meeting the challenge of the opioid epidemic -uc irvine medical grand rounds- jan 29, 2013
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Meeting the Challenge of the Opioid Epidemic -UC Irvine Medical Grand Rounds- Jan 29, 2013. Gary M. Franklin, MD, MPH Medical Director WA Dept of Labor and Industries Research Professor Depts of Environmental & Occupational Health Sciences, Neurology, and health Services - PowerPoint PPT PresentationTRANSCRIPT
GA RY M. F RA NKLI N, MD, MPH
MEDI CA L D IRE CTORWA DE PT OF L AB OR A ND IN DUSTR IE S
RESEA RC H PR OFE SSORDEP TS OF ENV I RONM ENTA L & OCCU PATION A L HE A LTH
SCIE NCE S, N EUR OLOGY, AN D HE A LTH SERV ICE SUNI V ERSITY OF WA SHI NGTON
Meeting the Challenge of the Opioid Epidemic
-UC Irvine Medical Grand Rounds-
Jan 29, 2013
"To write prescriptions is easy,but to come to an understanding with people is hard."-- Franz Kafka, “A Country Doctor”
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
Change in National Norms for Use of Opioids for Chronic, Non-cancer Pain
WAC-Washington Administrative Code4
Similarities Between Illicit & Prescription Drugs
Portenoy and Foley Pain 1986; 25: 171-186
Retrospective case series chronic, non-cancer pain
N=38; 19 Rx for at least 4 years2/3 < 20 mg MED/day; 4> 40 mg MED/day24/38 acceptable pain reliefNo gain in social function or employment
could be documentedConcluded: “Opioid maintenance therapy can
be a safe, salutary and more humane alternative…”
7
Pain champions, Pharma surrogates, and Astroturf organizations led the way
Older falsehoods Opioids not as addicting as we used to think
(<1%)-”pseudoaddiction” coined No ceiling on dose-standard was to increase dose to address
tolerance Pain as the fifth vital sign Patients should leave the ER in comfort-drove satisfaction scoresMore recent falsehoods* Were it not for the heavy hand of law enforcement/gov’t, we’d be
fine It’s all a methadone problem It’s all abuse It’s just a cluster of pill mills and a few others
*http://www.huffingtonpost.com/radley-balko/prescription-painkillers_b_1240722.html
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 More than 50% of patients on opioids for 3
months will still be on opioids 5 years laterBallantyne J. Pain Physician 2007;10:479-91; Martin BC et al. J Gen Intern Med 2011; 26: 1450-57
Limitations of Long-term (>3 Months) Opioid Therapy
8
Dentists and Emergency Medicine Physicians were the main prescribers for patients 5-29 years of age
0-4 5-9 10-14 15-19 20-24 25-29 30-39 40-59 60+0
100
200
300
400
500
600
700
800
900
GP/FM/DOIMDENTORTH SURGEM
Age Group
Rate
per
10,
000
pers
ons
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
10
Opioid-Related Deaths, Washington State Workers’ Compensation,
1992–2005
Franklin GM, et al, Am J Ind Med 2005;48:91-9
1995
1996
1997
1998
1999
2000
2001
2002
02468
101214
Definite Probable Possible
Deat
hs
Year
‘95 ‘97 ‘00 ‘02‘96 ‘98 ‘99 ‘01
11
Age-adjusted rate per
100,000 population
Unintentional and Undetermined Intent Drug Overdose Death Rates by State, 2007
MDMANHRICTDEDCVTNJ
12.512.511.711.111.1
9.88.8 7.97.5
National Vital Statistics System, http://wonder.cdc.gov
Moore, et al. Serious Adverse Drug Events Reported to the Food and Drug Administration, 1998-2005 - Arch Intern Med. 2007;167(16):1752-1759
Evidence linking specific doses to morbidity and mortality
Dunn et al, Ann Int Med 2010; 152: 85-92Risk of morbidity and mortality increased 8.9 fold
at 100 mg MEDEditorial-McLellan-White House Office of National
Drug Control Policy “Smarter, more responsible (prescribing) practices are the
only hope to avoid tragic, avoidable deaths”Braden et al, Arch Int Med 2010; 170: 1425-
32Opioid doses >120 mg/day MED and use of long acting Schedule II opioids associated with incresed risk of alcohol- or drug- related ER visit
*
Evidence linking specific doses to morbidity and mortality
Bohnert et al, JAMA 2011; 305: 1315-21• Risk of mortality 7.18 (chronic pain), 6.64
(acute pain)
Gomes et al, Arch Int Med 2011; 171: 686-91• Risk of mortality 2.04 at 100 mg and 2.88 at
200 mg
0
100
200
300
400
500
600
700
800
'97 '98 '99 '00 '01 '02 '03 '04 '05 '06 '07
15
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
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.”
