Risk evaluation and mitigation for use of opioids in chronic pain Leslie J Blackhall MD MTS David Ling MD Palliative Care, University of Virginia

Learning Objectives To be familiar with current epidemiology of opioid epidemic To have basic understanding of current opioid prescription regulations in Virginia To understand best practices for safe and effective opioid prescription and management To apply best practices in your local practice settings

Outline Epidemiology of our opioid challenge Context: New Opioid Regulations Evidence-based best practices: Risk assessment Medication agreement (‘contracts’) Monitoring: Prescription Monitoring Program (PMP) review Urine Drug screen Patient Safety Patient instruction Naxolone prescription and instruction

Outline (cont) Summarize Acute and Chronic Pain requirements Needed clinical data for clinical decision support Tools already implemented Acute pain (non-surgical) Chronic opioid management - maintenance Tools to be implemented Acute pain (surgical) Chronic opioid management – initiation Chronic opioid management – cancer and palliative care

Illicit Drug Use Of the 27.1 million people who used illicit drugs in the past month, most were using marijuana. But the second highest substance abused is prescription pain relievers – they are misused more than cocaine and heroin. NSDUH 2016

Prescription Drug Misuse Again, by far the greatest misused prescription drugs are pain relievers. NSDUH 2016

Where are the drugs coming from? Among all people misused prescription pain relievers in the past year, the most common source was from a friend or relative, in more than half (53.7 percent) of people. Specifically, 40.5 percent of people who misused pain relievers in the past year got them from a friend or relative for free, 9.4 percent bought their last pain reliever from a friend or relative, and 3.8 percent took their last pain reliever from a friend or relative without asking. 36.4 percent indicated that they obtained pain relievers through a prescription or health care provider, typically getting the pain relievers through a prescription from one doctor (34.0 percent). 4.9 percent reported that they bought the last pain reliever they misused from a drug dealer or stranger. NSDUH 2016

CDC guidelines Opioids are not first-line or routine therapy for chronic pain Establish and measure goals for pain and function Use immediate-release opioids when starting and for acute pain Start low and go slow When opioids are needed for acute pain, prescribe no more than needed Follow-up and re-evaluate risk of harm; reduce dose or taper and discontinue if needed Evaluate risk factors for opioid-related harms Check PDMP for high dosages and prescriptions from other providers Use urine drug testing to identify prescribed substances and undisclosed use Avoid concurrent benzodiazepine and opioid prescribing Arrange treatment for opioid use disorder if needed www.cdc.gov/drugoverdose/prescribing/guideline.html

Assess the patients risk for addiction and substance abuse Regulations Governing Prescribing Opioids and buprenorphine Virginia Board of Medicine March 15, 2017 Acute pain: Short supply Short acting opioids Chronic pain: Document personal and family history of addiction, substance abuse, and diversion Assess the patients risk for addiction and substance abuse UDS – at initiation, every 3 months for the first year, then at least every 6 months Written contract Check PMP at least every 3 months https://www.dhp.virginia.gov/medicine/medicine_laws_regs.htm

ORT https://www.opioidrisk.com/node/450 This tool should be administered to patients upon initial visit prior to beginning opioid therapy for pain management Score 3 or lower: low risk for future opioid abuse Score 4-7: moderate risk for future opioid abuse Score 8 or higher: high risk for future opioid abuse https://www.opioidrisk.com/node/450

Opioid “contracts” and safety plans PAIN MEDICATION SAFETY PLAN Our goal is to help you control your pain, and avoid serious side effects of medications.  Only one doctor (or his / her partners) should write prescriptions for pain medications. It is important to avoid getting pain medications from other providers in order to avoid dangerous drug interactions! The doctor prescribing your pain medications is ___________  If the pain medications you are prescribed are not working, call your doctor. Do not increase your dose on your own as this may increase the risk of side effects, and cause an overdose. Overdosing can result in difficulty breathing, confusion or death.  The benefits of opioid pain medications include improvement in pain control, level of functioning, sleep and energy. Adverse effects may include constipation, nausea, sedation, impaired respiration and even death, so it is important to only use these mediations as directed by your doctor. These medications can be addicting and we will work with you to avoid this problem.  We advise you not to drive or operate machinery while taking opioid medications or other medications that can slow your reflex time or cause sleepiness, unless directed by your doctor.  Only the patient and a family member who has been instructed to help with medications should have access to your pain medications. Other people could be harmed if they take medications prescribed for you, so it is important that you keep your prescriptions and medications secure and under your control.  We will contact the Virginia Prescription Monitoring Program for prescription review, and get urine tests occasionally as required by Virginia law. Your pain control is very important to us! We are dedicated to helping you improved your quality of life. Please call with questions or concerns. (insert numbers here) I acknowledge and understand the above plan _________________________________ Reviewed by _______________________________________________

