Disclosure of Commercial Support This program has received financial support and in-kind support from Purdue Pharma in the forms of an educational grant and logistical support Potential for conflict(s) of interest: – The Speaker has received payment from Purdue Pharma – Purdue Pharma developed and distributes, and benefits from the sale of products that will be discussed in this program: Buprenorphine transdermal (BuTrans®) Codeine monohydrate (Codeine Contin®) Hydromorphone hydrochloride (DILAUDID®, HYDROMORPH CONTIN®) Morphine sulfate (MS Contin®, MSIR®) Oxycodone Hydrochloride (OxyIR®, OxyNEO®) Oxycodone Hydrochloride / Naloxone Hydrochloride (Targin®) Tramadol hydrochloride (Zytram XL®)
Mitigating Potential Bias Potential sources of bias identified in the preceding 2 slides have been mitigated as follows: Information/recommendations provided in the following program will be evidence- and/or guideline-based and opinions of the speaker will be identified as such. Material was developed and reviewed by a steering committee composed of independent third party experts responsible for vetting the program’s needs assessment and subsequent content development to ensure accuracy and fair balance.
Disclaimer This presentation is for educational purposes only. It was developed by an independent team of subject-matter experts convened for this purpose. The opinions expressed in this presentation are not necessarily those of the sponsor, and neither product descriptions nor opinions should be attributed to the sponsor. The sponsor does not recommend any use of its products that is inconsistent with the product monographs of such products.
Question #1 What is your #1 barrier in dealing with CNCP patients 1.Having enough time to do it properly 2.Knowing what the proper outcomes are to measure 3.Fear of the College 4.Fear of creating Addiction 5.Fear of having opioids be diverted 6.Fear of the patient overdosing on opioids
Issues in the Management of Chronic Non-cancer Pain Results from 2012 needs assessment of 403 primary care physicians: – Uncertainty with regard to assessment of chronic non-cancer pain (CNCP) – Uncertainty with regard to effective treatment of chronic pain – Potential for opioid addiction and misuse – Prior negative experiences effectively managing patients with CNCP
Learning Objectives After attending this program, participants should be able to: Recognize the trajectory/continuum of chronic non-cancer pain (CNCP) Define an essential pain assessment strategy Break down barriers related to the use of non-pharmacological, non-opioid, and opioid treatment options for CNCP Discuss “success” in the management of CNCP
Patient Case: Julie 43-year-old female Executive secretary, mother of 2 Breast cancer: treated with mastectomy and chemotherapy Chemotherapy-induced peripheral neuropathy and myalgia x 4 years Does Julie have chronic pain?
Definition of Chronic Non-cancer Pain An unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage Pain without apparent biological value that has persisted beyond the normal tissue healing time (most commonly reported to be ≤3 months) International Association for the Study of Pain. 2012.
Overlapping Aspects of Chronic Pain Biological SocialPsychological PAIN
MIXED Categorizing Chronic Non-cancer Pain Superficial Deep Central Peripheral Other NEUROPATHIC NOCICEPTIVE (Inflammatory) Visceral Somatic Ashby MA, et al. Pain. 1992;51:153-161. Nicholson B. Am J Managed Care. 2006;12:S256-S262. Ballantyne JC. Oncologist. 2003;8:567-575.
Question #2 What would you want to accomplish in this pain assessment visit? 1.A measurement of pain severity 2.A differential diagnosis of her pain condition 3.A measurement of her addiction risk 4.A measurement of her functionality 5.All of the above
Pain Assessment: OPQRS O nset (and evolution) P attern Q uality R elieving / exacerbating factors S everity Assessment tools: Brief Pain Inventory Body Pain Diagram LANSS / DN4 DN4, Douleur Neuropathique 4. LANSS, Leeds Assessment of Neuropathic Symptoms and Signs.
