Pain and Chemical Dependency

1. Pain and Chemical Dependency Russell K. Portenoy, MDChairman Department of Pain Medicine and Palliative Care Beth Israel Medical Center, New York Professor of Neurology and Anesthesiology Albert Einstein College of Medicine

2. Pain and Chemical Dependency • The interface between pain and chemical dependency • Definitions and phenomenology • Focus on opioid pharmacotherapy

3. Neurobiology Clinical Issues Translational research Use and abuse of controlled prescription drugs Craving vs. analgesia vs. other effects Opioid systems Stigma and Under- treatment Impact of laws and regulations Genetics Pain and Chemical Dependency

4. Pain and Chemical Dependency • Key Terms and Concepts • Physical Dependence • Tolerance • Aberrant drug-related behavior • Pseudoaddiction • Abuse • Addiction

5. Pain and Chemical Dependency • Physical Dependence • Potential for abstinence on abrupt discontinuation or dose reduction, or administration of an antagonist • Highly variable phenomenology • Tachycardia, tachypnea • Nausea/vomiting, diarrhea, abdominal cramps • Sweating, rhinorrhea, piloerection • Myalgias and arthralgias • Anxiety, insomnia

6. Pain and Chemical Dependency • Physical Dependence • Not a problem if abstinence is avoided • Theoretical connection to the genesis of addiction/relapse, but neither necessary nor sufficient • Should never be labeled “addiction”

7. Pain and Chemical Dependency • Tolerance • Declining effect with drug exposure • Tolerance to side effects is desirable; tolerance to analgesia may be a problem • Large clinical experience is reassuring • Theoretical connection to the genesis of addiction/relapse, but neither necessary nor sufficient • Should never be labeled “addiction”

8. Pain and Chemical Dependency • Aberrant Drug-Related Behavior • Problematic behaviors or “red flags” for clinicians • Culture-bound, but defined by conventional practice, and by laws and regulations • Should be viewed as “data,” which must be interpreted in a differential diagnosis of addiction

9. Pain and Chemical Dependency • Aberrant Drug-Related Behavior (cont’d) • Aggressive complaining • Drug hoarding when symptoms milder • Requesting specific drugs • Acquisition of drugs from other medical sources • Unsanctioned dose escalation once or twice • Use of the drug to treat another symptom • Reporting unintended psychic effects • Occasional impairment

10. Pain and Chemical Dependency • Aberrant Drug-Related Behavior (cont’d) • Selling prescription drugs • Prescription forgery • Stealing or “borrowing” drug from another person • Injecting oral formulation • Obtaining prescriptions from non-medical source • Multiple episodes of prescription “loss” • Concurrent abuse of related illicit drugs • Multiple dose escalations despite warnings • Repeated gross impairment or dishevelment

11. Survey of Aberrant Drug-Related Behaviors (n = 388) (n = 215) (n = 98) (n = 33) (n = 26) (n = 16) Number of Behaviors Reported Passik et al, Clin Ther, 2004

12. Pain and Chemical Dependency • Abuse • Drug use outside of socially accepted norms • Includes any use of an illicit drug and some degree of aberrant use of prescription drugs • DSM IV: Psychoactive Substance Abuse • A maladaptive pattern of drug use that results in harm or places the individual at risk

13. Pain and Chemical Dependency • Addiction • Chronic disease with genetic, psychosocial, and environmental/situational influences, which can be induced in vulnerable people exposed to potentially abusable drugs • DSM IV definition of “substance dependence” refers to addiction, but problematic in patients with chronic pain

14. Pain and Chemical Dependency • Task Force of APS, AAPM, and ASAM: New definition of addiction A primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: • impaired control over drug use • compulsive use • continued use despite harm • craving Savage et al, JPSM, 2003

15. Pain and Chemical Dependency • Pseudoaddiction • Aberrant drug-related behavior in patients reacting to undertreatment of pain • Diagnostic challenge: May co-exist with addiction or other psychiatric disorders

16. Pain and Chemical Dependency • Diagnosis of Addiction • Suggested by the occurrence of aberrant drug-related behavior • Distinguish from other phenomena in the DDx • Addiction • Pseudoaddiction • Other psychiatric disorders, including personality disorders, confusional states, and family disturbances • Criminal intent • Diagnoses are not mutually exclusive

17. Populations with • advanced illness • Cancer • HIV/AIDS • Others Short-term or long-term opioid therapy Moderate to severe pain Populations with acute illness, injury, or surgery Opioid Therapy: Standard of Care