Prescription Monitor Program

Risk factors for overdose MEDD Benzodiazepine medications and other sedative medications (ambien). Respiratory diseases like OSA, COPD. Dementia, age Polypharmacy

Remember to consider delirium risk as well as respiratory depression Remember to consider risk to family / friends as well as individual risk

Naxolone Naloxone hydrochloride injection 2 mg/2 mL   Naloxone hydrochloride injection 2 mg/2 mL Narcan (naloxone hydrochloride) 4 mg/0.1 mL Administration route Intranasal using luer-lock atomizer Intranasal Administration instructions Spray one-half of the syringe into each nostril upon signs of opioid overdose. May repeat with second syringe in 2 to 3 minute if there is no response. Administer a single spray into one nostril upon signs of opioid overdose. May repeat with second nasal spray in the other nostril in 2 to 3 minutes if there is no response. Kit contents 2 prefilled syringes and 2 atomizers 2 nasal sprays Administration dose and volume 1 dose = 2 mg naloxone 1 dose = 1 mL into each nostril 1 dose = 4 mg naloxone 1 dose = 0.1 mL in one nostril Assembly Assembly is required No assembly required Cost (cash price with no insurance) $71.28 $135

Naxolone

Storage and disposal Don’t: Leave medications on a counter, or in your bathroom Throw them away when you are not taking them Do: Lock them up Flush or destroy them

Workflow and documentation Need to determine who is responsible for ordering, checking and documenting the: Safety plan / contract PMP UDS: when taking UDS document in chart when patient took last medication and dose. Narcan if applicable Patient instructions

The UDS was abnormal, now what? Call lab to ensure that it is abnormal if needed! Re-assess risks and benefits Safety plan for those who need opioids despite risk (ie metastatic cancer and similar conditions) Lower amount per prescription More frequent visits for monitoring and UDS Counseling

Needed Clinical Data for decision support Morphine Equivalent Daily Dose (MEDD) Concurrent (co-prescriptions) prescription of sedative medications Days supplied Opioid Risk Tool (or other risk assessment) Access to Prescription Monitoring Program database and date of review Last urine drug screen Distinguishing patients with acute vs chronic pain

Strategy #1 Let the system remember data and generate a reminder – (ie minimizing cognitive load). (c) 2018 Epic Systems Corporation

print patient instruction for the naloxone CDS tools in action: The system knows the dose (or MEDD) of the opioid, when the threshold is exceeded, when the last UDS was performed. It reminds you to prescribe naloxone print patient instruction for the naloxone (c) 2018 Epic Systems Corporation

Clinical documentation Strategy #2: Discrete data capture. As long as system can ‘understand’ the data, that data can be manipulated to meet your needs. (c) 2018 Epic Systems Corporation

Smart Documentation Low risk patient – MEDD < 50 and no co-prescription of sedative medications Based on my evaluation today, Mr. Magnum's current opioid therapy seems to be allowing him to function in daily activity without undue burden. There are minimal adverse effects noted. Mr. Magnum's current MEDD is 45 mg. If MEDD > 50: Based on my evaluation today, Mr. Magnum's current opioid therapy seems to be allowing him to function in daily activity without undue burden. There are minimal adverse effects noted. Mr. Magnum's current MEDD is 90 mg. This higher dose of opioid is required ***.

Smart Documentation If patient has co-prescription of sedating medications (and MEDD > 50):  Based on my evaluation today, Mr. Magnum's current opioid therapy seems to be allowing him to function in daily activity without undue burden. There are minimal adverse effects noted. Mr. Magnum's current MEDD is 90 mg. This higher dose of opioid is required ***. This patient continues to require the co-prescriptions of multiple classes of potentially sedating medications. I have discussed the risks and benefits of this approach with him. *** You can also document review of PMP (and have the system remember the date): Based on my evaluation today, Mr. Magnum's current opioid therapy seems to be allowing him to function in daily activity without undue burden. There are minimal adverse effects noted. Mr. Magnum's current MEDD is 90 mg. This higher dose of opioid is required ***. This patient continues to require the co-prescriptions of multiple classes of potentially sedating medications. I have discussed the risks and benefits of this approach with him. *** {Prescription Drug Monitoring Program:2105900001} ***

(c) 2018 Epic Systems Corporation

(c) 2018 Epic Systems Corporation