Pain Management and Addiction

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

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

Case Presentation - PL 57 M,C,♂
Alcohol related injure at 25 resulting in a hip replacement. 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

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

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.

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 Pain is a significant public health problem. It is the most common reason that people seek medical care, with nearly 40 million visits annually, costing the US economy more than an estimated $100 billion each year in healthcare, compensation, and litigations.1,2 Some studies suggest that more than a third of Americans experience a persistent pain condition at some point in their lives. 1. National Institutes of Health. New Directions in Pain Research. September PA 2. Arnst C. Conquering pain. New discoveries and treatments offer hope. Business Week March 1. National Institutes of Health. New Directions in Pain Research. Sept PA

Pain Standards JCAHO – Installs a Quality Standard on pain identification. (2001) Strong encouragement to increase the identification and 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.

Trend data: Distribution of prescription opioids, U. S
Trend data: Distribution of prescription opioids, U.S., 2000–2007 Source: DEA, ARCOS system, 2007 GRAMS PER 100K POPULATION Automation of Reports and Consolidated Orders System * Includes OTPs

Deaths per 100,000 related to unintentional overdose and annual sales of prescription opioids by year, Source: Paulozzi, CDC, Congressional testimony, 2007 Sources: unintentional drug poisoning mortality is from the National Vital Statistics System.. The drug poisoning mortality category is defined by E850-E858 in 1990 through 1998 and by X40-X44 in 1999 through The rate for 2005 is estimated as 95% of the unintentional poisoning death rate. Total sales are from DEA ARCOS. Opioid sales are in total morphine equivalents for all major opioids combined except codeine. The conversions are the same as those used in Paulozzi and Budnitz, Pharmacoepidemiology and Drug Safety, Sales data for 2006 is estimated from the first 3 quarters of 2006.

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

New Illicit Drug Use United States, 2006
Pain Relievers* Tranquilizers Cocaine Ecstasy LSD† Marijuana Inhalants Stimulants Sedatives Heroin 69 91 264 267 783 845 860 977 1,112 2,063 2,150 500 1,000 1,500 2,000 2,500 New Users (thousands) PCP† *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. 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 ; 2007. 11

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

Prescription Drug Misuse 20%
Addiction Abuse/Dependence 2-5% Prescription Drug Misuse 20% Aberrant Medication Use Behaviors: A spectrum of patient behaviors that may reflect misuse 40% Most patients with chronic pain on opioid medications are not addicted. “In patients who meet criteria for addiction, the onset of addiction is nearly always before the onset of chronic pain.” Studies have found similar rates of addiction in chronic pain patients when compared to addiction in the general population. A few more are misusing their medication in some way/shape/form More than that (possibly 30-40%) will exhibit AMTBs at some point Given their own population of patients: physicians are unreliable at “detecting” who will develop AMTBs, who is misusing their medications, and even worse at telling who has a problem with addiction. An expert in the field of addiction explained how good he was at recognizing a patient who was diverting: when the authorities came to his office and took the patient out in handcuffs. So while its our responsibility not to contribute to prescription drug misuse: it is NOT our responsibility to determine who is “addicted” out of the gates. This is why tools and safe practices are so important. If standards are in place, the problem will reveal itself. It takes a lot of stress out of pain management. Alcohol addiction 14% Illicit drug addiction 7.5%: National Co-morbidity Study (Warner 1995/Kessler 1997) 8.2% of Americans age >12 were illicit substance users; 2.7% used prescription drug non-medically (National Survey on Drug Use and Health) What is the % of patients with AMTB in chronic pain population? Prescription drug misuse: 24-32% in academic medical center (Chelminski et al, BMC Health Services Research 2005; Reid et al, JGIM, 2002) What is the % of patients with ADDICTION in chronic pain population? 3.2% to 18.9% (References: Fishbain, Clin J Pain 1992; Kouyanou, J Psychosom Res, 1997; Manchikanti, Pain Physician 2006) Total Chronic Pain Population Adapted from Passik. APS Resident Course, 2007

Where Pain Relievers Were Obtained Most Recent Nonmedical Use among Past Year Users Aged 12 or Older: 2006 Source Where Respondent Obtained Bought on Internet 0.1% Drug Dealer/ Stranger 3.9% Other 1 4.9% Source Where Friend/Relative Obtained More than One Doctor 1.6% More than One Doctor 3.3% Free from Friend/Relative 7.3% Free from Friend/Relative 55.7% One Doctor 19.1% One Doctor 80.7% Bought/Took from Friend/Relative 4.9% Bought/Took from Friend/Relative 14.8% Drug Dealer/ Stranger 1.6% Other 1 2.2% 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.”

