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Prescription Opioids
What we know, what we don’t know and what we don’t
know we don’t know
What we know
• Opioids have characteristics that inherently make them problematic for long term
use. These include risks related to tolerance, sleep disorders, impact on depression
with long term use, hypogonadism, suppression of endogenous endorphins,
increasing risk in patients over 65, increased risk of addiction, difficulty with use in
patients with certain comorbid medical problems (pulmonary, hepatic and
renal),and immunosuppression
• Increasing doses of opioids starting at about 50 mg per day start to dramatically
increase risks. The CDC reports 3 times the risk of overdose (not necessarily
lethal) at doses of 50-99 mg per day and over 11 times the risk of overdose at
doses of 100 mg or more per day when compared to doses less than20 mg per day.
Unfortunately, due to tolerance many patients on chronic opioid therapy do not get
relief at the lower doses over time.
• Population studies have shown from a population perspective that patients with
the same nociceptive pain generators in general do better when not treated with
opioids than when treated with opioids.
• There are currently no randomized, controlled trials of chronic opioid therapy for
more than 3-4 months. In addition, many of the studies excluded patients with the
psychiatric, SUD and medical comorbidities that we see most commonly.
• The risk of addiction is significantly higher than we once though and clinician ability
to predict who is taking their medication as directed is lower than what we once
thought.
April 2001
History of Opioid Addiction/Dependence
Déjà Vu All Over Again
Markel, Howard (2011). An
Anatomy of Addiction: Sigmund
Freud, William Halsted, and the
Miracle Drug Cocaine
• Sixteenth century-the first reports about addiction to opium
throughout Europe, India and China.
• Early 1800s- active ingredient in opium identified, Morphine, named
after the Greek god Morpheus. This was touted as the solution to
Opium Addiction.
• Throughout the early and mid-1800s, morphine was used during
surgical procedures as a general anesthetic and as relief for chronic
pain. By the end of the century there were just as many individuals
addicted to morphine as there were to opium.
• Late 1800s- medical profession’s creation of so many morphine addicts
led to experiments with cocaine as a potential antidote.
• Turn of the nineteenth century –Heroin discovered and felt to be nonaddictive. The Bayer Company started the production of heroin in 1898.
• Over the course of the next century, governments around the world,
would begin to recognize the dangers of heroin, morphine and opium.
Soon these drugs were outlawed for medicinal purposes, and pushed
underground.
• Late nineteenth century Laudanum (a tincture of raw opium in 50
percent alcohol) was prescribed to women complaining of “female
problems”. Epidemiological studies conducted in Michigan, Iowa, and
Chicago between 1878 and 1885 reported that at least 60 percent of the
morphine or opium addicts living there were women.
Markel, Howard (2011). An
Anatomy of Addiction: Sigmund
Freud, William Halsted, and the
Miracle Drug Cocaine
A Brief History of Opioid
Addiction
• Huge numbers of men and children, too, complaining of ailments
ranging from acute pain to colic, heart disease, earaches, cholera,
whooping cough, hemorrhoids, hysteria, and mumps were prescribed
morphine and opium.
• A survey of Boston’s drugstores published in an 1888 issue of Popular
Science Monthly -of 10,200 prescriptions reviewed, 1,481, or 14.5
percent, contained an opiate.
• During this period in the United States and abroad, the abuse of
addictive drugs such as opium, morphine, and, soon after it was
introduced to the public, cocaine constituted a major public health
problem.
• In 1996 Purdue marketed a new opioid formulation felt to be less
addictive than previous formulations and was touted as the new
treatment for chronic pain with minimal side effects and risk of
addiction. The name of that drug was Oxycontin.
Markel, Howard (2011). An
Anatomy of Addiction: Sigmund
Freud, William Halsted, and the
Miracle Drug Cocaine
A Brief History Opioid
Addiction
The NEW ENGLAND JOURNAL of MEDICINE
Flood of Opioids, a Rising Tide of Deaths
• Prescription opioids caused 11,499 of the deaths in 2007 —
more than heroin and cocaine combined
• Admissions to substance-abuse treatment programs increased
by 400% between 1998 and 2008
• Prescription painkillers are the second most prevalent type of
abused drug after marijuana
• In almost every age group, men have higher death rates from
drug overdoses than women
• About half of those who died had a medical history of pain
treatment
n engl j med 363;21nejm.orgnovember 18, 2010
To Summarize
• After 1900 and prior to 1986 Opioids were felt to be neither safe or effective
for chronic pain due to concerns related to tolerance, addiction and side effects
• 1986 to 2010- Opioids touted as safe and effective for chronic pain
• 1996 AAPM issued a consensus statement supporting LTOT Stating that the risk
for de novo addiction was low, respiratory depression induced by opioids was
short lived and was antagonized by pain, tolerance was not common and
efforts to control diversion should not limit opioid prescribing
• 2001 JACO mandates documentation of Pain as the Fifth Vital Sign with strong
recommendations about the use of opioids to address this problem
• 2001 – Media reports surface related to concerns about overdose deaths
supported by data from SAMHSA
• 2003 FSBS strongly urges prescribing opioids in an attempt to improve pain care
• 2010 Prescription overdose deaths nearly doubled between 2001 and 2010
• 2010 NEJM and other Medical Journals start the process of reporting concerns
about growing overdose risks of opioids
• 2010 Original Reports related to opioid safety focused on patients who were
non compliant and/or with addiction problems
• 2012 More journal articles began to focus on risks of opioids related to the
medication and potential medical concerns
The snowball effect of inaction
Characteristics of Patients Who are at Higher Risk for Over Sedation
and
Respiratory Depression
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•
•
•
•
•
Sleep apnea or sleep disorder diagnosis
Morbid obesity with high risk of sleep apnea
Snoring
Older age; risk is
• 2.8 times higher for individuals aged 61-70
• 5.4 times higher for age 71-80
• 8.7 times higher for those over age 80
No recent opioid use
Post-surgery, particularly if upper abdominal or thoracic surgery
Increased opioid dose requirement or opioid habituation
Longer length of time receiving
General anesthesia during surgery
Receiving other sedating drugs, such as benzodiazepines, antihistamines, diphenhydramine,
sedatives, or other central nervous system depressants
Preexisting pulmonary or cardiac disease or dysfunction or major organ failure
Thoracic or other surgical incisions that may impair breathing
Smoker
Joint Commission, Sentinel Event Issue 49, August
8, 2012
Dose-response relationship for
opioids and overdose
1. Cohort study (n=9940, 51 opioid overdoses, 6 fatal)
•
Risk of opioid overdose (vs. 1to <20 mg/day)
o >=100 mg/d:
HR 8.9 (4.0-20)
o 50 -<100 mg/d: HR 3.7 (1.5-9.5)
o 20-<50 mg/d:
HR 1.4 (0.57-3.6)
2. Case-control study (VA, 750 cases)
•
Risk of opioid overdose-related death (vs. 1 to <20 mg/day)
o >=100 mg/d:
HR 7.2 (4.8-11)
o 50-<100 mg/d: HR 4.6 (3.2-6.7)
o 20-<50 mg/d:
HR 1.9 (1.3-2.7)
3. Nested case-control study (Ontario, 498 cases)
•
Risk of opioid-related mortality (vs. 1 to <20 mg/day)
o >=200 mg/d:
OR 2.9 (1.8-4.6)
o 100-199 mg/d: OR 2.0 (1.3-3.2)
o 50-99 mg/d:
OR 1.9 (1.3-2.8)
o 20-49 mg/d:
OR 1.3 (0.94-1.8)
Dunn et al. Ann Intern Med 2010;152:85; Bohnert et al. JAMA 2011;305:1315; Gomes et al. Arch Intern
Med 2011;171:686
12
High Opioid Dose and Overdose Risk
11.18
Adjust ed Hazard Rat
io
10
8
6
3.11
4
2
1.00
1.19
0
1 - 19 mg/d
20 - 49 mg/d
50 - 99 mg/d
≥100 mg/d
Morphine MG Equivalent Dose
* Overdose defined as death, hospitalization, unconsciousness, or respiratory
failure.
