Opioids for Pain Treatment. Opioids for Chronic Pain and Addiction Treatment. Outline for Today. Opioids for pain treatment

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1 Opioids for Chronic Pain and Addiction Treatment Joseph Merrill M.D., M.P.H. University of Washington February 24, 2012 Outline for Today Opioids for pain treatment Trends Problems High dose prescribing Addiction issues and treatment Evaluation Treatment with methadone, buprenorphine Opioids for Pain Treatment Highly effective for post-op and cancer pain Effective for chronic pain conditions, but Benefit clearer for pain level than function Only short term use has been well studied Trials have generally excluded patients with psychiatric problems, especially addiction 1

2 Opioid Prescribing for Chronic Pain Chronic pain visits with potent opioids prescribed (%) 2 % 9 % Number of chronic pain visits with potent opioids prescribed 1.3 million 5.9 million National Ambulatory Medical Care Survey data, Caudill-Slosberg et al., PAIN, WA State Opioid Prescribing Approximate # of Doses* 35,000,000 30,000,000 25,000,000 20,000,000 15,000,000 10,000,000 5,000, Codeine Oxycodone Hydromorphone Source: DEA ARCOS *Grams of Active Ingredient / 'Defined Daily Dose' for each substance Hydrocodone Methadone Morphine Sales to hospitals and pharmacies Methadone does not include opiate treatment programs U.S. Long Acting Opioid Market $4,500,000 $4,000,000 $3,500,000 24% 15% 000 s $3,000,000 $2,500,000 35% 22% $2,000,000 48% $1,500,000 $1,000,000 $500,000 Growth Rate: 51% $ Billion LA Opioids $783,993 $1,180,144 $1,745,188 $2,357,831 $2,877,634 $3,560,751 $4,080,695 Source: IMS National Sales Perspective 2

3 CONSORT STUDY CONsortium to Study Opioid Risks & Trends PI Michael Von Korff Aims Study trends in long-term opioid use Assess risks of adverse events Assess the risks of misuse and psychosocial problems among persons using prescribed opioids long-term Group Health Cooperative & Kaiser Permanente of Northern California Combined population of about four million persons (> 1% of the U.S. population) Long-Term Episode: > 90 days & > 10 Rx fills and/or > 120 days supply Low dose: <20mg MED High dose: >20mg MED Percent with a Prevalent Episode of Long-Term Opioid Use: Group Health Cooperative & Kaiser N California % 4.5% 4.0% 3.5% 3.0% 2.5% 2.0% 1.5% 1.0% 0.5% 0.0% % annualized change 8.1 % annualized change Group Health Kaiser N CA Long-Term Episode: > 90 days & > 10 Rx fills and/or > 120 days supply 3

4 Provisional Results Prevalence of opioid use episodes per 1,000 adults: chronic non-cancer pain at Group Health Cooperative* *population of approximately 300,000 adults Supported by NIDR grant DA , Michael Von Korff & Connie Weisner PI s Chronic Use Lower Dose Chronic Use Higher Dose Prevalence of Long-Term Opioid Use by Age and Gender at Group Health, % 8.0% Males Females Females 65 + Prevalence % Long-term opioid use 7.0% 6.0% 5.0% 4.0% 3.0% 2.0% 1.0% 0.0% Females Males 65 + Males Females Males Prevalent Episodes of Long-Term Opioid Use by Depression Dx in Prior 2 Years, Kaiser N California (solid lines) & Group Health (dashed lines) Prevalence (%) of long-term opioid use 14.0% 12.0% 10.0% 8.0% 6.0% 4.0% 2.0% 0.0% % annualized change Depression Dx 5.9% annualized change 6.5% annualized change No Depression Dx 6.9% annualized change 4

5 Prevalent Episodes of Long-Term Opioid Use by Substance Abuse Dx in Prior 2 Years, Kaiser N California (solid lines) & Group Health (dashed lines) Prevalence (%) of long-term opioid use 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% Visit with opioid abuse Dx Visit with drug or alcohol abuse Dx No substance abuse visits Opioids for Pain Treatment: Summary Increasing use nationally for non-cancer pain Longer duration and higher dose use growing fastest Long-term use more common in: Women Older patients Patients treated for depression Patients with addiction diagnoses New Non-medical Users of Pain Relievers Aged 12 or Older Millions Source: Office of Applied Studies. (2003). Results from the 2002 National Survey on Drug Use and Health: National findings (DHHS Publication No. SMA , NHSDA Series H 22). Rockville, MD: Substance Abuse and Mental Health Services Administration. Nonmedical Use of Prescription Pain Relievers May 21,

