Transcript Aberrant Drug-Taking Behavior

Risk Management and
Documentation: The Critical
Step in Successful Chronic
Opioid Therapy Management
Steven Stanos, DO
© 2005 Rehabilitation Institute of Chicago
© 2005 Rehabilitation Institute of Chicago
TOLERANCE
and
DEPENDENCE
© 2005 Rehabilitation Institute of Chicago
X
=
ADDICTION
Volkow ND. In: Madras et al. eds. Cell Biology of Addiction, 2006.
© 2005 Rehabilitation Institute of Chicago
“Pseudoaddiction”
Inadequate Pain Management
FRUSTRATION
ANGER
PATIENT
TEAM
ISOLATION
AVOIDANCE
CRISIS
© 2005 Rehabilitation Institute of Chicago
Weissman,Haddox,
Pain (1989)
Addiction
“A primary, chronic neurobiological disease
with genetic, psychosocial and
environmental factors influencing its
development and manifestation”
Savage SR, et al. J Pain Symptom Manage, 2003:26:655-67
© 2005 Rehabilitation Institute of Chicago
Exposure to Chronic Opioid Analgesic
Therapy (COAT):
• Reported incidence: 3.3%
• CPPs with no previous or current history of
abuse or addiction: 0.19%
• Abuse Addiction Group: 3.3%
• Incidence of aberrant behavior: 11%
• Urine Tox Screens: 20% no opioid and/or nonprescribed substance in urine
• Illicit substances: 14%
Fishbain DA, et al. Pain Medicine 2008;9:4.
© 2005 Rehabilitation Institute of Chicago
© 2005 Rehabilitation Institute of Chicago
The Facts:
Sources of Analgesics Used Nonmedically1
• 70% of opioids used by nonpatients are obtained from
friends or family members
1. Office of Applied Studies, Substance Abuse and Mental Health Services Administration (SAMHSA). Results from the 2007 National Survey on
Drug Use and Health: National Findings. 2008.
© 2005 Rehabilitation Institute of Chicago
Prescription Analgesics:
Lifetime Nonmedical Opioid Use1
Lifetime Nonmedical Users of
Prescription Pain Relievers, millions
Methadone
0.9
Ultram®
1.0
Dilaudid®
1.1
OxyContin®
1.9
Morphine
2.1
Demerol®
2.9
Hydrocodone
4.5
Codeine
6.9
9.7
Percocet®, Percodan®, or Tylox®
13.1
Vicodin®, Lortab®, or Lorcet®
18.9
Darvocet®, Darvon®, or Tylenol with codeine®
0
5
10
1. Adapted from Office of Applied Studies, Substance Abuse and Mental Health Services Administration. The NSDUH
Report. Nonmedical use of prescription pain relievers. 2004.
© 2005 Rehabilitation Institute of Chicago
15
20
Preferred Routes of Abuse for Prescription
Opioids
100
97.2%
Users, %
80
60
40
13.1%
20
3.9%
0.6%
0.5%
0
Orally
Snorting
Smoking
Inhaling
Injecting
N=640 undergraduate students from a large public, Midwestern 4-year university in the United States.
1. McCabe SE et al. Addict Behav. 2007;32(3):562-575.
© 2005 Rehabilitation Institute of Chicago
Progression of Prescription Opioid Misuse
and Abuse1
1% IV
16%
Snorting
25.6%
IV
62.4%
Snorting
83%
Oral
Initial Route of Administration
(n=112)
Route of Administration at
Admission for Treatment
(n=133)
IV, intravenous.
N=187 subjects admitted for treatment of OxyContin abuse or dependence.
1. Hays LR. J Addict Dis. 2004;23(4):1-9.
© 2005 Rehabilitation Institute of Chicago
14.3%
Oral
DAWN* Mentions Per 1000
Prescriptions Dispensed
DAWN* Mentions Per 1000 Prescriptions Dispensed:
Account for Opioid Availability
© 2005 Rehabilitation Institute of Chicago
*DAWN, Drug Abuse Warning Network
Morphine
Oxycodone
Combos
Hydrocodone
Combos
Zacny J, et al. Drug Alcohol Depend. 2003;69:215-232.
