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Chronic opioid therapy in headache

Chronic opioid therapy in headache. Richard Wenzel, Pharm.D. Diamond Headache Clinic Inpatient Unit Chicago, IL. Disclosures. Speaker’s bureau, GlaxoSmithKline. Grim data. The United States of America: constitutes ~ 5% of the world’s population

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Chronic opioid therapy in headache

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  1. Chronic opioid therapy in headache Richard Wenzel, Pharm.D. Diamond Headache Clinic Inpatient Unit Chicago, IL

  2. Disclosures • Speaker’s bureau, GlaxoSmithKline

  3. Grim data The United States of America: • constitutes ~ 5% of the world’s population • consumes 80% of the global legal opiod supply • consumes 99% of the global hydrocodone supply • consumes 66% of the global illegal drug supply Pain Physician 2008:11:S63-S88

  4. Opioids in chronic pain: systemic review of efficacy and safety • 11 trials • Mean pain relief ~ 30% • Only 44% of open-label opiod patients elected to continue therapy • Dropout rate due to side effects ~ 33% • 5 of 8 studies failed to show improved function Kalso E, et al. Pain 2004;112:372-380

  5. Laboratory monitoring of Oxycontin™ (oxycodone): clinical pitfalls • Suspected patient of abusing or misusing (selling?) OxyContin™ • Frequent requests for dose escalation due to poor headache pain control • Urine-based immunoassay oxycodone drug screen was negative • Dismissed the patient from the physician’s practice • At the (distraught) patient's request, a second test using gas chromatography- mass spectrometry (quantitative, more sensitive) was performed on original urine sample, results were positive • For the urine-based immunoassay, the minimum level threshold was too high to detect the presence of oxycodone • Communication is essential Von Seggern RL, et al. Headache 2004;44:44-47.

  6. End Organ Damage Possibly Associated With Chronic Migraine “…..exposure to repeated attacks and sustained doses of analgesics appears to result in brainstem changes as patients progress from EM to CM…..they [brainstem changes] will tend to increase attack frequency and hence analgesic consumption.” Aurora SK, et al. Headache 2007;996-1003. Accompanying editorial comment – Dodick DW. Headache 2007;1004-1007 Welch KMA, et al. Headache. 2001;41:629-637; Kurth T, et al. BMJ. 2011;342:c7357; McWilliams L, et al. Pain. 2004; 111:77-83; O’Bryant SE, et al. Headache. 2006;46:1364-1376; Bigal M, et al. Headache. 2006;46:1334-1343; Breslau N, et al. Neurology. 2003;60:1308-1312.

  7. U.S Headache Consortium evidenced-based migraine treatment guidelines http://www.neurology.org/cgi/reprint/55/6/754.pdf Neurology 2000;55:754-762 American Academy of Family Physicians American Academy of Neurology American Headache Society American College of Emergency Physicians American College of Physicians/American Society of Internal Medicine American Osteopathic Association National Headache Foundation.

  8. General goalsUS Consortium Establish diagnosis Educate patient Preventive/acute drugs, devices, limits of use Set realistic expectations No cures, only management Create formal management plan Avoid precipitating causes

  9. Stratified care Endorsed by U.S. Headache Consortium Stratified-care - assess aggregate burden of migraine on patients’ lives, patients suffering most debilitating illness are prescribed migraine specific drugs from the onset

  10. Stratified Care MIDAS HIT Low Need OTCs DisabilityAssessment MigraineDiagnosis Moderate Need OTCs, Rx High Need Migraine Rx, Preventive Rx

  11. Migraine drug therapy Abortive/acute Intended to halt or significantly reduce an attack that is occurring or is about to occur Preventive Decrease frequency, severity, or duration of attacks

  12. Acute treatment goalsUS Consortium Treat attacks rapidly and consistently without recurrence RESTORE ABILITY TO FUNCTION Minimize use of rescue medications Optimize self-care Be cost-effective Minimal adverse effects Headache 2006;46:773-780.

