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Pain & Addiction 2009


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Pain & Addiction 2009

  1. 1. PAIN & ADDICTION Presented by: Stacy Seikel, MD Board Certified Addiction Medicine Board Certified Anesthesiology
  2. 2. DISCLAIMER Stacy Seikel, MD <ul><li>Medical Director, The Center for Drug-Free Living, Inc. , Orlando, FL </li></ul><ul><li>Member: ASAM, FSAM, AMA, FMA, OCMS </li></ul><ul><li>Officer/ Board Position: FSAM/OCMS </li></ul><ul><li>Board Certified, Addiction Medicine, Anesthesiology </li></ul><ul><li>Medical Review Officer (MRO) </li></ul><ul><li>Speakers Bureau: Reckitt Benckiser, Forrest, Alkermes </li></ul><ul><li>Some slides borrowed from Reckitt Benckiser, Sanford Silverman, MD, Berndt Wollschlaeger, MD </li></ul>
  3. 3. OBJECTIVES <ul><li>Discuss Pain and Addiction as co-morbid disease states </li></ul><ul><li>Discuss Epidemiology of Prescription Drug Abuse </li></ul><ul><li>Discuss methadone and buprenorphine and their roles in pain and addiction medicine </li></ul>
  4. 4. <ul><li>Pain and Addiction as Disease States </li></ul>
  5. 5. PAIN <ul><li>DEFINITION : an unpleasant sensory & </li></ul><ul><li>emotional experience associated with actual </li></ul><ul><li>tissue damage or described in terms of such </li></ul><ul><li>damage. </li></ul>
  6. 6. Analgesia and the Pain Pathway Adapted from Gottschalk A, Smith DS. Am Fam Physician. 2001;63:1979-84. Descending modulation Dorsal horn Ascending signals input Spinothalamic tract Dorsal root ganglion Peripheral nerve Peripheral nociceptors Pain Trauma Local anesthetics Opioids  2 agonists Opioids  2 agonists Centrally acting analgesics COX-2–specific inhibitors Traditional NSAIDs Local anesthetics AEDs Local anesthetics Corticosteroids Traditional NSAIDs Cox-2–specific inhibitors Substance P inhibitors Opioids Baclofen Clonidine Adapted from Gottschalk A, Smith DS. Am Fam Physician. 2001;63:1979-84. Adapted from Gottschalk A, Smith DS. Am Fam Physician. 2001;63:1979-84. Adapted from Gottschalk A, Smith DS. Am Fam Physician. 2001;63:1979-84. Adapted from Gottschalk A, Smith DS. Am Fam Physician. 2001;63:1979-84.
  7. 7. Opioid Dependence (DSM-IV) – AKA Addiction (3 or more within one year) <ul><li>Tolerance </li></ul><ul><li>Withdrawal </li></ul><ul><li>Larger amounts/longer period than intended </li></ul><ul><li>Inability to/persistent desire to cut down or control </li></ul><ul><li>Increased amount of time spent in activities necessary to </li></ul><ul><li>obtain opioids </li></ul><ul><li>Social, occupational and recreational activities given up or reduced </li></ul><ul><li>Opioid use is continued despite adverse consequences </li></ul>
  8. 8. Addiction <ul><li>… a primary, chronic, neurobiological disease, with genetic, psychosocial, and environmental factors influencing the development and manifestations. It is characterized by behaviors that include one or more of the following: </li></ul><ul><li>Impaired control over drug use </li></ul><ul><li>Compulsive use </li></ul><ul><li>Continued use despite harm </li></ul><ul><li>Craving </li></ul><ul><li>(ASAM, 2001) </li></ul>