Predicting aberrant behaviors
• High risk
– Family history of substance abuse
– Legal problems
– Drug or alcohol abuse
• Other
– Cigarette use, higher opioid dose, less opioid
reported side effects, MVA
– Mental health disorders
Michna E, et al. J Pain Sym Management 2004;28:250-8.
© 2005 Rehabilitation Institute of Chicago
Aberrant Drug-Related
Behavior: Implications
• Differential diagnosis of aberrant drug-related behavior
– Addiction
– Pseudoaddiction
– Other psychiatric disorders
• Axis I and Axis II disorders
• Mild encephalopathy
• Family disturbances
– Criminal intent: diversion
Portenoy RK, et al. In Lowinson JH, et al.(eds): Comprehensive Textbook of
Substance Abuse, Fourth Edition. Baltimore: Williams and Wilkins, 2005, pp. 863903. © 2005 Rehabilitation Institute of Chicago
Predicting opioid misuse at 1 year
Misuse (32%)
• Predictors
cocaine abuse
DUI conviction
male
cannabinoids
Ives TJ, et al. BMC Health Ser Res 2006;6:46.
© 2005 Rehabilitation Institute of Chicago
“Opioid misuse”
•
•
•
•
•
•
(-) tox screen
(+) for other
Multiple providers
Diversion
Forgery
Stimulant use
Patients Who May Not Benefit
From Opioid Therapy
• Excessive pain intensity
• Extreme ratings of emotional distress
• Poor perception of coping effectiveness
• Use of multiple pain descriptions
• Poor perceived social support
• Multiple pain sites
• Poor employment history
None of these are
absolute
contraindications
and lack predictive
validity at this point
• Long-term reliance on health professionals
• Addiction risk factors
• History of failure with chronic opioid therapy or allergic sensitivity
Nedeljkovik SS, et al. Clin J Pain. 2002;18:S39-S51.
Portenoy RK, et al. J Pain Symptom Manage. 1990;5:S46-S62.
Federation of State Medical Boards of the United States, Inc. Model Guidelines for the Use of
© 2005 Rehabilitation
Institute
Chicago
Controlled
Substances
forofthe
Treatment of Pain. May 2004.
A Chronic Pain Patient vs
an Addicted Patient
Pain Patient
Abuse
Addicted Patient
Appropriate use
Inappropriate use:
inadequate dose or
excessive dose
Inappropriate use
Quality of life 
Quality of life  or 
Quality of life 
Function 
Function  or 
Function 
© 2005 Rehabilitation Institute of Chicago
Aberrant Behavior vs Abuse
Aberrant
Behavior: 40%
Abuse:
20%
Addiction:
2%–5%
Total Pain Population
Webster LR, et al. Pain Med. 2005;6:432–442.
© 2005 Rehabilitation Institute of Chicago
Webster LR, Webster RM. Pain Med. 2005;6:432–442;
Summary
• Remember opioid pharmacokinetics
• Side effect management important to
improving chances of success
• Opioid hyperalgesia
• Endocrine effects
• Risk stratify patients
© 2005 Rehabilitation Institute of Chicago
Balance Act
RISKS
Working with Regulators;24(2):147.
