Transcript “Recognition and Management of Prescription Opioid Failure and

“Recognition and Management of
Prescription Opioid Failure and
Abuse in the Primary Care Setting”
William Morris, MD
Medical Director
Janus of Santa Cruz
Chronic Pain: Burden of Disease
• 9 in 10 Americans regularly suffer from pain
• Each year approx 50 million Americans suffer
from chronic pain
• Chronic pain is the most common cause of
chronic disability
• Almost 1/3 of Americans will suffer from
chronic pain at some point in their lives
Pain: Current Understanding of Assessment, Management, and
Treatments. National Pharmaceutical Council.
Overview
• Process for prescription of opioids for chronic
non-cancer pain
• Opioid “failures”
– excessive side effects
– inadequate analgesia
– Opioid “misuse” = opioid-related aberrant behaviors
• Clarification of terminology
• Recognizing and responding to aberrant opioidrelated behaviors
Clinical Guidelines for Opioid Use in
Chronic Pain
• 2010: American Society of Anesthesiologists –
http://journals.lww,com/anesthesiology/Fulltext/2010/04000/Pract
ice_G
• 2010: Drug Enforcement Agency –
www.deadiversion.usdoj.gov/pubs/manuals/pract/index.html
• uideline_for_Chronic_Pain_Management_13.aspx
• 2009: Institute for Clinical Systems Improvement –
www.icsi.org/pain_chronic_assessment_and_management_of_143
99/pain_chronic_assessment_and_management_of_guideline.html
• 2009: Journal of Pain – www.jpain.org/article/S15265900(08)00831-6/fulltext
• 2004: Federation of State Medical Boards of the United States –
www.fsmb.org/pdf/2004_grpol_controlled_substances.pdf
• 2003: Veterans Administration Guideline –
www.healthquality.va.gov/cot/cot_fulltext.pdf
Summary Process for Prescription
Opioids
Decision Phase
Implementation
Phase
Outcome
Phase
Goals met
Goals not met
Decision Phase –
Are Opioids Needed?
• Pain is moderate to severe
• Pain has significant impact on function and
quality of life
• Non-opioid therapies have failed
Decision PhaseAre Opioid Benefits > Risks?
• Strongest risk factors for abuse
– History of substance abuse personally/family
– Psychiatric comorbidity: severe depression/anxiety
– History of drug-related crime
– Regular contact with high risk group (substance
abusers)
– History of Sexual abuse – preadolescent
– Smokers
- Ives T el al. BMC Health Services Research 2006
- Redi MC et al. JGIM. 2002
- Michna E et al. JPSM 2004
- Akbik H et al. JPSM 2006
Decision for Opioids Benefit > Risk? (cont.)
• Risk assessment tools:
www.emergingsolutionsinpain.com
– Opioid Risk Tool: Webster LR and Webster RM. Pain
Medicine.2005;6;432-42
– Screener and Opioid Assessment for Patients with pain –
Revised (SOAPP-R): Butler et al. Journal of Pain.
2008;9:360-72
• Collateral information: family, friends, physicians,
pharmacists
• CURES report
Opioid Risk Tools
• ORT: scores to place in low, mod, high risk
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Family Hx of substance abuse
Personal Hx of Substance abuse
Hx of preadolescent sexual abuse
Psych disease (depression separate)
Age, Sex
• SOAPP-R: 24 ?’s self admin 1-4 scale totaled
– e.g: “How often do you feel bored?”
– “How often have you been sexually abused?”
– “How often have you felt impatient with your
doctors?”
Controlled Substance Utilization Review
and Evaluation System – “CURES”
• Office of state Attorney General
– http://ag.ca.gov/bne/cures.php
• Online “Prescription Drug Monitoring
Program” generates “patient activity report”
• Initial register online at:
http//ag.ca.gov/bne/cures.php
• Then must submit written application with
notarized copies of DEA and medical licenses,
govt. issued ID
Decision Phase –
Goals and Conditions of Opioid Rx
• Goals
– Analgesia
– Improved function: physical, social, vocational and
recreational
– Ask question what can patient realistically hope to be
able to do that they cannot do now?