6 Healthy Youth Survey th Grade, Use in past 30 days Hyperactivity drugs 4% Other illegal drugs Rx-type-opiate to get high 7% 8% Marijuana 20% Alcohol 28% 0% 5% 10% 15% 20% 25% 30% 35% 2010 WA DOH Healthy Youth Survey Generation Rx 5 4 Rate per 1,000 live births Source: Washington State Department of Health, Comprehensive Hospital Abstract Reporting System Prescription Opioids to Heroin? 39% of heroin users at a 2009 needle exchange survey in King County said: They were hooked on prescription type opiates prior to using heroin Associated with younger age, sedative use, and no crack use 6

7 Addiction Treatment Admissions Washington State Large increase in methadone maintenance treatment admissions for primary prescription opioid addiction Majority of private-pay methadone drug treatment is for prescription opioids In 2008, 56% of primary admits for prescription opioids were ages Treatment data for buprenorphine drug treatment are sparse, but show higher proportion of prescription opioid users Unintentional prescription opioid overdose deaths Washington Number of deaths Prescription Opioid + alcohol or illicit drug Prescription Opioid +/- Other Prescriptions Source: Washington State Department of Health, Death Certificates Opioid Abuse Trends Major growth in youth recreational use of opioids Large numbers making transition from prescription opioids to heroin Significant rise in opioid addiction treatment admissions related to prescription opioids Large increase in opioid related deaths 7

8 High Dose Opioid Prescribing No clinical trial evidence of effectiveness over about 180mg MED* Promoted as compassionate extension of cancer pain management Likely a response to distress when nothing else seems to help New evidence questions its safety * Ballantyne and Mao, NEJM 2003;349:1943 High Dose Prescribing Higher doses of prescribed opioids associated with increased risk of: Fracture in elderly Opioid overdose Overdose death and total mortality Pain dysfunction and addictive behaviors Patient-attributed problems with opioids A marker for patients who need more help! 8

9 Addiction in Opioid Pain Treatment: Why is this important? Safety Most opioid overdose deaths involve multiple substances Pain treatment with opioids not effective in the setting of active addiction Past addiction is a major risk factor for problems during opioid prescribing Addiction to opioids or other substances often requires specialized treatment Prescribing opioids to active users risks sanctions Getting an Addiction History Establish rapport listen to the pain story Start addiction history by asking about use in the distant past less threatening Assess past problems and treatment efforts Demonstrate support for past efforts to quit Look for a recovery story if problems were severe, there should be one! Past problems + current use = increased risk Chronic Pain Treatment Opioid plan No dose increase without prior discussion Prescribing is tentative and contingent on other activities Non-opioid medications For neuropathic pain, sleep, psychiatric symptoms Avoid benzodiazepines Non-medication treatment CBT if available, recovery support Something ACTIVE! We don t fix people! 9

10 Ongoing Monitoring Patients on long-term opioids require monitoring, including urine toxicology testing Intensity of monitoring should reflect risk Frame monitoring as assuring safe prescribing and, if past addiction, supporting sobriety Current addiction problems emerge over time New Monitoring Option: Prescription Monitoring Program State level programs capturing all scheduled medication prescribing, even cash purchased Goals are diversion reduction while maintaining access to pain treatment Operational in 37 states Washington State legislation passed 2007, refunded 2011 Operational as of January 2012 Using the PMP Each provider must register After registration, instructions allow access to the system Using patient name and birthday, a list of medications is generated and can be placed in the medical record 10

11 Clinic Level PMP Policy Each setting needs to develop policies Frequency of PCP checks Routine Response to aberrant behavior Who is responsible? Protocol for documenting PCP checks Responding to positive results Possible Response to Unapproved Prescriptions Verify positive result with pharmacy Patient is called back midway between dispensing visits for: Pill count Urine toxicology test Discussion of PMP information Request for patient to sign Release Of Information to prescribing physician(s) Responding to Aberrant Behaviors Types of aberrant behavior in pain or addiction treatment settings Importance of responding to aberrant behaviors Clinical strategies Get more data Increase treatment intensity Keep it safe! 11

12 Types of Aberrant Behaviors Requesting early refills Running out early Unexpected urine toxicology results Behavioral problems noted by staff Poor adherence to treatment plan Unexpected prescription monitoring program results Importance of Responding to Aberrant Behaviors Safety one problem may be the tip of an iceberg May reflect a new or undiagnosed problems Mental health Addiction Diversion New social stress Ignoring signs of problems opens provider to possible sanctions Over-reacting risks loss of appropriate pain treatment Clinical Strategy: Get More Information Respond promptly, especially to urine test results Discuss the aberrant behavior and your concerns. The patient s response is the most important information Is there a new stress? A new or worsening diagnosis? Is the response vague? Defensive? Are there misperceptions about pain treatment? Consider asking the patient to return for urine test, pill count, release of information 12