Naliboff et al, J Pain, 2011: 12: 288-296 RCCT dose escalation vs “hold the line” No improvement in any primary outcome 27% misuse/non-compliance
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
Washington Agency Medical Directors’ Opioid Dosing Guidelines
18
Developed with clinical pain experts in 2006Implemented April 1, 2007First guideline to emphasize dosing guidanceEducational pilot, not new standard or ruleNational Guideline Clearinghouse
http://www.guideline.gov/content.aspx?id=23792&search=wa+opioids
www.agencymeddirectors.wa.gov
19
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
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
20
http://www.agencymeddirectors.wa.gov/opioiddosing.aspMED, Morphine equivalent dose
Open-source Tools Added to June 2010 Update of Opioid Dosing Guidelines
21
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
Available as mobile app: http://www.agencymeddirectors.wa.gov/opioiddosing.asp
22
Washington State Primary Care Survey 2009:Physician Concerns
Please check the statement that most accurately reflects
your experience when prescribing opioids for chronic, non-cancer pain
NO concerns about development of psychological dependence, addiction, or diversion
2%
OCCASIONAL concerns about development of psychological dependence, addiction, or diversion
45%
FREQUENT concerns about development of psychological dependence, addiction, or diversion
54%
Morse JS et al, J Opioid Management 2011; 7: 427-433.
23
Washington State Primary Care Survey 2009: Adherence to State Guidelines
GuidanceNever or almost never
Sometimes Often
Always or
almost always
Use treatment agreement 10% 22% 20% 49%
Screen for substance abuse <1% 3% 15% 81%
Screen for mental illness <1% 12% 30% 58%
Use random urine screen 30% 32% 18% 20%
Use patient education 34% 38% 19% 9%
Track pain 40% 31% 15% 15%
Track physical function 69% 20% 7% 5%Morse JS et al, J Opioid Management 2011; 7: 427-433.
2009 CDC recommendations
For practitioners, public payers, and insurersSeek help at 120 mg/day MED if pain and
function not improvinghttp://www.cdc.gov/HomeandRecreationalSafety/pdf/pois
ion-issue-brief.pdf
Recent state policies
Connecticut WC policy-7/1/2012The 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)-4/1/2012Total 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
_x00
04_1
996
_x00
04_1
997
_x00
04_1
998
_x00
04_1
999
_x00
04_2
000
_x00
04_2
001
_x00
04_2
002
_x00
04_2
003
_x00
04_2
004
_x00
04_2
005
_x00
04_2
006
_x00
04_2
007
_x00
04_2
008
_x00
04_2
009
0
10,000
20,000
30,000
40,000
50,000
60,000
70,000
80,000
90,000
100,000
Yearly Trend of Scheduled Opioids(Franklin et al, Am J Ind Med 2012; 55: 325-31 )
Schedule II Schedule III Schedule IV
Num
ber o
f Opi
oid
Pre
scrip
tions
2000Q
1
2000Q
3
2001Q
1
2001Q
3
2002Q
1
2002Q
3
2003Q
1
2003Q
3
2004Q
1
2004Q
3
2005Q
1
2005Q
3
2006Q
1
2006Q
3
2007Q
1
2007Q
3
2008Q
1
2008Q
3
2009Q
1
2009Q
3
2010Q
1
2010Q
30.0%
5.0%
10.0%
15.0%
20.0%
25.0%
30.0%
35.0%
40.0%
Percent of Timeloss Claimants on Opioids 2000 - 2010
Opioids Highdose Opioids
Average Daily Dosage for Opioids, Washington Workers’ Compensation, 1996–2010
28
1996 Q11996 Q31997 Q11997 Q31998 Q11998 Q31999 Q11999 Q32000 Q12000 Q32001 Q12001 Q32002 Q12002 Q32003 Q12003 Q32004 Q12004 Q32005 Q12005 Q32006 Q12006 Q32007 Q12007 Q32008 Q12008 Q32009 Q12009 Q32010 Q1
020406080
100120140
MED
(mg/
day)
Long-acting opioids
Short-acting opioids
Year/Quarter
96-
Q1 96-
Q3 97-
Q1 97-
Q3 98-
Q1 98-
Q3 99-
Q1 99-
Q3 00-
Q1 00-
Q3 01-
Q1 01-
Q3 02-
Q1 02-
Q3 03-
Q1 03-
Q3 04-
Q1 04-
Q3 05-
Q1 05-
Q3 06-
Q1 06-
Q3 07-
Q1 07-
Q3 08-
Q1 08-
Q3 09-
Q1 09-
Q3 10-
Q1 10-
Q3
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
0
5
10
15
20
25
30
35
WA Workers' Compensation Opioid-related Deaths 1995-2010
Possible Probable Definite
Opi
oid-
rela
ted
Dea
th
Unintentional Prescription Opioid Overdose Deaths Washington 1995-2010
* Tramadol only deaths included in 2009, but not in prior years.
