Prescribing Opioid for. Opioid Naïve Patients AN OPIOD RX

Prescribing Opioid for Opioid Naïve Patients AN OPIOD RX

Optimal Approach to Initiating Opioids for Chronic Non-Cancer Pain AN OPIOID RX Assessment biopsychosocial Non-opioid treatments Opioid risks vs. benefits Psychological assessment Informed consent (signed agreement) Order Urine Drug Testing (and other labs as required) Individualize opioid titration 50 mg and 90 mg MED Document outcomes of treatment Reassess and monitor regularly exit strategy if goals not met or problematic behaviours.

Assessment biopsychosocial Do a comprehensive assessment to ensure opioids are a reasonable choice and to identify risk/benefit balance for the patient Document results of history, physical exam and results of relevant investigations Formulate Differential and Working Diagnosis Document Pain Diagnosis (e.g. predominantly nociceptive or neuropathic) Assess Home Environment (e.g. co-inhabitants risk of misuse of Opioids) Involve family and/or caregiver in management (e.g. obtain consent from patients to communicate with family) /.

Non-Opioid treatments Maximize and Continue with Non-pharmacological therapies, including patient self-management and life style management (weight loss, exercise, nutrition, sleep hygiene) Non-Opioid analgesics and/or adjuvants, as appropriate Review Patient co-morbidities (e.g. renal function, cardiovascular risk, ) Concomitant medications with respect to potential drug interactions /.

Opioid risks vs. benefits Inform patient of their role in safe use and monitoring effectiveness Set Goals of Treatment (Improved Functions) and Realistic Expectations (e.g. 30 % decrease in pain scores) Inform patient of potential Nausea, constipation, drowsiness, dizziness, itching Adverse Effect on driving and operating machinery Medical complications such as sexual dysfunction, sleep apnea, opioidinduced hyperalgesia, and hormonal effects Overdose, diversion, addiction, withdrawal Potentiation of harm with alcohol.

Psychological assessment Consider a tool to diagnosis and monitor mental disorders (e.g. PHQ- 9 for depression) Assess both any past and present mental disorders Treat any present mental disorders before initiating Opioids Assess Suicide and/or Accidental overdose risk based on any mental disorders Taper or avoid benzodiazepines if Opioids are to be initiated Assess Sleep and Environmental Stressors (e.g. work environment)

Informed consent (signed agreement) Obtain Informed Consent about the prescribing of Opioids Discuss and have patient review/sign an Opioid Treatment Agreement Be explicit about characterizing opioid prescribing as a trial and that opioid therapy will be be discontinued if it is not effective or benefits are outweighed by harms

Order Urine Drug Testing (and other labs as required) Consider using urine drug screening (UDS) To set a baseline measure of substance use that may help assess risk for addiction For ongoing monitoring of the patient s compliance with Opioids prescribed Point of care testing, normal lab urine drug testing and gas chromatography can all be useful depending on the clinical situation

Individualize Opioid titration Initiate with a low dose; increase gradually; monitor Opioid effectiveness and recognize optimal dose. Watch for any emerging risks/complications to prevent unwanted outcomes including misuse and addiction Track daily dose in morphine equivalents (MED) per day Consult a colleague if daily morphine equivalent dose exceeds 90 mg Consider Immediate Release vs. Controlled Release Consider Abuse- Deterrent Formulation vs. Non Abuse-Deterrent Oral vs. Transdermal (Fentanyl must not be used in Opioid Naïve Patients)

Document outcomes of treatment Analgesic Effect and Score Adverse Effects Discussed and attempts to manage Affect (mood and cognitive function) Aberrant Behaviour (lost Rx s, requests for early refills) Activities of Daily Living (Effect of Treatment)

Reassess and monitor regularly Function and Pain Scores ( e.g. Brief Pain Inventory) Employment Recreational Activities Interpersonal Relationships Overall Quality of Life Any evidence of abuse, misuse or diversion