Dunn et al. Opioid prescriptions for chronic pain and overdose. Ann Int Med 2010;152:85-92.
Overdose facts
• In 2011, drug misuse and abuse caused about 2.5 million emergency
department (ED) visits. Of these, more than 1.4 million ED visits
were related to pharmaceuticals.
• Between 2004 and 2005, an estimated 71,000 children (18 or
younger) were seen in EDs each year because of medication
overdose (excluding self-harm, abuse and recreational drug use).
• Among children under age 6, pharmaceuticals account for about
40% of all exposures reported to poison centers.
• Health officials using state medical records found that 59 percent of
patients who died of an overdose in Maryland in 2013 had had at
least one hospital or emergency room visit for an overdose in the
previous 12 months. Many of the patients had suffered multiple
overdoses. Some landed in the hospital more than 10 times before
dying.
Overdose Facts
• Deaths from drug overdose have been rising steadily over the past
two decades and have become the leading cause of injury death in
the United States.
• Every day in the United States, 114 people die as a result of drug
overdose, and another 6,748 are treated in emergency departments
(ED) for the misuse or abuse of drugs.
• Nearly 9 out of 10 poisoning deaths are caused by drugs
• Drug overdose was the leading cause of injury death in 2012. Among
people 25 to 64 years old, drug overdose caused more deaths than
motor vehicle traffic crashes.
• Drug overdose death rates have been rising steadily since 1992 with
a 117% increase from 1999 to 2012
Overdose Facts
• In 2012, 33,175 (79.9%) of the 41,502 drug overdose deaths in the
United States were unintentional, 5,465 (13.2%) were of suicidal intent,
80 (0.2%) were homicides, and 2,782 (6.7%) were of undetermined
intent.
• In 2012, of the 41,502 drug overdose deaths in the United States, 22,114 (53%)
were related to pharmaceuticals.
• Of the 22,114 deaths relating to pharmaceutical overdose in 2012, 16,007 (72%)
involved opioid analgesics (also called opioid pain relievers or prescription
painkillers), and 6,524 (30%) involved benzodiazepines. (Some deaths include
more than one type of drug.)
• In 2011, about 1.4 million ED visits involved the nonmedical use of
pharmaceuticals. Among those ED visits, 501,207 visits were related to antianxiety and insomnia medications, and 420,040 visits were related to opioid
analgesics.
• Benzodiazepines are frequently found among people treated in EDs for misusing
or abusing drugs. People who died of drug overdoses often had a combination of
benzodiazepines and opioid analgesics in their bodies.
• In the United States, prescription opioid abuse costs were about $55.7 billion in
2007.7 Of this amount, 46% was attributable to workplace costs (e.g., lost
productivity), 45% to healthcare costs (e.g., abuse treatment), and 9% to
criminal justice costs.
Opioid Overdoses
• Retrospective cohort study of adults with at least 1 ED visit for opioid
overdose between January 1, 2010, and December 31, 2011, derived
from population-based data of State Emergency Department Databases
and State Inpatient Databases for 2 large and diverse states: California
and Florida.
• During a 1-year period, 7% of the patients had frequent (2 or more) ED
visits, accounting for 15% of all opioid overdose ED visits.
• Middle age, male sex, public insurance, lower household income, and
comorbidities (such as chronic pulmonary disease and neurological
diseases) were associated with frequent ED visits
• Overall, 53% of the ED visits for opioid overdose resulted in
hospitalizations; patients with frequent ED visits for opioid overdose had
a higher likelihood of hospitalization
• 10.0 of the ED visits led to near-fatal events; patients with frequent ED
visits had a higher likelihood of a near-fatal event (adjusted odds ratio,
2.27; 95% CI, 1.96-2.66).
• Total charges in Florida were $208 million
CDC 2011
Potential Harms of Opioid Therapy
– More than Just Overdose
Sleep apnea
Worsening of pain
Impaired driving
Tolerance
Withdrawal symptoms
Addiction
Drug interactions
Immune system
changes
• Sleep Impairment
• Dysregulation of the
reward system
• Depression
• Hypogonadism
• Increased fall risk
• Cognitive Impairment
• Birth Defects
• Even in normal individuals, pain and mood are interdependent, in
part through endogenous opioid mechanisms.
• Individuals who are taking exogenous opioids continuously over the
long-term adapt by developing tolerance and dependence.
• Psychological factors can alter tolerance and thereby induce
withdrawal symptoms.
• For the dependent individuals, the need for more opioids becomes
the predominant reaction to stress.
• Although pain is seen as the primary reason to dose escalate, this
pain is augmented by psychosocial stressors
• Dependence on opioid pain treatment is not, as we once believed,
easily reversible; it is a complex physical and psychological state that
may require therapy similar to addiction treatment, consisting of
structure, monitoring, and counseling, and possibly continued
prescription of opioid agonists.
Ballentyne et al ARCH INTERN
MED/VOL 172 (NO. 17), SEP 24,
2012
Interdependence of mood,
tolerance/dependence, and pain.
• Startle response results indicated reduced hedonic response to
natural rewards among patients recently withdrawn from opioids
relative to extended care patients.
• The recently withdrawn patients showed increased activation to pill
stimuli in right dorsolateral prefrontal cortex relative to extended
care patients.
• Cortisol levels were elevated among recently withdrawn patients
and intermediate for extended care relative to healthy controls.
