Presentation on theme: "Pain Management and Addiction"— Presentation transcript:
1Pain Management and Addiction West Coast Symposium on Addictive DisordersLa Quinta, CAJune 3, 2011Stephen A. Wyatt, D.O.Middlesex HospitalMiddletown, CT
2Outline The Opiate Problem Introduction Identifying the problem with opiatesHow did it occur?Pain management vs. Opiate ControlDifferent types of painNociceptive and Neuropathic PainChronic Non-Cancer PainOpiatesDefinitionThe danger of long acting opiatesPotential for addictionIdentification and Monitoring of Pain & AddictionAssessmentMonitoringRed and Yellow flagsA way out
3Case 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 opiatesRemained on disabilityHospitalized d/t to Klonopin odVicodin (acetaminophen 500mg, Hydrocodone 5mg) #7 / 6 times a day.Suggested long acting opioid
4Came for consultation 3/09 Oxycontin 60mg #5 4 time a day Case Presentation - PLCame for consultation 3/09 Oxycontin 60mg # time a day
5Prevalence 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 duration1 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 year2 out of 3 US armed forces veterans report having persistent pain attributable to military service– 1 in 10 take prescription medicine to manage painAmerican Pain Foundation. Accessed March 2010.
6The Problem of Pain Costs US economy estimated $100 billion/year HealthcareWelfare & disability paymentsLost tax revenueLost productivity (work absence)40 million physician visits annuallyMost common reason for medical appointmentsPush toward opioid maintenance therapy in non malignant painPain 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 PA2. 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
7Pain StandardsJCAHO – 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.
8Trend data: Distribution of prescription opioids, U. S Trend data: Distribution of prescription opioids, U.S., 2000–2007 Source: DEA, ARCOS system, 2007GRAMS PER 100K POPULATIONAutomation of Reports and Consolidated Orders System* Includes OTPs
9Deaths per 100,000 related to unintentional overdose and annual sales of prescription opioids by year, Source: Paulozzi, CDC, Congressional testimony, 2007Sources: 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.
10Unintentional drug overdose deaths are rising faster for prescription opioids than for illicit drugs Source: CDC, National Vital Statistics System, 2006
11New Illicit Drug Use United States, 2006 Pain Relievers*TranquilizersCocaineEcstasyLSD†MarijuanaInhalantsStimulantsSedativesHeroin69912642677838458609771,1122,0632,1505001,0001,5002,0002,500New 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
12Who Misuses/Abuses Opioids and Why? NonmedicalUseRecreational abusersPatients with disease of addictionMedical UsePain patients seeking more pain reliefPain patients escaping emotional pain121212
13Prescription Drug Misuse 20% AddictionAbuse/Dependence2-5%Prescription Drug Misuse20%Aberrant Medication Use Behaviors:A spectrum of patient behaviorsthat may reflect misuse40%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/formMore than that (possibly 30-40%) will exhibit AMTBs at some pointGiven 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 PopulationAdapted from Passik. APS Resident Course, 2007
14Where Pain Relievers Were Obtained Most Recent Nonmedical Use among Past Year Users Aged 12 or Older: 2006Source Where Respondent ObtainedBought on Internet 0.1%Drug Dealer/ Stranger 3.9%Other 1 4.9%Source Where Friend/Relative ObtainedMore than One Doctor1.6%More than One Doctor 3.3%Free from Friend/Relative 7.3%Free from Friend/Relative 55.7%One Doctor19.1%One Doctor80.7%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.”
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”
16History 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.
17History 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.
18Genesis in two statutes of the early 1970s HistoryGenesis in two statutes of the early 1970sImplemented by regulations from HEW in 1975Revised by HHS in 1987 (42 CFR Part 2)Congress reaffirmed and reorganized the two statutes into a single act1. 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.
