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OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? • JAMES W. ATCHISON, DO (MODERATOR) • MEDICAL DIRECTOR • RIC CENTER FOR PAIN MANAGEMENT DISTINGUISHED PANEL • STEVEN STANOS, DO • BRIAN BRUEHL, MD • MICHAEL BRENNAN, MD • R. NORMAN HARDEN, MD DISCLOSURES • • • • • JAMES W. ATCHISON, DO STEVEN STANOS, DO BRIAN BRUEHL, MD MICHAEL BRENNAN, MD R. NORMAN HARDEN, MD LEARNING OBJECTIVES • Participants will be able to: – Direct patient education according to reference guidelines regarding safe prescribing, storage, and dose adjustments of opioids. – Utilize concepts of rational polyp pharmacy in chronic pain management. – Evaluate and recommend appropriate adjunct of treatments beyond medications for chronic pain management REMS BLUEPRINT REVIEW • MAJOR HEADINGS – Why Prescriber Education is Important – I. Assessing Patients for Treatment with ER/LA Opioid Analgesic Therapy – II. Initiating Therapy, Modifying Dosing, and Discontinuing Use of ER/LA Opioid Analgesics – III. Managing Therapy with ER/LA Opioid Analgesics 5/25/2017 presentation 5 REMS BLUEPRINT REVIEW • MAJOR HEADINGS – IV. Counseling Patients and Caregivers about the Safe Use of ER/LA Opioid Analgesics – V. General Drug Information ER/LA Opioid Analgesic Products – VI. Specific Drug Information 5/25/2017 presentation 6 CASE PRESENTATION • 48 y/o F presents for Tx w/ Hx of chronic Rt UL pain. S/P Fx of Radius & Ulna 2 y/a after fall. Pain level 5-8/10 ; referred due to completion of all w/u & Tx from ortho. Increased pain w/ all movements of arm and restricted use. Left knee pain w/ walking and standing tolerance of 25 minutes. Works as Administrative Assistant. Current Rx for Hydrocodone 5/325 to be used 12 q 4-6 hours as needed, and now taking 8 tabs per day. All records available for review. 5/25/2017 presentation 7 WHAT WOULD YOU DO? PROCESSES BEFORE RX • Hx/visit includes Risk Stratification • Review possible risks & side effects • Review Patient Counseling Document • Review/sign Patient Agreement • Complete UDS 5/25/2017 presentation INITIAL RX? 1. Hydrocodone 5/325 up to 4/day 2. Hydrocodone 10/325 up to 4/day 3. Rotate to other Short Acting opioid 4. Transition to Long Acting opioid 5. No Rx on 1st visit 8 RISK STRATIFICATION 5/25/2017 presentation 9 WHAT WOULD YOU DO? COMMONLY USED TOOLS WHICH IS BEST? • ORT • SOAPP-R • PSYCOLOGY INTERVIEW • COMM 5/25/2017 presentation 10 REVIEW & SIGN PATIENT AGREEMENT 5/25/2017 presentation 11 OPIOID ANALGESICS • PATIENT AGREEMENTS – OPIOID THERAPY UTILIZED ONLY AFTER ALL OTHER REASONABLE ATTEMPTS HAVE FAILED – SINGLE PHYSICIAN PRESCRIBER & PHARMACY – PT MUST AGREE TO COGNITIVE-BEHAVIORAL TX – PRESCRIPTIONS MUST LAST UNTIL THE NEXT VISIT • BRING IN ALL UNUSED MEDICATIONS OPIOID ANALGESICS • PATIENT AGREEMENT – PT MUST INFORM DOCTOR OF ALL OTHER MEDICATIONS AND CHANGES • NO BENZOS OR CARISOPRODOL • ? PREGABLIN – PT MUST AGREE TO RANDOM URINE TESTING – INFORM PATIENT OF ALL RISKS (LIST) • INCLUDING TOLERANCE, DEPENDANCE, ADDICTION • SIDE EFFECTS OPIOID ANALGESICS • PATIENT AGREEMENT – ANY EVIDENCE OF DRUG HOARDING, DRUG DIVERSION, UNAGREED-UPON DOSE CHANGES, LOSS OF RX, OR FAILURE TO FOLLOW THE AGREEMENT WILL (MAY?) RESULT IN TAPERING OF MEDICINE AND DISCONTINUATION OF DOCTOR-PATIENT RELATIONSHIP • DESIGNED TO LIMIT DIVERSION WHAT WOULD YOU DO? DO