• Actigraphy indicated disturbed sleep between recently withdrawn
patients and extended carepatients; extended care patients were
similar to controls.
• Dorsolateral prefrontal cortex activation to drug and natural reward
cues, startle responses to natural reward cues, day-time cortisol
levels, time in bed, and total time spent sleeping were all correlated
with the number of days since last drug use (ie, time in supervised
residential treatment).
Bunce et al J Addict Med 2014;00:
1–8)
Re-regulation of HPA Axis and Brain
Reward Systems
• 10 individuals with chronic low back pain were administered oral morphine daily
for 1 month.
• High-resolution anatomical images of the brain were acquired immediately
before and after the morphine administration period.
• Regional changes in gray matter volume were assessed on the whole brain using
tensor-based morphometry, and those significant regional changes were then
independently tested for correlation with morphine dosage.
• Thirteen regions evidenced significant volumetric change, and degree of change
in several of the regions was correlated with morphine dosage.
• Dosage-correlated volumetric decrease was observed primarily in the right
amygdala. Dosage-correlated volumetric increase was seen in the right
hypothalamus, left inferior frontal gyrus, right ventral posterior cingulate, and
right caudal pons.
• Follow-up scans that were conducted an average of 4.7 months after cessation
of opioids demonstrated many of the morphine-induced changes to be
persistent
• The results add to a growing body of literature showing that opioid exposure
causes structural and functional changes in reward- and affect-processing
circuitry
.
Younger et al Pain. 2011
Aug;152(8):1803-10
Opioids and Brain MRI
Changes
• Retrospective Analysis of 107 patients examined over a 7 year period
at Massachusetts General Hospital Center for Pain Medicine examined
• 1) the impact of opioid dose adjustment (increase or decrease) on
clinical pain score;
• 2) gender and age differences in response to opioid therapy; and
• 3) the influence of clinical pain conditions on the opioid analgesic
efficacy.
• Found that neither opioid dose increase, nor decrease, correlated with
point changes in clinical pain score in a subset of chronic pain patients
over a prolonged course of opioid therapy (an average of 704 days)
• This lack of correlation was consistent regardless of the type of chronic
pain including neuropathic, nociceptive, or mixed pain conditions.
Neither gender nor age differences showed a significant influence on
the clinical response to opioid therapy in these subjects.
Chen et al J Pain. 2013
Apr;14(4):384-92. doi:
10.1016/j.jpain.2012.12.012.
Opioid Dose Adjustment
Just Because They are Called Pain Medicines Does Not Mean that They are Best for Pain
Opioid Misuse Survey
• 2-hour interviews with 801 patients receiving long-term opioid
therapy
• 26% of patients used opioids for purposeful over sedation
• 39% increased the dose without a prescription
• 8% obtained extra opioids from other doctors
• 18% used opioids for purposes other than pain
• 20% for drank alcohol to relieve pain while on opioids
• 12% hoarded opioid medication
• Use of diverted prescription opioids by adolescents is now among
the most common forms of drug abuse
Fleming MF, Balousek SL, Klessig CL, Mundt MP, Brown DD. Substance
use disorders in a primary care sample receiving daily opioid therapy. J Pain.
2007;8:573-82.
Which Patients with LBP
are Treated with Opioids?
Factors associated with increased likelihood of opioid
prescribing:
o
o
o
o
Greater psychologic distress
Poorer health and unhealthy lifestyles
Use of sedative-hypnotics
Similar factors associated with use of high-dose opioids
Deyo RA et al. J Am Board Fam Med 2011;24:717; Kobus AM et al. J Pain 2012;13:1131
• Observational studies have found that patients using opioids, and
those on higher dose regimens, have poorer functional status and
lower quality of life than patients not using opioids or patients on
low-dose regimens
• Cohort studies of patients on worker’s compensation found that
those using opioids are delayed in returning to work relative to
patients not using opioids and patients receiving higher opioid doses
are also delayed returning to work relative to patients on lower
opioid doses
• Primary care back-pain patients using opioids initially have also been
found to have greater self-reported disability at follow-up after
adjusting for case mix
• Patients receiving rehabilitative services after withdrawing from
opioids have shown improved pain and function
• Evidence suggests that patients with affective illness and other
unfavorable prognostic indicators are more likely to receive COT,
more likely to use opioids for the long term and more likely to
escalate dose
Michael R. Von Korff, Best Practice
& Research Clinical Rheumatology
27 (2013) 663–672
COT Effectiveness
Federation of State Medical Boards 2013
• The decision to begin opioid therapy for chronic pain should be a shared
decision of the physician and patient after a discussion of the risks and a
clear understanding that the clinical basis for the use of these medications
for chronic pain is limited, that some pain may worsen with opioids, and
taking opioids with other substances or certain condition (i.e. sleep apnea,
mental illness, pre-existing substance use disorder) may increase risk
• Risks associated with opioids increase with escalating doses as well as in
the setting of other comorbidities(i.e. mental illness, respiratory disorders,
pre-existing substance use disorder and sleep apnea) and with concurrent
use with respiratory depressants such as benzodiazepines or alcohol.
• Prescribers should be prepared for risk management with opioids in
advance of prescribing and should use opioid therapy for chronic noncancer pain only when safer and reasonably effective options have failed.
Maintain opioid dosage as low as possible and continue only if clear and
objective outcomes are being met.
• When available, the state prescription drug monitoring program should be
checked in advance of prescribing opioids and should be available for
ongoing monitoring.
Patients at Highest Risk of an
Opioid Related Adverse Event
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Patients over 65
Patients on 50 mg of Morphine or equivalent per day
Concomitant use of CNS depressants (especially benzodiazepines)
Presence of significant medical comorbidities
• Patients with underlying lung disease
• Patients with underlying liver disease
• Patients with Sleep Apnea
• Obese Patients
Patients with active or history of substance use disorder (Including Nicotine
Dependence)
Patients with concomitant Mental Health Disorder
Recent initiation of opioids
Multiple opioid prescribers
Aberrant drug related behaviors
Use of methadone
Patients using Cannabinoids (even when legal)
Patients with Nicotine Dependence
Potential Risks for All Patients – Even
Those Perceived to be at Low Risk
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•
•
•
•
•
•
•
•
•
•
•
•
Endocrinopathies – Hypogonadism, Alterations in Growth Hormone
Hyperalgesia
Sleep Apnea
Constipation
Decline in Cognition
Immunosuppression
Respiratory Depression
Increased risk of symptoms of depression, PTSD, anxiety
Decline in functional Improvement
Increased risk of falls
Increased risk for accidents
Chronic Dry Mouth with Increased Risk of Dental Disease
Osteoporosis
• Opioid use was significantly associated with:
• the reporting of severe pain
• poor self rated health
• inactivity during leisure
• unemployment
• higher healthcare utilization
• living alone and
• lower quality of life
• The odds of recovery from chronic pain was decreased
fourfold in individuals using opioids
sjøgren P, Grønbæk m, Peuckmann V, ekholm o. A population-based
cohort study on chronic pain: the role of opioids. clin j Pain 2010;26:763–
9.
