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CLINICAL PRACTICE AND SAFETY IN PERSISTENT PAIN MANAGEMENT Chris Herndon, PharmD Associate Professor Southern Illinois University Edwardsville.

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Presentation on theme: "CLINICAL PRACTICE AND SAFETY IN PERSISTENT PAIN MANAGEMENT Chris Herndon, PharmD Associate Professor Southern Illinois University Edwardsville."— Presentation transcript:

1 CLINICAL PRACTICE AND SAFETY IN PERSISTENT PAIN MANAGEMENT Chris Herndon, PharmD Associate Professor Southern Illinois University Edwardsville

2 Disclosures Nothing to disclose

3 Objectives Define tolerance, addiction, hyperalgesia, misuse, abuse, diversion, and aberrant drug taking behaviors Describe the risks versus benefits of opioid therapy in the treatment of persistent noncancer pain Identify methods for stratifying risk of misuse among patients with chronic pain Develop monitoring strategies for patients requiring chronic opioid therapy based on risk level

4 Important Definitions Dependence Addiction (substance abuse disorder) Aberrant drug taking behavior Misuse Abuse Diversion Tolerance Pseudo-addiction (oligo-analgesia) Hyperalgesia

5 The Challenge in Treatment Untreated or undertreated pain Overdose, abuse, diversion

6 Important Definitions Dependence a physiologic, receptor response to an exogenous substance and the result from removing that substance Addiction (substance abuse disorder) Aberrant drug taking behavior Misuse Abuse Diversion Tolerance Pseudo-addiction (oligo-analgesia) Hyperalgesia

7 Important Definitions Dependence Addiction (substance abuse disorder) Impaired control over drug use, compulsive use, continued use despite harm, cravings Aberrant drug taking behavior Misuse Abuse Diversion Tolerance Pseudo-addiction (oligo-analgesia) Hyperalgesia

8 Important Definitions Dependence Addiction (substance abuse disorder) Aberrant drug taking behavior Any drug-related behaviors other than taking the med exactly as prescribed Misuse Abuse Diversion Tolerance Pseudo-addiction (oligo-analgesia) Hyperalgesia

9 Important Definitions Dependence Addiction (substance abuse disorder) Aberrant drug taking behavior Misuse The use of a medication, FOR THERAPEUTIC INTENT, other than exactly as directed by the prescriber Abuse Diversion Tolerance Pseudo-addiction (oligo-analgesia) Hyperalgesia

10 Important Definitions Dependence Addiction (substance abuse disorder) Aberrant drug taking behavior Misuse Abuse The use of a substance for a non-medical purpose to alter one’s state of conciousness Diversion Tolerance Pseudo-addiction (oligo-analgesia) Hyperalgesia

11 Important Definitions Dependence Addiction (substance abuse disorder) Aberrant drug taking behavior Misuse Abuse Diversion Knowingly transferring a controlled substance to a recipient other than for whom the substance is prescribed Tolerance Pseudo-addiction (oligo-analgesia) Hyperalgesia

12 Important Definitions Dependence Addiction (substance abuse disorder) Aberrant drug taking behavior Misuse Abuse Diversion Tolerance A state of pharmacological adaptation to a drug in which either efficacy or side effects diminish over time and higher doses are required to maintain effect Pseudo-addiction (oligo-analgesia) Hyperalgesia

13 Important Definitions Dependence Addiction (substance abuse disorder) Aberrant drug taking behavior Misuse Abuse Diversion Tolerance Pseudo-addiction (oligo-analgesia) exhibiting aberrant or addicted behaviors due to undertreatment of a legitimate pain syndrome Hyperalgesia

14 Important Definitions Dependence Addiction (substance abuse disorder) Aberrant drug taking behavior Misuse Abuse Diversion Tolerance Pseudo-addiction (oligo-analgesia) Hyperalgesia A phenomenon in which stimuli that hurt induce a response greater than expected. Opioid-induced hyperalgesia is represented by a worsening of pain with escalation of dose Webster LR, Fine PG. Approaches to improve pain relief while minimizing abuse liability. J Pain 2010; 11(7):