Important to realize that the evidence for opioid efficacy
mostly comes from survey and uncontrolled case series,
therefore each patient is his/her “n of 1” trial.
Decision Phase –
Goals and Conditions of Rx (cont.)
• Conditions of Rx “universal precautions”
– Treatment agreement - verbal or written?
– Informed consent/education
– One prescriber/one pharmacy
– Visit frequency
– No early refills
– Pill counts?
– Urine tox screens?
Urine Drug Tests An Objective Tool
• Shows patient is taking what they are
prescribed and not other substances
Aberrant
behavior
present
Aberrant
behavior
absent
total
POSITIVE urine
10 (8%)
26 (21%)
36 (29%)
NEGATIVE urine
17 (14%)
69 (57%)
86 (71%)
27 (22%)
95 (78%)
122
Katz NO. et al. Clinical J of Pain. 2002
Decision Phase –
Goals and Conditions for Rx
• Exit plan - mutually agreed upon criteria
– Lack of adequate analgesia
– Lack of adequate functional improvement
– Persistent, intolerable side effects
– Aberrant behaviors
Implementation Phase
• Dose initiation and titration
– How long is long enough? [2 months]
– How much is too much? [200mg daily oral
morphine equiv dose]
• Higher doses – refer to specialty pain clinic
Ballantyne, JC and Mao, JM. Opioid Therapy for Chronic Pain.
NEJM.2003;349:1943-53
• Management of side effects
Outcomes Phase –
When Goals are Met:
• Monthly med renewal visits
– Document pain score and side effects
– Treat side effects
– Tox screen if indicated
• Comprehensive Reassessment visits Q 3-6 months
• The “4 A’s”
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Analgesia?
Activity?
Acceptable SE profile?
Aberrant behaviors?
• “collateral” information remains important
Outcome Phase –
The Dark Side of Opioids
Goals not met
Excessive side Ineffective analgesia
Aberrant opioid-related
effects
- disease progression
behaviors
- tolerance
- non-addiction
- opioid resistant pain
- addiction
- opioid induced hyperalgesia
- opioid induced toxicity
Opioid-induced Hyperalgesia vs.
Opioid Toxicity
• Opioid-Induced Hyperalgesia
• Opioid toxicity
– Anesthesia/pain literature
– Setting of chronic, non-terminal
pain syndromes
– Continued poor pain control
despite moderate opioid doses
(>200mg/day)
– Diffuse pain, out of previous
distribution
– Absence of neuroactivation
– Absence of dehydration, renal
failure
– RX: dose reduction and opioid
rotation (NMDA antagonists?)
Lee, M et al. Pain Physician. 2011;14:145-61.
Silverman, S. Pain Physician. 2009; 12:679-84
– Palliative Care/oncologic
literature
– Increase in pain despite
rapid titration
– Allodynia, hyperalgesia
– Signs of neuroactivation:
myoclonus, delirium
– Dehydration, renal failure
– RX: opioid rotation with
marked reduction in dose,
benzos, hydration?
“Confusing Panopoly of Terms and
Definitions”
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Addiction
Habituation
Dependence
Substance abuse
Substance dependence
Substance misuse
Physical dependence
Psychological dependence
Evolution of Terminology
• Liaison Committee on Pain and Addiction (LCPA)
– American Pain Society
– American Academy of Pain Medicine
– American Society of Addiction Medicine
– 1991-2001 created consensus definitions
LCPA Consensus Definitions
• “Addiction” favored over “dependence”
• Clear separation of concepts of physical
dependence, tolerance, and addiction
• Addiction as a chronic disease
• Utility of distinguishing addiction from other
forms of aberrant drug behavior
Tolerance
• “a state of adaptation in which exposure to a
drug induces changes that result in a
diminution of one or more of the drug’s
effects over time”
Physical Dependence
• “a state of adaptation that is manifested by a
drug class specific withdrawal syndrome that
can be produced by abrupt cessation, rapid
does reduction, decreasing blood level of the
drug, and/or administration of an antagonist.”