Exit Strategy A trial of opioid therapy implies an exit strategy is understood from the beginning Opioid Treatment Agreement indicates common reasons for either reduction of opioid dose (tapering to lower dose) or stopping opioids (tapering to Zero) o o o o o Misuse, Abuse or Diversion of Opioids Opioid Tolerance Opioid Induced Hyperalgesia Development of Co-Morbid Medical Conditions (sleep apnea, endocrine issues) Adverse Effects (constipation, other GI issues, cognitive issues,

Prescribing Opioid for Legacy Patients OPIOIDSAFE

Managing Opioids for CNCP (Legacy Patients) Obtain and Review Informed Consent Patient Risk Factors for Abuse and Harm Assessed and Re-Assessed Inform patient of Potential Harms and Adverse Effects Order Urine Drug Testing Investigate new and/or ongoing symptoms and signs Determine if Opioid Formulation or Type is to be changed Society concerns and Social Situation Reviewed Attempt to Taper Opioid Dose Function and Pain Scores Evaluated Exit Strategy Reviewed.

Obtain Informed Consent Obtain Informed Consent about the prescribing of Opioids Discuss and have patient review/sign an Opioid Treatment Agreement Maximize and Continue with Non-pharmacological therapies, including patient self-management and life style management (weight loss, exercise, nutrition, sleep hygiene) Non-Opioid analgesics and/or adjuvants, as appropriate /.

Patient Risk Factors for Abuse and Harm Assessed Medical co-morbidities are evaluated/addressed (e.g. sleep apnea, renal insufficiency,pregnancy, elderly) Mental health and psychosocial co-morbidities are evaluated/addressed For patients taking benzodiazepines, particularly for elderly patients, consider a trial of tapering Use a screening tool to determine the patient s risk for opioid addiction The Opioid Risk Tool (ORT) is widely used Treatment modified according to level of risk /.

Inform Patient of Potential Harms Inform patient of their role in safe use and monitoring effectiveness Inform patient of potential Nausea, constipation, drowsiness, dizziness, itching Adverse Effect on driving and operating machinery Medical complications such as sexual dysfunction, sleep apnea, opioidinduced hyperalgesia, and hormonal effects Overdose, diversion, addiction, withdrawal Potentiation of harm with alcohol.

Order Urine Drug Testing Consider using urine drug screening (UDS) To set a baseline measure of substance use that may help assess risk for addiction For ongoing monitoring of the patient s compliance with opioids prescribed Point of care testing, normal lab urine drug testing and gas chromatography can all be useful depending on the clinical situation

Investigate new and/or ongoing symptoms and signs Review History and Physical Exam Evaluate any new symptoms or exam abnormalities Review previous investigations Search for any treatable causes of increased pain and/or decreased function Consider specialist referral (orthopedics, rheumatology, etc.) Order appropriate testing based on results of clinical evaluation

Determine if Opioid Opioid Formulation or Type is to be Consider Immediate Release vs. Controlled Release Weak vs. Strong Opioids Consider Abuse- Deterrent Formulation vs Non Abuse-Deterrent Oral vs. Transdermal (Fentanyl must not be used in Opioid Naïve Patients)

Society concerns and Social Situation Reviewed Assess Home Environment (e.g. co-inhabitants risk of misuse of Opioids) Involve family and/or caregiver in management (e.g. obtain consent from patients to communicate with family Assess compliance (e.g. dosettes) Consider Take Home Naloxone Kit for patients at high risk of overdose Review storage of Opioids Consider abuse-deterrent formulations where appropriate

Attempt to Taper Opioid Dose Periodically discuss with patient and attempt to Taper opioid dose, especially if daily dose of opioid is above 90 MED Taper slowly in most cases (10 % per week) Provide patient with information sheet on dealing with symptoms of Opioid Withdrawal Goal is to reduce daily Opioid dose to dose that provides optimal pain relief and reduces risk of harm Consider Opioid Rotation as a method to reduce total daily Opioid Dose

Function Assessment and Re-assessment Consider a questionnaire ( e.g. Brief Pain Inventory) Employment Recreational Activities Interpersonal Relationships Overall Quality of Life

Urine Drug Testing (UDT) in Pain Management Nov 5, 2017

Learning Objectives How and when to use urine drug testing (UDT) as part of a comprehensive management plan when prescribing opioids for chronic non-cancer pain Discuss how to manage unexpected UDT results

