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Grand Rounds Lehigh Valley Hospital February 23, 2005 James Patrick Murphy, M.D. * Medical Director Murphy Pain Center * Assistant Clinical Professor University of Louisville School of Medicine * Chair, Controlled Substances Taskforce Jefferson County (KY) Medical Society * Board of Directors Kentucky Pain Society C O M P L I A N C E ONE opioid. ONE pill 3 DOSES as often as PDR allows. Impact of Chronic Pain 35% of Americans suffer from chronic pain 50 million workdays are lost per year $100 billion is the estimated annual cost in lost productivity, medical costs, and lost income Diversion is Big Business A close second to cocaine More than heroin and marijuana Growing by 27% per year. Ref: ASAM Common Threads V, p. 272 Definitions Narcotic = Opioid ? Tolerance Dependence Addiction DSM-IV “Dependence” ( 3 or more in 12 months ) TOLERANCE WITHDRAWAL LARGER AMOUNTS THAN INTENDED UNSUCCESSFUL ATTEMPT TO QUIT TIME & ENERGY SPENT OBTAINING SOCIAL /OCCUPATIONAL SUFFERS USE DESPITE KNOWLEDGE OF HARM Addiction primary chronic Factors: genetic psychosocial environmental factors One or more: impaired control over drug use compulsive use continued use despite harm craving (ref: Principles of Addiction Medicine, 3rd ed.) neurobiologic Risk Factors for Addiction Environment occupation, peer group, culture, social instability Patient genetics, multiproblem family, psychiatric disorder Drug Availability Cost Speed reaching the brain Efficacy as a tranquilizer DRUG ABUSE WARNING NETWORK From 1995 – 2002 Narcotic mentions rose by 163 % From 1994 – 2001 Oxycodone increased Morphine increased Hydrocodone increased 230 % 210 % 131 % The Four D’s Dated Duped Disabled Dishonest The 5th D … DEFIANT High Maintenance 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. Credentials posted NADDI posted Location of office CME Join Organizations Police newsletter Police relationship Licensed personnel Screening patients No CS first visit KASPER UDT Pill counts Background checks Typed dictation Articles posted Pain School Support group Psychologist in office Complete records CS compliance flow chart Treatment agreements Fellowship training ASAM Addiction board certification Must come to office to make appmt No CS on premises Flow sheet in chart 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. KBML guidelines posted Speaking engagements Work with pharmaceutical reps Task force Media interviews Frequent follow ups Consultations Full evaluations FCE Goals DAST PAS Communication with primary care Only take referrals/no walk ins. 100 mile radius Team meetings MPC ladder SAFE score MPC aberrancy rating Write numerals on Rx Copy all rx Letter to pharmacies One pharmacy Non reproducible rx pad Lock rx pads in safe Two signatures on rx No call in of rx Numbered rx Fill date on rx Read three FAQs ? ...NOT SO FAST ! www.medsch.wisc.edu/ painpolicy www.usdoj.gov/dea www.Stoppain.org The Murphy Pain Center Therapeutic Ladder for Chronic Non-Malignant Pain W.H.O. CANCER PAIN MANAGEMENT LADDER Adapted from the World Health Organization Is there a “ceiling” to opioid dosing ? Concerns: addiction, diversion, pain, tolerance, toxicity, immunity, endocrine ( and the “RADAR SCREEN” ) ONE opioid. ONE pill per dose. 3 DOSES per day (or less) as often as PDR allows. Name: Ima Hurtin Date: today ____________________________________________ Rx: most appropriate opioid Mgm: as determined by careful titration Sig: ONE, per PDR recommendation Dispense: one month supply (no refills) Name: Ima Hurtin Date: today ____________________________________________ Rx: Percocet Mgm: 5 mgm / 325 Sig: ONE q. 4 – 6 hours prn (maximum of 3 per day) Dispense: 90 (one month supply) Name: Ima Hurtin Date: today ____________________________________________ Rx: Avinza Mgm: 30 mgm Sig: ONE p.o. daily Dispense: # 30 Step 3 What if they “need” more? PPPP P athological New disease Progression of disease P harmacological Tolerance Toxicity P sychological Depression Addiction P olice Diversion Advantages “Acceptable” pain control Less OPIOCENTRIC regimen Fewer pills (with your name on them) Less addiction, tolerance, toxicity, & diversion Less time on the “RADAR SCREEN” Disadvantages Some patients truly need a “designer” regimen. Higher doses may be needed. Some patients will need “breakthrough” meds. Solutions: Team meeting Specialty consultation Avinza Spheroidal Oral Drug Absorption System 15. AVINZA® prescribing information. San Diego, CA: Ligand Pharmaceuticals Incorporated; March 2002. Pharmacokinetics of AVINZA® (morphine sulfate extended-release capsules) vs Immediate-release Morphine Solution (IRMS)*15 Morphine Concentration (ng/mL) 18 AVINZA once daily IRMS 6 times daily 16 14 12 10 8 6 4 2 0 0 2 4 6 8 10 12 14 16 18 20 22 24 Time (hours) *Eliot L, Loewen G, Butler J, et al. 17th Annual Meeting of the American Academy of Pain Medicine; February 16, 2001; Miami, FL. Abstract and poster. 