This document discusses the opioid crisis in the United States and strategies to address it. It summarizes that national norms changed in the late 1990s to allow greater opioid prescribing without dosing guidance, which contributed to increased opioid-related deaths. The document recommends seeking help if opioid doses reach 120 mg/day of morphine equivalent and pain and function have not improved. It also outlines Washington state's opioid dosing guidelines and legislation aimed at curbing opioid overprescribing and related deaths.

1. Opioids: A Public Health Emergency
-National Summit on Opioid Safety-
Group Health Cooperative
Nov 1, 2012
Gary M. Franklin, MD, MPH
Research Professor
Departments of Environmental Health,
Neurology, and Health Services
University of Washington
Medical Director
Washington State Department of
Labor and Industries

2. DISCLOSURES
Gary Franklin has disclosed no financial
relationships that may pose a conflict of interest
There will be no unannounced disclosures of off-
label use of drugs, biologics or medical devices

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

4. “We can’t solve problems by
using the same kind of
thinking we used when we
created them”

5. Change in National Norms for Use of Opioids
for Chronic, Non-cancer Pain
 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
WAC Washington Administrative Code
5

6. Similarities Between Illicit & Prescription Drugs

7. Portenoy and Foley
Pain 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 2006, over 10,000 WA citizens were taking over 120
mg/day MED

8. Dentists and Emergency Medicine Physicians were the
main prescribers for patients 5-29 years of age
5.5 million prescriptions were prescribed to children and teens (19 years and under) in 2009
900
800
700
600
Rate per 10,000 persons
GP/FM/DO
500
IM
400 DENT
ORTH SURG
300
EM
200
100
0
0-4 5-9 10-14 15-19 20-24 25-29 30-39 40-59 60+
Age Group
Source: IMS Vector ®One National, TPT 06-30-10 Opioids Rate 2009

9. Limitations of Long-term (>3 Months)
Opioid Therapy
 Overall, the evidence for long-term analgesic efficacy
is weak
 Putative mechanisms for failed opioid analgesia may
be related to rampant tolerance
 The premise that tolerance can always be overcome
by dose escalation is now questioned
 100% of patients on opioids chronically develop
dependence
Ballantyne J. Pain Physician 2007;10:479-91
9

10. Opioid-Related Deaths,
Washington State Workers’ Compensation, 1992–2005
14
Definite Probable Possible
12
10
8
Deaths
6
4
2
0
„95 „96 „97 „98 „99 „00 „01 „02
Year
Franklin GM, et al, Am J Ind Med 2005;48:91-9
10

11. State mortality varies by regulatory
environment
Paulozzi and Stier, J Publ Health Pol 2010; 31:
422-32
 Per capita usage of opioids in NY 2/3 that in
PA
 Drug overdose deaths 1.6 fold higher in PA
compared to NY
 PDMP in NY better funded and uses
serialized, tamperproof Rx forms
But mortality rates probably not affected by
mandatory education alone

12. Opioid issues new cause of
successful malpractice claims
ASOA Closed Claims Database-N=8954
 50/295 medication management issues for CNCP
 59% inappropriate medication management
 24% high risk of misuse
 57% death
Fitzgibbon et al, Anesthesiology 2010; 112: 948-56

13. Washington Agency Medical Directors’
Opioid Dosing Guidelines
 Developed with clinical pain experts in 2006
 Implemented April 1, 2007
 First guideline to emphasize dosing guidance
 Educational pilot, not new standard or rule
 National Guideline Clearinghouse
 http://www.guideline.gov/content.aspx?id=23792&search=wa+opioids
13
www.agencymeddirectors.wa.gov

14. Washington Agency Medical Directors’
Opioid Dosing Guidelines
 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
14
www.agencymeddirectors.wa.gov

15. Guidance for Primary Care Providers on Safe and
Effective Use of Opioids for Chronic Non-cancer Pain
 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
http://www.agencymeddirectors.wa.gov/opioiddosing.asp
15
MED, Morphine equivalent dosec

16. Open-source Tools Added to June 2010
Update of Opioid Dosing Guidelines
 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
CAGE, “cut down” “annoyed” “guilty” “eye-opener”
16
http://www.agencymeddirectors.wa.gov/opioiddosing.asp#DC