  9. 10. What Addiction Isn’t: Physical Dependence <ul><li>Pharmacologic effect characteristic of opioids </li></ul><ul><li>Withdrawal or abstinence syndrome manifest on abrupt discontinuation of medication or administration of antagonist </li></ul><ul><li>Assumed to be present with regular opioid use for days-to-weeks </li></ul><ul><li>Becomes a problem if: </li></ul><ul><ul><li>Opioids not tapered when pain resolves </li></ul></ul><ul><ul><li>Opioids are inappropriately withheld </li></ul></ul>
  10. 11. What Addiction Isn’t: Tolerance <ul><li>Pharmacologic effect characteristic of opioids </li></ul><ul><li>Need to increase dose to achieve the same effect or diminished effect from same dose </li></ul><ul><li>Tolerance to various opioid effects occurs at differential rates </li></ul><ul><li>Tolerance to non-analgesic effects often beneficial to patients (sedation, respiratory depression) </li></ul><ul><li>Analgesic tolerance is rarely the dominant factor in the need for opioid </li></ul><ul><li>Patients requiring dose escalation most often have a change in pain stimulus (disease progression, infection, etc.) </li></ul>(Foley, 1991)
  11. 12. Addiction <ul><li>Compulsive Use </li></ul><ul><li>Loss of control </li></ul><ul><li>Continued use despite adverse consequences </li></ul>
  12. 13. “ Pseudo-Addiction” <ul><li>Pattern of drug seeking behavior of pain patients receiving inadequate pain management that can be mistaken for addiction </li></ul><ul><ul><li>Cravings and aberrant behavior </li></ul></ul><ul><ul><li>Concerns about availability </li></ul></ul><ul><ul><li>“ Clock-watching” </li></ul></ul><ul><ul><li>Unsanctioned dose escalation </li></ul></ul><ul><li>Resolves with reestablishing analgesia </li></ul>Weissman, DE, Haddox, JD. Opioid pseudo addiction-an latrogenic syndrome. Pain 1989, 36-363.
  13. 14. What is the Risk of Addiction and Aberrant Behavior? <ul><li>Boston collaborative Drug Surveillance Project: Porter and Jick, 1980. NEJM. </li></ul><ul><ul><li>4 cases of addiction in 11,882 patients with no prior history of abuse who received opioids during inpatient hospitalization. </li></ul></ul><ul><li>Dunbar and Katz, 1996, JPSM . </li></ul><ul><ul><li>20 patients with both chronic: pain and substance abuse problems on chronic opioid therapy </li></ul></ul><ul><ul><li>Nine out of 20 abused medication </li></ul></ul><ul><ul><li>Of the 11 who did not abuse the medications, all were active in recovery programs with good family support </li></ul></ul>
  14. 15. 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 Kafz Where is your patient ?
  15. 16. Differential Diagnosis of Aberrant Drug-Taking Attitudes and Behavior <ul><li>Addiction </li></ul><ul><li>Pseudo-addiction (inadequate analgesia) </li></ul><ul><li>Other psychiatric diagnosis </li></ul><ul><ul><li>Encephalopathy </li></ul></ul><ul><ul><li>Borderline personality disorder </li></ul></ul><ul><ul><li>Depression </li></ul></ul><ul><ul><li>Anxiety </li></ul></ul><ul><li>Criminal Intent </li></ul>(Passik & Portenoy 1996)
  16. 17. Aberrant Drug-taking Behaviors: The Model <ul><li>Probably more predictive </li></ul><ul><ul><li>Selling prescription drugs </li></ul></ul><ul><ul><li>Prescription forgery </li></ul></ul><ul><ul><li>Stealing or borrowing another patient’s drugs </li></ul></ul><ul><ul><li>Injecting oral formulation </li></ul></ul><ul><ul><li>Obtaining prescription drugs from non-medical sources </li></ul></ul><ul><ul><li>Concurrent abuse of related illicit drugs </li></ul></ul><ul><ul><li>Multiple unsanctioned