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Pain Management and Addiction West Coast Symposium on Addictive Disorders La Quinta, CA June 3, 2011 Stephen A. Wyatt, D.O. Middlesex Hospital Middletown,

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Presentation on theme: "Pain Management and Addiction West Coast Symposium on Addictive Disorders La Quinta, CA June 3, 2011 Stephen A. Wyatt, D.O. Middlesex Hospital Middletown,"— Presentation transcript:

1 Pain Management and Addiction West Coast Symposium on Addictive Disorders La Quinta, CA June 3, 2011 Stephen A. Wyatt, D.O. Middlesex Hospital Middletown, CT

2 Outline Identifying the problem with opiates How did it occur? Pain management vs. Opiate Control Introduction The Opiate Problem Nociceptive and Neuropathic Pain Chronic Non-Cancer Pain Different types of pain Definition The danger of long acting opiates Potential for addiction Opiates Assessment Monitoring Red and Yellow flags Identification and Monitoring of Pain & Addiction A way out

3 Case Presentation - PL 57 M,C,♂ 57 M,C,♂ Alcohol related injure at 25 resulting in a hip replacement. Alcohol related injure at 25 resulting in a hip replacement. Injury to his back at 32 resulting in disability. Onset of prescribed opiates Injury to his back at 32 resulting in disability. Onset of prescribed opiates Remained on disability Hospitalized d/t to Klonopin od Vicodin (acetaminophen 500mg, Hydrocodone 5mg) #7 / 6 times a day. Suggested long acting opioid

4 Case Presentation - PL Came for consultation 3/09 Oxycontin 60mg #5 4 time a day

5 Prevalence of Recurrent and Persistent Pain in the US 1 in 4 Americans suffer from recurrent pain (day-long bout of pain/month) 1 in 10 Americans report having persistent pain of at least one year’s duration 1 in 5 individuals over the age of 65 report pain persisting for more than 24 hours in the preceding month – 6 in 10 report pain persisting > 1 year 2 out of 3 US armed forces veterans report having persistent pain attributable to military service – 1 in 10 take prescription medicine to manage pain American Pain Foundation. Accessed March 2010.

6 The Problem of Pain  Costs US economy estimated $100 billion/year  Healthcare  Welfare & disability payments  Lost tax revenue  Lost productivity (work absence)  40 million physician visits annually  Most common reason for medical appointments  Push toward opioid maintenance therapy in non malignant pain National Institutes of Health. New Directions in Pain Research. Sept PA

7 Pain Standards JCAHO – Installs a Quality Standard on pain identification. (2001) JCAHO – Installs a Quality Standard on pain identification. (2001) Strong encouragement to increase the identification and treatment of pain. Strong encouragement to increase the identification and treatment of pain. The development of new and very effective opiates for the treatment of pain. The development of new and very effective opiates for the treatment of pain. The tremendous rise in the prescription of opiates for non-cancer pain. The tremendous rise in the prescription of opiates for non-cancer pain.

8 Trend data: Distribution of prescription opioids, U.S., 2000–2007 Source: DEA, ARCOS system, 2007 GRAMS PER 100K POPULATION * Includes OTPs

9 Deaths per 100,000 related to unintentional overdose and annual sales of prescription opioids by year, Source: Paulozzi, CDC, Congressional testimony, 2007

10 Unintentional drug overdose deaths are rising faster for prescription opioids than for illicit drugs Source: CDC, National Vital Statistics System, 2006

11 New Illicit Drug Use United States, 2006 PCP † Pain Relievers * Tranquilizers Cocaine EcstasyLSD † Marijuana Inhalants StimulantsSedativesHeroin ,112 2,063 2, ,000 1,500 2,000 2,500 New Users (thousands) Substance Abuse and Mental Health Services Administration, Office of Applied Studies National Survey on Drug Use and Health. Department of Health and Human Services Publication No. SMA ; *533,000 new nonmedical users of oxycodone aged ≥ 12 years. Past year initiates for specific illicit drugs among people aged ≥ 12 years. † LSD, lysergic acid diethylamide; PCP, phencyclidine.

12 Medical Use Pain patients seeking more pain relief Pain patients escaping emotional pain Who Misuses/Abuses Opioids and Why? Nonmedical Use Recreational abusers Patients with disease of addiction

13 Total Chronic Pain Population Aberrant Medication Use Behaviors: A spectrum of patient behaviors that may reflect misuse 40% Prescription Drug Misuse 20% Addiction Abuse/Dependence 2-5% Adapted from Passik. APS Resident Course, 2007

14 Where Pain Relievers Were Obtained Most Recent Nonmedical Use among Past Year Users Aged 12 or Older: 2006 Note: Totals may not sum to 100% because of rounding or because suppressed estimates are not shown. 1 The Other category includes the sources: “Wrote Fake Prescription,” “Stole from Doctor’s Office/Clinic/Hospital/Pharmacy,” and “Some Other Way.” Bought/Took from Friend/Relative 14.8% Drug Dealer/ Stranger 3.9% Bought on Internet 0.1% Other 1 4.9% Free from Friend/Relative 7.3% Bought/Took from Friend/Relative 4.9% One Doctor 80.7% Drug Dealer/ Stranger 1.6% Other 1 2.2% Source Where Respondent Obtained Source Where Friend/Relative Obtained One Doctor 19.1% More than One Doctor 1.6% Free from Friend/Relative 55.7% More than One Doctor 3.3%

15 “Doctors are easy to find and they don’t carry guns” Medical Economics  “To stop Rx diversion, the agency (DEA) has hired hundreds of new investigators and expanded it’s local and state task forces”  “Quantity alone…may indicated diversion and trigger an investigation”

16  In 1872, California passed the first anti-opium law.  The administration of laudunum, an opium preparation, or any other narcotic constituted a felony.  In 1881, the California was it a misdemeanor to maintain a place where opium was made available.  Private use was not covered by the legislation.  Same year, California became the first state to establish a separate bureau to enforce narcotic laws, and one of the first states to treat addicts.  Connecticut, in 1874, established the narcotic addict was incompetent to attend to his personal affairs.  The law required that he be committed to a state insane asylum for "medical care and treatment.“  Nevada, in1877, first to make it illegal to sell or dispense opium without a physician's prescription.  Oregon, in 1887, first to pass a comprehensive anti-substance abuse law. History

