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Howard A. Heit, MD, FACP, FASAM

The Truth About Opioid Pain Management: Patient Evaluation, Addiction, Physical Dependence, and Federal Regulations. Howard A. Heit, MD, FACP, FASAM

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Howard A. Heit, MD, FACP, FASAM

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  1. The Truth About Opioid Pain Management: Patient Evaluation, Addiction, Physical Dependence, and Federal Regulations Howard A. Heit, MD, FACP, FASAM Board Certified in Internal Medicineand Gastroenterology/HepatologyCertified in Addiction Medicineand as a Medical Review OfficerChronic Pain Specialist Assistant Clinical ProfessorGeorgetown University

  2. An unpleasant sensory and emotional experience that is associated with actual or potential tissue damage, or described in terms of such injury — IASP, 1994 Pain

  3. Pain is the most common complaint for which individuals seek medical attention! Foley K. JAMA. 2000;283(1):115.

  4. Chronic pain • Pain that has outlived its usefulness • Acute pain • An adaptive, beneficial response necessary for the preservation of tissue integrity Oaklander AK. Neuroscientist. 1999;5(5):302-310.

  5. Abuse Analgesia Principle of Balance • Dual obligation of governments • Establish system of controls to prevent abuse, trafficking, & diversion of CS • Ensure medical availability Pain & Policy Studies Group. Achieving Balance in State Pain Policy: A Progress Report Card. 3rd ed. 2007.

  6. Past-Year Initiates of Illicit Drug Use: 2006 Persons aged ≥12 yrs Number (in millions) SAMHSA. (2007). Results from the 2006 National Survey on Drug Use and Health: National Findings (Office of Applied Studies, NSDUH Series: H-32, DHHS Publication No. SMA 07-4293). Rockville, MD.`

  7. Sources of Diverted Rx Drugs • Thefts & losses • Armed robberies • Night break-ins • Employee & customer pilferage • Growing number of “rogue” Internet pharmacies • International smuggling • Study within Eastern 22 states from 2000-2003 • Almost 28 million CS dosage units diverted • Approximately 7 million (25%) were opioids • Media focus on diversion stemming only from prescribers can hinder patient access to care Joranson DE, Gilson AM. J Pain Symptom Manage. 2005;30:299-301. Brushwood DB, Kimberlin CA. J Am Pharm Assoc. 2004;44:439-44. Inciardi JA, et al. Pain Med. 2007;8:171-83. National Center on Addiction & Drug Abuse at Columbia University. “You’ve Got Drugs!” Prescription Drug Pushers on the Internet. 2007.

  8. N a t i o n a l S u r v e y o n D r u g Use a n d H e a l t h (NSDUH) • Source of prescription pain relievers of persons aged 18 to 25 in the 2005 • Who obtained the drug for their most recent non-medical use • Who were dependent on or abused prescription pain relievers • Prescriptions from one doctor (12.7% to 13.6%) NSDUH Report: How Young Adults Obtain Prescription Pain Relievers for Nonmedical Use Issue 39, 2006

  9. Barriers to Pain Management • Addiction/Misuse/Diversion of Controlled Substances

  10. Addiction • Addiction is 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, and craving (5 C’s) Consensus Document. The American Academy of Pain Medicine. The American Pain Society. The American Society of Addiction Medicine. 2001.

  11. Physical Dependence • Physical dependence is a state of adaptation that is manifested by a drug class-specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist Consensus Document. The American Academy of Pain Medicine. The American Pain Society. The American Society of Addiction Medicine. 2001.

  12. Physical dependence and addiction can coincide, but physical dependence does not equal addiction in all cases. Physical dependence is a neuro-pharmacological phenomenon while addiction is both a neuropharmacological and behavior phenomenon

  13. Genetics SocialEnvironment Neurochemical Triangle of the Disease of Addiction

  14. Tolerance • Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug’s effects over time • Key: All other conditions being constant • BAD: Disease or syndrome is progressing • GOOD: Functional activity is increasing Consensus Document. The American Academy of Pain Medicine. The American Pain Society. The American Society of Addiction Medicine. 2001.