18. Role of opioid therapy for chronic nonmalignant pain Unresolved Clinical Issues Treatment of pain in patients with chemical dependency Opioids for Chronic Pain: Unresolved Issues

19. Tragedy of needless pain War on drugs Opioids for Chronic Pain: Historical Context

20. Risk of Abuse and Addiction: Evolving View • Acute pain: very unlikely • Cancer pain and pain at EOL: very unlikely • Chronic nonmalignant pain: • Surveys and studies of patients without abuse or psychopathology show rare addiction • Surveys of populations referred to pain treatment programs show mixed results

21. War on drugs Tragedy of needless pain Opioids for Chronic Pain: Historical Context

22. Increasing Prescription Drug Abuse Drug Abuse Warning Network National Household Survey On Drug Use and Health

23. Opioids are abusable, particularly by those with addiction. Regulators and law enforcement must stem diversion and abuse • Opioids are • essential drugs. • Patients with pain, • including those with • addiction, must have • access to treatment Opioids for Chronic Pain: The Need for Balance

24. What Is the Potential Need for Opioid Therapy? • Starting point: epidemiology of pain • Acute severe pain extremely prevalent • Chronic pain reported by • 30-80% of cancer patients depending on stage • 2-40% of general population (Gureje et al, JAMA, 1998; Verhaak et al, Pain, 1998) • Recent study: 30-40% overall, at least partially disabling in about 30% (Portenoy et al, J Pain, 2004) • Little known about pain in patients with addiction, but one survey noted “chronic severe pain” in 24-37% of addicts in treatment (Rosenblum et al, JAMA, 2003)

25. What Is the Potential Need for Opioid Therapy? • Millions of patients with acute pain • Millions of patients with cancer pain or pain related to some other life-threatening medical illness • Millions more, if even if a small proportion of patients with chronic noncancer pain are candidates

26. Need for Therapy and Need for “Balance”: Implications • Clinicians must determine • Who can I treat without help? • Who can I treat with consultative help? • Who should I refer? • Clinicians must appreciate that opioid therapy for chronic pain requires • Knowledge of the principles of prescribing • Knowledge of an approach to the assessment and management of issues related to chemical dependency

27. Need for Therapy and Need for “Balance”: Implications • Safe and effective therapy requires • Comprehensive assessment • Appropriate positioning of therapy • Risk assessment and appropriate structuring of treatment • Optimal administration over time • Risk management over time • Monitoring and documentation

28. Positioning Opioid Therapy • Assessment is the first step • Characterize the pain • Define etiology, syndrome and pathophysiology • Clarify impact and prior therapies • Evaluate relevant comorbidities • Physical/medical • Psychosocial and psychiatric, including personal and family history of substance use

29. Pharmacotherapy Rehabilitative approaches Psychological approaches Interventional approaches Complementary and alternative approaches Lifestyle changes Positioning Opioid Therapy • Consider a multimodality approach targeting pain and disability

30. Positioning Opioid Therapy • Analgesic pharmacotherapy • Opioids • Nonopioid analgesics • Adjuvant analgesics

31. Positioning Opioid Therapy • Consider opioids for all patients with moderate or severe chronic pain but weigh the influences • What is conventional practice? • Are there alternatives with equal or better therapeutic ratio? • Is the patient at relatively high risk of toxicity? • Are drug-related behaviors likely to be responsible?

32. Risk Assessment and Management • Know the laws and regulations • Assess initial level of risk • “Structure” therapy to match risk • Assess and diagnose behaviors during therapy • Possess strategies to appropriately respond to aberrant behaviors

33. Opioid Therapy: Laws and Regulations • International laws and treaties • International Narcotics Control Board • No direct influence on prescribers • Federal laws and regulations • FDA assesses safety and efficacy • DEA monitors and addresses abuse/diversion • State laws and regulations • Medical boards and law enforcement • Variable from state to state

34. Opioid Therapy:Judging Initial Risk • Numerous validated measures, none yet in widespread use • CAGE-AID(Brown and Rounds, Wisc Med J, 1995) • Screening Instrument for Substance Abuse Potential (SISAP) (Coambs et al, Pain Res Manage, 1996) • Substance Abuse Subtle Screening Inventory (SASSI)(www.sassi.com)

35. Opioid Therapy:Judging Initial Risk • Numerous validated measures, none yet in widespread use • Screening tool for Addiction Risk (STAR) (Friedman et al, Pain Med, 2003) • Screener and Opioid Assessment for Patients with Pain (SOAPP)(Butler et al, Pain, 2004) • Pain Medicine Questionnaire(Adams et al, J Pain Symptom Manage, 2004)

