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Meeting the Challenge of the Opioid Epidemic -UC Irvine Medical Grand Rounds- Jan 29, 2013

Meeting the Challenge of the Opioid Epidemic -UC Irvine Medical Grand Rounds- Jan 29, 2013. Gary M. Franklin, MD, MPH Medical Director WA Dept of Labor and Industries Research Professor Depts of Environmental & Occupational Health Sciences, Neurology, and health Services

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Meeting the Challenge of the Opioid Epidemic -UC Irvine Medical Grand Rounds- Jan 29, 2013

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  1. Meeting the Challenge of the Opioid Epidemic-UC Irvine Medical Grand Rounds-Jan 29, 2013 Gary M. Franklin, MD, MPH Medical Director WA Dept of Labor and Industries Research Professor Depts of Environmental & Occupational Health Sciences, Neurology, and health Services University of Washington

  2. "To write prescriptions is easy, but to come to an understanding with people is hard." -- Franz Kafka, “A Country Doctor”

  3. Change in National Norms for Use of Opioids for Chronic, Non-cancer Pain • By the late 1990s, at least 20 states passed new laws, regulations, or policies moving from near prohibition of opioids to use without dosing guidance • WA law: “No disciplinary action will be taken against a practitioner based solely on the quantity and/or frequency of opioids prescribed.” (WAC 246-919-830, 12/1999) • Laws were based on weak science and good experience with cancer pain WAC-Washington Administrative Code 4

  4. Similarities Between Illicit & Prescription Drugs

  5. Portenoy and Foley Pain 1986; 25: 171-186 • Retrospective case series chronic, non-cancer pain • N=38; 19 Rx for at least 4 years • 2/3 < 20 mg MED/day; 4> 40 mg MED/day • 24/38 acceptable pain relief • No gain in social function or employment could be documented • Concluded: “Opioid maintenance therapy can be a safe, salutary and more humane alternative…”

  6. Pain champions, Pharma surrogates, and Astroturf organizations led the way Older falsehoods Opioids not as addicting as we used to think (<1%)-”pseudoaddiction” coined No ceiling on dose-standard was to increase dose to address tolerance Pain as the fifth vital sign Patients should leave the ER in comfort-drove satisfaction scores More recent falsehoods* Were it not for the heavy hand of law enforcement/gov’t, we’d be fine It’s all a methadone problem It’s all abuse It’s just a cluster of pill mills and a few others *http://www.huffingtonpost.com/radley-balko/prescription-painkillers_b_1240722.html

  7. Limitations of Long-term (>3 Months) Opioid Therapy • Overall, the evidence for long-term analgesic efficacy is weak • Putative mechanisms for failed opioid analgesia may be related to rampant tolerance • The premise that tolerance can always be overcome by dose escalation is now questioned • 100% of patients on opioids chronically develop dependence • More than 50% of patients on opioids for 3 months will still be on opioids 5 years later Ballantyne J. Pain Physician 2007;10:479-91; Martin BC et al. J Gen Intern Med 2011; 26: 1450-57 8

  8. Dentists and Emergency Medicine Physicians were the main prescribers for patients 5-29 years of age 5.5 million prescriptions were prescribed to children and teens (19 years and under) in 2009 Source: IMS Vector ®One National, TPT 06-30-10 Opioids Rate 2009

  9. Opioid-Related Deaths, Washington State Workers’ Compensation, 1992–2005 ‘95 ‘97 ‘00 ‘02 ‘96 ‘98 ‘99 ‘01 Year Franklin GM, et al, Am J Ind Med 2005;48:91-9 10

  10. Unintentional and Undetermined Intent Drug Overdose Death Rates by State, 2007 12.5 12.5 11.7 11.1 11.1 9.8 8.8 7.9 7.5 MD MA NH RI CT DE DC VT NJ Age-adjusted rate per 100,000 population National Vital Statistics System, http://wonder.cdc.gov 11

  11. Moore, et al. Serious Adverse Drug Events Reported to the Food and Drug Administration, 1998-2005 - Arch Intern Med. 2007;167(16):1752-1759

  12. Evidence linking specific doses to morbidity and mortality Dunn et al, Ann Int Med 2010; 152: 85-92 • Risk of morbidity and mortality increased 8.9 fold at 100 mg MED • Editorial-McLellan-White House Office of National Drug Control Policy • “Smarter, more responsible (prescribing) practices are the only hope to avoid tragic, avoidable deaths” Braden et al, Arch Int Med 2010; 170: 1425-32 Opioid doses >120 mg/day MED and use of long acting Schedule II opioids associated with incresed risk of alcohol- or drug- related ER visit *

  13. Evidence linking specific doses to morbidity and mortality Bohnert et al, JAMA 2011; 305: 1315-21 • Risk of mortality 7.18 (chronic pain), 6.64 (acute pain) Gomes et al, Arch Int Med 2011; 171: 686-91 • Risk of mortality 2.04 at 100 mg and 2.88 at 200 mg

