Optimizing Pain Relief While Reducing Risk: Finding Your Comfort Zone

Optimizing Pain Relief While Reducing Risk: Finding Your Comfort Zone
Colleen O’Connell, MD FRCPC

Faculty/Presenter Disclosure
Faculty: Colleen O’Connell, MD FRCPC Relationships with commercial interests: Grants/Research Support: industry-sponsored research by Acorda, Allergan, Biogen, Cytokinetics, Eli-Lilly, Xenoport Speakers Bureau/Honoraria: Allergan, Biogen, Boehringer, Eli Lilly, Pfizer, Purdue Pharma, Valeant Consulting Fees: Allergan, Biogen, Prairie Plant This slide must be visually presented to the audience AND verbalized by the speaker.

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®, MS•IR®) Oxycodone Hydrochloride (Oxy•IR®, OxyNEO®) Oxycodone Hydrochloride / Naloxone Hydrochloride (Targin®) Tramadol hydrochloride (Zytram XL®) This slide must be visually presented to the audience AND verbalized by the speaker.

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. This slide must be visually presented to the audience AND verbalized by the speaker.

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
Having enough time to do it properly Knowing what the proper outcomes are to measure Fear of the College Fear of creating Addiction Fear of having opioids be diverted 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 A needs assessment was conducted in June Invitations to participate in the needs assessment was sent to 29,542 Canadian physicians that practice under one or more of the following categories: Pain management General practitioner/family medicine Palliative care Sports medicine Emergency medicine Geriatrics Internal medicine 403 Canadian physicians completed the survey (315 English, 88 French) Questions in the questionnaire were developed by a group of Canadian physicians considered key opinion leaders in management of CNCP; questions were based on results from physician focus groups completed earlier in 2012 Information also taken from evaluations submitted by participants attending “Improving Patient & Physician Satisfaction: Time Management & Communication Skills,” a current CME program that was developed based on information gathered from physician and patient focus groups in early 2012

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

Does Julie have chronic pain?
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) This definition suggests that pain is a subjective experience that interferes with the psychic and the social along with physical function. Pain is multidimensional, making it difficult to separate objective evidence of disease, i.e., the biological, and the subjective experience of discomfort and dysfunction. Reference: International Association for the Study of Pain. Classification of chronic pain. Descriptions of chronic pain syndromes and definitions of pain terms. Second edition (Revised) Available at: Accessed January 30, 2013. International Association for the Study of Pain

Overlapping Aspects of Chronic Pain
Psychological Social Biological PAIN

Categorizing Chronic Non-cancer Pain
Superficial Somatic NOCICEPTIVE (Inflammatory) Deep Visceral MIXED Central References: Ashby MA, Fleming BG, Brooksbank M, et al. Description of a mechanistic approach to pain management in advanced cancer. Preliminary report. Pain. 1992;51(2): Nicholson B. Differential diagnosis: nociceptive and neuropathic pain. Am J Manag Care. 2006;12(9 Suppl):S Ballantyne JC. Chronic pain following treatment for cancer: the role of opioids. Oncologist. 2003;8(6): Peripheral NEUROPATHIC Other Ashby MA, et al. Pain. 1992;51: Nicholson B. Am J Managed Care. 2006;12:S256-S262. Ballantyne JC. Oncologist. 2003;8:

Question #2 What would you want to accomplish in this pain assessment visit? A measurement of pain severity A differential diagnosis of her pain condition A measurement of her addiction risk A measurement of her functionality All of the above

Pain Assessment: OPQRS
Onset (and evolution) Pattern Quality Relieving / exacerbating factors Severity Assessment tools: Brief Pain Inventory Body Pain Diagram LANSS / DN4 Onset (and evolution): Spontaneous or event-triggered? Work / motor vehicle accident? Illness / iatrogenic (post-surgical)? Evolution of pain problem over time Pattern: Number and location of different pains Location (localized or radiating) Timing (intermittent, constant, breakthrough) Rapidly progressive or stable Quality: Neuropathic pain: Burning, shooting, lancinating, tingling, pins and needles Nociceptive pain: Somatic pain: aching, sharp, well located, increased by mobilization / weight bearing Visceral pain: dull, crampy, diffuse Relieving / exacerbating factor: Movement / rest / specific positions Physical measures (heat, cold, massage) Anxiety / stress Weather / seasonal Severity: 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 VRS (verbal rating scale): “0 – 10” DN4, Douleur Neuropathique 4. LANSS, Leeds Assessment of Neuropathic Symptoms and Signs.

