Principles for more cautious and selective opioid prescribing for chronic non-cancer pain

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Presentation was originally done at Group Health Cooperative’s National Summit on Opioid Safety: http://www.ghinnovates.org/?p=3502 …

Presentation was originally done at Group Health Cooperative’s National Summit on Opioid Safety: http://www.ghinnovates.org/?p=3502
Presentation by: Jane C. Ballantyne, MD FRCA, with the Department of Anesthesiology and Pain Medicine at UW Medicine.

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  • 1. Principles for more cautious and selective opioid prescribing for chronic non-cancer pain JANE C. BALLANTYNE MD FRCA DEPARTMENT OF ANESTHESIOLOGY AND PAIN MEDICINE
  • 2. Silas Weir Mitchell in “Characteristics”, an autobiographical account of his experience treating injured soldiers after the Civil War, 1866If any man want to learn sympathetic charity, let him keep pain subdued for sixmonths by morphia, and then make the experiment of giving up the drug. Bythis time he will have become irritable, nervous and cowardly. The nerves,muffled, so to speak, by narcotics, will have grown to be not less sensitive butacutely, abnormally capable of feeling pain, and of feeling as pain a multitudeof things not usually competent to cause it.
  • 3. 20th century and a new moral imperative Caution persisted throughout most of the century Until the 1980s, the teaching was that opioids did not work well for chronic pain, and addiction risk was unacceptably high Change came about for two reasons:  Palliative care specialists believed that chronic pain was equally deserving of treatment with strong analgesics and that existence of pain somehow protected against addiction  Pharmaceutical industry developed and aggressively promoted „designer‟ opioids
  • 4. 2003 No support in the literature for using high doses High doses associated with sensitization (hyperalgesia) as well as desensitization (tolerance) High doses associated with endocrine and immune consequences
  • 5. Current evidence Observational Epidemiological Clinical case series and open label  For wider population, analgesic follow up studies support efficacy effectiveness is not substantiated and safety of opioids  Function of opioid treated patients seems poor, opioid treated pain patients are less Generally doses are low to likely to work than non-treated matched moderate and length of treatment cohorts is 1-2 yrs, pain relief is partial  Lack of safety of opioids has been revealed, especially for high doses (death, No conclusion on function or fracture, endocrine effects) quality of life  Beginning to understand how many dose escalate (most of those that stay on) Many people who are started on opioids discontinue either because  Beginning to understand who dose of adverse effects or inadequate escalates (adverse selection) pain relief
  • 6. Is the difference a reflection of duration and dose?Short term effectiveness Longer term effectiveness After a reasonable trial of non-opioid and non-pharmacological treatments,  3 yrs later her dose has been escalated she is started on opioids multiple times, usually after adverse life events 6 months later pain and function have improved  She no longer has good pain relief, has stopped working, and no dose is enough
  • 7. Why populations look worse than published cohortsCohort of patients who Population of patients at astart on opioids given time point Do well Do well Unknown Unknown Do bady Do badly Come off Come off
  • 8. Charles Alexander Bruce “Report on the Manufacture of Tea and on the extent and produce of the tea plantations in Assam” Calcutta, 1839. This Scottish superintendent of tea culture in Assam pleads for the cessation of poppy culture and the prohibition of opium imports.This vile drug has kept, and does now keep down the population: the womenhave fewer children than those of other countries, and the children…ingeneral die at manhood; very few old men being seen in this unfortunatecountry in comparison with others. Would it not be the highest of blessings, ifour humane and enlightened Government would stop these evils by a singledash of the pen, and save Assam, and all those who are about to emigrate intoit as Tea cultivators, from the dreadful results attendant on the habitual useof Opium? We should in the end be richly rewarded by having a fine healthyrace of men growing up for our plantations, to fell our forests. This can neverbe affected by the feeble opium-smokers of Assam, who are more effeminatethan women.
