A Paradigm Shift in Chronic Opioid Prescribing Michael

A Paradigm Shift in Chronic Opioid Prescribing Michael

A Paradigm Shift in Chronic Opioid Prescribing Michael Larson PhD Marshfield Clinic Health System Director of Controlled Medication Policy Disclosure Statement I, Michael Larson PhD, do have a relevant financial interest or other relationship(s) with a commercial entity producing health-care related product and/or services: Insert the following information: Affiliation/Financial Interest Name of Corporate Organization(s) Grant/Research Support Consultant Speaker's Bureau Major Stock Shareholder Other Financial or Material Support Ameritox Ltd (Royalties) Marshfield Clinic Health System: Snapshot of a Physician Led Organization

Objectives Review reasons for change in prescribing chronic opioid therapy (COT) for chronic non-cancer pain Discuss recommendations for prescribing COT for non-cancer pain, as recommended by: The Center for Disease Control and Prevention (CDC) The Wisconsin Medical Examining Board (MEB) and MCHS Guidelines Be able to safely initiate, manage and discontinue opioids for patients according to those guidelines Review issues of opioid use disorders and treatment options for this with focus on

Medication Assisted Treatments. 2/27/20 4 Purpose of the Training This training covers: Cautious, evidence-based opioid prescribing for managing chronic pain, when indicated. Discussion of opioid use disorders and treatment options. This training does NOT cover: A comprehensive review of the management of chronic pain. Acute pain management, end of life pain management or palliative care. A comprehensive review of substance use disorders. 2/27/20

5 Good Video Understanding Pain: Brainman stops his opioids https:// www.youtube.com/watch?v =MI1myFQPdCE Key Take-Home Points 1. Focus in the past was too much on opioids. 2. Problems from opioids, risk of opioids (e.g., falls) and increase risk of ACCIDENTAL OVERDOSE and even DEATH. 3. Chronic use of opioids SENSITIZE the nervous system and actually INCREASE PAIN (Hyperalgesia). 4. Some develop ADDICTION to opioids (opioid use disorder). 5. OPIOIDS ARE NO LONGER RECOMMENDED FOR CHRONIC NON-CANCER PAIN. 6. Patients need an ACTIVE RECOVERY PLAN. 2/27/20

7 Howd we get here? Not a bad doctor problem HCPs learned misinformati on Pain is the 5th Vital Sign Aggressive Marketing Decades of Pain 2/27/20

8 Opioids in America A Crisis, An Epidemic, A National Emergency 2/27/20 9 Deaths by Age Group (1999-2016) Highest overall rate of fatal overdose in ages 2554 https://www.cdc.gov/nchs/products/databriefs/ db294.htm 2/27/20 10

Wisconsin Data The age-adjusted rates of drug overdose deaths increased 72 percent from 2007 to 2016. Both illicit and prescription drug deaths are contributing to this epidemic. The age-adjusted mortality rate was 38 percent higher for males than for females. 2/27/20 11 What we learned about Acute Pain

Bio-Medical Model Injury Chemical signals sent to Brain Ouch! 2/27/20 12 Acute Pain Treatment. Rehab and Rest Short Course of

Opioids Success ! 2/27/20 13 So we tried this same model for chronic pain. But it didnt work. Why??? 2/27/20 14 Pain

Biomedical Model Socio-PsychoSpiritual-Biomedical Model Measured Primarily by Measured with Functional Goals 2/27/20 15 Clinical Evidence Summary No longterm outcomes (>1 year) for pain/ function

Dose escalation does not improve pain / function but does increase overdose risk / harms Inconsiste nt results with various dosing protocols, initiation with LA/ER opioids increased overdose

risk Increased likelihood of longterm use when opioids used for acute pain 2/27/20 16 Contextual Evidence Summary Effective nonpharmacolog ic therapies: exercise, CBT, intervention al procedures

Effective non-opioid medications: APAP, NSAIDS, anticonvulsa nt, antidepressa nts Factors that increase risk for harm: Pregnancy older age MH D/O SUD Sleep D/O sleep apnea Etc. Providers

lack confidence to prescribe opioids safely and are concerned about OUD but patients are ambivalent about risks / benefits 2/27/20 17 Things Change 2/27/20 18 Center for Disease

Control and Prevention Opioid Prescribing Guidelines 2/27/20 19 CDC Opioid Guidelines: Online and now Mobile App MME Calculator Prescribing Guidance Motivational Interviewing Interactive Tool 2/27/20 20 CDC Opioid Prescribing Guidelines 1. Consider non-pharmacologic or non-opioid pharmacologic therapy first

