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Gary M. Franklin, MD, MPH, FAAN
Reversing the opioid epidemic and improving outcomes for pain patientsMay 3, 2019 North Central ACH
Research ProfessorDepartments of Environmental Health, Neurology, and Health ServicesUniversity of Washington
Medical DirectorWashington State Department of Labor and Industries
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2
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
Deat
hs
Definite Probable Possible
Year
‘95 ‘97 ‘00 ‘02‘96 ‘98 ‘99 ‘01
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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
• Degenhardt et al Lancet Psychiatry 2015; 2: 314-22; POINT prospective cohort: DSM-5 opioid use disorder: 29.4%
• Spillover effect to to SSDI* and to heroin (40% new initiates started on Rx opioids)
Slide 3
*Franklin et al, Am J Ind Med 2015; 58: 245-51
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Rapidly increasing mortality in middle aged, lower educated whitesCase and Deaton, PNAS, 2015
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You will not be able to effectively alter epidemic if you don’t understand how the epidemic beganBy the late 1990s, at least 20 states passed new laws,
regulations, or policies moving from near prohibition of opioids to use without dosing guidance-stated goal was to provide a safe “safe haven” for prescribingWA 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 developsPain as 5th vital sign campaign and JOINT COMMISSION/CMS
satisfaction survey
Slide 5
WAC-Washington Administrative Code
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Another falsehood-addiction is rare-less than 1%N Engl J Med. 1980;302:123.
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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
By 2006, 10,000 patients in WA public programs were on >100 mg MED/day
How many chronic pain patients in your practice are on doses over 100 mg/day? How many are on combinations of opioids and benzodiazepines or sedative hypnotics?
Slide 7
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Purdue Project Tango-2014From the NYT 4/1/19Lawsuits lay bare Sackler family’s role in opioid crisis
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Three key strategic goals to reverse the opioid epidemic
1. Prevent the next cohort of our citizens from transitioning from acute/subacute opioids to chronic opioids by dramatically reducing acute opioid doses and duration
• Dental, post-op opioids, sports injuries, adolescents
2. Systematically address and treat the millions of patients already on long term, often high dose opioids
• Tapering, MAT if taper fails, Spoke and hub• But need much more rigorous screening methods
3. Deliver community based, multimodal care for pain• Cognitive behavioral therapy, psychologically informed physical therapy• Goal is to improve patient self-efficacy
• BUT we need much more information on the impact on patients of opioid policy efforts
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Evidence of effectiveness of COATThe 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).
Slide 10
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Krebs et al. SPACE randomized trial: JAMA 2018; 319: 872-82
• Pragmatic trial opioid vs non-opioid meds over 12 months• Outcomes: pain-related function, pain intensity, and adverse effects• N=240 with mod/severe chronic LBP or hip/knee osteoarthritis despite
analgesic use in MSP VA clinics• 234/240 (97.5%) completed trial• Pain-related function no different at 12 months• Pain intensity better in non-opioid group• Adverse effects worse in opioid group“Treatment with opioids was not superior to treatment with nonopioidmedications for improving pain-related function over 12 months. Results do not support initiation of opioid therapy for moderate to severe chronic back pain or hip or knee osteoarthritis pain.”
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responding to the EVIDENCE:morphine equivalent dose RELATED RISK
12
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<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 dose2012: CT work comp: 90 mg/day MED2013: OH State medical Board: 80 mg/day MED2013: Am College Occ. & Environ Med: 50 mg/day MED2014: CA work comp: 80-120 mg/day MED2016: CDC 50 mg/day MED yellow flag; 90 mg/day MED red flag
• Risk of adverse ±overdose event increases at >50 mg MED/day
• Risk increases greatly at ≥100 MED/day
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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
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Risk/Benefit of Opioids for Chronic Non-Cancer Pain(Franklin; Neurology; Sept 2014 Position paper of the AAN)
Slide 14
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Risk/Benefit of Opioids for Chronic Non-Cancer Pain(Franklin; Neurology; Sept 2014 Position paper of the AAN)
• Because of the paucity of evidence of effectiveness with chronic use, and poor risk profile, esp. for dependence and addiction, opioids should not be used routinely for the treatment of routine musculoskeletal conditions, headaches or fibromyalgia*
• CDC 2016 guidelines (https://www.cdc.gov/drugoverdose/prescribing/guideline.html)
• WA Agency Medical Director Guidelines-2015 (http://agencymeddirectors.wa.gov/guidelines.asp)
Slide 15
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GRAY ZONE
ADDICTED NOT ADDICTED
Meets DSM criteria for addiction
• No lost prescriptions• No ER visits• No early prescriptions• No requests for dose
escalation• No UDT aberrancies• No doctor shopping
(PMP)
Most patients on chronic opioids are highly dependent or addicted
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Open-source Tools Added June 2010 Update of AMDG Opioid Dosing Guideline
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
Slide 17
Available as mobile app: http://www.agencymeddirectors.wa.gov/opioiddosing.asp
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Slide 18
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Slide 19
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0
100
200
300
400
500
600
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
Washington Unintentional Prescription Opioid Deaths 1995 – 2015
44% sustained decline
Definite Prescription Opioid (rx opioid+/-other prescriptions) Possible Prescription Opioid (rx opioid+alcohol or illicit drug)
Source: Washington State Department of Health
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Clinically Meaningful Improvement• Clinically meaningful improvement is improvement in pain and
function of at least 30% • Assess and document function and pain using validated tools
at each visit where opioids are prescribed • Recommend use of quick and free tools to track function and
pain• PEG: Pain intensity, interference with Enjoyment of life,
and interference with General activity• Graded Chronic Pain Scale: Pain intensity and pain
interferenceTools can be found at: http://www.agencymeddirectors.wa.gov/Files/2015AMDGOpioidGuideline.pdf
Slide 22
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Non-Pharmacologic Alternatives• Do NOT pursue diagnostic tests unless risk factors or specific reasons are
identified-no MR in first 6 wks in absence of red flags• Use interventions such as listening, providing reassurance, and involving the
patient in care• Recommend graded exercise, cognitive behavioral therapy, mindfulness based
stress reduction (MBSR), various forms of meditation and yoga or spinal manipulation in patients with back pain
• Address sleep disturbances, BUT, the greatest risk lies in co-prescribing benzodiazepines and sedative/hypnotics with opioids, even at lower doses of opioids
• Refer patient to a multidisciplinary rehabilitation program if s/he has significant, persistent functional impairment due to complex chronic pain
Slide 23
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Pharmacologic Alternatives• Use NSAIDs for minor to moderate pain • Consider antidepressants (TCAs/SNRIs) and anticonvulsants for
neuropathic pain, other centralized pain syndromes, or fibromyalgia
• Avoid carisoprodol (SOMA) due to the risk of misuse and abuse. Do NOT prescribe muscle relaxants beyond a few weeks as they offer little long-term benefit
• Prescribe melatonin, TCAs, trazodone, or other non-controlled substances if the patient requires pharmacologic treatment for insomnia
Slide 24
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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.
http://dx.doi.org/10.15585/mmwr.rr6501e1. Slide 25
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CDC Opioid Guidelines-March 2016• Opioid Selection, Dosage, Duration, Follow-Up, and
Discontinuation4.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 26
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Dentists and Emergency Medicine Physicians were the main prescribers for patients 5-29 years of age
0
100
200
300
400
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600
700
800
900
0-4 5-9 10-14 15-19 20-24 25-29 30-39 40-59 60+
Rate
per
10,
000
pers
ons
Age Group
GP/FM/DO
IM
DENT
ORTH SURG
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
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Dr Paul Moore, ADA Council on Scientific Affairs, on the 2016 CDC opioid guidelines
• "For dental practitioners, the importance of these recommendations should be carefully considered," said Dr. Moore, who also holds a doctorate in pharmacology and teaches at the University of Pittsburgh School of Dental Medicine. "Every year, millions of adolescents receive their first introduction to opioids following the extraction of their third molars. Many of these young adults may have never received these centrally-acting analgesics before in their lives. We have a special responsibility to counsel them about their dangers and educate them about their safe use of opioids when taken for acute postoperative pain.
http://www.ada.org/en/publications/ada-news/2016-archive/march/cdc-offers-new-recommendations-for-opioids
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Acute Opioid Prescribing in Adults by Specialty
29Source: DOH Prescription Monitoring Program Data
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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
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New Persistent Opioid Use After Minor and MajorSurgical Procedures in US Adults
JAMA Surg. 2017;152(6):e170504. doi:10.1001/jamasurg.2017.0504
Incidence of New Persistent Opioid Use by Surgical Condition. The incidence of new persistent opioid use was similar between the 2 groups (minor surgery, 5.9% vs major surgery, 6.5%; odds ratio, 1.12; SE, 0.06; 95% CI, 1.01-1.24). By comparison, the incidence in the non-operative control group was only 0.4%.