17 The federal Harrison Narcotic Act was passed in Official title of the Harrison bill had been "An Act to provide for the registration of, with collectors of internal revenuer and to impose a special tax upon all persons who produce, import, manufacture, compound, deal in, dispense, sell, distribute, or give away opium or coca Leaves,* their salts, derivatives or preparations, and for other purposes." After passage of the law, this clause ["in the course of his professional practice only"] was interpreted by law-enforcement officers to mean that a doctor could not prescribe opiates to an addict to maintain his addiction. History

18 Genesis in two statutes of the early 1970s Implemented by regulations from HEW in 1975 Revised by HHS in 1987 (42 CFR Part 2) Congress reaffirmed and reorganized the two statutes into a single act History

19 Model Policy for the Use of Controlled Substances for the Treatment of Pain Federation of State Medical Boards House of Delegates, May Accessed March Federation of State Medical Boards of the United States, Inc

20 FSMB Model Policy Basic Tenets Pain management is important and integral to the practice of medicine Use of opioids may be necessary for pain relief Use of opioids for other than a legitimate medical purpose poses a threat to the individual and society Physicians have a responsibility to minimize the potential for abuse and diversion Physicians may deviate from the recommended treatment steps based on good cause Not meant to constrain or dictate medical decision-making FSMB, Federation of State Medical Boards

21 Pain

22 The challenge is that “treating pain is neither an absolute science nor risk-free” Scott M. Fishman, MD - Anesthesia & Analgesia. 2007;105:8-9 Scott M. Fishman, MD - Anesthesia & Analgesia. 2007;105:8-9

23 Pain Acute Pain Acute Pain Trauma, injury, dental procedures, and labor and delivery Trauma, injury, dental procedures, and labor and delivery Chronic Malignant Pain Chronic Malignant Pain Cancer Cancer Chronic Nonmalignant Pain Chronic Nonmalignant Pain Arthritis, Disc Disease Arthritis, Disc Disease Withdrawal-related Pain Withdrawal-related Pain

24 A. Nociceptive B. Inflammatory C.Neuropathic D.Noninflammatory/ Nonneuropathic Noxious Peripheral Stimuli Peripheral Nerve Damage No Known Tissue or Nerve Damage Abnormal Central Processing Multiple Mechanisms Inflammation Multiple Types of Pain Adapted from Woolf CJ. Ann Intern Med. 2004;140: Chong MS, Bajwa ZH. J Pain Symptom Manage. 2003;25:S4-S11. Patients may experience multiple pain states simultaneously 1 Examples Strains and sprains Bone fractures Postoperative Osteoarthritis Rheumatoid arthritis Tendonitis Diabetic peripheral neuropathy Post-herpetic neuralgia HIV-related polyneuropathy Fibromyalgia Irritable bowel syndrome

25 Pain Perception of pain as a 4-step model Perception of pain as a 4-step model Transduction: Acute stimulation in the form of noxious thermal, mechanical, or chemical stimuli is detected by nociceptive neurons. Transduction: Acute stimulation in the form of noxious thermal, mechanical, or chemical stimuli is detected by nociceptive neurons. Transmission: Nerve impulses transferred via axons of afferent neurons from the periphery to the spinal cord, to the medial and ventrobasal thalamus, to the cerebral cortex Transmission: Nerve impulses transferred via axons of afferent neurons from the periphery to the spinal cord, to the medial and ventrobasal thalamus, to the cerebral cortex Perception: Cortical and limbic structures in the brain are involved in the awareness and interpretation of pain. Perception: Cortical and limbic structures in the brain are involved in the awareness and interpretation of pain. Modulation: Pain can be inhibited or facilitated by mechanisms affecting ascending as well as descending pathways. Modulation: Pain can be inhibited or facilitated by mechanisms affecting ascending as well as descending pathways.

26 The Pain Pathway Transduction – Peripheral Sensory nociceptive Transmission – Ascending spinal interpretation

27 Peripheral nerve stimulation in Pain Nociceptors quality of pain perceived dependent on: Nociceptors quality of pain perceived dependent on: site of stimulation, site of stimulation, nature of the fibres transmitting the sensation. nature of the fibres transmitting the sensation. sharp immediate pain ("first pain") transmitted by A delta fibres, sharp immediate pain ("first pain") transmitted by A delta fibres, prolonged unpleasant burning pain mediated through the smaller unmyelinated C fibres. prolonged unpleasant burning pain mediated through the smaller unmyelinated C fibres. Modulation receptors on their surfaces effect sensitivity to stimulation. Modulation receptors on their surfaces effect sensitivity to stimulation. GABA, GABA, opiate, opiate, bradykinin, bradykinin, histamine, histamine, Serotonin Serotonin capsaicin receptors capsaicin receptors

28 Mediation of transmission of Pain Neurotransmitters mediate transmission of pain in both brain and spinal cord. Excitatory neurotransmitters: Glutamate and tachykinins, act at the various neurokinin receptors including as substance P ('P is for pain'), neurokinin A and neurokinin B, and on other substances that transmit pain impulses from incoming nerves in the dorsal horn. Inhibitory neurotransmitters: gamma amino butyric acid (GABA) most prominent.

29 The Pain Pathway Modulation - Midbrain - Thalamus, - Limbic system Perception - Cerebral Cortex

30 Modulation of Pain Descending Pain Regulation: norepinephrine - alpha-2 stimulatory effects serotonin opiates relieve pain by stimulating mu and delta receptors at a host of sites.

