Best Practices: Eight Principles for Safer Opioid Prescribing

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1 Best Practices: Eight Principles for Safer Opioid Prescribing Lynn R. Webster, MD Vice President of Scientific Affairs PRA International Salt Lake City, UT February 11, 2015

2 Dr Webster: Disclosures 12-Month disclosures of financial relationships with commercial interests: Honorarium: Consultant Honorarium: Advisory Board Travel Expenses Acura Pharmaceuticals Depomed Acura Pharmaceuticals AstraZeneca Egalet AstraZeneca BioDelivery Sciences International Inspirion Pharmaceuticals BioDelivery Sciences International CVS Caremark Insys Therapeutics Bristol-Myers Squib (BMS) Grunenthal USA Kaleo Depomed Mallinckrodt Pharmaceuticals Mallinckrodt Pharmaceuticals Grunenthal USA Nevro Corporation Signature Therapeutics Inspirion Pharmaceuticals Synchrony Healthcare Teva Pharmaceuticals Insys Therapeutics Travena Jazz Pharmaceuticals Kaleo Mallinckrodt Pharmaceuticals Nektar Therapeutics Nevro Corporation Orexo Pharmaceuticals Teva Pharmaceuticals Travena This presentation does not contain off-label or investigational use of drugs or products

3 Planning Committee, Disclosures Vitaly Gordin, MD Director of Pain Division Penn State Hershey Medical Center Hershey, PA No relevant financial relationships Jennifer Westlund, MSW Director of Education American Academy of Pain Medicine No relevant financial relationships Angela Casey VP, Medical Director PharmaCom Group No relevant financial relationships

4 Target Audience The overarching goal of PCSS-O is to offer evidence-based trainings on the safe & effective prescribing of opioid medications in the treatment of pain &/or opioid addiction Our focus is to reach providers &/or providers-in-training from diverse healthcare professions including physicians, nurses, dentists, physician assistants, pharmacists, & program administrators

5 Educational Objectives At the conclusion of this activity participants should be able to: 1. Understand the major risk factors for unintentional opioid overdose deaths in patients with chronic pain 2. Devise a plan to implement 8 simple principles for safer opioid prescribing that can save lives

Major Reasons for Opioid-Associated Deaths Over-prescribing (Physician) Starting dose too high Dose escalation too rapid Over reliance on conversion tables Inadequate risk

6 Major Reasons for Opioid-Associated Deaths Over-prescribing (Physician) Starting dose too high Dose escalation too rapid Over reliance on conversion tables Inadequate risk assessment Non-adherence (Patient) To control pain To cope Substance abuse Unanticipated co-morbidities QT prolongation Pharmacogenetics & methadone metabolism Sleep disordered breathing

7 Rate Rates of Prescription Opioid Sales & Deaths, Sales per kg per 100,000 people Deaths per 100,000 people Centers for Disease Control and Prevention. CDC Vital Signs: Prescription Painkiller Overdoses in the US Chen LH, et al. Drug-poisoning deaths involving opioid analgesics: United States, NCHS data brief, no Hyattsville, MD: NCHS Warner M, et al. Trends in drugpoisoning deaths involving opioid analgesics and heroin: United States, CDC Health E- Stats Chen LH, et al. Quick Stats. MMWR. 2015;64:32..

8 Number of deaths Number of Deaths Involving Opioid Analgesics, fold increase in deaths since Warner M, et al. Trends in drug-poisoning deaths involving opioid analgesics and heroin: United States, CDC Health E-Stats Chen LH, et al. Quick Stats. MMWR. 2015;64:32.

9 Rate per 100,000 Number of deaths among women Prescription Opioid Deaths Are a Growing Problem Among Women Although men are still more likely to die of prescription opioid overdoses, the gap between men & women is closing Prescription opioid overdose deaths among women have increased >400% since 1999, compared to 265% among men 0 Male Female 0 CDC Vital Signs. Prescription Painkiller Overdoses. A growing epidemic, especially among women Paulozzi L. CDC. Populations at risk for opioid overdose

1. Assess patients for risk of abuse before starting opioid therapy and manage accordingly 2. Watch for and treat comorbid mental disease if present 3.

