Opioids: A Public Health Emergency-National Summit on Opioid Safety-     Group Health Cooperative            Nov 1, 2012  ...
DISCLOSURESGary Franklin has disclosed no financialrelationships that may pose a conflict of interestThere will be no unan...
"To write prescriptions is easy,but to come to an understanding withpeople is hard."-- Franz Kafka, “A Country Doctor”
“We can’t solve problems byusing the same kind ofthinking we used when wecreated them”
Change in National Norms for Use of Opioids        for Chronic, Non-cancer Pain By the late 1990s, at least 20 states  pa...
Similarities Between Illicit & Prescription Drugs
Portenoy and Foley           Pain 1986; 25: 171-186 Retrospective case series chronic, non-cancer pain N=38; 19 Rx for a...
Dentists and Emergency Medicine Physicians were themain prescribers for patients 5-29 years of age        5.5 million pres...
Limitations of Long-term (>3 Months)                      Opioid Therapy Overall, the evidence for long-term analgesic ef...
Opioid-Related Deaths,Washington State Workers’ Compensation, 1992–2005            14                                 Defi...
State mortality varies by regulatoryenvironmentPaulozzi and Stier, J Publ Health Pol 2010; 31:422-32 Per capita usage of ...
Opioid issues new cause ofsuccessful malpractice claimsASOA Closed Claims Database-N=8954  50/295 medication management i...
Washington Agency Medical Directors’               Opioid Dosing Guidelines Developed with clinical pain experts in 2006...
Washington Agency Medical Directors’                Opioid Dosing Guidelines Part I – If patient has not had clear improv...
Guidance for Primary Care Providers on Safe andEffective Use of Opioids for Chronic Non-cancer Pain Establish an opioid t...
Open-source Tools Added to June 2010Update of Opioid Dosing Guidelines   Opioid Risk Tool: Screen for past and current   ...
CDC recommendations-2009 For practitioners, public payers, and insurers Seek help at 120 mg/day MED if pain and  functio...
WA State Opioid Dosing Guidelinecontributes to reversal of opioid epidemic Franklin GM, Mai J, Turner J, et al. Bending th...
10-Q3                                                                                                                     ...
WA Workers Compensation Opioid-related Deaths 1995-2010                       35Opioid-related Death                      ...
Unintentional Prescription Opioid Overdose Deaths               Washington 1995-2010                              600     ...
Washington State Legislation: ESHB 2876,         On Opioid Treatment. 2010 Repeals current regulation; new regs by June 2...
Washington State Opioid TreatmentRegulations  Emphasize tracking patients for improved   pain AND function  Emphasize wi...
What can PCP do to safely and effectively use opioids for CNCP Opioid treatment agreement Screen for prior or current su...
Improving Physician Access to       Pain Specialists in Washington       State Issue   Moderate capacity problem: not en...
Incent best practices in community settings to    prevent/treat chronic pain    Cognitive behavioral therapy    Graded e...
There is substantial clustering among   providers on dosing and mortalityCA CWCI study-Swedlow et al, March, 2011: 3% of  ...
Early opioids and disability in WA WC. Spine2008; 33: 199-204  Population-based, prospective cohort  N=1843 workers with...
Disability generated in workers‟ compensation   may be a public health problem of the highest   order 1954-4% of men 25-5...
38% Increase since 2001
Concrete steps to take Track high MED and prescribers Reverse permissive laws and set dosing standards for    chronic, n...
Unfinished business Guidelines for peri-operative use of opioids Looming large population dependent/addicted  from Rx op...
It‟s an emergency, so move aheadgingerlyIf you do something effective to reverse a decade ofbad public policy, you will g...
New state policiesConnecticut WC policy-7/1/2012  The total daily dose of opioids should not be increased above 90mg  oral...
THANK YOU!For electronic copies of this presentation, please e-mail      Melinda Fujiwaravasudha@u.washington.edu For ques...
Opioids: A Public Health Emergency
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Opioids: A Public Health Emergency