Danish Population Studies
What we understand now
• The Centers for Disease Control and Prevention (CDC) has declared that
the United States is in the midst of an epidemic of deaths from
prescription drug overdose
• The CDC reports that drug overdose, particularly due to the increase in
nonmedical use of prescription pain relief (opioid) drugs, is the leading
cause of deaths from unintentional injuries in the United States, now
exceeding deaths from Motor Vehicle Accidents
• FROM 1999 TO 2010 THE NUMBER OF PEOPLE IN the United States
dying annually from opioid analgesic–related overdoses quadrupled,
from 4,030 to 16,651.1
• Opioid dependence is much more common than previously believed
and has been estimated to affect more than one-third of patients with
chronic pain
• Newly prescribed opioids after short-stay surgery are associated with a
44% increase in risk of becoming a long-term opioid user within 1 year
What we understand now
• Evidence of long-term efficacy for chronic non-cancer pain (≥16 weeks) is
limited and of low quality
• With daily opioid use, physical dependence and tolerance can develop in
days or weeks
• Successfully tapering chronic pain patients from opioids can be difficult –
even for patients who are motivated to discontinue opioid use
• Estimates vary. Between 4% and 26% of patients receiving COT have an
opioid use disorder. Among patients without an opioid use disorder, more
than one in ten misuse opioids by: intentional over-sedation; concurrently
using alcohol for pain relief; hoarding medications; increasing dose on their
own; and borrowing opioids from friends.
• No randomized trials show long-term effectiveness of high opioid doses for
chronic non-cancer pain. Many patients on high doses continue to have
substantial pain and related dysfunction.
• Higher doses come with increased risks for adverse events and side effects
including overdose, fractures, hormonal changes, and increased pain
sensitivity
What we understand now
• Increased opioid prescribing resulted in 423% inflation‐adjusted increase
in expenditures for chronic back pain
• ‐ >50% of regular prescription opioid users have LBP
• Factors associated with increased likelihood of opioid Prescribing –
Opioids and adverse selection
•
•
•
•
Greater psychologic distress
Poorer health and unhealthy lifestyles
Use of sedative‐hypnotics
Patients with addiction (including nicotine dependence)
• Effects on function not consistently demonstrated in randomized trials
• Some observational studies suggest opioid use associated with poorer functional
outcomes
• Opioid use in acute LBP associated with poorer functional outcomes and
subsequent long‐term use
• Data indicate use of opioids related in part to presence of psychosocial
factors that put patients at increased use for adverse opioid‐related drug
events
Deyo RA et al. J Am Board Fam Med 2011;24:717; Kobus AM et al. J Pain 2012;13:1131
The costs of inaction
• More Hospitalizations
• US ED costs for opioid related visits (other than heroin) 299,498 in 2004 and 885,348 in 2013
• More Legal Expenses
• More Workplace Costs
• Workman’s Comp Insurance Claims without opioid use $13,00; cost with short acting opioid
$39,000; cost with long acting opioid $117,000
• The Cost of Overdoses
• In 2009, total costs of opioid overdoses were estimated at approximately $20.4 billion with
indirect costs constituting 89% of the total.
• Direct medical costs were approximately $2.2 billion. ED costs and inpatient costs were
estimated to be $800 million and $1.3 billion, respectively.
• Absenteeism costs were $335 million and lost future earnings due to mortality were $18.2
billion.
NY Times The Soaring Cost of the
Opioid Economy June 2013
• More Pills, More Business
• In 2013, workers’ compensation insurers in California will spend about $100 million on
tests, up 200-fold since 2002
• Screening Industry in the US $800 million in 2000, $ 2 billion in 2013
Opioid Costs in the US
• ED – Cases in which an opioid other than heroine was cited as a
reason for an ED visit
• 2004 - 299,498
• 2011- 885,348
• Without Opioids - $13,000
• With Short Acting Opioids - $39,000
• With Long Acting Opioids - $117,000
• Between 2001 and 2008, opioid prescriptions as a share of all
drugs used to treat workplace injuries jumped 63 percent
• In California, workplace insurers spent $252 million on opioids in
2010, which represented about 30 percent of all prescription
costs; in 2002, opioids accounted for 15 percent of drug
expenditures
Meier and Marsh, NY Times June
22, 2013
• Average Workman’s Comp Costs
What we don’t know
• Is there a subset of patients in whom opioid therapy when added to a multimodality
treatment plan as part of their pain care that will do better with opioids added to
that plan rather than if they were prescribed non opioids for pain and multimodality
care in the first place? (All of the studies on opioids use placebo as their control and
do not use other care modalities)
• Do patients on opioids have an increased or decreased tendency when taken as a
group to improve function and participate in other aspects of care when compared
to similar patients when treated with non opioid modalities only?
• Now that we have so many patients on high dose opioid therapy what is the best
approach to improving safety and effectively treating their pain?
• Now that we have so many patients on benzodiazepines and opioids should our
focus be on new starts mainly or is it possible to slowly tackle the patients on this
combination in a slow but steady process of getting them on a better regimen
• What is the cost differential between a non opioid approach to pain and an opioid
approach. Using opioids has turned out to be very expensive without a very good
“bang for our buck” relative to effectiveness and safety.
• Almost all of the randomized trials of opioids for chronic noncancer
pain were short-term efficacy studies.
• Critical research gaps on use of opioids for chronic noncancer pain
include:
• lack of effectiveness studies on long-term benefits and harms of
opioids (including drug abuse, addiction, and diversion);
• insufficient evidence to draw strong conclusions about optimal
approaches to risk stratification, monitoring, or initiation and
titration of opioid therapy; and
• lack of evidence on the utility of informed consent
and opioid management plans, the utility of opioid rotation, the
benefits and harms specific to methadone or higher doses of
opioids, and treatment of patients with chronic noncancer pain at
higher risk for drug abuse or misuse.
• Currently, clinical decisions regarding the use of opioids for chronic
noncancer pain need to be made based on weak evidence
Chou et al Pain 2009
Feb;10(2):147-59.
Research gaps on use of opioids for
chronic noncancer pain
• a. In patients with chronic pain, what is the effectiveness of long-term opioid
therapy versus placebo or no opioid therapy for long-term (>1 year) outcomes
related to pain, function, and quality of life?