YOU REGULARLY USE THESE? • YES • NO 5/25/2017 presentation 15 REVIEW RISKS AND SIDE EFFECTS OF OPIOIDS 5/25/2017 presentation 16 Clinical Effects of Opioids Desirable effects Analgesia Relief of Anxiety Undesirable effects Nausea/vomiting Urinary Retention Mental Status Changes Respiratory Depression Tolerance / Dry Mouth / Drug Dependence Circumstantial effects Sedation Cough Suppression Euphoria Decreased Bowel Motility Mycek, et al., eds. Pharmacology, 2d ed. Philadelphia; Lippincott-Raven, 1997. Opioid Adverse Effects Usually dose related and some are drug specific Common Constipation Dry mouth Nausea/Vomiting Sedation Sweating Less Common Respiratory depression Bad dreams/hallucinations Dysphoria/delirium Myoclonus/seizures Arrhythmia Pruritis/urticaria Urinary retention Amenorrhea/sexual dysfunction 5/25/2017 presentation 18 Anticipate/Manage Side Effects Respiratory Depression - Sedation precedes respiratory depression Role of sedation scales? - Respiratory rate alone is not an indication of respiratory function. - Use Naloxone sparingly Respiratory depression reverses before analgesia Limit to doses of 100 micrograms at a time One amp (0.4mg) in 4ml NS Inject 1 ml at a time- can always give more. 5/25/2017 presentation 19 WHAT WOULD YOU DO? UPDATED HISTORY • Continues Hydrocodone at 10/325 QID • She experiences: – – – – Constipation Sleepiness in the afternoon Occasional nausea Occasional SOB • She is not sleeping well at night 5/25/2017 presentation OPTIONS • Add Colace, Sennakot, Miralax, etc, daily • Start Provigil in am & noon • Use compazine PRN • Use Albuteral inhaler PRN • Start Clonazepam at HS? • Repeat UDS 20 REVIEW OF PATIENT COUNSELING DOCUMENT 5/25/2017 presentation 21 Patient Counseling Document (PCD) • The DOs and DON’Ts of Extended-Release / Long - Acting Opioid Analgesics • DO: – – – Read the Medication Guide Take your medicine exactly as prescribed Store your medicine away from children and in a safe place – Flush unused medicine down the toilet – Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Patient Counseling Document (PCD) • DON’T: Do not give your medicine to others Do not take medicine unless it was prescribed for you Do not stop taking your medicine without talking to your healthcare provider Do not break, chew, crush, dissolve, or inject your medicine. If you cannot swallow your medicine whole, talk to your healthcare provider. Do not drink alcohol while taking this medicine • For additional information go to: dailymed.nlm.nih.gov Safe Storage of Opioids Monitor Patients should always be in a position to know if any pills are missing • Take note of how many pills are in each prescription bottle or pill packet • Keep track of your refills for your own medication, as well as for other members of the household • Make sure friends and relatives— especially grandparents—are aware of the risks and regularly monitor their own medicines Secure Secure prescriptions the same way as other valuables in the home, like jewelry or cash • Take prescription medications out of the medicine cabinet and hide them in a place only you know about • Encourage relatives and friends to secure their medications • If possible, keep all medicines in a safe place • An existing fire safe or gun safe • Use a cut-proof bag designed for travel safety • Locking medicine box or cabinet APF. PainSAFE™. Problems with Opioids Can Be Prevented. Available at: http://www.painfoundation.org/painsafe/healthcareprofessionals/pharmacotherapy/opioids/preventing-problems.html. Accessed February 3, 2012. 