1. Substance Abuse Issues in Chronic Pain Management Steven D. Passik, PhD Director, Oncology Symptom Control and Research Community Cancer Care, Inc. Indianapolis, IN ALSAC, FDA 1/30/02

2. The Four “A’s” of Pain Treatment Outcomes Analgesia (pain relief) Activities of Daily Living (psychosocial functioning) Adverse effects (side effects) Aberrant drug taking (addiction-related outcomes) Passik & Weinreb, 1998

3. The 4 A’s: Analgesia Using a scale of 0 to 10, in which 0 means no pain and 10 means the worst pain imaginable, please rank the following: What was your pain level on average during the past week? What was your pain level at its worst during the past week? Compare your average pain during the past week with the average pain you had before you were treated with your current pain relievers. What percentage of your pain has been relieved? Selected Questions 5.3±2.0 SD 8.5±6.6 SD 57.8%±26.1% SD

4. The 4 A’s: Analgesia Is the amount of pain relief you are now obtaining from your current pain relievers enough to make a real difference in your life? (To doctor) Is the pain relief clinically significant? Selected Questions Yes No 9.7% (n = 27) 90.3% (n = 250) Unsure Yes No 11.9%(n = 32) 3.4% (n = 9) 84.7% (n = 227)

5. The 4 A’s: Activities of Daily Living Physical Functioning MoodFamily Relationships Social Relationships Sleep Patterns Overall Functioning 20 40 60 80 100 0 80.8 15.6 3.6 25.2 4.7 70.1 42.1 3.2 54.7 47.7 4.0 48.8 33.6 6.5 59.9 19.3 2.5 78.2 Patients Reporting (%) Better Same Worse

6. The 4 A’s: Adverse Side Effects Are you able to tolerate your current pain relievers? Are you experiencing any side effects from your current pain relievers? Selected Questions Yes No 35.9%(n = 32) 63.0%(n = 172) 1.2%(n = 3) Yes No 98.8%(n = 250)

7. Severity of the constipation you are experiencing: The 4 A’s: Adverse Side Effects (To doctor) Are the side effects tolerable for the patient? None Mild Moderate Severe 19.3% (n = 36) 42.2% (n = 79) 28.9% (n = 54) 9.6% (n = 18) Yes No Unsure 93.5% (n = 217) 3.9%(n = 9) 2.6%(n = 6)

8. Aberrant Drug-taking Behaviors: The Model Probably more predictive –Selling prescription drugs –Prescription forgery –Stealing or borrowing another patient’s drugs –Injecting oral formulation –Obtaining prescription drugs from non-medical sources –Concurrent abuse of related illicit drugs –Multiple unsanctioned dose escalations –Recurrent prescription losses Probably less predictive –Aggressive complaining about need for higher doses –Drug hoarding during periods of reduced symptoms –Requesting specific drugs –Acquisition of similar drugs from other medical sources –Unsanctioned dose escalation 1 – 2 times –Unapproved use of the drug to treat another symptom –Reporting psychic effects not intended by the clinician Passik and Portenoy, 1998

9. Creating a Checklist for Monitoring Outcome During Long- term Opioid Therapy Steven D. Passik, PhD Community Cancer Care, Inc. Indianapolis, Indiana

10. 4th “A” - Aberrant Drug-related Behavior Adverse consequences possibly resulting from drug use Purposeful over sedation241 (89.6) Negative mood Change252 (92.6) Decline in psychological function255 (94.1) Decline in social function259 (94.9) Appearing intoxicated260 (95.6) Decline in physical function262 (96.0) Increasingly unkempt or impaired266 (97.8) Worrisome drug effects (“Getting High”)267 (98.2) Involvement in MVA267 (98.5) Engages in sale of sex to obtain drugs229 (100*) Frequency of behavior=0 n (%) * No answer: 53

11. 4th “A” - Aberrant Drug-related Behavior Possible loss of control or diversion of medications Requests frequent early renewals220 (81.8) Increases dose without authorization235 (86.7) Reports lost or stolen prescriptions246 (90.8) Requests higher doses in worrisome manner248 (91.2) Attempts to obtain prescriptions from other doctors255 (94.4) Uses medication for purpose other than described (to help sleep)255 (95.2) Engages in staff splitting223 (97.8) Changes route of administration269 (98.5) Frequency of behavior=0 n (%)

12. 4th “A” - Aberrant Drug-related Behavior Preoccupation with opioids or other drugs Asks for medication by name238 (89.8) Does not comply with other recommended treatments253 (93.0) Reports no effects of other medications255 (94.4) Misses appointments except for medication renewal256 (94.5) Contact with street culture258 (97.0) Abusing alcohol and street drugs265 (98.1) Hording of medication267 (98.9) Frequency of behavior=0 n (%)

13. 4th “A” - Aberrant Drug-related Behavior Other occurrences of potential concern Patient arrested or detained by police266 (97.8) Patient a victim of abuse269 (98.5) Associate(s) arrested or detained by police269 (98.5) Frequency of behavior=0 n (%)