dose escalations </li></ul></ul><ul><ul><li>Recurrent prescription losses </li></ul></ul><ul><li>Probably less predictive </li></ul><ul><ul><li>Aggressive complaining about need for higher doses </li></ul></ul><ul><ul><li>Drug hoarding during periods of reduced symptoms </li></ul></ul><ul><ul><li>Requesting specific drugs </li></ul></ul><ul><ul><li>Acquisition of similar drugs </li></ul></ul><ul><ul><li>Unsanctioned dose escalation 1-2 times </li></ul></ul><ul><ul><li>Unapproved use of the drug to treat another symptom </li></ul></ul><ul><ul><li>Reporting psychic effects not intended by the clinician </li></ul></ul>Passik and Portency, 1998
  17. 18. Opioid Addiction <ul><li>Opioid addiction is a chronic, progressive, relapsing medical condition </li></ul><ul><li>Profound neurobiologic changes accompany the transition from opioid use to opioid addiction </li></ul><ul><li>Pharmacologic treatments are effective in normalizing the neurobiologic status, decreasing illicit opioid use, medical and social complications </li></ul>
  18. 19. <ul><li>High risk </li></ul><ul><li>Costs </li></ul><ul><li>Prescription abuse </li></ul><ul><li>Morbidity & Mortality </li></ul>The Nexus Of Pain And Addiction Is A Major Contributor To Current Epidemic Addiction Pain
  19. 20. <ul><li>Epidemiology: </li></ul><ul><li>Pain, Prescription Opioid Abuse </li></ul>
  20. 21. PAIN FACTS <ul><li>Pain costs $150 billion annually </li></ul><ul><li>65 Million Americans suffer painful disability </li></ul><ul><li>90% of all diseases noticed due to pain </li></ul><ul><li>Untreated pain results in unemployment </li></ul><ul><li>Untreated pain associated with alcohol and medication abuse </li></ul><ul><li>90% of patients in US pain clinics are taking opioid analgesics </li></ul>
  21. 22. Factors Responsible For Increased Demand In Managing Chronic Pain <ul><li>Pharmaceutical companies marketing </li></ul><ul><li>Numerous organizations providing guidelines </li></ul><ul><li>Patient advocacy groups </li></ul><ul><li>Enactment of Patient’s bill of rights in many states </li></ul><ul><li>Unproven regulations by JCAHO misunderstood by media and public </li></ul><ul><li>Perceived patient’s right to pain relief </li></ul><ul><li>Increased availability to internet </li></ul><ul><li>“ Pill Mills” </li></ul><ul><li>High street value of prescription drugs </li></ul><ul><li>Perceived legitimacy and safety prescription drugs (pharm parties) </li></ul>
  22. 23. Prescription Opioid Abuse <ul><li>Has always existed </li></ul><ul><li>Recent explosive increase parallels that of demand for pain management </li></ul><ul><li>Paradigm shift in 1990’s to aggressively treat pain </li></ul><ul><li>Pain is the 5th vital sign </li></ul><ul><li>Epidemic is the byproduct of compassion and fundamental lack of understanding of complex nature of pain and nexus of chemical dependency (addiction) </li></ul>
  23. 24. Drug Diversion <ul><li>Doctor shopping </li></ul><ul><li>Internet sales </li></ul><ul><li>Drug theft </li></ul><ul><li>Improper prescribing </li></ul><ul><li>Sharing amongst family and friends </li></ul><ul><li>Diversion and abuse of methadone </li></ul>
  24. 25. Prescription Opioid Abuse Is a Significant and Costly Public Health Problem Birnbaum HG et al. Clin J Pain . 2006;22:667-676. Total cost of prescription opioid abuse in the United States was $8.6 billion in 2001 and continues to grow. Health Care 30% Workplace 53% Criminal Justice 17% $4.6 billion $1.4 billion $2.6 billion