45 OPIOID SAFETY • STORAGE OF MEDICATIONS – LIMIT NUMBER OF PERSONS THAT ARE AWARE YOU ARE USING PAIN MEDS • BE AWARE OF OTHER PATIENTS OR PERSONS AROUND PHYSICIAN’S OFFICE • BE AWARE OF PERSONS WATCHING AT PHARMACY • LIMIT DISCUSSIONS WITH FAMILY AND FRIENDS – KEEP MEDS AWAY FROM FAMILY MEMBERS • DO NOT ASK THEM TO GET MEDICATIONS FROM STORAGE OPIOID SAFETY • DATA FROM 2009-2010 National Survey on Drug Use and Health – 70% of the 2.4 million Americans who abuse prescription drugs for the first time each year get them from friends and family • 1/3 are teenagers OPIOID SAFETY • DATA FROM 2009-2010 National Survey on Drug Use and Health – Casual Abusers of Rx Drugs(< 1x/wk) • 55% got substances FREE from friends/family • 11% PURCHASED substance from friends or family • 5% TOOK WITHOUT PERMISSION substances from family/friends OPIOID SAFETY • DATA FROM 2009-2010 National Survey on Drug Use and Health – Chronic Users/Abusers of Rx Drugs(> 1x/wk for more than a year) • 41% got substances WITH OR WITHOUT PERMISSION from friends/family • 25% PURCHASED substance from dealer or the internet • 25% OBTAINED THEM FROM A DOCTOR WHAT WOULD YOU DO? UPDATED HISTORY • After 4 months, she calls into clinic for early refill as she is out of her pills and is not sure why? 5/25/2017 presentation OPTIONS • Manage this over the phone until next visit • Review Patient Agreement and DC from the clinic • Review pharmacy issues • Review storage issues • Repeat UDS? 29 UDS MONITORING 5/25/2017 presentation 30 WHAT WOULD YOU DO? UDS RESULTS • No Substances present? • Hydrocodone and Hydromorphone present – – – – – – w/ Oxymorphone w/ benzodiazepine w/ ETOH w/ THC w/ Cocaine w/ Morphine, codeine, and oxycodone 5/25/2017 presentation OPTIONS • Repeat the test w/ Inc sensitivity – continue Tx • Counsel pt and repeat at next visit – continue Tx • Counsel pt and DC from clinic – Give 1 month Rx? • Counsel pt and Refer to Addiction Medicine – Give 1 month Rx? 31 Choosing Opioid Therapy • Chronic pain management should be individualized • Selection of a specific opioid based on criteria: efficacy, tolerability, safety, and ease of use. • Initiated at a low dose and gradually increasemonitor pain reduction and side effects. • Patients must be fully informed about the nature of their treatment, benefits and harmful effects • Long acting versus breakthrough doses WHAT WOULD YOU DO? ADDITIONAL HISTORY • Received Rx for Hydrocodone 10/325 QID for 6 months (compliant!). • She previously split some pills in ½, but is now receiving less response to whole pills. Pain 7-9/10 • Having a difficulty time working. 5/25/2017 presentation OPTIONS 1. Increase Hydrocodone to 68 tabs/day 2. Rotate to other SA Opioid 3. Initiate LA/ER Opioid 4. Test UDS & Continue current Hydrocodone 5. Stop the medication 6. Refer to Addiction Medicine 7. Further Work-up? 33 ROTATING SA THERAPY 5/25/2017 presentation 34 WHAT WOULD YOU DO? SA OPTIONS • Oxycodone – w/ Aceteminophen? • • • • Hydromorphone Morphine Sulphate Oxymorphone Tapentadol • How many MEQ? 5/25/2017 presentation OPTIONS • Taper the Hydrocodone, then start new med • Stop Hydrocodone; start new med at lower MEQ • Stop Hydrocodone; start new med at same MEQ • Stop Hydrocodone; start new med at Inc MEQ 35 DEPENDENCE IS NOT ADDICTION • Physical dependence: – “Physical dependence is a state of adaptation that is manifested by a drug class specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist.” DEPENDENCE IS NOT ADDICTION • Addiction: – “Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. – It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving.” OPIOID ANALGESICS • TOLERANCE – NEED FOR INCREASING AMOUNT OF THE DRUG TO ACHIEVE THE SAME EFFECT DUE TO THE PROGRESSIVE LOSS OF EFFECTIVENESS OF THE DRUG WITH ALL OTHER CONDITIONS CONSTANT INITIATING LA THERAPY 5/25/2017 presentation 39 WHAT WOULD YOU DO? LA OPTIONS • Oxycontin • MSContin/Oramorph/ MSER/Avinza • Duragesic, Fentanyl Patch • Opana ER • Exalgo • Nucynta ER • Dolphine, Methadone • Butrans Patch • Zohydro ER, Hysingla ER 5/25/2017 presentation OPTIONS • Taper the Hydrocodone, then start new med • Stop Hydrocodone; start new med at lower MEQ • Stop Hydrocodone; start new med at same MEQ • Stop Hydrocodone; start new med at Inc MEQ • Start new med and use Hydrocodone for BTP 40 WHAT WOULD YOU DO? INFLUENCES • Dosage Issues • Insurance coverage • Side Effects/History • Current Medications • Social History • REMS rules 5/25/2017 presentation START/DON’T START • MS Contin • Fentanyl • Avinza • Oxycontin • Opana ER • Nucynta ER • Methadone • Butrans • Zohydro ER 41 INITIATING THERAPY OF ER/LA OPIOIDS • According to Blueprint - may be used for initial dosing in non-tolerant pts. – – – – – – – Avinza 30 mg daily Butrans patch 5 mcg/hr every 7 days Dolophine 2.5-10 mg every 8-12 hours Embeda 20 mg/0.8 mg every 12-24 hours Nucynta ER 50 mg every 12 hours Opana ER 5 mg every 12 hours Oxycontin 10 mg every 12 hours INITIATING THERAPY OF ER/LA OPIOIDS • According to Blueprint - should not be used for initial dosing in non-tolerant pt – – – – Duragesic patch Exalgo Kadian MS Contin (?) • Require a calculation of dose from current use – Based on conversion tables? • There are increasing concerns with this! INITIATING THERAPY OF ER/LA OPIOIDS • According to Blueprint - Initial titration interval: – (minimum number of days before it can be changed again) • • • • • Oxycontin – 1-2 days Kadian – 2 days MS Contin – 2 days Opana ER – 2 days Avinza – 3 days INITIATING THERAPY OF ER/LA OPIOIDS • According to Blueprint - Initial titration interval: – (minimum number of days before it can be changed again) • • • • • • Butrans – 3 days Embeda – 3 days Nucynta ER – 3 days Duragesic – 72 hours Exalgo – 3-4 days Dolophine – Not reported – should be 7 days or more MODIFYING DOSING OF ER/LA OPIOIDS • Titrate increase in ER/LA opioid medication on regular intervals – 25-33% changes for 1-2 visits – 10-20% for continuing visits • Eventually titrate SA opioid to return to only PRN use MODIFYING DOSING OF ER/LA OPIOIDS • Stop further titration of ER/LA opioid when: – Adequate analgesic effects – Unacceptable side effects – No increase in analgesic response for 1 – 2 changes – Ceiling levels • Avinza, Butrans, Nucynta, ?Dolphine SIGNS/SYMPTOMS OF ONSET RESPIRATORY DEPRESSION • Any Trouble Breathing – Hypopnea or apnea • Cannot be easily aroused – Intoxicated behavior – confusion, slurred speech, stumbling • Unusual snoring, gasping, or snorting (especially with sleep) • Fingertips/lips