Figure Legend:
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Why Consider Post-op Pill/Duration Recs?
• The vast majority of pills prescribed post-op are left over and may be used for subsequent misuse or diversion
• Voepel-Lewis et al, JAMA Pediatrics 2015; 169: 497-8-leftover pills in kids via parent diaries
• T&A 52 pills dispensed 44 pills left (day 4)• MSK 34 pills dispensed 30 pills left• Minor abd, 31 pills dispensed 28 pills left
GU,periph proc
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Resnick et al. J Oral Maxillofac Surg 2019; Feb 16-How much is used for asymptomatic molars?• Prospective study at Boston Children’s• June-Oct 2018• N=81• 75/81 (93%)used NO post-op oxycodone
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Brat et al, BMJ 2018;360:j5790 http://dx.doi.org/10.1136/bmj.j5790
• 37.6 million commercially insured 2008-2016• 1 million opioid naïve patients undergoing surgery• Composite outcome dependence, abuse or overdose• Total duration of opioid use was the strongest predictor of
misuse, with each refill and additional week of opioid use associated with an adjusted increase in the rate of misuse of 44.0%
• Highest risk in 15-24 yr age group
Why Consider Post-op Pill/Duration Recs?
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Schroeder et al, JAMA Int Med 2019; 179: 145-152-dental opioids in young people and subsequent opioid use/abuse• Optum Research Database 2015• Opioid naïve patients aged 16-25 receiving dental opioids• N=29,791; compared to 2 age-and sex-matched controls unexposed
to opioids• 6.9% vs 0.1 % received another opioid within one year• 5.8% vs 0.4% received an opioid abuse related diagnosis within on
year
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Continued Use by Initial Days of TherapyMMWR March 17, 2017
0
5
10
15
20
25
30
35
40
0 5 10 15 20 25 30 35 40 45
Prob
abili
ty o
f con
tinui
ng u
se in
%
Number of days of first episode of opioid use
One year probability Three year probability
Source: Shah et al. MMWR 2017 Mar 17;66(10):265-9
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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 37
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Postoperative Prescribing Supplement
Slide 39
Completed formatting of the Prescribing Opioids for Postoperative Pain– Supplemental Guidance.Available on the AMDG website along with the Robert Bree Collaborative website.
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Table 1: Evidence-Based Duration of Opioid Prescriptions on Discharge Following Surgery
Type I – Expected rapid recovery Dental procedures such as extractions or simple oral surgery (e.g., graft, implant).
• Prescribe a nonsteroidal anti-inflammatory drug (NSAID) or combination of NSAID and acetaminophen for mild to moderate pain as first-line therapy.
• If opioids are necessary, prescribe ≤3 days (e.g., 8 to 12 pills) of short-acting opioids in combination with an NSAID or acetaminophen for severe pain. Prescribe the lowest effective dose strength.
• For more specific guidance, see the Bree Collaborative Dental Guideline on Prescribing Opioids for Acute Pain Management.
Procedures such as laparoscopic appendectomy, inguinal hernia repair, carpal tunnel release, thyroidectomy, laparoscopic cholecystectomy, breast biopsy/lumpectomy, meniscectomy, lymph node biopsy, vaginal hysterectomy.
• Prescribe non-opioid analgesics (e.g., NSAIDs and/or acetaminophen) and non-pharmacologic therapies as first-line therapy.
• If opioids are necessary, prescribe ≤3 days (e.g., 8 to 12 pills) of short-acting opioids in combination with an NSAID or acetaminophen for severe pain. Prescribe the lowest effective dose strength.
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Table 1: Evidence-Based Duration of Opioid Prescriptions on Discharge Following Surgery
Type II – Expected medium term recovery Procedures such as anterior cruciate ligament (ACL) repair, rotator cuff repair, discectomy, laminectomy, open or laparoscopic colectomy, open incisional hernia repair, open small bowel resection or enterolysis, wide local excision, laparoscopic hysterectomy, simple mastectomy, cesarean section.
• Prescribe non-opioid analgesics (e.g., NSAIDs and/or acetaminophen) and non-pharmacologic therapies as first-line therapy.
