Long-term Opioid Treatment (LtOT) Risk and Dose Reduction Initiatives at Group Health: Rationale and Experience To Date

Michael Von Korff Group Health Research Institute

Disclosures:Dr. Von Korff has funding for research on opioids through grants to Group Health

Research Institute from Pfizer Inc. and from a consortium of drug companies conducting FDA-mandated post-marketing surveillance studies for extended

release opioids.

Acknowledgments:Some research reported in this talk was supported by grants to Group Health Research Institute from the National Institute of Drug Abuse (DA022557), the

National Institute on Aging (AG034181), the Patient-Centered Outcomes Research Institute (IHS-1306-02198) and Pfizer Inc.

In 1996, pain specialty societies encouraged more liberal prescribing of opioids for chronic pain

Addiction: “Misunderstanding of addiction and mislabeling of patients as addicts result in unnecessary withholding of opioid medications.”

Tolerance: “For most opioids, there does not appear to be an arbitrary upper dosage limit.”

Diversion: “Efforts to stop diversion should not interfere with prescribing opioids for pain management.”

Overdose: “Respiratory depression induced by opioids tends to be a short-lived phenomenon, generally occurs only in the opioid-naive patient, and is antagonized by pain.”

American Pain Society (APS) & American Academy of Pain Medicine (AAPM), 1996

Concurrently, industry-supported CME sought to alter conservative norms for opioid prescribing for chronic pain

“There’s no question that our best, strongest pain medicines are the opioids, but these are the same drugs that have a reputation for causing addiction and other terrible things.”

“Now, in fact, the rate of addiction amongst pain patients who are treated by doctors is much less than one percent. They don’t wear out. They go on working.”

“They do not have serious medical side effects…these drugs…should be used much more than they are for patients in pain.”

“We doctors were wrong in thinking that opioids can’t be used long-term. They can be, and they should be….It is not acceptable to say ‘I don’t believe in using strong pain medications for chronic pain’. We need to stop saying this.”

Excerpts from Purdue Pharma educational video on long-term use of opioids for chronic pain: “I Got My Life Back!”

Milligrams per 100 persons per year

Source: Kenan K, Mack K, Paulozzi L. Open Medicine 2012; 6:e41.

Initiatives to change prescribing norms were successful, leading to large increases in opioid prescribing

In 1999, six states (shown in red) had high rates of drug treatment admissions for non-heroin opiate addiction

Admissions per 100,000 population aged 12 and over

SOURCE: Center for Behavioral Health Statistics and Quality, Substance Abuse and

Mental Health Services Administration, Treatment Episode Data Set *TEDS).

Data received through 11.03.10

1999 (range 1-50)

2005 (range 0-214)

By 2005, rates of treatment for prescription opioid addiction had increased dramatically nationwide

Admissions per 100,000 population aged 12 and over

SOURCE: Center for Behavioral Health Statistics and Quality, Substance Abuse and

Mental Health Services Administration, Treatment Episode Data Set *TEDS).

Data received through 11.03.10

2009 (range 1-379)

By 2009, a national epidemic of prescription opioid addiction was evident. There were more than 750,000 treatment episodes for

addiction to prescription opioids from 1999-2009

Admissions per 100,000 population aged 12 and over

SOURCE: Center for Behavioral Health Statistics and Quality, Substance Abuse and

Mental Health Services Administration, Treatment Episode Data Set *TEDS).

Data received through 11.03.10

A patient who became addicted to opioids prescribed for chronic pain tells her story

“I wasn’t very active…I never really left the house other than to go to work. I couldn’t go out in the yard to play with the grandkids…or any of those kinds of things.”

“It took the best part of 16 months before I could focus again, before I could stop that craving.”

“If I were still on that medication, I would probably be dead.”

Follow-up interview a with patient featured as an opioid success story in a drug company CME video: “I Got My Life Back”.

