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TheOpioid Epidemic
Some Key issues for Physicians and other Healthcare workers
Richard Ries [email protected]
Harborview Medical Center and the University of Washington
Seattle, Washington
Len Paul0zzi MD MPHCDC Atlanta Georgia
Ries Conflict of Interest Statement
Dr Ries is on Speaker’s bureaus for Janssen, Reckitt-Benckiser, and Alkermes
Dr Ries has Grant funding from: NIH- NIDA-NIAAA
Contingency Management Alcohol in Mentally Ill
Brief Interventions of Drug Abuse in Prim Care
PTSD-- Exposure +/- Sertraline CM for Alcohol in Native Am Indians RCT of Injectable Naltrexone is Severe
Alc DOD- Suicide Prevention grantRRies 2014
3
Mary presents with serious multiple fractures after an
auto crash
32 y o w female with history of minor traumas (twisted ankle, back spasms), ER scripts 2 years ago for 5 days of oxycodone
Stabilized fractures of L femur and tibia, L wrist, abrasions, but post stabilization on standard opioid pain control, complains of pain, shows sweating, diarhea, feels cold and shakes, blood pressure elevates
Further info from family finds pt is prescribed oxycodone for chronic back pain, also xanax for anxiety, often appears sleepy, they think she might have a drug problem, and may be taking too much medication or maybe not as prescribed
RRies 2014
4
Motor vehicle traffic, poisoning, and drug poisoning (overdose) death rates
United States, 1980-2010
Paulozzi - CDC NCHS Data Brief, December, 2011, Updated with 2009 and 2010 mortality data
1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 20100
5
10
15
20
25
Motor Vehicle Traffic Poisoning Drug Poisoning (Overdose)
Year
Death
s p
er
100,0
00 p
opula
tion
Death Rates for Drug Overdose by State, 2010
3.4 - 10.9* 10.9* - 13.9 14.0 - 28.9
Age-adjusted rate per 100,000 population
10.0
9.6
7.8
8.6
10.6
6.3
3.4
6.7
7.3
13.9
11.8
11.4
9.6
14.4
13.2
15.0
23.8
11.8
10.9
11.4
19.4
10.7
6.812.7
23.6
10.9
12.9
16.9
14.6
16.1
12.9
16.9
15.3
28.9
13.1
17.5
10.4
16.4
17.0
20.7
11.6
NH 11.8VT 9.7MA 11.0RI 15.5CT 10.1NJ 9.8DE 16.6MD 11.0DC 12.912.5
Footnote: *10.9 is in two ranges due to rounding. HI is 10.88 while WI is 10.94RRies 2014
6
Opioid analgesic overdose death rates by sex and race , U.S., 2009
Source: National Vital Statistics System; crude rates
7
Drug overdose deaths by major drug type,
US, 1999-2010
CDC/NCHS National Vital Statistics System, CDC Wonder. Updated with 2010 mortality.
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 20100
2,000
4,000
6,000
8,000
10,000
12,000
14,000
16,000
18,000
Opioids HeroinCocaine Benzodiazepines
Year
Num
ber
of
Death
s
Journal of Analytical Toxicology, Volume 27, Number 2 March 2003
Oxycodone Involvement in Drug Abuse Deaths: A DAWN-Based Classification Scheme Applied to an Oxycodone Postmortem Database Containing Over 1000 Cases* Authors: Cone E.J.1; Fant R.V.1; Rohay J.M.1; Caplan Y.H.2; Ballina M.3; Reder R.F.3; Spyker D.3; Haddox J.D.
Of 1014 cases:30 (3.3%) involved oxycodone as the single reported chemical entity; of these,
The vast majority (N = 889, 96.7%) were multiple drug abuse deaths
The most prevalent drug combinations were
oxycodone in combination with benzodiazepines, alcohol, cocaine, other narcotics, marijuana, or antidepressants.
Exhibit 2: Past Year Initiation of Non-Medical Use of Prescription-type
Psychopharmaceutics, Age 12 or Older: In Thousands, 1965 to 20051
0
500
1000
1500
2000
2500
3000N
ew U
sers
(x
1000
)
Analgesics Tranquilizers Stimulants Sedatives
While Opiates have grown fastest, Benzos are not far behind
Source: SAMHSA, OAS, NSDUH data , July 2007
Benzo’s the Hidden Drug
• While there are hundreds of recent articles on Prescription Opiate problems-
• Most literature on Benzo Abuse/Dependence is > 10 years old
• Toxicology studies of Opiate deaths usually find Benzo’s too –respiratory depression is additive.