2. Establish treatment goals 3. Before and periodically discuss known risks and realistic benefits 4. If indicated, start with immediate release (IR Formulations because lower doses, limited use) 5. Start with lowest dose possible 6. For acute pain, start with lowest effective dose of IR 7. Evaluate benefits and risks within 1-4 weeks after starting opioids or with dose escalation 2/27/20 21 Center for disease control and prevention opioid prescribing guidelines 8. Before starting and continually throughout: Evaluate risk factors Incorporate strategies to mitigate risk

9. Use PDMP before initiating and periodically 10.Use Urine Drug testing (Annually is recommended) 11.Avoid prescribing opioid and benzodiazepines concurrently (New JAMA study examines risk further) Boxed Warning regarding the combination of opiates and benzodiaze pines http://www.fda.gov/Drugs/DrugSafety/ucm518473.htm 12. Offer treatment for opioid use disorder 2/27/20 22 Greater than 200 mg/day = 24 (Dr. McNett) Concurrent Benzodiazepine = X 3 - 50-99 mg/d + Benzo = 9.33 - 100-199 mg/d + Benzo = 33+ - 200 or more mg/day + Benzo =

70+ Courtesy of the Center for Disease Control and Prevention Conversion to Morphine Milligram Equivalents (MMEs) *This is not a conversion table, only to calculate MMEs* Medication Total Daily Dose X Multiplier Total Daily Total Daily 50 mg 90 mg MMEs MMEs Total Daily 200 mg MMEs

Codeine x 0.15 333 mg 600 mg 1333 Fentanyl Patch (mcg) x 2.4 25 mcg (=60 mg MMEs) 37.5 mcg 75-100 mcg Hydrocodone

x1 50 mg 90 mg 200 mg Hydromorphon x 4 e 12.5 mg 22.5 mg 50 mg Butrans (mcg) x 1.8 27.8 mcg

50 mcg 111 mcg Morphine x1 50 mg 90 mg 200 mg Oxycodone x 1.5 33.3 mg 60 mg 133.2 mg

Oxymorphone x3 16.7 mg 30 mg 66.8 mg Tapentadol x 0.4 125 mg 225 mg 500 mg Tramadol x 0.2

250 mg 450 mg 1000 mg CDC Learn More: www.cdc.gov/drugoverdose/prescribing/guideline.html Conversion to Morphine Milligram Equivalents (MMEs) *This is not a conversion table, only to calculate MMEs* Medication Total Daily Dose X Multiplier Total Daily Total Daily 50 mg 90 mg MMEs MMEs Total Daily

200 mg MMEs Codeine x 0.15 333 mg 600 mg 1333 Fentanyl Patch (mcg) x 2.4 25 mcg (=60 mg MMEs) 37.5 mcg

75-100 mcg Hydrocodone x1 50 mg 90 mg 200 mg Hydromorphon x 4 e 12.5 mg 22.5 mg 50 mg Butrans (mcg) x 1.8

27.8 mcg 50 mcg 111 mcg Morphine x1 50 mg 90 mg 200 mg Oxycodone x 1.5 33.3 mg 60 mg

133.2 mg Oxymorphone x3 16.7 mg 30 mg 66.8 mg Tapentadol x 0.4 125 mg 225 mg 500 mg Tramadol

x 0.2 250 mg 450 mg 1000 mg CDC Learn More: www.cdc.gov/drugoverdose/prescribing/guideline.html Conversion to Morphine Milligram Equivalents (MMEs) *This is not a conversion table, only to calculate MMEs* Medication Total Daily Dose X Multiplier Total Daily 50 mg MMEs

Total Daily 90 mg MMEs 12.5 mg 20+* mg Total Daily 200 mg MMEs Methadone 1-20 mg/day x 4 21-40 mg/day x8 41-60 mg/day x 10

25* mg Methadone: Thex conversion factor increases at higher doses. *Due >/=61 12 to this, the calculation of MME is different than other medications. CDC Learn More: www.cdc.gov/drugoverdose/prescribing/guideline.html Start from the position that opioids (and benzodiazepines) are not indicated for chronic long-term use. 2/27/20 27 Wisconsin Medical Examining Board (MEB) and MCHS

