Opioid Management

1. Opioid Management Ashok Kumar MD FACP. Associate Professor Dept of Internal Medicine Sanford Medical School

2. PRESENTATION OBJECTIVE • UNDERSTAND THE EXTENT OF UNINTENTIONAL EXCESSIVE USE OF OPIOIDS IN OUR PRACTICE AND ABUSE BY PATIENTS • Analyze the risk versus benefit of high dose opioid use in chronic non-cancer pain (CNCP) • Discuss implementation of an opioid surveillance program targeted at patients currently receiving high dose opioids • LEARN SAFE UTILIZATION OF OPIOIDS IN PAIN MANAGEMENT

3. TREATMENT GOAL • Reduce abuse and overdose of opioids and other controlled prescription drugs while ensuring patients with pain are safely and effectively treated.

5. 2012 CDC Update • 22,134 prescription drug overdose deaths in 2010 • Opioid analgesics • 75% of Rx overdose deaths (16,651) • 76% increase in opioid overdose deaths than in 1999 (4,030 deaths) • Other medication classes highly associated with overdose deaths • Benzodiazepines • Antidepressants • Antipsychotics

6. Develop and Test Prevention Strategies Identify Risk and Protective Factors Define the Problem The Public Health Approach to Prevention Ensure Widespread Adoption

7. Rates of Opioid Overdose Deaths, Sales, and Treatment Admissions, United States, 1999–2010 CDC. MMWR 2011. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm60e1101a1.htm?s_cid=mm60e1101a1_w. Updated with 2009 mortality and 2010 treatment admission data.

8. Background, Relevance, & Importance • National Data • Nearly 15,000 people die yearly from Rx opioid overdoses • Deaths now outnumber motor vehicle accidents • Deaths outnumber combined deaths from heroin plus cocaine • Enough opioid analgesics were prescribed in 2010 to treat every adult around the clock for 1 month in the U.S. • The excessive use of opioid analgesics has now been labeled an “epidemic” CDC. Vital Signs. Novermber 2011. Available from: http://www.cdc.gov/vitalsigns

9. Motor Vehicle Traffic, Poisoning, and Drug Poisoning (Overdose) Death RatesUnited States, 1980–2010 NCHS Data Brief, December, 2011. Updated with 2009 and 2010 mortality data.

10. Deaths Related to Drug Overdoses CDC. Vital Signs. November 2011. Available from: http://www.cdc.gov/vitalsigns

12. Opioid Prescriptions Dispensed by Retail Pharmacies—United States, 1991–2011 IMS Vector One. From “Prescription Drug Abuse: It’s Not what the doctor ordered.” Nora Volkow National Prescription Drug Abuse Summit, April 2012. Available at http://www.slideshare.net/OPUNITE/nora-volkow-final-edits.

13. TOP 10 CONTROLLED SUBSTANCES IN SD BY NUMBER OF DOSES DISPENSED : 2012

14. Trends for Drug Use and Death CDC. Vital Signs. November 2011. Available from: http://www.cdc.gov/vitalsigns. Goodman, F. THE TALK. Opioid Trial Exit Strategy. VA PBM December 18,2012.

15. PROBLEM • DEATHS FROM UNINTENTIONAL OVER DOSE • OF MEDICATIONS ARE INCREASING OVER THE YEARS

16. Develop and Test Prevention Strategies Identify Risk and Protective Factors Define the Problem The Public Health Approach to Prevention Ensure Widespread Adoption

17. High Risk Populations • People taking high daily doses of opioids • People who “doctor shop” • People using multiple abusable substances like opioids, benzodiazepines, other CNS depressants, illicit drugs • Low-income people and those living in rural areas • Medicaid populations • People with substance abuse or other mental health issues White AG, Birnbaum HG, Schiller M, Tang J, Katz NP. Analytic models to identify patients at risk for prescription opioid abuse. Am J Managed Care 2009;15(12):897-906. Hall AJ, Logan JE, Toblin RL, Kaplan JA, Kraner JC, Bixler D, et al. Patterns of abuse among unintentional pharmaceutical overdose fatalities. JAMA 2008;300(22):2613-20. Paulozzi LJ, Logan JE, Hall AJ, et al. A comparison of drug overdose deaths involving methadone and other opioid analgesics in West Virginia. Addiction 2009;104(9):1541-8. Dunn KM, Saunders KW, Rutter CM, Banta-Green CJ, Merrill JO, Sullivan MD, et al. Opioid prescriptions for chronic pain and overdose: a cohort study. Ann Intern Med 2010;152(2):85-92. Bohnert AS, Valenstein M, Bair MJ, Ganoczy D, McCarthy JF, Ilgen MA, et al. Association between opioid prescribing patterns and opioid overdose-related deaths. JAMA 2011;305(13):1315-1321.

18. Patient Population Most at Risk • Middle-aged adults • Men: higher risk • People living in rural areas • Twice as likely to overdose on Rx painkillers • Whites and Native Americans • Most likely ethnicities to overdose • 1 in 10 Native Americans report using opioid analgesics for nonmedical purposes in 2010 • Large percentage of VA Black Hills patients CDC. Vital Signs. November 2011. Available from: http://www.cdc.gov/vitalsigns

20. WHEN DOES THE RISK OUTWAY BENEFIT?

21. Three studies have assessed dose cutoffs for safety • Bohnert et al. Association Between Opioid Prescribing Patterns and Opioid Overdose-Related Deaths. 2011 • Dunn et al. Opioid prescriptions for chronic pain and overdose: a cohort study. Ann Intern Med. 2010 • Gomes et al. Opioid Dose and Drug-Related Mortality in Patients With Nonmalignant Pain. Arch Intern Med. 2011

22. High Opioid Dose and Overdose Risk 11.18 3.11 1.19 1.00 * Overdose defined as death, hospitalization, unconsciousness, or respiratory failure. Dunn et al. Opioid prescriptions for chronic pain and overdose. Ann Int Med 2010;152:85-92.

