The document summarizes a national summit on opioid safety convened to develop consensus on safer opioid prescribing practices for chronic non-cancer pain. The summit goals were to: 1) develop consensus principles for more selective, cautious opioid use; 2) share approaches to mitigate risks; 3) share how to change practice and implement guidelines. It provided background on the opioid epidemic and research showing risks increasing with higher doses and limited evidence of long-term benefits. Draft principles for safer opioid prescribing included starting with non-opioid treatments, carefully evaluating risks, limiting dose escalation, and tapering patients off opioids when risks outweigh benefits.

1. National
Summit
on
Opioid
Safety
Convened with
support from the
Group Health
Foundation
Co-sponsored by: Group Health Research Institute, Project ROAM,
and Physicians for Responsible Opioid Prescribing (PROP)

2. National Summit on Opioid Safety: Our Goals
1. Develop a working consensus among Summit
participants on principles for more selective, cautious, and
effective use of opioids for chronic noncancer pain.
2. Share effective approaches and tools to mitigate
risks of chronic opioid therapy.
3. Share information and experience on how to change
practice and implement guidelines to achieve more
selective, cautious, and effective opioid prescribing.
4. Build a national network of people working to achieve
safer and more effective chronic pain management in
community practice settings.

3. National Summit on Opioid Safety: Background
The following slides and videos provide essential background
information that will help you fully participate in the Summit.
We ask everyone attending the Summit to :
(1) Take ten minutes to review these slides.
(2) Watch the video developed by Group Health, and
the four PROP videos. Each video is about five minutes long.
If you wish, review the materials that Group Health
used in implementing its COT risk mitigation initiative:
The on-line physician education program (link provided)
Full review of this program takes about 90 minutes, including 30 minutes for 11
vignettes of potentially difficult doctor-patient encounters. There is also a resources page
with links to relevant materials.
Group Health’s guideline and materials (links provided)
Please feel free to send links to these materials to others who may be interested.

4. National Summit on Opioid Safety: Background
The following slides provide background
information on trends in opioid prescribing
and the epidemic of prescription opioid
overdose and addiction. Information on COT
effectiveness and safety is also presented.

5. Starting in the 1990’s, U.S. retail sales of
prescription opioids increased dramatically
Milligrams per 100 persons per year
Source: Kenan K, Mack K, Paulozzi L. Open Medicine 2012; 6:e41.

6. Group Health research found large increases in per capita use of
Chronic Opioid Therapy (COT). Was this change in practice warranted?
Percent in episode of long-term opioid use for chronic pain
Long-Term Episode:
> 90 days &
> 10 Rx fills and/or
> 120 days supply
Boudreau et al., 2008

7. Nationally, with increased opioid prescribing, drug overdose deaths
involving prescription opioids increased four-fold from 1999 to 2009
Fatal Overdose Involving Prescription Opioids
Source: CDC

8. And, United States drug abuse treatment admissions for prescription
opioid addiction increased six-fold, to over 140,000 a year
Drug Abuse Tx Admissions: Non-Heroin Opiate addiction
Source: SAMHSA TEDS data

9. In terms of effectiveness, short-term trials suggested only
modest benefits of COT for chronic non-cancer pain
“Short-term use of opioids [for chronic pain]
is associated with modest but favorable effects
on pain and physical functioning.”
Papaleontiou et al, JAGS 2011.

10. Chronic Opioid Therapy (COT) guidelines were widely
disseminated based on low quality evidence
“In the Canadian guideline, just 3 of 24 recommendations were based on RCTs.
Nineteen recommendations were based solely or partially on consensus opinion.
In the United States guideline, 21 of 25 recommendations were viewed as supported
by only low-quality evidence.
In other words, the developers of the guidelines found that what we know about
opioids is dwarfed by what we don’t know.”
Roger Chou, CMAJ 2010.

11. Randomized trial data for COT were meager relative
to other drugs commonly used long-term
Number US Adults
Medication Class N of Trials N of Patients Person-Years (est.) Using Long-Term
Anti-hypertensivesa 147 464,000 1,857,000 48 million
Statinsb 26 169,000 753,000 34 million
NSAIDsc 31 116,000 117,000 6 million
Opioids: chronic paind 62 12,000 1,500 5 million
Source:
a. Law et al., BMJ 2009.
b. CTT Collaboration, Lancet 2010.
c. Trelle et al., BMJ 2011.
d. Furlan et al. Pain Res Manage 2011.