• b. How does effectiveness vary depending on: 1) the specific type or cause of
pain (e.g., neuropathic, musculoskeletal [including low back pain], fibromyalgia,
sickle cell disease, inflammatory pain, and headache disorders); 2) patient
demographics (e.g., age, race, ethnicity, gender); 3) patient comorbidities
(including past or current alcohol or substance abuse and related disorders,
mental health disorder and those at high risk for addiction and medical
comorbidities)?
• c. In patients with chronic pain, what is the comparative effectiveness of opioids
versus non-opioid therapies (pharmacological or non-pharmacological) on
outcomes related to pain, function, and quality of life?
• d. In patients with chronic pain, what is the comparative effectiveness of opioids
plus non-opioid interventions (pharmacological or non-pharmacological) versus
opioids or non-opioid interventions alone on outcomes related to pain, function,
quality of life, and doses of opioids used?
Questions asked by the Agency for
Healthcare Research and Quality
Effectiveness and Comparative
Effectiveness
Opioid Effectiveness and Risk
• For effectiveness and comparative effectiveness, we identified no
studies of long-term opioid therapy in patients with chronic pain versus
no opioid therapy or nonopioid alternative therapies that evaluated
outcomes at 1 year or longer
• No studies examined how effectiveness varies based on various factors,
including type of pain and patient characteristics. Most placebocontrolled randomized trials were shorter than 6 weeks in duration and
no cohort studies on the effects of long-term opioid therapy versus no
opioid therapy on outcomes related to pain, function, or quality of life
were found.
• Regarding harms, new evidence from observational studies suggests
that being prescribed long-term opioids for chronic pain is associated
with increased risk of abuse, overdose, fractures, and myocardial
infarction, versus not currently being prescribed opioids.
• In addition, several recent studies suggest that the risk is dosedependent, with higher opioid doses associated with increased risk.
Opioid Effectiveness and Risk
• Rates of opioid abuse were 0.6 percent to 8 percent and rates of
dependence were 3.1 percent to 26 percent in primary care settings,
and rates of abuse were 14.4 percent, misuse 8 percent, and
addiction 1.9 percent in pain clinic settings
• Rates of aberrant drug-related behaviors (e.g., positive urine drug
tests, medication agreement violations) ranged from 5.7 percent to
37.1 percent
• Opioids were associated with overdose, increased risk of fracture,
myocardial infarction and use of testosterone replacement or
medications for erectile dysfunction versus no opioid use
• In patients with chronic pain prescribed long-term opioid therapy,
observational studies reported an association between higher doses
of opioids and risk of abuse, overdose, fracture, myocardial
infarction, motor vehicle accidents, and use or testosterone
replacement or medications for erectile dysfunction
Evidence for safety and
effectiveness of opioids
• Most clinical and policy decisions regarding use of long-term opioid
therapy must necessarily still be made on the basis of weak or
insufficient evidence.
• This is in accordance with findings from a 2009 U.S. guideline on use of
opioids for chronic pain, which found 21 of 25 recommendations
supported by only low-quality evidence,105 and a 2010 Canadian
guideline,106 which classified 3 of 24 recommendations as based on
(short-term) randomized trials and 19 recommendations as based solely
or partially on consensus opinion. Although randomized trials show
short-term, moderate improvements in pain in highly selected, low-risk
populations with chronic pain, such efficacy-based evidence is of limited
usefulness for informing long-term opioid prescribing decisions in
clinical practice.
• Evidence on long-term opioid therapy for chronic pain is very limited,
but suggests an increased risk of serious harms that appears to be dosedependent. Based on our review, most clinical and policy decisions
regarding use of long-term opioid therapy must necessarily still be made
on the basis of weak or insufficient evidence
What we don’t know we don’t
know
• How can we look at the contributions of the system to our current
dilemma. Currently care is delivered in a siloed approach that interferes
with the collaboration necessary to treat patients with chronic pain?
• Is the solution that we need more pain specialists and/or to give
primary care clinicians the time and space that they need to do what
they do best (teach about disease self management, case management,
safe medication prescribing, and careful selection of tests and referrals).
Many patients with chronic pain can be well cared for in primary care if
clinicians are given enough time per visit, visits per year and ability to
coordinate care and develop the needed patient clinician relationship.
• If opioids are used the issue of addiction and dependence for some
patients must be part of the treatment plan. What is the best solution to
this. The literature shows that patients with Opioid SUD don’t do well
without some type of medication assisted treatment offered.
• What is the cost effectiveness of offering some type of cbt (even if it is in
groups) to all patients with chronic pain. This may prevent a lot of the
problems that we are facing now.
• How do we turn this around with what we have and our current limited
resources?
The Perfect Storm - 1986-2010
• Pain as the Fifth Vital Sign
• Pharmaceutical Company development of newer Opioids with touted less
risk along with pharmaceutical company money for provider education
• Managed Care with
• The shrinking of primary care reimbursement and time spent per
patient
• Lack of funding for substance abuse treatment
• Lack of funding for a biopsychosocial approach to pain with limitations
on PT, CBT and care coordination
• Minimal training of health care providers in pain and addiction
• The transition from the information age to the age of too much
information – desensitizing patients and providers to risks
• U.S. = 4.6% of Worlds Population
Uses 80% of Global Opioid Supply
Uses 99% of world’s hydrocodone
402% increase in Rx of opioids
Challenge:
Principles for all chronic noncancer pain patients
• 1. Self-care is the foundation for effective chronic non-cancer pain care –
Patient efforts to remain active and sustain rewarding life activities usually
matter more than treatments prescribed for chronic pain.
• 2. Your relationship with the patient supports effective self-care – Listening,
empathy, and encouraging patients to remain active and sustain rewarding life
activities characterizes excellent care for patients with chronic pain.
• 3. Guide care by progress toward resuming activities – To track outcomes, have
patients rate their ability to participate in rewarding life activities that pain
makes difficult on a 0–10 scale (where 0 is “no difficulty” and 10 is “extreme
difficulty”). 4. Prioritize long-term effectiveness over short-term pain relief –
Differentiate treatments offered for short-term pain relief from steps patients
take to resume activities. Short-term pain relief can be helpful, but long-term
benefits of medications for chronic non-cancer pain are often modest, and
risks may outweigh potential benefits.
Don’t forget about lifestyle changes
Principles when considering longterm use of opioids
• 1. Put patient safety first – Find common ground with patients by
emphasizing their safety.
• 2. Think twice before prescribing long-term opioids for axial low back
pain, headache and fibromyalgia – The long-term benefits of opioids for
these conditions are unproven, while risks of addiction, overdose and
other serious adverse effects are significant.
• 3. Systematically evaluate risks – Do not consider a therapeutic trial of
opioids for chronic non-cancer pain before assessing risks of opioid
misuse and abuse by taking a thorough history, reviewing the medical
record, and checking Prescription Drug Monitoring Program data.
