Transcript Slide 1

Pain Management: Narcotics,
Implantable Therapies
Maher Fattouh MD
Adjunct Assistant Clinical Professor University Wisconsin
Medical Director, Advanced Pain Management
Board Certified Anesthesia & Pain Management
1. Describe how cautious, evidence-based prescribing
practices can lower opioid-related overdose deaths
while maintaining appropriate access for medically
needed treatment of chronic pain.
2. Identify “best practice” strategies that can be used
by clinicians for pain management treatment.
3. Explain evidence-based practice and policies for
provider education and patient education programs
being utilized across the US.
Papaver Somniferum
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Morphine
Codeine
Heroin
Hydrocodone (Vicodin, Lortab)
Methadone
Oxycodone (Percodan, Oxycontin)
Hydromorphone (Dilaudid)
Meperidine (Demerol)
New opioids, Tapentadol,
Buprenorphine ( Nucynta, Butrans
,etc.)
Source: United States General Accounting Office: Dec. 2003, 􀁬OxyContin Abuse and Diversion and
Efforts to Address the Problem.􀁬
16000
Number of deaths
14000
12000
prescription opioid
cocaine
heroin
10000
8000
6000
4000
2000
0
'99
'00
'01
'02
'03
'04
'05
'06
Year
Source: CDC
10
9
8
7
6
5
4
3
2
1
0
1.8 %
0.7 %
0.2 %
1-19 mg.
0.3 %
20-49 mg.
50-99 mg.
100+ mg.
Average Daily Opioid Dose in Morphine Equivalents
Dunn et al., Annals Int Med, 2010
5.0%
4.5%
4.0%
3.5%
3.0%
2.5%
2.0%
1.5%
1.0%
Group Health
Kaiser N CA
0.5%
0.0%
97 998 999 000 001 002 003 004 005
19
1
1
2
2
2
2
2
2
Chronic Opioid Therapy:
90 days &
> 10 Rx fills and/or
> 120 days supply
Persons with cancer excluded
Boudreau et al, Pharmacoepi Drug Safety, 2009
• Opioid addiction is rare in pain
patients. Physicians are needlessly
allowing patients to suffer because
of opiophobia.
• Opioids are safe and effective for
chronic pain.
• Opioid therapy can be easily
discontinued.
A Three-pronged Approach
• Primary Prevention- prevent new cases of
opioid addiction
• Secondary Prevention- provide people
who are addicted with effective
treatment
• Supply control- collaborate with law
enforcement, DEA and OPMC to
overprescribing and black-market
availability
• Require urine toxicology for all patients receiving
long term opioid therapy
• Require a physical exam and documentation that
alternative treatments have failed
• Set dosing limits to prevent high dose prescribing
• Require screening for addiction before & during
treatment
• Require screening for depression before initiating
therapy
• Mandate training in pain and addiction
Source: Couto JE, Goldfarb NI, Leider HL, Romney MC, Sharma S. High rates of inappropriate drug
use in the chronic pain population. Popul Health Manag. 2009;12(4):185–190.
• Disagreements among providers
• Patients getting confusing and
conflicting messages
• At war with our patients
• Delays in prescription refills
• Patients are dying from
overdoses
• What is conventional practice for this type of pain or
pain patient?
• Is there an alternative therapy that is likely to have an
equivalent or better therapeutic index for pain control,
functional restoration, and improvement in quality of
life?
• Does the patient have medical problems that may
increase the risk of opioid-related adverse effects?
• Is the patient likely to manage the opioid therapy
responsibly?
Fine PG, Portenoy RK. Clinical guide to opioid analgesia. Vendome Group, New York, 2007
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Who can I treat without help?
Who would I be able to treat with the
assistance of a specialist?
Who should I not treat, but rather
refer, if opioid therapy is a
consideration
Fine PG,Portenoy RK. Clinical guide to opioid analgesia. Vendome Group, New York, 2007
• All patients with moderate-severe pain, pain related
functional impairment or diminished quality of life
due to pain should be considered for opioid
therapy. (low evidence, strong rec.)
• Patients with frequent or continuous pain on a daily
basis should be treated with around-the-clock (ATC)
opioid therapy. (low evidence, weak rec)
• Clinicians should anticipate, assess for, and identify
potential opioid associated adverse effects.