  • 9. Longer duration and higher dose associated with Higher rates of overdose and death Less likelihood of being able to wean if necessary  Difficulty controlling acute pain, surgical recovery, terminal pain  Continued use during pregnancy – neonatal abstinence Higher rates of mental health & substance use disorder, less able to control usage Higher rates of falls and fractures in the elderly Less likelihood of returning to function or work Higher rates of endocrinopathy affecting fertility, libido & drive Higher rates of immune dysfunction1. Dunn KM, Saunders KW, Rutter CM, et al. Ann Intern Med. Jan 19 2010;152(2):85-92.2. Martin BC, Fan MY, Edlund MJ et al J Gen Intern Med. Dec 2011;26(12):1450-1457.3. Miller M, Sturmer T, Azrael D et al J Am Geriatr Soc. Mar 2011;59(3):430-438.4. Darnall BD, Stacey BR. Arch Intern Med. Mar 12 2012;172(5):431-432.5. Afsharimani B, Cabot P, Parat MO. Cancer Metastasis Rev. Jun 2011;30(2):225-238.6. Tavare AN, Perry NJ, Benzonana LL, Takata M, Ma D. . Int J Cancer. Mar 15 2012;130(6):1237-1250.
  • 10. Principles for more cautious and selective opioid prescribing for chronic non-cancer pain First major principle For 90% chronic pain presenting to primary care physicians, medical approaches are often unsatisfactory Second major principle Opioids do not have proven efficacy or safety at high doses or for prolonged usage
  • 11. First major principle Medical approaches are often unsatisfactoryRecognition of this is the cultural change needed
  • 12. “The problem ofunrelieved pain remainsas urgent as ever.”“At least 100 millionAmericans suffer fromchronic pain, costing upto $635 billion annuallyin treatment and lostproductivity.”“In the committee‟sview, addressing thenation‟s enormousburden of pain willrequire a culturaltransformation in theway pain isunderstood, assessed, an Cultural transformation?d treated.”
  • 13. Cultural transformation needed is demedicalization of the most common pain conditions OLD PATHWAY NEW PATHWAY
  • 14. Treating chronic pain Chronic pain is never simple Use measurement tools as a means of understanding the scope of the problem  eg PHQ-9, GAD, ORT Primary treatments for chronic pain i. Motivation/activation/self-help ii. Counseling Secondary treatments for chronic pain i. Low risk analgesics (eg gabapentin) ii. Psych meds for depression/anxiety/PTSD
  • 15. Second major principle Opioids have proven efficacy and (relative) safety for the treatment of acute pain and pain at the end of lifeOpioids do not have proven efficacy and safety for the treatment of pain long-term1.Ballantyne JC, Shin N.S. Clin J Pain. 2008;24(6):469-478.2.Ballantyne JC. Data review presented to FDA May 30th and 31st 2012. 2012.3.Noble M, Treadwell JR, Tregear SJ, et al. Cochrane Database Syst Rev. 2010(1):CD006605.4.Eriksen J, Sjogren P, Bruera E, et al Pain. 2006 2006;125:172-179.5.Dillie KS, Fleming, M.F., Mundt, M.P., French, M.T. J Am Board Fam Med. 2008;21(2):108-117.6.Toblin RL, Mack KA, Perveen G, Paulozzi LJ. Pain. Jun 2011;152(6):1249-1255.
  • 16. Lack of supportive evidence for efficacy and safety underlies the need to reserve opioids for serious pain What is serious pain? Pain with a clear pathoanatomic or disease basis Underlying cause is disabling  Cannot be improved by primary disease treatment or lifestyle changes (eg elderly, disabled) Goal of pain treatment is comfort All other treatments (best efforts) have failed1.Chou R, Fanciullo GJ, Fine PG, et al. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain.J Pain. Feb 2009;10(2):113-130.2.Sullivan MD, Ballantyne JC. What are we treating with chronic opioid therapy? Arch Int Med. 2012;172(5):433-434.