17. CDC recommendations-2009
 For practitioners, public payers, and insurers
 Seek help at 120 mg/day MED if pain and
function not improving
 http://www.cdc.gov/HomeandRecreationalSafety/pdf/p
oision-issue-brief.pdf

18. WA State Opioid Dosing Guideline
contributes to reversal of opioid epidemic
Franklin GM, Mai J, Turner J, et al. Bending the
prescription opioid dosing and mortality curves:
impact of the Washington State Opioid Dosing
Guideline. Am J Ind Med 2012; 55: 325-31

19. 10-Q3
2010 Q1
10-Q1
2009 Q3
09-Q3
2009 Q1
09-Q1
Washington Workers‟ Compensation, 1996–2010
2008 Q3
08-Q3
2008 Q1
08-Q1
2007 Q3
07-Q3
2007 Q1
07-Q1
2006 Q3
06-Q3
2006 Q1
06-Q1
Long-acting opioids
2005 Q3
05-Q3
Short-acting opioids
2005 Q1
05-Q1
2004 Q3
04-Q3
Average Daily Dosage for Opioids,
2004 Q1
04-Q1
2003 Q3
03-Q3
Year/Quarter
2003 Q1
03-Q1
2002 Q3
02-Q3
2002 Q1
02-Q1
01-Q3
2001 Q3
01-Q1
2001 Q1
00-Q3
2000 Q3
00-Q1
2000 Q1
99-Q3
1999 Q3
99-Q1
1999 Q1
98-Q3
1998 Q3
98-Q1
1998 Q1
97-Q3
1997 Q3
97-Q1
1997 Q1
96-Q3
1996 Q3
19
96-Q1
1996 Q1
80
60
40
20
0
120
140
100
MED (mg/day)

20. WA Workers' Compensation Opioid-related Deaths 1995-2010
35
Opioid-related Death
30
25
20
15
10
5
0
Possible Probable Definite

21. Unintentional Prescription Opioid Overdose Deaths
Washington 1995-2010
600
500
420
Number of deaths
400
300
200
100 24
0
95
96
97
98
99
00
01
02
03
04
05
06
07
08
09
10
Prescription Opioid + alcohol or illicit drug
Prescription Opioid +/- Other Prescriptions
* Tramadol only deaths included in 2009, but not in prior years.
Source: Washington State Department of Health, Death Certificates

23. Washington State Legislation: ESHB 2876,
On Opioid Treatment. 2010
 Repeals current regulation; new regs by June 2011
 Provides specific dosing guidance and guidance
on consultations, assessments, and tracking
 Signed into law by Governor Gregoire March 25, 2010
23

24. Washington State Opioid Treatment
Regulations
 Emphasize tracking patients for improved
pain AND function
 Emphasize widely agreed-upon best practices
 Screening for substance abuse and other comorbidities
 Prudent use of urine drug screens
 Opioid treatment agreement
 Single pharmacy and single prescriber
 Encourage use of Prescription Monitoring Program-
begins 1/1/2012
and Emergency Department Information Exchange,
when available
24

25. What can PCP do to safely and
effectively use opioids for CNCP
 Opioid treatment agreement
 Screen for prior or current substance
abuse/misuse (alcohol, illicit drugs, heavy
tobacco use)
 Screen for depression
 Prudent use of random urine drug screening
(diversion, non-prescribed drugs)
 Do not use concomitant sedative-hypnotics or
benzodiazepines
 Track pain and function to recognize tolerance
 Seek help if MED reaches 120 mg and pain
and function have not substantially improved
 Use State PDMP

26. Improving Physician Access to
Pain Specialists in Washington
State
 Issue
 Moderate capacity problem: not enough pain
specialists
 Interventional anesthesiologists generally won‟t see
these patients to assist with opioid issues
 Solution
 Advanced training for primary care to increase
proficiency
 Telephonic or video consultation with experts
[Project ECHO at UW
(http://depts.washington.edu/anesth/care/pain/echo/
index.shtml)]
Public payers working on payment codes to
26
incentivize these activities