are blue/purple SIGNS/SYMPTOMS OF ONSET RESPIRATORY DEPRESSION • Recent Review Article in NEJM – Edward Boyer, MD, PhD N Engl J Med 2012; 367; 146-155 • Internet Education/Assistance – Opioids911.org – Many Others WHAT WOULD YOU DO? WHAT ABOUT NALOXONE? • I’ve thought about it! • I regularly prescribe it! • I don’t see the need for it! 5/25/2017 presentation 50 ROTATING LA TREATMENT 5/25/2017 presentation 51 WHAT WOULD YOU DO? UPDATED HISTORY • She returns a year later no • DC Opana ER; change to better and wishes to Duragesic Patch @ 100 change medications. mcg/hr • DC Opana ER; start Oxycontin at 80 mg q12 h • Currently on Opana ER 40 mg q8h/MSIR 15 mg qid • Begin tapering Opana ER by 10 mg per dose daily until off and then start MSER at 15 mg q 12 h 5/25/2017 presentation 52 II. Initiating Therapy, Modifying Dosing, and Discontinuing Use of ER/LA Opioid Analgesics • e. (LO3) Prescribers should understand the concept of incomplete crosstolerance when converting patients from one opioid to another. • f. (LO4) Prescribers should understand the concepts and limitations of equianalgesic dosing and follow patients closely during all periods of dose adjustments. MODIFYING DOSING OF ER/LA OPIOIDS • Equianalgesic Dosing – Based on Morphine Equivalents – Some meds much less reliable – Conversion Tables • Lots of variability • May be cause of some deaths/injuries? OPIOID DOSING: CONVERSION AND RISK CONVERSION TO MORPHINE MEQ LOW MODERATE HIGH VERY HIGH MORPHINE x1 0 - 30 mg 31 - 100 mg 101 - 200 mg > 200 mg HYDROCODONE x1 0 - 30 mg 31 - 100 mg 101 - 200 mg > 200 mg OXYCODONE x 1.5 0 - 20 mg 21 - 66 mg 67 - 133 mg > 133 mg HYDROMORPHONE x4 0 - 7.5 mg 7.6 - 25 mg 26 - 50 mg > 50 mg OXYMORPHONE x3 0 - 10 mg 11 - 33 mg 34 - 66 mg > 66 mg TAPENTADOL x 0.33 0 - 75 mg 76 - 250 mg 251 - 500 mg > 500 mg METHADONE x3 0 - 10 mg 11 - 30 mg 31 - 60 mg > 60 mg FENTANYL PATCH x 5 NONE 12 mcg/hr 24 - 50 mcg/hr > 50 mcg/hr BUPRENORPHINE PATCH ? 0 - 35 mcg 36 - 52.5 mcg 52.6 - 105 mcg > 106 mcg ? 0 - 200 mg 201 - 400 mg TRAMADOL > 400 mg Methadone Conversion Relative potency based on Morphine Equivalent dose per day - MEDD < 500mg, Conversion 5:1 - MEDD < 1000mg, Conversion 10:1 - MEDD > 1000mg Conversion 20:1 Ratios are starting points. Different variations in potency ratios 5/25/2017 presentation 56 INCOMPLETE CROSS-TOLERANCE • Current doses of ER/LA med not providing adequate analgesia – ?Tolerance vs Receptor responses • A new/different ER/LA med may not have similar potency – Will act differently at the receptors • Overdose is possible MODIFYING DOSING OF ER/LA OPIOIDS • Best Option – Taper current med to easier level • Lower dose of current ER/LA med to make easier conversion • Start new ER/LA with low dose of current med • Complete transition without change in SA opioid • Begin to increase new ER/LA • Still needs frequent FU due to inc pain WHAT WOULD YOU DO? WHICH IS A TAMPER RESISTANT ER/LA OPIOID? UPDATED HISTORY • Some concerns about the safety of storage and • Fentanyl Patches family members accessing • Avinza (morphine) the medications. • Opana ER (oxymorphone) • Embeda (MS/Naltrexone) • Oxymorphone ER 5/25/2017 presentation 59 • • • • • CURRENTLY APPROVED ABUSE DETERRENT LA/ER OPIOIDS Oxycontin (Oxycodone) Opana ER (Oxymorphone) Exalgo (Hydromorphone) Embeda (Morphine/Naltrexone) Hysingla ER (Hydrocodone) • Suboxone (Buprenorphine/Naloxone) 5/25/2017 presentation 60 DISCONTINUE TREATMENT 5/25/2017 presentation 61 WHAT WOULD YOU DO? UPDATED HISTORY • She returns a year later no better and wishes to stop treatment. INITIAL TREATMENT • Refer to detox unit • Stop the MSIR • Lower LA Opana ER to 30 mg q8h, and reduce • Currently on Opana ER 40 monthly mg q8h/MSIR 15 mg qid • Lower LA Opana ER to 30 mg q8h, and reduce weekly 5/25/2017 presentation 62 WHAT IF THERE IS A PROBLEM OR THEY ARE NOT WORKING? 