15 Guidelines on opioid use GuidelineYes or No?Caveats Chou (APS & AAPM)Yes, moderate to severe pain ; benefits outweigh risks Risk assessment, strict monitoring, and exit strategies Am Geriatrics SocietyYes, moderate to severe pain; benefits outweigh risks What is conventional practice for pain syndrome? Is prescriber qualified or should specialist be consulted Trescot (ASIPP)Maybe, severe pain; benefits must strongly outweigh risks Provides decision algorithm and extensive review, no clear recs 1.Chou R, et al. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain 2009;10(2): American Geriatrics Society. Pharmacologic management of persistent pain in older persons. J Am Geriatr Soc 2009;57: Trescot AM, et al. Opioids in the management of chronic non-cancer pain: An update of American Society of Interventional Pain Physicians’ Guidelines. Pain Physician 2008;11(2 Suppl):S5-S62.

16 Cochrane Systematic Review: Long-term opioid management for chronic noncancer pain Noble M, Treadwell JR, Tregear SJ, Coates VH, Wiffen PJ, Akafomo C, Schoelles KM. Long-term opioid management for chronic noncancer pain. Cochrane Database of Systematic Reviews 2010, Issue 1. Art. No.: CD DOI: / CD pub2 RouteDiscontinued AE Discontinued Lack of Efficacy Aberrant Behavior Oral (n=3040)22.9%10.3% 0.27% Transdermal (n = 1628) 12.1%5.8% Intrathecal (n = 231) 7.6%

17 What is considered “high dose” Walker JM, et al. Chronic opioid use is a risk factor for the development of central sleep apnea and ataxic breathing. J Clin Sleep Med 2007;3(5):

18 How and what should we monitor (inpatient)? Opioid induced sedation Ramsay Pasero Opioid-Induced Sedation Scale (POSS) Respiratory depression Respiratory rate < 8? 10? Continuous pulse-oximetry End-tidal capnography Jarzyna D, et al. American Society for Pain Management Nursing guidelines on monitoring for opioid-induced sedation and respiratory depression. Pain Management Nursing 2011;12(3):

19 Validated Risk Assessment Tools Acronym of tool α Number of questionsCompletionTime to complete SOAPP®-R24 itemsSelf-report< 10 minutes DIRE7 itemsClinician administered< 5 minutes ORT5 itemsClinician administered< 5 minutes COMM40 itemsSelf-report< 10 minutes CAGE4 itemsEither< 5 minutes PDUQ42 itemsClinician administered20 minutes STAR14 itemsSelf-report< 5 minutes SISAP5 itemsClinician administered< 5 minutes PMQ26 itemsSelf-report< 10 minutes α - SOAPP®-R (Screener and Opioid Assessment for Patient’s in Pain-revised); DIRE (Diagnosis, Intractability, Risk, and Efficacy); ORT (Webster’s Opioid Risk Tool); COMM (Current Opioid Misuse Measure); CAGE (Cut-down, Annoyed, Guilt, Eye-opener); PDUQ (Prescription Drug Use Questionnaire); STAR (Screening Tool for Addiction Risk); SISAP (Screening Instrument for Substance Abuse Potential); PMQ (Pain Medication Questionnaire)

20 Example of common screening tool Opioid Risk Tool Family history of substance abuseFemaleMale Alcohol1 point3 points Illegal drugs2 points3 points Prescription drugs4 points Personal History of Substance abuseFemaleMale Alcohol3 points Illegal Drugs4 points Prescription Drugs5 points Age (16 yrs to 45 yrs)1 point Preadolescent sexual abuse3 points0 points Depression1 point ADD, OCD, Bipolar, or Schizophrenia2 points Low Risk 0 – 3 points, Moderate Risk 4 – 7 points, High Risk > 8 points Webster LR, Webster RM. Predicting aberrant behaviors in opioid treated patients. Pain Med 2005;6(6)

