Opioids and Work Injuries-Managing Pain in the Workplace-

FPM-ANZCASeptember 17, 2016

Gary M. Franklin, MD, MPHResearch Professor

Departments of Environmental Health, Neurology, and Health Services

University of Washington

Medical DirectorWashington State Department of

Labor and Industries

1

"To write prescriptions is easy,but to come to an understanding with people is hard."-- Franz Kafka, “A Country Doctor”

“We can’t solve problems by using the same kind of

thinking we used when we created them”

Availability of opioids* for pain management (2010-2012 average)

(Consumption in defined daily doses for statistical purposes (S-DDD) per million inhabitants per day)

*Codeine, dextropropoxyphene, dihydrocodeine, fentanyl, hydromorphone, ketobemidone, morphine, oxycodone, pethidine, tilidine and trimeperidinefrom International Narcotics Control Board: https://www.incb.org/incb/en/narcotic-drugs/Availability/availability.html

“Pharmaceutical heroin”

The worst man-made epidemic in modern medical history

• Over 200,000 deaths

• Many more hundreds of thousands of overdose admissions

• Millions addicted and/or dependent-”lost generation”– Degenhardt et al Lancet Psychiatry

2015; 2: 314-22; POINT prospective cohort: DSM-5 opioid use disorder: 29.4%

• Spillover effect to Federal disability programs*(Franklin et al, Am J Ind Med 2015; 58: 245-51)

N Engl J Med. 1980;302:123.

Portenoy and FoleyPain 1986; 25: 171-186

Retrospective case series chronic, non-cancer pain

N=38; 19 Rx for at least 4 years

2/3 < 20 mg MED/day; 4> 40 mg MED/day

24/38 acceptable pain relief

No gain in social function or employment could be documented

Concluded: “Opioid maintenance therapy can be a safe, salutary and more humane alternative…”

By the late 1990s, at least 20 states

passed new laws, regulations, or

policies moving from near prohibition

of opioids to use without dosing

guidance WA law: “No disciplinary action will be

taken against a practitioner based solely on

the quantity and/or frequency of opioids

prescribed.” (WAC 246-919-830, 12/1999)

Laws were based on weak science and

good experience with cancer pain:

Thus, no ceiling on dose and axiom to

use more opioid if tolerance develops

You will not be able to effectively alter epidemic if

you don’t understand how the epidemic began

WAC-Washington Administrative Code

9

Coronial deaths involving oxycodone and oxycodone supply, Victoria, Australia, 2000-09

Rintoul et al, Injury Prevention 2011; 17: 254-9

0

100

200

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400

500

600

700

800

'97 '98 '99 '00 '01 '02 '03 '04 '05 '06 '07

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Unintentional Overdose Deaths Involving Opioid Analgesics Parallel Opioid Sales

United States, 1997–2007

National Vital Statistics System, multiple cause of death data set and Drug Enforcement Administration ARCOS system; 2007 opioid sales figure is preliminary

Distribution by drug companies 96 mg/person in 1997

698 mg/person in 2007

Enough for every American to take 5 mg Vicodin every 4 hrs for 3 weeks

Overdose deaths 2,901 in 1999

11,499 in 2007

Opioid sales *(mg/person)

0

2000

4000

6000

8000

10000

12000

14000

'99 '00 '01 '02 '03 '04 '05 '06 '07

Opioid deaths

627%

increase

296% increase

Year

Year

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Opioid-Related Deaths, Washington State Workers’ Compensation, 1992–2005

Franklin GM, et al, Am J Ind Med 2005;48:91-9

0

2

4

6

8

10

12

14

Dea

ths

Definite Probable Possible

Year

‘95 ‘97 ‘00 ‘02‘96 ‘98 ‘99 ‘01

Do function and QOL improve?

“Epidemiological studies are less positive, and report failure of opioids to improve QOL in chronic pain patients.”

Eriksen, J Pain 2006: 125: 172-179 “…it is remarkable that opioid treatment of long-

term/chronic non-cancer pain does not seem to fulfill any of the key outcome opioid treatment goals: pain relief, improved quality of life and improved functional capacity.”