Onset (and evolution) Spontaneous or event-triggered? Work / motor vehicle accident? Illness / iatrogenic (post-surgical)? Evolution of pain problem over time

Pattern: Number and location of different pains Location (localized or radiating) Timing (intermittent, constant, breakthrough) Rapidly progressive or stable

Quality: Neuropathic pain: Burning, shooting, lancinating, tingling, pins and needles Nociceptive pain: Somatic pain: aching, sharp, localized, increased by activity, relieved by rest Visceral pain: dull, crampy, diffuse

Relieving / exacerbating factors Movement / rest / specific positions Physical measures (heat, cold, massage) Anxiety / stress Lack of sleep Weather / seasonal

Severity 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
X X X Reference Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singapore. 1994;23(2): X Movement, stress, fatigue, working at the computer Heat, rest, massage, TENS Acetaminophen, amitriptyline 48 Adapted from Cleeland CS, et al. Ann Acad Med Singapore. 1994;23(2): 20

Question #3 What type of pain is likely affecting Julie? Nociceptive
Neuropathic Mixed

Julie’s Diagnosis Neuropathic pain Possible nociceptive elements
Sequelae of peripheral neuropathy; potential impact of deconditioning

Psychosocial History Disability Social Family configuration
Level of education Type of work Income Isolation Secondary benefits of pain (conscious or unconscious) Psychological Personal / family history Previous physical, sexual, and/or emotional abuse Current life stressors Family / cultural factors Catastrophizing Disability Ideal pain management is multi-disciplinary and addresses not just the biological/physical aspects of pain, but also the psychological and social aspects of a patient’s history / life.

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?
Yes, I always order imaging in all of my pain patients No, I only order imaging if there are obvious signs of serious pathology Possible, I treat each case on an individual basis

Non-pharmacologic Treatment Options
Type of treatment Options Lifestyle Cessation of tobacco products, weight loss, nutritional counselling Physical Heat, 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/psychiatric Biofeedback, cognitive behaviour therapy, counselling, social worker support, hypnosis, relaxation Occupational Occupational therapy, work conditioning programs Complementary/alternative Acupuncture, herbal remedies, massage, mindfulness meditation, reflexology Reference: Jackman RP, Purvis JM, Mallett BS. Chronic nonmalignant pain in primary care. Am Fam Physician. 2008;78(10): Jackman RP, et al. Am Fam Physician. 2008;78(10):

Pharmacologic Treatment Options: Non-opioid Analgesics
Acetaminophen NSAIDs – topical vs. systemic Salicylates Muscle relaxants Tricyclic antidepressants (TCAs) SNRIs Gabapentenoids/anticonvulsants Cannabinoids ? References: Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain© 2010 National Opioid Use Guideline Group (NOUGG). Moulin DE, Clark AJ, Gilron I, et al. Pharmacological management of chronic neuropathic pain – Consensus statement and guidelines from the Canadian Pain Society. Pain Res Manage. 2007;12(1):13-21. NSAID, non-steroidal anti-inflammatory drug. SNRI, serotonin noradrenaline reuptake inhibitors. National Opioid Use Guideline Group (NOUGG), Moulin DE, et al. Pain Res Manage. 2007;12(1):13-21.