• Sales of Benzo’s are also increasing dramatically
•Simple Tox screens often miss Clon- and Alprazolam
11
Characteristics of unintentional pharmaceutical overdose deaths
(N=295), West Virginia, 2006
Characteristic Pct.
History of substance abuse 78.3
Other mental illness 42.7
Nonmedical route of administration 22.4
Previous overdose 16.9
TOTAL 100.0
Sources: Hall et al, JAMA, 2008 and Toblin et al, J Clin Psych, 2010
Source Where Pain Relievers Were Obtained for Most Recent
Nonmedical Use among Past Year Users Aged 12 or Older
Note: Totals may not sum to 100% because of rounding or because suppressed estimates are not shown.
1 The Other category includes the sources: “Wrote Fake Prescription,” “Stole from Doctor’s Office/Clinic/Hospital/Pharmacy,” and “Some Other Way.”
Bought/Took from Friend/Relative
14.8%
Drug Dealer/Stranger
3.9%
Bought on Internet
0.1% Other 1
4.9%
Free from Friend/Relative
7.3%
Bought/Took from
Friend/Relative
4.9%
OneDoctor80.7%
Drug Dealer/Stranger
1.6%Other 1
2.2%
Source Where Respondent Obtained
Source Where Friend/Relative Obtained
One Doctor19.1%
More than One Doctor1.6% Free from
Friend/Relative55.7%
More than One Doctor3.3%
2006
RRies 2014
Opioid Abstinence Syndrome
Symptoms: craving, anxiety, irritability, restlessness, nervousness, insomnia, rhinorrhea, lacrimation, nausea, abdominal cramps, myalgias, arthralgias
Signs: tachycardia, hypertension, mydriasis, piloerection, diaphoresis, tremor
Depending on opioid abused, starts within 4-6
hours, full intensity at 24 to 72 hours, can last for 7-14 days— Eg oxycodone vs methadone
Though less medically dangerous than alcohol or BZP, appears to drive relapse to opioid use at much higher rate.
Clinical Opiate Withdrawal Scale (COWS) 1
Resting Pulse Rate: (record beats per minute)
Measured after patient is sitting or lying for one minute
0 pulse rate 80 or below 1 pulse rate 81-100 2 pulse rate 101-120 4 pulse rate greater than 120 Sweating: over past ½ hour not
accounted for by room temperature or patient activity. 0 no report of chills or flushing 1 subjective report of chills or flushing 2 flushed or observable moistness on
face 3 beads of sweat on brow or face 4 sweat streaming off face Restlessness Observation during
assessment 0 able to sit still 1 reports difficulty sitting still, but is
able to do so 3 frequent shifting or extraneous
movements of legs/arms 5 Unable to sit still for more than a few
seconds
Pupil size 0 pupils pinned or normal size for room
light 1 pupils possibly larger than normal for
room light 2 pupils moderately dilated 5 pupils so dilated that only the rim of the
iris is visible Bone or Joint aches If patient was
having pain previously, only the additional component
attributed to opiates withdrawal is scored 0 not present 1 mild diffuse discomfort 2 patient reports severe diffuse aching of
joints/ muscles 4 patient is rubbing joints or muscles and
is unable to sit still because of discomfort Runny nose or tearing Not accounted
for by cold symptoms or allergies 0 not present 1 nasal stuffiness or unusually moist eyes 2 nose running or tearing 4 nose constantly running or tears
streaming down cheeks
COWS p2 GI Upset: over last ½ hour 0 no GI symptoms 1 stomach cramps 2 nausea or loose stool 3 vomiting or diarrhea 5 Multiple episodes of diarrhea or
vomiting Tremor observation of
outstretched hands 0 No tremor 1 tremor can be felt, but not
observed 2 slight tremor observable 4 gross tremor or muscle
twitching Yawning Observation during
assessment 0 no yawning 1 yawning once or twice during
assessment 2 yawning three or more times
during assessment 4 yawning several times/minute
Anxiety or Irritability 0 none 1 patient reports increasing irritability or
anxiousness 2 patient obviously irritable anxious 4 patient so irritable or anxious that
participation in the assessment is difficult Gooseflesh skin 0 skin is smooth 3 piloerrection of skin can be felt or hairs
standing up on arms 5 prominent piloerrection