© 2005 Rehabilitation Institute of Chicago
BENEFIT
Federal Guidelines
Controlled Substances Act (CSA) (1970)
Drug Enforcement Administration (DEA) (1973)
Model Guidelines for the Use of Controlled Substances for
the Treatment of Pain (1997)
Model Guidelines (1998)
Model Policy for the Use of CS for Pain Management
(2004)
© 2005 Rehabilitation Institute of Chicago
History of Opioid Guidelines
“Old View”
1993 College of Phys and Surgeons: Canadian
1994: AHCPR. Acute LB Problems in Adults: Clinical
Practice Guides
1997: AAPM and APS
“The use of opioids for the treatment of chronic pain”
1998: Federation of State Medical Boards of US
2001: AAPM, APS, ASAM: consensus statement:
clarify addiction terminology
2008:
APS and ACP Opioid Guidelines
© 2005 Rehabilitation Institute of Chicago
FSMB Model Policy
• Controlled substance are necessary for public
health
• Access to appropriate and effective pain relief
• Pain management is part of quality medical
practice for all patients
• Physicians should not fear regulatory scrutiny
• Dosage or duration of prescriptions will not
solely determine legitimacy of treatment
• Physical dependence is not synonymous with
addiction
© 2005 Rehabilitation Institute of Chicago
Management Issues
© 2005 Rehabilitation Institute of Chicago
Approach to Risk Assessment Suggested
for All Controlled Substances1
• Make diagnosis with appropriate differential
• Assess for the potential for risk (eg, abuse,
misuse, and diversion)
• Regularly Assess the “Four A’s” of Pain
Medicine
– Routine assessment of analgesia, activity,
adverse effects, and aberrant behavior
• Stratify risk (eg, none, low, moderate, high)
• Modify treatment to mitigate the identified risk
DL, Heit HA, Almahrezi A. Universal precautions in pain medicine: a rational approach to the treatment of chronic pain.
• 1.PainGourlay
Documentation
Med. Mar-Apr 2005;6(2):107-112.
© 2005 Rehabilitation Institute of Chicago
APS/AAPM Guidelines for Chronic Opioid
Therapy: Recommendations by Category
1. Patient Selection and Risk
Stratification
8. Opioid-Related Adverse
Effects
2. Informed Consent and Opioid
Management Plans
9. Use of Psychotherapeutic
Cointerventions
3. Initiation and Titration of COT
10. Driving and Work Safety
4. Methadone
11. Identifying a Medical Home
and When to Obtain
Consultation
5. Monitoring
6. High-Risk Patients
7. Dose Escalations, High-Dose
Opioid Therapy, Opioid
Rotation, Indications for
Discontinuations of Therapy
12. Breakthrough Pain
13. Opioids in Pregnancy
14. Opioid Policies
Chou R et al. J Pain. 2009;10(2):113-130.
APS/AAPM=American Pain Society/American
Academy of Pain Medicine; COT=chronic opioid
therapy
© 2005 Rehabilitation Institute of Chicago
Algorithm for Opioid Treatment of
Chronic Pain
Patient Selection
Initial Patient Assessment
Comprehensive Pain Management Plan
Trial of Opioid Therapy
Patient Reassessment
Continue Opioid Therapy
© 2005 Rehabilitation Institute of Chicago
5
Implement Exit Strategy
Alternatives
to Opioid
Therapy
Assessment Issues To Evaluate
With Every Patient
• Pain intensity, onset , location, duration, quality
• Pain-related disabilities and other comorbidities
– biophysical
– psychosocial
• Prior therapies and treatments
– pharmacologic and nonpharmacologic
• Current medications/allergies
• Medical, psychiatric, social history
• Substance abuse history
• Risk level for aberrant drug-related behavior
© 2005 Rehabilitation Institute of Chicago
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Patient Care Agreement
• Reminder: opioids  one modality in multifaceted
approach to achieving goals of therapy
• Detailed outline of procedures and expectations
between patient and doctor
• Prohibited behaviors, and grounds for tapering or
discontinuation
• Limitations on prescriptions
• Emergency issues
• Refill and dose-adjustment procedures
• Exit strategy
• May contain elements of Informed Consent discussion
• Inclusion of above points will satisfy medico-legal issues
© 2005 Rehabilitation Institute of Chicago
10
Patient Education Begins With
Discussion of Opioid Therapy
• Benefits
• Risks
• Alternatives
• Patient concerns
Bolen J. J Opioid Manag. 2006;2(4):193-200.