(moderate evidence, strong rec)
• Breakthrough pain should be assessed prevented
and/or treated. (moderate evidence, strong rec)
• Methadone should be initiated and titrated
cautiously only by clinicians well versed in its use
and risks. (moderate evidence, strong rec)
• Patients taking opioid analgesics should be
reassessed for ongoing attainment of therapeutic
goals, adverse effects, and safe and responsible
medication use. (moderate evidence, strong rec)
• 1.1 Prior to initiating COT, clinicians should conduct a
history, physical examination and appropriate testing,
including an assessment of risk of substance abuse,
misuse, or addiction (strong recommendation, lowquality evidence).
• 1.2 Clinicians may consider a trial of COT as an option
if CNCP is moderate or severe, pain is having an
adverse impact on function or quality of life, and
potential therapeutic benefits outweigh or are likely
to outweigh potential harms (strong
recommendation, low-quality evidence).
• 2.1When starting COT, informed consent should be
obtained. A continuing discussion with the patient
regarding COT should include goals, expectations,
potential risks, and alternatives to COT (strong
recommendation, low-quality evidence).
• 2.2Clinicians may consider using a written COT
management plan to document patient and clinician
responsibilities and expectations and assist in patient
education (weak recommendation, low-quality
evidence).
• 3.1 Clinicians and patients should regard initial
treatment with opioids as a therapeutic trial to
determine whether COT is appropriate (strong
recommendation, low-quality evidence).
• 3.2 Opioid selection, initial dosing, and titration should
be individualized according to the patient’s health
status, previous exposure to opioids, attainment of
therapeutic goals, and predicted or observed harms
(strong recommendation, low-quality evidence). There
is insufficient evidence to recommend short-acting
versus long-acting opioids, or as-needed versus roundthe-clock dosing of opioids.
• 4.1 Methadone is characterized by complicated and
variable pharmacokinetics and pharmacodynamics
and should be initiated and titrated cautiously, by
clinicians familiar with its use and risks (strong
recommendation, moderate-quality evidence).
• 5.1 Clinicians should reassess patients on COT
periodically and as warranted by changing
circumstances. Monitoring should include
documentation of pain intensity and level of
functioning, assessments of progress towards
achieving therapeutic goals, presence of adverse
events, and adherence to prescribed therapies (strong
recommendation, low-quality evidence).
• 5.3 In patients on COT not at high risk and not
known to have engaged in aberrant drug-related
behaviors, clinicians should consider periodically
obtaining urine drug screens or other information
to confirm adherence to the COT plan of care
(weak recommendation, low-quality evidence).
• 6.1 Clinicians may consider COT for patients with
CNCP and history of drug abuse, psychiatric
issues, or serious aberrant drug-related
behaviors only if they are able to implement
more frequent and stringent monitoring
parameters. In such situations, clinicians should
strongly consider consultation with a mental
health or addiction specialist (strong
recommendation, low-quality evidence).
• 6.2 Clinicians should evaluate patients engaging in
aberrant drug-related behaviors for
appropriateness of COT or need for restructuring of
therapy, referral for assistance in management, or
discontinuation of COT (strong recommendation,
low-quality evidence).
• 7.1 When repeated dose escalations occur in patients
on COT, clinicians should evaluate potential causes and
re-assess benefits relative to harms (strong
recommendation, low-quality evidence).
• 7.2 In patients who require relatively high doses of COT,
clinicians should evaluate for unique opioid-related
toxicities, changes in health status, and adherence to
the COT treatment plan on an ongoing basis, and
consider more frequent follow-up visits (strong
recommendation, low-quality evidence).
• 7.3 Clinicians should consider opioid rotation when
patients on COT experience intolerable adverse effects or
inadequate benefit despite dose increases (weak
recommendation, low-quality evidence).
• 7.4 Clinicians should taper or wean patients off of COT
who engage in intractable aberrant drug-related
behaviors or drug abuse/diversion, experience no
progress towards meeting therapeutic goals, or
experience intolerable adverse effects (strong
recommendation, low-quality evidence)
• 8.1 Clinicians should anticipate, identify and treat
common opioid-associated adverse effects (strong
recommendation, moderate-quality evidence)
• 9.1 As CNCP is a complex biopsychosocial condition,
clinicians who prescribe COT should routinely integrate
psychotherapeutic interventions, functional restoration,
interdisciplinary therapy, and other adjunctive nonopioid therapies (strong recommendation, moderatequality evidence).
• 10.1 Clinicians should counsel patients on COT
about transient or lasting cognitive impairment that
may affect driving and work safety. Patients should
be counseled not to drive or engage in potentially
dangerous activities when impaired of if they
describe or show signs of impairment (strong
recommendation, low-quality evidence).