• Prescribe ≤7 days (e.g., up to 42 pills) of short-acting opioids for severe pain. Prescribe the lowest effective dose strength.
• For those exceptional cases that warrant more than 7 days of opioid treatment, the surgeon should re-evaluate the patient before a third prescription and taper off opioids within 6 weeks after surgery.
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Table 1: Evidence-Based Duration of Opioid Prescriptions on Discharge Following Surgery
Type III – Expected longer term recovery Procedures such as lumbar fusion, knee replacement, hip replacement, abdominal hysterectomy, axillary lymph node resection, modified radical mastectomy, ileostomy/colostomy creation or closure, thoracotomy.
• Prescribe non-opioid analgesics (e.g., NSAIDs and/or acetaminophen) and non-pharmacologic therapies as first-line therapy.
• Prescribe ≤14 days of short-acting opioids for severe pain. Prescribe the lowest effective dose strength.
• For those exceptional cases that warrant more than 14 days of opioid treatment, the surgeon should re-evaluate the patient before refilling opioids and taper off opioids within 6 weeks after surgery.
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Table 1: Evidence-Based Duration of Opioid Prescriptions on Discharge Following Surgery
Patients on Chronic Opioid Analgesic Therapy Elective surgery in patients on chronic opioid therapy
• Prescribe non-opioid analgesics (e.g., NSAIDs and/or acetaminophen) and non-pharmacologic therapies as first-line therapy.
• Resume chronic opioid regimen if patients are expected to continue postoperatively.
• Follow the recommendation above for prescribing the duration of short acting opioids following a particular surgery (e.g., 3, 7, or 14 days). An increased number of pills per day may be expected compared to an opioid naïve patient. Patients on chronic opioid therapy should have a similar tapering period as opioid naïve patients postoperatively. Prescribe the lowest effective dose strength.
• For those exceptional cases that warrant more than 14 days of opioid treatment after hospital discharge, the surgeon should re-evaluate the patient before refilling opioids and taper off opioids within 6 weeks after surgery to no higher total daily dose than was present pre-operatively.
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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
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WA Bree Opioid Metrics
General prescribing
• Prevalence of opioid use
% with ≥1 opioid Rx of all enrollees, by age
Long-term prescribing
• Chronic opioid use % with ≥60 days supply of opioids in the quarter• High dose use % with doses ≥50 and ≥90 mg/day MED in chronic opioid users• Concurrent use % with ≥60 days supply of sedatives among chronic opioid usersShort-term prescribing
• Days supply of first Rx % with ≤3, 4-7, 8-13, and ≥14 supply among new opioid patients• Transition of chronic
use% new opioid patients transitioning to chronic use the next quarter
Morbidity and Mortality
• Opioid overdose deaths Rate of overdose deaths involving opioids• Non-fatal overdoses Rate of non-fatal overdoses • Opioid use disorder Rate of opioid use disorder among patients with ≥3 quarters of use
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Improve systems/community capacity to treat pain/addiction• Deliver coordinated, stepped care services aimed at
improving pain and addiction treatment • Cognitive behavioral therapy or graded exercise to improve
patient self-efficacy • Opioid overdose case management by ED to identify
behavioral health needs, evaluate for MAT, notify providers involved and discuss recommendations (e.g.Vermont spoke and hub)
• Increase access to pain and addiction experts (e.g. WA telepain)
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Emerging examples of stepped care management/collaborative care for pain
• VA Health System Stepped Care Model of Pain Management• Dorflinger et al. A Partnered Approach to Opioid Management, Guideline
Concordant Care and the Stepped Care Model of Pain Management. J Gen IntMed 2014; Suppl 4, 29: S870-6.
• Vermont Spoke and Hub regional support for medication assisted treatment for opioid use disorder/severe dependence
• WA state Centers of Occupational Health and Education/Healthy Worker 2020
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Prescribing Opioids in Older Adults
• Goal – Reduce risk of falls Follow same best practices for
prescribing opioids (AMDG)
Prescribe immediate-release opioids at the lowest effective dose (AMDG)o Initiate opioid therapy at a 25%
to 50% lower dose than that recommended for younger adults
A collaboration of state agencies, working together to improve health care quality for Washington State citizens
Source: AHRC
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THANK YOU!
For electronic copies of this presentation, please e-mail Laura Black [email protected]
For questions or feedback, please e-mail Gary Franklin [email protected]
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