© 2005 Rehabilitation Institute of Chicago
12
Opioid Benefits
• Reduction in pain
• Reduction in pain-related disability
• Improved function and quality of life
© 2005 Rehabilitation Institute of Chicago
13
The Four “A’s” of Pain
Treatment Outcomes
 Analgesia (pain relief)
 Activities of daily living (psychosocial
functioning)
 Adverse effects (side effects)
 Aberrant drug taking (addiction-related
outcomes)
Passik SD, Weinreb HJ. Adv Ther. 2000;17:70–83.
The Spectrum of Risk and
Patient Triage
Low
Risk of
Abuse
Moderate
Risk of
Abuse
High
Risk of
Abuse
Porter J, et al. N Engl J Med. 1980;302:123 [Evidence Level B]; Dunbar SA, et al. J Pain Symptom Manage.
1996;11:163–171 [Evidence Level B]; Savage SR. Clin J of Pain. 2002;18(4):S28–S38 [Evidence Level C]; Passik SD,
et al. Pain Med. 2003; 4:186–189 [Evidence Level C]; Gourlay D, et al. Pain Medicine. 2005;6(2):107–112 [Evidence
Level C]; Webster LR, et al. Pain Med. 2005;6:432–442. [Evidence Level B]
Universal Precautions
in Pain Medicine
1.
Make a Diagnosis with Appropriate Differential
2.
Psychological Assessment Including Risk of Addictive Disorders
3.
Informed Consent
4.
Treatment Agreement
5.
Pre- and Post-intervention Assessment of Pain Level and
Function
6.
Appropriate Trial of Opioid Therapy ± Adjunctive Medication
7.
Reassessment of Pain Score and Level of Function
8.
Regularly Assess the “Four A’s” of Pain Medicine
9.
Periodically Review Pain Diagnosis and Comorbid Conditions,
Including Addictive Disorders
10. Documentation
Gourlay D, et al. Pain Med. 2005;6:107–112.
Driving: Evidence Based Review
 No impairment psychomotor abilities
(moderate)
 No impairment cognitive impairment
(inconsistent)
 No impairment after dose (strong)
 No greater incidence MV violations, accidents
(strong)
Fishbain DA, et al. J Pain Symptom Management 2003;25:559-77.
© 2004 Rehabilitation Institute of Chicago
Cognition and psychomotor function with oxycodone CR
N= 30, stable opioid dose
 Attention, visual orientation, motor
coordination, vigilance evaluated1
 Driving did not differ between patients
and age-independent controls1
Increased effort during driving with
opioid/APAP2
1.Gaertner J, et al. Acta Anaesthesiol Scand 2006;50.
2. Verster JC, et al. Clin J Pain 2006;22:499-504.
© 2004 Rehabilitation Institute of Chicago
Meet Carla
• 44-year-old female with debilitating LBP
• Initial surgery unsuccessful, as were other
treatment attempts with NSAIDs, muscle
relaxants, interventional spine procedures,
and acupuncture
• Underwent second back surgery 4 yrs ago
– fusion performed but only partially
successful
– she now complains of persistent right
posterior thigh and calf pain
– continuing pain interferes more and
more with work delivering mail for post
office
© 2005 Rehabilitation Institute of Chicago
58
Current Pain Medications
• Modified-release (long-acting) oxycodone 40 mg bid and
hydrocodone/APAP* 5/325 mg 1-2 tabs for breakthrough
pain; max 8 tabs/day
• Patient states the only thing enabling her to work is her
medication, but complains it’s not working as well as before
– “this pain is really getting me down—I can’t sleep and
my asthma has flared up”
– she admits she no longer visits family or friends: “I’d
rather just stay home—I just feel so worthless…so sad
all the time”
• You discuss long-term disability with her and she gets
teary-eyed and says: “I’m a worker, doc, disability is
for sissies!”