Total scores with observer’s initials Score: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal
RRies 2014
COWS scale in fill out form ---download
http://www.naabt.org/documents/cows_induction_flow_sheet.pdf
Medically Supervised Opioid Withdrawal
Methadone substitution and taper- not advised for novice doctors….you have to know methadone half lives and build up
Clonidine -2 adrenergic agonist Acts on autoreceptors in locus coeruleus to
decrease noradrenergic output Major side effect hypotension Push dose until withdrawal sx abate or
diastolic BP <60 Use adjunctive benzodiazepines, anti-
emetics, antidiarrheals
BuprenorphineRRies 2014
Key Medications in Acute Opioid Withdrawal
Buprenorphine/Naltrexone 16 mg x 1 16 mg, 8 mg, 4 mg 16 mg maintenance to outpt
Sedation Gabapentin 400 tid – 800 tid esp if BZPs involved Mirtazapine 7.5 or 14 mg ( more is less sedative) Tizanidine to 4-12 mg tid ( muscle spasm and sedation) Quetiapine 200 - 400 HS esp if agitated/psychotic Olazapine 10 mg hs “ “ “
Autonomic stabilization Clonidine .1 tid to 1 mg tid over time
RRies 2014
Journal of Analytical Toxicology, Volume 27, Number 2 March 2003
Oxycodone Involvement in Drug Abuse Deaths: A DAWN-Based Classification Scheme Applied to an Oxycodone Postmortem Database Containing Over 1000 Cases* Authors: Cone E.J.1; Fant R.V.1; Rohay J.M.1; Caplan Y.H.2; Ballina M.3; Reder R.F.3; Spyker D.3; Haddox J.D.
Of 1014 cases:30 (3.3%) involved oxycodone as the single reported chemical entity; of these,
The vast majority (N = 889, 96.7%) were multiple drug abuse deaths
The most prevalent drug combinations were
oxycodone in combination with benzodiazepines, alcohol, cocaine, other narcotics, marijuana, or antidepressants.
Opioids + Benzos
Short acting Opioid and Long acting Benzo ( Clonazepam or Diazepam) Classic opioid WD, migrating to
hyperadrenergic autonomic + anxiety and possible seizures
Though not published, using combination of Bup + anticonvulsant covers this Gabapentin 400 tid, or 600 tid helps
bothRRies 2014
For those with Severe Opioid Dependence -----Withdrawal only (Detox)
---vs. Maintenance vs----Block ?
Withdrawal Only— High Relapse (90+ % ) whether fast or slow
Detox Relapse incurred Morbidity, Mortality, Cost Not only costly, but ethical?
Maintenance Bup/Ntx- Training certification fits ACO Prim
Care Methadone--- only in Federally certified clinics
Block – Naltrexone Oral– adherence issues, but OK after long term
stabilization Injectable– fits in with “abstinence model”, good at inpt
DC
RRies 2014
Treatment duration (days)
Rem
aini
ng in
tre
atm
ent
(nr
)
Bup
0
5
10
15
20
0 50 100 150 200 250 300 350
Control
Buprenorphine
Treatment Retention and more…
Kakko J et al. Lancet 2003
75% retention
75% UTS negative
20% mortality in placebo group
RRies 2014
RRies 2014
BMJ. 2003 May 3;326(7396):959-60.
Loss of tolerance and overdose mortality after inpatient opiate detoxification: follow up study.Strang J1, McCambridge J, Best D, Beswick T, Bearn J, Rees S, Gossop M.
Med Sci Law. 1990 Jan;30(1):12-6.
Mortality following release from prison.Harding-Pink D.Author information Abstract. The mortality rate during the first year after release was about 5 deaths/1000 person years, a rate over four times the age-adjusted rate in the general population. The majority of deaths were due to overdose by opiate drugs among young, frequently imprisoned drug abusers, and occurred within the first few weeks after release.
Arch Gen Psychiatry. 2011 Dec;68(12):1238-46. Epub 2011 Nov 7.
Adjunctive Counseling during Brief and Extended Buprenorphine-naloxone Treatment for Prescription Opioid Dependence: a 2-phase Randomized Controlled Trial.Weiss RD, Potter JS, Fiellin DA,.
RESULTS:
Phase 1 ( 2 week detox measured at 12 weeks), 6.6% (43 of 653) had successful outcomes -ie 10 weeks after detox
Phase 2 (12 week detox) 49.2% ie end of detox but still on med
Success rates 8 weeks after completing the buprenorphine-naloxone taper (phase 2, week 24) dropped to 8.6% (31 of 360), again with no counseling difference.