13 Clinical Strategy: Increase Treatment Intensity Address any new issues Referrals, tests, close follow up Reinvigorate behavioral changes Ask for documentation Patient s response to increased treatment intensity is key information Get help when you are struggling opioid review committee, team meeting Clinical Strategy: Keep It Safe! Urgency of response depends on risk of the aberrancy (overdose >>> missed apt.) Lower doses are safer! May require change of setting or level of care Transition from pain to addiction treatment can be complicated and requires patient motivation Stopping Prescribed Opioids Some aberrant behaviors may not necessitate cessation of opioids Some setting require no taper (diversion, low dose opioids) High dose opioid patients may need opioid addiction treatment A team approach to decision making is best 13

14 Transition to Addiction Treatment Goals of treatment: Addiction treatment entry and retention Retention in medical care Consider transfer to methadone maintenance rather than rapid opioid taper Requires close communication with addiction program Contingent on patient progress toward treatment Transition to buprenorphine Induction requires opioid withdrawal Careful with transition from methadone Opioid Addiction Treatment Highly effective option for heroin or prescription opioid addiction Medication-assisted treatment far superior to detox and non-medication assisted treatment Treatment programs for addictions other than opioid will not accept patients on opioids Multi-problem pain patients on higher doses of opioids are much more complex than even the same patient in addiction treatment Opioid Addiction Treatment Methadone Maintenance is most effective Methadone treatment reduces: Overall and overdose deaths Drug use Criminal behavior Spread of infectious diseases (HIV, TB) Methadone may not be used for addiction treatment outside specially licensed programs 14

15 Methadone Maintenance Treatment Higher dose treatment improves outcomes Longer duration of treatment improves outcomes Psychosocial services improve outcomes Poor outcomes after discharge from treatment Maintenance superior to supported detox Methadone Maintenance Limitations Highly structured program (6 days/week) Limited clinical flexibility and medical services Highly stigmatized treatment Methadone Maintenance programs may resist accepting pain patients: Daily dosing may be inadequate for pain No resources to treat pain Collaboration with physicians is unusual Methadone Maintenance Pearls Ask patients about recent urine test results, take home status, dose trajectory Advise staying in treatment until social, medical, psychiatric, legal and family issues are stable Discuss possibility of extended take home doses as an alternative to tapering off 15

16 Office Based Buprenorphine for Opioid Dependence Federal legislation (DATA 2000): Allows trained MDs to prescribe Schedule III-V drugs approved for addiction treatment Initially limited to 30 patients/group practice, but now each MD can treat up to 100 patients Safer than methadone With naloxone, reduced abuse potential Full Agonist vs Partial Agonist Activity Full Agonist Partial Agonist Antagonist Log Dose of Opioid Zubieta et al.,

17 Buprenorphine Superior to psychosocial treatment alone Longer treatment duration is more effective Comparable to MMT on many outcomes, but not as good at retaining patients Medication cost higher than MMT, but total costs hard to compare in different settings Patients with co-morbid pain and addiction may benefit from physician management Issues in Prescribing Buprenorphine Patient selection Set up office protocols for referrals, initial evaluation, induction, monitoring Induction requires withdrawal assessment Psychosocial treatment requirements (AA/NA and/or counseling) Payment policies Criteria for stopping buprenorphine Using Buprenorphine is Gratifying! Highly satisfying practice! Can turn around the lives of our most problematic patients No one improves like a patient in recovery Can attend to medical and mental health issues that went unmanaged Just try a patient and see! 17

18 Support for Using Buprenorphine Initial 8-hour training (required) Physician Clinical Support Network Project ROAM telemedicine support Two more ROAM trainings March 13 th in Spokane May 12 th in Cle Elum Telehealth Support Project ECHO developed in New Mexico Connects rural clinics to specialty expertise UW ECHO for hepatitis C, chronic pain, and rural opioid addiction management (ROAM) Weekly lunchtime conferences for case discussions, didactics, and community building Opioids for Chronic Pain and Addiction Treatment Large increase in opioid prescribing Highest risk patients receive highest risk regimens Evaluating addiction is an important aspect of opioid prescribing Opioid addiction treatment is effective New models to support MDs are being developed 18