31 Perceived Pain - Suffering At risk patients At risk patients Past history of substance use disorder Past history of substance use disorder Emotionally traumatized Emotionally traumatized Dysfunctional / alcoholic family Dysfunctional / alcoholic family Lacks effective coping skills Lacks effective coping skills Dependent traits Dependent traits Stimulus augmenters-deficit in hedonic tone Stimulus augmenters-deficit in hedonic tone Paul Farnum, MD PHP, BC

32 Vicious Cycle of Uncontrolled Pain Pain Altered Functional Status Decreased Mobility Avoidance Behaviors Social Limitations Diminished Self- Efficacy

33 Does Not Necessarily Equal Chronic Pain Suffering Suffering Ed Salsizt

34 Fine PG, et al. J Support Oncol. 2004;2(suppl 4):5-22. Portenoy RK, et al. In: Lowinson JH, et al, eds. Substance Abuse: A Comprehensive Textbook. 4th ed. Philadelphia, PA: Lippincott, Williams & Wilkins; 2005: Multimodal Treatment Lifestyle Change Exercise, weight loss Strategies for Pain and Associated Disability Pharmacotherapy Opioids, nonopioids, adjuvant analgesics Interventional Approaches Injections, neurostimulation Physical Medicine and Rehabilitation Assistive devices, electrotherapy Psychological Support Psychotherapy, group support Complementary and Alternative Medicine Massage, supplements

35 Considerations What is conventional practice for this type of pain or pain patient? What is conventional practice for this type of pain or pain patient? Is there an alternative therapy that is likely to have an equivalent or better therapeutic index for pain control, functional restoration, and improvement in quality of life? Is there an alternative therapy that is likely to have an equivalent or better therapeutic index for pain control, functional restoration, and improvement in quality of life? Does the patient have medical problems that may increase the risk of opioid-related adverse effects? Does the patient have medical problems that may increase the risk of opioid-related adverse effects? Is the patient likely to manage the opioid therapy responsibly? Is the patient likely to manage the opioid therapy responsibly? Who can I treat without help? Who can I treat without help? Who would I be able to treat with the assistance of a specialist? Who would I be able to treat with the assistance of a specialist? Who should I not treat, but rather refer, if opioid therapy is a consideration? Who should I not treat, but rather refer, if opioid therapy is a consideration? Fine PG, Portenoy RK. Clinical Guide to Opioid Analgesia. Vendome Group, New York, 2007.

36 Non Pharmacologic Interventions  Behavioral Interventions-ie guided imagery, biofeedback  Meditation  Osteopathic Manipulation, Chiropractic, Body work  Acupuncture with or without stimulation  Physical Therapy modalities  Tran-cutaneous Nerve Stimulation  Hypnosis

37 Non-Opiate Approaches Transduction: nonsteroidal anti-inflammatory drugs (NSAIDs) and cyclooxygenase (COX)-2 inhibitors -- target the inflammatory processes Transduction: nonsteroidal anti-inflammatory drugs (NSAIDs) and cyclooxygenase (COX)-2 inhibitors -- target the inflammatory processes Transmission: Local anesthetics, gamma-aminobutyric acid (GABA) agonists, non-N-methylD-asparate (NMDA) antagonists, COX inhibitors, corticosteroids. Transmission: Local anesthetics, gamma-aminobutyric acid (GABA) agonists, non-N-methylD-asparate (NMDA) antagonists, COX inhibitors, corticosteroids. Perception: Influenced by the situation as well as by the individual's experience and culture Perception: Influenced by the situation as well as by the individual's experience and culture Modulation. Antidepressants are useful in treating chronic pain because they increase the availability of serotonin or norepinephrine. in pain-modulating descending pathways. Recent studies identified tapentadol, bicifadine, as effective. Modulation. Antidepressants are useful in treating chronic pain because they increase the availability of serotonin or norepinephrine. in pain-modulating descending pathways. Recent studies identified tapentadol, bicifadine, as effective.

38 There is more to treating pain than Opiates…. but opiates remain important!

39 Opiates

40 Opiates & Opioids Opiates = naturally present in opium  e.g. thebaine, codeine, morphine Opioids = manufactured  Semisynthetics are derived from an opiate  heroin from morphine  buprenorphine from thebaine  Synthetics are completely man-made to work like opiates  methadone

41 Function at Receptors: Full Agonists Mureceptor Full agonist binding …  activates the mu receptor  is highly reinforcing  is the most abused opioid type  includes heroin, methadone, & others

42 Formulation Points to Consider Dose-limiting issues and toxicity with co-analgesics Dose-limiting issues and toxicity with co-analgesics 4 g/day acetaminophen limit 4 g/day acetaminophen limit Importance of titration Importance of titration Risk of overdose, challenges of dose conversion during rotation Risk of overdose, challenges of dose conversion during rotation Pharmacokinetics versus temporal patterns of pain Pharmacokinetics versus temporal patterns of pain Adherence Adherence Cost Cost Convenience Convenience Caregiving issues Caregiving issues

43

44 Medical issues in opioid prescribing Potential benefits Potential benefits Analgesia Analgesia Function Function Quality of life Quality of life Potential risks Toxicity Functional impairment Physical dependence Addiction Hyperalgesia

45 Are opioids effective for CNMP? What do we know? What do we know? What don’t we know? What don’t we know? What don’t we know about: What don’t we know about: Addiction Addiction Chronic pain Chronic pain Effects of long term opioid analgesia Effects of long term opioid analgesia

46 46 Review of opioid efficacy In short-term studies: In short-term studies: Single IV study Single IV study Oral studies ≤ 32 wks Oral studies ≤ 32 wks Both demonstrate that CNMP can be opioid responsive Both demonstrate that CNMP can be opioid responsive

47 47 Review of opioid efficacy (cont.) In long-term studies: In long-term studies: Usually observational – non randomized / poorly controlled Usually observational – non randomized / poorly controlled Treatment durations ≤ 6 years. Treatment durations ≤ 6 years. Patients usually attain satisfactory analgesia with moderate non-escalating doses (≤ 195 mg morphine/d), often accompanied by an improvement in function, with minimal risk of addiction. Patients usually attain satisfactory analgesia with moderate non-escalating doses (≤ 195 mg morphine/d), often accompanied by an improvement in function, with minimal risk of addiction. The question of whether benefits can be maintained over years rather than months remains unanswered. The question of whether benefits can be maintained over years rather than months remains unanswered. Ballantyne JC: Southern Med J 2006; 99(11):

48 Back Pain There has been 423% increase in the expenditure for spine-related narcotic analgesics from 1997 to 2004* There has been 423% increase in the expenditure for spine-related narcotic analgesics from 1997 to 2004* Yet in assessment of health status there has been no significant improvement. Yet in assessment of health status there has been no significant improvement. * JAMA February 13,2008 Vol. 299, No. 6

