[PPT] - Objectives The New Era of Safe To understand the risks associated PowerPoint Presentation

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The New Era of Safe Opioid Prescribing: Cases from the Field and Tips for Frontline Providers

Soraya Azari, MD Associate Professor of Medicine

Roadmap

Case 1 Case 2 Cases 3 & 4

Objectives

฀

To understand the risks associated with chronic

pioid therapy and be able to explain these to

patients

฀

To be able to explain to patients about the "four quadrants" of chronic pain management and the importance of multi-modal chronic pain management

฀

To consider the ways we can all prescribe opioids more safely for patients

Case 1

฀

46yo M with a history of HTN, depression, generalized anxiety disorder, asthma/COPD, chronic low back pain on opioid therapy, HCV, hx “polysubstance abuse”, and homelessness is admitted to the hospital with a COPD flare and acute kidney injury (Cr 1.6, from 0.8).

฀

He was taking: gabapentin, venlafaxine ER, and the following opioids:

฀ Morphine sulfate CR 30mg po tid ฀ Oxycodone IR 15mg po qid ฀ MED = 180mg daily ฀ http://agencymeddirectors.wa.gov/mobile.html

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Case 1 continued

฀

He received treatment for his asthma/COPD exacerbation and IVF  creatinine to 1.3.

฀

He reported doing well – taking his pain pills and abstaining from cocaine. He was buying diazepam

ff the street (10/d). He is homeless & estranged

from family. Has few trustworthy friends.

฀

His main complaint is severe, uncontrolled pain in his back (sharp and tight, paraspinal), and closely watched the clock for his next PRN.

฀

He was seen by Pain Consult and described poor pain control. He’d been buying methadone off the street and that was helping much more than the

morphine. He had been out of his gabapentin.

Case continued

Which of the following represents the best management plan with regard to his opioids?

A.

A) Increase opioids

B.

B) Decrease opioids

C.

C) Maintain current dose

D.

D) Stop opioids

A) Increase opioids B) Decrease opioids C) Maintain current dose D) Stop opioids

0% 11% 58% 32%

Case continued

฀

The patient was transitioned from morphine sulfate ER to methadone 20mg po TID + hydromorphone 8mg po q4hrs PRN (MME 720mg).

฀

Missed his initial follow-up appointment but then got repeat labs showing an increase of his creatinine back to 1.6. He could not be contacted by phone despite several attempts.

฀

5 days after discharge he was found dead.

฀

Cause of death: acute mixed drug intoxication

฀ Serum methadone = 1600ng/mL

Lessons: the New Epidemic

฀

Drug overdose

฀ Surpassed motor veh. accidents as leading cause of

accidental death in 25-64 year olds (in 2014)

฀ 64,000 dead in 2016 ฀ ~40% of overdose deaths involve a prescription

pioid

฀ Rx-opioid overdose: quadrupled (2000-2014)  now

fentanyl

฀ Increased risk: high dose, hx of substance use or

mental health disorder

CDC Rx Opioids.

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Number of deaths for leading causes of death:

฀Heart disease: 633,842 ฀Cancer: 595,930 ฀Chronic lower respiratory diseases:

155,041

฀Accidents (unintentional injuries):

146,571

฀Stroke (cerebrovascular diseases): 140,323 ฀Alzheimer’s disease: 110,561 ฀Diabetes: 79,535 ฀Influenza and Pneumonia: 57,062 ฀Nephritis, nephrotic syndrome and

nephrosis: 49,959

฀Intentional self-harm (suicide): 44,193

Response to an Epidemic

฀

Payers

฀ Starting Jan 1, 2019 Medicare will limit initial

pioid prescriptions to 7 days, and will require

“consultation” for approval of MME >90mg (1.6 million patients)

฀ 7d limit already true for SFHP Medical Patients

฀

Medical Boards (in collaboration w/DOJ)

฀ Investigating all doctors/NPs that wrote rx for

pioid to a patient that died of overdose.

Starting in 2011-12 (2600 cases)

฀ Contact your risk management if letter

received

฀

Accreditation Bodies

฀ Joint Commission: new Pain Assessment and

Management Standards for hospitals (rel Jan 2018).

฀ Website here: goo.gl/3LP5Mv

฀

Media

Prescribing Patterns

J Pain Res. 2017; 10: 383–387.