Opioid Prescribing Guidelines 2/27/20 28 Summary of new guidelines regarding opioids(COT) is not 1. Chronic Opioid Therapy 2. 3. 4. 5. indicated for chronic non-cancer pain. If COT is used, prescribe the lowest effective dose, keeping below 50 mg of morphine milligrams equivalent (MME) for risk mitigation. If COT is used at a higher dose that is associated with increased risk for

unintentional overdose (50-90 mg of MME) then mitigate risk by prescribing Naloxone. COT at a dose above 90 mg MME is CONTRAINDICATED due to risk and likelihood of opioid induced hyperalgesia (requires informed consent process). COT combined with benzodiazepines is CONTRAINDICATED due to increased risk of MEB / MCHS: Opioid Prescribing Guidelines Assessment of the patient Initiation of opioids if indicated o Guidelines for initial and ongoing prescribing o Informed consent process Goals for patients on opioids chronically Special guidelines for prescribing Oxycodone (IR) and Methadone for chronic non-cancer pain Discussion of dose reduction and weaning / discontinuation process Process of dose reduction and weaning 2/27/20

30 MEB / MCHS: Opioid Prescribing Guidelines Assessment of the patient PRIORITY: Identify the potential cause of the pain Medical History and Physical Exam Current and Past Treatments Responses Other co-existing conditions that could complicate treatment (e.g., COPD, Sleep Apnea, Renal Disease, etc.) Impact on function, family hx, mental health 2/27/20 31 2/27/20 32 Assess benefits of current treatment plan

Use Pain Enjoyment General Activity (PEG) Assessment instead of simple pain score Questions Score 1) What number best describes your Pain on average in the past week? (from 0=no pain to 10=pain as bad as you can imagine) 2) What number best describes how, during the past week, pain has interfered with your Enjoyment of life? (from 0=does not interfere to 10=completely interferes) 3) What number best describes how, during the past week, pain has interfered with your General activity? (from 0=does not interfere to 10=completely interferes) Total A 30% improvement in PEG Score is considered clinically meaningful. 2/27/20 33

Score Review the following categories Score Personal history of substance abuse: (add all applicable points together) Alcohol (Yes = 3 points) Illicit drugs (Yes = 4 points) Prescription drug (Yes = 5 points) Family history of substance abuse: points together) Alcohol (Yes = 2 points) Illicit drugs (Yes = 3 points) Prescription drug (Yes = 4 points) (add all applicable History of adverse childhood event (Yes = 1 point) (Physical, sexual, psychological abuse or neglect, exposure to violent environments during childhood) Active Psychological Condition:

Anxiety / Depression (Yes = 1 point) ADD, ADHD, bipolar or schizophrenia (Yes = 2 points) Risk level: Low 0 3 Moderate 4 7 (caution with using chronic opioids) High 8 or more (chronic opioid use is contraindicated) 2/27/20 34 Score Review the following categories Personal history of substance abuse: (add all applicable points together) Alcohol (Yes = 3 points) History of OWI x 2 Illicit drugs (Yes = 4 points) Long history of marijuana use. Prescription drug (Yes = 5 points) Family history of substance abuse: (add all applicable points together) Alcohol (Yes = 2 points) Multiple family members with alcohol prob. Illicit drugs (Yes = 3 points) Prescription drug (Yes = 4 points)

History of adverse childhood event (Yes = 1 point) History of Abuse (Physical, sexual, psychological abuse or neglect, exposure to violent environments during childhood) Active Psychological Condition: Anxiety / Depression (Yes = 1 point) Yes chronic depression. ADD, ADHD, bipolar or schizophrenia (Yes = 2 points) Risk level: Low 0 3 Moderate 4 7 (caution with using chronic opioids) Score 7 Points 2 Points 1 Point 1 Point 2/27/20 1135

Assess Risk of Overdose Consider the RIOSORD: Risk Index for Overdose or Serious Opioid-Induced Respiratory Depression Assess risk for accidental overdose. Zedler, et. al., Pain Medicine 2015; 16: 1566-1579 (article in Toolkit) 2/27/20 36 2/27/20 37 Opioid Induced Respiratory Depression (OIRD) Probability based on Calculated Risk Index Risk Index Score OIRD Probability (%)

0-24 3 25-32 14 33-37 23 38-42 37 43-46 51 47-49 55

50-54 60 55-59 79 60-66 75 >66 86 2/27/20 38 MEB / MCHS: Opioid Prescribing Guidelines Assessment of the patient Initiation of opioids if indicated

o Guidelines for initial and ongoing prescribing o Informed consent process Goals for patients on opioids chronically Special guidelines for prescribing Oxycodone (IR) and Methadone for chronic non-cancer pain Discussion of dose reduction and weaning / discontinuation process Process of dose reduction and weaning 2/27/20 39 MEB / MCHS: Opioid Prescribing Guidelines Initiation of opioids if indicated - Guidelines for initial and ongoing prescribing Review and Sign Medication Treatment Agreement o This should be REVIEWED AND SIGNED when the patient: HAS been on prescribed opioids or tramadol (or a benzodiazepine or stimulant) for GREATER THAN 3 months OR The plan is that they WILL BE ON one of those medications for GREATER THAN 3 months