  13. Quality of evidence = AScientific effect = ++/+++Clinical impression = ++/+++US Consortium Triptans by oral, nasal, subcutaneous Dihydroergotamine intranasal “limit use due to increased risk of rebound and dependency” • Butorphanol nasal spray • Acetaminophen plus codeine

  14. Quality of evidence = B • “Limit use. Reserved for emergency department use or rescue medication.” • Butorphanol IM • Meperidine IM/IV • Methadone IM

  15. Narcotic use among headache sufferers • American Migraine Prevalence and Prevention Study (AMPP); longitudinal, population-based • Questionnaires sent to 120,000 U.S. households • ~78,000 responses • Narcotic data from subset analysis of ~ 28,000 “severe headache” patients, 2005 to 2009 Headache 2012;52:18-36.

  16. Medication use among all migraineurs • 18% triptans • 12% narcotics • 6% butalbital-containing product Headache 2012;52:18-36.

  17. AMPP narcotic use among “severe” sufferers • 70% non-narcotic users • 16% current narcotic users (within last 90 days) • 14% previous users (use during 2005-2008, but no current use) • Among narcotic users: • 66% used one narcotic agent • 20% use two agents • 8% used three agents • 94% also consumed at least one non-narcotic headache medication

  18. AMPP narcotic use among “severe” sufferers • 42% were prescribed hydrocodone product • 23% acetaminophen with codeine • 21% acetaminophen with propoxyphene

  19. AMPP narcotic use among “severe” sufferers • Compared to non-narcotic users, narcotic users had statistically significantly more: • Depression and/or anxiety • Consumption of health care resources (physician visits, ER visits, specialists visits) • Likelihood to be unmarried, unemployed, and have a lower household income

  20. When to consider chronic narcotics for headache? • Individualized • Greater than 15 days/month, intractable severe pain unresponsive to reasonable outpatient (inpatient?) therapies administered over the span of months to years • Absence of significant psychiatric disorders, including absence of addiction history • Practitioner dependent • Knowledge with prescribing nacotics - > consider referral • Resources for continual monitoring • Established practitioner/patient relationship

  21. Scheduled narcotic therapy for chronic headache • Potential advantages • Improved functionality • Provides continuous, often pre-emptive pain-relief • Restore proper pathophysiology of dysfunctional CNS opioid functions? • Improved quality of life • others • Potential disadvantages • Tolerance/habituation • Misuse/abuse • Medication-induced headache/hyperalgesia? • tolerability

  22. Some keys to success • Consider narcotic contract with patient • Single prescriber, no replacements for “lost” prescriptions, no “missed” appointments, family/partner input • Documentation • indication, expected benefits/risks, reasons for discontinuation, potential for withdrawal, etc. • Psychological services – initial and ongoing • Routine monitoring • functional status • adverse effects • inappropriate use – self-treating anxiety, insomnia, etc. • drug screen

  23. More keys • Educate patient • Sparse published literature to support opioid use • Little long-term efficacy data • No long-term safety studies • Realistic expectations

  24. Daily scheduled opioids for intractable head pain Saper J, et al. Neurology 2004;62:1687-1694

  25. Diagnoses 19% 10% 71% Saper, Neurology 2004

  26. Program description • Three year follow-up • Treatment contract • “Rescue” drugs as needed for exacerbation • Psychological interventions • Side effect management Saper, Neurology 2004

  27. Patient enrollment Total # 160 (100%) Continued program at least 3 years 70 (44%) Discontinued program 55 (34%) Lost to follow up 18 (11%) Transferred to local MD 10 (6%) Died (all non-headache related) 7 (4%) Saper, Neurology 2004

  28. Medications prescribed • Morphine • 52 patients (74%), median dose = 150mg (60mg-900mg) • Oxycodone • 14 patients (20%), median dose =85mg (10mg-360mg) • Methadone • 13 paients (19%), median dose = 30mg (7.5mg-70mg) • Fentanyl • 4 patients (6%), mean dose = 75mcg (8mcg-75mcg) Saper, Neurology 2004