49 Opioid Hyperalgesia Cellular responses to chronic opioid intake: Cellular responses to chronic opioid intake: an increase in neuropeptides such as dynorphin 11, cholecystokinin, 12 and substance P 13 an increase in neuropeptides such as dynorphin 11, cholecystokinin, 12 and substance P 13 all of which have been demonstrated to enhance pain sensitivity all of which have been demonstrated to enhance pain sensitivity the activation of glial cells, producing inflammatory cytokines and resulting in amplified pain. 14 the activation of glial cells, producing inflammatory cytokines and resulting in amplified pain Vanderah TW, Suenaga NM, Ossipov MH, Malan TP Jr. Lai J. Porreca F. J Neuwsci ;21: Xie JY. Herman DS, Stiller CO. el al. JNeurosci. 2005;25: King T, Gardel) LR. Wang R. et al. Pain. 2005;! 16: Watkins LR. Hutchinson MR, Ledeboer A. Wieseler-Frank J, Milligan ED, Maier SF. Brain Behav linrmin. 2007;2];J

50 Opioid Hyperalgesia Methadone maintenance patients have a reduction in their pain tolerance. 1 Methadone maintenance patients have a reduction in their pain tolerance. 1 Ballantyne NEJM report 2003, review of opioid therapy for chronic pain- “neither safe nor effective” 2 Ballantyne NEJM report 2003, review of opioid therapy for chronic pain- “neither safe nor effective” 2 1. Doverty M, White JM. Somogyi AA, Bochner F. Ali R. Ling W. Pain. 2001:90: Ballantyne JC. Mao J. N Engl J Med. 2003:349:

51 Conclusions as to opioid efficacy Opioids are an essential treatment for some patients with CNMP. Opioids are an essential treatment for some patients with CNMP. They are rarely sufficient They are rarely sufficient They almost never provide total lasting relief They almost never provide total lasting relief They ultimately fail for many They ultimately fail for many They pose some hazards to patients and society They pose some hazards to patients and society It is not possible to accurately predict who will be helped – but those with contraindications are at high risk It is not possible to accurately predict who will be helped – but those with contraindications are at high risk

52 Use of Opiates in Pain Management

53 Positioning Opioid Therapy for Chronic Pain Chronic non-cancer pain: evolving perspective Chronic non-cancer pain: evolving perspective Consider for all patients with severe chronic pain, but weigh the influences Consider for all patients with severe chronic pain, but weigh the influences What is conventional practice? What is conventional practice? Are there reasonable alternatives? Are there reasonable alternatives? What is the risk of adverse events? What is the risk of adverse events? Is the patient likely to be a responsible drug-taker? Is the patient likely to be a responsible drug-taker? Fine PG, Portenoy RK. Clinical Guide to Opioid Analgesia, 2 nd edition, Jovey RD, et al. Pain Res Manag. 2003;8(Suppl A):3A-28A. Eisenberg E, et al. JAMA. 2005;293: Gilron I, et al. N Engl J Med. 2005;352:

54 Treatment goals in managing CNMP:  Improve patient functioning  Identify and eliminate positive reinforcers  Increase physical activity  Avoid opioid misuse and other drug use The goal is NOT pain eradication!

55 Chronic Opioid Therapy Guidelines and Treatment Principles Patient Selection Patient Selection and Risk Stratification ( ) Initial Patient Assessment Informed Consent and Opioid Management Plans ( ) High-Risk Patients ( ) Alternatives to Opioid Therapy Use of Psycho- therapeutic Cointerventions (9.1) Comprehensive Pain Management Plan Driving and Work Safety (10.1) Identifying a Medical Home* and When to Obtain Consultation ( ) Chou R, et al. J Pain. 2009;10: *Clinician accepting primary responsibility for a patient’s overall medical care.

56 Chronic Opioid Therapy Guidelines and Treatment Principles (cont) Trial of Opioid Therapy Initiation and Titration of Chronic Opioid Therapy ( ) Methadone (4.1) Opioids and Pregnancy (13.1) Patient Reassessment Monitoring ( ) Dose Escalations, High-Dose Opioid Therapy, Opioid Rotation, Indications for Discontinuation of Therapy ( ) Opioid Policies (14.1) Implement Exit Strategy Opioid-Related Adverse Effects (8.1) Continue Opioid Therapy Monitoring ( ) Breakthrough Pain (12.1) Chou R, et al. J Pain. 2009;10: *Clinician accepting primary responsibility for a patient’s overall medical care.

57 Initial Visits Initial comprehensive evaluation Risk assessment Prescription monitoring assessment Urine drug test Opioid treatment agreement Opioid consent form Patient education

58 Principles of Responsible Opioid Prescribing Patient Evaluation Patient Evaluation Pain assessment and history Pain assessment and history Directed physical exam Directed physical exam Review of diagnostic studies Review of diagnostic studies Analgesic and other medication history Analgesic and other medication history Personal history of illicit drug use or substance abuse Personal history of illicit drug use or substance abuse Personal history of psychiatric issues Personal history of psychiatric issues Family history of substance abuse/psychiatric problems Family history of substance abuse/psychiatric problems Assessment of comorbidities Assessment of comorbidities Accurate record keeping Accurate record keeping Fine PG, Portenoy RK. Clinical Guide to Opioid Analgesia, 2nd edition, 2007.

59 A maladaptive pattern of substance use, leading to clinically significant impairment or distress, as manifested by three (or more) of the following, occurring at any time in the same 12-month period: 1. Tolerance, as defined by either of the following: a) a need for markedly increased amounts of the substance to achieve intoxication or the desired effect, or b) markedly diminished effect with continued use of the same amount of the substance 2. Withdrawal, as manifested by either of the following: a) the characteristic withdrawal syndrome for the substance, or b) the same (or closely related) substance is taken to relieve or avoid withdrawal symptoms DSM-IV Criteria for Opioid Dependence

60 3. The substance is often taken in larger amounts or over a longer period than was intended 4. There is a persistent desire or unsuccessful efforts to cut down or control substance use 5. A great deal of time is spent in activities necessary to obtain the substance, use the substance, or recover from its effects 6. Important social, occupational, or recreational activities are given up or reduced because of substance use 7. The substance use is continued despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance DSM-IV Criteria for Opioid Dependence

61  Control (loss of)  Compulsion to use  Consequences (continued use despite negative consequences – family, occupational/educational, legal, psychological, medical )  Craving Characteristics of Addiction: The 4 “Cs”