.
RRies 2014
Best Treatment by FAR---
• Prevention -- Prevention – Prevention• Avoid Opioids in most non-severe
syndromes• Use Opioids like Steroids…aggressively
with built in short taper for most acute cases
• The US uses more presc opioids than most of the rest of the world combined
RRies 2014
Spine (Phila Pa 1976). 2008 Jan 15;33(2):199-204. doi: 10.1097/BRS.0b013e318160455c.
Early Opioid Prescription and Subsequent Disability among workers with back injuries: the Disability Risk
Identification Study Cohort.Franklin GM1, Stover BD, Turner JA, Fulton-Kehoe D, Wickizer TM; Disability Risk
• To examine whether prescription of opioids within 6 weeks of low back injury is associated with work disability at 1 year.
• Nearly 14% (254 of 1843) of the sample were receiving work disability
• After adjustment for pain, function, injury severity, and other baseline covariates, receipt of opioids for more than 7 days (odds ratio = 2.2; 95% confidence interval, 1.5-3.1) and receipt of more than 1 opioid prescription were associated significantly with work disability at 1 year.
• CONCLUSION: • Prescription of opioids for more than 7 days for workers with acute
back injuries is a risk factor for long-term disability. Further research is needed to elucidate this association.
RRies 2014
RRies 2014
Outcomes: Buprenorphine, Methadone, LAAM:
Treatment RetentionP
erce
nt R
etai
ned
0
20
40
60
80
100
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17
20% Lo Meth
58% Bup
73% Hi Meth
53% LAAM
Study Week
RRies 2014
-10 -9 -8 -7 -6 -5 -40
10
20
30
40
50
60
70
80
90
100
Intrinsic Activity
Log Dose of Opioid
Full Agonist(Methadone)
Partial Agonist(Buprenorphine)
Antagonist (Naloxone)
Intrinsic Activity: Full Agonist (Methadone), Partial Agonist (Buprenorphine), Antagonist (Naloxone)
Naltrexone for Opioid Dependence
Most ideal pharmacologic treatment
Requires complete withdrawal before initiation or severe withdrawal will be precipitated
Requires Naloxone challenge test
Risk of OD if medication stopped
In general poor patient compliance with oral form but superb treatment for selected patients
Now available in long acting injectionRRies 2014
Lancet. 2011 Apr 30;377(9776):1506-13.
Injectable Extended-release Naltrexone for Opioid Dependence: a Double-blind, Placebo-controlled, Multicentre Randomised Trial.Krupitsky E, Nunes EV, Ling W, Illeperuma A, Gastfriend DR, Silverman BL.
FINDINGS: 6 month study of 250 patients randomly assigned to XR-NTX (n=126) or placebo (n=124).
XR-NTX Placebo Inj% Weeks abstinent 90·0% versus 35·0% (p=0·0002)
Opioid-free days 99·2% versus 60·4% (p=0·0004)
Decreased craving –10.1 versus -0.7 (p<0·0001)
Retention days 168 vs 96 days (p=0·0042)
Two patients in each group discontinued owing to adverse events. No XR-NTX-treated patients died, overdosed, or discontinued owing to severe adverse events.
RRies 2014
RRies 2014
12 step facilitation …is a method to help get patients to 12 step meetings and maximize their
benefit Why get people to 12 step meetings?
20-50% of trauma( med-surg) and psychiatric in and outpts will have current, history or episodic substance problems
Substance treatment may be unavailable or even if used, 12 step will likely be involved
Positive effects include not only the group support and socialization, but key psychological/therapeutic content elements.
Addiction is a chronic potentially relapsing disease….Usual TREATMENT is not usually structured for this BUT AA is
RRies 2014
Alcohol Abstinence Rates at 8 Years by Duration of Meeting Attendance in the
First Year
71.3
56.2
42.7
35.3
0
10
20
30
40
50
60
70
80
Per
cent
Abs
tine
nt
Moos, et al., 2004
None 1-16 17-32 33+
Weeks of Participation in AA year 1.
(n = 201) (n = 89) (n = 89) (n = 94)
x 2 = 25.5, p < .01
Best Treatment by FAR--- Prevention -- Prevention –
Prevention
Avoid Opioids in most non-severe syndromes
Use Opioids like Steroids…aggressively with built in short taper for most acute cases
The USA uses more presc opioids than most of the rest of the world combined
RRies 2014