© 2005 Rehabilitation Institute of Chicago
59
Physical Examination
• Alert, flat affect, minimal pain behaviors (grimacing and guarding)
– reports average pain intensity at rest as 4-6/10
– comments that by the end of the work day “pain is 12/10”
• Well-healed scar lower lumbar spine
• Spine mobility limited to 30 degrees of flexion secondary to pain
• Severe myofascial tenderness bilateral lumbar paraspinals and
gluteus muscles
• Straight leg raise testing negative bilaterally
• Absent right ankle muscle stretch reflex, present on left
• Decreased light touch sensation right posterior calf
© 2005 Rehabilitation Institute of Chicago
60
Additional History
• During initial visit, patient reports
being discharged from her previous
physician after random urine screen
tested positive for an opioid not
prescribed
– when asked, she says she does not know which opioid it was
and swears she takes medications as prescribed
• “I’ve never run out early—I take them just like my doctor
prescribed!”
– physician also calls previous primary care provider about her
urine toxicology screen, who states: “Her urine screen was
positive for hydromorphone. I don’t write that stuff. I don’t put
up with patients playing games with me. I discharged her.”
© 2005 Rehabilitation Institute of Chicago
61
Additional History (cont)
• Further history reveals that she is a nonsmoker; has previous
history of marijuana use “at least 10 years ago” and family
history of alcohol abuse
• Since she is of childbearing age, you discuss pregnancy and
opioid use with her
• She is administered abbreviated Beck Depression Inventory
– 7-item, self-administered questionnaire for use in primary
care
– each item correlates to a symptom of major depressive
disorder
– Carla’s score is >5, which is positive for depressive
symptoms/signs
© 2005 Rehabilitation Institute of Chicago
62
What Is Carla’s Risk Based
on Her Opioid Risk Tool (ORT) Score?
0-3: low risk (6%)
Mark each box that applies:
Female
Male
Family history of substance abuse
4-7: moderate risk (28%)
8: high risk (>90%)
1
3
Illegal drugs
2
3
Prescription drugs
4
4
3
3
Alcohol
Personal history of substance abuse
Alcohol
Age (mark box if between 16-45 years)
4
5
1
History of preadolescent sexual abuse
3
0
2
2
1
1
Illegal drugs
Prescription drugs
Carla’s Score: 12
4
5
1
Psychological disease
ADO, OCD, bipolar, schizophrenia
Depression
Scoring totals:
Graphic courtesy of Lynn Webster, MD
Webster LR et al. Pain Med. 2005;6(6):432-442.
© 2005 Rehabilitation Institute of Chicago
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12
Urine Toxicology: Know What
Your Lab Does
•
•
•
•
First step (screen) immunoassay
Second step (screen) gas chromatography
– good for natural opioids such as heroin
– not adequate for synthetic/semi-synthetic opioids
For synthetic/semi-synthetic opioids, need high-performance liquid
chromatography/mass spectroscopy
– most labs do not do routinely
Consult with lab for
– what procedures done routinely
– what drugs screened for routinely
– what are the assay sensitivities
– confirmation of reporting unexpected results
– confirmation of checking for adulterated urine (specific gravity,
creatinine)
© 2005 Rehabilitation Institute of Chicago
65
What Is Carla’s Risk Now
Based on Her ORT Score?
0-3: low risk (6%)
Mark each box that applies:
8: high risk (>90%)
1
3
Illegal drugs
2
3
Prescription drugs
4
4
3
3
4
4
5
5
Age (mark box if between 16-45 years)
1
1
History of preadolescent sexual abuse
3
0
2
2
1
1
Personal history of substance abuse
Alcohol
Illegal drugs
Prescription drugs
Carla’s Score: 7
Male
Family history of substance abuse
Alcohol
4-7: moderate risk (28%)
Female
Psychological disease
ADO, OCD, bipolar, schizophrenia
Depression
Scoring totals:
7
Graphic courtesy Lynn Webster, MD
© 2005 Rehabilitation Institute of Chicago
66
Webster LR et al. Pain Med. 2005;6(6):432-442.