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Lessons: Pain V. Addiction

฀

Distinguishing between pain and an opioid use disorder?

฀ Opioid use disorder

฀ 4 Rs

Risk of bodily harm
Relationship trouble
Role failure
Repeated attempts to cut back

฀ 4 Cs

Loss of Control
Continued use despite harm
Compulsion (time & activities)
Craving

฀ Withdrawal and tolerance

Benzos + opioids

Time/hustle to buy street pills

I need more; pain pills are not holding me Homeless, disconnected from family

Addiction Treatment

฀

Buprenorphine-certified providers:

฀ http://www.samhsa.gov/medication-assisted-

treatment/physician-program-data/treatment- physician-locator

฀

Opioid treatment program directory:

฀ http://dpt2.samhsa.gov/treatment/directory.aspx

฀

Substance use treatment warm line: 1-855-300-

3595. 10a-6pm EST

Lessons: Prevention

*covered by Medicaid

$45 $500, PA $0

Lessons: Communication

But this pain…do you want me to start shooting dope??

฀

No, I don’t want you to start injecting heroin. You don’t want that either. You should feel proud that you don’t use needles anymore.

฀

I don’t think you can safely continue on opioid pain

pills. I want to give you a better, safer treatment

because I think you have severe, uncontrolled pain, and an opioid use disorder.

฀

I’m not going to leave you. You are suffering right

now. The treatments I can offer you are methadone

maintenance programs, or buprenorphine-naloxone.

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5

Take-Home Point

฀

Unintentional overdose is a significant risk for patients on chronic opioid therapy.

฀

Active substance use disorders are a contra- indication for long-term opioid therapy for pain. Refer patients for treatment.

฀

Be empathic and sensitive when saying “no.” Then see them more, not less.

Case 2

฀

DA is a 57yo M with a history of CVA, HCV, depression, cocaine & opioid use disorders, and chronic venous insufficiency ulcers admitted to hospital with cellulitis and worsening of LE wounds.

฀ 4 hospitalizations in past 3 months ฀ clinical alerts about suspended pain agreements. He

has not engaged in prim care.

฀

He complains of severe bilateral lower extremity

pain. He states that he needs more for pain (the
xycodone 5mg tabs you started are not enough).

The pain is 10/10, localizes to ulcers, feels like knives, and is constant (for months).

Case 2 continued

Which of the following represents the best management plan with regard to his opioids?

A.

A) Increase opioids

B.

B) Decrease opioids

C.

C) Maintain current dose

A) Increase opioids B) Decrease opioids C) Maintain current dose

5% 25% 70%

Case 2 Continued

฀

The patient was given escalating doses of

xycodone and started on morphine sulfate SR.

฀ Ultimately: morphine sulfate SR 30mg po tid +

xycodone IR 30mg q4hrs prn pain + IV dilaudid for

breakthrough pain (MME 360mg/d).

฀

He was later placed on adjunctive agents including:

฀ Gabapentin ฀ Venlafaxine XR ฀ Baclofen ฀ Topiramate

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Case 2 Continued

฀

D/C from hospital  sees new PCP, requests opioid refill

฀

PCP explains no refill due to:

฀ Active substance use disorder ฀ Prior difficulty with chronic opioid agreements ฀ Active mental health disorder

฀

Patient because physically aggressive (lunged at provider) and verbally abusive. Institutional police was called.

฀ Patient stated that he was told he would receive more

pioids.

฀ Provider was trying to explain new “rules” of opioid

rx. 1997 2015

Lessons: A new era

฀

CDC Opioid Guidelines*

฀ Opioids not 1st line ฀ Non-pharm. and non-opioid tx are

preferred

฀ Chronic opioids often start with

acute rxs. Use lowest dose, <3d

฀ Limit MME to <50mg daily ฀ Monitor closely: urine drug screen,

PDMP, risk/benefit

฀

Surgeon General letter (TurnTheTideRx.org)

https://www.cdc.gov/drugoverdose/pdf/guidelines_factsheet-a.pdf

A new era

฀

Primary Care-Based Chronic Opioid Prescribing in the SFHN

฀ Active mental health and substance use disorders are

contra-indications for chronic opioid therapy (>3 months)