  14. Unintentional Overdose Deaths Involving Opioid Analgesics Parallel Opioid Sales United States, 1997–2007 • Distribution by drug companies • 96 mg/person in 1997 • 698 mg/person in 2007 • Enough for every American to take 5 mg Vicodin every 4 hrs for 3 weeks Opioid sales * (mg/person) • 627% • increase Year • Overdose deaths • 2,901 in 1999 • 11,499 in 2007 Opioid deaths • 296% increase Year National Vital Statistics System, multiple cause of death data set and Drug Enforcement Administration ARCOS system; 2007 opioid sales figure is preliminary 15

  15. Do function and QOL improve? • “Epidemiological studies are less positive, and report failure of opioids to improve QOL in chronic pain patients.” Eriksen, J Pain 2006: 125: 172-179 • “…it is remarkable that opioid treatment of long-term/chronic non-cancer pain does not seem to fulfill any of the key outcome opioid treatment goals: pain relief, improved quality of life and improved functional capacity.” • Naliboff et al, J Pain, 2011: 12: 288-296 • RCCT dose escalation vs “hold the line” • No improvement in any primary outcome • 27% misuse/non-compliance

  16. Franklin et al, Natural History of Chronic Opioid Use Among Injured Workers with Low Back Pain-Clin J Pain, Dec, 2009 • 694/1843 (37.6%) received opioid early • 111/1843 (6%) received opioids for 1 yr • MED increased sign from 1st to 4th qtr • Only minority improved by at least 30% in pain (26%) and function (16%) • Strongest predictor of long term opioid use was MED in 1st qtr (40 mg MED had OR 6) • Avg MED 42.5 mg at 1 yr; Von Korff 55 mg at 2.7 yrs

  17. Developed with clinical pain experts in 2006 Implemented April 1, 2007 First guideline to emphasize dosing guidance Educational pilot, not new standard or rule National Guideline Clearinghouse http://www.guideline.gov/content.aspx?id=23792&search=wa+opioids Washington Agency Medical Directors’Opioid Dosing Guidelines 18 www.agencymeddirectors.wa.gov

  18. Part I – If patient has not had clear improvement in pain AND function at 120 mg MED (morphine equivalent dose) , “take a deep breath” If needed, get one-time pain management consultation (certified in pain, neurology, or psychiatry) Part II – Guidance for patients already on very high doses >120 mg MED Washington Agency Medical Directors’Opioid Dosing Guidelines 19 www.agencymeddirectors.wa.gov

  19. Guidance for Primary Care Providers on Safe and Effective Use of Opioids for Chronic Non-cancer Pain • Establish an opioid treatment agreement • Screen for • Prior or current substance abuse • Depression • Use random urine drug screening judiciously • Shows patient is taking prescribed drugs • Identifies non-prescribed drugs • Do not use concomitant sedative-hypnotics • Track pain and function to recognize tolerance • Seek help if dose reaches 120 mg MED, and pain and function have not substantially improved http://www.agencymeddirectors.wa.gov/opioiddosing.asp MED, Morphine equivalent dose 20

  20. Open-source Tools Added to June 2010 Update of Opioid Dosing Guidelines • Opioid Risk Tool: Screen for past and current substance abuse • CAGE-AID screen for alcohol or drug abuse • Patient Health Questionnaire-9 screen for depression • 2-question tool for tracking pain and function • Advice on urine drug testing Available as mobile app: http://www.agencymeddirectors.wa.gov/opioiddosing.asp 21 http://www.agencymeddirectors.wa.gov/opioiddosing.asp#DC

  21. Washington State Primary Care Survey 2009: Physician Concerns Morse JS et al, J Opioid Management 2011; 7: 427-433. 22

  22. Washington State Primary Care Survey 2009: Adherence to State Guidelines Morse JS et al, J Opioid Management 2011; 7: 427-433. 23

  23. 2009 CDC recommendations • For practitioners, public payers, and insurers • Seek help at 120 mg/day MED if pain and function not improving • http://www.cdc.gov/HomeandRecreationalSafety/pdf/poision-issue-brief.pdf

  24. Recentstate policies Connecticut WC policy-7/1/2012 The total daily dose of opioids should not be increased above 90mg oral MED/day (Morphine Equivalent Dose) unless the patient demonstrates measured improvement in function, pain or work capacity. Second opinion is recommended if contemplating raising the dose above 90 MED/day. MaineCare (Medicaid)-4/1/2012 Total 45 day maximum for non-cancer pain New Mexico-Rule 16.10.14-Proposed rules Aug, 2012 A health care practitioner shall, before prescribing, ordering, administering or dispensing a controlled substance listed in schedule II, III or IV, obtain a patient PMP report for the preceding twelve (12) months

