities log on to
19
SLIDES
20
SLIDES
For additional CME activities log on to
21
SLIDES
22
SLIDES
For additional CME activities log on to
23
SLIDES
24
SLIDES
For additional CME activities log on to
25
SLIDES
26
GUIDELINES »» Emerging treatments in neurogastroenterology: a multidisciplinary working group consensus statement on opioid-induced constipation. Camilleri M, et al. Neurogastroenterol Motil. 2014;26(10):1386-1395. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4358801/pdf/ nihms664356.pdf
»» Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. Chou R, et al. J Pain. 2009;10(2):113-130. https://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 http://www.va.gov/painmanagement/docs/cpg_opioidtherapy_fulltext.pdf
»» CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016 Dowell D, et al. MMWR Recomm Rep. 2016;65(No. RR 1):1-49. https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm
»» The management of constipation in palliative care: clinical practice recommendations.
For additional CME activities log on to
RESOURCE CENTER
Larkin PJ, et al. Palliat Med. 2008;22(7):796-807. http://journals.sagepub.com/doi/pdf/10.1177/0269216308096908
27
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. https://www.theacpa.org/uploads/ACPA-Opioid_Constipation_Chart-V4.pdf
»» Patient Education Handout This leaflet provides patients with approaches to mitigating opioid-induced constipation and includes a list of questions about constipation for patients to ask their doctors or clinics. https://www.acponline.org/system/files/documents/patients_families/ products/health_tips/oic_en.pdf
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. http://www.exchangecme.com/resourcePDF/chronicpain/ BowelFunctionIndex.pdf
»» Bristol Stool Form Scale
RESOURCE CENTER
This visual scale is used to help patients characterize their stool. It classifies the most commonly passed stool forms into 7 types. https://www.bladderandbowelfoundation.org/wp-content/ uploads/2014/12/BBC002_Bristol-Stool-Chart-Jan-2016.pdf
28
OTHER RESOURCES »» Consensus recommendations on initiating prescription therapies for opioid-induced constipation. Argoff CE, et al. Pain Med. 2015;16(12):2324-2337. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4738423/pdf/PME-16-2324.pdf
»» A Clinical Guide to Opioid Analgesia. 2nd edition. Fine PG, Portenoy RK. New York, NY: Vendome Group, LLC; 2007. https://www.amazon.com/A-Clinical-Guide-Opioid-Analgesia/dp/1933692626#
»» Consensus recommendations for the management of constipation in patients with advanced, progressive illness. Librach SL, et al. J Pain Symptom Manage. 2010;40(5):761-773. http://www.jpsmjournal.com/article/S0885-3924(10)00599-3/pdf
»» Responsible Opioid Prescribing. A Clinician’s Guide. 2nd Edition, revised and expanded. Wilson PR. Pain Med. 2015;16(5):1027-1028. https://academic.oup.com/painmedicine/article-lookup/doi/10.1111/pme.12711
SUGGESTED READINGS »» Constipation in people prescribed opioids. Ahmedzai SH, Boland J. BMJ Clin Evid. 2010;pii:2407. http://www.ncbi.nlm.nih.gov/pubmed/21718572
»» Naloxegol for opioid-induced constipation in patients with noncancer pain.
RESOURCE CENTER
Chey WD, et al. N Engl J Med. 2014;370(25):2387-2396. http://www.nejm.org/doi/pdf/10.1056/NEJMoa1310246
»» 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. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4041290/
For additional CME activities log on to
29
»» Opioid-induced bowel dysfunction: epidemiology, pathophysiology, diagnosis, and initial therapeutic approach. Dorn S, et al. Am J Gastroenterol Suppl. 2014;2(1):31-37. http://www.nature.com/ajgsup/journal/v2/n1/pdf/ajgsup20147a.pdf
»» Establishing “best practices” for opioid rotation: conclusions of an expert panel. Fine PG, et al. J Pain Symptom Manage. 2009;38(3):418-425. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4065110/pdf/nihms576124.pdf
»» Impact of constipation on opioid therapy management among long-term opioid users, based on a patient survey. Gupta S, et al. J Opioid Manag. 2015;11(4):325-338. https://www.ncbi.nlm.nih.gov/pubmed/?term=26312960
»» 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. http://www.ncbi.nlm.nih.gov/pubmed/?term=ishihara+m+2012+clin+j+pain
»» 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. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4424379/
»» Treatment with methylnaltrexone is associated with increased survival in patients with advanced cancer.
RESOURCE CENTER
Janku F, et al. Ann Oncol. 2016;27(11):2032-2038. https://www.ncbi.nlm.nih.gov/pubmed/?term=27573565
»» The impact of opioid-induced constipation among chronic pain patients with sufficient laxative use. LoCasale RJ, et al. Int J Clin Pract. 2015;69(12):1448-1456. http://onlinelibrary.wiley.com/doi/10.1111/ijcp.12718/abstract
30
»» Symptom severity of patients with advanced cancer in palliative care unit: longitudinal assessments of symptoms improvement. Tai S-Y, et al. BMC Palliat Care. 2016;15:32. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4787050/pdf/12904_2016_Article_105.pdf
»» Randomized, double-blind, placebo-controlled trial of oral docusate in the management of constipation in hospice patients. Tarumi Y, et al. J Pain Symptom Manage. 2013;45(1):2-13. http://www.jpsmjournal.com/article/S0885-3924(12)00249-7/pdf
»» Randomized, double-blind trial of oral methylnaltrexone for the treatment of opioidinduced constipation in patients with chronic noncancer pain.
RESOURCE CENTER
Rauck R, et al. Pain Pract. November 2016. [Epub Ahead of Print]. http://onlinelibrary.wiley.com/doi/10.1111/papr.12535/epdfw
For additional CME activities log on to
31
NOTES
32
NOTES
For additional CME activities log on to
33
NOTES
34
Please visit the CLINICAL RESOURCE CENTER for additional information and resources
www.EXCHANGECME.com/OICRESOURCES
© 2017 Global Education Group and Integritas Communications. All rights reserved. No part of this syllabus may be used or reproduced in any manner whatsoever without written permission except in the case of brief quotations embedded in articles or reviews.