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11.1 Patients on COT should identify a clinician who
accepts primary responsibility for their overall medical
care. This clinician may or may not prescribe COT, but
should coordinate consultation and communication among
all clinicians involved in the patient’s care (strong
recommendation, low-quality evidence).
11.2 Clinicians should pursue consultation, including
interdisciplinary pain management, when patients with
CNCP may benefit from additional skills or resources that
they cannot provide (strong recommendation, moderatequality evidence).
• 12.1 In patients on around-the-clock COT with
breakthrough pain, clinicians may consider asneeded opioids based upon an initial and
ongoing analysis of therapeutic benefit versus
risk (weak recommendation, low-quality
evidence).
• 13.1 Clinicians should counsel women of
childbearing potential about risks and benefits of
COT during pregnancy and after delivery. Clinicians
should encourage minimal or no use of COT during
pregnancy, unless potential benefits outweigh risks.
If COT is used during pregnancy, clinicians should be
prepared to anticipate and manage risks to the
patient and newborn (strong recommendation, lowquality evidence).
•Analgesia
•Activities of Daily Living
•Adverse Events
•Aberrant Drug-Taking Behaviors
Biological
Age ≤ 45 years
• Gender
• Family history of prescription drug or alcohol abuse
• Cigarette smoking
Psychiatric
• Substance use disorder
• Preadolescent sexual abuse (in women)
• Major psychiatric disorder (eg, personality disorder,
anxiety or depressive disorder, bipolar disorder)
Social
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Prior legal problems
History of motor vehicle accidents
Poor family support
Involvement in a problematic subculture
Katz NP, et al. Clin J Pain.2007;23:103-118; Manchikanti L, et al. J
Opioid Manag. 2007;3:89-100. Webster LR, Webster RM. Pain Med.
2005;6:432-442.
Low Risk
• No past/current history of substance abuse
• Noncontributory family history of substance abuse
• No major or untreated psychological disorder
Moderate Risk
• History of treated substance abuse
• Significant family history of substance abuse
• Past/comorbid psychological disorder
High Risk
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Active substance abuse
Active addiction
Major untreated psychological disorder
Significant risk to self and practitioner
RiskWebster LR, Webster RM. Pain Med.
2005;6:432-442.
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Diagnosis with appropriate differential
Psychological assessment including risk of addictive disorders
Informed consent (verbal or written/signed)
Treatment agreement (verbal or written/signed)
Pre-/post-intervention assessment of pain level and function
Appropriate trial of opioid therapy adjunctive medication
Reassessment of pain score and level of function
Regularly assess the “Four As” of pain medicine: Analgesia,
Activity, Adverse Reactions, and Aberrant Behavior
9. Periodically review pain and comorbidity diagnoses, including
addictive disorders
10.Documentation
Gourlay DL, Heit HA. Pain Med. 2009;10 Suppl 2:S115-123. Gourlay DL, et al. Pain Med. 2005;6(2):107-112.
• I have resolved key points before initiating opioid therapy
• Diagnosis established and opioid treatment plan developed
• Established level of risk
• I can treat this patient alone/I need to enlist other
consultants to co-manage this patient (pain or addiction
specialists)
• I have considered non-opioid modalities
• Pain rehabilitation program
• Behavioral strategies
• Non-invasive and interventional techniques
• Drug selection, route of administration,
dosing/dose titration
• Managing adverse effects of opioid therapy
• Assessing outcomes
• Written agreements in place outlining patient
expectations/responsibilities
• Consultation as needed
• Periodic review of treatment efficacy, side effects,
aberrant drug-taking behaviors
• The dichotomy of “pro-opioid” and “antiopioid” is a false one, and serves neither the
practitioner, the patient or society well. The
ethical clinician is “pro-health”, and makes
treatment decisions with her/his patient within
that context.
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The United States is facing a public health crisis fueled by
overprescribing of opioids.
Prescribers and the public need to be better informed
about risks of opioid use/misuse
Interventions to bring this epidemic under control are
within our grasp.
Clinicians need to learn how to select patients for opioid
therapy, when indicated, and manage them as safely and
effectively as possible
On-line Resources
American Academy of Pain Medicine
http://www.painmed.org/clinical_
info/guidelines.html
American Pain Society
http://www.ampainsoc.org/pub/cp_
guidelines.htm
http://www.ampainsoc.org/links/
clinician1.htm
Federation of State Medical Boards
http://www.fsmb.org/RE/PAIN/
resource.html
American Academy of Pain Management http://www.aapainmanage.org/
Literature/Publications.php
Assessment and Risk Management Tools http://www.painedu.org/soap.asp
http://www.painknowledge.org