• 4. Consider intermittent opioid use – Continuous use of long acting
opioids has not been proven more effective or safer than intermittent
use of short-acting opioids
• 5. Do not sustain opioid use long-term without decisive benefits – Initial
evaluation of long-term opioid use should be based on a therapeutic
trial lasting no more than 90 days, preferably less
• 6. Keep opioid doses as low as possible – Reaching doses of 50–100 mg
morphine equivalents or higher should trigger reevaluation of the
therapy.
• Pain is time limited related solely to tissue damage. The patient is a
passive participant in their care. Biomedical Models for pain care
have led to
• (1) an expensive search for pain-generating lesions;
• (2)successive referrals to specialists trained in ‘‘hunt and cure’’
pain management ,the sequential care model
• (3) exposure to invasive procedures, increasing the risk for falsepositive results or a complication, such as failed low back surgery
syndrome, inattention to pain control while seeking nociceptive
cause, and initiating a cascade of neurochemical processes
resulting in peripheral and central sensitization, neuronal
plasticity, kindling, cortical reorganization, spontaneous pain,
psychological trauma, and emotional scarring
• (4) Greater use of opioids, interventions, procedures and surgery
Gallagher, Phys Med Rehabil Clin N
Am
15 (2004) 855–882
Biomedical Model for Pain
The negative impact of a biomedical approach
to disease
• A biopsychosocial approach to disease in which an
understanding of the psychosocial impact of a patient’s life is
important in almost every disease that we treat
•
•
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Pain
Diabetes
Hypertension
Heart Disease
Cancer
Psychiatric Problems
Substance Use Disorder Problems
• Deconditioning and postural changes leading to
musculoskeletal pain and new pain generators
• Central nervous system changes, such as sensitization and
kindling, leading to emotionally augmented pain
• Medication side effects and toxicity
• Family role change, sexual dysfunction, marital distress, and
divorce
• Psychological distress and dysfunctional coping
• Compromised job performance, job stress, or job loss
• Financial strain and loss of health insurance
• Psychiatric comorbidity, including depression, suicide, and
violence
Gallagher Phys Med Rehabil Clin N
Am
15 (2004) 855–882
Biopsychosocial consequences of
pain
BIOPSYCHOSOCIAL MODEL OF PAIN
BIOMEDICAL
- Pathology
- Injury
- Nociception
SOCIOCULTURAL
- Age, Sex, Race
- Income, Education
- Social Milieau
PSYCHOLOGICAL
- Anxiety, Depression
- Cognitive Factors
- Behavioral Factors
• The Brain receives and sends information related to pain. A two way street
• The brain changes constantly in response to injuries, disease, traumatic events,
stress, thoughts, beliefs, memories, pleasant and painful stimuli
• Neuroplastic Transformation
• What We Fire We Wire
• In Chronic Pain the brain is wired to turn pain on even if the injury has
subsided
• What we don’t use we lose
• When we make them we break them. When we break them, we make them.
• Developing multiple strategies for counter stimulation of the brain provides
ways to create new pathways to “turn down” the painful perceptions
• Deconditioned brains like deconditioned muscles increase susceptibility to
pain
Moskowitz and Golden
Neuroplastic Transformation
Neuroplasticity and Chronic Pain
How do Opioids Impair
Neuroplasticity
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Hypogonadism
Impact on Glial Cells
Cognitive Impairment that may impact learning
Suppression of endogenous endorphins
Creation of a “fix me” environment in which the patient is invested in
passive cure
Negative impact on sleep
Increased risk of opioid induced depression
Worsening of underlying mental health concerns
Increased Risk of SUD
Withdrawal symptoms exacerbating end of dose failure symptoms
Focus on medication needs as dependence occurs
• Patients aged >18 addressed to exercise therapy for persisting LBP.
Methods: The individually designed physiotherapy program provided 7
sessions patients were given advice to stay active and continue exercise
program on discharge.
• Aim: To identify predictors of functional outcome on discharge and at 1
year
• The primary outcome measure was the Roland and Morris Disability
Questionnaire (RMDQ) patients scoring improvement >30% were
classified as respondent. NRS Pain Score was also measured
• Results: 211 participated in the program, Average RMDQ score was
reduced by 35% at T1 and by 31% at T2; NRS by 28% (T1) and 24% (T2);
125 patients (59%) were responders on discharge; 106 (50%) at followup
• Only severe pain intensity predicted poor treatment response on
discharge. At one year, younger age and better mental health predicted
improved outcome, while use of drugs and previous LBP treatments
were associated with worse response. Adherence to the exercise
program almost doubled the probability of a favorable outcome
Cecchi et al Eur J Phys Rehab Med
1/6/14
Exercise and Chronic Back Pain
Exercise is important for everyone
Elements of Cognitive Behavioral Therapy
• Education
• Self Management Techniques
• Help patients focus on increasing physical functioning and management
of their pain rather than expecting a cure
• Teaching biofeedback, relaxation, and stress management techniques
• Providing patients with coping skills in other areas, such as with
interpersonal problems, work related problems and relationship
problems
• Emphasize to patients the importance of identifying and then
modifying maladaptive thoughts about pain
• Provide patients with guidance about increasing activities of daily living
with appropriate pacing activities
• Provide help to improve sleep
• Review the appropriate use of potential pharmacologic and non
pharmacologic modalities
• Assist patients with proper goal setting
• Provide relapse prevention strategies
CBT Studies Demonstrate
Improvement In
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Pain Intensity and Interference
Perceived Disability
Depression
Pain Catastrophizing
Life Satisfaction
Principles for more selective and cautious opioid
prescribing
Principles for patients using opioids long-term
• 1. Clearly communicate standardized expectations to reduce
risks – Opioids have important hazards for patients, for family
members, and for the community..
• 2. Adhere to recommended precautions – Close and sustained
monitoring of COT is the standard for care.
• 3. Avoid prescribing opioids and sedatives concurrently –
Concurrent use of opioids and other CNS depressants
increasesrisks of overdose and other adverse effects.
• 4. Revisit discontinuing opioids or lowering dose – Regularly
reassess whether doses can be reduced or opioids
discontinued entirely
• 5. Identify and treat prescription opioid misuse disorders –
When identified, patients with prescription opioid abuse or
addiction should be treated rather than discharged from care.
Opioid Addiction/Dependence
• Neuroadaptations that arise when exogenous opioids are taken
continuously and long-term.
• Tolerance and dependence are 2 such central adaptations.
• Tolerance is the need to increase dose to achieve the same effect.
• Dependence is the physiologic response either to an
uncompensated increase in tolerance or to the withdrawal of a drug.
• Tolerance may develop for both the euphoric and the analgesic
effects of opioids and can be produced by psychological as well as
pharmacological factors.