Pharmacologic Treatment Options: Stepped Approach to Opioid Selection
Third-line for severe pain: methadone Second-line for severe pain: fentanyl transdermal First-line for severe pain: hydrocodone, hydromorphone, morphine, oxycodone, tapentadol Second-line for mild-to-moderate pain: buprenorphine transdermal, hydromorphone, hydrocodone, morphine, oxycodone,** or tapentadol Severe pain Reference: Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain© 2010 National Opioid Use Guideline Group (NOUGG). First-line for mild-to-moderate pain: codeine* or tramadol* Mild-to-moderate pain Consider an opioid if NRS >5/10 *±acetaminophen **±acetaminophen, aspirin, NSAID, or naloxone NRS, numerical rating scale. NSAID, non-steroidal anti-inflammatory drug. Adapted from: National Opioid Use Guideline Group (NOUGG), 2010.

Pharmacologic Treatment Options: Chronic Neuropathic Pain
Add additional agents sequentially if partial but inadequate pain relief‡ TCA gabapentin or pregabalin SNRI topical lidocaine* tramadol or controlled-release opioid analgesic Reference: Moulin DE, Clark AJ, Gilron I, et al. Pharmacological management of chronic neuropathic pain – Consensus statement and guidelines from the Canadian Pain Society. Pain Res Manage. 2007;12(1):13-21. 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. Moulin DE, et al. Pain Res Manage. 2007;12(1):13-21.

Question #5 What are my goals for this patient? Cure
Complete pain relief Complete restoration of her function 75% relief in her pain by next visit 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 Take 2-hour car trip to visit mom Walk through the park 2X / week Try out a rehab yoga class

Cautions With The Use of Opioids

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 X X X 5 Reference:
Webster LR, Webster RM. Predicting aberrant behaviors in opioid-treated patients: preliminary validation of the Opioid Risk Tool. Pain Med. 2005;6: X 5 Adapted from: Webster LR, et al. Pain Med. 2005;6:

Incorporating Risk Level of Misuse/Addiction into Pain Management
Group III – Preferably treat by addiction medicine Methadone or Buprenorphine is 1st 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 Most patients Fewest patients Risk level

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

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 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. Most guidelines on opioid prescribing recommend the use of written prescribing agreements in spite of the fact that there is actually no evidence that they change patient behaviour. With properly documented informed consent, there is a less compelling need to use one in a low risk patient. On the other hand, it would be prudent for the clinician to ask all identified high risk patients to sign one. References: Fishman S, Mahajan G, Jung SW, et al. The trilateral opioid contract. Bridging the pain clinic and the primary care physician through the opioid contract. J Pain Symptom Manage. 2002;24(3): Fishman S, Kreis PG. The opioid contract. Clin J Pain. 2002;18(4 Suppl):S70-5. Wallace LS, Keenum AJ, Roskos SE, et al. Development and validation of a low-literacy opioid contract. J Pain. 2007;8(10): Fishman S, et al. J Pain Symptom Manage. 2002;24(3): Fishman S, et al. Clin J Pain. 2002;18(4 Suppl):S70-5. Wallace LS, et al. J Pain. 2007;8(10):