  15. History of AA • AA/NA compatible with treatment of all medical and mental disorders • Should be considered essential in treatment of addictive disorders John Chappel, MD, FASM, Professor Emeritus, University of Nevada at Reno ASAM Review Courses on the 12-Step Programs

  16. Prevalence of Addiction in theGeneral Population • Approximately 10% (3% - 16%) • Relapse rate with long-term opioid use is unknown Portenoy RK, Savage SR. J Pain Sympt Manage. 1997;14(3):S27-35.

  17. Opioid Treatment for Pain and Addiction • Addiction to opioids in the context of pain treatment has been reported to be rare in those with no history of addictive disorders. Portenoy, R.K., Savage, S.R. Journal of Pain and Symptom Management. Vol. 14 No. 3 (Suppl.) Sept. 1997 Fishbain DA, Cole B et al. Pain Medicine 9(4): 2008; 444-459

  18. Iatrogenic Addiction • Iatrogenic addiction occurs when a patient, with a negative personal or family history for alcohol or drug addiction or abuse, is appropriately prescribed a controlled substance & subsequently in the therapeutic course meets the diagnostic criteria for addiction to that substance Heit HA, Gourlay DL. Treatment of Pain in Substance Abuse Disordered Population. Ballantyne JC, Rathmell JP, Fishman SM (eds). Bonica’s Management of Pain. 4th ed. Lippincott Williams & Wilkins. In Press.

  19. Treatment of Pain with Opioids • “All substances are poisons. The right dose differentiates a poison and a remedy.” - Paracelsus, 1493- 1541 AD

  20. Goals of Treating Chronic Pain • Decrease pain • Increase function • Use medications that do not have unacceptable side effects

  21. Patient Evaluation • Initial evaluation • Each appointment

  22. Universal Precautions in Pain Medicine • The term “Universal Precautions” originated from the infectious disease model • Careful 10-point assessment of all persistent pain patients within the biopsychosocial model • Appropriate “boundary setting” before writing the first prescription • By using this approach to the pain patient • Stigma can be reduced • Patient care improved • Overall risk of pain management be reduced Gourlay D, Heit HA et al. Pain Med. 2005;6(2):107-112.

  23. Universal Precautions in Pain Medicine • Diagnosis with appropriate differential • Psychological assessment including risk of addictive disorders • Informed consent (verbal vs written/signed) • Treatment agreement (verbal vs written/signed) • Pre/post intervention assessment of pain level and function Gourlay D, Heit HA et al. Pain Med. 2005;6(2):107-112.

  24. Universal Precautions in Pain Medicine • Appropriate trial of opioid therapy +/- adjunctive medication • Reassessment of pain score and level of function • Regularly assess the “Four A’s” of pain medicine • Analgesia, Activity, Adverse reactions, & Aberrant behavior 1 • Periodically review pain diagnosis and comorbid conditions, including addictive disorders • Documentation 1Passik SD, Weinreb HJ. Adv Ther. 2000;17(2):70-83.Gourlay D, Heit HA et al. Pain Med. 2005;6(2):107-112.

  25. Universal Precautions: Patient Triage • Group I: Who is your patient? • Group II: Who is our patient? • Group III: Who is my patient? Gourlay D, Heit HA et al. Pain Med. 2005;6(2):107-112.

  26. No Pain Severe Pain Very Severe Worst Possible MildPain Moderate Pain

  27. Stratifying Risk: Opioid Risk Tool FEMALE MALE • Family history of substance abuse Alcohol 1 3 Illegal drugs 2 3 • Prescription drugs 4 4 • Personal history of substance abuse Alcohol 3 3 Illegal drugs 4 4 • Prescription drugs 5 5 • Age (if between 16-45) 1 1 • History of preadolescent sexual abuse 3 0 • Psychological disease • Attention deficit disorder, obsessive-compulsive disorder, bipolar, schizophrenia2 2 • Depression1 1 • Scoring Totals • Five-question clinical interview to assess patients • Specifically developed to screen patients with chronic pain who will be using opioids • Quantifies the level of risk for patient • Three risk categories • Low: 0 - 3 points • Moderate: 4 - 7 points • High: 8 points and above Webster LR, Webster RM. Pain Med. 2005;6:432-442.