• Dependence is manifest as withdrawal symptoms (eg, sweating,
anxiety, insomnia) that are caused by rebound at central
noradrenergic nuclei, and the less well understood effects of
hyperalgesia (increased pain sensation) and anhedonia (inability to
feel pleasure).
Addiction
• In CNCP, rates were believed to be 2-
18%.
• July 2011 study assessed rates of opioid
abuse/dependence using both DSM-IV
and proposed DSM-V criteria in CNCP:
35%
Boscarino JA, Rukstalis MR, Hoffman SN. Prevalence of prescription opioid-use disorder among chronic pain patients: comparison of the DSM-5 vs. DSM-4 diagnostic criteria.
Jour of Add Dis 2011;30:185-94.
Total cost to society (billions of dollars) at each percentage of additional
people treated for opioid dependency
5
10 25 50
28.6 28.4 28 27.3 25.9
0
5
Source: New England Comparative
Effectiveness Public Advisory
Council
0
DSM V - Opioid SUD Need at least 2
• 1. Uses more than intended, or for longer than intended
• 2. Efforts to control or cut back when needed have been unsuccessful
• 3. Large amounts of time are spent obtaining, using, or recovering from
opioid use
• 4. Cravings (this symptom may be present even after remission)
• 5. Recurrent use resulting in problems at work, home, or school
• 6. Continued use despite recurrent social or interpersonal problems
resulting from opioid use
• 7. Curtailing important activities in favor of opioid use
• 8. Opioid use despite potentially hazardous outcomes
• 9. Continued opioid use despite knowledge that its use is causing or
exacerbating a persistent physical or psychological problem
• 10 Tolerance or a need for increased amounts of opioid
• 11. Withdrawal symptoms
DSM V
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Early Remission – 3-12 months
Sustained Remission – Greater than 12 months
Mild – 2-3 symptoms
Moderate 4-5 symptoms
Severe – 6 or more symptoms
• Each Psychiatric Diagnosis includes Substance/Medication induced
category with specifications related to whether onset is during
intoxication or withdrawal
ASAM Short Definition of
Addiction
• Addiction is a primary, chronic disease of brain reward, motivation,
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memory and related circuitry.
Dysfunction in these circuits leads to characteristic biological,
psychological, social and spiritual manifestations.
This is reflected in an individual pathologically pursuing reward and/or
relief by substance use and other behaviors.
Addiction is characterized by inability to consistently abstain,
impairment in behavioral control, craving, diminished recognition of
significant problems with one’s behaviors and interpersonal
relationships, and a dysfunctional emotional response.
Like other chronic diseases, addiction often involves cycles of relapse
and remission.
Without treatment or engagement in recovery activities, addiction is
progressive and can result in disability or premature death.
Very Short Definition
•
•
•
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•
Addiction is characterized by
Inability to consistently Abstain
Impairment in Behavioral control
Craving; or increased “hunger” for drugs or rewarding experiences
Diminished recognition of significant problems with one’s behaviors
and interpersonal relationships
• Dysfunctional Emotional response.
Opioid Withdrawal
Tachycardia
Sweating
Restlessness
Bone or Joint aches
Runny nose or tearing
GI Upset
Tremor
Yawning
Anxiety or Irritability
Gooseflesh skin
Craving
76
Addiction treatment and a
biopsychosocial approach to pain
go hand in hand – body – education
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Pain and addiction triggers
The role of diet
The role of exercise
The role of pacing activities
Safe Medication Use
Education about the role of Dopamine, Serotonin,
Norepinephrine and Endorphins in recovery
Addiction treatment and pain treatment
go hand in hand - Spirit
Reduce sadness,helplessness
Information about pain and addiction
Prayer,meditation
Meaningful rituals
Spiritual healing
Support groups
Addiction treatment and pain treatment
go hand in hand - Mind
Sleep hygiene
Relaxation, imagery
Self hypnosis
Pain diary, journaling
Distraction
Repattern thinking
Attitude adjustment
Reduce fear, anxiety, stress
Addiction Treatment and Pain Treatment
Go Hand in hand - Social Interactions
Functional restoration
Improved communication
Family Interaction
Problem Solving
Vocational Training
Volunteering
Support Groups
Treating Addiction
• Responds like all other chronic diseases
• Discontinuation of treatment increases risk of relapse
• Relapse prevention and treatment is part of addiction
treatment
• Addiction treatment involves the involvement of multiple
brain circuits
• Reward, motivation, learning, inhibitory control, and executive
function
• Treatment can involve Pharmacologic as well as Cognitive
Behavioral Intervention. However, even when medication is
used a comprehensive cognitive behavioral approach is
important for success
8
1
Characteristics of Medications for Opioid-Addiction Treatment.
VolkowND etal.N EnglJMed2014;370:2063-2066.
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Improve survival
Increase retention in treatment
Decrease illicit opioid use
Decrease hepatitis and HIV seroconversion
Decrease criminal activities
Increase employment
Improve birth outcomes
SAMHSA
MAT outcomes
Benefits of Action
• A study of heroin-overdose deaths in Baltimore between 1995 and
2009 found an association between the increasing availability of
methadone and buprenorphine and an approximately 50% decrease
in the number of fatal overdoses.
Schwartz RP, Gryczynski J, O’Grady KE,
et al. Opioid agonist treatments and heroin
overdose deaths in Baltimore, Maryland,
1995-2009. Am J Public Health 2013;103:917-
Pharmacotherapy for Substance
Use Disorders
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Improves Survival
Increases retention in treatment
Decreases illicit opioid use
Decreases hepatitis and HIV seroconversion
Decreases criminal activities
Increases employment
Improves birth outcomes with perinatal substance users
Neurobiology: Methadone
• Blocks the euphoric and sedating effects of other
opioids
• reduces withdrawal symptoms and the craving for
other opioids
• Allows a person to participate in normal daily
activities
• Has a long half life and is excreted slowly allowing
for once a day dosing to prevent withdrawal and
craving
• Has a shorter half life for pain control making once
a day dosing more difficult for patients with chronic
pain.
• High doses may be associated with hyperalgesia
Methadone Treatment
• Methadone maintenance treatment: a treatment
program in which patients with opioid SUD receive
daily doses of methadone.
• Multi-component treatment program
− Encourages abstinence from other drugs of
abuse including alcohol
− Resocialization – Sober supports
− Vocational training
− Coordination of healthcare
• HIV
• Hepatitis C
• Pregnancy
• reduced or stopped use of injection drugs;
• Reduced risk of acquiring or transmitting diseases such as HIV,
hepatitis B or C, bacterial infections, endocarditis, soft tissue
infections, thrombophlebitis, tuberculosis, and STDs;
• possible reduction in sexual risk taking
• reduced risk of overdose
• reduced mortality – the median death rate of opiate-dependent
individuals in MMT is 30 percent of the rate of those not in MMT;
• reduced criminal activity;
• improved family stability
• Improved employment potential;
• improved pregnancy outcomes
cdc
Methadone Treatment
benefits
Methadone Treatment
• Drawbacks
− Physical dependence, possibly strengthening
neurobiological adaptation to opiate dependence.