FDA Issues Draft Guidance for Abuse-Deterrent Opioid Development
ABUSE-DETERRENT FORMULATIONS (ADFs) – Categorization Physical/Chemical barriers Physical barriers can prevent chewing, crushing, cutting, grating, or grinding Chemical barriers can resist extraction of the opioid using common solvents Agonist/Antagonist combinations An opioid antagonist can be added to interfere with, reduce, or defeat the euphoria associated with abuse 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 Delivery System Certain drug release designs or the method of drug delivery can offer resistance to abuse Prodrug Prodrug lacks opioid activity until transformed in the gastrointestinal tract Combination Two or more of the above methods can be combined to deter abuse Opioid analgesics can be abused in a number of ways. For example, they can be swallowed whole, crushed and swallowed, crushed and snorted, crushed and smoked, or crushed, dissolved and injected. Abuse-deterrent formulations should target known or expected routes of abuse for the opioid drug substance for that formulation. As a general framework, abuse-deterrent formulations can be categorized as follows 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 like water, alcohol, or other organic solvents. Physical and chemical barriers can change the physical form of an oral drug rendering it less amenable to abuse. 2. Agonist/Antagonist combinations – An opioid antagonist can be added to interfere with, reduce, or defeat the euphoria associated with abuse. The antagonist can be sequestered and released only upon manipulation of the product. For example, a drug product may be formulated such that the substance that acts as an antagonist is not clinically active when the product is swallowed but becomes active if the product is crushed and injected or snorted. 3. Aversion – Substances can be combined to produce an unpleasant effect if the dosage 89 form is manipulated prior to ingestion or a higher dosage than directed is used. 4. Delivery System (including depot injectable formulations and implants) – Certain drug release designs or the method of drug delivery can offer resistance to abuse. For example, a sustained-release depot injectable formulation that is administered intramuscularly or a subcutaneous implant can be more difficult to manipulate. 5. Prodrug – A prodrug that lacks opioid activity until transformed in the gastrointestinal tract can be unattractive for intravenous injection or intranasal routes of abuse. 6. Combination – Two or more of the above methods can be combined to deter abuse. The FDA has made public its draft directives outlining the research steps drug manufacturers would need to conduct in order to label an opioid as abuse deterrent. According to an FDA official, the agency is hoping to incentivize drug companies to further develop safer opioids through the increased revenues that might result from having abuse-deterrent labeling. This guidance is intended to assist sponsors who wish to develop formulations of opioid drug products with potentially abuse-deterrent properties (abuse-deterrent formulations). Specifically, the guidance explains FDA’s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties, how those studies will be evaluated, and what labeling claims may be approved based on the results of those studies. 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 Health 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 20131 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 20132 CR morphine with a sequestered core of naltrexone: Contains pellets of an extended-release oral formulation of morphine sulphate, an opioid receptor agonist, with a sequestered core of naltrexone hydrochloride, an opioid receptor antagonist. Proper use requires the capsules to be swallowed whole or the contents of the capsules to be sprinkled on apple sauce. The pellets in the capsules are not to be crushed, dissolved, or chewed before swallowing. Misuse or abuse by tampering with the formulation by crushing or chewing the pellets causes the rapid release and absorption of both morphine and naltrexone. The resulting morphine dose may be fatal, particularly in opioid-naïve individuals. In opioid-tolerant individuals, the absorption of naltrexone may increase the risk of precipitating withdrawal. There is no evidence that the naltrexone reduces the abuse liability of EMBEDA. In March 2011, Pfizer voluntarily recalled from U.S. wholesalers and retailers all dosage forms of CR morphine with a sequestered core of naltrexone because a pre-specified stability requirement was not met during routine testing. Source: Oxycodone/Naloxone CR tablets: Drug Abuse Studies A series of clinical studies designed to explore the abuse/misuse potential of Oxycodone/Naloxone CR tablets, were conducted in dependent or non-dependent recreational opioid users. The studies included both subjective measures, e.g., Drug Liking VAS and objective measures, e.g., pupillometry. Collectively for these studies, the subjective results produced were supported by similar results in objective measures, and were consistent with the established pharmacology of naloxone. One comparison demonstrated reduced Drug Liking for Oxycodone/Naloxone CR tablets relative to oxycodone powder when each was administered intranasally. In another comparison, solutions containing a 2:1 ratio by weight of oxycodone HCl to naloxone HCl were administered by the intravenous route to explore the abuse and misuse potential of Oxycodone/Naloxone CR tablets. In this comparison, the oxycodone/naloxone solutions demonstrated reduced Drug Liking relative to the oxycodone solution alone when each was administered intravenously. The clinical significance of these results has not yet been established. If abused parenterally or intranasally by individuals dependent on opioid agonists, Oxycodone/Naloxone CR tablets are expected to produce marked withdrawal symptoms – because of the systemic opioid receptor antagonist characteristics of naloxone by these routes – or to intensify withdrawal symptoms already present. Source: Canadian Product Monograph Oxycodone Hydrochloride / Naloxone Hydrochloride Controlled Release Tablets, July 2013. CR hydromorphone – tablet is non-deformable: Tablets designed with the OROS® Push-Pull™ technology to release hydromorphone at a relatively constant rate and achieve stable plasma levels over a 24-hour period allowing for once daily administration of hydromorphone. The tablet is non-deformable and does not appreciably change in shape in the GI tract. Source: Canadian Product Monograph HYDROmorphone hydrochloride Prolonged Release Tablets, August 2013. CR oxycodone – reformulated (USA); CR oxycodone-resistant to crushing (Canada): The FDA has determined that the reformulated product has abuse-deterrent properties. The tablet is more difficult to crush, break, or dissolve. It also forms a viscous hydrogel and cannot be easily prepared for injection. The agency has determined that the physical and chemical properties of the reformulated product are expected to make the product difficult to inject and to reduce abuse via snorting. However, abuse of CR oxycodone-reformulated by these routes, as well as the oral route, is still possible. The reformulated product also may reduce incidents of therapeutic misuse, such as crushing the product to sprinkle it onto food or to administer it through a gastric tube. Source: IR oxycodone – new formulation: Formulated with Aversion® technology, which creates a unique combination of pharmaceutical ingredients that helps reduce the abuse potential from crushing, snorting or injecting the medication. Aversion® technology causes the active ingredients to gel, forming clumps instead of powder when crushed to prevent injection, and to irritate the nasal passages to prevent inhalation. FDA is requiring post approval epidemiological study to assess whether the technology results in a decrease of the consequences of misuse and abuse. Source: Acura Pharmaceuticals, INC Quarterly Report, May 2013; Oxecta Pharmacy Alert, CypressCare.com ER oxymorphone – reformulated: While there is an increased ability of ER oxymorphone – reformulated to resist crushing relative to the original formulation, study data show that the reformulated version’s extended-release features can be compromised when subjected to other forms of manipulation, such as cutting, grinding, or chewing, followed by swallowing. ER oxymorphone – reformulated can be readily prepared for injection, despite the company’s claim that these tablets have “resistance to aqueous extraction (i.e., poor syringeability).” It also appears that ER oxymorphone – reformulated can be prepared for snorting using commonly available tools and methods. The postmarketing investigations are inconclusive, and even if one were to treat available data as a reliable indicator of abuse rates, one of these investigations also suggests the troubling possibility that a higher percentage of ER oxymorphone – reformulated abuse is via injection than was the case with the original formulation. Source: NOC, Notice of Compliance; CR, controlled release; ER, extended release; IR, immediate-release. 1http:// 2http://

