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Opioid Therapy, Pain, and Addiction at the Crossroads

Opioid Therapy, Pain, and Addiction at the Crossroads. Kenneth L. Kirsh , Ph.D. Clinical Research Educator and Research Scientist Millennium Laboratories Millennium Research Institute San Diego, CA. The Opioid Pendulum. Opiophilia. Opiophobia.

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Opioid Therapy, Pain, and Addiction at the Crossroads

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  1. Opioid Therapy, Pain, and Addiction at the Crossroads Kenneth L. Kirsh, Ph.D. Clinical Research Educator and Research Scientist Millennium Laboratories Millennium Research Institute San Diego, CA

  2. The Opioid Pendulum Opiophilia Opiophobia Balance of Addiction Medicine and Pain Management Principles1 1Gourlay, D.L. et al. Universal precautions in pain medicine: A rational approach to the treatment of chronic pain. Pain Medicine. 2005; 6(2): 107-112.

  3. Nearly 20 years of expanded opioid prescribing: What have we learned? • Something fundamental about the clinical use of opioids? OR • Something fundamental about what our healthcare system is bad at?

  4. What is our healthcare system bad at? • Chronicity • Conditions with major motivational/psychiatric component • Communication among professionals • Ongoing risk assessment • Conditions that intersect badly with SES • Stigmatization Goldney RD, et al. Depression, diabetes, and quality of life: A population study. Diabetes Care. 2004;27(5): 1066-1070. Patrick DL, et al. Symptom management in cancer pain: Pain, depression, and fatigue. Journal of the National Cancer Institute. 2003; 95(15): 1110-1117. Winkleby MA, et al. Social class disparities in risk factors for disease: Eight-year prevalence patterns by level of education. Preventative Medicine. 1990; 19: 1-12.

  5. Two Commonly Used Classes of Medications PPIsOpioids Yoshikawa I, et al. Long-term treatment with proton pump inhibitor is associated with undesired weight gain. World J Gastroenterol. 2009; 15(38):4794-4798.

  6. Pushing the Pendulum Towards Opiophilia • Trivialization of risk and overstatement of benefits • To individual patients • To society • Pain management is easy, just follow the numbers • Pain patients vs. addicts • The delivery system will deliver us

  7. Base Rates of Addiction/Abuse: Vulnerabilities in the Population • 8.7% Illicit Drugs • 6.2% Alcohol • 26.5% Nicotine SAMHSA, Results from the 2011National Survey on Drug Use and Health: Summary of National Findings. NSDUH Series H-44, HHS Publication No. (SMA) 12-4713. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2012.

  8. Pseudo-addiction? • Weissman & Haddox • N of 1 case study • Inpatient • Became surly anduncooperative • Pain managementimproved, behaviorimproved • Passik, Kirsh, & Webster • Failures to demonstrate it empirically • Use of illegal drugs covered? • Overuse of prescribed medications by outpatients covered? • Primary vs. secondary alcoholism as a better model Weissman DE, Haddox JD. Opioid pseudoaddiction – an iatrogenic syndrome. Pain. 1989;36(3): 363-366. Passik S, et al. Pseudoaddiction revisited: A commentary on clinical and historical considerations. Pain Management, 2011;

  9. AIDS Patients and Aberrant Behaviors Passik SD, et al. Pain and aberrant drug-related behaviors in medically ill patients with and without histories of substance abuse. Clinical Journal of Pain. 2006; 22(2): 173-181.

  10. Non-Medical Use of Psychotherapeutic Percent Using in Past Month SAMHSA. Results From the 2007 National Survey on Drug Use and Health. DHHS Publication No. SMA 06-4194, 2006. Obtained from http://www.samhsa.gov/data/nsduh/2k7nsduh/2k7Results.htm

  11. New Illicit Drug Use in the United States: 2002 Numbers in Thousands 2500 2000 1500 1000 500 Inhalants Sedatives Heroin Stimulants Marijuana Pain Relievers LSD PCP Cocaine Ecstasy Tranquilizers SAMHSA. Results From the 2002 National Survey on Drug Use and Health. DHHS Publication No. SMA 06-4194, 2006. Obtained from Obtained from http://www.samhsa.gov/data/nhsda/2k2nsduh/results/2k2Results.htm#toc.

  12. Doctors on Trial: Pain Docs or Drug Dealers? Satterfield J. Pain clinic owner standing trial on charges she traded pills for cash. Knoxnews. September 25, 2012: Retrieved from http://www.knoxnews.com/news/2012/sep/25/pain-clinic-owner-standing-trial-on-charges-she/

  13. What Makes News? • Sex • & • Drugs • & • Rock and Roll

  14. This?

  15. Or This?

  16. What Constitutes Functional Improvement, Anyway? Slowing the rate of decline? Improvement?

  17. Pushing the Pendulum Toward Opiophobia • Opioid strawman • Addiction is resident in drugs • Hyperalgesia

  18. The Opioid Strawman

  19. Where does Addiction Live?

  20. Addiction is not Simply a Disease of Exposure Burroughs: Exposure • Current • Exposure is necessary not sufficient • Exposure to drug • Vulnerable person • Vulnerable time Burroughs W. Junkie. New York, NY: Ace Books; 1973.