Franklin et al, Natural History of Chronic Opioid Use Among Injured Workers with Low Back Pain-Clin J Pain,

Dec, 2009

• 694/1843 (37.6%) received opioid early

• 111/1843 (6%) received opioids for 1 yr

• MED increased sign from 1st to 4th qtr

• Only minority improved by at least 30% in pain (26%) and function (16%)

• Strongest predictor of long term opioid use was MED in 1st qtr (40 mg MED had OR 6)

• Avg MED 42.5 mg at 1 yr; Von Korff 55 mg at 2.7 yrs

Evidence of effectiveness of COAT

The Agency for Healthcare Research and Quality’s (AHRQ) recent draft report, “The Effectiveness and Risks of Long-term Opioid Treatment of Chronic Pain,” which focused on studies of effectiveness measured at > 1 year of COAT use, found insufficient data on long term effectiveness to reach any conclusion, and “evidence supports a dose-dependent risk for serious harms”. (AHRQ 2014; Chou et al, Annals Int Med, 13 Jan 2015).

Enduring adaptation produced by established behaviorsAddiction criteria may be different for pain patients on chronic

opioids

For the illicit drug user:

•Procurement behaviors

For the pain patient – much more complex:

•Continuous opioid therapy may prevent opioid seeking•Memory of pain, pain relief and possibly also euphoria•Even if the opioid seeking appears as seeking pain relief, it becomes an adaptation that is difficult to reverse•It is hard to distinguish between drug seeking and relief seeking

Ballantyne JC, Stannard C. New addiction criteria: Diagnostic challenges persist in treating pain with opioids. IASP: Pain clinical updates, Dec 2013; 21: 1-7; URL: http://iasp.files.cms-plus.com/FileDownloads/PCU_21-5_web.pdf

responding to the EVIDENCE:morphine equivalent dose RELATED RISK

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0

1

2

3

4

5

6

7

8

9

10

<20 mg/day 20-49 mg/day 50-99 mg/day >=100 mg/day

Risk Ratio

Dose in mg MED

Risk of adverse event

Dunn 2010

Bohnert 2011

Gomes 2011

Zedler 2014

Courtesy G. Franklin 2014

2007: WA State AMDG initially recommends 120 MED threshold dose

2009: CDC recommends: 120 mg/day MED

2012: CT work comp: 90 mg/day MED

2013: OH State medical Board: 80 mg/day MED

2013: Am College Occ. & Environ Med: 50 mg/day MED

2014: CA work comp: 80-120 mg/day MED

• Risk of adverse ±

overdose event

increases at >50 mg

MED/day

• Risk increases greatly

at ≥100 MED/day

Early opioids and disability in WA WC. Spine 2008; 33: 199-204

Population-based, prospective cohort

N=1843 workers with acute low back injury and at least 4 days lost time

Baseline interview within 18 days(median)

14% on disability at one year

Receipt of opioids for > 7 days, at least 2 Rxs, or > 150 mg MED doubled risk of 1 year disability, after adjustment for pain, function, injury severity

Risk/Benefit of Opioids for Chronic Non-Cancer Pain-Franklin; Neurology; Sept 2014-Position paper of the AAN-

Risk/Benefit of Opioids for Chronic Non-Cancer Pain-Franklin; Neurology; Sept 2014; AAN Position paper-

Opioids should not be used routinely for the treatment of routine musculoskeletal conditions, headaches or fibromyalgia*

*WA DLI opioid guidelines, 2013 http://1.usa.gov/1nYlarL

• Alternative treatments, particularly programs that take a psycho-physical approach, have stronger evidence base1

• Opioids generally are deactivating and not activating

• Reduced prescribing for non-specific back pain would significantly reduce overall prescribing and availability, and thus safety – public health benefit

• Eliminating prescribing for common indications that have failed would be a step towards identifying cases that do derive benefit

WHY NOT PRESCRIBE FOR CHRONIC LOW BACK PAIN?