  • 17. 90 days is a key point 90 days is often used in definitions of chronic pain Studies show that after 90 days continuous use, opioid treatment is more likely to become life- long Studies show that patients who continue opioids > 90 days tend to be high risk patients 1.Turk DC, Okifuji A. Pain terms and taxonomies. In: Bonicas Management of Pain (4th ed). 2.Braden JB, Fan MY, Edlund MJ et al J Pain. Nov 2008;9(11):1026-1035. 3.Korff MV, Saunders K, Thomas Ray G, et al. Clin J Pain. Jul-Aug 2008;24(6):521-527. 4.Martin BC, Fan MY, Edlund MJ et al J Gen Intern Med. Dec 2011;26(12):1450-1457. 5.Volinn E, Fargo JD, Fine PG. Pain. Apr 2009;142(3):194-201.
  • 18. You get to 90 days Is the patient a suitable candidate for opioids? BENEFIT RISK Intractable pain-  Substance abuse Hx producing disease  Family Hx sub abuse  Childhood sexual abuse Goal is comfort  PTSD  Anxiety1.Sullivan MD, Ballantyne JC. Arch Int Med. 2012;172(5):433-434.  Depression2.Martin BC, Fan MY, Edlund MJ et al J Gen Intern Med. Dec2011;26(12):1450-1457.3.Schwartz AC, Bradley R, Penza KM, et al. Psychosomatics. Mar-  Other MHDApr 2006;47(2):136-142.4.Seal KH, Shi Y, Cohen G et al JAMA. 2012;307(9):940-947.
  • 19. Principles of chronic opioid therapyExpect it to be time consuming and resource heavy
  • 20. If the choice is to continue Develop clear understanding of risks and benefits (use care agreement) Use single prescriber, single pharmacy Regular pick up Monitor  Pain and function  Psych status  Prescription monitoring service (if available)  UDTs Continue counseling 1.Chou R, Fanciullo GJ, Fine PG, et al. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. Feb 2009;10(2):113-130. 2.Source: Agency Medical Directors‟ Group http://www.agencymeddirectors.wa.gov/Files/OpioidGdline.
  • 21. General principles for dosing At treatment initiation, establish effective dose Start with short-acting, taken as needed Dose escalation may be needed to overcome tolerance, but should be modest Doses > 100 mg morphine or morphine equivalence require close scrutiny because safety is markedly compromised at this dosing level Long-acting opioids are less useful because of tolerance, may be indicated for „maintenance‟ 1.Martin BC, Fan MY, Edlund MJ et al J Gen Intern Med. Dec 2011;26(12):1450-1457. 2.Edlund MJ, Martin BC, Fan MY et al Drug Alcohol Depend. Nov 1 2010;112(1-2):90-98. 3.Saunders KW, Dunn KM, Merrill JO, et al. J Gen Intern Med. Apr 2010;25(4):310-315. 4.Von Korff M, Merrill JO, Rutter CM et al Pain 2011;152:1256-62
  • 22. Doses > 100 mg MED are a red flag Pain is not responsive Insurmountable tolerance (no dose is enough) Difficulty controlling use Misuse 1.Morasco BJ, Duckart JP, Carr TP et al Pain. Dec 2010;151(3):625-632. Addiction 2.Edlund MJ, Martin BC, Fan MY et al Drug Alcohol Depend. Nov 1 2010;112(1- 2):90-98. Diversion 3.Weisner CM, Campbell CI, Ray GT, et al. Pain. Oct 2009;145(3):287-293.
  • 23. SUMMARY Basic principles for cautious opioid prescribing Opioids do NOT have proven efficacy and safety for treating chronic pain Opioids are powerful drugs and should be reserved for serious pain Chronic pain is never simple – approach holistically Measurement based care is the new gold standard Chronic opioid therapy is not a simple solution; expect it to be time and resource heavy 90 days is a key point for reassessment > 100 mg MED is a red flag
  • 24. Tightening the lid on pain prescriptions Barry Meier, NYT April 8 2012Few programs are in place to deal with patients now onhigh opioid dosages who are not benefiting from them. Ifthe patients were taken off the medications, many wouldexperience severe withdrawal or have to take addictiontreatment drugs for years. Even avid believers in the newdirection, like Dr. Ballantyne, suggest that it might benecessary to keep those patients on the opioids and tofocus instead on preventing new pain patients from gettingcaught in the cycle.“I think we are dealing with a lost generation of patients,”she said.