10 1. Assess patients for risk of abuse before starting opioid therapy and manage accordingly 2. Watch for and treat comorbid mental disease if present 3. Conventional conversion tables can cause harm and should be used cautiously when rotating (switching) from one opioid to another 4. Avoid combining benzodiazepines with opioids, especially during sleep hours 5. Start methadone at a very low dose and titrate slowly regardless of whether your patient is opioid tolerant or not 6. Assess for sleep apnea in patients on high daily doses of methadone or other opioids and in patients with a predisposition 7. Tell patients on long-term opioid therapy to reduce opioid dose during upper respiratory infections or asthmatic episodes 8. Avoid using long-acting opioid formulations for acute, postoperative, or trauma-related pain Webster LR. Pain Med. 2013;14:

11 Assess patients for risk of abuse before starting opioid therapy & manage accordingly 1 BEST PRACTICES Webster LR. Pain Med. 2013;14:

12 Oreos As Addictive As Cocaine? For Rats, At Least Photo by Bob MacDonnell courtesy of Connecticut College Student-faculty research suggests Oreos can be compared to drugs of abuse in lab rats. Connecticut College News. October 15,

13 Vulnerability to Opioid Addiction Individuals respond differently to opioid exposure Addictive disease after opioid exposure No addictive disease with exposure No addictive disease due to lack of exposure

14 Genetic Vulnerability to Addiction? Fischer 344 Lewis Sprague- Dawley Abstinence Polysubstance Abuse Average Drug rejecting Drug seeking Drug neutral Webster LR, Dove B. Avoiding Opioid Abuse While Managing Pain: A Guide for Practitioners. North Branch, MD: Sunrise River Press

15 Drug-abusing behavior Level of Abuse in Stressful Environments Low Moderate High Patient stress level Webster LR, Dove B. Avoiding Opioid Abuse While Managing Pain: A Guide for Practitioners. North Branch, MD: Sunrise River Press

16 Screening Tools to Assess Patient Risk Before Prescribing Opioids Use one of several available tools to assess patient risk of developing problematic drug-taking behaviors Based on biological, social, & psychiatric risk factors Tool # of items Administered by ORT Opioid Risk Tool 5 patient SOAPP Screener & Opioid Assessment for Patients with Pain 24, 14, or 5 patient DIRE Diagnosis, Intractability, Risk, & Efficacy Score 7 clinician Implement a plan according to risk level eg, for high-risk patients, refer for psychiatric evaluation or co-manage with a chemical dependency expert prior to opioid trial Webster LR. Pain Med. 2013;14: Webster LR, Webster RM. Pain Med. 2005:6: Butler SF, et al. Pain. 2004;112: Belgrade MJ, et al. J Pain. 2006;7:

17 Identify Misuse Once Opioid Treatment Begins Periodic monitoring for effects on analgesia, daily activities, adverse events, ADRBs, cognition, function, & QOL can be assisted by tools Tool # of items Administered by PADT Pain Assessment & Documentation Tool 41 clinician COMM Current Opioid Misuse Measure 17 patient Check state prescription monitoring programs Utilize measures such as urine drug testing ADRBs=aberrant drug-related behaviors; QOL=quality of life Webster LR. Pain Med. 2013;14: Passik SD, et al. J Opioid Manage. 2005: Passik SD, et al. Clin Ther. 2004; Butler SF, et al. Pain. 2007;130:

18 Watch for & treat comorbid mental disease if present 2 BEST PRACTICES Webster LR. Pain Med. 2013;14:

19 Overlapping Effects Psychiatric disorders 50% overlap Pain disorders Peles E, et al. Pain. 2005;113: Potter JS, et al. Am J Drug Alcohol Abuse. 2008;34: Rosenblum A, et al. JAMA. 2003;289: Sheu R, et al. Pain Med. 2008;9:911-7.

Overlapping Effects Psychiatric disorders 60% overlap Addiction disorders National Institute on Drug Abuse. Comorbid Drug Abuse and Mental Illness.

20 Overlapping Effects Psychiatric disorders 60% overlap Addiction disorders National Institute on Drug Abuse. Comorbid Drug Abuse and Mental Illness. A Research Update from the National Institute on Drug Abuse National Institute on Drug Abuse. Comorbidity: Addiction and Other Mental Illness. Research Report Series. NIH Publication No

21 Comorbid Pain & Mental Disease Co-occurrence of mental health disorders with chronic pain place patient at high risk for: Misuse Drug-drug interactions Overdose Assess for the presence of mental disease before initiating opioid therapy When indicated, consult with experts in mental health fields to co-ordinate care Webster LR. Pain Med. 2013;14:

22 An Olympian Challenge: Managing a Critical Interplay A trio diagnosis Addiction disorder Psychiatric disorder Pain disorder Webster LR, Dove B. Avoiding Opioid Abuse While Managing Pain: A Guide for Practitioners. North Branch, MD: Sunrise River Press

23 Number of ED visits for drugrelated suicide attempts (thousands) Suicide All drugs Opioid analgesics 41% increase in drug suicide attempts % increase in opioid suicide attempts Substance Abuse and Mental Health Services Administration. Drug Abuse Warning Network, 2011: National Estimates of Drug-Related Emergency Department Visits. HHS Publication No. (SMA) , DAWN Series D-39. Rockville, MD: SAMHSA, 2013.