฀ No prescriptions on first visit ฀ Review of medical records ฀ Pain agreement signature annually ฀ Regular urine drug screen testing ฀ Regular prescription activity report monitoring ฀ Discontinuation for abnormal urine drug screens or

ther concerning behaviors

฀ “stimulant rule”

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Opioid Exposure and Risk of LT Use

฀

ER docs “high intensity” v. “low intensity” opioid prescribers (7 v. 24%) in Medicare patients  patients treated by “high intensity” providers more likely to be

pioids at 1 yr (OR 1.3; NNH = 48)

฀

Surgery:

฀ Long term use in ~6% following surgery (risk: tobacco,

SUD, mood/anxiety d/o, preop pain disorders)

฀ High risk procedures TKA, open chole, THA. (risk: M,

>50yo, hx SUD, hx depression, BZD or antidepressant use)

฀

Hospitalized patients (previously naïve): 25% discharged with opioids; 4% use at 1 year. VA: long- term opioid use in 5% surg, 15% medical d/c (v. 19%

/p). (Risk: # days rx, dose)

฀

D/C from rehab: 28% on opioids at 6mo. (higher ORT scores in those on opioids)

Barnett et al NEJM 2017. Brummett et al JAMA Surgery 2017. Calcaterra et al. JGIM 2016. Furlan AD J Rehabil Med. 2016. J. Hosp. Med. 2018 April;13(4):243-248

Opioid Stewardship

Pain = Opioids

Hospital Compare Scores Opioid Stewardship

Calcaterra SL et al. JGIM

2016. Deyo

et al. JGIM 2016

SLIDE 8

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Case epilogue

฀

Patient was not prescribed opioids from PCP

฀

Patient started treatment in methadone clinic

฀

He also received:

฀ Housing ฀ Para-transit ฀ In-home support ฀ Meals-on-wheels ฀ Visiting nurse (wound care) ฀ Durable medical equipment including electric chair

฀

Patient has not been admitted since that time & is not taking chronic opioid therapy for pain

Take-Home Points

฀

Do not start patients on high-dose opioid therapy in the hospital for chronic pain conditions WITHOUT CLOSE COLLABORATION & AGREEMENT WITH THE OUTPATIENT PROVIDERS

฀

Communicate the “rules” for chronic opioid therapy

฀

Offer methadone to all inpatients with opioid use disorders – regardless of whether they follow-up with a methadone treatment program!

฀ Methadone 10-20mg  re-evaluate in 1hr and if still

in withdrawal, can give additional 10-20mg, NTE 40mg/day. CAUTION: renal failure, resp dz.

฀ Do not titrate up dose. Monitor for sedation (peak at

2-3hrs!)

Case 3

฀

A 34yo F with a history of obesity, PCOS, and low back pain presenting for primary care follow-up. She describes sharp pain in L back, 8/10, with

ccasional radiation down her leg x2 weeks. She

denies weakness and numbness and has a normal neurologic exam.

฀

Pain terrible – missing work. Using her husband’s pain pills (hydrocodone-acetaminophen) and is wondering if you can prescribe some.

฀

You try NSAIDs, ice/heat, massage and basic wall exercises and ask her to return in 2 weeks.

Case 3 continued

฀

2 weeks: pain is still very severe (8/10), “tight and throbbing”, almost constant. She

฀ Tried the ibuprofen (some effect), as does ice/heat

(temporary). Still using her husband’s hydrocodone- acetaminophen and says that’s her preferred agent. Trouble sleeping.

฀

PHQ-2 neg. +stress and anxiety about life at

home. She does not smoke or use drugs or alcohol.

SLIDE 9

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Evaluation

฀

Empower

฀ What are you doing to control your pain? ฀ Acknowledge suffering while focusing on strength and

recovery

฀

Educate

฀ Back pain is common (mean point prevalence 18%;

lifetime prevalence 39%)

฀ At 1 mo. ~1/3 with mod. pain (20% activity); 1 year,

~1/3 with mod. pain

฀ Opioid efficacy ฀ Chronic pain in 5 minutes video

฀

Evaluate

฀ Function (work, apt), substance use, and psychiatric

Von Korff M, Saunders K. Spine (Phila Pa 1976). 1996 Dec 15;21(24):2833.