  25. Average Daily Dosage for Opioids, Washington Workers’ Compensation, 1996–2010 96-Q1 96-Q3 97-Q1 97-Q3 98-Q1 98-Q3 99-Q1 99-Q3 00-Q1 00-Q3 01-Q1 01-Q3 02-Q1 02-Q3 03-Q1 03-Q3 04-Q1 04-Q3 05-Q1 05-Q3 06-Q1 06-Q3 07-Q1 07-Q3 08-Q1 08-Q3 09-Q1 09-Q3 10-Q1 10-Q3 Long-acting opioids Short-acting opioids Year/Quarter 28

  26. Unintentional Prescription Opioid Overdose Deaths Washington 1995-2010 * Tramadol only deaths included in 2009, but not in prior years. Source: Washington State Department of Health, Death Certificates

  27. There is substantial clustering among providers on dosing and mortality CA CWCI study-Swedlow et al, March, 2011: 3% of prescribers account for 55% of Schedule II opioidRxs:http://www.cwci.org/research.html Dhalla et al, Clustering of opioid prescribing and opioid-related mortality among family physicians in Ontario. Can Fam Physician 2011; 57: e92-96 Upper quintile of frequent opioid prescribers associated with last opioid Rx in 62.7% of public plan beneficiary unintentional poisoning deaths DLI sent letters to all prescribers with any patient on opioid doses at or above 120 mg/day MED-ONLY N=60 • Call their attention to AMDG Guidelines and new WA state regulations • Associate medical director will meet with these docs personally

  28. What can PCP do to safely and effectively use opioids for CNCP? • Opioid treatment agreement • Screen for prior or current substance abuse/misuse (alcohol, illicit drugs, heavy tobacco use) • Screen for depression • Prudent use of random urine drug screening (diversion, non-prescribed drugs) • Do not use concomitant sedative-hypnotics or benzodiazepines • Track pain and function to recognize tolerance • Seek help if MED reaches 120 mg and pain and function have not substantially improved • Use PDMP!

  29. Concrete steps to take Track high MED and prescribers Reverse permissive laws and set dosing and best practice standards for chronic, non-cancer pain Implement AMDG Opioid Dosing Guidelines (http://www.agencymeddirectors.wa.gov/opioiddosing.asp) Implement effective Prescription Monitoring Program; check the PDMP on every new injured worker who receives opioid Rx Encourage/incent use of best practices (web-based MED calculator, use of state PMPs) DO NOT pay for office dispensed opioids ID high prescribers and offer assistance Incent community-based Rx alternatives (activity coaching and graded exercise early, opioid taper/multidisciplinary Rx later) Offer assistance (academic detailing, free CME,ECHO)

  30. Nov, 2012 WA Workers CompensationOpioid Guideline* Adoption of the 2010 AMDG Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain This Supplement provides additional information and guidance for treating work-related injuries DOH pain management rules, 2010 AMDG Guideline and this Supplement are reflective of the practice standard for prescribing opioids for a work-related injury or occupational disease. *www.lni.wa.gov/ClaimsIns/Files/OMD/MedTreat/FINALOpioidGuideline010713.pdf

  31. Proper and Necessary Care for Opioid Prescribing Stop and Take a Deep Breath at 6 weeks and before COT Clinically Meaningful Improvement in Function Case Definition & Algorithms for Discontinuing COT Managing Surgical Pain in Workers on COT Addiction Treatment

  32. 100 80 60 40 20 0 0 1 2 3 4 5 6 7 8 9 10 11 12 Disability Prevention is the Key Health Policy Issue % of cases on time loss Time loss duration (months) Adapted from Cheadle et al. Am J Public Health 1994; 84:190–196.

  33. Early opioids and disability in WA WC. Spine 2008; 33: 199-204 • Population-based, prospective cohort • N=1843 workers with acute low back injury and at least 4 days lost time • Baseline interview within 18 days(median) • 14% on disability at one year • Receipt of opioids for > 7 days, at least 2 Rxs, or > 150 mg MED doubled risk of 1 year disability, after adjustment for pain, function, injury severity

  34. 38% Increase since 2001

  35. Opioid Use in Workers’ Compensation • Measuring the Impact of Opioid Use • Beyond acute phase, effective use should result in clinically meaningful improvement in function (CMIF) • CMIF is an improvement in function of at least 30% compared to start of treatment or in response to a dose change • Evaluation of clinically meaningful improvement should occur at 3 critical phases (acute, subacute and during COT) Continuing to prescribe opioids in the absence of CMIF or after the development of a severe adverse outcome is not proper and necessary care. In addition, the use of escalating doses to the point of developing opioid use disorder is not proper and necessary care.

  36. THANK YOU! For electronic copies of this presentation, please e-mail Laura Black ljl2@uw.edu For questions or feedback, please e-mail Gary Franklin meddir@uw.edu

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