Review ePDMP website ON DATE that prescription is written May consider a Urine Drug Test (UDT) here (if concerns about illicit substance use) OR could do after on medication (must be done ANNUALLY) 2/27/20 40 Please Add Delegates Assign Delegates These are your support staff (CMAs, LPNs, RNs) that assist in checking the PDMP and/or preparing prescriptions. RNs can be a delegate or have an individual account. Managers please assist your prescribers in identifying their delegates. Login to the Wisconsin PDMP website (Login) and follow the steps under Delegate Management. 2/27/20 42

You do NOT need to check ePDMP IF: a. The patient is receiving hospice care. b. The prescription order is for a number of doses that is intended to last the patient three days or less and is not subject to refill. c. The drug is administered to the patient. d. Due to emergency, it is not possible for the practitioner to review the patients PDMP records before issuing a prescription order for the patient. e. The practitioner is unable to review the patients PDMP records because the PDMP digital platform is not operational or because of another technological failure, if the practitioner reports that failure to the CSB. 2/27/20 43 Final ePDMP NOTE Legal advice from the Wisconsin Medical Society regarding Use of Delegates to check ePDMP / PDMP: 1. Prescribers do not need to perform every

check by themselves. 2. Delegates can pull PDMP data. 3. Delegates cannot be 100% responsible for the review. 4. The practitioner must still review the patients record from the PDMP. 2/27/20 44 not CHECK the ePDMP? What are the penalties for failure to review a patients ePDMP records where required by law? Though the Controlled Substances Board has indicated that its priority is to promote educate and train practitioners about the benefits and requirements of the ePDMP, it also has discretion to refer matters of noncompliance to a practitioners licensing board for investigation. Failure by a physician to review a patients records from the ePDMP before issuing a prescription order where required by law is a form of unprofessional conduct that may result in discipline by the Medical Examining Board.

2/27/20 45 MEB / MCHS: Opioid Prescribing Guidelines Initiation of opioids if indicated - Guidelines for initial and ongoing prescribing Prescribe NALOXONE (offer prescription) if patient meets any of the following criteria: o Is on greater than 50 MME (e.g., is on oxycodone 10 mg qid (40 mg) that is equivalent to 60 MME) o Is on ANY opioid or tramadol that is CONCURRENTLY PRESCRIBED WITH A BENZODIAZEPINE due to increased potential for overdose o Is on an opioid or tramadol and has a co-existing health condition that could impact breathing / respiratory depression (e.g., sleep apnea, COPD, etc.) o Has a history of being overly sleepy with medication or has a history of a potential medication related overdose Assess appropriateness for medication due to this history 2/27/20

46 ive g to ne e o r su han e B re t for mo dose one ad h t me Naloxone (Narcan) Nasal 4 mg/actuation Spray, NonAerosol ad directed, may repeat every 3 minutes. Call 911. Naloxone Prescriptions from Q2 2015 to Q2 2017

Q2 '15 Q3 '15 Q4 '15 Q1 '16 Q2 '16 Q3 '16 Q4 '16 Q1 '17 Q2 '17 Naloxone Prescriptions vs All Patients on > 50 mg MME Total Patients on >50 mg MME Naloxone Prescriptions Q3 '16 Q4 '16 Q1 '17 Q2 '17 MEB / MCHS: Opioid Prescribing Guidelines Initiation of opioids if indicated - Guidelines for initial and ongoing prescribing Start LOW and go SLOW:

o Prescribe lowest effective dose - This is typically a short-acting / immediate release formulation Hydrocodone is an example Limit use of oxycodone due to street value and likely higher potential for abuse / misuse / diversion o Time-limited if possible o Clear instructions on how to use: Hydrocodone 5/325 mg prn up to tid #90 (note when they should use the medication and how). Test to see how much they actually need. AVOID: Hydrocodone 5/325 mg 1-2 prn every 4-6 hours #90. The person could take up to 12/day. Goal is to AVOID more than 4 short-acting / immediate release doses per day (too many ups and downs), go to a long-acting then. 2/27/20 50 MEB / MCHS: Opioid Prescribing Guidelines Initiation of opioids if indicated - Guidelines for initial and ongoing prescribing ASSESS progress, side-effects and benefit in 2-4 weeks: o Assess how they are using the medication and how it is working