Treatment: The Broader Context of Pain

Lumbosacral strain

Tired. Stressed.

Worried something is wrong with her body.

Husband disabled. Sole wage

earner. IHSS hours decreased.

Pharmacologic Physical Complementary and Alternative Medicine Cognitive and Behavioral

What Are My Alternatives?

Pharmacologic

NSAIDs
Neuroleptics
Antidepressants
Muscle relaxants
Topicals
Opioid medications/Tramadol
Pumps (baclofen, lidocaine)
Buprenorphine

Physical

Physical Therapy
Joint injections
Directed Exercise Program
Pacing daily activity
Heat or ice
Trigger point injections

Complementary and Alternative Medicine

Acupuncture (community and schools)
Mindfulness Based Stress Reduction and

meditation

Yoga
Massage
Supplements (glucosamine chondroitin,

SAM-e)

Guided imagery
Breathing exercises

Cognitive and Behavioral

Pain Groups
Cognitive and behavioral therapy
Visualization, deep breathing, meditation
Sleep hygiene
Gardening, being outdoors, going to

church, spending time with friends and family, etc.

Pain ToolKit

Check out: https://healthinsight.org/Internal/assets/SMART/Pain%20Guidelines%20alternative%20to%20opioids-final.pdf

SLIDE 10

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https:// goo.gl/G gsemj

SPACE Trial

฀

240 VA patients 2013-15 with moderate to severe chronic back or hip or knee OA pain despite analgesic use

฀ Excluded: patients on LT opioids or SUD ฀ Included: severe depression (~20%), PTSD (~20%) ฀ 13% F, 88% white, 65% LBP, 35% hip/knee OA, 25%

current smokers, 3% Etoh, 10% illicit drugs

฀

Randomized to either:

฀ Opioids: IR  LA  fentanyl (to max 100ME) ฀ Non-opioids: APAP/NSAIDs  TCA, gaba, top lido 

pregabilin, dulox, tramadol (11%)

฀ Monthly visit w/pharm., BPI (1˚), pain intensity (2˚)

฀

Outcome (1 yr):

฀ BPI: no difference, pain intensity (better in non-opioid),

more side effects (opioid)

JAMA 2018. 319(6):872-82

Can it work?

฀

Biopsychosocial Treatment

฀ Patients with chronic neck or back pain >3mos (taken

sick leave)(~50% depressed)

฀ 3 week inpatient multidisciplinary treatment (5d/w;

8h/d)

฀ Physical exercises ฀ Ergonomic training ฀ Psychotherapy ฀ Patient education ฀ Behavioral therapy ฀ Workplace-based interventions

฀ At 6 months: 67% returned to work; SF-36 score

improved

Buchner et al. Scandinavian Journal of Rheumatology. 2006: 363

Case cont’d

฀

Rx baclofen. Referred to Healthy Spine clinic.

฀

Phone check in: baclofen is making her sleepy and she still has pain. She’s been trying to do her exercises, think positively, and use the ice/heat and massage. She also got some muscle rub.

SLIDE 11

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11

Question

Which of the following is the best course of action?

A.

A) Start Opioids

B.

B) Continue Plan

C.

C) Something else

A) Start Opioids B) Continue Plan C) Something else

5% 63% 32%

Case continued

฀

Urine drug screen normal. CURES with no

prescriptions. Discussion of risks/benefits.

฀

Rx opioids as treatment trial.

฀

2 weeks later: no more sick days. Taking ~1-3 pills per day. Sleep had improved. She attended her healthy spine appointment & was taught additional exercises.

฀

Epilogue: Patient continued on opioid for ~3 months, taking less over time and with no concerning behaviors. Patient had also been doing basic fertility treatments and became pregnant, and stopped opioids completely.

Take Home Point

฀

Think of the four quadrants when developing treatment options with your patients. Cultivate their resilience & strength.

฀

Opioids may still be required for patients that have failed multi-modal therapy and who do not have active substance use or mental health disorders.

Case 4

฀

LE is a 65yo M with a hx of DJD, remote substance abuse, HTN, HCV, and depression presenting for follow-up. He has been on long-standing chronic

pioid therapy for DJD pain with the following:

฀ Oxycontin 180mg po tid ฀ Methadone 20mg po tid ฀ MME 1400mg/day

SLIDE 12

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Question

All of the following are risks of long-term, high- dose chronic opioid therapy except:

A.