  25. 26. Annual Numbers of New Nonmedical Users of Pain Relievers, by Age at Initiation: 1965-2003, SAMHSA
  26. 27. Drug Mortality Rate, Source, and Misuse of Prescription Drugs: Data from the 2002, 2003, and 2004 National Surveys on Drug Use and Health, SAMHSA
  27. 28. Increase in New Starts of Prescription Opioid Abuse Among Teenagers Adapted from Manchikanti L. Pain Physician . 2006;9:287-321. 700 600 500 400 300 200 100 0 Percent Increase 1992 2003 542% —Incidence of new starts of prescription opioid abuse among teenagers 150% —Prescriptions written for controlled substances 14% —US population 212% ----Number of 12-17 year olds abusing CS 81% ---Adults abusing controlled substances
  28. 29. Past Year Users of Selected Drugs (Prevalence), Including Nonmedical Users of Prescription Psychotherapeutic Drugs: Annual Averages Based on 2002-2004 SAMHSA
  29. 30. Past Year Initiates (Incidence) of Illicit Drug Use, by Drug: Annual Averages Based on 2002-2004 (12 or older, 2002-2004) SAMHSA
  30. 31. Annual number of new non-medical users of Oxycontin
  31. 32. Drug-Related Emergency Department Visits With Nonmedical Use of Opioid Analgesics (DAWN) Adapted from the Drug Abuse Warning Network. DHHS Publication No. 07-4256, 2007. Total = 598,542 Narcotic analgesics alone = 160,363 <ul><li>1 out of 3 visits were from nonmedical use of opioid analgesics in 2005. </li></ul><ul><li>Of these, oxycodone and hydrocodone account for about 60%. </li></ul>Methadone Fentanyl Hydrocodone Morphine 51,225 (32%) 42,810 (26.7%) 15,183 (9.5%) 41,216 (25.7%) 9,160 (5.7%) Oxycodone
  32. 33. DAWN Comparison 2004 V. 2005 Adapted from the Drug Abuse Warning Network. DHHS Publication No. 07-4256, 2007.
  33. 34. Role of Physicians in Prescription Drug Abuse <ul><li>The 5 D’s </li></ul><ul><li>Dated : doctors who have not kept up with standards of practice </li></ul><ul><li>Duped : doctors easily manipulated by addicts, perhaps of difficulty in confronting patients, pride </li></ul><ul><li>Disabled : doctors who are impaired by illness or chemical dependency </li></ul><ul><li>Dishonest : doctors who willfully prescribe and use their licenses to deal drugs </li></ul><ul><li>Denial : doctors who refuse to admit that they are wrong, “I know what I am doing” </li></ul>Principles of Addiction Medicine, 3 rd Ed, 2005
  34. 35. CASA (The National Center on Addiction and Substance Abuse at Columbia University) 2005 0f 979 physicians <ul><li>Lack of Awareness </li></ul><ul><li><20% received any medical school training in identifying prescription drug diversion </li></ul><ul><li><40% received any training in medical school in identifying prescription drug abuse and addiction </li></ul><ul><li>Inadequate Risk Management </li></ul><ul><li>43% do not ask about prescription drug abuse as part of patient history </li></ul><ul><li>33% do not request records from previous health care providers for new patients </li></ul><ul><li>Inadequate Treatment of Patients </li></ul><ul><li>74% have not prescribed a controlled substance due to concern about patient abuse in the past year </li></ul>
  36. 37. Guidelines and Prescribing Principles for Opioid Therapy