− Daily administration at a licensed methadone treatment
center is required
− Early mild to moderate opioid like effects; e.g. sedation,
reduction in cognitive awareness
− Long term maintenance effects on hormonal adaptations;
reductions in testosterone, menstruation, calcium
metabolism, opioid hyperalgesia
− Drug/drug interactions
− Neonatal abstinence syndrome in babies born to
methadone-maintained mothers
Neurobiology: Naltrexone
• Naltrexone, an opiate antagonist.
− Binds to the opiate receptor without activation
• Available as both oral and injectable formulations.
− Oral typically daily administration, however may be given
on a three times per week schedule (Monday: 100 mg –
Wednesday: 100 mg – Friday: 150 mg)
− Injectable form is given once monthly.
• Evidence of reduction in opioid craving through a
combination of;
− Reduced opioid receptor activation due to partial
endorphins blockade
− Total blockade reducing initial consideration of opioid use.
• Injectable product resulting more positive results
Naltrexone Treatment
Drawbacks
• Blockade of opioid receptors interferes with
opiate analgesia
• Opioid dependent patients must be detoxified
from opioids before naltrexone can be started
• Compliance is the major drawback to the oral
product.
• Injectable requires continued patient compliance
after detoxification until administration.
Neurobiology: Buprenorphine
• Opioid Partial agonist
− High affinity for mu opioid receptor
− Slow dissociation from receptor
− Displaces other opioids from mu receptor
including Heroin
− Improved safety profile due to reduction in
potential respiratory depression
Buprenorphine Treatment
• Approved for office based treatment
• Opioid partial agonist properties reduce potential for overdose
• Once a day administration for patients with opioid SUD
without pain
• Split dosing may be necessary for patients with chronic pain
• Fewer drug interactions described than for methadone
currently
• Relative blocking of other opioids
• Significant reduction in craving
• Improved reentry into normal socialization
• Helps to shift from drug abusing behavior to normal life
activities
Buprenorphine Treatment
• Drawbacks
− Physical dependence, possible strengthening of
the opioid dependence
− Potential diversion for abuse
− Reduces the patients drive to put in place relapse
prevention behaviors due to the pharmacologic
reduction in the drive to use other opioids.
− There is evidence of both neuronal and hormonal
adaptation.
Neonatal abstinence syndrome can occur in
babies born to mothers maintained on
buprenorphine though less than that seen in the
methadone treated patient.
Treatment Selection
− Lack of access to a methadone treatment center has been a
major limitation to this form of treatment
− Buprenorphine has limitations in access due to a lack of
waivered physician availability though office based treatment
has improved treatment access in rural areas in particular.
− Does a physician prescribing buprenorphine / naloxone have
access to assistance with drug counseling in their community
− Need for detoxification from opiates prior to the administration of
naltrexone. Can be a challenge due to relapse potential in the
period following last dose of opioid and time necessary for opioid
to be eliminated and physical dependence to resolve.
Pcss-o
• Logistical considerations
Treatment Selection
 Naltrexone
 For the patient currently abstinent with history of frequent relapse,
opiate craving
• Not anticipating surgical or other treatment, likely to need opioid
analgesia.
• Available if the physician is not waivered to provide office based
treatment of opioid dependence.
 Methadone
• Requires Access to a MMT treatment program
• Better for patient in need of greater supervision
 Buprenorphine
• Opportunity for coordination with other services both medical and
psychiatric.
• Concurrent chronic pain treatment
• Requires
• Access to waivered physician
• Access to relapse prevention treatment to be provided
simultaneously with buprenorphine / naloxone treatment.
Cost
• Comparison of medication assisted treatment vs. no
medication for inpatient, outpatient, and pharmacy costs
− 29% lower for patients who received a medication for opioid
dependence versus patients treated without medication.
• Injectable sustained release naltrexone had fewer opioidrelated and non–opioid-related hospitalizations than patients
receiving oral medication.
• Total healthcare costs were not significantly different between
oral or injectable naltrexone and buprenorphine/ naltrexone
and were 49% lower than those for methadone.
Baser, AJ of Managed Care, 2011
Non Medically Assisted
Opioid Treatment
• Abstinence remains an option particularly in
the young person or those with a low level of
dependence.
• However:
− There is strong evidence of improved outcomes
with medication assisted maintenance treatment
− Patients should be made aware of their options
− Treatment providers should be aware of these
medications to better educate patients and make
appropriate treatment recommendations.
Barriers to treatment
• utilization-management techniques such as limits on dosages
prescribed, annual or lifetime medication limits, initial
authorization and reauthorization requirements, minimal
counseling coverage, and “fail first” criteria requiring that
other therapies be attempted first
• MAT has been shown to prevent relapse and death but is
strongly discouraged by lifetime limits
• State health officials hope to curb overdose deaths by using hospital data
to target patients who have been admitted for previous overdoses but
survived.
• The state Department of Health and Mental Hygiene announced plans
Monday to offer rehab services and drug education to these patients —
many of whom are expected to wind up in the hospital again. Doctors
could also prescribe patients with the drug naloxone, an overdosereversing drug.
• Health officials using state medical records found that 59 percent of
patients who died of an overdose in Maryland in 2013 had had at least
one hospital or emergency room visit for an overdose in the previous 12
months. Many of the patients had suffered multiple overdoses. Some
landed in the hospital more than 10 times before dying.
Baltimore Sun
Why do we wait for an Overdose to
offer Treatment
Lessons Learned
• VA/DOD. FDA, CDC, IOM, FSB, ACP, JACO, AAPM, APS have all revised
recommendations regarding Chronic Opioid Therapy
• Some recommendations include the complex nature of chronic pain
• Others focus on patient selection, opioid formulation, and screening for
aberrant drug taking aberrant behavior without further addressing the
biopsychosocial complexities of chronic pain etiologies and treatment
options
• Studies also demonstrate the risks and overuse of inpatient opioid therapy
• The cost ineffectiveness of opioid therapy raises concerns of increased costs
of care when patients are given opioids in addition to concerns about safety
and efficacy
• 50% decrease from 2009 to 2010 in number of opioid‐related deaths in the
State of Washington once dose limits in primary care established. Decline in
percentage of Workers Comp patients remaining out of work also declined
• Treatment for Opioid SUD is effective and cost effective when made
available. This needs to be tackled at the local, state and national level for
there to be succes.