12. The lack of large trials is significant given uncertainties about the
long-term safety of COT. There are initial data pointing to a wide
spectrum of potential adverse health effects including...
System Potential adverse effects
Respiratory Overdose, Sleep apnea, Community-acquired pneumonia
Gastrointestinal Bowel obstruction, Chronic constipation
Musculoskeletal Fractures, Osteoporosis
Reproductive Hypogonadism, Infertility, Amenorrhea, Sexual dysfunction
Immune system Immunosuppression, Infection
Cardiovascular Myocardial infarction
Oral health Xerostomia (dry mouth), Tooth decay
Neuropsychological Depression, Anxiety, Apathy
Cognitive impairment
Hyperalgesia
Opioid dependence and addiction
Behavioral Opioid misuse and abuse
Opioid diversion
Motor vehicle accidents
Baldini, Lin & Von Korff, Primary Care Companion CNS, 2012.

13. Given uncertainties and controversies, research was initiated at
Group Health concerning key questions
How is COT being managed by physicians and used by patients?
What are the risks and benefits of COT in primary care settings?
Given what is known, what steps should be taken to reduce patient risks?

14. In a large survey, we found COT patients typically reported
moderate to severe pain--at all opioid dose levels.
Average
Pain Intensity
<50 mg. MED 50 to <120 mg. MED >120 mg. MED
Source: CONSORT Survey (N=2119) Group Health Cooperative and Kaiser Permanente N CA

15. We found that most COT patients reported substantial
pain-related activity limitation, increasing with opioid dose.
Pain-Related Activity
Limitation Days in
Last 3 months
<50 mg. MED 50 to <120 mg. MED >120 mg. MED
Source: CONSORT Survey (N=2119) Group Health Cooperative and Kaiser Permanente N CA

16. We found that COT patients receiving higher opioid dose
were less likely to be working.
100%
80% 39% 36%
Employment Status
56%
60% Working
18%
Retired
32%
40% Not working
26%
20% 46%
30%
18%
0%
Lower dose Medium Dose Higher dose
<50 mg. MED 50 to <120 mg. MED >120 mg. MED
Source: CONSORT Survey (N=2119) Group Health, Seattle WA and Kaiser Permanente N CA

17. And, we found that more than half of COT patients on
medium to high dose were clinically depressed.
Percent with PHQ-8 depression scale > 10
Merrill et al., In press

18. We were the first to report markedly higher overdose risk among
COT patients on higher opioid dose, others soon replicated.
GHRI findings replicated in Veterans Health Administration
and Canadian studies published in 2011
*
* * p<0.05
*
*
*
* **

19. In addition to direct risks to COT patients, opioid diversion
has also been increasing, placing community members at
risk of prescription opioid overdose and addiction.
Percent of US population aged 12+ ever using Percent of US 12th graders using prescription
prescription opioids non-medically opioids non-medically in the past year
16% Vicodin Oxycontin
13.6% 12%
14%
12% 9.6% 9.6%
10%
9.8% 8.1%
10% 8%
8%
5.8% 6% 5.2% 4.9%
6% 4.0%
4%
4%
2% 2%
0% 0%
1998 2001 2008 2002 2007 2011
Source: National Survey of Drug Use and Health Source: Monitoring the Future

20. National data show that most persons using prescription
opioids non-medically obtain them from friends or relatives.
Source: National Survey of Drug Use and Health
Other includes:
drug dealer, Other
multiple doctors,
internet, fake Rx,
stealing.
10 %
Rx from
One Doctor Rx from
Free from One Doctor
19 % Friend/Relative 19 % Other
81 %
56 %
15 %
Bought/Took from
Friend/Relative
Where the person with non-medical Where the relative/friend
use obtained the drug obtained the drug

21. And, most of the morphine equivalents dispensed are
received by COT patients on higher dose regimens, thereby
becoming available for diversion for non-medical use.
Percent total morphine equivalents (ME) dispensed in 2008
100%
80% 27 % Average daily
of total ME
dispensed dose < 50 mg.
60%
40% Average daily
dose > 50 mg. 13 %
60 % of total ME
20% of total ME dispensed
dispensed
0%
Chronic Pain Patients All Other Pain Patients
Using Opioids Long-term (Acute & Cancer Pain)

22. In April 2011, the White House Office of National Drug Control
Policy declared an epidemic of prescription drug abuse.
“Prescription drug misuse and
abuse is a major public health and
public safety crisis. As a nation, we
must take urgent action to ensure
the appropriate balance between
the benefits of these medications
and the risks they pose. ”

23. Based on initial research, and remaining uncertainties, what steps
should be taken now to increase prescription opioid safety?
Group Health undertook major initiatives to reduce risks to patients
We helped establish Physicians for Responsible Opioid Prescribing
to educate physicians and advocate for safer prescribing practices
to integrate research, efforts to improve care and public advocacy.
Care Science Advocacy
Group Health implemented a risk mitigation initiative to make
opioid prescribing for chronic noncancer pain as safe and
effective as possible.