Addiction
• “a primary, chronic, neurobiologic disease,
with genetic, psychosocial, and environmental
factors influencing its development and
manifestations. It is characterized by
behaviors that include one or more of the
following: impaired control over drug use,
compulsive use, continued use despite harm,
and craving”
Addiction
• “a primary, chronic, neurobiologic disease,
with genetic, psychosocial, and environmental
factors influencing its development and
manifestations. It is characterized by
behaviors that include one or more of the
following: impaired control over drug use,
compulsive use, continued use despite harm,
and craving”
Addiction
• “a primary, chronic, neurobiologic disease,
with genetic, psychosocial, and environmental
factors influencing its development and
manifestations. It is characterized by
behaviors that include one or more of the
following: impaired control over drug use,
compulsive use, continued use despite harm,
and craving”
Addiction
• “a primary, chronic, neurobiologic disease,
with genetic, psychosocial, and environmental
factors influencing its development and
manifestations. It is characterized by
behaviors that include one or more of the
following: impaired control over drug use,
compulsive use, continued use despite harm,
and craving”
Addiction
• “a primary, chronic, neurobiologic disease,
with genetic, psychosocial, and environmental
factors influencing its development and
manifestations. It is characterized by
behaviors that include one or more of the
following: impaired control over drug use,
compulsive use, continued use despite harm,
and craving”
Aberrant Opioid-Related Behaviors
• Examples of non-addiction aberrant
behaviors:
– Noncompliance
– Diversion
– Seeking euphoria
– Medical “coping”
– Pseudoaddiction
Chronic Pain Population
on Opioids
Aberrant Opioid-Related
Behaviors
Addiction
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Behaviors LESS
indicative of addiction
Anxiety over symptoms
Med hoarding
Taking other’s meds
Requesting a specific
med
Openly getting meds
from other providers
Complaints about
needing higher dose
• Behaviors MORE
indicative of addiction
• Buying street drugs
• Illegal activities
• Multiple lost or stolen
meds
• Prescription forgery
• Injection or snorting
meds
• Performed sex for drugs
• Resistance to med
change despite SEs
Passik SD, et. al. Clinical J Pain. 2006;22:173-181
Aberrant Opioid-Related Behavior
Survey Tools
• Addiction Behaviors Checklist
Wu, et al. J. Pain Symp Manage. 2008;32(4):342-51.
– Clinician considers presence of behaviors since last visit and within
current visit
– e.g. ran out of meds early? Reports worsening relationship with
family?
• Current Opioid Misuse Measure
Butler, et al. Pain. 2007;130:144-56.
– 17 questions asked of patient with 0-4 response
Chronic Pain Population
on Opioids
Aberrant Opioid-Related
Behaviors 30 - 40%
Addiction
2-5%
Personal Observations from Dealing
with Challenging Patients
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Assuming opioids = only way to Rx severe pain
Multiple opioids of same type
High doses without pain specialist input
Continued dose escalation despite lack of
significant improvement
• Absence of weighing benefit against risk
• Assuming aberrant behaviors = addiction
Having the Conversation
• Clearly lay out my concerns –
– I first focus on lack of analgesia and side effect
– Then discuss specific examples of aberrant opioidrelated behaviors
• Present your assessment that risk of harm is
greater than benefit
– If I have relationship with patient, I focus on my
wanting the best for them
– If first visit, I focus on my ethical obligation to “do no
harm”
• Refer back to opioid agreement if you have one
Having the Conversation (cont.)
• “It doesn’t make sense to keep doing something
that is more likely to harm you than help you,
does it?”
• I acknowledge that this is not an easy problem to
deal with
• Don’t back them into a corner - I remind them;
– My diagnosis could be wrong
– I would not be offended if they transferred care to
another physician
– I will not abandon them.
Having the Conversation (cont.)
• I offer choice around how opioids are tapered,
not if they will be tapered, with as much
flexibility as is safe.
• Try to decide: tapering because of addiction or
because of opioid side effects and/or failure?
– Addiction should include in the care plan referral for
recovery treatment
– Addiction may require medication assisted
treatment: methadone or buprenorphine
Insanity: doing the same thing over
and over again and expecting
different results
- Albert Einstein
RECOVERY
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