Pain Assessment: OPQRS O nset (and evolution) – Spontaneous or event-triggered? – Work / motor vehicle accident? – Illness / iatrogenic (post-surgical)? – Evolution of pain problem over time
Pain Assessment: OPQRS P attern: – Number and location of different pains – Location (localized or radiating) – Timing (intermittent, constant, breakthrough) – Rapidly progressive or stable
Pain Assessment: OPQRS R elieving / exacerbating factors – Movement / rest / specific positions – Physical measures (heat, cold, massage) – Anxiety / stress – Lack of sleep – Weather / seasonal
Pain Assessment: OPQRS S everity – Patient self-report is the best measure we have today to assess pain severity – Descriptive, numeric and analog pain rating scales are available – Most common measure is the “0 – 10” verbal rating scale (VRS)
Julie’s Brief Pain Inventory Julie Movement, stress, fatigue, working at the computer Heat, rest, massage, TENS Acetaminophen, amitriptyline Adapted from Cleeland CS, et al. Ann Acad Med Singapore. 1994;23(2):129-38. X X X 48 X
Question #3 What type of pain is likely affecting Julie? 1.Nociceptive 2.Neuropathic 3.Mixed
Julie’s Diagnosis Neuropathic pain Possible nociceptive elements Sequelae of peripheral neuropathy; potential impact of deconditioning
Psychosocial History Psychological Personal / family history Previous physical, sexual, and/or emotional abuse Current life stressors Family / cultural factors Catastrophizing Social Family configuration Level of education Type of work Income Isolation Secondary benefits of pain (conscious or unconscious) Disability
Physical Exam in Chronic Non-cancer Pain General exam – posture, muscular tone Spinal exam – mobility, palpation, look for trigger points Neurological exam – motor strength, reflexes, sensory exam (including presence of allodynia, hyperalgesia, hypo- or hyperesthesia) Inflammatory elements – pain, swelling, erythema
Question #4 Would you order imaging for Julie? 1.Yes, I always order imaging in all of my pain patients 2.No, I only order imaging if there are obvious signs of serious pathology 3.Possible, I treat each case on an individual basis
Non-pharmacologic Treatment Options Type of treatmentOptions LifestyleCessation of tobacco products, weight loss, nutritional counselling PhysicalHeat, cold, massage, exercise, manipulation, physical therapy, stretching and yoga, surgical therapies (nerve blocks, trigger point injections, spinal infusion, or stimulation), transcutaneous electric nerve stimulation, intramuscular stimulation, radiofrequency lesioning Psychological/psychiatricBiofeedback, cognitive behaviour therapy, counselling, social worker support, hypnosis, relaxation OccupationalOccupational therapy, work conditioning programs Complementary/alternativeAcupuncture, herbal remedies, massage, mindfulness meditation, reflexology Jackman RP, et al. Am Fam Physician. 2008;78(10):1155-62.
Pharmacologic Treatment Options: Non-opioid Analgesics Acetaminophen NSAIDs – topical vs. systemic Salicylates Muscle relaxants Tricyclic antidepressants (TCAs) SNRIs Gabapentenoids/anticonvulsants Cannabinoids ? National Opioid Use Guideline Group (NOUGG), 2010. Moulin DE, et al. Pain Res Manage. 2007;12(1):13-21. NSAID, non-steroidal anti-inflammatory drug. SNRI, serotonin noradrenaline reuptake inhibitors.
Pharmacologic Treatment Options: Stepped Approach to Opioid Selection Mild-to-moderate pain First-line for mild-to-moderate pain: codeine* or tramadol* Second-line for mild-to-moderate pain: buprenorphine transdermal, hydromorphone, hydrocodone, morphine, oxycodone,** or tapentadol Severe pain First-line for severe pain: hydrocodone, hydromorphone, morphine, oxycodone, tapentadol Second-line for severe pain: fentanyl transdermal Third-line for severe pain: methadone Adapted from: National Opioid Use Guideline Group (NOUGG), 2010. Consider an opioid if NRS >5/10 *±acetaminophen **±acetaminophen, aspirin, NSAID, or naloxone NRS, numerical rating scale. NSAID, non-steroidal anti-inflammatory drug.