  37. 38. <ul><li>PAIN MANAGEMENT </li></ul><ul><li>≠ </li></ul><ul><li>OPIOID DISPENSING </li></ul>
  38. 39. Universal Precautions in Pain Medicine <ul><li>1. Diagnosis with appropriate differential </li></ul><ul><li>2. Psychological assessment including risk of addictive disorders </li></ul><ul><li>3. Informed consent (verbal v. written/signed) </li></ul><ul><li>4. Treatment agreement (verballv.written/signed) </li></ul><ul><li>5. Pre/Post Intervention Assessment of Pain Level and Function </li></ul>Heit, Gourlay, Pain Medicine; 6,2005. Universal Precautions in Pain Medicine:A Rational Approach to the Treatment of Chronic Pain
  39. 40. Universal Precautions in Pain Medicine (cont’d) <ul><li>6. Appropriate trial of opioid therapy +/- adjunctive medication </li></ul><ul><li>7. Reassessment of pain score and level of function </li></ul><ul><li>8. Regularly assess the “Four A’s” of pain medicine : Analgesia, Activity, Adverse reactions, Aberrant behavior </li></ul><ul><li>9. Periodically review pain diagnosis and co-morbid conditions, including addictive disorders </li></ul><ul><li>10. Documentation </li></ul>
  40. 41. Assessment Benefit-Risk: New Paradigms in Chronic Pain Treatment GOOD PRACTICE <ul><li>Goal of therapy is pain relief and improved function </li></ul><ul><li>Predictable </li></ul><ul><li>pharmacokinetics </li></ul><ul><li>Evaluate interaction </li></ul><ul><li>with alcohol </li></ul><ul><li>Long vs short acting </li></ul><ul><li>Level of difficulty to alter </li></ul><ul><li>delivery system </li></ul><ul><li>Street value </li></ul>Efficacy Abuse Potential Safety
  41. 42. Establish Treatment Goals <ul><li>Set realistic patient expectations for analgesia and functionality </li></ul><ul><ul><li>Smart goals </li></ul></ul><ul><ul><ul><li>Realistic pain control </li></ul></ul></ul><ul><ul><ul><li>Improved functionality and productivity </li></ul></ul></ul><ul><ul><ul><li>Improved quality of life </li></ul></ul></ul><ul><ul><li>Concomitant physical therapy to improve treatment outcomes </li></ul></ul><ul><li>Commit the patient to routine evaluation of treatment outcomes </li></ul><ul><ul><li>Pain relief </li></ul></ul><ul><ul><li>Physical and psychosocial function </li></ul></ul><ul><li>Commit the patient to monitoring and routine follow-up </li></ul>Adapted from Trescot AM et al. Pain Physician. 2006;9:1-40. X “ High” (Euphoria) Pain Control
  42. 43. Return Periodically and Review Outcomes Adapted from Trescot AM et al. Pain Physician. 2006;9:1-40. <ul><li>Stable doses </li></ul><ul><li>Analgesia: decreased pain level (pain score) </li></ul><ul><li>and increased level of function in </li></ul><ul><li>postintervention reassessment </li></ul><ul><li>No evidence or suspicion of abuse </li></ul><ul><li>No unmanageable side effects </li></ul><ul><li>Improved activity and quality of life </li></ul>Success—continue therapy <ul><li>Despite dose escalation or switching </li></ul><ul><li>to other opioids </li></ul><ul><li>Inadequate analgesia </li></ul><ul><li>Inadequate improvement in function </li></ul><ul><li>Intolerable side effects </li></ul><ul><li>Abuse </li></ul><ul><li>Noncompliance </li></ul>Failure—discontinue therapy Review comorbidities and pain diagnosis periodically
  43. 44. PAIN MANAGEMENT = RATIONAL POLYPHARMACY Ongoing PT, Psych, interventional mgt.
  44. 45. Buprenorphine and Methadone use in pain and addiction medicine.