Hill et al Lancet 2011;378:1560-71; slide courtesy Jane Ballantyne, MD

WA State leads on reversing the epidemic

• 2005-Reported first deaths-Franklin et al, Am J Ind Med 2005; 48:91-99

• 2007-AMDG Guideline was first U.S. guideline with a dosing threshold (120 mg/day MED in 2007, updated 2010, substantial update 2015)

• 2010-1st report of clear association of high doses with overdoses (Dunn, Von Korff et al, Ann Int Med 2010; 152: 85-92)

• 2010 WA legislature-repeals old, permissive rules and establishes new standards-ESHB 2876-and DOH rules for all prescribers-MD, DO, ARNP, DPM, DDS)

• 2011-UW Telepain-Dr Tauben et al

• Part I – If patient has not had clear improvement in pain AND function at 120 mg MED (morphine equivalent dose) , “take a deep breath”– If needed, get one-time pain management consultation

(certified in pain, neurology, or psychiatry)• Part II – Guidance for patients already on very high

doses >120 mg MED

23

Washington Agency Medical Directors’ Opioid Dosing Guidelines

www.agencymeddirectors.wa.gov

Establish an opioid treatment agreement

Screen for Prior or current substance abuse

Depression

Use random urine drug screening judiciously Shows patient is taking prescribed drugs

Identifies non-prescribed drugs

Do not use concomitant sedative-hypnotics

Track pain and function to recognize tolerance

Seek help if dose reaches 120 mg MED, and pain and function have not substantially improved

Guidance for Primary Care Providers on Safe and Effective Use of Opioids for Chronic Non-cancer Pain

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http://www.agencymeddirectors.wa.gov/opioiddosing.asp

MED, Morphine equivalent dosec

Open-source Tools Added to June 2010 Update of Opioid Dosing Guidelines

CAGE, “cut down” “annoyed” “guilty” “eye-opener”

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Opioid Risk Tool: Screen for past and current substance abuse

CAGE-AID screen for alcohol or drug abuse

Patient Health Questionnaire-9 screen for depression

2-question tool for tracking pain and function

Advice on urine drug testing

http://www.agencymeddirectors.wa.gov/opioiddosing.asp#DC

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Opio

id-r

ela

ted D

eath

WA Workers' Compensation Opioid-related Deaths 1995-2010

Possible Probable Definite

Washington State Department of Health

Unintentional Prescription Opioid Overdose Deaths 1995-2014

Source: Washington State Department of Health, Death Certificates

37% sustained decline

*Does not include heroin or illicit only deaths

Agency Medical Directors Group Website

Slide 29

Slide 30

Garg et al, J Pain 14: 1620-1628

38% Increase since 2001

The Mercier-Franklin Opioid Boomerang, 1991-2015 WA Workers

Compensation

54%

59%

64%

69%

74%

79%

84%

89%

94%

99%

14% 19% 24% 29%

Projected Percent of Claims With Opioids by Accident Quarter

Projected Percent of Loss and Percent of Claims Claims with Opioids Compared to All Claims

2015.75

1991.25

2010.25

2012.25

2009.00

CDC Opioid Guidelines-March 2016• Determining When to Initiate or Continue Opioids for Chronic

Pain1. Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. If opioids are used, they should be combined with nonpharmacologic therapy and nonopioid pharmacologic therapy, as appropriate.2. Before starting opioid therapy for chronic pain, clinicians should establish treatment goals with all patients, including realistic goals for pain and function, and should consider how therapy will be discontinued if benefits do not outweigh risks. Clinicians should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety.3. Before starting and periodically during opioid therapy, clinicians should discuss with patients known risks and realistic benefits of opioid therapy and patient and clinician responsibilities for managing therapy.

Slide 35

CDC Opioid Guidelines-March 2016• Opioid Selection, Dosage, Duration, Follow-Up, and Discontinuation

4.When starting opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extended-release/long-acting (ER/LA) opioids.5.When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to ≥90 MME/day.6.Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed.7.Clinicians should evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy for chronic pain or of dose escalation. Clinicians should evaluate benefits and harms of continued therapy with patients every 3 months or more frequently. If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids.