A) sleep disordered breathing

B.

B) hypogonadism

C.

C) unintentional overdose

D.

D) pneumonia

E.

E) BPH

F.

F) osteoporotic fracture

A) sleep disordered bre... B) hypogonadism C) unintentional overdose D) pneumonia E) BPH F) osteoporotic fracture

0% 4% 13% 78% 4% 0%

Question

฀

All of the following are risks of long-term, high- dose chronic opioid therapy except:

฀

A) sleep disordered breathing

฀

B) hypogonadism

฀

C) unintentional overdose

฀

D) pneumoinia

฀

E) BPH

฀

F) osteoporotic fracture

Risks of High Dose

฀

Excess mortality (LA opioids, 60% increased risk all-cause mort)

฀

Unintentional overdose (~0.7%/year 20-100MED) and re-exposure (91% w/rx at 10mos. post OD)

฀

Opioid use disorder (~20%)

฀

Secondary Hypogonadism (~50% of men)

฀ Dec bone mineral density & inc. fracture risk

฀

Sleep-disordered breathing (60-70% of patients)

฀

Pneumonia (case-control)

฀

Others

฀ Opioid-induced hyperalgesia? ฀ Cardiac toxicity with methadone Miller M, et al. JAMA Intern Med. 2015;175(4):608-15. Rose AR, et al. J Clin Sleep Med. 2014;10(8):847-

52. Guilleminault C, et al. Lung 2010;188(6):459-68. Rubinstein AL, et al. Clin J Pain. 2013;29(10):840-
5. Dublin Setal. JAGS, 2011;59(10): 1899.

Smith HS, Elliott JA. Pain Physician. 2012;15(3 Suppl): ES145-56. Teng Z et al. Plos One. 2015;10(6)

Case continued

฀

Had repeatedly abnormal urine drug screens, including:

฀ Absence of oxycodone ฀ Presence of opiates (morphine) ฀ Presence of benzodiazepines (not prescribed)

฀

Oxycodone not high enough to control his pain. He is also prescribed ibuprofen. He declines knee injection and has not attended physical therapy.

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13

Case 4

Which of the following is the best management strategy:

A.

A) Increase opioids

B.

B) Decrease opioids

C.

C) Maintain current dose

D.

D) Stop opioids

A) Increase opioids B) Decrease opioids C) Maintain current dose D) Stop opioids

0% 0% 0% 0%

Abnormal Urine Drug Screens in Chronic Opioid Therapy

฀

COMMON

฀ SFGH, RFPC Clinic Utox (2015), n=711 utoxes (230

patients)

฀ 51% of utoxes inappropriate; 61% of patients with at

least one abnormality

46% rx opioid non-detection (oxycodone), 10% (BZD)

฀ Denver Health (2014)

฀ 30% of utoxes abnormal  12% rx opioid non-

detection

฀

How to Respond?

฀ Policies! (87% of RFPC survey respondents) ฀ Algorithms from consensus of expert

pinions:https://static-

content.springer.com/esm/art%3A10.1007%2Fs11606-017-4211- y/MediaObjects/11606_2017_4211_MOESM1_ESM.pdf J Gen Intern Med. 2018 Feb;33(2):166-176.

Opioid Use Disorder v. Pain

฀ Opioid use disorder

฀ 4 Rs

Risk of bodily harm
Relationship trouble
Role failure
Repeated attempts to cut back

฀ 4 Cs

Loss of Control
Continued use despite harm
Compulsion (time & activities)
Craving

฀ Withdrawal and tolerance

Running out each month early BZD use with opioids Not attending f/u appts

Case Continued

฀

Provider established contingencies for ongoing prescriptions and patient unable to adhere to agreement.

฀

Taper initiated.

SLIDE 14

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14

High dose opioids (>90MME) Concerning Behaviors?

Yes

Evaluate for opioid use disorder Present? Treat Not Present? Give warning. If behavior continues, re- eval OUD

No

1. Bone Density Scan, 2. EKG if on

methadone, 3. Sleep Study, 4. total AM testosterone Risks Outweigh Benefits?