“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”

History 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 The federal Harrison Narcotic Act was passed in 1914.
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.

Genesis in two statutes of the early 1970s
History 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 1. Two statutes in early 1970s: Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment and Rehabilitation Act of 1970; and the Drug Abuse Prevention, Treatment and Rehabilitation Act of These statutes were then implemented through regulations released by the Department of Health, Education, and Welfare (HEW) in 1975. 2. The Department of Health and Human Services (HHS) revised the 1975 regulations in 1987 (title 42, part 2 of the Code of Federal Regulations). 3. Congress merged the two acts by combining the original statutes into one act (the Public Health Service Act; title 42, section 290dd-3 of the United States Code). The merger did not affect the confidentiality regulations.

Federation of State Medical Boards of the United States, Inc
Model Policy for the Use of Controlled Substances for the Treatment of Pain Federation of State Medical Boards House of Delegates, May Accessed March 2010. 19

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 20

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

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

Multiple Types of Pain A. Nociceptive B. Inflammatory Neuropathic
Pathophysiology of Pain Multiple Types of Pain Examples Strains and sprains Bone fractures Postoperative Osteoarthritis Rheumatoid arthritis Tendonitis Diabetic peripheral neuropathy Post-herpetic neuralgia HIV-related polyneuropathy Fibromyalgia Irritable bowel syndrome A. Nociceptive B. Inflammatory Neuropathic Noninflammatory/ Nonneuropathic Noxious Peripheral Stimuli Inflammation Multiple Mechanisms Peripheral Nerve Damage No Known Tissue or Nerve Damage Abnormal Central Processing Patients may experience multiple pain states simultaneously1 Adapted from Woolf CJ. Ann Intern Med. 2004;140: 1. Chong MS, Bajwa ZH. J Pain Symptom Manage. 2003;25:S4-S11. 24

Pain 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. 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. Modulation: Pain can be inhibited or facilitated by mechanisms affecting ascending as well as descending pathways.

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

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

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.

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

Modulation of Pain Descending Pain Regulation:
Descending connections that modulate incoming pain impulses. Incoming painful stimuli are transmitted (A) to the dorsal horn, and from there (B) to the periaqueductal grey (PAG). Descending impulses pass (C) to the raphe nuclei, especially the nucleus raphe magnus, in the upper medulla, and thence back to the dorsal horn via reticulospinal fibres (D). The above shows only the serotonergic descending fibres. Other pain-suppressing impulses pass from the PAG to the locus coeruleus, and from there to the dorsal horn. Descending Pain Regulation: norepinephrine - alpha-2 stimulatory effects serotonin opiates relieve pain by stimulating mu and delta receptors at a host of sites.

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

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

Does Not Necessarily Equal
Chronic Pain Suffering Ed Salsizt

Multimodal Treatment Lifestyle Change Pharmacotherapy
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 Fine PG, et al. J Support Oncol. 2004;2(suppl 4): Portenoy RK, et al. In: Lowinson JH, et al, eds. Substance Abuse: A Comprehensive Textbook. 4th ed. Philadelphia, PA: Lippincott, Williams & Wilkins; 2005:

Considerations 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? 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? Who can I treat without help? 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? Fine PG, Portenoy RK. Clinical Guide to Opioid Analgesia. Vendome Group, New York, 2007.

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

Non-Opiate Approaches
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. 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.

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

Opiates

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

Function at Receptors: Full Agonists
Mu receptor Full agonist binding … activates the mu receptor is highly reinforcing is the most abused opioid type includes heroin, methadone, & others

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

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

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

Review of opioid efficacy
In short-term studies: Single IV study Oral studies ≤ 32 wks Both demonstrate that CNMP can be opioid responsive We can’t wait until we know Therefore use non opioids when you can Use moderate doses of opioids when you must

Review of opioid efficacy (cont.)
In long-term studies: Usually observational – non randomized / poorly controlled 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. The question of whether benefits can be maintained over years rather than months remains unanswered. Ballantyne JC: Southern Med J 2006; 99(11):

Back Pain 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. * JAMA February 13,2008 Vol. 299, No. 6