  45. 46. Substance Abuse <ul><li>Nearly 1/3 of the US population has </li></ul><ul><li>used illicit drugs and an estimated 6- </li></ul><ul><li>15% have a substance use disorder </li></ul><ul><li>or some type. </li></ul><ul><li>Substance Abuse and Mental Health Administration, 2007 </li></ul>
  46. 47. <ul><li>Problem </li></ul><ul><li>Pain and Addiction CAN coexist </li></ul><ul><li>SO DOES Pain and Depression (reduced hedonic tone) </li></ul><ul><li>Addiction in General Population (6-15%) </li></ul><ul><li>Varies with the drug, gender, economic status, race </li></ul><ul><li>Addiction in Chronic Pain Population </li></ul><ul><li>Probably increased (at least 15%) </li></ul><ul><li>We use the same terms, with different meaning </li></ul><ul><li>Lack of precision in definitions around </li></ul><ul><li>abuse/dependency/addiction </li></ul>Pain and Addiction
  47. 48. Addiction - a side effect of opiate analgesic therapy? <ul><li>Published rates of abuse and/or addiction in chronic pain populations are < 10%* </li></ul><ul><li>Suggests that known risk factors for abuse or addiction in the general population would be good predictors for problematic prescription opioid use </li></ul><ul><ul><li>History of early substance use </li></ul></ul><ul><ul><li>Personal/family history of substance abuse </li></ul></ul><ul><ul><li>Co-morbid psychiatric disorders </li></ul></ul>Fishbain, 1992, 1996
  48. 49. Correlates of analgesic abuse in chronic pain patients with a history of addiction <ul><li>Absence of family support </li></ul><ul><li>Lack of 12-step involvement </li></ul><ul><li>Recent history of polysubstance abuse (not alcohol abuse alone) </li></ul><ul><li>Previous history of chronic opioid therapy </li></ul><ul><li>Failure in improvement of pain symptoms (Dunbar & Katz, 1996) </li></ul>
  49. 50. <ul><li>Little evidence to suggest that a patient with CNMP who is responsive to opioid therapy is at increased risk for patterns of “problematic” prescription opioid use </li></ul><ul><li>An individual with chronic pain AND untreated addictive disease WILL NOT get better with opioid prescription </li></ul>Pain and Chemical Dependency (Addiction) Risk of addiction? Compton, P; ASAM 2005
  50. 51. The rationale for opioid therapy
  51. 52. Analgesic Choices for Chronic Pain: Opioids <ul><li>Treat moderate to severe pain </li></ul><ul><li>No ceiling effect </li></ul><ul><li>No major organ dysfunction </li></ul><ul><li>Generally manageable side effects </li></ul>
  52. 53. Incidence of Adverse Events of Opioids <ul><li>No evidence of major organ dysfunction </li></ul><ul><li>Constipation is most persistent side effect </li></ul><ul><li>Evidence suggests development of tolerance to sedative and cognitive effects </li></ul>
  53. 54. PHARMACOTHERAPY WEAK OPIOID ANALGESICS <ul><li>codeine </li></ul><ul><li>hydrocodone (Vicoden) </li></ul><ul><li>oxycodone (Percocet) </li></ul><ul><li>propoxyphene (Darvocet) </li></ul><ul><li>tramadol (Ultram, Ultracet) </li></ul>
  54. 55. PHARMACOTHERAPY STRONG OPIOIDS <ul><li>Agonists </li></ul><ul><li>Morphine </li></ul><ul><li>Oxycodone </li></ul><ul><li>Methadone </li></ul><ul><li>Meperidine </li></ul><ul><li>Hydromorphone </li></ul><ul><li>Fentanyl </li></ul><ul><li>Sufentanil </li></ul><ul><li>Mixed agonists -antagonists </li></ul><ul><li>Pentazocine </li></ul><ul><li>Nalbuphine </li></ul><ul><li>Butorphanol </li></ul><ul><li>Partial agonist </li></ul><ul><li>Buprenorphine </li></ul>
  55. 56. Federal laws governing addiction treatment
  56. 57. Methadone and Pain <ul><li>Methadone may be prescribed for the treatment of pain in any patient </li></ul><ul><li>This includes pain patients without addiction and pain patients with a history of addiction </li></ul>