Pharmacologic Treatment Options: Chronic Neuropathic Pain Moulin DE, et al. Pain Res Manage. 2007;12(1):13-21. TCAgabapentin or pregabalin SNRItopical lidocaine* tramadol or controlled-release opioid analgesic fourth-line agents† *5% gel or cream – useful for focal neuropathy such as postherpetic neuralgia. † Cannabinoids, methadone, lamotrigine, topiramate, valproic acid. ‡ Do not add SNRIs to TCAs. SNRI, serotonin noradrenaline reuptake inhibitors. TCA, tricyclic antidepressants. Add additional agents sequentially if partial but inadequate pain relief ‡
Question #5 What are my goals for this patient? 1.Cure 2.Complete pain relief 3.Complete restoration of her function 4.75% relief in her pain by next visit 5.Realistic improvement in her functionality
Patient’s Goals of Treatment Set SMART goals at each visit: – Specific – Measurable – Action-oriented / Achievable – Realistic / Relevant – Time-dependent goals Think of opioid prescribing as a test or trial Walk through the park 2X / week Take 2-hour car trip to visit mom Try out a rehab yoga class
Screening for Medication Misuse Risk Ask questions in a routine, straightforward manner – Ask about number of drinks per day and per week and sedative use – Family history of psychiatric or addictive disorders CAGE questionnaire Opioid Risk Tool – 5 questions, 5 minutes – Specific to pain and opioid use – Quantifies risk level – Non-confrontational – Easy to use
Opioid Risk Tool Adapted from: Webster LR, et al. Pain Med. 2005;6:432-42. X X X 5
Incorporating Risk Level of Misuse/Addiction into Pain Management Most patients Fewest patients Risk level Group III – Preferably treat by addiction medicine Methadone or Buprenorphine is 1 st choice Exhaust all other options before considering opioids Daily dispensing weekly, less “abusable” meds Group II – Trial of treatment by primary care physician with collaboration with Pain doctor(if available) More assessment and focus on functional goals Written Treatment Agreement, urine drug test 3-4 times per year, collateral information. Be prepared for contingency plan Follow-up monthly, dispense every 2 weeks, choose opioids carefully Group I – Treatment by primary care physician Utilize all treatment options, including opioids; focus on side effects Written Treatment Agreement, urine drug test 1-2 times per year Follow-up every 2-3 months, dispense meds every 4 weeks
Questions When Initiating Opioid Therapy Initial choice of opioid? Dose? Route of administration? Frequency? Monitoring and follow up? Safety?Adverse effects?
Initiating Opioid Therapy Basic considerations: Patient age Patient opioid exposure and experience Patient fears (stigma) Caregiver and physician attitudes, preferences, and biases Compliance Convenience Cost/coverage Pharmaco-clinical considerations: Patient sensitivities/allergies Administration and absorption limitations Metabolism and clearance Opioid profile Fine PG. Journal of Pain. 2001.
Written Treatment Agreement Recommended in all guidelines Low-cost, low-tech strategy Helps to demonstrate informed consent Effective boundary setting tool Must be readable, reasonable, and have some flexibility Fishman S, et al. J Pain Symptom Manage. 2002;24(3):335-44. Fishman S, et al. Clin J Pain. 2002;18(4 Suppl):S70-5. Wallace LS, et al. J Pain. 2007;8(10):759-66. TREATMENT AGREEMENT I,__________________, understand that compliance with the following guidelines is important in continuing pain treatment with Dr. __________. I understand that I have the following responsibilities: I will take medications only at the dose and frequency prescribed. I will not increase or change medications without the approval of this doctor. I will not request opioids or any other pain medicine from physicians other than from this doctor.
FDA Issues Draft Guidance for Abuse-Deterrent Opioid Development ABUSE-DETERRENT FORMULATIONS (ADFs) – Categorization 1.Physical/Chemical barriers – Physical barriers can prevent chewing, crushing, cutting, grating, or grinding – Chemical barriers can resist extraction of the opioid using common solvents 2.Agonist/Antagonist combinations – An opioid antagonist can be added to interfere with, reduce, or defeat the euphoria associated with abuse 3.Aversion – Substances can be combined to produce an unpleasant effect if the dosage form is manipulated prior to ingestion or a higher dosage than directed is used 4.Delivery System – Certain drug release designs or the method of drug delivery can offer resistance to abuse 5.Prodrug – Prodrug lacks opioid activity until transformed in the gastrointestinal tract 6.Combination – Two or more of the above methods can be combined to deter abuse http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdfhttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf January 2013
Novel Opioid Formulations with Potential to Reduce Abuse/Misuse CR morphine with a sequestered core of naltrexone – FDA approved August 2009 – Voluntarily recalled from U.S. market March 2011, “leaking core” of naltrexone Oxycodone/Naloxone CR tablets – H ealth Canada NOC December 2009 CR hydromorphone – tablet is non-deformable – Health Canada NOC November 2009; FDA approved March 2010 CR oxycodone – reformulated (USA); CR oxycodone-resistant to crushing (Canada) – FDA approved April 2010; Health Canada NOC August 2011 – FDA approved abuse-deterrent labelling April 2013 1 New labelling indicates that the product has physical and chemical properties that are expected to make abuse by injection difficult and to reduce abuse via the intranasal route IR oxycodone – new formulation – FDA approved June 2011 ER oxymorphone – reformulated – FDA approved December 2011 – FDA denied petition that original formulation not withdrawn due to safety and efficacy and allowed generics May 2013 2 NOC, Notice of Compliance; CR, controlled release; ER, extended release; IR, immediate-release. 1 http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm347857.htm1 http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm347857.htm; 2 http://www.fda.gov/Drugs/DrugSafety/ucm351357.htm. http://www.fda.gov/Drugs/DrugSafety/ucm351357.htm.