19Federation of State Medical Boards of the United States, Inc Model Policy for the Use of Controlled Substances for the Treatment of PainFederation of State Medical Boards House of Delegates, May Accessed March 2010.19
20FSMB Model Policy Basic Tenets Pain management is important and integral to the practice of medicineUse of opioids may be necessary for pain reliefUse of opioids for other than a legitimate medical purpose poses a threat to the individual and societyPhysicians have a responsibility to minimize the potential for abuse and diversionPhysicians may deviate from the recommended treatment steps based on good causeNot meant to constrain or dictate medical decision-makingFSMB, Federation of State Medical Boards20
22Scott 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
24Multiple Types of Pain A. Nociceptive B. Inflammatory Neuropathic Pathophysiology of PainMultiple Types of PainExamplesStrains and sprainsBone fracturesPostoperativeOsteoarthritisRheumatoid arthritisTendonitisDiabetic peripheral neuropathyPost-herpetic neuralgiaHIV-related polyneuropathyFibromyalgiaIrritable bowel syndromeA. NociceptiveB. InflammatoryNeuropathicNoninflammatory/NonneuropathicNoxiousPeripheralStimuliInflammationMultiple MechanismsPeripheral Nerve DamageNo Known Tissue or Nerve DamageAbnormal Central ProcessingPatients may experience multiple pain states simultaneously1Adapted from Woolf CJ. Ann Intern Med. 2004;140:1. Chong MS, Bajwa ZH. J Pain Symptom Manage. 2003;25:S4-S11.24
25Pain 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 cortexPerception: 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.
27Peripheral 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,Serotonincapsaicin receptors
28Mediation 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.
29The Pain Pathway - Cerebral Cortex Midbrain Thalamus, Limbic system Perception- Cerebral CortexModulationMidbrainThalamus,Limbic system
30Modulation 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 effectsserotoninopiates relieve pain by stimulating mu and delta receptors at a host of sites.
31Perceived Pain - Suffering At risk patientsPast history of substance use disorderEmotionally traumatizedDysfunctional / alcoholic familyLacks effective coping skillsDependent traitsStimulus augmenters-deficit in hedonic tonePaul Farnum, MD PHP, BC
32Vicious Cycle of Uncontrolled Pain AvoidanceBehaviorsDecreasedMobilityPainSocialLimitationsAlteredFunctionalStatusDiminishedSelf-Efficacy32
33Does Not Necessarily Equal Chronic PainSufferingEd Salsizt
34Multimodal Treatment Lifestyle Change Pharmacotherapy Exercise, weight lossStrategies for Pain and Associated DisabilityPharmacotherapyOpioids, nonopioids, adjuvant analgesicsInterventional ApproachesInjections, neurostimulationPhysical Medicine and RehabilitationAssistive devices, electrotherapyPsychological SupportPsychotherapy, group supportComplementary and Alternative MedicineMassage, supplementsFine 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:
35ConsiderationsWhat 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.
36Non Pharmacologic Interventions Behavioral Interventions-ie guided imagery, biofeedbackMeditationOsteopathic Manipulation, Chiropractic, Body workAcupuncture with or without stimulationPhysical Therapy modalitiesTran-cutaneous Nerve StimulationHypnosis
37Non-Opiate Approaches Transduction: nonsteroidal anti-inflammatory drugs (NSAIDs) and cyclooxygenase (COX)-2 inhibitors -- target the inflammatory processesTransmission: 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 cultureModulation. 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.
38There is more to treating pain than Opiates… There is more to treating pain than Opiates…. but opiates remain important!