24. In 2010, Group Health implemented uniform COT standards with
patient care plans documented in the EMR for all COT patients.
Percent of COT patients with care plans
Guideline implementation
September 2010
Within one year, COT care plans were developed and documented in the EMR
for almost all of the 7,000 + Group Health patients using opioids long-term.
Trescott et al, Health Affairs, 2011

25. As part of this initiative, urine drug screening of COT patients
was markedly increased in Group Health clinics.
Baseline Guideline Guideline
(2008-9) Planning Implementation
(2009-10) (2010-11) Turner et al, work in progress

26. From 2007 to 2011, the percent of Group Health COT patients
on high opioid doses was cut in half, by reducing dose escalation.
Percent of COT patients receiving > 120 mg. morphine equivalent dose
Community Physicians
17.8 % > 120 mg. MED
Group Health
9.4 % > 120 mg. MED
Von Korff et al, work in progress

27. To achieve more selective and cautious COT prescribing, new
practice norms are needed. The National Summit on Opioid
Safety will consider the following draft principles:
Draft Principles for More Selective and Cautious Use of Opioids for Chronic Pain
1) Begin treatment of chronic pain with non-opioid modalities, including encouragement to
resume rewarding life activities, gradual increases in physical activities such as walking, physical
therapy, massage, cognitive behavioral therapy, chronic pain support groups, and safer medications
such as anti-depressants. Learning to manage chronic pain can take time, so don’t give up on
safer modalities too soon.
2) Carefully evaluate patient risks of addiction before considering opioids for chronic non-
cancer pain. Ask about personal and family history of substance use problems. If available, check
a Prescription Monitoring Program database to see if the patient is obtaining controlled substances
from other sources. Do not overestimate your ability to identify patients who are at high risk of
prescription opioid addiction.

28. Draft principles continued:
3) If opioids are considered, start with short-term or intermittent opioid use for severe pain flare-
ups as an alternative to sustained opioid use. The claimed benefits of long-acting opioids and
time-scheduled opioid dosing for management of chronic non-cancer pain have not been proven by
controlled studies, and they lead to higher opioid dose. Tell patients that around the clock opioid use
over long periods of time may not sustain analgesic benefits that may be needed when pain is
severe. Do not be afraid of well controlled PRN use of opioids.
4) When chronic opioid therapy is considered, initiate treatment cautiously as a time-limited
therapeutic trial. Agree upon criteria for decisive improvement in performance of activities in work,
family and social life, and for pain control, to test whether the therapeutic trial achieves hoped-for
benefits. Set expectations that the therapeutic trial will not be continued unless decisive
benefits are observed. Use of opioids requires an ongoing, open and honest dialogue about pain
control, function and problems with the medications. If the clinician and/or the patient is not ready
for ongoing, open and honest dialogue, then opioids should not be considered.
5) Avoid opioid dose escalation to levels where discontinuation becomes difficult and risks of
adverse events are increased.

29. Draft principles continued:
6) Taper patients off opioids (or to a lower dose if that is not possible) if benefits are limited,
problems arise, or benefits for quality of life are not sustained over time. Continually revisit
whether the patient is ready to discontinue opioid use or reduce dose. Many patients using opioids
long-term remain ambivalent about opioid use, so opportunities to discontinue use or lower dose may
arise over time.
7) Do not overestimate your ability to predict which patients will misuse or abuse prescription
opioids, or even to detect opioid misuse or abuse among patients using opioids long-term. Remain
vigilant for adverse medical effects of opioids as well as indications of abuse, misuse or diversion.
8) Patients who abuse opioids or develop addiction should be treated for addiction. If you are
prescribing opioids long-term, referral resources for addiction treatment should be
available. Management with buprenorphine may be a helpful option for some patients.

30. Chronic Opioid Therapy Reconsidered
Please take 20 minutes to review the brief videos providing important information.
The first video was developed by Group Health. The other four were developed by
Physicians for Responsible Opioid Prescribing. They present expert opinions and relevant
patient stories. The expert opinions are based in scientific evidence, but uncertainties
remain.
Most experts now agree there is markedly increased opioid-related morbidity and mortality.
And, most experts now agree there is inadequate evidence to be assured that long-term
opioid use for chronic pain is safe and effective.
Clinicians observe that some patients do well, but patients are also harmed. The balance of
benefits to harms remains controversial.
NOTE: Please feel free to pass along links to these materials and videos to interested
colleagues, even if they are not able to attend the National Summit on Opioid Safety.