Dr Jones Decides to… (cont)
• Initiate antidepressant: sertraline 50 mg
qd
• Refer to physical therapy for lumbar
stabilization and aerobic conditioning
• Counsel patient regarding transient or
lasting cognitive impairment associated
with opioid therapy that may affect her
driving/work safety
• Schedule recurring monthly follow-up
visits
© 2005 Rehabilitation Institute of Chicago
68
Monthly Follow-up Visits
Over 4 Months
• Patient reports fairly good general baseline pain control
– over time complains that after a couple of
hours walking her mail delivery route the
persistent right posterior thigh and calf pain is
almost unbearable
– “I just keep working”
• She finally tried increasing her hydrocodone/APAP 5/325
mg tabs to 12/day with little benefit
– Dr Jones considers possibility of tolerance or
pseudoaddiction vs aberrant behavior
indicative of addiction
© 2005 Rehabilitation Institute of Chicago
69
Pseudoaddiction
• Pattern of drug-seeking behavior of patients
with pain receiving inadequate pain management
that can be mistaken for addiction
– concerns about availability
– “clock watching”
– unsanctioned dose escalation
• May resolve with reestablishment of adequate
analgesia or adjustment of analgesic
dose/schedule
© 2005 Rehabilitation Institute of Chicago
70
Dr Jones Decides to Rotate to Different
Long- and Short-Acting Opioids (cont)
• Dr Jones prescribes long-acting morphine 75 mg
q12hr (60 mg + 15 mg available doses)
• He also rotates from hydrocodone/APAP to shortacting oxymorphone 5 mg, 1 tab for pain prior to
increased activity, max 2/day
• Schedules follow-up visit in a week
© 2005 Rehabilitation Institute of Chicago
75
Carla: 1-Week Follow-up
• Analgesia: Reports good pain relief with new meds,
average 3-4/10; breakthrough pain well controlled,
no greater than 6/10 at end of workday
– “It seems to work faster and last longer”
• AEs: None
• ADLs: Improved; able to walk entire mail route with
tolerable level of pain
• Aberrant Drug-Taking Behavior: None, taking meds
as Rx’d
• Assessment Impression: Good pain control on
current dose, mood greatly improved, says sleeping
well with better pain control
• Action Plan: Continue Rx as prescribed; follow-up
monthly 3x, then reassess frequency of follow-up
visits
© 2005 Rehabilitation Institute of Chicago
77
Monthly Follow-up Visits
• Patient initially managed well on modified-release (long-acting)
morphine 75 mg q12hr and short-acting oxymorphone 5 mg as
needed for breakthrough pain
– reports good pain control and improved function
– working full time, increased activity in community with family and
friends
• At subsequent visits patient appears more anxious
– work has been “so stressful” lately and “I just can’t keep up like
before”
• Calls for refill of breakthrough pain medicine 7 days early, 2 months
in a row
© 2005 Rehabilitation Institute of Chicago
78
The Spectrum of Risk and
Patient Triage
Low
Risk of
Abuse
Moderate
Risk of
Abuse
High
Risk of
Abuse
Porter J, et al. N Engl J Med. 1980;302:123 [Evidence Level B]; Dunbar SA, et al. J Pain Symptom Manage.