40Opiates & Opioids Opiates = naturally present in opium e.g. thebaine, codeine, morphineOpioids = manufacturedSemisynthetics are derived from an opiateheroin from morphinebuprenorphine from thebaineSynthetics are completely man-made to work like opiatesmethadone
41Function at Receptors: Full Agonists MureceptorFull agonist binding …activates the mu receptoris highly reinforcingis the most abused opioid typeincludes heroin, methadone, & others
42Formulation Points to Consider Dose-limiting issues and toxicity with co-analgesics4 g/day acetaminophen limitImportance of titrationRisk of overdose, challenges of dose conversion during rotationPharmacokinetics versus temporal patterns of painAdherenceCostConvenienceCaregiving issues
44Medical issues in opioid prescribing Potential benefitsAnalgesiaFunctionQuality of lifePotential risksToxicityFunctional impairmentPhysical dependenceAddictionHyperalgesia
45Are opioids effective for CNMP? What do we know?What don’t we know?What don’t we know about:AddictionChronic painEffects of long term opioid analgesia
46Review of opioid efficacy In short-term studies:Single IV studyOral studies ≤ 32 wksBoth demonstrate that CNMP can be opioid responsiveWe can’t wait until we knowTherefore use non opioids when you canUse moderate doses of opioids when you must
47Review of opioid efficacy (cont.) In long-term studies:Usually observational – non randomized / poorly controlledTreatment 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):
48Back PainThere 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
49Opioid Hyperalgesia Cellular responses to chronic opioid intake: an increase in neuropeptides such as dynorphin11, cholecystokinin,12 and substance P13all of which have been demonstrated to enhance pain sensitivitythe activation of glial cells, producing inflammatory cytokines and resulting in amplified pain.1411. 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
50Opioid HyperalgesiaMethadone maintenance patients have a reduction in their pain tolerance.1Ballantyne NEJM report 2003, review of opioid therapy for chronic pain- “neither safe nor effective”21. 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:
51Conclusions as to opioid efficacy Opioids are an essential treatment for some patients with CNMP.They are rarely sufficientThey almost never provide total lasting reliefThey ultimately fail for manyThey pose some hazards to patients and societyIt is not possible to accurately predict who will be helped – but those with contraindications are at high risk
53Positioning Opioid Therapy for Chronic Pain Chronic non-cancer pain: evolving perspectiveConsider for all patients with severe chronic pain, but weigh the influencesWhat 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
54Treatment goals in managing CNMP: Improve patient functioningIdentify and eliminate positive reinforcersIncrease physical activityAvoid opioid misuse and other drug useThe goal is NOT pain eradication!
55Chronic Opioid Therapy Guidelines and Treatment Principles Patient SelectionPatient Selection and Risk Stratification ( )Initial Patient AssessmentInformed Consent and Opioid Management Plans ( )High-Risk Patients ( )Alternatives to Opioid TherapyUse of Psycho-therapeutic Cointerventions (9.1)Comprehensive Pain Management PlanDriving 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.
56Chronic Opioid Therapy Guidelines and Treatment Principles (cont) Trial of Opioid TherapyInitiation and Titration of Chronic Opioid Therapy ( )Methadone (4.1)Opioids and Pregnancy (13.1)Patient ReassessmentMonitoring ( )Dose Escalations, High-Dose Opioid Therapy, Opioid Rotation, Indications for Discontinuation of Therapy ( )Opioid Policies (14.1)Continue Opioid TherapyMonitoring ( )Breakthrough Pain (12.1)Implement Exit StrategyOpioid-Related Adverse Effects (8.1)Chou R, et al. J Pain. 2009;10: *Clinician accepting primary responsibility for a patient’s overall medical care.
58Principles of Responsible Opioid Prescribing Patient EvaluationPain assessment and historyDirected physical examReview of diagnostic studiesAnalgesic and other medication historyPersonal history of illicit drug use or substance abusePersonal history of psychiatric issuesFamily history of substance abuse/psychiatric problemsAssessment of comorbiditiesAccurate record keepingFine PG, Portenoy RK. Clinical Guide to Opioid Analgesia, 2nd edition, 2007.
59DSM-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, orb) markedly diminished effect with continued use of the same amount of the substance2. Withdrawal, as manifested by either of the following:a) the characteristic withdrawal syndrome for the substance, orb) the same (or closely related) substance is taken to relieve or avoid withdrawal symptoms1. 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.]
60DSM-IV Criteria for Opioid Dependence 3. The substance is often taken in larger amounts or over a longer period than was intended4. There is a persistent desire or unsuccessful efforts to cut down or control substance use5. A great deal of time is spent in activities necessary to obtain the substance, use the substance, or recover from its effects6. Important social, occupational, or recreational activities are given up or reduced because of substance use7. 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 substance1.