Urine Drug Testing (UDT) Management tool for patients treated with controlled substances or at risk for substance use May use UDT as an option for assessment and should be aware of benefits and limitations, appropriate test ordering and interpretation, and have a plan to use results

Prior to UDT Inform the patient Take careful history of medication/drug use in the past week Collect the sample in physicians office; ensure proper labelling

Point of Care Testing Rapid test performed in clinic e.g. urine dipsticks, cups Immunoassay drug screens are designed to classify substances as either present or absent according to a predetermined cut-off threshold When the amount of drug in the urine sample is equal to or exceeds the cut off concentration of a particular device, the outcome is a positive result POINT OF CARE (POC) LABORATORY TESTING COMPARISON

Laboratory Testing Specimen sent to laboratory Gas or Liquid Chromatography/ Mass Spectrometry is a more definitive laboratory based procedure to identify specific drug and/or metabolites and is needed in 3 instances: To specifically identify the drug; for example, that morphine is the opiate causing the positive immunoassay response To identify drugs not otherwise included in other testing To contest results disputed by the patient POINT OF CARE (POC) LABORATORY TESTING COMPARISON

Comparison - ADVANTAGES Point of Care -Immunoassay Rapid Results Concurrently test for multiple drug classes Very responsive for morphine and codeine Laboratory - Chromatography Identifies specific drug Confirmation of results More accurate for semisynthetic and synthetic opioids Does not cross react with poppy seeds POINT OF CARE (POC) LABORATORY TESTING COMPARISON

Validation Patients may tamper with urine samples to hide aberrant behaviours by: adding adulterants diluting the sample substituting another individuals sample for their own ingesting excessive water or diuretics prior to giving a sample Tests performed to improve the reliability of urine sample results NORMAL CHARACTERISTICS OF A URINE SPECIMEN Temperature (within 4 mins) 32-38 Degrees Celcius ph 4.5-8.0 Urinary Creatinine >20 mg/dl Specific Gravity >1.003

What To Do With Abnormal UDT Results: General Approach Take careful history of medication/drug use in the past week and discuss openly with the patient without being accusatory (potential for false positive and false negative) Check with lab re: potential error What kind of urine test was done? Interpret results in the context of the patient s clinical presentation and assessments Possibly ask the lab to re-run the sample with chromotgraphy if response still unclear UDT, urine drug test.

Unexpected Results Case Table of Contents 1 Is the patient taking the opioid I prescribed? 2 I didn t prescribe that! 3 I didn t expect to find that in your urine sample! 4 Did my patient tamper with the urine sample?

Unexpected Results Case 1 Is the patient taking the opioid I prescribed?

John 39 year old male Currently taking CR oxycodone resistant to crushing 40 mg q12h for chronic back pain On duloxetine 60 mg daily for some neuropathic features with effect Using some quetiapine 25 qhs to sleep ORT score: 8 1 for age 4 for use of THC in college, enough that he failed a semester, then righted himself and graduated, now denies using any 3 for Dad having an alcohol problem; folks split up when he was young due to it.

You do a routine urine on visit today Shows THC Negative for oxycodone, TCAs, benzodiazepines Now what do you do?

Would you? A) Fire him as he is lying to you? B) Tell him that you can no longer prescribe opioids as he is not taking them anyways? C) Confront him about the THC? D) Check when he last took CR oxycodone resistant to crushing? E) Call the lab to check the results? Take careful history of medication/drug use in the past week and discuss openly with the patient without being accusatory

Available at: http://nationalpaincentre.mcmaster.ca/opioid/ Interpreting Unexpected Results of Urine Drug Screens Unexpected Result UDS negative for prescribed opioid Possible Explanations False negative Non-compliance Diversion Actions for the Physician Table B-3.1 Repeat test using chromatography; specify the drug of interest (e.g. oxycodone often missed by immunoassay) Take a detailed history of the patient s medication use for the preceding 7 days (e.g. could learn that patient ran out several days prior to test) Ask patient if they ve given the drug to others Monitor compliance with pill counts

John Restarted marijuana use and problems at work and home Financial issue selling CR oxycodone and some quetiapine CR oxycodone discontinued (should this be tapered?) Quetiapine prescribing decreased to 7days supply Offered resources for drug counselling and treatment programs Revised ORT score - High Risk Regular and random UDT

Unexpected Results Case 2 I didn t prescribe that!