23. Summary of Study Safety Information • Doses over 50 mg ME daily • Increased risk for overdose or death • Doses over 100 mg ME • Further elevation in risk of overdose or death • Doses above 100 mg ME daily where risk elevates the most? • Doses greater than 200 mg ME daily provide the most risk • Unknown what dose above 200 infers highest risk • Risk of death and overdose-related adverse events is highly associated with total daily dose • Bohnert et al. Association Between Opioid Prescribing Patterns and Opioid Overdose-Related Deaths. 2011 • Dunn et al. Opioid prescriptions for chronic pain and overdose: a cohort study. Ann Intern Med. 2010 • Gomes et al. Opioid Dose and Drug-Related Mortality in Patients With Nonmalignant Pain. Arch Intern Med. 2011

24. Develop and Test Prevention Strategies Identify Risk and Protective Factors Define the Problem The Public Health Approach to Prevention Ensure Widespread Adoption

25. BLACK HILLS VA INITIATIVE

26. VA Black Hills Specific Information • VA Black Hills • Highest utilizer of oxycodone SA in VISN 23 • 2nd highest utilizer of long-acting opioids in VISN 23 • VISN 23 • 4th highest user of oxycodone SA • August 2012 VA Black Hills dispensing numbers (for perspective) • 136,128 opioid analgesic tablets dispensed • Does not include: • Any codeine formulation • Cough syrup • Fentanyl patches • 77,000 tablets containing oxycodone • 6500 tablets of oxycodone SA

28. HEALTH CARElDefiningEXCELLENCEin the 21st Century

29. Opioid Analgesic Dosing: What is high dose?

30. Identified as Next Steps by VISN CMO • Focus on patients receiving oxycodone SA • Convert to alternative analgesics as appropriate • Eliminate new prescribing of oxycodone SA • It is a nonformulary agent • Utilize other analgesics • Focus on patients receiving greater than 200mg ME daily • Dose reduction to less than or equal to 200 mg ME daily

31. What Cutoffs Have Others Used? • Minneapolis VA • 200 mg ME daily • Believed that other VAs have gone to this cutoff as well • Orlando VA • Currently seeking P&T for approval of 200 mg ME daily cutoff • State of Washington • 120 mg ME daily • For doses over 120 mg ME daily, Patient must • Demonstrate improved function or • Seek pain consultation

32. PROCESS IMPLEMENTED • VA DIRECTOR SENT A LETTER TO ALL PATINTS ABOUT THE ISSUE OF OPIOD USE IN THE VA FOR CHRONIC PAIN , AND THE ASSOCIATED INCREASED RISKS INCLUDING DEATH • POSTERS AT VA ENTERANCE AND AT PATIENT WAITING AREAS • PROVIDER EDUCATION • ELECTRONIC TEMPLATE CREATED FOR DOSE REDUCTION

33. Current Processes • Chart review assessed patients receiving oxycodone SA • Excluded patients with active cancer • Chart review assessed patients receiving ≥ 200 mg ME daily • Excluded patients with active cancer • Provided education regarding safety • High dose opioid analgesic use for CNCP • Opioid analgesic tapering and oxycodone SA conversions

37. STRATEGIES THAT WAS NOT EFFECTIVE • Random decrease in dose without patient education at a face to face encounter

38. Prescription Drug Monitoring Programs (PDMPs) • Operational in 42 states • Focus PDMPs on • Patients at highest risk of abuse and overdose • Prescribers who clearly deviate from accepted medical practice • Implement PDMP best practices

39. CAUTION • FEDERAL PRACTIONERS CAN GET DATTA ON PRESCRIPTIOS FROM PRIVATE SECTOR BUT NOT THE OTHER WAY AROUND • PRACTIONERS CAN CALL VA TO GET PRESCRIPTION INFORMATION ON VA PATIENTS.

40. Patient Review and Restriction Programs(aka “Lock-In” Programs) • Applies to patients with inappropriate use of controlled substances • 1 prescriber and 1 pharmacy for controlled substances • Improve coordination of care and ensure appropriate access for patients at high risk for overdose • Evaluations show cost savings as well as reductions in ED visits and numbers of providers and pharmacies

41. Safe Prescribing for Pain Universal precautions approach Treatment agreements Signs of possible abuse vs. under-treatment of pain Discontinuing treatment/proper disposal Appropriate uses of pain medication Risk/benefit framework Screening tools Epidemiology of prescription drug abuse Expectations of opioid treatment

42. Clinical Guidelines • Improve prescribing and treatment • Basis for standard of accepted medical practice for purposes of licensure board actions • Several consensus guidelines available • Common themes among guidelines

45. Conclusion • Adverse events and death associated with opioid analgesic use have increased substantially over the past 20 years • Risk of opioid-related adverse events increases with dose • Doses greater than 50 mg ME daily show elevated risk • Highest risk appears to be in those on more than 200 mg ME daily Risk stratify your patient population on opioids Implement a structured stepwise program to reduce dose in patients on high dose