62 Nomenclature in Pain Treatment  Tolerance  Decreased effect over time  Physical Dependence  Withdrawal symptoms upon discontinuation  Addiction  Impaired control, compulsive use, continued use in spite of negative consequences  Pseudo Addiction  Behavior surrounding obtaining adequate pain meds  Pseudo Tolerance  Worsening of underlying condition

63 Identifying Who Is at Risk for Opioid Abuse and Diversion Predictive tools Predictive tools Aberrant behaviors Aberrant behaviors Urine drug testing Urine drug testing Prescription monitoring Prescription monitoring programs programs Severity and duration of pain Severity and duration of pain Pharmacist communication Pharmacist communication Family and friends Family and friends Patients Patients

64 Risk Assessment Tools Addiction Severity Index (ASI) Assess current and lifetime substance-use problems and prior treatment Drug Abuse Screening Test (DAST-10) Screen for probably drug abuse or dependence Addiction Behaviors Checklist (ABC) Evaluate and monitor behaviors indicative of addiction related to prescription opioids in patients with chronic pain Passik SD, Squire P. Pain Med. 2009;10 Suppl 2:S

65 Risk Assessment Tools (cont) Screening Instrument for Substance Abuse Potential (SISAP) Identify individuals with possible substance-abuse history Opioid Risk Tool (ORT) Predict which patients might develop aberrant behavior when prescribed opioids for chronic pain Diagnosis, Intractability, Risk, Efficacy (DIRE) g Predict the analgesic efficacy of, and patient compliance to, long-term opioid treatment in the primary care settin g Passik SD, Squire P. Pain Med. 2009;10 Suppl 2:S

66 Risk Assessment Tools (cont) Screener and Opioid Assessment for Patients with Pain- Revised (SOAPP-R) Screener and Opioid Assessment for Patients with Pain- Revised (SOAPP-R) Predict aberrant medication-related behaviors in patients with chronic pain considered for long-term opioid therapy Predict aberrant medication-related behaviors in patients with chronic pain considered for long-term opioid therapy Empirically-derived, 24-item self-report questionnaire Empirically-derived, 24-item self-report questionnaire Reliable and valid Reliable and valid Less susceptible to overt deception than past version Less susceptible to overt deception than past version Scoring:  18 identifies 90% of high-risk patients Scoring:  18 identifies 90% of high-risk patients Passik SD, Squire P. Pain Med. 2009;10 Suppl 2:S Butler SF, et al. J Pain. 2008;9:

67 Opioid Risk Tool  5-item initial risk assessment  Stratifies risk into low (6%), moderate (28%) and high (91%)  Family History  Personal History  Age  Preadolescent sexual abuse  Past or current psychological disease  Webster, Webster. Pain Med. 2005

68

69 Mark each box that applies FemaleMale 1.Family history of substance abuse –Alcohol –Illegal drugs –Prescription drugs  1  2  4  3  4 2.Personal history of substance abuse –Alcohol –Illegal drugs –Prescription drugs  3  4  5  3  4  5 3.Age (mark box if years)  1 4.History of preadolescent sexual abuse  3  0 5.Psychological disease –ADD, OCD, bipolar, schizophrenia –Depression  2  1  2  1 ORT Validation Exhibits high degree of sensitivity and specificity 94% of low-risk patients did not display an aberrant behavior 91% of high-risk patients did display an aberrant behavior N = 185 ADD, attention deficit disorder; OCD, obsessive-compulsive disorder. Webster LR, Webster RM. Pain Med. 2005;6:

70 Source: Journal of Pain, The 2009; 10: e22 (DOI: /j.jpain )Journal of Pain, The 2009; 10: e22 Copyright © 2009 American Pain Society Terms and ConditionsTerms and Conditions

71 SOAPP Mr. Jackson’s Score = 3 To score the SOAPP, add ratings of all questions. A score of 4 or higher is considered positive Sum of Questions SOAPP Indication  4 4 + < 4- Name:_________________ Date:___________ The following survey is given to all patients who are on or being considered for opioids for their pain. Please answer each question as honestly as possible. This information is for our records and will remain confidential. Your answers will not determine your treatment. Thank you. Please answer the questions below using the following scale: 0 = Never, 1 = Seldom, 2 = Sometimes, 3 = Often, 4 = Very Often 1. How often do you have mood swings? 2. How often do you smoke a cigarette within an hour after you wake up? 3. How often have you taken medication other than the way that it was prescribed? 4. How often have you used illegal drugs (for example, marijuana, cocaine, etc.) in the past five years? 5. How often in your lifetime have you had legal problems or been arrested? Please include any additional information you wish about the above answers. Thank you Chris Jackson 9/16/09 О О

72 Risk Assessment Tools (cont) Pain Medication Questionnaire (PMQ) Assess risk for opioid medication misuse in patients with chronic pain Current Opioid Misuse Measure (COMM) Periodically monitor aberrant medication-related behaviors in patients with chronic pain currently on opioid therapy

73 Principles of Responsible Opioid Prescribing Drug selection, route of administration, dosing/dose titration Managing adverse effects of opioid therapy Assessing outcomes Written agreements in place outlining patient expectations/responsibilities Consultation as needed Periodic review of treatment efficacy, side effects, aberrant drug-taking behaviors

74 74 Initiation of opioid therapy Is there a clear diagnosis? Is there a clear diagnosis? Is there documentation of an adequate work-up? Is there documentation of an adequate work-up? Is there impairment of function? Is there impairment of function? Has non-opioid multimodal therapy failed? Has non-opioid multimodal therapy failed? Have contraindications been ruled out? Have contraindications been ruled out? Begin opioid therapy: Document Document Monitor Monitor Avoid poly-pharmacy Avoid poly-pharmacy

75 Medical Records Maintain accurate, complete, and current records Maintain accurate, complete, and current records Medical Hx & PE Medical Hx & PE Diagnostic, therapeutic, lab results Diagnostic, therapeutic, lab results Evaluations/consultations Evaluations/consultations Treatment objectives Treatment objectives Discussion of risks/benefits Discussion of risks/benefits Tx and medications Tx and medications Instructions/agreements Instructions/agreements Periodic reviews Periodic reviews Discussions with and about patients Discussions with and about patients Fishman SM. Pain Med. 2006;7: Federation of State Medical Boards of the United States, Inc. Model Policy for the Use of Controlled Substances for the Treatment of Pain