  29. Outcome measures • Patients with at least 50% pain reduction at 3 years • 26% of initially enrolled patients (41/160) • 59% of 3-year patients (41/70) Saper, Neurology 2004

  30. Saper, Neurology 2004

  31. Other 3-year data • 67% reached 50% HI improvement within 1st month • No reduction in prophylactic or other rescue drugs • Efficacy unrelated to gender, diagnosis, anxiety/depression • Despite structured program (patient screening, contract, frequent visits, psych services, etc.) problem drug behavior observed in more than 50% of patients Saper, Neurology 2004

  32. Problem drug behaviorsDose violations, lost prescriptions, multiple prescribers, etc.

  33. Warning signs Dose escalation requests Self-initiated dose escalations Early refill requests Emergency Dept visits Missed appointments Lost prescriptions Forgery of prescriptions Multiple prescribers Conflicting history others Communication is essential

  34. Paradoxical hypersensitivity • Triptan efficacy decreases if a narcotic has been consumed within the previous 6 months • Opiod-induced hyperalgesia? • May lower pain-sensation threshold • NMDA receptor-mediated neurotoxicity? • Down-regulation of opiod receptors? • Increase in excitatory neuropeptides? • Often marked by allodynia and worsening pain despite increasing narcotic doses • Possibly irreversible Headache 2012;52:467-482 Anesthesiology 2006;104;570-587. Headache Curr 2006;3:53-62. J. Curr Pain Headache Rep 2006;10:67-70.

  35. Other unpublished data • Methadone only agent prescribed • 2.5mg-10mg tid • Antagonizing glutamate • 70% of “positive treatment response” patients at two months maintained this response at one year • “….represent a less complex group of patients..” Rothrock JF. Headache 2008;48:850-854. Rothrock JF. Headache 2007;47:1232-1233.

  36. Acute migraine medications and evolution from episodic to chronic migraine: AMPP “Compounds containing barbiturates and opiates were associated with a twofold increased risk of [transformed migraine]” - barbiturates OR 2.06, 95% CI = 1.3-3.1 - opiates OR = 1.98, 95% CI 1.4-2.8 Mean days/month of exposure Barbiturates = 10.74 Opiates = 9.91 ONE DOSE EVERY THREE DAYS Headache 2008;48:1157-1168.

  37. Evolution of Chronic Migraine Chronic Migraine Episodic Migraine Severe Impairment Mood and anxiety disorders Moderate Impairment Sleep disorders and IBS Mild Impairment Medication overuse Normal Cady R, et al. Curr Pain Headache Rep. 2005;9:47-52.

  38. Dependence-related behavior in medication-overuse headache (MOH) • 80% of individuals presenting to specialized headache centers with CDH are over-using acute medications, majority of which are narcotics • Lack of universally accepted MOH definition • MOH cause of, or consequence of, chronic headache • Difficult to determine without psychological assessment • Referral? Headache 2010;50:1597-1611

  39. Medication overuse headache (MOH) and dependence • Risk factors for dependence on acute medications • History of migraine, history of opiod overuse, previous withdrawal • “MOH thus appears to belong to the spectrum of addictive behaviors. In clinical practice, behavioral management of MOH should be undertaken besides pharmacological management.” Headache 2008;48:1026-1036.

  40. Differences in the personality profile of MOH suffers and drug addicts: MMPI-2 results • MOH patient – chronic pain controls the user’s behavior (e.g. seeking medications to avoid pain) • Addict – drug use controls the user’s behavior (e.g. seeking medications for euphoria and/or avoid withdrawal) Headache 2011;51:1212-1227.