Source: Washington State Department of Health, Death Certificates
95 96 97 98 99 00 01 02 03 04 05 06 07 08 09 10
0
100
200
300
400
500
600
Prescription Opioid + alcohol or illicit drug
Prescription Opioid +/- Other Prescriptions
Num
ber o
f dea
ths
24
420
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: e92-96Upper 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-ONLY N=60• Call their attention to AMDG Guidelines and new WA state
regulations• Associate medical director will meet with these docs personally
What can PCP do to safely and effectively use opioids for CNCP?
Opioid treatment agreementScreen for prior or current substance
abuse/misuse (alcohol, illicit drugs, heavy tobacco use)
Screen for depressionPrudent use of random urine drug screening
(diversion, non-prescribed drugs)Do not use concomitant sedative-hypnotics or
benzodiazepinesTrack pain and function to recognize toleranceSeek help if MED reaches 120 mg and pain and
function have not substantially improvedUse PDMP!
Concrete steps to take Track high MED and prescribers Reverse permissive laws and set dosing and best practice
standards for chronic, non-cancer pain Implement AMDG Opioid Dosing Guidelines (
http://www.agencymeddirectors.wa.gov/opioiddosing.asp) Implement effective Prescription Monitoring Program;
check the PDMP on every new injured worker who receives opioid Rx
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)
35
Nov, 2012 WA Workers CompensationOpioid Guideline*
Adoption of the 2010 AMDG Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain
This Supplement provides additional information and guidance for treating work-related injuriesDOH pain management rules, 2010 AMDG
Guideline and this Supplement are reflective of the practice standard for prescribing
opioids for a work-related injury or occupational disease.
*www.lni.wa.gov/ClaimsIns/Files/OMD/MedTreat/FINALOpioidGuideline010713.pdf
36
Clinically Meaningful
Improvement in Function
Case Definition
&
Algorithmsfor
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
Disability Prevention is the Key Health Policy Issue
Adapted from Cheadle et al. Am J Public Health 1994; 84:190–196.
12111098765432100
20
40
60
80
100
Time loss duration (months)
% o
f ca
ses
on t
ime
loss
Early opioids and disability in WA WC. Spine 2008; 33: 199-204
Population-based, prospective cohortN=1843 workers with acute low back injury
and at least 4 days lost timeBaseline interview within 18 days(median) 14% on disability at one yearReceipt 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
38% Increase since 2001
Opioid Use in Workers’ Compensation
1
Measuring the Impact of Opioid Use Beyond acute phase, effective use should result in
clinically meaningful improvement in function (CMIF) CMIF is an improvement in function of at least 30%
compared to start of treatment or in response to a dose change
Evaluation of clinically meaningful improvement should occur at 3 critical phases (acute, subacute and during COT)Continuing to prescribe opioids in the absence of CMIF or after
the development of a severe adverse outcome is not proper and necessary care. In addition, the use of escalating doses to the
point of developing opioid use disorder is not proper and necessary care.
For electronic copies of this presentation, please
e-mail Laura [email protected]
For questions or feedback, please
e-mail Gary [email protected]
THANK YOU!