o Make early corrections in their understanding of when to use the medication I used my 3 pills all at once so I could mow my lawn but then over did it and was in pain, so I had to use more medication and ran out early. I knew they would work better if I used them with a beer, so that is what I did. Correct these early on. Goal is to AVOID injury, so may not want them to use the medication to OVERDO. o Perform pill counts or assess how much they are using, it will help guide future prescriptions. 2/27/20 51 MEB / MCHS: Opioid Prescribing Guidelines Assessment of the patient Initiation of opioids if indicated o Guidelines for initial and ongoing prescribing o Informed consent process Goals for patients on opioids chronically Special guidelines for prescribing Oxycodone (IR)

and Methadone for chronic non-cancer pain Discussion of dose reduction and weaning / discontinuation process Process of dose reduction and weaning 2/27/20 52 MEB / MCHS: Opioid Prescribing Guidelines Goals for patients on opioids chronically Discuss the patients goals for their treatment plan Make sure to reassess progress Target those goals and if progress is not being made, consider changes in the medication If no progress towards goals (e.g., weight loss) during the TRIAL, then consider weaning off and attempting different treatment Review that goal is not to allow patient to do things that their body no longer can do (e.g., will cause injury) 2/27/20

53 MEB / MCHS: Opioid Prescribing Guidelines Goals for patients on opioids chronically 28-day prescriptions, can have 1 additional Do Not Fill (must be filled within 60-days or is voided, so can try 2 but if not filled will be voided). Check PDMP when prescription(s) are written. People on COT 50 MME or more should really be seen every 3 months or less. People on COT < 50 MME should be seen a minimum of every 6 months but every 2-3 months is preferred. Individuals >90 MME need to be REDUCED to 90 MME or less (preferred) or Informed Consent. Individuals on COT (regular use of medication daily) should be ABSTINENT FROM ALCOHOL due to increase risk of OVERDOSE. 2/27/20 54 What are the goals for

better, safer care? 1. Can the patient be weaned off the OPIOID, the benzodiazepine OR BOTH? o o Patient will have to CHOOSE what medication to start with. If person declines despite best efforts with motivational interviewing, then consider temporary pause with clear INFORMED CONSENT DISCUSSION AND DOCUMENTATION OF RISK. 2. If not #1, can we taper OPIOID to 50 mg MME or LESS? 3. If not #1 and #2, can we taper OPIOID to 90 mg MME or LESS? The answer should be YES!!! Do this slowly with a kind and caring approach. o If patient declines after best efforts, then consider temporary pause with clear INFORMED CONSENT DISCUSSION AND DOCUMENTATION OF RISK. 2/27/20 55

Greater than 200 mg/day = 24 (Dr. McNett) Concurrent Benzodiazepine = X 3 - 50-99 mg/d + Benzo = 9.33 - 100-199 mg/d + Benzo = 33+ - 200 or more mg/day + Benzo = 70+ Courtesy of the Center for Disease Control and Prevention Informed Consent If benefits of continued medication therapy as prescribed outweigh the risks, document an informed consent discussion in the patients medical record and the medical decision making supporting the continued use. Informed consent discussion includes o Purpose, risk, benefits o Alternatives available and risks and benefits o Patient has had the opportunity to ask questions and receive answers 2/27/20

57 2/27/20 58 MEB / MCHS: Opioid Prescribing Guidelines Assessment of the patient Initiation of opioids if indicated o Guidelines for initial and ongoing prescribing o Informed consent process Goals for patients on opioids chronically Special guidelines for prescribing Oxycodone (IR) and Methadone for chronic non-cancer pain Discussion of dose reduction and weaning / discontinuation process Process of dose reduction and weaning 2/27/20 59

MEB / MCHS: Opioid Prescribing Guidelines Special guidelines for prescribing Oxycodone (IR) and Methadone for chronic non-cancer pain MEB is strongly discouraging the prescribing of oxycodone at any dose due to no clear evidence of improved efficacy but has more abuse potential and may promote addiction to a greater degree than other opioids MCHS strongly discourages oxycodone at higher doses as these are not indicated for chronic non-cancer pain (use of 15, 20 and 30 mg IR must be clearly justified) UDTs every 6 months and closer monitoring. 2/27/20 60

High Dose Oxycodone IR Prescribing in MCHS 15 mg, 20 mg, 30 mg oxycodone IR Tablets. 42 Unique Prescribers Comparing Q1 2018 with Q4 2016 Opioid agreement Receiving High Dose YES Oxycodone IR (1.2% of all patients on COT) 38% reduction in 100% +16% from Q4 individuals prescribed 2016 these doses.