  21. Does Drug Selection Matter? Long-acting Opioids vs. Short Acting Opioids Fentanyl Patch Fentanyl TIRF Setnik B, et al. The abuse potential of remoxy, an extended-release formulation of oxycodone, compared with immediate-release and extended-release oxycodone. Pain Medicine. 2011; 12(4): 618-631

  22. Hyperalgesia • Easy to demonstrate in: • Rats1 • Humans on opioids in acute pain • Chronic pain???2 • Undeniable that some people are better off, off opioids • Is this • Hyperalgesia? • Hypogonadism? • Psychological/Existential distress? • Having normal bowel movements? 1Tassorrelli C, et al. Nitroglycerin induces hyperalgesia in rats: A time course study. European Journal of Pharmacology. 2003; 464(2-3): 159-162. 2Fishbain DA, et al. Do opioids induce hyperalgesia in humans? An evidence-based structured review. Pain Medicine. 2009; 10(5): 829-839.

  23. Risk Management is a Package Deal • Screening and risk stratification • Use of PMP data • Compliance Monitoring • Urine screening • Pill/Patch counts • Education regarding drug storageand sharing • Psychotherapy and highly “structured” approaches • Abuse-deterrent formulations Passik SD, Kirsh KL. The interface between pain and drug abuse and the evolution of strategies to optimize pain management while minimizing drug abuse. Experimental and Clinical Psychopharmacology. 2008; 16(5): 400-404.

  24. Population of Rx Opioid Users Is Heterogeneous “Self-Treaters” “Adherent” “Recreational users” “Chemical copers” “Substance abusers” “Substance abusers” “Addicted” (SUD) “Addicted” (SUD) Nonmedical Users Pain Patients Passik SD, Kirsh KL. The interface between pain and drug abuse and the evolution of strategies to optimize pain management while minimizing drug abuse. Experimental and Clinical Psychopharmacology. 2008; 16(5): 400-404.

  25. Assessment of Addiction Risk • Measures for screening for addiction risk • STAR/SISAP1 • CAGE AID2 • Opioid Risk Tool (Emerging Solutions in Pain)3 • SOAPP (see painedu.org)4 • Psychiatric interview assessment of risk • Chemical • Psychiatric • Social/Familial • Genetic • Spiritual 1Friedman R, Mehrotra D. Treating pain patients at risk: Evaluation of a screening tool in opioid-treated pain patients with and without addiction. Pain Medicine. 2003; 4(2): 182-185 2Brown RL, Rounds LA. Conjoint screening questionnaires for alcohol and other drug abuse: Criterion validity in a primary care practice. Wisconsin Medical Journal. 1995; 94(3): 135-140 (retrieved from http://www.integration.samhsa.gov/images/res/CAGEAID.pdf on February 18, 2013). 3Webster LR. Predicting aberrant behaviors in opioid treated patients: Preliminary validation of the opioid risk tool. Pain Medicine. 2005; 6(6): 432-442. 4Akbik H, et al. Validation and Clinical Application of the Screener and Opioid Assessment for Patients with Pain (SOAPP). Journal of Pain and Symptom Management. 2006; 32(3):287-293.

  26. How do Different Risk Measures Compare? • A recent study at a pain practice in Tennessee • A retrospective study of discharged patients • N=48 • Risk rating of each patient with all four measures: • Clinical semi-structured interview by a psychologist • DIRE (Belgrade et al, 2006) • ORT (Webster & Webster, 2005) • SOAPP (Butler et al, 2004) • “Medium” or “High” risk rating = Accurate prediction • This measure assesses sensitivity (not specificity). Moore TM, et al. A comparison of common screening methods for predicting aberrant drug-related behavior among patients receiving opioids for chronic pain management. Pain Medicine. 2009; 10(8): 1426-1433.

  27. Accuracy in Predicting Discharge(Aberrant Drug-Related Behaviors) Moore TM, et al. A comparison of common screening methods for predicting aberrant drug-related behavior among patients receiving opioids for chronic pain management. Pain Medicine. 2009; 10(8): 1426-1433.

  28. The Growth of Prescription Monitoring Programs • 2003 • 14 states had monitoring programs • 36 states had no prescription monitoring programs • 2012 • 41 states had prescription drug monitoring programs • 9 states had no monitoring program Data collected from http://www.pmpalliance.org/content/data

  29. Aberrant Behaviors Versus Urine Toxicology Testing 53/122 (43%) of patients had “problems” (positive urine screen or behavioral issues) Katz N, Fancuillo GJ. Role of urine toxicology testing in management of chronic opioid therapy. Clinical Journal of Pain. 2002; 18(4): S76-S82.