61Control (loss of) Compulsion to use Characteristics of Addiction: The 4 “Cs”Control (loss of)Compulsion to useConsequences (continued use despite negative consequences – family, occupational/educational, legal, psychological, medical)Craving
62Nomenclature in Pain Treatment ToleranceDecreased effect over timePhysical DependenceWithdrawal symptoms upon discontinuationAddictionImpaired control, compulsive use, continued use in spite of negative consequencesPseudo AddictionBehavior surrounding obtaining adequate pain medsPseudo ToleranceWorsening of underlying condition
63Identifying Who Is at Risk for Opioid Abuse and Diversion Predictive toolsAberrant behaviorsUrine drug testingPrescription monitoringprogramsSeverity and duration of painPharmacist communicationFamily and friendsPatients63
64Risk Assessment Tools Addiction Severity Index (ASI) Assess current and lifetime substance-use problems and prior treatmentDrug Abuse Screening Test (DAST-10)Screen for probably drug abuse or dependenceAddiction Behaviors Checklist (ABC)Evaluate and monitor behaviors indicative ofaddiction related to prescription opioids in patients with chronic painPassik SD, Squire P. Pain Med. 2009;10 Suppl 2:S
65Risk Assessment Tools (cont) Screening Instrument for Substance Abuse Potential (SISAP)Identify individuals with possible substance-abuse historyOpioid Risk Tool (ORT)Predict which patients might develop aberrant behavior when prescribed opioids for chronic painDiagnosis, Intractability, Risk, Efficacy (DIRE)Predict the analgesic efficacy of, and patient compliance to, long-term opioid treatment in the primary care settingPassik SD, Squire P. Pain Med. 2009;10 Suppl 2:S
66Risk Assessment Tools (cont) 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 therapyEmpirically-derived, 24-item self-report questionnaireReliable and validLess susceptible to overt deception than past versionScoring: 18 identifies 90% of high-risk patientsPassik SD, Squire P. Pain Med. 2009;10 Suppl 2:SButler SF, et al. J Pain. 2008;9:
67Opioid Risk Tool 5-item initial risk assessment Stratifies risk into low (6%), moderate (28%) and high (91%)Family HistoryPersonal HistoryAgePreadolescent sexual abusePast 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 AMTBHigh risk group: 91% risk - had at least 1 AMTBThe tool itself can be found on this website noted on this slide.Webster, Webster. Pain Med. 2005Daniel Alford, MD, MPH
69ORT Validation Mark each box that applies FemaleMaleFamily history of substance abuseAlcoholIllegal drugsPrescription drugs 1 2 4 3Personal history of substance abuse 5Age (mark box if years)History of preadolescent sexual abuse 0Psychological diseaseADD, OCD, bipolar, schizophreniaDepressionExhibits high degree of sensitivity and specificity94% of low-risk patients did not display an aberrant behavior91% of high-risk patients did display an aberrant behaviorN = 185ADD, attention deficit disorder; OCD, obsessive-compulsive disorder.Webster LR, Webster RM. Pain Med. 2005;6:2569
71SOAPP 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 Often1. 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 youChris Jackson9/16/09Mr. Jackson’s Score = 3To score the SOAPP, add ratings of all questions.A score of 4 or higher is considered positiveООSum of QuestionsSOAPP Indication 4+< 4-71
72Risk Assessment Tools (cont) Pain Medication Questionnaire (PMQ)Assess risk for opioid medication misuse in patients with chronic painCurrent Opioid Misuse Measure (COMM)Periodically monitor aberrant medication-related behaviors in patients with chronic pain currently on opioid therapy
73Principles of Responsible Opioid Prescribing Drug selection, route of administration, dosing/dose titrationManaging adverse effects of opioid therapyAssessing outcomesWritten agreements in place outlining patient expectations/responsibilitiesConsultation as neededPeriodic review of treatment efficacy, side effects, aberrant drug-taking behaviors
74Initiation 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:DocumentMonitorAvoid poly-pharmacy
75Medical Records Maintain accurate, complete, and current records Medical Hx & PEDiagnostic, therapeutic, lab resultsEvaluations/consultationsTreatment objectivesDiscussion of risks/benefitsTx and medicationsInstructions/agreementsPeriodic reviewsDiscussions with and about patientsFishman 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 Pain75