15. AVINZA® prescribing information. San Diego, CA: Ligand Pharmaceuticals Incorporated; March 2002. Pharmacokinetics of AVINZA® (morphine sulfate extended-release capsules) vs MS Contin (MSC)18 Morphine Concentration (ng/mL) 24 AVINZA once daily MSC twice daily 20 16 12 8 4 0 0 4 8 12 16 20 24 Time (hours) *Dose-normalized to a 100-mg daily dose. 18. Portenoy RK, Sciberras A, Eliot L, Loewen G, Butler J, Devane J. Steady-state pharmacokinetic comparison of a new, extended-release, once-daily, morphine formulation, AVINZA®, and a twice-daily controlled release morphine formulation in patients with chronic moderate-to-severe pain. J Pain Symptom Manage. 2002;23:292-300. Steady-state Pharmacokinetics of AVINZA® (morphine sulfate extendedrelease capsules) vs OxyContin®19 % Maximum Concentration 100 AVINZA once daily OxyContin twice daily 80 60 40 20 0 5 10 15 20 25 Time (hours) 19. Eliot L, Geiser R, Loewen G. Steady-state pharmacokinetic comparison of a new, once-daily, extended-release morphine formulation (Morphelan™) and OxyContin® twice daily. J Oncol Pharm Pract. 2001;7:1-8. AVINZA® (morphine sulfate extendedrelease capsules) “Sprinkle-dose” Pharmacokinetics21 Morphine Concentration (ng/mL) 8 7 6 5 Sprinkle Dose Intact Capsule 4 3 2 1 0 0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 Time (hours) 21. Eliot L, Butler J, Devane J, Loewen G. Pharmacokinetic evaluation of a sprinkle-dose regimen of a once-daily, extended-release morphine formulation. Clin Ther. 2002;24:260-268. Avinza A capsule is not preferred on the “street” 30 pills per month (fewer DAWN mentions?) No bolus effect (fewer side effects?) Enters brain slowly (less euphoria / addiction?) Level steady state (less tolerance?) Easy to titrate slowly (less risk of overmedication) Pearls Sell the patient on the drug. Don’t try to go from a handful of short actings to Avinza. Use the “aberrancy moment” to make the change to Avinza. COMPLIANCE Model Policy for the Use of Controlled Substances for the Treatment of Pain May 2004 Federation of State Medical Boards of the United States www.fsmb.org The Board will judge the validity of the physician’s treatment based on available documentation C ompliance monitored O ften assessed M edical Records P lan of treatment L egitimate diagnosis I nformed consent A ddiction assessment N on-addictive medications C onsultation(s) E valuation (History and Physical) Compliance “The Board expects that physicians incorporate safeguards into their practices to minimize the potential for abuse and diversion” Drug screens / pill counts / PMP Often Assessed o c mpliance AAAA The Four A’s Analgesia Activities of daily living Adverse effects Aberrant drug-related behaviors Ref: Passik SD, et al. Clin Ther. 2004;26:552-561 Medical Records coMpliance Up to date / Accessible Plan comPliance “…should state objectives that will be used to determine success” L egitimate comp Liance “Physicians will not be sanctioned for prescribing opioid analgesics for legitimate medical purposes.” “Legitimate… if based on sound clinical judgment” “Document one or more recognized medical indications for the use of a controlled substance” Informed Consent complIance “The physician should discuss the risks and benefits of the use of controlled substances” Addiction Screen Ance compli “Special attention should be given to those patients with pain who are at risk for medication misuse, abuse or diversion.” Prevalence of Illicit Drug Use in KY % Third Party Medicare M/M Medicaid Illicit 17 10 24 39 Other opioid 2 2 3 6 Absence 26 24 36 56 Total 30 26 40 60 Ref: Manchikanti KMA Feb 2005 Non-Addictive Trial complia Nce “The Board will refer to current clinical practice guidelines….” WHO PAIN MANAGEMENT LADDER Adapted from the World Health Organization Consultation complianCe “The physician should be willing to refer the patient as necessary for additional evaluation and treatment.” Evaluation compliancE “A medical history and physical must be obtained.” Content reflects the complexity of case. Substance abuse history. C ompliance monitored O ften assessed M edical Records P lan of treatment L egitimate diagnosis I nformed consent A ddiction assessment N on-addictive medications C onsultation(s) E valuation (History and Physical) C O M P L I A N C E ONE opioid. ONE pill 3 DOSES as often as PDR allows. Websites www.legalsideofpain.com www.murphypaincenter.com [email protected]