Addressing Drug Diversion

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Webinar Objectives Addressing Drug Diversion Bernice Burkarth, MD, HMDC, FAAHPM BBurkarth@treasurehealth.org October12, 2017 At the completion of this Webinar, participants will be able to: Identify tools and strategies to minimize drug diversion in the practice of hospice and palliative care Discuss electronic tools used in prescribing controlled substances in hospice and palliative care Discuss strategies to identify and address both patient and family drug diversion CDC Prescriber Education PRESCRIPTION PAIN KILLER OVERDOSES AT EPIDEMIC LEVELS CDC press release November 1, 2011 Overdoses involving prescription painkillers are at epidemic levels and now kill more Americans than heroin and cocaine combined, CDC Director Thomas Frieden, M.D., M.P.H. The SCOPE of PAIN Safe and Competent Opioid Prescriber Education Boston University COPE Collaborative Opioid Prescribing Education Substance Abuse and Mental Health Services Administration American Academy of Addiction Psychiatry The 10 Steps of Universal Precautions in Pain Medicine 1. Make a Diagnosis With Appropriate Differential 2. Psychological Assessment, Including Risk of Addictive Disorders 3. Informed Consent 4. Treatment Agreement 5. Pre or Post Intervention Assessment of Pain Level and Function The 10 Steps of Universal Precautions in Pain Medicine 6. Appropriate Trial of Opioid Therapy With or Without Adjunctive Medication 7. Reassessment of Pain Score and Level of Function 8. Regularly Assess the "4 A's" of Pain Medicine 9. Periodically Review Pain Diagnosis and Comorbid Conditions, Including Addictive Disorders 10. Documentation Gourlay D, Heit HA, Universal precautions in pain medicine: The Treatment of Chronic Pain With or Without the Disease of Addiction. Medscape Neurology. 2005;7(1) 2005 Medscape Gourlay D, Heit HA, Universal precautions in pain medicine: The Treatment of Chronic Pain With or Without the Disease of Addiction. Medscape Neurology. 2005;7(1) 2005 Medscape 5 6 1

Opioid Risk Assessments Tools: prior to initiating long term therapy ORT (Opioid Risk Tool) SOAPP R (The Screener and Opioid Assessment for Patients with Pain Revised ) SISAP (Screening Instrument for Substance Abuse Potential) DIRE (The Diagnosis, Intractability, Risk, Efficacy) tool Opioid Risk Assessments Tools: monitoring for signs of opioid misuse in patients receiving long term opioid therapy PDUQ p (Prescription Drug Use Questionnaire patient version) COMM (Current Opioid Misuse Measure) PMQ (Patient Medication Questionnaire) Opioid Risk Assessments Tools: monitoring for signs of opioid misuse in patients receiving long term opioid therapy PADT (Pain Assessment and Documentation Tool) ABC (Action Behavior Checklist) Patient Provider Agreement Include as part of informed consent Incorporate drug disposal guidelines and expectations Inclusion of caregivers in agreement and accountability the "4 A's" of Pain Medicine Analgesia Activity Adverse effects Aberrant behaviors Pharmacologic Advances Abuse Deterrent Preparations Kenneth L. Kirsh, PhD; Steven D. Passik, PhD. Managing Drug Abuse, Addiction, and Diversion in Chronic Pain: The 4 A's for Ongoing Monitoring Medscape Neurology. 2005;7(2) 2005 Medscape 11 2