3% -16% from Q4 2016 81% +18% from Q4 2016 19% -5% from Q4 0% -2% from Q4 2016 0% -14% from Q4 Urine Screen <365 days 81% +16% Urine Screen >365 days or

16% Opioid agreement NO MEB / MCHS: Opioid Prescribing Guidelines Special guidelines for prescribing Oxycodone (IR) and Methadone for chronic non-cancer pain MEB guidelines directly state: CAUTION WITH METHADONE, only prescribed by providers with clear experience and understanding with this medication: o o o Stronger respiratory depressant effect Potent effect on prolonging QTc

Increase in potential impact when on concurrent benzodiazepines Requirements due to increased risk: o o o o EKG prior to starting, at 3 months and annually thereafter; Avoid combining with benzodiazepines; UDT every 6 months Naloxone with all patients on methadone and review overdose risk 2/27/20 62 Methadone Prescribing in MCHS ***Includes for palliative care and oncology*** 30 Unique Prescribers Comparing Q1 2018 with Q2 2016 Receiving Methadone Prescriptions

(1.1% of all patients on COT) 59% Reduction in people on Methadone Urine Screen <365 days Urine Screen 85% +25% 15% Opioid agreement YES Opioid agreement NO 94% +19% from Q2 2016

8% -17% from Q2 2016 85% +32% from Q2 2016 9% 0% -7% from Q2 2016 6% MEB / MCHS: Opioid Prescribing Guidelines Assessment of the patient Initiation of opioids if indicated o Guidelines for initial and ongoing prescribing o Informed consent process Goals for patients on opioids chronically Special guidelines for prescribing Oxycodone (IR) and Methadone for chronic non-cancer pain

Discussion of dose reduction and weaning / discontinuation process Process of dose reduction and weaning 2/27/20 64 MEB / MCHS: Opioid Prescribing Guidelines Discussion of dose reduction and weaning / discontinuation process Understand people on opioids for a long-time will have a great deal of fear when discussing dose reductions They will require time to process information Help them understand that their body will change as the opioids are reduced o The pain may NOT increase and could improve (hyperalgesia; they have been injuring themselves; changes in system) o Their body has adapted to the original injury or surgery, trust the body o They may learn to pace themselves better and understand their body 2/27/20

65 Assure patient does not feel abandoned I know you have real pain. I see your pain is affecting your ability to enjoy many things in life. Living with pain is hard, but I believe you can have a better quality of life. I am committed to helping you create a plan that will allow you to manage your pain better. Opioids may play a role in your pain management. Can I share with you some concerns I have about your dose. 2/27/20 66 Having the Conversation This conversation

Instead of this: Try saying this: Starting the conversation The government wants me to stop your oxycodone. I am concerned about your safety with the oxycodone that I am prescribing. May I talk to you more about this? My hands are tied, I cant prescribed this anymore. Continuing the conversation I know you have pain, but I cannot

give you this medicine anymore. You will have to figure something else out. Have you heard about the increased risk overdose in people taking oxycodone? How do you feel about this? AND / OR Have you heard about how these medications could be making your pain worse? May I tell you how this occurs? 2/27/20 67 Having the Conversation This conversation Instead of this:

Try saying this: The overdose conversation You are going to die if you continue to use this medication, likely in your sleep! Oxycodone and medications like it, do substantially increase the risk of overdose because it reduces your ability to take in air called respiratory depression. When the dose is high as yours, your risk is 3 x greater (50-90 MME) or 11 x greater (> 90) or 24 x greater (>200). What do you think about this information? The Hyperalgesia

conversation Just trust me, it makes your pain worse and is probably the cause of all the pain you have! Provider: Hyperalgesia occurs because our body may not be able to tolerate the high dose (that you are on). We now know that this is common. Patient: But it works for me. Provider: It only appears as if it works because after your take the medication you feel somewhat better but what we know is happening is that your body has become sensitized to the opioid. That is what is making your pain worse in general. 2/27/20 68

Having the Conversation When the conversation starts like this: Instead of saying this: Try saying this: Patient on hydrocodone for 3 years: Patient requests a higher dose - I know you have pain, but I cannot give you more hydrocodone and really we should not be using it at all. - I am going to cut your monthly supply in half this month.