Titrating Opioids: Precautions Ideally start with immediate release opioid and switch to a long-acting preparation During titration, temporary drowsiness can occur Patients should be advised not to drive or perform potentially hazardous activities while titrating the opioid dose – until tolerance to drowsiness occurs Monitor for constipation – Consider prescribing a laxative at the start of treatment For individuals aged >70 years, start lower and go slower
When to Switch Opioids Nausea Vomiting Constipation Somnolence/dizziness Urinary retention Pain reduction Improved physical, psychological, and social functioning Improved quality of life Potential Benefits 1 Potential Side Effects 2 Switch if side effects are greater than the benefit Switch if tolerance develops 1. Boulanger A, et al. Pain Res Manage. 2007;12(1):39-47. 2. National Opioid Use Guideline Group (NOUGG), 2010.
How to Switch Opioids Use opioid tables to calculate a total daily equianalgesic dose of the new opioid 1.Switch to 50-70% of the predicted dose of the new opioid and titrate to effect again – Decision to cut dose and by what percentage may depend on the reason for switch OR 2.Start the new opioid and titrate while decreasing the dose of the old opioid – Sustained-release morphine 15 mg ≅ controlled-release oxycodone 10 mg ≅ controlled-release hydromorphone 3 mg Fine PG, et al. J Pain Symptom Manage. 2009;38(3):418-25. MacPherson ML. Demystifying Opioid Conversion Calculations. 2010. Webster LR, et al. Pain Med. 2012;13(4):571-4.
When to Stop Opioid Therapy Resolution of underlying problem No meaningful pain relief Patient wants to discontinue Does not achieve therapeutic goals even with effective pain relief (e.g., improved physical or social functioning) Persistent adverse effects despite careful titration and switching Opioid hyperalgesia despite switching Not cooperating with treatment plan (medication use or activity/goals) Persistent out-of-bounds behaviours consistent with addiction/diversion – Unable to follow the treatment agreement Diagnosis of an addiction disorder and refuses referral for treatment Ballantyne JC, et al. N Engl J Med. 2003;349(20):1943-53. Benyamin R, et al. Pain Physician. 2008;11(2 Suppl):S105-20. Chou R, et al. J Pain. 2009;10(2):131-46. Porreca F, et al. Pain Med. 2009;10(4):654-62. Slatkin NE. Curr Med Res Opin. 2009;25(9):2133-50.
How To Stop Opioid Therapy 1.Discuss and document (with significant other?): – Withdrawal is not dangerous – Typical withdrawal symptoms and time course 2.Offer an alternative treatment plan 3.Use caution with sedatives – withdrawal is more risky Patients who are diverting or addicted may refuse to comply and leave your practice
How to Stop Opioid Therapy (cont’d) It is not life threatening unless patient is “fragile” Fast or slow – 10% per day, daily pharmacy dispensing – 10% per week Use pharmacological aids – Clonidine, loperamide, NSAID, carbamazepine, gabapentin, pregabalin Methadone (buprenorphine) taper Educating the patient is the most effective treatment! NSAID, non-steroidal anti-inflammatory drug.
Framing Treatment Success Make a plan with the patient to set goals for treatment success Reframe success for you and the patient – There may not be big improvements, but rather small and incremental ones (i.e., there is no “cure”) Reduction of pain by 30% or 2 points on scale of 0 to 10 – Did the patient meet a functional goal or part of a goal? – Is the patient more positive than on previous visits? – Has there been even a small improvement in pain relief? – Has BPI scale gone down? – Has mobility improved? You must learn to accept situations that fail Know when to refer to a specialist Remember: You are treating the patient, not the pain BPI, Brief Pain Inventory.