76Initiation of Therapy for Chronic Pain Marcus DA. Am Fam Physician. 2000;61(5):
77Monitoring Chronic Pain Review of Efficacy of Therapy Marcus DA. Am Fam Physician. 2000;61(5):
79Opiate 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, exercisesMake increased drugs contingent on increased activity
82Pain Treatment in Patients with an Addiction These patients suffer thrice:from the painful diseasefrom the addiction, which makes pain management difficultfrom the health care provider’s ignorance
83Pain Treatment in Patients with an Addiction Must consider:High tolerance to medicationsLow pain thresholdHigh risk for relapsePain treatmentInadequate pain treatmentPsychological status
84Pain Treatment in Patients with an Addiction Search for physical causesIdentify and address possible non-pain sustaining factorsAddress and improve functional statusTreat associated symptoms, if indicatedCase management
85Pain Treatment in Patients with an Addiction Address addictionUse non-pharmacologic approaches, if effectiveUse non-opioid analgesics, if effectiveProvide effective opioid doses, if neededTreat associated symptoms, if indicated
86Identifying and Managing Abuse and Diversion Assessing risk and aberrant behaviorsPerforming scheduled and random UDTsUtilization of PMPsAssessing stress and adequacy of pain controlDeveloping good communication with pharmacistsReceiving input from family, friends, and other patients
88Signs of Potential Abuse and Diversion Request appointment toward end-of-office hoursArrive without appointmentTelephone/arrive after office hours when staff are anxious to leaveReluctant to have thorough physical exam, diagnostic tests, or referralsFail to keep appointmentsUnwilling to provide past medical records or names of HCPsUnusual storiesHowever, emergencies happen: not every person in a hurry is an abuser/diverterDrug Enforcement Administration. Don't be Scammed by a Drug Abuser Cole BE. Fam Pract Manage. 2001;8:37-41.8888
89Urine Drug Testing When to test? What type of testing? Randomly, annually, PRNWhat type of testing?POC, GS/MSHow to interpretMetabolism of opioidsFalse positive and negative resultsWhat to do about the resultsConsult, refer, change therapy, discharge
90Positive and Negative Urine Toxicology Results Positive forensic testingLegally prescribed medicationsOver-the-counter medicationsIllicit drugs or unprescribed medicationsSubstances that produce the same metabolite as that of a prescribed or illegal substanceErrors in laboratory analysisNegative compliance testingMedication bingeingDiversionInsufficient test sensitivityFailure of laboratory to test for desired substancesHeit HA, Gourlay DL. J Pain Symptom Manage. 2004;27:90
91Urine Drug TestingInitial testing done with class-specific immunoassay drug panelsTypically do not identify individual drugs within a classFollowed by a technique such as GC/MSTo identify or confirm the presence or absence of a specific drug and/or its metabolitesHeit HA, Gourlay D. J Pain Sympt Manage. 2004:27:9191
92Detection of Opioids Opiate immunoassays detect morphine and codeine Do not detect synthetic opioidsMethadoneFentanylDo not reliably detect semisynthetic opioidsOxycodoneHydrocodoneHydromorphoneGC/MS will identify these medicationsHeit HA, Gourlay D. J Pain Sympt Manage. 2004:27:9292
93UDT Laboratory-Based Tests RESULTS OF CONTROLLED SUBSTANCE UDT: WORKPLACEDonor 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: 04/15/2008Class 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/mlValidity Test Result Normal Range CREATININE NORMAL at 33.4 mg/dL ≥ 20 mg/dL SPECIFIC GRAVITY NORMAL ≥ pH NORMALGC/MS, LC/ MS, ELISAHigh sensitivity, high specificityExpensiveQuantitative1-3 days for resultsELISA, 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
94Risk Evaluation and Mitigation Strategies Position of the FDAThe current strategies for intervening with [the problem of prescription opioid addiction, misuse, abuse, overdose and death] are inadequateNew 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 expeditiouslyIf not, [FDA] cannot guarantee that these products will remain on the marketRappaport 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.