76 Marcus DA. Am Fam Physician. 2000;61(5): Initiation of Therapy for Chronic Pain

77 Monitoring Chronic Pain Review of Efficacy of Therapy Marcus DA. Am Fam Physician. 2000;61(5):

78 Opioid Treatment Agreement Accessed March 2010.

79 79 Opiate management of pain A trial (6 mo±) generally is safe A trial (6 mo±) generally is safe (IF contraindications are ruled out) Opiate use and decreased activity results in a worsened condition. Opiate use and decreased activity results in a worsened condition. Push functional restoration, exercises Push functional restoration, exercises Make increased drugs contingent on increased activity Make increased drugs contingent on increased activity

80 Monitoring: Regularly assess the 5 A’s: Regularly assess the 5 A’s: Analgesia Analgesia Adverse effects Adverse effects Activity / function Activity / function Aberrant behaviors Aberrant behaviors Affect Affect

81 Treating the Addicted Patient in Pain

82  These patients suffer thrice:  from the painful disease  from the addiction, which makes pain management difficult  from the health care provider’s ignorance Pain Treatment in Patients with an Addiction

83 Must consider:  High tolerance to medications  Low pain threshold  High risk for relapse  Pain treatment  Inadequate pain treatment  Psychological status

84  Search for physical causes  Identify and address possible non-pain sustaining factors  Address and improve functional status  Treat associated symptoms, if indicated  Case management Pain Treatment in Patients with an Addiction

85  Address addiction  Use non-pharmacologic approaches, if effective  Use non-opioid analgesics, if effective  Provide effective opioid doses, if needed  Treat associated symptoms, if indicated  Address addiction

86 Identifying and Managing Abuse and Diversion Assessing risk and aberrant behaviors Assessing risk and aberrant behaviors Performing scheduled and random UDTs Performing scheduled and random UDTs Utilization of PMPs Utilization of PMPs Assessing stress and adequacy of pain control Assessing stress and adequacy of pain control Developing good communication with pharmacists Developing good communication with pharmacists Receiving input from family, friends, and other patients Receiving input from family, friends, and other patients

87 Differential Diagnosis of Aberrant Drug-Taking Attitudes and Behavior Addiction (out-of-control, compulsive drug use) Addiction (out-of-control, compulsive drug use) Pseudoaddiction (inadequate analgesia) Pseudoaddiction (inadequate analgesia) Other psychiatric diagnosis Other psychiatric diagnosis Organic mental syndrome (confused, stereotyped drug-taking) Organic mental syndrome (confused, stereotyped drug-taking) Personality disorder (impulsive, entitled, chemical-coping behavior) Personality disorder (impulsive, entitled, chemical-coping behavior) Chemical coping (drug overly central) Chemical coping (drug overly central) Depression/anxiety/situational stressors (self-medication) Depression/anxiety/situational stressors (self-medication) Criminal intent (diversion) Criminal intent (diversion) Passik SD, Kirsh KL. Curr Pain Headache Rep. 2004;8:

88 Signs of Potential Abuse and Diversion Request appointment toward end-of-office hours Arrive without appointment Telephone/arrive after office hours when staff are anxious to leave Reluctant to have thorough physical exam, diagnostic tests, or referrals Fail to keep appointments Unwilling to provide past medical records or names of HCPs Unusual stories However, emergencies happen: not every person in a hurry is an abuser/diverter Drug Enforcement Administration. Don't be Scammed by a Drug Abuser Cole BE. Fam Pract Manage. 2001;8:37-41.

89 Urine Drug Testing When to test? When to test? Randomly, annually, PRN Randomly, annually, PRN What type of testing? What type of testing? POC, GS/MS POC, GS/MS How to interpret How to interpret Metabolism of opioids Metabolism of opioids False positive and negative results False positive and negative results What to do about the results What to do about the results Consult, refer, change therapy, discharge Consult, refer, change therapy, discharge

90 Positive forensic testing Positive forensic testing Legally prescribed medications Legally prescribed medications Over-the-counter medications Over-the-counter medications Illicit drugs or unprescribed medications Illicit drugs or unprescribed medications Substances that produce the same metabolite as that of a prescribed or illegal substance Substances that produce the same metabolite as that of a prescribed or illegal substance Errors in laboratory analysis Errors in laboratory analysis Negative compliance testing Negative compliance testing Medication bingeing Medication bingeing Diversion Diversion Insufficient test sensitivity Insufficient test sensitivity Failure of laboratory to test for desired substances Failure of laboratory to test for desired substances Heit HA, Gourlay DL. J Pain Symptom Manage. 2004;27: Positive and Negative Urine Toxicology Results

91 Urine Drug Testing Initial testing done with class-specific immunoassay drug panels Initial testing done with class-specific immunoassay drug panels Typically do not identify individual drugs within a class Typically do not identify individual drugs within a class Heit HA, Gourlay D. J Pain Sympt Manage. 2004:27: Followed by a technique such as GC/MS To identify or confirm the presence or absence of a specific drug and/or its metabolites

92 Detection of Opioids Opiate immunoassays detect morphine and codeine Opiate immunoassays detect morphine and codeine Do not detect synthetic opioids Do not detect synthetic opioids Methadone Methadone Fentanyl Fentanyl Do not reliably detect semisynthetic opioids Do not reliably detect semisynthetic opioids Oxycodone Oxycodone Hydrocodone Hydrocodone Hydromorphone Hydromorphone GC/MS will identify these medications GC/MS will identify these medications Heit HA, Gourlay D. J Pain Sympt Manage. 2004:27:

