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Gary Franklin


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Coordinating Multiple Stakeholders
National Rx Drug Abuse Summit

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Gary Franklin

  1. 1. Coordinating Multiple Stakeholders April 10-12, 2012 Walt Disney World Swan Resort
  2. 2. Accepted Learning Objectives:1. Describe the relationship between prescriptiondrug morbidity and mortality and the under-treatment of pain.2. Identify measurement-based care as standardof care in pain medicine and describe how tomeasure pain, mood and function in everyclinical encounter.3. Evaluate how new state and federal policychanges will likely allow more prudent and saferuse of opioids for chronic, non-cancer pain.
  3. 3. Disclosure Statement•  All presenters for this session, Dr. Alex Cahana and Dr. Gary M. Franklin, have disclosed no relevant, real or apparent personal or professional financial relationships.
  4. 4. Opioids: A public health emergency -National Rx Summit- Orlando, FL April 10-12, 2012 Gary M. Franklin, MD, MPH Research Professor Departments of Environmental Health, Neurology, and Health Services University of Washington Medical Director Washington State Department of Labor and Industries
  5. 5. "To write prescriptions is easy,but to come to an understanding withpeople is hard."-- Franz Kafka, A Country Doctor
  6. 6. “We can’t solve problems byusing the same kind ofthinking we used when wecreated them” !
  7. 7. 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 Code7
  8. 8. 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…
  9. 9. 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: 1450-579
  10. 10. Opioid-Related Deaths,Washington State Workers’ Compensation, 1992–2005 14 Definite Probable Possible 12 10 8 Deaths 6 4 2 0 ‘95 ‘96 ‘97 ‘98 ‘99 ‘00 ‘01 ‘02 Year Franklin GM, et al, Am J Ind Med 2005;48:91-9 10
  11. 11. Franklin et al, Natural History of ChronicOpioid 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
  12. 12. Unintentional and Undetermined Intent Drug Overdose Death Rates by State, 2007 MD 12.5 MA 12.5 NH 11.7 RI 11.1 CT 11.1 DE 9.8 DC 8.8 VT 7.9 NJ 7.5 Age-adjusted rate per 100,000 population National Vital Statistics System, http://wonder.cdc.gov12
  13. 13. Evidence linking specific doses to morbidity and mortalityDunn 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 deathsBraden 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*
  14. 14. Evidence linking specific doses to morbidity and mortalityBohnert 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 at200 mg
  15. 15. Unintentional Overdose Deaths Involving Opioid Analgesics Parallel Opioid Sales United States, 1997–2007 Distribution by drug Opioid sales * (mg/ companies person)   96 mg/person in 1997 627%   698 mg/person in 2007 increase   Enough for every American to take 5 mg Vicodin every 4 Year hrs for 3 weeks Overdose deaths Opioid deaths   2,901 in 1999 296%   11,499 in 2007 increase Year National Vital Statistics System, multiple cause of death data set and Drug Enforcement Administration ARCOS system;15 2007 opioid sales figure is preliminary
  16. 16. State mortality varies by regulatory environmentPaulozzi and Stier, J Publ Health Pol 2010; 31: 422-32• Per capita usage of opioids in NY 2/3 that in PA• Drug overdose deaths 1.6 fold higher in PAcompared to NY• PDMP in NY better funded and uses serialized,tamperproof Rx formsBut mortality rates probably not affected bymandatory education alone
  17. 17. Fitzgibbon et al, Anesthesiology 2010; 112: 948-56ASOA Closed Claims Database-N=8954 –  50/295 medication management issues for CNCP •  59% inappropriate medication management •  24% high risk of misuse •  57% death
  18. 18. Washington Agency Medical Directors’ Opioid Dosing Guidelines•  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 –
  19. 19. Washington Agency Medical Directors’ Opioid Dosing Guidelines•  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 MED19
  20. 20. Guidance for Primary Care Providers on Safe andEffective 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 MED, Morphine equivalent dose20
  21. 21. 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 CAGE, cut down annoyed guilty eye-opener21
  22. 22. New CDC recommendations For practitioners, public payers, and insurers Seek help at 120 mg/day MED if pain and function not improving HomeandRecreationalSafety/pdf/poision- issue-brief.pdf
  23. 23. Yearly Trend of Scheduled Opioids (Franklin et al, Am J Ind Med Dec 27 2011) 100,000Number of Opioid Prescriptions 90,000 80,000 70,000 60,000 50,000 40,000 30,000 20,000 10,000 0 Schedule II Schedule III Schedule IV
  24. 24. 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% 35.0% 40.0% 2000Q1 2000Q2 2000Q3 2000Q4 2001Q1 2001Q2 2001Q3 2001Q4 2002Q1 2002Q2 2002Q3 2002Q4 2003Q1 2003Q2 2003Q3 2003Q4 2004Q1 2004Q2Opioids 2004Q3 2004Q4 2005Q1 2005Q2 2005Q3 2005Q4 2000 - 2010 2006Q1Highdose Opioids 2006Q2 2006Q3 2006Q4 2007Q1 2007Q2 2007Q3 2007Q4 Percent of Timeloss Claimants on Opioids 2008Q1 2008Q2 2008Q3 2008Q4 2009Q1 2009Q2 2009Q3 2009Q4 2010Q1 2010Q2 2010Q3 2010Q4