24 Why Suicide? Non-Pain Patients Escape from severe suffering Only option Hopelessness Permanent solution Kraft TL, et al. Arch Suicide Res. 2010;14:

25 Conventional conversion tables can cause harm & should be used cautiously when rotating (switching) from one opioid to another 3 BEST PRACTICES Webster LR. Pain Med. 2013;14:

the equivalent doses of different opioids Individual consideration is necessary for every patient

26 WARNING! Equianalgesic Conversion Tables Equianalgesic tables provide insufficient guidance to determine the equivalent doses of different opioids Individual consideration is necessary for every patient Webster LR. Pain Med. 2013;14: Knotkova H, et al. J Pain Symptom Manage. 2009; 38: Webster LR, Fine PG. Pain Med. 2012;13: Webster LR, Fine PG. Pain Med. 2012;13:571-4.

27 Steps in Opioid Rotation Slowly decrease one opioid while slowly titrating the new opioid to effect Webster LR. Pain Med. 2013;14: Webster LR, Fine PG. Pain Med. 2012;13:571-4.

28 Steps in Opioid Rotation 10%-30% increments 10%-20% increments IR Supplement Webster LR. Pain Med. 2013;14: Webster LR, Fine PG. Pain Med. 2012;13:571-4.

29 Steps in Opioid Rotation 10%-20% increments IR Supplement 10%-30% increments Webster LR. Pain Med. 2013;14: Webster LR, Fine PG. Pain Med. 2012;13:571-4.

30 Steps in Opioid Rotation In most cases, the complete switch can occur within 3-4 weeks If you are not experienced in switching opioids in patients on long-term opioid therapy, seek expert consultation Webster LR. Pain Med. 2013;14: Webster LR, Fine PG. Pain Med. 2012;13:571-4.

31 Avoid combining benzodiazepines with opioids, especially during sleep hours 4 BEST PRACTICES Webster LR. Pain Med. 2013;14:

32 Most Common Drugs Involved in Overdoses in the United States In 2013, there were 43,982 drug overdose deaths 22,767 (51.8%) were related to pharmaceuticals 16,235 (71.3%) involved opioid analgesics 6,973 (30.6%) involved benzodiazepines People who died of drug overdoses often had a combination of benzodiazepines & opioids in their bodies In 2011, ~1.4 million ED visits involved nonmedical use of pharmaceuticals 501,207 visits involved anti-anxiety & insomnia medications 420,040 visits involved opioid analgesics CDC. Prescription Drug Overdose in the United States: Fact Sheet

33 Benzodiazepines & Chronic Pain Patients Enhance the respiratory depressant effects of opioids Frequently co-prescribed with opioids (up to 50% of patients) In 1 population, 80% of patients prescribed high-dose opioids were co-prescribed benzodiazepines More common in chronic pain patients with substance use disorders Consider an alternative For anxiety disorders When a sleep aid is indicated, eg, an anticonvulsant or lowdose trazodone For patients with neuropathic pain, low-dose trazodone at bedtime may be dually beneficial Webster LR. Pain Med. 2013;14: Webster LR, et al. Postgraduate Med. 2015; early online. Deyo RA, et al. J Am Board Fam Med. 2011;24: King SA, Strain JJ. Clin J Pain. 1990;6: Manchikanti L, et al. Pain Physician. 2009;12: Braden JB, et al. Arch Intern Med. 2010;170: Dasgupta N. Opioid analgesic prescribing and overdose mortality in North Carolina [dissertation]. Chapel Hill, NC: University of North Carolina at Chapel Hill; Weisner CM, et al. Pain. 2009;145:

34 Start methadone at a very low dose & titrate slowly regardless of whether your patient is opioid tolerant or not 5 BEST PRACTICES Webster LR. Pain Med. 2013;14:

35 Methadone-Related Deaths Methadone contributed to nearly 1 in 3 prescription opioid deaths in ,000 people die every year of overdose related to methadone 6 times as many people died of methadone overdose in 2009 than a decade before CDC. Prescription Drug Overdoses. CDC Vital Signs; July 2012.