Electronic Tools Electronic Prescribing Organizational Processes Pill counts at every visit Providing lock boxes Random urine drug screen Prescription Drug Monitoring Programs 14 Organizational Processes Prescribing in smaller quantities Providing patient and caregiver education on safe storage of medications Providing patient and caregiver education on safe drug disposal FDA guidance Take back programs Medicines recommended for disposal by Abstral tablets (sublingual) Fentanyl Actiq oral transmucosal lozenge * Fentanyl Citrate Arymo ER, tablets (extended release) Morphine Sulfate Avinza capsules (extended release) Morphine Sulfate Belbuca soluble film (buccal) Buprenorphine Buprenorphine, tablets (sublingual) * Buprenorphine Buprenorphine ; Naloxone Buprenorphine ; Naloxone, tablets (sublingual) * Butrans transdermal patch system Buprenorphine 15 https://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensu 16 ringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm#recommend Daytrana transdermal patch system Methylphenidate Demerol, tablets * Meperidine Demerol, oral solution * Meperidine Diastat/Diastat AcuDial, rectal gel [for disposal instructions: click on link, then go to "Label Diazepam information" and view current label] Dilaudid, tablets * Hydromorphone Dilaudid, oral liquid * Hydromorphone Dolophine tablets * Methadone Duragesic patch (extended release) * Fentanyl Embeda capsules (extended release) Morphine Sulfate; Naltrexone Exalgo tablets (extended release) Hydromorphone https://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuri 17 ngsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm#recommend Fentora tablets (buccal) Fentanyl Citrate Hysingla ER tablets (extended release) Hydrocodone Bitartrate Kadian capsules (extended release) Morphine Sulfate Methadone, oral solution * Methadone Methadose, tablets * Methadone Morphabond (extended release) Morphine Sulfate Morphine Sulfate, tablets (immediate release) * Morphine Sulfate Morphine Sulfate oral solution * Morphine Sulfate MS Contin tablets (extended release) * Morphine Sulfate Nucynta ER (extended release) Tapentadol https://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/en 18 suringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm#recommend 3

Onsolis (PDF 297KB), soluble film (buccal) Fentanyl Citrate Opana, tablets (immediate release) Oxymorphone Opana ER (extended release) Oxymorphone Oxecta, tablets (immediate release) Oxycodone Oxycodone, capsules Oxycodone Oxycodone oral solution Oxycodone Oxycontin tablets (extended release) Oxycodone Percocet, tablets * Acetaminophen; Oxycodone Percodan, tablets * Aspirin; Oxycodone Suboxone film (sublingual) Targiniq ER (extended release) Vantrela ER, tablets (extended release) Xartemis XR tablets Xtampza ER capsules (extended release) Xyrem oral solution Zohydro ER capsules (extended release) Zubsolv tablets (sublingual) Buprenorphine ; Naloxone Oxycodone ; Naloxone Hydrocodone Bitartrate Oxycodone ; Acetaminophen Oxycodone Sodium Oxybate Hydrocodone Bitartrate Buprenorphine ; Naloxone https://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/e 19 nsuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm#recommend https://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ens uringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm#recommend 20 Challenges: Whose drugs are they? In most states, hospices have little control over the pills after a patient dies. The U.S. Drug Enforcement Administration encourages hospice staff to help families destroy leftover medications, but the agency forbids those staff members from destroying the meds themselves unless that is allowed by state law. Leftover pills belong to the family, which has no legal obligation to destroy them or give them up Bailey, M. (2017, August 21). Dying at home in pain doesn t keep relatives from stealing the pills. Washingtonpost.com. Retrieved August 29, 2017, from https://www.washingtonpost.com/national/health science/dying at home in pain doesnt keep relatives from stealing the pills/2017/08/18/d262b9ba 8105 11e7 902a 2a9f2d808496_story.html?utm_term=.4d33df79083f Getting Legislative Help Ohio Delaware New Jersey South Carolina These states have passed laws giving hospice staff authority to destroy unused drugs after patients die. Bailey, M. (2017, August 21). Dying at home in pain doesn t keep relatives from stealing the pills. Washingtonpost.com. Retrieved August 29, 2017, from https://www.washingtonpost.com/national/health science/dying at home in pain doesnt keep relatives from stealing the pills/2017/08/18/d262b9ba 8105 11e7 902a 2a9f2d808496_story.html?utm_term=.4d33df79083f 21 22 NHPCO on the Frontline: Supporting a National Policy and Uniform Set of Practices NHPCO has already drafted legislation and has been working with Congress to expand the ability of hospice professionals to take a more active role in helping families dispose of these drugs. Getting Legislative Help Advocating for cooperation with agencies that limit smaller, but more frequent prescription fills Medicaid VA NHPCO Response to KHN/Post. Edo Banach Responds to Kaiser Health News August 22, 2017 23 24 4