21 Opioid Metabolism

22 Phase I Enzyme(s) Metabolite (s)Phase II Enzyme/Metaboli te BuprenorphineCYP 3A4NorbuprenorphineUGT/ Glucoronides Codeine (Prodrug) CYP 2D6, CYP 3A4Morphine, Noroxycodone UGT/ Glucoronides FentanylCYP3A4NorfentanylN/A HydrocodoneCYP 2D6 CYP 3A4 Hydromorphone Norhydrocodone UGT/Glucoronides HydromorphoneN/A UGT/Glucoronides MethadoneCYP 3A4, 2D6, 2C19, 2C8, 2C9, 2B6 EDDPN/A MorphineN/A UGT/Glucoronides (A) OxycodoneCYP 2D6 CYP 3A4 Oxymorphone Noroxycodone UGT/Glucoronides OxymorphoneN/A UGT/Glucoronides TapentadolCYP2D6, 2C9 & 2C19 (all minor) Inactive metabolitesUGT/Glucoronides Tramadol (Prodrug) CYP2D6 (major) CYP 3A4 O- desmethyltramadol (M1) N-desmethyltramadol Glucoronidation and/or sulfation

23 Drug Testing Biological specimens Urine, blood, hair, saliva, sweat, and nails All have different specificity and sensitivity Urine mostly preferred Ease of collection Possibly higher drug concentrations and longer detection window

24 Urine Drug Screen Immunoassay Most commonly used Disadvantage – false positives Gas chromatography – mass spectrometry (GC –MS) Confirmatory test for specific drug More sensitive and reliable Disadvantage - Cost * Know which test your institution uses are what compounds are being tested

25 Length Detection Time in Urine DrugTime Codeine48 Hours Hydromorphone2 -4 Days Methadone3 Days Morphine48 – 72 Hours Oxycodone2 -4 Days Alcohol7 – 12 Hours Cocaine2 -4 Days Marijuana Single Use Moderate Use (4x’s/week) Daily Use Long – Term Heavy Smoker 3 Days 5 – 7 Days 10 – 15 Days > 30 Days Moeller KE, Lee KC, Kissack JC. Urine drug screening: practical guide for clinicians. Mayo Clin Proc. 2008;83(1):

26 Presented by CO*RE Collaboration for REMS Education Achieving Safe Use While Improving Patient Care Presented by CO*RE Collaboration for REMS Education Collaborative for REMS Education

27 Patient Counseling Document Required for CR / LA REMS DO Read the med guide Take exactly as prescribed Flush unused meds down toilet Call healthcare provider for med advise or SE DON’T Give your medicine to others Take medicine unless prescribed for you Stop taking your medicine without direction Break, chew, crush, dissolve, or inject your medicine Drink alcohol while taking this medicine Accessed 10/12/12.

28 Patient-Prescriber Agreement Form Required for TIRF REMS

29 Appropriate Documentation The 4 “As” of pain management Analgesia Adverse effects Aberrant drug taking behavior Activity Diagnosis, prognosis, and correlation of symptoms

30 Chronic Disease Management Principles Risk assessment Opioid risk tools Psychiatric screens Previous record review Policies and expectations Office visits Nursing utilization ED utilization Refill policies Non-pharm adherence Education / referral Individual Group Treatment agreements Consent Educational Punitive Conduct agreements Risk management PMP review Drug screening Pill count Case discussion Assessment Validated scales The 4 “A”s Frequency of visits VAS: visual analog scale; NRS: numeric rating scale; BPI: Brief Pain Inventory; MPQ: McGill Pain Questionnaire; NPRS: Neuropathic Pain Rating Scale Pathways for primary care

31 Conclusions


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