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

2. 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

3. 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

4. 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

5. 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

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

7. 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

8. 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

9. 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

10. 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

11. 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 _______________________________________________

12. Prescription Monitor Program

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

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

15. 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

16. Naxolone

18. 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

19. 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

20. 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

23. 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

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

25. 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

26. 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

27. 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 ***.

28. 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: } ***

29. (c) 2018 Epic Systems Corporation

30. (c) 2018 Epic Systems Corporation