  57. 58. Methadone and Pain <ul><li>Methadone has been used as an effective analgesic agent for decades. New information about NMDA receptor antagonist actions, combined with its relatively low cost, has generated increasing interest for use in pain management. </li></ul><ul><li>The use of methadone as a treatment for addiction has complicated efforts to appropriately position the drug for analgesic therapy. For example, some physicians erroneously believe that a special license is required to prescribe methadone as an analgesic agent. This concern is particularly strong when the patient is receiving MMT and the use of methadone is being considered for pain. </li></ul>
  58. 59. Methadone for Addiction <ul><li>In order to use Methadone for Opioid Addiction Therapy (OAT), one must obtain a special federal license and be affiliated with an opioid addiction treatment program (“methadone clinic”) </li></ul>
  59. 60. Opioid Therapy for the Addicted Patient – Choices <ul><li>Short acting opioids (NOT!!!!) </li></ul><ul><li>Sustained release opioids? </li></ul><ul><li>Methadone </li></ul><ul><li>Buprenorphine </li></ul>
  60. 61. Methadone for pain and addiction <ul><li>Potent mu agonist </li></ul><ul><li>Useful for addiction and pain </li></ul><ul><li>Need federal license for addiction only management </li></ul><ul><li>Composed 50/50 racemic L and D isomer </li></ul><ul><li>L isomer mu agonist </li></ul><ul><li>D isomer inactive but NMDA antagonist </li></ul><ul><li>Long T1/2, good oral bioavailability </li></ul><ul><li>Analgesic T1/2 4-8 hours </li></ul>
  61. 62. Methadone Conversion Ratios <ul><li>Patients with prior morphine experience require a greater reduction in the estimated methadone dose than relatively morphine-naive patients. </li></ul><ul><li>It is not known whether this variability in the estimated dose ratio between morphine and methadone is unidirectional or should also be considered when switching from methadone to morphine. </li></ul>Indelicato RA, Portnoy RK (2002);
  62. 63. Buprenorphine and Pain
  63. 64. Buprenorphine: What is it? <ul><li>Buprenorphine joined methadone, LAAM, and naltrexone as the fourth medication for treating opiate addiction </li></ul><ul><li>May be used off label for pain </li></ul><ul><li>May be particularly effective in patients with pain and addiction </li></ul>
  64. 65. Buprenorphine: Why is it needed? <ul><li>Federal law prohibits physicians from prescribing methadone (or other DEA Schedule II medications) for maintenance therapy or opiate addiction* EXCEPT in a federally licensed opiate treatment program (OTP) (this includes methadone maintenance). </li></ul><ul><li>* There is a difference between detoxification and tapering a non addicted patient off opiates once pain is resolved. </li></ul>
  65. 66. Legislation: DATA 2000 <ul><li>Permits qualified physicians to obtain a waiver to treat opioid addiction with Schedule III, IV, and V opioid medications (or combinations of such medications) </li></ul><ul><ul><li>Medications must be approved by the FDA for that indication </li></ul></ul><ul><ul><li>Medications may be prescribed or dispensed </li></ul></ul>
  66. 67. Legislation: DATA 2000 <ul><li>Medications Approved by FDA 10/8/02 for use in the treatment of Opioid Addiction are: </li></ul><ul><ul><li>Subutex® CIII 2mg, 8mg sublingual tablet </li></ul></ul><ul><ul><ul><li>Buprenorphine </li></ul></ul></ul><ul><ul><li>Suboxone® CIII 2/.5mg, 8/2mg sublingual tablet </li></ul></ul><ul><ul><ul><li>Buprenorphine and Naloxone (4:1 ratio) </li></ul></ul></ul><ul><li>No other opioid agonist or partial agonist medications have been approved </li></ul><ul><li>Methadone is Schedule II </li></ul><ul><li>Buprenorphine is Schedule III </li></ul>
  67. 68. Pharmacology: Partial Opioid Agonists <ul><li>Bind to and activates opiate mu receptor </li></ul><ul><li>Increasing dose does not produce as great an effect as does increasing the dose of a full agonist (less of a maximal effect is possible) </li></ul><ul><li>“ Ceiling effect” on respiratory depression </li></ul><ul><li>Example: buprenorphine </li></ul>
  68. 69. -10 -9 -8 -7 -6 -5 -4 0 10 20 30 40 50 60 70 80 90 100 Intrinsic Activity Log Dose of Opioid Full Agonist (Morphine) Partial Agonist (Buprenorphine) Antagonist (Naloxone) Intrinsic Activity: Full Agonist (Morphine), Partial Agonist (Buprenorphine), Antagonist (Naloxone)