Essential Follow-up Documentation: The 6 As Checklist A nalgesia (pain relief — BPI score) A ctivities (physical and psychosocial functioning — BPI interference score) A dverse effects (and your advice) A mbiguous drug-taking behaviours (and your advice) A ccurate medication record A ffect (use a validated scale) Gourlay DL, et al. Pain Med. 2005;6:107-12. BPI, Brief Pain Inventory.
Making a Difference for People With Pain Active listening / empathy is often most important Help patients find meaning in living a life with pain Maintain a positive outlook / celebrate small gains Advocate for improved pain management resources
Key Take-home Points Chronic pain is more than longstanding acute pain and requires a biopsychosocial approach to assessment and treatment Utilize a SMART goal-directed approach that focuses on functional improvement Search out and optimize non-pharmacological treatments in your community All pharmacotherapy should be prescribed using an individual risk-benefit approach Prescribe opioids with universal precautions according to the Canadian Opioid Guidelines Utilize validated clinical tools to demonstrate improved outcomes
Pain Assessment Tools Pain diagram Brief Pain Inventory (BPI) Visual Analogue Scale (VAS) Quality of Life Scale for Pain DN4 (Douleur Neuropathique en 4 Questions)
Opioid Risk Assessment Tools Opioid Risk Tool (ORT) CAGE Questionnaire (adapted to include drugs) Urine Drug Screening (UDS) Screener and Opioid Assessment for Patients with Pain– Revised (SOAPP-R) Current Opioid Misuse Measure (COMM) Aberrant Drug-Related Behaviours Indicative of Opioid Misuse Interview Guide for Alcohol Consumption Interview Guide for Substance Use
Patient Management Tools The 6 As progress report Opioid Manager (nationalpaincentre.mcmaster.ca) Switching Opioids form (nationalpaincentre.mcmaster.ca) Self-Management Toolkit (swselfmanagement.ca/smtoolkit/) – The basics of helping patients better self-manage their health Strategies to Support Self-Management in Chronic Conditions: Collaboration with Clients (rnao.ca/bpg/guidelines/self- management) – Evidence-based practice guidelines published by the Registered Nurses Association of Ontario
Resources for Patients Organization Chronic Pain Association of Canadachronicpaincanada.com Canadian Pain Coalitioncanadianpaincoalition.ca Canadian Institute for the Relief of Pain and Disabilitycirpd.org Managing My Painmanagingmypain.ca Med School for You Chronic Pain Self-Managementmedschoolforyou.com Arthritis Societyarthritis.ca Patients Like Mepatientslikeme.com Pain Toolkitpaintoolkit.org
Provincial Resources for Patients British Columbia Pain BCpainbc.ca Chronic Disease Self-Management Programsselfmanagementbc.ca/chronicpainprog ram Alberta Better Choices, Better Healthalbertahealthservices.ca/services.asp? pid=service&rid=1008382 People in Pain Networkpipain.com Saskatchewan LiveWell Chronic Disease Management www.saskatoonhealthregion.ca/your_health/p s_cdm_livewell_with_chronic_conditions.htm Manitoba Get Better Togetherrha-central.mb.ca/service.php?id=65
Provincial Resources for Patients Ontario Living a Healthy Life Central Easthealthylifeworkshop.ca Living Well South Eastlivingwellseontario.ca Living Healthy Champlainlivinghealthychamplain.ca Living a Healthy Life South Westswselfmanagement.ca Take Control Take Chargetakecontroltakecharge.ca Healthy Changehealthychange.ca Quebec Association québécoise de la douleur chronique douleurchronique.org Association de soutien et d'information face à la douleur asid.qc.ca My Tool Box/L’ateliermytoolbox.mcgill.ca
Provincial Resources for Patients Atlantic Canada Action Atlanticpaincantwait.ca New Brunswick My Choices – My Healthgnb.ca/0053/phc/workshop-e.asp Nova Scotia Your Way to Wellnessyourway2wellness.gov.ns.ca Newfoundland & Labrador Improving Health: My Wayhealth.gov.nl.ca/health/chronicdisease/imp roving_health_my_way.html Prince Edward Island Living a Healthy Lifegov.pe.ca/health/livingahealthylife