Opioid Hyperalgesia Cellular responses to chronic opioid intake:
an increase in neuropeptides such as dynorphin11, cholecystokinin,12 and substance P13 all of which have been demonstrated to enhance pain sensitivity the activation of glial cells, producing inflammatory cytokines and resulting in amplified pain.14 11. Vanderah TW, Suenaga NM, Ossipov MH, Malan TP Jr. Lai J. Porreca F. J Neuwsci ;21: 12. Xie JY. Herman DS, Stiller CO. el al. JNeurosci. 2005;25: 13. King T, Gardel) LR. Wang R. et al. Pain. 2005;! 16: 14. Watkins LR. Hutchinson MR, Ledeboer A. Wieseler-Frank J, Milligan ED, Maier SF. Brain Behav linrmin. 2007;2];J

Opioid Hyperalgesia 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 1. Doverty M, White JM. Somogyi AA, Bochner F. Ali R. Ling W. Pain. 2001:90: 2. Ballantyne JC. Mao J. N Engl J Med :349:

Conclusions as to opioid efficacy
Opioids are an essential treatment for some patients with CNMP. They are rarely sufficient They almost never provide total lasting relief They ultimately fail for many 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

Use of Opiates in Pain Management

Positioning Opioid Therapy for Chronic Pain
Chronic non-cancer pain: evolving perspective Consider for all patients with severe chronic pain, but weigh the influences What is conventional practice? Are there reasonable alternatives? What is the risk of adverse events? Is the patient likely to be a responsible drug-taker? Fine PG, Portenoy RK. Clinical Guide to Opioid Analgesia, 2nd edition, 2007. 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: 53

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!

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.

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) Continue Opioid Therapy Monitoring ( ) Breakthrough Pain (12.1) Implement Exit Strategy Opioid-Related Adverse Effects (8.1) Chou R, et al. J Pain. 2009;10: *Clinician accepting primary responsibility for a patient’s overall medical care.

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

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

DSM-IV Criteria for Opioid Dependence
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 1. This and the following slides list the DSM-IV criteria for dependence on a psychoactive substance. The criteria are generic – that is, they apply to all substances, including opioids. [Reference: American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. American Psychiatric Association, Washington, D.C., 1994.]

DSM-IV Criteria for Opioid Dependence
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 1.

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

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

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

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

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) Predict the analgesic efficacy of, and patient compliance to, long-term opioid treatment in the primary care setting Passik SD, Squire P. Pain Med. 2009;10 Suppl 2:S

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 Empirically-derived, 24-item self-report questionnaire Reliable and valid Less susceptible to overt deception than past version 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:

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 (*May be deleted for one-hour version of presentation) This 5-item tool was designed for use on an initial visit, prior to prescribing opioid therapy, to assess for aberrant medication-taking behavior (AMTB). To review, aberrant medication-taking behavior is a spectrum of patient behavior that may reflect misuse, including abuse/dependence. The tool was validated among patients in a pain clinic. Low risk group: 6% risk - 94% did not exhibit any aberrant medication-taking behavior (AMTB) Moderate risk group: 28% risk - had at least 1 AMTB High risk group: 91% risk - had at least 1 AMTB The tool itself can be found on this website noted on this slide. Webster, Webster. Pain Med. 2005 Daniel Alford, MD, MPH

ORT Validation Mark each box that applies
Female Male Family history of substance abuse Alcohol Illegal drugs Prescription drugs  1  2  4  3 Personal history of substance abuse  5 Age (mark box if years) History of preadolescent sexual abuse  0 Psychological disease ADD, OCD, bipolar, schizophrenia Depression 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: 25 69

Source: Journal of Pain, The 2009; 10:113-130. e22 (DOI:10. 1016/j
Source: Journal of Pain, The 2009; 10: e22 (DOI: /j.jpain ) Copyright © 2009 American Pain Society Terms and Conditions

SOAPP О О Mr. Jackson’s Score = 3
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 Mr. Jackson’s Score = 3 To score the SOAPP, add ratings of all questions. A score of 4 or higher is considered positive О О Sum of Questions SOAPP Indication  4 + < 4 - 71

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

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

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

Medical Records Maintain accurate, complete, and current records
Medical Hx & PE Diagnostic, therapeutic, lab results Evaluations/consultations Treatment objectives Discussion of risks/benefits Tx and medications Instructions/agreements Periodic reviews 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 75

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

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

Opioid Treatment Agreement
Accessed March 2010.