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Presentation was originally done at Group Health Cooperative’s National Summit on Opioid Safety: http://www.ghinnovates.org/?p=3502.
Presentation by Gary M. Franklin, MD, MPH, Research Professor for the Departments of Environmental Health, Neurology, and Health Services University of Washington

Medical Director
Washington State Department of
Labor and Industries

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  • Within 1-2 years, however, unintentional deaths from opioids began to cross my desk in the WA workers compensation system. We then more systematically reviewed all deaths in our system, and published the first peer reviewed paper describing these deaths specifically related to prescribed opioids. These numbers are small because they occurred in the workers compensation population. At the same time, however, a similar trend involving fifty times as many deaths was occurring statewide.
  • The vertical line in this figure indicates the date on which the Guidelines were released. We believe the Guidelines have already had an impact on substantially reducing the higher doses of the most potent, long-acting opioids in our workers compensation system.
  • Our second strategy is legislation…The WA legislature passed legislation in March, 2010 that will repeal the currently permissive rules by June, 2011, and will implement new rules largely reflective of the dosing guidance and other best practices emphasized in the Guidelines. The lead sponsor, Rep Jim Moeller, is an addiction counselor who inherited dozens of patients on very high dose opioids when a “pill mill” in Vancouver, WA was shut down by the Drug Enforcement Agency. He had never previously seen these types of doses in his HMO practice, and became convinced that a new standard embodying best practices was needed.
  • Besides the specific dosing guidance, all of the best practices are in common across all recent published opioid guidelines. There is some evidence of effectiveness of treatment agreements combined with urine drug screens, and some state insurers have reported decreased drug use with restrictions to single pharmacy and single providers.
  • Opioids: A Public Health Emergency