May I talk to you about other treatments that might work better for your pain and are safer in the long run? Patient has been on morphine SR for 8 years: Patient asks at appointment why he has been prescribed such a dangerous drug after he hears on the new about the high rates of overdose. - That morphine was prescribed by his previous provider. - I never thought it was good for you. - I am not sure how to

taper you off of this, so I will send you to the Pain Clinic Yes, this is a concern to me also. We are realizing that opioids are not the best option for treating pain. Just as treatments change for diseases like diabetes and heart disease, treatments can change for pain also. Lets talk about other options for your pain management. 2/27/20 69 More immediate risk factors: Respiratory respiratory depression (Normal BMI +opioid risk central sleep apnea = OSA of obesity) Digestive slow gastric emptying and GI motility, constipation

Integument rash and intense itching Cognitive changes Urinary Urinary retention can lead to kidney damage over time More long-term risk factors: Endocrine Opioid induced androgen deficiency (OPIAD) causes decreased testosterone Reproductive decreased libido and fertility problems and erectile dysfunction, neonatal overdose risks Neurological can increase depression or worsen existing depression. Opioid induced hyperalgesia, somnolence Skeletal impairs cell turnover and hormone stimulation of bone growth (osteoporosis) Muscular fatigue can cause decreased activity leading to muscle weakness, risk of falls. Cardiovascular some can increase risk of MI or heart attack Develop a New Plan and SELL it! 2/27/20 71

2/27/20 72 MEB / MCHS: Opioid Prescribing Guidelines Assessment of the patient Initiation of opioids if indicated o Guidelines for initial and ongoing prescribing o Informed consent process Goals for patients on opioids chronically Special guidelines for prescribing Oxycodone (IR) and Methadone for chronic non-cancer pain Discussion of dose reduction and weaning / discontinuation process Process of dose reduction and weaning 2/27/20 73 MEB / MCHS:

Opioid Prescribing Guidelines Process of dose reduction and weaning General Recommendations: Slow is best, recommend 10-15% of total daily dose every 4 weeks. Can pause at times but be persistent. Reduce short-acting first (if on long-acting and short-acting) but may have to add it back in to balance reductions. o Goal is to reduce the short-acting onset sensation that is more noticeable o People tend to be more connected to the short-acting medication, need to break that first. o May add in small doses of short-acting to balance the reduction percentages. 2/27/20 74 MEB / MCHS: Opioid Prescribing Guidelines Process of dose reduction and weaning General Recommendations: EXCEPTIONS: Methadone and Fentanyl Leave the short-acting and reduce methadone FIRST

until the person is completely off of methadone o Methadone is difficult, so go slow all the way thru but VERY SLOW at the end doses (2.5 mg once daily for 1 month is usually the final dose) o People will likely not feel well for 60-90 Days after last dose of methadone, so then reduce the short-acting that will hide the symptoms Leave the short-acting and reduce Fentanyl first o Fentanyl is 2.4 times stronger than morphine and the steps between patches are quite big, so the short-acting will hide some of the % reductions. o For example: Going from 25 mcg to 12 mcg is more than a 50% reduction or likely going from 60 MME to 28 MME. Need to hide that experience. 2/27/20 75 MEB / MCHS: Opioid Prescribing Guidelines Process of dose reduction and weaning General Statements: Goals: o o o

o #1 is to get them OFF of chronic opioids if possible. If #1 is not possible, the #2 goal is to get dose to < 50 MME If #2 goal is not possible, then #3 goal is to get dose to <90 MME Be open and honest that these are your goals Must be encouraging, people do quite well when the approach is slow and gradual, allows time for the body to adjust They will notice brain waking up, may notice emotions / humor returning, sex-drive (in men) returning May need to consider other treatments. 2/27/20 76 MEB / MCHS: Opioid Prescribing Guidelines Process of dose reduction and weaning Monitoring Progress: See patients every 2 months during the reduction process (minimum) Document their changes, question sleep, energy,

bowel movements, sex drive, personality or anything else that may be a positive change Encourage appropriate pacing as they become more aware of their bodies Advise that withdrawal symptoms should NOT be occurring when dose is around 10%, if they are consider slowing the process VS adding medication 2/27/20 77 MEB / MCHS: Opioid Prescribing Guidelines Process of dose reduction and weaning Monitoring Progress: Advise them on other medications that may be on their list that are already helping with the symptoms and pain (e.g., muscle relaxers or neuropathic pain medications) o Can consider clonidine 0.2 mg po bid or different dose o Can consider tizanidine 2 mg po tid or different dose If pain becomes a concern, they may be open to trialing medications or treatments they have

declined in the past, consider: o Offering trial of neuropathic or antidepressant o Offering trial of physical therapy or procedures 2/27/20 78 MEB / MCHS: Opioid Prescribing Guidelines Process of dose reduction and weaning Weaning / discontinuation can be faster if violation of Medication Treatment Agreement Can reduce by ~20% every 1-2 weeks due to illicit substance abuse or use of dangerous combinations. Can discontinue suddenly if EVIDENCE OF DIVERSION is present (e.g., high dose medication with negative UDT or other information). Must complete INCIDENT REPORT / RL Solutions to properly document within our system. 2/27/20 79