36 Death rate per 100 kilograms Death Rate from Overdose Caused by a Single Prescription Painkiller Substance Abuse and Mental Health Administration, Center for Behavioral Statistics and Quality, Drug Abuse Warning Network Medical Examiner Component, CDC. Prescription Drug Overdoses. CDC Vital Signs; July 2012.

37 Blood level Simulated Methadone Dosing α (analgesic) β (non-analgesic) Toxicity Analgesia Hours Days Webster LR. Unintentional overdose deaths: reversing the trend. Presented at: The American Academy of Pain Medicine s 28th Annual Meeting; February 22-26, 2012; Palm Springs, CA.

38 Legal Review of Opioid Deaths: Methadone Starting doses mg/day Most <30 mg/day ~90% opioid tolerant ~80% died within 4 days of first methadone Snoring common Occasional upper respiratory infection/flu onset preceded death Webster LR, Rich B. Pain Med. 2011;12:S59-65.

39 Initiating Methadone Consider starting patients, whether or not they are opioid naïve, on 15 mg/day in divided doses (qh8) Increase the total daily dose by no more than 25%-50%, no more frequently than weekly If you are not experienced prescribing methadone, consult with a clinician who is Webster LR. Pain Med. 2013;14:

40 Assess for sleep apnea in patients on high daily doses of methadone or other opioids & in patients with a predisposition 6 BEST PRACTICES Webster LR. Pain Med. 2013;14:

41 Percent of patients Sleep Disorders & Opioids: Events per Hour AHI=apnea-hypopnea index CAI=central apnea index OMAI=obstructive & mixed apnea Index AHI 5 events/hour CAI 5 events/hour OMAI 5 events/hour Sleep apnea: type indeterminate Bars indicate hi/lo of 95% CI n = 140 Webster LR, et al. Pain Med. 2008;9:

42 Rate ratio Rate Ratios by Increase of Morphine Equivalent Dose AWAITING PERMISSION TO USE FROM PUBLISHER Central p<.001 Hypopnea p< Obstructive p< REM apnea/hypopnea p= Morphine equivalent dose (mg/day) Walker JM, et al. J Clin Sleep Med. 2007;3:

43 Assess for Sleep Apnea Refer the following patients for formal sleep apnea evaluation Patients who require >50 mg/day of methadone Patients who require >150 mg/day of morphine equivalent dose of other opioids Patients with a predisposition or risk factors for sleep apnea At risk patients may require inpatient evaluation to monitor for & determine safety of opioid therapy Webster LR. Pain Med. 2013;14:

44 Tell patients on long-term opioid therapy to reduce opioid dose during upper respiratory infections or asthmatic episodes 7 BEST PRACTICES Webster LR. Pain Med. 2013;14:

45 Reduce Opioid Dose During Because of a decreased margin of safety, advise patients to reduced their daily opioid doses by 30% during events with acute respiratory tract compromise These include: Flu Pneumonia Upper respiratory infections Cigarette use Chronic obstructive pulmonary disease Asthmatic episodes Webster LR. Pain Med. 2013;14: Webster LR, et al. Postgrad Med. 2015; online first.

46 Avoid using long-acting opioid formulations for acute, post-operative, or trauma-related pain 8 BEST PRACTICES Webster LR. Pain Med. 2013;14:

47 Reserve Long-Acting Opioids for Opioid-Tolerant Patients Reserve long-acting/extended-release opioids, including transdermal patches, for patients who have developed tolerance to opioids ie, who already take regular, daily, around-the-clock opioids Do not use for acute, postoperative, or trauma-related pain Webster LR. Pain Med. 2013;14: Webster LR, et al. Postgrad Med. 2015; online first.