Slide 36

CDC Opioid Guidelines-March 2016• Assessing Risk and Addressing Harms of Opioid Use

8.Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms. Clinicians should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, higher opioid dosages (≥50 MME/day), or concurrent benzodiazepine use, are present.9.Clinicians should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving opioid dosages or dangerous combinations that put him or her at high risk for overdose. Clinicians should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months.10.When prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.11.Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible.12.Clinicians should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder.

Slide 37

38

Clinically Meaningful Improvement in

Function

Case Definition

for

Discontinuing COT

Managing Surgical Pain in

Workers on COT

Stop and Take a Deep Breath at 6 weeks and

before COT

Proper and Necessary Care

for Opioid

Prescribing

Addiction Treatment

WA AMDG Guideline June, 2015

When to Discontinue Opioids

• Patient request

• No CMIF as measured by validated instruments for at least 3 months during COT

• Risk from continued treatment outweighs benefit, including decrease in function or concomitant medications

• Severe adverse outcome or overdose event

• Non-compliance with DOH’s pain management rules or AMDG Guideline

• Urine drug tests (UDT) results and/or patient-specific PMP data are aberrant or unexpected

• Drug-seeking, aberrant, or diversion behaviors

http://www.agencymeddirectors.wa.gov/Files/2015AMDGOpioidGuideline.pdf

Slide 39

How to Taper Opioids

• Start with a taper of ≤10% per week. Rate depends on concurrent treatments or modalities

– Consider a compulsory taper (2-3 weeks) if the patient does not agree to a voluntary taper or patient with substance use disorder refuse treatment referral

• Prescribe clonidine for withdrawal symptoms such as restlessness, sweating, or tremor

• Use adjunctive therapy during taper or discontinuation (e.g. counseling , psychopharmacological support, SIMP)

• Do NOT reverse taper but it can be slowed. Taper needs to be unidirectional

• Refer patients with opioid use disorder to treatment

Slide 40

Washington State Department of Health

Unintentional Opioid Overdose Deaths Washington 1995-2014

Source: Washington State Department of Health, Death Certificates

Rise in Heroin Deaths not due to Increasing Regulation

• Rise started well before ANY regulation

• Occurring in all states, most of which have done no regs

• Main rise in heroin deaths in 18-30 year olds

• Main increase in prescription opioid deaths in 35-55 year age groups

Date of download: 1/18/2016Copyright © 2016 American Medical

Association. All rights reserved.

From: The Changing Face of Heroin Use in the United States: A Retrospective Analysis of the Past 50 Years

JAMA Psychiatry. 2014;71(7):821-826. doi:10.1001/jamapsychiatry.2014.366

Percentage of the Total Heroin-Dependent Sample That Used Heroin or a Prescription Opioid as Their First Opioid of AbuseData

are plotted as a function of the decade in which respondents initiated their opioid abuse.

Figure Legend:

Dentists and Emergency Medicine Physicians were the

main prescribers for patients 5-29 years of age

0

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0-4 5-9 10-14 15-19 20-24 25-29 30-39 40-59 60+

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00

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Age Group

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IM

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EM

5.5 million prescriptions were prescribed to children and teens (19 years and under) in 2009

Source: IMS Vector ®One National, TPT 06-30-10 Opioids Rate 2009

Date of download: 5/23/2016Copyright © 2016 American Medical

Association. All rights reserved.

From: Opioid Prescribing After Surgical Extraction of Teeth in Medicaid Patients, 2000-2010

JAMA. 2016;315(15):1653-1654. doi:10.1001/jama.2015.19058

Proportion of Medicaid Patients Dispensed Opioids Following Surgical Extraction of Teeth, 2000-2010a

Table Title:

Opioid use for third molar extractions by oral/maxillofacial surgeons

53 third molar extractions/month

4436 practicing OMFS (80%)

2.8 million third molar extractions/year with

20 tabs hydrocodone

56 million tabs hydrocodone/year

Mieche et al, Pediatrics,Nov 2015: Prescription opioids in adolescence

and future opioid misuse• Prospective panel data from the Monitoring the

Future Study• N=6220 surveyed in 12th grade and followed up

through age 23 • Legitimate opioid use before high school

graduation is independently associated with a 33% increase in the risk of future opioid misuse after high school. This association is concentrated among individuals who have little to no history of drug use and, as well, strong disapproval of illegal drug use at baseline.