1996;11:163–171 [Evidence Level B]; Savage SR. Clin J of Pain. 2002;18(4):S28–S38 [Evidence Level C]; Passik SD,
et al. Pain Med. 2003; 4:186–189 [Evidence Level C]; Gourlay D, et al. Pain Medicine. 2005;6(2):107–112
© 2005 Rehabilitation Institute of Chicago
Dr Jones Decides to…
• Not refill her medication early after latest request
• Schedule follow-up appointment the next day to discuss
in person recent issues
– reviews aberrant behavior
– urine toxicology screen from previous followup visit
• positive for opioids (morphine and oxymorphone)
• positive for benzodiazepines
• At visit patient admits she recently started taking her
husband’s alprazolam 1-2 times/day
– “I’m so stressed out”
© 2005 Rehabilitation Institute of Chicago
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Dr Jones Decides to…
• Continue patient on current treatment, with detailed
compliance strategies
– 14-day supply of medication
– more frequent office visits
– urine toxicology monitoring at every visit
• Refer to psychiatrist for evaluation and treatment of
depression to rule out generalized anxiety disorder
© 2005 Rehabilitation Institute of Chicago
82
Possible Outcomes
• Good
• Bad
© 2005 Rehabilitation Institute of Chicago
Possible Outcome: Good
• Analgesia: Good pain control, 3/10 baseline,
5-6/10 worst pain managed with breakthrough
pain med
• AEs: None
• ADLs: Working full time; less anxious, active
treatment w/psychiatrist & staff psychologist →
better stress management
• Aberrant Drug-Taking Behavior: No early refill
requests, taking breakthrough Rx as needed; no
unprescribed meds in urine screen
• Assessment Impression: Learning relaxation
techniques in therapy to apply at work and home;
started home exercise program; says she’s “doing
great”
• Action Plan: Continue current treatment regimen
© 2005 Rehabilitation Institute of Chicago
83
Possible Outcomes
• Good
• Bad
© 2005 Rehabilitation Institute of Chicago
Possible Outcome: Bad
•
•
•
•
•
•
Analgesia: Patient complains of poor pain control especially
when walking. “I need more pain meds—my pain is 12/10”
AEs: None
ADLs: Only able to work half a day several times a week,
missing work more frequently, increased down time at home
Aberrant Drug-Taking Behavior: Several early refill requests;
not compliant with physical therapy or psychology visits;
phone message from Urgent Care Center of patient
requesting pain medicine
Assessment Impression: Chronic S1 radiculopathy, opioid
management noncompliance, possible opioid addiction vs
opioid-nonresponsive pain syndrome
Action Plan: Not a candidate for opioid therapy, taper from
opioids in consultation with addictionologist; consider
interventional therapy and refer to psychology/psychiatry
services for more intensive evaluation/treatment
© 2005 Rehabilitation Institute of Chicago
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© 2005 Rehabilitation Institute of Chicago
© 2005 Rehabilitation Institute of Chicago
Risk Evaluation & Mitigation
Strategies (REMS)
• FDA Amendments Act (FDAA) (March 2008)
• Applicants submit REMS to ensure benefits outweigh
risks
• Elements to ensure safe use:
A. Health care providers have training or experience
B. Dispensers specially certified
C. Drug dispensed in certain settings with evidence of
safe use
D. Patients subject to monitoring and registry
© 2005 Rehabilitation Institute of Chicago
RESPONSE
1. Implement a national Prescription
Monitoring Program (PMP) with real-time
data
2. REMS should cover entire class of
opioids
3. Develop REMS education with expert
input
4. REMS mustFDA-2009-N-0143
protect and not interfere
access
© 2005 Rehabilitation Institute of Chicago
© 2005 Rehabilitation Institute of Chicago
© 2005 Rehabilitation Institute of Chicago
© 2005 Rehabilitation Institute of Chicago
Summary: Ground Rules for Prescribing
Opioid Analgesics
• Proper patient selection and assessment
• Opioid analgesics are but one component of a
comprehensive treatment plan
• Prescribe opioids on a trial basis
• Ongoing patient reassessment, documentation
• Opioid therapy modifiable through titration, rotation, and
conversion, based upon individual variability
• Any treatment can be continued, discontinued, or modified
© 2005 Rehabilitation Institute of Chicago
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