  28. One Drink: 12 oz Beer = 5 oz Wine = 1.5 oz Liquor (80 proof)

  29. Differences Between a Chronic Pain Patient and an Addicted Patient Pain Patient 1. Not out of control with medications 2. Medications improve quality of life 3. Will want to decrease medication if side effects are present Addicted Patient 1. Out of control with medications 2. Medications cause decreased quality of life 3. Medication continues or increases despite side effects Schnoll SH, Finch J. J Law Med Ethics. 1994;22(3):252-256.

  30. Differences Between a Chronic Pain Patient and an Addicted Patient Pain Patient 4. Concern about the physical problem 5. Follows the agreement for the use of the opioids 6. Frequently has medicinesleft over Addicted Patient 4. Unaware or in denial about any problems 5. Does not follow the agreement for use of the opioids 6. Does not have medicines left over, loses prescriptions, and always has a “story” Schnoll SH, Finch J. J Law Med Ethics. 1994;22(3):252-256.

  31. Federal Regulations for Prescribing a Scheduled Controlled Substance .

  32. Federal vs State Regulations • Health care professionals must comply with both federal and state regulations that govern prescribing a scheduled controlled substance (CS)* • When federal law or regulations differ from state law or regulation, the more stringent rule would apply *Model Policy for the Use of Controlled Substances for the Treatment of Pain. Policy Statement: Federation of State Medical Boards of the United States, Inc; 2004 .

  33. Federal Regulations • May administer, prescribe or dispense a schedule II CS to a person with intractable pain, in which no relief or cure is possible or none has been found after a reasonable effort 21 CFR 1306.07 • This language has served as the basis to define “intractable pain” in state law.

  34. Federal Regulations • May treat acute/chronic pain with a schedule II CS in a recovering narcotic-addicted patient 21 CFR 1306.07 • One must keep good records to document the physician is treating a pain syndrome, not the disease of narcotic addiction

  35. Teamwork With the Dispensing Pharmacist • The pharmacist is a critical link in the chain of medication distribution to the patient, dispensing drugs that are available by prescription only • All prescriptions for opioids should have written on them • Chronic pain patient • Acute pain patient • Patient should use one pharmacy for obtaining their medications • Provide the pharmacist with a copy of the “Agreement For Opioid Maintenance Therapy For Noncancer/Cancer Pain”

  36. Basic Boundary Setting Enhanced Boundary Setting Inform, Set and Enforce Boundaries with Your Patient Based on Mutual Trust and Honesty Consultation with Appropriate Specialist: Example: Addiction Medicine, Mental Health Gourlay D, Heit HA et al. Pain Med. 2005;6(2):107-112.

  37. Inform, Set and Enforce Boundaries with Your Patient Based on Mutual Trust and Honesty Discharge Patient Gourlay D, Heit HA et al. Pain Med. 2005;6(2):107-112.

  38. Conclusion • Health care practitioners can prescribe scheduled controlled substance (CS) approved by the FDA consistent with state and federal regulations to give their patients the best quality of life possible given the reality of their medical condition

  39. Conclusion: Wisdom From Lilly • After placement of the Deep Brain Stimulator on December 19, 2007, I was walking hand in hand with my granddaughter Lilly. She looks up at me and says: • “PopPop you are not crooked any more.” • Visual physical exam • “Your boo boo is getting better!” • Assessment of my pain generator • “That means you can play me with more – right?” • Assessment of my functional activity

  40. “God, grant me the Serenity to accept the things I cannot change; Courage to change the things I can; and the WISDOM to know the difference.” AA Serenity Prayer

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