36. Opioid Therapy:Judging Initial Risk • Other studies suggest specific predictors of problematic use • Prior history of substance abuse (Michna et al, J Pain Symptom Manage, 2004) • Need to increase the dose, considering oneself addicted, and preference for a specific route (Compton et al, J Pain Symptom Manage, 1998) • Focus on opioids during visits, need for early refills or dose escalation, multiple calls or early visits, other prescription problems, and obtaining opioids from other sources(Chabal et al, Clin J Pain, 1997)

37. Opioid Therapy:Judging Initial Risk • Clinical experience suggests other factors: • Family history of substance abuse • Any major psychiatric pathology • Heavy tobacco or alcohol use • History of criminal activity • History of physical/sexual abuse • Contact with high risk people or environments • Chaotic home situation • Family history of major psychiatric pathology

38. Opioid Therapy:Judging Initial Risk • Most important factors: • Prior history of substance abuse • Family history of substance abuse • Major psychiatric pathology

39. Initial “Structuring” of Therapy to Reduce Risk • Based on assessment, categorize patient into low or high perceived risk • Structure the therapy to match the perceived risk • Improves the ability to monitor • May help the vulnerable patient maintain control

40. Initial “Structuring” of Therapy to Reduce Risk • May initiate therapy with: • Requirement of all prior records and permission to contact other health care professionals • Requirement of consultation with addiction medicine specialist or other mental health professional • Written agreement, perhaps a formal “contract” • Prescription of long-acting drug only • Frequent visits • Small prescription (one-week or two-week supply)

41. Initial “Structuring” of Therapy to Reduce Risk • May initiate therapy with: • Urine drug screen • Requirement that only one pharmacy be used (with contact) • Requirement that pill bottle be returned for count • Instruction that there will be no early refills or replacement of loss drug without police report • Requirement of concurrent nonpharmacologic therapy • Requirement that others (e.g., spouse) be allowed to comment periodically on progress

42. Initial “Structuring” of Therapy to Reduce Risk • Written “contract” or treatment agreement • Use remains controversial • Advantages • Explicit instructions • Educational tool • Can clarify the roles of PCP and specialist • Potential disadvantages • Can be perceived as capricious or punitive • Can be stigmatizing • Can limit clinical flexibility and add liability

43. Initial “Structuring” of Therapy to Reduce Risk • Opioid “contract”: common elements • Avoid improper use • Terms of disciplinary termination • Limitations for replacing or changing prescriptions • Inform physician (e.g., side effects, other meds) • Random drug screens • Terms regarding appointments • Requirement for consultation • Limits on drug refills (e.g., phone allowances or in person) • Side effects education (including withdrawal) • Terms of nondisciplinary termination Fishman et al, J Pain Symptom Manage, 1999

44. Initial “Structuring” of Therapy to Reduce Risk • Role of urine drug screen • Advantages • Can confirm that prescribed drug is taken and that other drugs are not • Makes a strong statement potentially useful in monitoring (“trust but verify”) • Disadvantages • Cannot confirm that the proper dose is taken • Can be misinterpreted • Can be stigmatizing

45. Opioid Therapy:Principles of Prescribing • Selection of the drug • Selection of the route • Optimal dosing • Side effect management • Monitoring outcomes • Managing the poorly responsive patient

46. Opioid Therapy: Monitoring Outcomes • Assess the “Four A’s” over time • Analgesia (pain relief) • Activities of daily living (physical and psychosocial functioning) • Adverse effects (side effects) • Aberrant drug-related behavior

47. Opioid Therapy:Monitoring Outcomes • Monitoring drug-related behaviors: • Step 1: Are there aberrant drug-related behaviors? • Step 2: If yes, assess (consider consultations) • Step 3: How should they be interpreted? • What are the diagnoses? • What factors are driving the behaviors?

48. Opioid Therapy:Monitoring Outcomes • DDx of aberrant drug-related behavior • Addiction • Pseudoaddiction • Other psychiatric disorders • Personality disorders • Encephalopathy • Family disturbances • Criminal intent

49. Responding to Aberrant Drug-Related Behaviors • Depends on diagnoses • May or may not continue opioid therapy • May or may not refer to specialist in addiction medicine, pain medicine, or other

50. Responding to Aberrant Drug-Related Behaviors • If opioid continues, restructure therapy with one or more of the following • Required ongoing treatment by addiction medicine specialist, mental health care professional or others • Ongoing coordination with sponsor or program, if addiction therapy is ongoing • Written agreement, perhaps a formal “contract” • Prescription of long-acting drug only • Frequent visits • Small prescription (one-week or two-week supply)