Excerpts from You Tube video by Physicians for Responsible Opioid Prescribing (PROP): https://www.youtube.com/watch?v=hwtSvHb_PRk

GOOGLE: Oxycontin Poster Children

67.7%

19.4%12.9%

0%

10%

20%

30%

40%

50%

60%

70%

80%

Lower Dose Medium Dose Higher Dose

Most LtOT patients in primary care are managed on lower dose regimens (< 50 mg. Morphine Equivalent Dose)

<50 mg. MED 50 to <120 mg. MED >120 mg. MED

Source: CONSORT Survey 2008 (N=2119) Group Health Cooperative and Kaiser Permanente N CA

Opioids used non-medically are usually obtained from friends or relatives who get them by prescription from one physician, or they are obtained by prescription from a physician.

LtOT patients receiving higher opioid dose account for 60% of all morphine equivalents dispensed for acute or chronic pain.

Indirect prescribing risks (via diversion) may be increased by higher dose prescribing

Direct risks of high opioid dose: Overdose risk increases with dose among LtOT patients

0

2

4

6

8

10

Dunn et al. 2010 Bohnert et al. 2011 Gomes et al. 2011

Od

ds

Ra

tio

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lati

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to

Lo

w D

os

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OT

<20 mg. MED 20 to < 50 mg. MED 50 to <100 mg. MED 100+ mg. MED 200+ mg. MED

*

*

*

*

*

* **

* p<0.05

Prevalence of DSM-5 prescription opioid use disorder among LtOT patients

Degenhardt et al., 2015Von Korff, provisional data

N=1422 Australian LtOT patientsN=705, Group Health LtOT patients; preliminary analyses

24.4 %

17.9 %

20.8 %

Australia, Lifetime opioid use disorder assessed using the Composite International Diagnostic Interview administered to community-based LtOT patients by telephone interview. Group Health, One year Rx opioid use disorder assessed using the PRISM administered to health plan LtOT patients by telephone interview.

20.7 %

14.2 %16.6 %

Problem opioid use is more commonly noted in medical records of LtOT patients on higher doses

Palmer et al. In press

Percent with Problem Opioid Use Documented in Electronic Health Record

Highest COT dose in Study Period (2006-12)

LtOT patients with time-scheduled use (& higher doses)more often report problems with opioid use

p=.0002

p<.0001

p<.0001 p=.0004

p=.004

Most LtOT patients report average pain intensity in the moderate to severe range at all LtOT dose levels

32% 37% 41%

54%55% 52%

13% 8% 7%

0%

20%

40%

60%

80%

100%

Lower dose Medium Dose Higher dose

Mild (0-3)

Moderate (4-6)

Severe (7-10)

Average Pain Intensity

Source: CONSORT Survey (N=2119) Group Health Cooperative and Kaiser Permanente N CA

<50 mg. MED 50 to <120 mg. MED >120 mg. MED

Among patients on medium to high LtOT dose, most report frequent pain-related activity limitation days

43%58% 67%

14%

15%15%43%

27%18%

0%

20%

40%

60%

80%

100%

Lower dose Medium Dose Higher dose

<10 Days

10 to <30 Days

30+ Days

Pain-Related ActivityLimitation Days

Source: CONSORT Survey (N=2119) Group Health Cooperative and Kaiser Permanente N CA

<50 mg. MED 50 to <120 mg. MED >120 mg. MED

Washington State initiatives to reduce LtOT dose: Altered prescribing norms/expectations

Group Health Integrated Group Practice

Group Health took additional steps to alter prescribing norms and expectations regarding use of high opioid doses

Initiatives in 2007

State guideline recommended caution in prescribing doses exceeding 120 mg. morphine equivalent dose (MED)

Group Health implementation methods

Consulting specialists and medical staff leaders recommendedmore cautious opioid prescribing for chronic pain.

Periodic, voluntary in-service training sessions on opioid prescribingdiscouraged use of high opioid doses.

Reports to physicians and clinic Medical Directors tracked LtOT patients receiving high doses (>120 mg. MED).