MEB / MCHS: Opioid Prescribing Guidelines Process of dose reduction and weaning Monitoring Progress: Continue to perform UDTs and Pill Counts / Refills as you go thru the process. This may help to identify overuse or misuse of the medication early on. As the dose reduces if a patient becomes more hostile or angry or misuse is noted, you may be exposing an opioid use disorder that has been medically managed by high doses. KEY QUESTION: Is person willing to try other treatments for pain OR do they remain focused on only opioids (or receiving other medications benzodiazepines) 2/27/20 80 MEB / MCHS: Opioid Prescribing Guidelines Process of dose reduction and weaning Monitoring Behavior and if they do any of the following at any time:

Running out early Indicate other treatments are indicated, medication may not be the answer Is this a sign of addictive behavior? Unapproved self escalation Is this a sign of addictive behavior? Rude or pushy with staff Should not be tolerated Interested only in mono-therapy Contraindicated, need an active treatment plan Lost or stolen prescriptions

If MME > 60 mg, provide of daily dose until next refill is due If MME < 60 mg, do not refill until next refill is due Illegal or unauthorized medications in UDS Sign something else is going on investigate 2/27/20 81 MEB / MCHS: Opioid Prescribing Guidelines Process of dose reduction and weaning Monitoring Progress: If person is focused on only medications and the reduction may be exposing an Opioid Use Disorder (addiction), then consider: o Discussing their RELATIONSHIP with the medication to tease apart pain issues from how CONNECTED they are to the medication. o Are they noticing that they DO NOT FEEL NORMAL in between doses or

on less medication. NOT pain wise but emotionally. o Remember these medications have impact on the dopamine system and may experiencing how that system has changed in the context of the chronic opioids. o Engage the patient in a quest to understand this better. PLEASE DO NOT CALL THEM AN ADDICT OR TELL THEM THEY HAVE AN ADDICTION. This is something they have to discover on their own. 2/27/20 82 Opioid Use Disorder (OUD) Review issues of opioid use disorders (OUD) and treatment options for this with focus on Medication Assisted Treatments (MAT) 2/27/20 83 MCHS and Chronic Opioid Therapy

How are we doing as a system? 2/27/20 84 Annual total morphine equivalents prescribed at MCHS Reduced by 29% from 2016 to 2017 Reduced 49.5% since 2012 2011 2012 2013 2014 2015

2016 2017 comparing Q2 2017 to Q1 2018 22% Overdose Risk Reduction **>100 MME: 52% reduction from Q2 2016 to Q1 2018 (outside of guidelines). 29% Overdose Risk Reduction 50-99 MME 100-199 MME Q2 2017

Q3 2017 Q4 2017 Q1 2018 35% Overdose Risk Reduction 200-399 MME 62.5% Overdose Risk Reduction >400 MME Calculated reduction of overall overdose risk is 32.6% in 1 year (all doses). 2/27/20 86 What is your role in opioid safety?

Follow the Guidelines Educate Be Safe Minimize opioid Rxs Assure the patient PDMP Avoid combining high risk meds Explain the plan Medication Agreement / Informed Consent Limit titrating

Provide Alternatives UDS / UDT Taper when needed Offer resources Naloxone, MAT 2/27/20 87 Summary of new guidelines regarding opioids(COT) is not 1. Chronic Opioid Therapy 2. 3. 4. 5.

indicated for chronic non-cancer pain. If COT is used, prescribe the lowest effective dose, keeping below 50 mg of morphine milligrams equivalent (MME) for risk mitigation. If COT is used at a higher dose that is associated with increased risk for unintentional overdose (50-90 mg of MME) then mitigate risk by prescribing Naloxone. COT at a dose above 90 mg MME is CONTRAINDICATED due to risk and likelihood of opioid induced hyperalgesia (requires informed consent process). COT combined with benzodiazepines is CONTRAINDICATED due to increased risk of Way too much information Contact Michael Larson PhD with questions or comments. [email protected] Remember to complete your Continuing Education evaluation to receive credit. If you have specific questions or concerns, please

use the Controlled Medications Shared Email. Thank You! 2/27/20 89

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