93 UDT Laboratory-Based Tests GC/MS, LC/ MS, ELISA GC/MS, LC/ MS, ELISA High sensitivity, high specificity High sensitivity, high specificity Expensive Expensive Quantitative Quantitative 1-3 days for results 1-3 days for results ELISA, enzyme-linked immunosorbent assay; GC, gas chromatography; LC, liquid chromatography; MS, mass spectrometry. Hammett-Stabler CA, Webster LR. A Clinical Guide to Urine Drug Testing. Stamford, CT: PharmaCom Group Inc; RESULTS OF CONTROLLED SUBSTANCE UDT: WORKPLACE Donor Name: Jack Donor ID #: Specimen ID #: Accession #: None assignedReason for test: Random Date collected: 04/11/2008Time collected: 1648 Date received: 04/15/2008Date reported: 04/15/2008 Class or AnalyteResultScreen Cut-Off AMPHETAMINESNEGATIVE 1,000 ng/ml BARBITUATESNEGATIVE 200 ng/ml BENZODIAZEPINESNEGATIVE 200 ng/ml CANNABINOIDSNEGATIVE 50 ng/ml COCAINENEGATIVE 300 ng/ml METHADONENEGATIVE 150 ng/ml OPIATESPOSITIVE 100 ng/ml Validity TestResultNormal Range CREATININENORMAL at 33.4 mg/dL ≥ 20 mg/dL SPECIFIC GRAVITYNORMAL ≥ pHNORMAL

94 Risk Evaluation and Mitigation Strategies Position of the FDA Position of the FDA The current strategies for intervening with [the problem of prescription opioid addiction, misuse, abuse, overdose and death] are inadequate The current strategies for intervening with [the problem of prescription opioid addiction, misuse, abuse, overdose and death] are inadequate New authorities granted under FDAAA: [FDA] will now be implementing Risk Evaluation and Mitigation Strategies (REMS) for a number of opioid products New authorities granted under FDAAA: [FDA] will now be implementing Risk Evaluation and Mitigation Strategies (REMS) for a number of opioid products [FDA expects] all companies marketing these products to [cooperate] to get this done expeditiously [FDA expects] all companies marketing these products to [cooperate] to get this done expeditiously If not, [FDA] cannot guarantee that these products will remain on the market If not, [FDA] cannot guarantee that these products will remain on the market Rappaport BA. REMS for Opioid Analgesics: How Did We Get Here? Where are We Going? FDA meeting of manufacturers of ER opioids, FDA White Oak Campus, Silver Spring, MD. March 3, 2009.

95 NASPER National All Schedules Prescription Electronic Reporting Act  Signed into law by President Bush August 2005  Point of care reference to all controlled substances prescribed to a given patient  Each state will implement it’s own program  Treatment tool vs. Law enforcement tool? Source: 2002 National Survey on Drug Use and Health (NSDUH). Results from the 2002 National Survey on Drug Use and Health: National Findings. Department of Health and Human Services Sale of Opioids

96 States with Pharmacy Monitoring Programs Operational PMP:32Start-up phase: 6In legislative process: 11No action: 1 Office of Diversion Control. Accessed March 2010.

97 Case Study: Opioid Renewal Clinic What is the impact of a structured opioid renewal program? Primary goal: reduce oxycodone SA use to 3% of opioids Primary goal: reduce oxycodone SA use to 3% of opioids Setting Setting Primary care Primary care Managed by nurse practitioner and clinical pharmacist Managed by nurse practitioner and clinical pharmacist Philadelphia VA pain clinic Philadelphia VA pain clinic Structured program Structured program Electronic referral by PCP Electronic referral by PCP Signed Opioid Treatment Agreement Signed Opioid Treatment Agreement UDT UDT Support from multidisciplinary pain team: addiction psychiatrist, rheumatologist, orthopedist, neurologist, and physiatrist Support from multidisciplinary pain team: addiction psychiatrist, rheumatologist, orthopedist, neurologist, and physiatrist Multimodal management Multimodal management Opioids Opioids NSAIDs and acetaminophen for osteoarthritis NSAIDs and acetaminophen for osteoarthritis Transcutaneous electrical stimulation (TENS) units Transcutaneous electrical stimulation (TENS) units Antidepressants and anticonvulsants for neuropathic pain Antidepressants and anticonvulsants for neuropathic pain Reconditioning exercises Reconditioning exercises Wiedemer NL, et al. Pain Med. 2007;8(7):

98 Opioid Renewal Clinic: Results OTAs increased: 63  214 OTAs increased: 63  214 Monthly UDTs increased: 80  200 Monthly UDTs increased: 80  200 Oxycodone SA use decreased Oxycodone SA use decreased Quarterly costs: $130,000  $5,000 Quarterly costs: $130,000  $5,000 Percent of opioids: 22.5%  0.4% Percent of opioids: 22.5%  0.4% ER visits reduced 73% ER visits reduced 73% Unscheduled PCP visits reduced 60% Unscheduled PCP visits reduced 60% PCPs satisfied (questionnaire) PCPs satisfied (questionnaire) 171/335 patients referred had aberrant drug-taking behaviors 171/335 patients referred had aberrant drug-taking behaviors 45% adhered to OTA (resolved aberrant behaviors) 45% adhered to OTA (resolved aberrant behaviors) 38% self-discharged from ORC 38% self-discharged from ORC 13% referred for addiction treatment 13% referred for addiction treatment 4% consistently negative UDT 4% consistently negative UDT Wiedemer NL, et al. Pain Med. 2007;8(7):

99 Pharmacologic Sequestered antagonist Bio-available antagonist Pro-drug Combination Mechanisms Physical Difficult to crush Difficult to extract Aversive Component Capsaicin – burning sensation Ipecac – emetic Denatonium – bitter taste Deterrent Packaging RFID – Protection Tamper-proof bottles Increasing Direct Abuse Deterrence Opioid Abuse-Deterrent Strategies Hierarchy Prescription Monitoring

100 Remaining Questions How much does the barrier approach deter the determined abuser? How much does the barrier approach deter the determined abuser? How much do agonist/antagonist compounds retain efficacy? How much do agonist/antagonist compounds retain efficacy? How much do agonist/antagonist compounds pose serious adversity? How much do agonist/antagonist compounds pose serious adversity?