48 References Belgrade MJ, et al. J Pain. 2006;7: Peles E, et al. Pain. 2005;113: Braden JB, et al. Arch Intern Med. 2010;170: Potter JS, et al. Am J Drug Alcohol Abuse. 2008;34: Butler SF, et al. Pain. 2004;112: Rosenblum A, et al. JAMA. 2003;289: Butler SF, et al. Pain. 2007;130: Sheu R, et al. Pain Med. 2008;9: CDC Vital Signs. Prescription Painkiller Overdoses in the US. Student-faculty research suggests Oreos can be compared to drugs of abuse in lab rats. Connecticut College News. October CDC Vital Signs. Prescription Drug Overdoses. July , CDC Vital Signs. Prescription Painkiller Overdoses. A growing SAMHSA, Center for Behavioral Statistics and Quality, Drug epidemic, especially among women Abuse Warning Network Medical Examiner Component, CDC. Prescription Drug Overdose in the United States: Fact SAMHSA. Drug Abuse Warning Network, 2011: National Sheet Estimates of Drug-Related Emergency Department Visits. Chen LH, et al. Drug-poisoning deaths involving opioid HHS Publication No. (SMA) , DAWN Series D-39. analgesics: United States, NCHS data brief, no. Rockville, MD: SAMHSA, Hyattsville, MD: NCHS Walker JM, et al. J Clin Sleep Med. 2007;3: Chen LH, et al. Quick Stats. MMWR. 2015;64:32. Warner M, et al. Trends in drug-poisoning deaths involving Dasgupta N. Opioid analgesic prescribing and overdose opioid analgesics and heroin: United States, CDC mortality in North Carolina [dissertation]. Chapel Hill, NC: Health E-Stats University of North Carolina at Chapel Hill; Webster LR, Webster RM. Pain Med. 2005:6: Deyo RA, et al. J Am Board Fam Med. 2011;24: Webster LR, Dove B. Avoiding Opioid Abuse While Managing King SA, Strain JJ. Clin J Pain. 1990;6: Pain: A Guide for Practitioners. North Branch, MD: Sunrise River Press Knotkova H, et al. J Pain Symptom Manage. 2009; 38: Webster LR, et al. Pain Med. 2008;9: Kraft TL, et al. Arch Suicide Res. 2010;14: Webster LR, Rich B. Pain Med. 2011;12:S59-65 Manchikanti L, et al. Pain Physician. 2009;12: Webster LR, Fine PG. Pain Med. 2012;13: NIDA. Comorbid Drug Abuse and Mental Illness. A Research Update from the National Institute on Drug Abuse Webster LR, Fine PG. Pain Med. 2012;13: NIDA. Comorbidity: Addiction and Other Mental Illness. Webster LR. Unintentional overdose deaths: reversing the Research Report Series. NIH Publication No trend. Presented at: The American Academy of Pain Medicine 28th Annual Meeting; Feb 22-26, 2012; Palm Springs, CA. Passik SD, et al. Clin Ther. 2004; Webster LR. Pain Med. 2013;14: Passik SD, et al. J Opioid Manage. 2005: Webster LR, et al. Postgraduate Med. 2015; early online. Paulozzi L. CDC. Populations at risk for opioid overdose Weisner CM, et al. Pain. 2009;145:

49 Questions & Answers Please type your question in the text chat box

50 PCSS-O Colleague Support Program PCSS-O Colleague Support Program is designed to offer general information to health professionals seeking guidance in their clinical practice in prescribing opioid medications. PCSS-O Mentors comprise a national network of trained providers with expertise in addiction medicine/psychiatry and pain management. Our mentoring approach allows every mentor/mentee relationship to be unique and catered to the specific needs of both parties. The mentoring program is available at no cost to providers. For more information on requesting or becoming a mentor visit: pcss-o.org/ask-colleague Listserv: A resource that provides an Expert of the Month who will answer questions about educational content that has been presented through PCSS-O project. To join pcss-o@aaap.org.

51 PCSS-O is a collaborative effort led by American Academy of Addiction Psychiatry (AAAP) in partnership with: Addiction Technology Transfer Center (ATTC), American Academy of Neurology (AAN), American Academy of Pain Medicine (AAPM), American Academy of Pediatrics (AAP), American College of Physicians (ACP), American Dental Association (ADA), American Medical Association (AMA), American Osteopathic Academy of Addiction Medicine (AOAAM), American Psychiatric Association (APA), American Society for Pain Management Nursing (ASPMN), International Nurses Society on Addictions (IntNSA), and Southeast Consortium for Substance Abuse Training (SECSAT). For more information visit: For questions pcss-o@aaap.org Funding for this initiative was made possible (in part) by Providers Clinical Support System for Opioid Therapies (grant no. 1H79TI025595) from SAMHSA. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.

Addiction Prediction: Errors from the bedside hurt patients with pain. Objectives. CDC guideline for prescribing OPIOIDS for Chronic Pain

Addiction Prediction: Errors from the bedside hurt patients with pain Renee C.B. Manworren, PhD, APRN, BC, PCNS-BC, AP-PMN, FAAN Director of Nursing Research and Professional Practice Posy and Fred Love