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

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

Treating the Addicted Patient in Pain

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

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

Search for physical causes Identify and address possible non-pain sustaining factors Address and improve functional status Treat associated symptoms, if indicated Case management

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

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

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

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. 88 88

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

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

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

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

UDT Laboratory-Based Tests
RESULTS OF CONTROLLED SUBSTANCE UDT: WORKPLACE Donor Name: Jack Donor ID #: Specimen ID #: Accession #: None assigned Reason for test: Random Date collected: 04/11/2008 Time collected: 1648 Date received: 04/15/2008 Date reported: 04/15/2008 Class or Analyte Result Screen Cut-Off AMPHETAMINES NEGATIVE ,000 ng/ml BARBITUATES NEGATIVE ng/ml BENZODIAZEPINES NEGATIVE ng/ml CANNABINOIDS NEGATIVE ng/ml COCAINE NEGATIVE ng/ml METHADONE NEGATIVE ng/ml OPIATES POSITIVE ng/ml Validity Test Result Normal Range CREATININE NORMAL at 33.4 mg/dL ≥ 20 mg/dL SPECIFIC GRAVITY NORMAL ≥ pH NORMAL GC/MS, LC/ MS, ELISA High sensitivity, high specificity Expensive Quantitative 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; 2008. 93

Risk Evaluation and Mitigation Strategies
Position of the FDA 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 [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 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.

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? Sale of Opioids 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

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

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 Setting Primary care Managed by nurse practitioner and clinical pharmacist Philadelphia VA pain clinic Structured program Electronic referral by PCP Signed Opioid Treatment Agreement UDT Support from multidisciplinary pain team: addiction psychiatrist, rheumatologist, orthopedist, neurologist, and physiatrist Multimodal management Opioids NSAIDs and acetaminophen for osteoarthritis Transcutaneous electrical stimulation (TENS) units Antidepressants and anticonvulsants for neuropathic pain Reconditioning exercises Pain Med Oct-Nov;8(7): The opioid renewal clinic: a primary care, managed approach to opioid therapy in chronic pain patients at risk for substance abuse. Wiedemer NL, Harden PS, Arndt IO, Gallagher RM. Philadelphia VA Medical Center, Philadelphia, Pennsylvania 19104, USA. Comment in: Pain Med Oct-Nov;8(7):544-5. OBJECTIVE: To measure the impact of a structured opioid renewal program for chronic pain run by a nurse practitioner (NP) and clinical pharmacist in a primary care setting. PATIENTS AND SETTING: Patients with chronic noncancer pain managed with opioid therapy in a primary care clinic staffed by 19 providers serving 50,000 patients at an urban academic Veterans hospital. DESIGN: Naturalistic prospective outcome study. INTERVENTION: Based on published opioid prescribing guidelines and focus groups with primary care providers (PCPs), a structured program, the Opioid Renewal Clinic (ORC), was designed to support PCPs managing patients with chronic noncancer pain requiring opioids. After training in the use of opioid treatment agreements (OTAs) and random urine drug testing (UDT), PCPs worked with a pharmacist-run prescription management clinic supported by an onsite pain NP who was backed by a multi-specialty Pain Team. After 2 years, the program was evaluated for its impact on PCP practice and satisfaction, patient adherence, and pharmacy cost. RESULTS: A total of 335 patients were referred to the ORC. Of the 171 (51%) with documented aberrant behaviors, 77 (45%) adhered to the OTA and resolved their aberrant behaviors, 65 (38%) self-discharged, 22 (13%) were referred for addiction treatment, and seven (4%) with consistently negative UDT were weaned from opioids. The 164 (49%) who were referred for complexity including history of substance abuse or need for opioid rotation or titration, with no documented aberrant drug-related behaviors, continued to adhere to the OTA. Use of UDT and OTAs by PCPs increased. Significant pharmacy cost savings were demonstrated. CONCLUSION: An NP/clinical pharmacist-run clinic, supported by a multi-specialty team, can successfully support a primary care practice in managing opioids in complex chronic pain patients. Wiedemer NL, et al. Pain Med. 2007;8(7):