  25. 25. 10-Q3 2010 Q1 10-Q1Washington Workers Compensation, 1996– 2009 Q3 09-Q3 2009 Q1 09-Q1 2008 Q3 08-Q3 Average Daily Dosage for Opioids, 2008 Q1 08-Q1 2007 Q3 07-Q3 2007 Q1 07-Q1 2006 Q3 06-Q3 2006 Q1 06-Q1 Long-acting opioids 2005 Q3 05-Q3 Short-acting opioids 2005 Q1 05-Q1 2004 Q3 04-Q3 2004 Q1 04-Q1 2003 Q3 03-Q3 2003 Q1 Year/Quarter 2010 03-Q1 2002 Q3 02-Q3 2002 Q1 02-Q1 2001 Q3 01-Q3 2001 Q1 01-Q1 2000 Q3 00-Q3 2000 Q1 00-Q1 1999 Q3 99-Q3 1999 Q1 99-Q1 1998 Q3 98-Q3 1998 Q1 98-Q1 97-Q3 1997 Q3 97-Q1 1997 Q1 96-Q3 1996 Q3 96-Q1 1996 Q1 140 120 100 80 60 40 20 0 25 MED (mg/day)
  26. 26. WA Workers Compensation Opioid-related Deaths 1995-2010 35 30Opioid-related Death 25 20 15 10 5 0 Possible Probable Definite
  27. 27. Unintentional Prescription Opioid Overdose Deaths Washington 1995-2010 600 500 420 Number of deaths 400 300 200 100 24 0 95 96 97 98 99 00 01 02 03 04 05 06 07 08 09 10 Prescription Opioid + alcohol or illicit drug Prescription Opioid +/- Other Prescriptions* Tramadol only deaths included in 2009, but not in prior years.Source: Washington State Department of Health, Death Certificates
  28. 28.  Repeals current regulation; new expected by June 2011 Provides specific dosing guidance and guidance on consultations, assessments, and tracking Signed into law by Governor Gregoire March 25, 201028
  29. 29. Washington State Opioid Treatment Regulations Final 1/2/2011•  Emphasize tracking patients for improved pain AND function•  Emphasize widely agreed-upon best practices –  Screening for substance abuse and other comorbidities –  Prudent use of urine drug screens –  Opioid treatment agreement –  Single pharmacy and single prescriber•  Encourage use of Prescription Monitoring Program- begins 1/1/2012 and Emergency Department Information Exchange, when available29
  30. 30. 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
  31. 31. Improving Physician Access to Pain Specialists in Washington State•  Issue –  Moderate capacity problem: not enough pain specialists –  Interventional anesthesiologists generally won t see these patients to assist with opioid issues•  Solution –  Advanced training for primary care to increase proficiency –  Telephonic or video consultation with experts [Project ECHO at UW ( care/pain/echo/index.shtml)] –  Public payers working on payment codes to incentivize these activities31
  32. 32. Components Being Developed for Community-based Treatment of Chronic Pain•  Cognitive behavioral therapy•  Graded exercise•  Activity coaching•  Interdisciplinary care•  Care coordination32
  33. 33. Other new directions for chronic pain treatment Incentivize best practices for chronic pain care in community setttings, eg, medical home concept for chronic pain E.g., cognitive behavioral therapy to
  34. 34. Cautious Prescribing Practices When Considering Therapy With Opioids -Physicians for Responsible Opioid Prescribing- Von Korff M et al. Ann Intern Med 2011;155:325-328©2011 by American College of Physicians
  35. 35. There is substantial clustering among providers on dosing and mortalityCA CWCI study-Swedlow et al, March, 2011: 3% of prescribers account for 55% of Schedule II opioid Rxs: 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 deathsDLI will send letters to all prescribers with any patient on opioid doses at or above 120 mg/day MED•  Call their attention to AMDG Guidelines and new WA state regulations•  Associate medical director will meet with these docs personally
  36. 36. 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
  37. 37. 38% Increase since 2001
  38. 38. 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 (•  Implement effective Prescription Monitoring Program•  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)
  39. 39. Unfinished business•  Address low capacity in communities to prevent/Rx chronic pain•  Guidelines for peri-operative use of opioids•  Looming large population dependent/ addicted from Rx opioids•  Develop guidelines Re tapering –  PCP routine taper; Detox/pain clinic taper +/- buprenorphine•  Rx of opioid use disorder/addiction
  40. 40. It’s an emergency, so move ahead gingerly If you do something effective to reverse a decadeof bad public policy, you will get pushback: FauberJ. Follow the money: Pain, policy, and profit.2/19/12.  URL: PainManagement/31256  But remember that the docs in the trencheswelcome assistance, tools, and best practices -National survey of PCP network for low income patients: 1/3 reported a severe outcome (death or life-threatening event); 1/3 do not initiate prescribing of opioids Leverence RR, et al. J Am Board Fam Med 2011; 24: 551-561
  41. 41. THANK YOU!For electronic copies of thispresentation, please e-mail Melinda Fujiwaravasudha@u.washington.eduFor questions or feedback, please e-mail Gary Franklin