  30. Unexpected UDT Results Chronic Opioid Therapy Michna E, Jamison RN, Pham LD, et al. Urine toxicology screening among chronic pain patients on opioid therapy: frequency and predictability of abnormal findings. Clin J Pain 2007; 23: 173-179.

  31. Teaching about Medication Storage and Sharing • Sharing prescriptionmeds seen as safeby “self-treaters” • Need to educate patientsabout medication storage • New devices being developedto help only the patient haveaccess and on a scheduleprogrammed by the MD or RN http://www.lockyourmeds.org/meducation/

  32. Opioid Renewal Clinic • Procedure • Consult from PCP • Eligibility • Workup & pain dx • Opioid TreatmentAgreement • Baseline urine drugtest • PCP CONTINUES TO BERESPONSIBLE TOPRESCRIBE OPIOIDS • Strategy • Opioid Treatment Agreement • Second change agreement • Frequent visits • Prescribed opioids on short-term basis • ie, weekly or bi-weekly • Random UDT • Pill counts • Co-management with additional services Wiedemer NL,et al. The opioid renewal clinic: A primary care, managed approach to opioid therapy in chronic pain patients at risk for substance abuse. Pain Medicine. 2007; 8(7): 573-584.

  33. Opioid Renewal Clinic(n=171) Aberrant behavior = 171No aberrant behavior = 164 Wiedemer NL,et al. The opioid renewal clinic: A primary care, managed approach to opioid therapy in chronic pain patients at risk for substance abuse. Pain Medicine. 2007; 8(7): 573-584.

  34. NIDA Study: Adherence Therapy for Opioid Abusing Pain Patients • 40 pain patients at 2 sites in Virginia & New York • Evidence of opioid efficacy for diagnosis • >6 mo duration, constant, moderate-severe intensity (VAS >7 despite daily opioids) • Substance abuse co-morbidity • Opioid abuse dependence, >2 on “problems with pain meds”, no current substance dependence, & lifetime dependence or current abuse permissible • Psychiatric co-morbidity • No unstable major psychiatric disorders, current suicidal/homicidal ideation, or medication dose considerations • Medical co-morbidity • No unstable/severe medical conditions or planned surgery within study period; no meds that interact with methadone Haller D, Acosta MC. Characteristics of pain patients with opioid-use disorder. Psychosomatics. 2010; 51: 257-266.

  35. NIDA Study: Adherence Therapy for Opioid Abusing Pain Patients Haller D, Acosta MC. Characteristics of pain patients with opioid-use disorder. Psychosomatics. 2010; 51: 257-266.

  36. Differential Diagnosis: Aberrant Drug-Taking Attitudes & Behavior • Addiction • Compton1 • Fleming2 • Pseudo-addiction • Elander3 1Compton P, et al. Screening for addiction in patients with chronic pain and ‘problematic’ substance use: Evaluation of a pilot assessment tool. Journal of Pain and Symptom Management. 1998; 16(6): 355-363. 2Fleming MF, et al. Substance use disorders in a primary care sample receiving daily opioid therapy. The Journal of Pain. 2007; 8(7): 573-582. 3Elander J, et al. Understanding the causes of problematic pain management in sickle cell disease: evidence that pseudoaddiction plays a more important role than genuine analgesic dependence. Journal of Pain and Symptom Management. 2004; 27(2):156-169.

  37. Differential Diagnosis: Aberrant Drug-Taking Attitudes & Behavior • Other psychiatric diagnosis • Organic mental syndrome • Personality disorder • Chemical coping • Depression/anxiety/situational stressors • Wasan1 • Criminal intent • Katz2 • Jung & Reidenberg3 1Wasan AD,et al. Psychiatric history and psychological adjustment as risk factors for aberrant drug-related behavior among patients with chronic pain. Clinical Journal of Pain. 2007; 23(4): 307-315. 2Katz, N. et al. (2010). Usefulness of prescription monitoring programs for surveillance—analysis of Schedule II opioid prescription data in Massachusetts, 1996–2006. Pharmacoepidemiology and Drug Safety, 19(2), 115-123. 3Jung B, Reidenberg MM. Physicians being deceived. Pain Medicine. 2007; 8(5): 433-437.

  38. We Are All Stakeholders • Patients • Professionals • Law enforcement • Media • 3rd Party Payors Passik SD, Heit H, Kirsh KL. Reality and responsibility: A commentary on the treatment of pain and suffering in a drug-using society. Journal of Opioid Management. 2006; 2(3):123-127.

  39. 3rd Party Payors • Frequent visits • Urine screens • Psychological care • Abuse deterrent opioids • Less drug per prescription Joranson DE. Are health-care reimbursement policies a barrier to acute and cancer pain management? Journal of Pain and Symptom Management. 1994;9(4): 244-253.

  40. Conclusions

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