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 Tolerance to sedation due to a dose change should occur within 4 to 10 days in most people.

When to Switch Opioids Pain reduction Improved physical, psychological, and social functioning Improved quality of life Nausea Vomiting Constipation Somnolence/dizziness Urinary retention Potential Benefits1 Potential Side Effects2 References Boulanger A, et al. Chronic pain in Canada: Have we improved our management of chronic pain? Pain Res Manage. 2007;12(1):39-47. Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain© 2010 National Opioid Use Guideline Group (NOUGG). Switch if side effects are greater than the benefit Switch if tolerance develops 1. Boulanger A, et al. Pain Res Manage. 2007;12(1): 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 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 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 Speaker to give personal experiences with whatever option above that they use. References Fine PG, Portenoy RK; Ad Hoc Expert Panel on Evidence Review and Guidelines for Opioid Rotation. Establishing “best practices” for opioid rotation: conclusions of an expert panel. J Pain Symptom Manage. 2009;38(3): MacPherson ML. Demystifying Opioid Conversion Calculations. Bethesda, MD: American Society of Health-System Pharmacists, Inc Webster LR, Fine PG. Overdose deaths demand a new paradigm for opioid rotation. Pain Med. 2012;13(4):571-4. Fine PG, et al. J Pain Symptom Manage. 2009;38(3): MacPherson ML. Demystifying Opioid Conversion Calculations 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 References: Ballantyne JC, Mao J. Opioid therapy for chronic pain. N Engl J Med. 2003;349(20): Benyamin R, Trescot AM, Datta S, et al. Opioid complications and side effects. Pain Physician. 2008;11(2 Suppl):S Chou R, Fanciullo GJ, Fine PG, et al. Opioids for chronic noncancer pain: prediction and identification of aberrant drug-related behaviors: a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. J Pain. 2009;10(2): Porreca F, Ossipov MH. Nausea and vomiting side effects with opioid analgesics during treatment of chronic pain: mechanisms, implications, and management options. Pain Med. 2009;10(4): Slatkin NE. Opioid switching and rotation in primary care: implementation and clinical utility. Curr Med Res Opin. 2009;25(9): Ballantyne JC, et al. N Engl J Med. 2003;349(20): Benyamin R, et al. Pain Physician. 2008;11(2 Suppl):S Chou R, et al. J Pain. 2009;10(2): Porreca F, et al. Pain Med. 2009;10(4): Slatkin NE. Curr Med Res Opin. 2009;25(9):