Slide 47

Protect our children from potential abuse and addiction

• For teens ≤ 20 years, limit Rx’s to no more than 3 days (or 10 tabs) of short acting opioids for acute, self-limited conditions – Dental extractions (56 million vicodin 5 mg/year)

• NSAIDS/Tylenol preferred

– Sports injuries at ED/urgent care

• Could be implemented with: prior authorization only if ≥4 days, hard stops embedded in EMR, mandatory informed consent after 3 days

• This is a “high road” issue which would generate little pushback

Why consider reportability of Rx opioid overdose events

• LaRochelle et al, Opioid prescribing after non-fatal overdose and association with repeated overdose: A cohort study. Ann Int Med 2015; doi:10.7326/M15-0038

• N=2848 commercially insured patients; non-fatal overdose between May 2000-Dec 2012

• Over a median follow-up of 299 days, opioids were dispensed to 91% of patients after an overdose. Seven percent of patients (n = 212) had a repeated opioid overdose. At 2 years, the cumulative incidence of repeated overdose was 17% (95% CI, 14% to 20%) for patients receiving high dosages of opioids after the index overdose, 15% (CI, 10% to 21%) for those receiving moderate dosages, 9% (CI, 6% to 14%) for those receiving low dosages, and 8% (CI, 6% to 11%) for those receiving no opioids

Slide 49

1. Prevent future dependence, addiction and overdose among our citizens

• Repeal permissive 1999 “model” pain language

• Adopt and operationalize the CDC guidelines via:

Setting new prescribing standards through state licensing boards

Leveraging public health care purchasing programs (e.g. Medicaid)

• Foster strong collaboration across public program at the highest level of state government and among leaders in the medical community

Second key to prevention:Protect our children and teenagers

• For patients ≤ 20 years, limit Rx’s to no more than 3 days (or 10 tabs) of short acting opioids for acute use

– Dental extractions (56 million Vicodin 5 mg/year) and sports injuries at emergency department/urgent care

NSAIDS or Tylenol preferred

• Could be implemented with system changes (eg, EMR “hard stops” or mandatory informed consent after 3 days)

2. Optimize capacity to effectively treat pain and addiction

• Deliver coordinated, stepped care services aimed at improving pain and addiction treatment – Opioid overdose case management

– Cognitive behavioral therapy or graded exercise to improve patient’s functioning and ability to self manage their pain

– Medication-assisted treatment (MAT) for patients with opioid use disorder

• Increase access to pain and addiction experts for primary care via telepain (mentor consultation service)

• Incorporate these alternative treatments for pain and care coordination into payer contracts (e.g. Medicaid)

3. Metrics to guide both “state-of-the-state” and provider quality efforts

• Use a common set of metrics

• Start with public programs

• Establish a process for public/private implementation (e.g. WA statutory, governor appointed “Bree Collaborative”)

• Use metrics to notify outlier prescribers

Rapidly increasing mortality in middle aged, lower educated whites

Case and Deaton, PNAS, 2015

For electronic copies of this presentation, please e-mail Laura

Blackljl2@uw.edu

For questions or feedback, please e-mail Gary Franklin

meddir@u.washington.edu

THANK YOU!

Australia mortality from prescribed opioids

• Opioids other than heroin comprise a larger proportion of opioid overdose deaths in 2012 compared to the 1990s

• Pharmaceutical opioids combined constituted the largest proportion (70%) of deaths in 2012

• Although heroin deaths on their own still comprise 30%

• Heroin deaths are still increasing

From Roxburgh, Burns, Hall, and Degenhardt, UNSW:

https://ndarc.med.unsw.edu.au/sites/default/files/ndarc/resources/Amanda%20Roxburgh%20-%20changing%20nature%20of%20opioid%20overdose.pdf

Number of opioid overdose deaths by intent and opioid type among 15 to 54 year olds, 2010 to 2012

Efforts in Australia to reverse epidemic and likelihood of success

• New, less abusable formulations +/-

• Electronic Recording and Reporting of Controlled Drugs system +++++

• Alternative approaches to pain +++++++++