Documentation Patient assessment Pain assessment The 4 A s of pain medicine Harris, DG. Management of Pain in Advanced Disease. British Medical Bulletin 2014, 1 12. Teoha, Penelope J., Camm, Christian F. NICE Opioids in Palliative Care A Guideline Summary. Penelope J. Teoha, Christian F. Camm BA (Hons.). Annals of Medicine and Surgery 2012; 1(1): 44 48. Portenoy, Russell K., Sibirceva, Una,Smout, Randall, Horn, Susan, Connor, Stephen, Blum, Ronald H.. Opioid Use and Survival at the End of Life: A Survey of a Hospice Population. Spence, Carol, Fine, Perry G. Journal of Pain and Symptom Management. Vol. 32 No. 6 December 2006 Review of medication safety guidelines 25 QUESTIONS Common Elements in Guidelines for Prescribing Opioids for Chronic Pain. CDC. National Center for Injury Prevention and Control Division of Unintentional Injury Prevention Edlund, Mark J., Martin Bradley C., Devries, Andrea, Fan, Ming Yu, Brennan Braden, Jennifer, Sullivan, Mark D. Trends in use of opioids for chronic noncancer pain among individuals with mental health and substance use disorders: the TROUP study. Clin J Pain. 2010 January ; 26(1): 1 8 Chakravarthy Bharath, Shah, Shyam, Lotfipour, Shahram. Prescription Drug Monitoring Programs and Other Interventions to Combat Prescription Opioid Abuse. Western Journal of Emergency Medicine. Volume XIII, NO. 5 : November 2012 Throckmorton, Douglas C. Opioid Prescribing Practices and Pain Management: Role of FDA. American Academy of Hospice and Palliative Care Medicine. October, 2013 27 Gardiner, Clare; Gott, Merryn; Ingleton, Christine; Hughes, Philippa; Winslow, Michelle;. Bennett, Michael I. Attitudes of Health Care Professionals to Opioid Prescribing in End of Life Care: A Qualitative Focus Group Study. Journal of Pain and Symptom Management. Vol. 44 No. 2 August 2012 Bailey, M. (2017, August 21). Dying at home in pain doesn t keep relatives from stealing the pills. Washingtonpost.com. Retrieved August 29, 2017, from https://www.washingtonpost.com/national/health science/dying athome in pain doesnt keep relatives from stealing thepills/2017/08/18/d262b9ba 8105 11e7 902a 2a9f2d808496_story.html?utm_term=.4d33df79083f Universal Precautions for Drug Misuse and Diversion in Hospice and Palliative Care Could an Ounce of Prevention Be Worth a Pound of Cure? (FR434) Cass, CleanneThomson, RuthBledsoe, RebeccaDurkin, Elizabeth et al. Journal of Pain and Symptom Management, Volume 49, Issue 2, 365 366 Kenneth L. Kirsh, PhD; Steven D. Passik, PhD. Managing Drug Abuse, Addiction, and Diversion in Chronic Pain: The 4 A's for Ongoing Monitoring Medscape Neurology. 2005;7(2) 2005 Medscape Dmitry M. Arbuck, MD, Timothy J. Atkinson, PharmD, BCPS, Martin D. Cheatle, PhD, Amber Fleming, PsyD, HSPP, Gary W. Jay, MD, Lee Kral, PharmD, Amanda Macone, MD, Jordan L. Newmark, MD, Chinyere Ogbonna, MD, MPH, James A.D. Otis, MD, MBA, Tracey L. Perkins, RN, MSN, FNP C, Jennifer H. Scruggs, RN, MSN, ANP BC, Tejinder Swaran Singh, MD, Forest Tennant, MD, DrPH, Bob Twillman, PhD, Opioid Prescribing and Monitoring: How to Combat Opioid Abuse and Misuse Responsibly 5

Edlund M, Martin B, Russo J, et al. The role of opioid prescription in incident opioid abuse and dependence among individuals with chronic non cancer pain: the role of opioid prescription. Clin J Pain. 2014;30(7):557 564. 6