How To Stop Opioid Therapy
Discuss and document (with significant other?): Withdrawal is not dangerous Typical withdrawal symptoms and time course Offer an alternative treatment plan 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
Analgesia (pain relief — BPI score) Activities (physical and psychosocial functioning — BPI interference score) Adverse effects (and your advice) Ambiguous drug-taking behaviours (and your advice) Accurate medication record Affect (use a validated scale) Adequate follow-up documentation is essential to diagnosing an evolving addiction/diversion problem. The results of serial evaluations using clinical tools such as the BPI should be gathered here. The “6 As” provide a checklist of essential follow-up documentation, and are specifically looked for by College investigators if charts are reviewed. Document pain relief using a verbal (1 to 10) rating scale or a visual analogue scale for the best pain and worst pain since last visit. Document any changes in the patient’s function. Give some specific examples, if possible. Note any opioid side effects and what your advice to the patient is. Carefully document any episodes of early refills, lost medication, double doctoring, etc., and your response. Keep an accurate medication record of the drug, the strength, the dosing instructions, and amount to dispense. As the last entry in your visit record, write: “To last until ____” as an easy reminder the next time you see the patient. Affect: some physicians are now documenting the patient’s affect as the sixth A. References: Gourlay DK, Heit HA, Almahrezi A. Universal precautions in pain medicine: a rational approach to the treatment of chronic pain. Pain Med. 2005;6: BPI, Brief Pain Inventory. Gourlay DL, et al. Pain Med. 2005;6:

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

Resources

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 Canada chronicpaincanada.com Canadian Pain Coalition canadianpaincoalition.ca Canadian Institute for the Relief of Pain and Disability cirpd.org Managing My Pain managingmypain.ca Med School for You Chronic Pain Self-Management medschoolforyou.com Arthritis Society arthritis.ca Patients Like Me patientslikeme.com Pain Toolkit paintoolkit.org

Provincial Resources for Patients
British Columbia Pain BC painbc.ca Chronic Disease Self-Management Programs selfmanagementbc.ca/chronicpainprogram Alberta Better Choices, Better Health albertahealthservices.ca/services.asp?pid=service&rid= People in Pain Network pipain.com Saskatchewan LiveWell Chronic Disease Management Manitoba Get Better Together rha-central.mb.ca/service.php?id=65

Ontario Living a Healthy Life Central East healthylifeworkshop.ca Living Well South East livingwellseontario.ca Living Healthy Champlain livinghealthychamplain.ca Living a Healthy Life South West swselfmanagement.ca Take Control Take Charge takecontroltakecharge.ca Healthy Change healthychange.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’atelier mytoolbox.mcgill.ca

Atlantic Canada Action Atlantic paincantwait.ca New Brunswick My Choices – My Health gnb.ca/0053/phc/workshop-e.asp Nova Scotia Your Way to Wellness yourway2wellness.gov.ns.ca Prince Edward Island Living a Healthy Life gov.pe.ca/health/livingahealthylife Newfoundland & Labrador Improving Health: My Way health.gov.nl.ca/health/chronicdisease/improving_health_my_way.html

Optimizing Pain Relief While Reducing Risk: Finding Your Comfort Zone

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Optimizing Pain Relief While Reducing Risk: Finding Your Comfort Zone

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Presentation on theme: "Optimizing Pain Relief While Reducing Risk: Finding Your Comfort Zone"— Presentation transcript:

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