5/25/2017 presentation 63 DEPENDENCE IS NOT ADDICTION • Physical dependence: – “Physical dependence is a state of adaptation that is manifested by a drug class specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist.” DISCONTINUING USE OF ER/LA OPIOIDS • Dependance is not addiction – Withdrawal symptoms include: • • • • • • • • Severe dysphoria Sweating Nausea Rhinorrea Depression Severe fatigue Vomiting Pain AVOIDING WITHDRAWAL DISCONTINUING USE OF ER/LA OPIOIDS • Tapering recommendations – Variable rate and pattern • 10% of dose per day to q weekly – Have a detailed patient agreement • May write out entire schedule? • Removing from clinic/starting other Tx? – Frequent FU visits • Limit amount of Rx per visit DISCONTINUING USE OF ER/LA OPIOIDS • Tapering recommendations – Slow the taper after reaching 1/3 of original dose – Monitor for withdrawal, worsening pain or mood and associated function • Objective measures – Consider urine testing - compliance WHY ARE YOU TAPERING: COMPLIANCE vs INEFFECTIVENESS? 5/25/2017 presentation 69 DISCONTINUING USE OF ER/LA OPIOIDS • Use SA opioids to complete taper? – The last step off the ER/LA meds – Follow similar % reduction with the SA meds – Monitor for reduction in mood and function II. Initiating Therapy, Modifying Dosing, and Discontinuing Use of ER/LA Opioid Analgesics • RECOMMENDATIONS – STRUCTURE – COMPLIANCE – DOCUMENTATION DISCONTINUING USE OF ER/LA OPIOIDS • DISPOSING OF MEDICATIONS – FDA INSTRUCTIONS • FLUSH MEDICATIONS • DRUG TAKEBACK DAYS • NEW PHARMACY REGULATIONS – CONCERNS • ENVIRONMENTAL Counseling Patients and Caregivers about the Safe Use of ER/LA Opioid Analgesics • HOW DO YOU WANT YOUR OFFICE TO HANDLE ALL OF THIS? – WRITTEN MATERIALS/HANDOUTS/DVD/WEB • • • • • PATIENT COUNSELING FORM SPECIFIC MEDICATION INFORMATION SIDE EFFECT AWARENESS PATIENT AGREEMENT OFFICE POLICIES – DRIVING OR OPERATING MACHINERY – SHOULD THEY SIGN ALL OF THESE? • DOCUMENT THAT THEY RECEIVED THEM ALL? Counseling Patients and Caregivers about the Safe Use of ER/LA Opioid Analgesics • HOW DO YOU WANT YOUR OFFICE TO HANDLE ALL OF THIS? – TELEPHONE POLICIES/ISSUES • SAME DAY APPOINTMENTS? – MEDICATION NOT WORKING? – SIDE EFFECTS? – THEFT OR LOSS? • DAYTIME vs NIGHTTIME NUMBERS? • DOCUMANTATION OF PHONE CALLS? – IS THIS REALLY A GOOD PT TO HAVE ON OPIOIDS? • HOW OFTEN ARE THEY CALLING? Counseling Patients and Caregivers about the Safe Use of ER/LA Opioid Analgesics • HOW DO YOU WANT YOUR OFFICE TO HANDLE ALL OF THIS? – FOLLOW-UP QUESTIONS • DID YOU SHARE YOUR MEDS? – ANY LOST OR STOLEN? • DID YOU BREAK/CHEW/ALTER MEDS OR ADJUST THE DOSE? • DID YOU DRINK ALCOHOL? • DID ANY OF YOUR OTHER MEDS CHANGE? – DO WE NEED TO ASK THESE AT EVERY VISIT? • CAN IT BE DONE ON A COMPUTER KIOSK? WHAT WOULD YOU DO? I FIND REMS PRINCIPLES: • Helpful • Not Helpful 5/25/2017 presentation 76 QUESTIONS