Mary 66 year old female Spinal stenosis 2 failed surgeries in 1999 and 2006 Intolerant of NSAIDS/ COX-2 No personal of family history of drugs or alcohol No history of mental health issues

Mary Has taken acetaminophen 650 QID on a regular basis Reports constipation with acetaminophen/codeine 30mg (not filled Rx in 1 year) Reports significantly decreased QoL over last 6 months After exhausting more physical and psychological modalities, you are considering a trial of oxycodone 5mg

Mary Baseline UDT recommendation roadmap Do this on everyone UDS immunoassay is positive for benzodiazepines and opioids

Mary Now what do you do? Take careful history of medication/drug use in the past week and discuss openly with the patient without being accusatory

Available at: http://nationalpaincentre.mcmaster.ca/opioid/ Interpreting Unexpected Results of Urine Drug Screens Table B-3.1 Unexpected Result Possible Explanations Actions for the Physician UDS positive for nonprescribed opioid or benzodiazepines False positive. Patient acquired opioids from other sources (doubledoctoring, street ) Repeat UDS regularly Ask the patient if they accessed opioids from other sources Assess for opioid misuse/addiction (See Guideline, Part B, Recommendation 12) Review/revise treatment agreement

Known Agents To Cause Interference in Urine Drug Test Results Opioids Marijuana Cocaine Amphetamines Benzodiazepines Dextromethorphan Diphenhydramine (methadone assay only) Poppy seeds Quinine Quinolone antibiotics Rifampin Verapamil (methadone assay only) Efavirenz Hemp seed NSAIDs PPIs Tolmetin Coca leaf tea Amantadine Bupropion Chlorpromazine Desipramine Labetalol Methylphenidate Phentermine Phenylephrine Pseudoephedrine Ranitidine Selegiline Tolmetin Trazodone Typical antipsychotics Oxaprozin Sertraline NSAID, non-steroidal anti-inflammatory drug. PPI, proton pump inhibitor. Adapted from Peppin JF, et al. Pain Med 2012;13:886-96., Reisfield et al Ann Clin Lab Med 1997, Piergies et al Arch Path Lab Med 1997

Mary Explanation of Mary's results: Benzodiazepines: Occasionally takes her sisters diazepam 5mg pills Uses acetaminophen/codeine 8mg on a regular basis (up to 8 per day)

Mary Explanation of Mary's results: Benzodiazepines: Diazepam metabolizes to nordiazepam, temazepam and oxazepam. Opioids Codeine metabolizes to morphine

Benzodiazepines and Opioids Increases the risk of sedation, overdose, and diminished function in all patients, especially as age advances Benzodiazepines increase opioid toxicity and risk of overdose Canadian Guideline for Safe and Effective Use of Opioids for CNCP Part B

Mary The presence of a substance that we are not expecting to find can be used to educate patients on safety of drug interactions and toxicity Mary was counseled on the danger of acetaminophen toxicity and use of benzodiazepines Additional counseling points: Definition of misuse Information on safe storage, no sharing, safe disposal, etc. Opioid Treatment Agreement

Mary Treatment Plan Not start oxycodone prescriptions for now Explore reasons for benzodiazepine use and possible nonbenzodiazepine treatments for this (medication, psychological, behavioural) Repeat urine test in 3-4 weeks to ensure benzodiazepines are now negative (diazepam can remain positive for 3 weeks) Ensure Mary's daily acetaminophen intake is below a level of concern

Unexpected Results Case 3 I didn t expect to find that in your urine sample!