27. Incent best practices in community settings to
prevent/treat chronic pain
 Cognitive behavioral therapy
 Graded exercise
 Activity coaching
 Interdisciplinary care
 Care coordination
Centers for Occupational Health and Education will
expand to 100% of WA injured workers by 2015
Medical Home concept to prevent transition to chronic
pain, and more adequately treat chronic pain
27

28. There is substantial clustering among
providers on dosing and mortality
CA CWCI study-Swedlow et al, March, 2011: 3% of
prescribers account for 55% of Schedule II opioid
Rxs:http://www.cwci.org/research.html
Dhalla et al, Clustering of opioid prescribing and opioid-
related mortality among family physicians in Ontario. Can
Fam Physician 2011; 57: e92-96
Upper quintile of frequent opioid prescribers associated
with last opioid Rx in 62.7% of public plan beneficiary
unintentional poisoning deaths
DLI sent letters to all prescribers with any patient on opioid
doses at or above 120 mg/day MED
 Call their attention to AMDG Guidelines and new WA
state regulations
 Associate medical director will meet with these docs
personally

29. 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

30. Disability generated in workers‟ compensation
may be a public health problem of the highest
order
 1954-4% of men 25-54 unemployed
 2010-20% of men 25-54 unemployed
 Federal (SSD) disability-8 million-will be bankrupt in
7 years
 Workers‟ compensation is likely contributing a large
proportion of the permanently unemployed/disabled
to State, Federal and private disability programs
David Leonhardt, Men, Unemployment, and
disability, NYT, 4/8/2011

31. 38% Increase since 2001

32. Concrete steps to take
 Track high MED and prescribers
 Reverse permissive laws and set dosing standards for
chronic, non-cancer pain
 Implement AMDG Opioid Dosing Guidelines
(http://www.agencymeddirectors.wa.gov/opioiddosing.asp)
 Implement Prescription Monitoring Program
 Encourage/incent use of best practices (web-based MED
calculator, use of state PMPs)
 DO NOT pay for office dispensed opioids
 ID high prescribers and offer assistance
 Incent community-based Rx alternatives (activity coaching and
graded exercise early, opioid taper/multidisciplinary Rx later)
 Offer assistance (academic detailing, free CME,ECHO)

33. Unfinished business
 Guidelines for peri-operative use of opioids
 Looming large population dependent/addicted
from Rx opioids
 Develop guidelines Re tapering
 PCP routine taper; Detox/pain clinic taper +/-
buprenorphine
 Rx of opioid use disorder/addiction
New WA WC guidelines address these issues

34. It‟s an emergency, so move ahead
gingerly
If you do something effective to reverse a decade of
bad public policy, you will get pushback: Fauber J.
Follow the money: Pain, policy, and profit. 2/19/12.
URL:http://www.medpagetoday.com/Neurology/PainManag
ement/31256
 But remember that the docs in the trenches welcome
assistance, tools, and best practices
-National survey of PCP network for low income
patients: 1/3 reported a severe outcome (death
or life-threatening event); 1/3 do not initiate
prescribing of opioids*
 WA prescribers are MUCH more concerned about
dependence/addiction than about regulatory scrutiny
*Leverence RR, et al. J Am Board Fam Med 2011; 24: 551-561

35. New state policies
Connecticut WC policy-7/1/2012
The total daily dose of opioids should not be increased above 90mg
oral MED/day (Morphine Equivalent Dose) unless the patient
demonstrates measured improvement in function, pain or work
capacity. Second opinion is recommended if contemplating raising the
dose above 90 MED/day.
MaineCare (Medicaid)-4/1/2012
Total 45 day maximum for non-cancer pain
New Mexico-Rule 16.10.14-Proposed rules
Aug, 2012
A health care practitioner shall, before
prescribing, ordering, administering or dispensing a controlled
substance listed in schedule II, III or IV, obtain a patient PMP
report for the preceding twelve (12) months

36. THANK YOU!
For electronic copies of this
presentation, please e-mail
Melinda Fujiwara
vasudha@u.washington.edu
For questions or feedback,
please
e-mail Gary Franklin
meddir@u.washington.edu