95NASPER National All Schedules Prescription Electronic Reporting Act Signed into law by President Bush August 2005Point of care reference to all controlled substances prescribed to a given patientEach state will implement it’s own programTreatment tool vs. Law enforcement tool?Sale of OpioidsSource: 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
96States with Pharmacy Monitoring Programs Operational PMP:32Start-up phase: 6In legislative process: 11No action: 1Office of Diversion Control. Accessed March 2010.
97Case Study: Opioid Renewal Clinic What is the impact of a structured opioid renewal program? Primary goal: reduce oxycodone SA use to 3% of opioidsSettingPrimary careManaged by nurse practitioner and clinical pharmacistPhiladelphia VA pain clinicStructured programElectronic referral by PCPSigned Opioid Treatment AgreementUDTSupport from multidisciplinary pain team: addiction psychiatrist, rheumatologist, orthopedist, neurologist, and physiatristMultimodal managementOpioidsNSAIDs and acetaminophen for osteoarthritisTranscutaneous electrical stimulation (TENS) unitsAntidepressants and anticonvulsants for neuropathic painReconditioning exercisesPain 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):
98Opioid Renewal Clinic: Results OTAs increased: 63 214Monthly UDTs increased: 80 200Oxycodone SA use decreasedQuarterly costs: $130,000 $5,000Percent 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 behaviors45% adhered to OTA (resolved aberrant behaviors)38% self-discharged from ORC13% referred for addiction treatment4% consistently negative UDTPain 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):
99Opioid Abuse-Deterrent Increasing Direct Abuse Deterrence Strategies HierarchyCombination MechanismsPharmacologicSequestered antagonistBio-available antagonistPro-drugAversive ComponentCapsaicin – burning sensationIpecac – emeticDenatonium – bitter tasteIncreasing Direct Abuse DeterrencePhysicalDifficult to crushDifficult to extractDeterrent PackagingRFID – ProtectionTamper-proof bottlesPrescription Monitoring99
100Remaining QuestionsHow 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?
101Does Not Necessarily Equal WHAT IS ADDICTION?Does Not Necessarily EqualPhysical DependenceAddictionEd Salsizt
102Does Not Necessarily Equal Pain and AddictionDoes Not Necessarily EqualChronic PainSufferingEd Salsizt
103Pain Treatment in Patients with an Addiction Avoid the patient’s drug of choiceConsider safer longer acting opioidsUse medication with lower street valueAvoid self administration, if possibleCase management
104Pain Treatment in Patients with an Addiction Explain potential for relapseExplain the rationale for the medicationEducate the patient and the support systemEncourage family/support system involvementFrequent follow-upsConsultations and multidisciplinary approach
105Pain Control for Opioid Maintained Patients Must satisfy baseline opioid requirements before treating painThe usual maintenance dose (e.g., methadone) will not control the painThe usual methadone dose needs to be supplemented with appropriate medication(s) for pain controlMay need slightly higher amounts for slightly longer periods of time
107Pain 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
108Other psychiatric disorder Encephalopathy Family disturbance Differential Diagnoses ofAberrant Drug Related BehaviorsAddictionPseudoaddictionOther psychiatric disorderEncephalopathyFamily disturbanceCriminal intentExacerbation of pain syndromeSide effect(s) of opioid
109Aberrant Drug Related Behaviors - Less Predictive of an Addiction Aggressively complaining of the need for more drugDrug hoarding during periods of reduced painRequesting specific drugsOpenly acquiring similar drugs from other medical sources if primary provider is absent or under-treatedUnsanctioned dose escalation or other non-compliance on one or two occasions
110Selling prescription drugs Prescription forgery Aberrant Drug Related Behaviors -Predictive of an AddictionSelling prescription drugsPrescription forgeryStealing or “borrowing” drugsObtaining prescription drugs form non-medical sourcesConcurrent abuse of alcohol or illicit drugsMultiple dose escalations or other non-compliance with therapy
111Aberrant Drug Related Behaviors - Predictive of an Addiction 7. Multiple episodes of prescription “loss”8. Prescriptions from other clinicians/EDs without seeking primary prescriber9. Deterioration in function that appears to be related to drug use10. Resistance to change in therapy despite significant side effects from the drug
112Syndrome of opioid abuse/dependence Other substance use disorder Differential Diagnosis of Functional DownturnSyndrome of opioid abuse/dependenceOther substance use disorderOther psychiatric disorderExacerbation of pain syndromeOther medical problemSide effect of opioid1. 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.