  41. Patient “failing” therapy Failed several acute agents Early intervention? Non-oral route? Failed adequate trial of at least two preventives? Consider referral National Headache Foundation maintains a state-by-state list of headache physicians Patients can obtain this list for free www.headaches.org 888-643-5552

  42. Migraine in Emergency Department • 219 patients • 68% had taken medication within 24 hours prior to ED • 5% were on preventive medications prior to admission • 63% had no documented discharge medication • 64% reported return of headache within 24 hours of discharge • Only 22% were pain free upon discharge from ED Gupta MX, et al. Headache 2007;47:1125-1133.

  43. Treatment in ED 57 patients 65% given “migraine cocktail” Only four patients given migraine specific drug Per MD, 35% “headache resolved”, 29% “headache improved” Not a single patient was able to return to normal function at discharge Blumenthal H, et al. Headache 2003;43:1026-1031 Rankin L. Editorial. Headache 2003;43:1032-1033.

  44. “Repeater” phenomenon • 10% of ED headache patients are “repeaters”, accounting for 50% of all headache-related ED visits • In comparison to non-repeaters, repeaters are more: • Triptan-naïve • More alexithymic • Depressed Headache 2010;50:348-356.

  45. Treatment in Emergency Department Establish diagnosis Hydration, antiemetic, & supportive measures ED visits avoidable (or can be minimized) with improved education and outpatient therapy Enroll in appropriate outpatient therapy Contracts? Diamond S, et al. Headache Quarterly 2001;12:183-194. Diamond S, et al. Consultant 1999 (August):2313-2320. Schwartz TH, et al. Headache 2002;42:519-522. AAN. Neurology 1995;45:585-587.

  46. Treatment in ED Supported by RCT DHE 0.25mg –1mg IV, IM, SC Sumatriptan SC Droperidol IV Magnesium 0.5gm-1gm IV\ Haloperidol IM Supported by non-RTC evidence Valproic acid (next slide) Ketorolac 30mg-60mg IV, IM Levetiracetam 500mg-1000mg Metoclopramide IV Antihistamines (diphenhydramine IV/IM, hydroxyzine IM) Selective use of narcotics (contracts?) Headache 2012;52:114-128 Headache 2012;52:292-306 Headache 2012;52:467-482

  47. Rapid infusion valproic acid Recent and ongoing research 300mg – 1000mg per dose May be given two to four times daily May be given with oral formulations Serum levels do not correlate with efficacy Dilute in 50ml Normal Saline infused 5 to 15 minutes Can be diluted 1:1 in syringe for slow IV push TERATOGENIC (need pregnancy test) Norton J. Headache 2000;40:755-757 Edwards K, et al. Headache 2001;41-976-980

  48. “Do butalbital-containing products (BCP) have a role in the management of migraine?” • Butalbital-containing products (BCP) given to 17% to 36% of diagnosed migraineurs, often as treatment of choice • National Ambulatory Medical Care Survey • #1 = BCP with 2.3 million prescriptions • NOT A SINGLE TRIAL EXISTS DEMONSTRATING BCP ARE EFFECTIVE FOR MIGRAINE • BCP are well-established causes of dependency, withdrawal symptoms, MIH, poorly controlling migraine • Women are 164% more likely than men to get a BCP Wenzel R, Sarvis C. Pharmacotherapy 2002;22(8):1029-1035. Headache 2012;52:672-674 Headache 2010;50:1194-1197. ]

  49. “Should butalbital-containing products be banned? Yes”Young M, Chiang Siow, H. Current Pain and Headache Reports 2002;6:151-155 . “Why Should American Headache and Migraine Patients Still Be Treated With Butalbital-Containing Medicine?” Tfelt-Hansen PC,Diener HC. Headache 2012;52:672-674

  50. Scant evidence to support BCP or narcotics as migraine treatments, especially as drugs of choice “No randomized, placebo-controlled studies prove or refute efficacy for [BCP] in the treatment of acute migraine headaches …. Based on concerns of over-use, medication overuse headache, and withdrawal, the use of [BCP] should be limited and carefully monitored.” US Headache Consortium’s evidence-based migraine treatment guidelines .

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