  69. 70. <ul><li>O nset of action: 30 – 60 min utes (after S/L administration) </li></ul><ul><li>P eak effects: 1 – 4 hours </li></ul><ul><li>H alf-life ~24 to 36 hours or longer </li></ul><ul><li>Analgesic half life 4-8 hrs </li></ul>Duration of Action
  70. 71. Buprenorphine/Naloxone Combination (Suboxone®) <ul><li>Addition of naloxone to buprenorphine to decrease abuse potential of tablets </li></ul><ul><li>If taken as medically directed (dissolve under tongue), predominant buprenorphine effect </li></ul><ul><li>If opioid dependent person dissolves tablet and injects, predominant naloxone effect (and precipitated withdrawal) </li></ul>
  71. 72. Safety Overview <ul><li>Highly safe medication (acute and chronic dosing) </li></ul><ul><li>Primary side effects: like other mu agonist opioids (e.g., nausea, constipation), but may be less severe </li></ul><ul><li>No evidence of significant disruption in cognitive or psychomotor performance with buprenorphine maintenance (or with methadone maintenance) </li></ul><ul><li>No evidence of organ damage with chronic dosing with buprenorphine or methadone </li></ul>
  72. 73. Safety <ul><li>Low risk of clinically significant problems </li></ul><ul><li>No reports of respiratory depression in clinical trials comparing buprenorphine to methadone </li></ul><ul><li>Pre-clinical studies suggest high doses of buprenorphine should not produce respiratory depression or other significant problems </li></ul><ul><li>Overdose of buprenorphine combined with other drugs may cause problems (reviewed below) </li></ul><ul><li>Less QT prolongation than methadone </li></ul>
  73. 74. Safety <ul><li>Reports of deaths when buprenorphine injected along with non-medical doses of benzodiazepines </li></ul><ul><ul><li>Reported from France, where buprenorphine-only tablets available: appears patients dissolve and inject tablets </li></ul></ul><ul><li>Probably possible for this to occur with other sedatives as well </li></ul><ul><li>Probably occurs when buprenorphine taken SL with oral benzodiazepines </li></ul>
  74. 75. Acute Pain Management for Patients on Suboxone <ul><li>Ensure some form of maintenance therapy is continued (bup or methadone) </li></ul><ul><li>Maintenance WILL NOT treat acute pain </li></ul><ul><li>Try non-opioid analgesics first </li></ul>
  75. 76. Acute Pain Management <ul><li>Mild – moderate pain, i.e. dental extraction: </li></ul><ul><ul><li>Continue buprenorphine maintenance </li></ul></ul><ul><ul><li>Use short acting opioids (effect may be blocked) </li></ul></ul><ul><li>Moderate – Severe pain i.e. hip replacement </li></ul><ul><ul><li>Discontinue buprenorphine (may “bridge with tramadol </li></ul></ul><ul><ul><li>or 3 days of opiates) </li></ul></ul><ul><ul><li>Treat pain with opioids </li></ul></ul><ul><ul><li>Reinduction with buprenorphine </li></ul></ul>
  76. 77. Buprenorphine and Chronic Pain <ul><li>Is an effective opioid analgesic 30X more potent than morphine </li></ul><ul><li>Ceiling effect on analgesia </li></ul><ul><li>Analgesic t1/2 is shorter than actual (serum) t1/2 hence requires BID-TID dosing </li></ul><ul><li>In US only parental (buprenex) is FDA approved for pain </li></ul>
  77. 78. Can One Use Suboxone ® or Subutex ® for Analgesia? <ul><li>The buprenorphine products Suboxone ® and Subutex ® are the two </li></ul><ul><li>Schedule III narcotic medications currently approved for the treatment </li></ul><ul><li>of opioid dependence under the federal Drug Addiction Treatment Act </li></ul><ul><li>of 2000 (DATA). </li></ul><ul><li>The off-label use of the sublingual formulations of buprenorphine </li></ul><ul><li>(Suboxone,Subutex) for the treatment of acute or chronic pain is not </li></ul><ul><li>prohibited under DEA requirements. </li></ul><ul><li>One does not need a wavier from CSAT but a valid license to prescribe </li></ul><ul><li>schedule III controlled substances. </li></ul>
  78. 79. Thank You.