Frank 34 year old male C6-7 fracture from snowmobile accident subsequent fusion C5 to T1 PMHx ADD SHx Recently separated with 2 children Smoker 1 ppd ETOH max 3 per day and 15 per week Denies street drug use FHx mental illness - ADD

Frank Meds Oxycodone-acetaminophen 1-2 Q4h PRN 8 per day Meloxicam 15mg PO Qdaily Tx No change with physio, chiro, acupuncture VAS Neck pain 8/10 radiating to trapezius and shoulder bilaterally

Frank CAGE-AID Low Risk Opioid Risk Tool 4/7 moderate risk Male age 16-45 1 Hx of ADD 2 Current depression 1

Assessment UDS immunoassay in office Opiates EDDP Oxycodone Cocaine TCA - negative negative positive positive negative Now what do you do? Take careful history of medication/drug use in the past week and discuss openly with the patient without being accusatory

Available at: http://nationalpaincentre.mcmaster.ca/opioid/ Interpreting Unexpected Results of Urine Drug Screens Table B-3.1 Unexpected Result Possible Explanations Actions for the Physician UDS positive for illicit drugs (e.g. cocaine, cannabis) False positive Patient is occasional user or addicted to the illicit drug Cannabis is positive for patients THC:CBD (Sativex ) or using medical marijuana Repeat UDS regularly Assess for abuse/addiction and refer for addiction treatment as appropriate Ask about medical prescription of THC:CBD or medical marijuana access program

Frank Admitted to cocaine use intermittently Offered resources for drug counselling and treatment programs Revised ORT score - High Risk Regular and random UDT Treated with non opioid pharmaceuticals and modalities; or Structured opioid treatment with tight boundaries

Random UDTs When a patient steps out of bounds Explain need for good communication system patient cell # or answering system After seeing pt, choose some random dates and record on chart Receptionist writes down in a daily TO-DO list and calls pt by 10:00am to come in Patient has 24hrs to comply or violation

What if? He does not admit to the use? Denies it vehemently? Gets angry and defensive? What are your next options?

Unexpected Results Case 4 Did my patient tamper with the urine sample? If there is a will, there is a way Misuse, Abuse, and Diversion of prescription medications are great motivators to tamper with a UDT

Emma 57 year old female Chronic low back pain Diabetic polyneuropathy Rx with fentanyl transdermal patch 50ug/72 hours Pregabalin 150mg BID Nortriptyline 25mg for sleep and pain

Emma ORT Low Score of 2 as son has a history of drug abuse Opioid treatment agreement signed Never asks for early refills Never loses meds Random UDT annually negative for illicit drugs Always negative for fentanyl but active patch and old patch remnants seen on body

Emma Annual UDT January 2016 Negative for illicit drugs Negative for opioids Negative for fentanyl Specific Gravity 1.000 (Normal is 1.003-1.030)

Emma Is Emma taking her fentanyl? Has her urine sample been tampered with? How else can you test for tampering? How do you address any concerns with Emma? Now what do you do? Take careful history of medication/drug use in the past week and discuss openly with the patient without being accusatory

Interpreting Unexpected Results of Urine Drug Screens Table B-3.1 Unexpected Result Possible Explanations Actions for the Physician Urine creatinine is lower than 2-3 mmol/liter (>20 mg/dl), specific gravity is <1.003 or sample is cold Patient added water to sample Delay in handling sample (urine cools within minutes) Repeat UDS Consider supervised collection or temperature testing Take a detailed history of the patient s medication use for the preceding 7 days Review/revise treatment agreement Available at: http://nationalpaincentre.mcmaster.ca/opioid/

Emma Repeat UDS supervised if possible (female staff to observe) Emma admits that she is only using acetaminophen/codeine 8mg Her son (a known drug abuser) has been stealing her fentanyl patches and usually makes sure she has a new patch on the day before she sees you What do you do now?

Emma Discuss medication safety with Emma? Alternate plans for storage, or daily dispensing Consider changing medication to lower abuse risk or ingested with daily dispensing? Consider personal safety ramifications for Emma? Offer resources for support and safety plan. Consider legal issues in regards to the son? Plans may include other community resources. Consider Emma s safety in dealing with her son. Review patient responsibilities regarding the Opioid treatment agreement

Summary UDS is a recommendation in The Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain UDS point of care immunoassay and laboratory chromatography have different advantages/disadvantages and limitations Your first action with an unexpected result should be Take careful history of medication/drug use in the past week and discuss openly with the patient without being accusatory Each type of unexpected result has a DDx and appropriate physician actions