14. Differential Diagnosis of Aberrant Drug-Taking Attitudes and Behavior Addiction Pseudo-addiction (inadequate analgesia) Other psychiatric diagnosis –Encephalopathy –Borderline personality disorder –Depression –Anxiety Criminal Intent (Passik & Portenoy 1996)

15. Defining the Problems Difficulties in assessing the risk of aberrant behavior and addiction Misunderstandings about what addiction is and the shortcomings of present definitions when applied to the clinical pain management situation The absence of well-articulated management strategies for patients with different substance abuse-related problems and aberrant behavior

16. What is the Risk of Addiction and Aberrant Behavior? Boston Collaborative Drug Surveillance Project: Porter and Jick, 1980. NEJM. –4 cases of addiction in 11,882 patients with no prior history of abuse who received opioids during inpatient hospitalization Dunbar and Katz, 1996. JPSM. –20 patients with both chronic pain and substance abuse problems on chronic opioid therapy –Nine out of 20 abused medication –Of the 11 who did not abuse the medications, all were active in recovery programs with good family support

17. Spectrum of Risk of Addiction or Aberrant Behavior <1% ~ 45% LOW Short-term exposure to opioids in non-addicts Porter and Jick HIGH Long-term exposure to opioids in addicts, Dunbar and Katz Where is your patient?

18. Addiction or aberrant behavior results from a combination of –Chemical –Psychiatric –Social/Familial –Genetic –Spiritual Influences

19. “Pseudo-Addiction” Pattern of drug seeking behavior of pain patients receiving inadequate pain management that can be mistaken for addiction –Cravings and aberrant behavior –Concerns about availability –“Clock-watching” –Unsanctioned dose escalation Resolves with reestablishing analgesia Weissman DE, Haddox JD. Oploid pseudo addiction- an iatrogenic syndrome. Pain 1989;36:363.

20. Consider the Risk of Not Treating Pain in Addicts Passik, et al. 2001. Study comparing addicts with AIDS to cancer patients and their response to under-treatment –Aberrant behavior is set in motion by under-treatment

21. The Non-Addicted Pain Patient Who Is a “Chemical Coper” Bears resemblance to addiction with regard to the “centrality” of the drug and drug procurement to the patient CCs need structure, psych input, and drug treatments that decentralize the pain medicine to their coping Decentralize pain medication: reduce its meaning, undo conditioning, undo socialization – accomplished through pain-related psychotherapy and prudent drug selection

22. Tailoring The Approach The uncomplicated patient – minimal structure The patient with comorbid psychiatric and coping difficulties – moderate structure and heavy psych/rehab input Addicted patients – highly structured –The actively abusing –The patient in drug free recovery –The patient on methadone maintenance

23. Summary There is a difference between addiction and the complex issues of noncompliance and aberrant behavior during pain management that has been poorly articulated The pain population is diverse – the application of opioid therapy to this diverse population requires careful assessment and tailored approaches that recognizes this diversity

24. Redefining Addiction for the Chronic Pain Setting

25. What Addiction Isn’t: Physical Dependence Pharmacologic effect characteristic of opioids Withdrawal or abstinence syndrome manifest on abrupt discontinuation of medication or administration of antagonist Assumed to be present with regular opioid use for days-to-weeks Becomes a problem if: –Opioids not tapered when pain resolves –Opioids are inappropriately withheld

26. What Addiction Isn’t: Tolerance Pharmacologic effect characteristic of opioids Need to increase dose to achieve the same effect or diminished effect from same dose Tolerance to various opioid effects occurs at differential rates Tolerance to non-analgesic effects often beneficial to patients (sedation, respiratory depression) Analgesic tolerance is rarely the dominant factor in the need for opioid dose escalation Patients requiring dose escalation most often have a change in pain stimulus (disease progression, infection, etc.) (Foley, 1991)

27. DSM-IV Substance Use Disorder and the Typical Pain Patient on Opioids Need for markedly increased doses to achieve effect Diminished effect with same dose Withdrawal syndrome Taking substance to relieve or avoid withdrawal symptoms Dose escalation or prolonged use Persistent desire or unsuccessful efforts to cut down or control substance use Excessive time spent obtaining, using or recovering from use of the substance Activities abandoned because of substance use Use despite harm A maladaptive pattern of substance use leading to significant impairment or distress as manifested by 3 or more of the following 9 symptoms:

28. Behaviors That Raise the Suspicion of Addiction Probably more predictive –Selling prescription drugs –Prescription forgery –Stealing or borrowing another patient’s drugs –Injecting oral formulation –Obtaining prescription drugs from non-medical sources –Concurrent abuse of related illicit drugs –Multiple unsanctioned dose escalations –Recurrent prescription losses Probably less predictive –Aggressive complaining about need for higher doses –Drug hoarding during periods of reduced symptoms –Requesting specific drugs –Acquisition of similar drugs from other medical sources –Unsanctioned dose escalation 1 – 2 times –Unapproved use of the drug to treat another symptom –Reporting psychic effects not intended by the clinician After Portenoy, in press.

29. Summary Substance abuse issues are complex during pain management and they defy simple solutions These issues require tactical and humane approaches that combine thoughtful diagnosis, structure and a team approach