101 WHAT IS ADDICTION? WHAT IS ADDICTION? Does Not Necessarily Equal Physical Dependence Addiction Ed Salsizt

102 Pain and Addiction Pain and Addiction Does Not Necessarily Equal Chronic Pain Suffering Suffering Ed Salsizt

103 Pain Treatment in Patients with an Addiction  Avoid the patient’s drug of choice  Consider safer longer acting opioids  Use medication with lower street value  Avoid self administration, if possible  Case management

104 Pain Treatment in Patients with an Addiction  Explain potential for relapse  Explain the rationale for the medication  Educate the patient and the support system  Encourage family/support system involvement  Frequent follow-ups  Consultations and multidisciplinary approach

105  Must satisfy baseline opioid requirements before treating pain  The usual maintenance dose (e.g., methadone) will not control the pain  The usual methadone dose needs to be supplemented with appropriate medication(s) for pain control  May need slightly higher amounts for slightly longer periods of time Pain Control for Opioid Maintained Patients

106 Monitoring: Regularly assess the 5 A’s: Regularly assess the 5 A’s: Analgesia Analgesia Adverse effects Adverse effects Activity / function Activity / function Aberrant behaviors Aberrant behaviors Affect Affect

107 Commonly reported association of persistent pain with psychological illness. Direction of causality is unknown between persistent pain and affective illness. Indication are that psychological disorder is a common correlate of persistent pain, and that this association is observed in a wide range of cultural settings. Pain and Affective Disorders JAMA. 1998;280: Ed Salsizt

108 1. Addiction 2. Pseudoaddiction 3. Other psychiatric disorder 4. Encephalopathy 5. Family disturbance 6. Criminal intent 7. Exacerbation of pain syndrome 8. Side effect(s) of opioid Differential Diagnoses of Aberrant Drug Related Behaviors

109 Aberrant Drug Related Behaviors - Less Predictive of an Addiction 1. Aggressively complaining of the need for more drug 2. Drug hoarding during periods of reduced pain 3. Requesting specific drugs 4. Openly acquiring similar drugs from other medical sources if primary provider is absent or under-treated 5. Unsanctioned dose escalation or other non-compliance on one or two occasions

110 1. Selling prescription drugs 2. Prescription forgery 3. Stealing or “borrowing” drugs 4. Obtaining prescription drugs form non-medical sources 5. Concurrent abuse of alcohol or illicit drugs 6. Multiple dose escalations or other non- compliance with therapy Aberrant Drug Related Behaviors - Predictive of an Addiction

111 7. Multiple episodes of prescription “loss” 8. Prescriptions from other clinicians/EDs without seeking primary prescriber 9. Deterioration in function that appears to be related to drug use 10. Resistance to change in therapy despite significant side effects from the drug Aberrant Drug Related Behaviors - Predictive of an Addiction

112 1. Syndrome of opioid abuse/dependence 2. Other substance use disorder 3. Other psychiatric disorder 4. Exacerbation of pain syndrome 5. Other medical problem 6. Side effect of opioid Differential Diagnosis of Functional Downturn

113 A Way Out

114 Drug Abuse Treatment Act (DATA) 2000 Schedule III substances  ADDICTION:  Obtain DEA waiver; MD/DO  30 patients only for addiction  2007: 30/100 pt limit  Once daily dosing  PAIN:  Any provider with a schedule III DEA can prescribe.  Divided dosing.

115  Open label study 95 consecutive patients on long term opioid therapy (LTOA) failing treatment based on:  Increased pain  Decreased Functional Capacity  Emergence of opioid addiction (8%)  Induced on buprenorphine 4-16mg (8mg mean dose)  86% Experienced moderate to substantial pain relief  Mood and function improved  8% Discontinued due to side effects or increased pain

116 Buprenorphine: Pain Dosage OFF LABEL  Opioid Naïve  1-2 mg BID- QID (3-6mg/day)  Opioid Tolerant  4mg TID-QID (12-16mg/day)  24mg/day upper limits  32mg/day maximum dose  Cost  Suboxone 8mg $5.97 Costco $2.15 FSS  Suboxone 2 mg

117 Breaths/Minute PLBuprenorphine (mg, sl) Human respiratory rate Adapted from Walsh et al., 1994 Ceiling effect on respiratory depression

118 Buprenorphine-Benzodiazepine Relative Contraindication  CNS depressants and sedatives (eg, benzodiazepines ):  All opioids have additive sedative effects when used in combination with other sedatives  Increased potential for respiratory depression, heavy sedation, coma, and death (France, IV aprazolam and buprenorphine)  Despite favorable safety, use caution with concomitant psychotropics (eg, benzodiazepines)

119 Disadvantages: Buprenorphine for Pain Disadvantages of buprenorphine over pure mu agonists: Disadvantages of buprenorphine over pure mu agonists:  Binds so well to mu receptor that other opioids have little effect  No prn short acting opioids for breakthrough pain  Ceiling on effectiveness  24 mg “yellow light  32mg “red light  Ed Johnson Phd, Personal Communication  Surgery, Trauma? FENTANYL?

120 Buprenorphine: Dosage Forms  Buprenex: Buprenorphine IM formulation *  Suboxone 8/2 mg, 2/0.5mg ** Buprenorphine/Naloxone sublingual tablet  Subutex 2mg, 8mg** Buprenorphine sublingual tablet  Transdermal Buprenorphine Not FDA approved in the US  Implant Investigational * Intramuscular form FDA approved for pain **Sublingual form FDA approved for addiction

121  If non-opioids are ineffective, may need to increase or stop buprenorphine and add a pure Mu agonist for pain (OR-fentanyl)  May need to switch to pure Mu agonist for maintenance (baseline requirements)  Care needed if/when buprenorphine is restarted for maintenance Buprenorphine maintained patients

122   Case Presentation - PL  Unable to taper at home  Referred to Inpatient Detox for Induction to Buprenorphine  Significant difficult in getting to moderate withdrawal state  Inducted on 24mg of Buprenorphine  Remains on this dose 2 years later.

123 Conclusion Use of opioids may be necessary for pain relief Balanced multimodal care –Use of opioids as part of complete pain care –Anticipation and management of side effects –Judicious use of short and long acting agents –Focus on persistent and breakthrough pain –Maintain standard of care  H&P, F/U, PRN referral, functional outcomes, documentation Treatment goals –Improved level of independent function –Increase in activities of daily living –Decreased pain

124 Pharmacovigilance Pharmacovigilance Functional outcomes Functional outcomes Standard medical practice Standard medical practice FSMB policy FSMB policy Open Issues Open Issues What is meant by pain management? What is meant by pain management? Who needs what treatment? Who needs what treatment? Do universal approaches work? Do universal approaches work? Does it improve outcomes? Does it improve outcomes? For patients For patients For regulators For regulators Conclusion (cont)

125 Some Resources     PainEdu Manual  Opioid Risk Management Supplement   Links to many pain sites   Current status of laws regarding opioid Rx   Purdue site with access to patient management forms


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