Opioid Renewal Clinic: Results
OTAs increased: 63  214 Monthly UDTs increased: 80  200 Oxycodone SA use decreased Quarterly costs: $130,000 $5,000 Percent of opioids: 22.5% 0.4% ER visits reduced 73% Unscheduled PCP visits reduced 60% PCPs satisfied (questionnaire) 171/335 patients referred had aberrant drug-taking behaviors 45% adhered to OTA (resolved aberrant behaviors) 38% self-discharged from ORC 13% referred for addiction treatment 4% consistently negative UDT Pain Med Oct-Nov;8(7): The opioid renewal clinic: a primary care, managed approach to opioid therapy in chronic pain patients at risk for substance abuse. Wiedemer NL, Harden PS, Arndt IO, Gallagher RM. Philadelphia VA Medical Center, Philadelphia, Pennsylvania 19104, USA. Comment in: Pain Med Oct-Nov;8(7):544-5. OBJECTIVE: To measure the impact of a structured opioid renewal program for chronic pain run by a nurse practitioner (NP) and clinical pharmacist in a primary care setting. PATIENTS AND SETTING: Patients with chronic noncancer pain managed with opioid therapy in a primary care clinic staffed by 19 providers serving 50,000 patients at an urban academic Veterans hospital. DESIGN: Naturalistic prospective outcome study. INTERVENTION: Based on published opioid prescribing guidelines and focus groups with primary care providers (PCPs), a structured program, the Opioid Renewal Clinic (ORC), was designed to support PCPs managing patients with chronic noncancer pain requiring opioids. After training in the use of opioid treatment agreements (OTAs) and random urine drug testing (UDT), PCPs worked with a pharmacist-run prescription management clinic supported by an onsite pain NP who was backed by a multi-specialty Pain Team. After 2 years, the program was evaluated for its impact on PCP practice and satisfaction, patient adherence, and pharmacy cost. RESULTS: A total of 335 patients were referred to the ORC. Of the 171 (51%) with documented aberrant behaviors, 77 (45%) adhered to the OTA and resolved their aberrant behaviors, 65 (38%) self-discharged, 22 (13%) were referred for addiction treatment, and seven (4%) with consistently negative UDT were weaned from opioids. The 164 (49%) who were referred for complexity including history of substance abuse or need for opioid rotation or titration, with no documented aberrant drug-related behaviors, continued to adhere to the OTA. Use of UDT and OTAs by PCPs increased. Significant pharmacy cost savings were demonstrated. CONCLUSION: An NP/clinical pharmacist-run clinic, supported by a multi-specialty team, can successfully support a primary care practice in managing opioids in complex chronic pain patients. Wiedemer NL, et al. Pain Med. 2007;8(7):

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

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

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

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

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

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

Pain Control for Opioid Maintained Patients
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

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

Pain and Affective Disorders
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. JAMA. 1998;280: Ed Salsizt

Other psychiatric disorder Encephalopathy Family disturbance
Differential Diagnoses of Aberrant Drug Related Behaviors Addiction Pseudoaddiction Other psychiatric disorder Encephalopathy Family disturbance Criminal intent Exacerbation of pain syndrome Side effect(s) of opioid

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

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

Aberrant Drug Related Behaviors - Predictive of an Addiction
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

Syndrome of opioid abuse/dependence Other substance use disorder
Differential Diagnosis of Functional Downturn Syndrome of opioid abuse/dependence Other substance use disorder Other psychiatric disorder Exacerbation of pain syndrome Other medical problem Side effect of opioid 1. If the chronic pain patient who has previously been doing well has a downturn in functioning (i.e., worsening pain, poorer functioning), then consider these possibilities to account for this change. 2. For example, it may be the case that the patient has developed a syndrome of opioid abuse or dependence (i.e., addiction to opioids), or another substance use disorder. If such is suspected, then the patient needs to be assessed for such and an appropriate treatment plan created. This may include closer monitoring of the patient, referral to a more intensive level of treatment (such as a program specializing in the treatment of chronic pain and addiction), and/or substance abuse treatment services.

A Way Out

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.

Induced on buprenorphine 4-16mg (8mg mean dose)
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

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

Ceiling effect on respiratory depression
17 Human respiratory rate 16 15 14 Breaths/Minute 13 12 11 10 1 2 4 8 16 32 PL Buprenorphine (mg, sl) Adapted from Walsh et al., 1994

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)

Disadvantages: Buprenorphine for Pain
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?

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

Buprenorphine maintained patients
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

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.

Conclusion H&P, F/U, PRN referral, functional outcomes, documentation
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 40 123

Conclusion (cont) Pharmacovigilance Open Issues Functional outcomes
Standard medical practice FSMB policy Open Issues What is meant by pain management? Who needs what treatment? Do universal approaches work? Does it improve outcomes? For patients For regulators 40 124

www.AOAAM.org www.pcss-b.org www.painedu.com www.pain.com
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

Pain Management and Addiction

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