Physicians with unusually large numbers of LtOT patients on high opioid doses received guidance from the clinic Medical Director.

Washington State initiatives to reduce LtOT risks: Multi-faceted risk reduction

Initiatives in 2010

The Washington State guideline was updated and supported by enabling legislation

Group Health Integrated Group Practice

Group Health implemented a major multi-faceted risk reductioninitiative based on the Washington State guideline

Group Health multi-faceted risk reduction

Trescott et al., Health Affairs, 2011

A single physician was designated as responsible for managing opioids for every LtOT patient

Individualized LtOT care plans were documented in standardized format in the EMR

Standardized tools for patient education, treatment agreements, care plans, morphine equivalent dose calculation were made available

Minimum standards were set for frequency of LtOT monitoring visits and for urine drug screening based on risk stratification by dose and drug abuse risk factors

Refill ordering processes were altered to prevent short-notice refills and patients running out over a weekend

Group Health implementation methods

Guideline defined standards of care and best practices

Rapid Progress Improvement Workshop defined standard work

Registry flagged high dose patients

Performance measures were tracked by the Registry

Clinic-based incentives were provided for achieving performance targets

Medical staff leadership championed change

On-line CME followed by in-clinic meetings to discuss changes

Consulting specialist and local experts provided guidance and support

Did Washington State and Group Health initiatives reduce opioid dose among LtOT patients?

Percent of patients on high COT doses (> 120 mg. MED)

was lowered by 63% from 2006 to 2014 in GH Clinics

Baseline Altered PrescribingExpectations

Multi-faceted RiskReduction

63% lower than in 2006

34% lower than in 2006

Baseline Altered PrescribingExpectations

Multi-faceted RiskReduction

Percent of patients getting excess days supply of opioidswas lowered by 57% from 2006 to 2014 in GH Clinics

57% lower than in 2006

27% lower than in 2006

Was use of high doses among LtOT patients lowered by tapering or by avoiding dose escalation?

Avoiding large dose escalations: From <40 mg. to >120 mg. YES

Avoiding small dose escalations: From 50-119 mg. to >120 mg. YES

Partial/smaller tapers: From >120 mg. to 50--119. mg. YES

Larger tapers: From >120 mg. to < 40 mg. NO

0%

1%

2%

3%

4%

5%

2005 S

ept

2006 M

ar

2006 S

ep

2007 M

ar

2007 S

ep

2008 M

ar

2008 S

ep

2009 M

ar

2009 S

ep

2010 M

ar

2010 S

ep

2011 M

ar

Although opioid dose levels were reduced, use of LtOT continued to increase

Group Health – Group practice

Group Health – Contracted care

Percent of adults (age 18+) receiving 70+ days supply of opioids in 3 months

Can use of “universal precautions” be increased by a health plan quality

improvement initiative?

COT care plans were developed for almost allGroup Health patients within one year (N ≅ 7000)

0%

20%

40%

60%

80%

100%

Jun-1

0

Aug

-10

Oct

-10

Dec

-10

Feb-1

1

Apr-

11

Jun-1

1

Aug-1

1

Oct

-11

Dec

-11

Percent of COT patients with care plans

Guideline implementationSeptember 2010

Trescott et al., Health Affairs, 2011

Urine drug screening rates, previously low, increased markedly with implementation

Baseline(2008-9)

Guideline Planning(2009-10)

Guideline Implementation

(2010-11)

Summary

Long-term opioid treatment (LtOT) patients typically report substantial pain and dysfunction.

LtOT risks increase with opioid dose.

DSM-5 prescription opioid use disorder is common among LtOT patients. The prevalence of problem opioid use increases with dose.

LtOt doses were lowered by changing shared physician norms/expectations regarding opioid prescribing.

Use of LtOT universal precautions was increased through a multi-faceted quality improvement initiative.

Work in Progress: We are now evaluating effects of LtOT dose and risk reduction on patient outcomes (including pain, function, opioid use disorder, motor vehicle accidents, medically attended injuries, opioid use disorder, and overdose).