114Drug Abuse Treatment Act (DATA) 2000 Schedule III substances ADDICTION:Obtain DEA waiver; MD/DO30 patients only for addiction2007: 30/100 pt limitOnce daily dosingPAIN:Any provider with a schedule III DEA can prescribe.Divided dosing.
115Induced on buprenorphine 4-16mg (8mg mean dose) Open label study 95 consecutive patients on long term opioid therapy (LTOA) failing treatment based on:Increased painDecreased Functional CapacityEmergence of opioid addiction (8%)Induced on buprenorphine 4-16mg (8mg mean dose)86% Experienced moderate to substantial pain reliefMood and function improved8% Discontinued due to side effects or increased pain
117Ceiling effect on respiratory depression 17Human respiratory rate161514Breaths/Minute1312111012481632PLBuprenorphine (mg, sl)Adapted from Walsh et al., 1994
118Buprenorphine-Benzodiazepine Relative Contraindication CNS depressants and sedatives (eg, benzodiazepines):All opioids have additive sedative effects when used in combination with other sedativesIncreased potential for respiratory depression, heavy sedation, coma, and death (France, IV aprazolam and buprenorphine)Despite favorable safety, use caution with concomitant psychotropics (eg, benzodiazepines)
119Disadvantages: Buprenorphine for Pain Disadvantages of buprenorphine over pure mu agonists:Binds so well to mu receptor that other opioids have little effectNo prn short acting opioids for breakthrough painCeiling on effectiveness24 mg “yellow light32mg “red lightEd Johnson Phd, Personal CommunicationSurgery, Trauma? FENTANYL?
120Buprenorphine: Dosage Forms Buprenex: Buprenorphine IM formulation *Suboxone 8/2 mg, 2/0.5mg **Buprenorphine/Naloxone sublingual tabletSubutex 2mg, 8mg**Buprenorphine sublingual tabletTransdermal Buprenorphine Not FDA approved in the USImplant Investigational*Intramuscular form FDA approved for pain**Sublingual form FDA approved for addiction
121Buprenorphine 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
122Case Presentation - PL Unable to taper at home Referred to Inpatient Detox for Induction to BuprenorphineSignificant difficult in getting to moderate withdrawal stateInducted on 24mg of BuprenorphineRemains on this dose 2 years later.
123Conclusion H&P, F/U, PRN referral, functional outcomes, documentation Use of opioids may be necessary for pain reliefBalanced multimodal careUse of opioids as part of complete pain careAnticipation and management of side effectsJudicious use of short and long acting agentsFocus on persistent and breakthrough painMaintain standard of careH&P, F/U, PRN referral, functional outcomes, documentationTreatment goalsImproved level of independent functionIncrease in activities of daily livingDecreased pain40123
124Conclusion (cont) Pharmacovigilance Open Issues Functional outcomes Standard medical practiceFSMB policyOpen IssuesWhat is meant by pain management?Who needs what treatment?Do universal approaches work?Does it improve outcomes?For patientsFor regulators40124
125www.AOAAM.org www.pcss-b.org www.painedu.com www.pain.com Some ResourcesPainEdu ManualOpioid Risk Management SupplementLinks to many pain sitesCurrent status of laws regarding opioid RxPurdue site with access to patient management forms