    1. 1. Opioids: A Public Health Emergency-National Summit on Opioid Safety- Group Health Cooperative Nov 1, 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
    2. 2. DISCLOSURESGary Franklin has disclosed no financialrelationships that may pose a conflict of interestThere will be no unannounced disclosures of off-label use of drugs, biologics or medical devices
    3. 3. "To write prescriptions is easy,but to come to an understanding withpeople is hard."-- Franz Kafka, “A Country Doctor”
    4. 4. “We can’t solve problems byusing the same kind ofthinking we used when wecreated them”
    5. 5. 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 5
    6. 6. Similarities Between Illicit & Prescription Drugs
    7. 7. 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…”By 2006, over 10,000 WA citizens were taking over 120 mg/day MED
    8. 8. Dentists and Emergency Medicine Physicians were themain prescribers for patients 5-29 years of age 5.5 million prescriptions were prescribed to children and teens (19 years and under) in 2009 900 800 700 600 Rate per 10,000 persons GP/FM/DO 500 IM 400 DENT ORTH SURG 300 EM 200 100 0 0-4 5-9 10-14 15-19 20-24 25-29 30-39 40-59 60+ Age GroupSource: IMS Vector ®One National, TPT 06-30-10 Opioids Rate 2009
    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 Ballantyne J. Pain Physician 2007;10:479-91 9
    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. State mortality varies by regulatoryenvironmentPaulozzi 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 PA compared to NY PDMP in NY better funded and uses serialized, tamperproof Rx formsBut mortality rates probably not affected bymandatory education alone
    12. 12. Opioid issues new cause ofsuccessful malpractice claimsASOA Closed Claims Database-N=8954  50/295 medication management issues for CNCP  59% inappropriate medication management  24% high risk of misuse  57% death Fitzgibbon et al, Anesthesiology 2010; 112: 948-56
    13. 13. 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  http://www.guideline.gov/content.aspx?id=23792&search=wa+opioids 13 www.agencymeddirectors.wa.gov
    14. 14. 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 MED 14 www.agencymeddirectors.wa.gov
    15. 15. 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 http://www.agencymeddirectors.wa.gov/opioiddosing.asp 15 MED, Morphine equivalent dosec
    16. 16. Open-source Tools Added to June 2010Update 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-opener” 16 http://www.agencymeddirectors.wa.gov/opioiddosing.asp#DC
    17. 17. CDC recommendations-2009 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/p oision-issue-brief.pdf
    18. 18. WA State Opioid Dosing Guidelinecontributes to reversal of opioid epidemic Franklin GM, Mai J, Turner J, et al. Bending the prescription opioid dosing and mortality curves: impact of the Washington State Opioid Dosing Guideline. Am J Ind Med 2012; 55: 325-31
    19. 19. 10-Q3 2010 Q1 10-Q1 2009 Q3 09-Q3 2009 Q1 09-Q1Washington Workers‟ Compensation, 1996–2010 2008 Q3 08-Q3 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-Q3Average Daily Dosage for Opioids, 2004 Q1 04-Q1 2003 Q3 03-Q3 Year/Quarter 2003 Q1 03-Q1 2002 Q3 02-Q3 2002 Q1 02-Q1 01-Q3 2001 Q3 01-Q1 2001 Q1 00-Q3 2000 Q3 00-Q1 2000 Q1 99-Q3 1999 Q3 99-Q1 1999 Q1 98-Q3 1998 Q3 98-Q1 1998 Q1 97-Q3 1997 Q3 97-Q1 1997 Q1 96-Q3 1996 Q3 19 96-Q1 1996 Q1 80 60 40 20 0 120 140 100 MED (mg/day)
    20. 20. WA Workers Compensation Opioid-related Deaths 1995-2010 35Opioid-related Death 30 25 20 15 10 5 0 Possible Probable Definite
    21. 21. 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
    22. 22. Washington State Legislation: ESHB 2876, On Opioid Treatment. 2010 Repeals current regulation; new regs by June 2011 Provides specific dosing guidance and guidance on consultations, assessments, and tracking Signed into law by Governor Gregoire March 25, 2010 23
    23. 23. Washington State Opioid TreatmentRegulations  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 available 24
    24. 24. 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 State PDMP
    25. 25. 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 (http://depts.washington.edu/anesth/care/pain/echo/ index.shtml)] Public payers working on payment codes to 26 incentivize these activities
    26. 26. Incent best practices in community settings to prevent/treat chronic pain Cognitive behavioral therapy Graded exercise Activity coaching Interdisciplinary care Care coordinationCenters for Occupational Health and Education will expand to 100% of WA injured workers by 2015Medical Home concept to prevent transition to chronic pain, and more adequately treat chronic pain 27
    27. 27. 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:http://www.cwci.org/research.htmlDhalla 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 sent letters to all prescribers with any patient on opioiddoses 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
    28. 28. Early opioids and disability in WA WC. Spine2008; 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
    29. 29. Disability generated in workers‟ compensation may be a public health problem of the highest order 1954-4% of men 25-54 unemployed 2010-20% of men 25-54 unemployed Federal (SSD) disability-8 million-will be bankrupt in 7 years Workers‟ compensation is likely contributing a large proportion of the permanently unemployed/disabled to State, Federal and private disability programsDavid Leonhardt, Men, Unemployment, anddisability, NYT, 4/8/2011
    30. 30. 38% Increase since 2001
    31. 31. Concrete steps to take Track high MED and prescribers Reverse permissive laws and set dosing standards for chronic, non-cancer pain Implement AMDG Opioid Dosing Guidelines (http://www.agencymeddirectors.wa.gov/opioiddosing.asp) Implement 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)
    32. 32. Unfinished business 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/addictionNew WA WC guidelines address these issues
    33. 33. It‟s an emergency, so move aheadgingerlyIf you do something effective to reverse a decade ofbad public policy, you will get pushback: Fauber J.Follow the money: Pain, policy, and profit. 2/19/12. URL:http://www.medpagetoday.com/Neurology/PainManag ement/31256 But remember that the docs in the trenches welcomeassistance, 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* WA prescribers are MUCH more concerned aboutdependence/addiction than about regulatory scrutiny *Leverence RR, et al. J Am Board Fam Med 2011; 24: 551-561
    34. 34. New state policiesConnecticut 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 painNew Mexico-Rule 16.10.14-Proposed rulesAug, 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
    35. 35. THANK YOU!For electronic copies of this presentation, please e-mail Melinda Fujiwaravasudha@u.washington.edu For questions or feedback, please e-mail Gary Franklin meddir@u.washington.edu

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