No

Continue meds & monitoring. Discuss taper

Yes Imminent Safety risk? Yes Taper quickly No

Strongly Encourage Taper

A Word on Tapers & High Dose

฀

Evidence-base: low quality evidence of improved

utcomes for VOLUNTARY, slow tapers

฀

Interest: survey of patients on >50MME: 49% wanted to cut back or stop

฀

Reality: These are difficult. Go slow & see person

ften (10% per week-month). Remember, we

started the meds.

฀ Counsel in advance about possibility of OUD ฀ Team based care ฀ Alternatives for pain management

฀

Safety: naloxone

Case continued

฀

Taper ongoing until Utox positive for heroin

฀

Epilogue: Started on buprenorphine-naloxone and doing well. Adhering to medical treatment (including physical therapy), no missed appointments, no requests for dose escalations.

฀ “I’m so glad I’m off that Oxycontin”

Buprenorphine-naloxone

฀

Evidence-based, highly effective treatment for

pioid use disorders. Also effective for pain.

฀

Requires special waiver to prescribe (“x license”), which requires 8 hours of training

฀

Substance use treatment warm line: 1-855-300-

3595. 10a-6pm EST

SLIDE 15

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15

Take-Home Points

฀

There are several possible long-term consequences to chronic, high-dose opioids

฀

Abnormal urine drug screens are common. Abnormal  opioid use disorder.

฀

For patients that have an opioid use disorder, consider office-based tx with bupe-naloxone.

Summary

฀

There has been more recognition of the risks associated with chronic opioid therapy, including unintentional death from overdose.

฀

Active substance use and mental health disorders are contra-indications for chronic opioid therapy. Refer patients to appropriate substance use and mental health treatment.

฀

The culture has changed because of these safety risks – it’s our job to educate patients and tell them why this matters.

Summary Continued

฀

Keep in mind the biopsychosocial model for chronic pain, and remember the “four quadrants” when considering pain treatment options.

฀

Opioids may still be needed for pain that is refractory to multi-modal treatment.

฀

High-dose opioids are associated with several side effects that include risk of overdose, addiction, hypogonadism, and sleep-disordered breathing, among others.

฀

Voluntary tapers can work, and benefit from a strong pt-provider relationship and team-based care.

฀

Give yourself a break: this is hard work. Forgive your patients – they are trying their best.

Resources

฀

Patients:

฀

Pain Toolkit: http://www.paintoolkit.org/downloads/Pain_Toolkit_patient_booklet_copy_S hort_Versions.pdf

฀

Chronic Pain Facebook Groups

฀

You tube videos to educate patients about pain:

฀ Chronic pain in 5 minutes:

https://www.youtube.com/watch?v=C_3phB93rvI

฀

Treatment options: https://vimeo.com/74825810

฀

Providers:

฀

ZSFG: Pain Consult Clinic, Chronic Pain Groups, Healthy Spine, Wellness Center, Substance Use Warm Line, Bob Brody, Ed Lor, Arthur Wood, Scott

Steiger. 4 Quadrants Doc (shared google doc): goo.gl/ASB2JJ

฀

Washington Agency Medical Directors Guidelines: http://www.agencymeddirectors.wa.gov/Files/2015AMDGOpioidGuideline.pd f

฀

SFHP patient/provider resources: http://www.sfhp.org/providers/painmanagement/resource-tools/

฀

Handouts on ancillary pharmacologic agents (email me) & what’s covered

With permission from Peter Moore.

SLIDE 16

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16

Resources Cont’d

฀

Opioid Tapers:

฀ CDC Taper Guide:

https://www.cdc.gov/drugoverdose/pdf/clinical_pocket_ guide_tapering-a.pdf

฀ On-line schedule generator:

http://www.hca.wa.gov/medicaid/pharmacy/ documents/taperschedule.xls

฀

Joint Commission Pain Assessment Guidelines, 2018

฀ https://www.jointcommission.org/assets/1/18/Joint_

Commission_Enhances_Pain_Assessment_and_Manag ement_Requirements_for_Accredited_Hospitals1.PDF

฀

Chronic pain group manuals

฀ https://www.va.gov/painmanagement/docs/cbt-

cp_therapist_manual.pdf

฀

Thank you