Improving safety and efficacy of
opioid prescribing for pain in
primary care
William C. Becker, MD, FASAM
Instructor
Section of General Internal Medicine
Yale University School of Medicine
Disclosure
I have no potential or actual conflict of
interest related to this presentation.
Learning objectives
• To understand terminology related to use of
opioids for chronic non-cancer pain
• To appreciate the prevalence of chronic noncancer pain, opioid prescribing and adverse
events related to opioids
• To review fundamental components of effective
management of chronic non-cancer pain
• To understand practical techniques for
improving safety and efficacy of opioid
prescribing for pain
Chronic Pain
• Pain lasting most of the day during most days for > 3
months
• Point prevalence in U.S. adults: 15-20%
• Lifetime prevalence in U.S. adults: 50-75%
• Pain is most often-reported symptom in office visits
after URI
• Multi-faceted disorder that, by definition,
has bio- psycho- social components
Prescription opioids
• Full opioid receptor agonists used to treat pain (acute
and chronic)
– e.g. morphine, oxycodone, hydrocodone, methadone,
codeine, hydromorphone, fentanyl
Reward pathways
Adverse effects of opioids
Addiction: compulsive substance use despite harm =
DSM-IV dependence, at least 3 of the following:
 Tolerance
 Withdrawal
 Greater amounts/longer period than intended
 Persistent desire/unsuccessful efforts to cut down
 Inordinate amount of time obtaining, using, or recovering
 Important social, occupational or recreational activities given up or reduced
due to substance use
 Use continued despite knowledge of having a persistent or recurrent physical
or psychological problem likely caused or exacerbated by substance
Incidence in opioid treatment for pain: ~2% per year
Contrast with: “Physiologic Dependence”
Adverse effects, continued
• Misuse  Use other than how prescribed:
– To get high
– More than prescribed
– Selling, trading = “diversion”
Adverse effects, continued
• “Drug-seeking Behavior”  requests for opioid
medications for the purpose of getting high
• “Aberrant Behaviors”  among patients on opioids for
chronic pain, behaviors that may be indicative of misuse
or addiction
–
–
–
–
Early refills
Frequent phone calls
Doctor shopping
Prescription forgery
Adverse effects, cont’d
•
•
•
•
•
•
•
•
•
Constipation
Nausea
Itching
Dizziness
Clouded mentation
Sedation
Falls
Overdose
Death
Annual sales of Rx opioids and
unintentional overdose death
1990 - 2006
8
600
6
400
5
4
300
3
200
2
Deaths per 100,000
Opioid sales (mg per
person)
100
1
0
Sales in mg/person
500
'90
'91
'92
'93
'94
'95
'96
'97
'98
'99
'00
'01
'02
'03
'04
'05
'06
Crude rate per 100,000
7
0
Source: Paulozzi, CDC, Congressional testimony, 2007
How did we get here?
• 1990s
– Under-treatment of pain
– Pain as the 5th vital sign
– Pain as a human rights issue
– Early data that opioid risks were low, some of
which intentionally minimized
– Interwined cultural and medical trend towards
“a pill for what ails ya’”
Juggling?
Balancing
BENEFITS
HARMS
Case
57 M w/ chronic low back pain for 15 years after being
thrown out of a jeep
• Worked as officer in NHPD until 50
• Lives with wife and 3 daughters, active in community
• Admits to cocaine and speed for 1-2 years 25 years ago
• Pain has been worsening and interferes with functioning
• Dx based on hx/PE/MRI: spinal stenosis
• You prescribe NSAIDS, capsaicin, physical therapy
• After 8 weeks pt still experiencing significant pain that is
negatively affecting function; you start opioids (MSContin
15 mg TID titrated to 30 mg TID) to good effect:
improved pain and function
• One month later, routine UDT positive for cocaine
What do you do now?
We’ll get to that discussion but also…
What should you have done in the first
place?
Practical techniques for improving efficacy
and safety of opioid prescribing
Where it all begins
Comprehensive approach to high-quality management of
chronic pain
• Empathize, partner with the patient
• Perform a complete history and physical
• Set functional goals
• Utilize shared decision-making
• Employ multi-modal treatment plan
• Employ rational polypharmacy
When using opioids:
• Follow the harm/benefit paradigm
• Perform frequent monitoring, reassessment and
DOCUMENTATION
Empathize/Partner with your
patient
Pain
Loss of
Function
Depression
Stress
“Identification with and
understanding of
another person's
situation or feelings”
Breaking the cycle
• “You’ve been through a lot.”
• “My goal is help *you* manage this better” –
EMPOWER the patient to be the locus of
control/change
• “Your pain will not go away entirely. Our goal is
to get better control of it.”
• “Moving, stretching, activity will help you reach
your goal.”
• “Uncontrolled pain makes mood worse, bad
mood makes pain worse – have to work on
both.”
Complete history and physical
•
•
•
•
•
Region/systems involved
Quality of pain
Temporal characteristics
Degree of intensity
Time since onset
This is the biological approach….
necessary but not sufficient
Biopsychosocial Model of Pain
Overall functional status
Don’t Miss the Red Flags
• ‘B’ symptoms: fever,
weight loss, night
sweats, malaise
• Sudden focal
neurologic symptoms
• Acute worsening of
chronic pain
• Failing to thrive
•
•
•
•
Tumors
Fractures
Infection
Cauda Equina
Syndrome
• Addiction
• Suicidality
Complete history and physical,
cont’d
Full standard exam plus:
– Focus on function –
• Watch the patient walk
• Ask the patient to transition from seated to
standing position
• Ask the patient to stand on the floor, flex the back,
extend the back
Set Functional Goals
Functional Status:
• What’s a typical day like?
• What’s the most active thing you do?
• Do you ever stay in bed all day?
• Do you get any exercise?
• How have these things changed over the
past weeks/months/years?
What would you (realistically) like to be able
to do?
Utilize Shared-Decision Making
• Uncontrolled chronic pain is found more
often in patients who
– Are passive
– Catastrophize
– Perceive an external locus of control
• Counteract these by requiring the patient
to make decisions and set goals with you.
Employ multi-modal approach
SELF CARE
Behavioral
therapies
SELF EFFICACY
Pharmacologic
treatment
Physical activity
Employ Rational Polypharmacy
• Anti-nociceptive agents
– NSAIDs
– Acetaminophen
– Opioids
• Anti-neuropathic agents
– Anti-convulsants
– Tricyclics
• Anti-depressants
When Using Opioids, Follow the
Harm/Benefit Paradigm
CONTINUE IF BENEFIT OUTWEIGHS HARM.
DISCONTINUE IF HARM OUTWEIGHS BENEFIT.
Perform frequent monitoring, reassessment and DOCUMENTATION
Initiating opioid treatment: When?
• When functional goals have not been
achieved with non-opioid therapies
(acetaminophen, ibuprofen, lidocaine,
capsaicin, TCAs, gabapentin, physical
therapy)
• New patient already on opioids
Initiating opioid treatment: Who?
• Active addiction (alcohol, illicit drugs, prescription
medications) is a contraindication
• Risk factors for misuse that should prompt closer follow
up but do not necessarily preclude opioid therapy
– Younger age
– Personal history of substance abuse
• Illicit, prescription, alcohol, smoking
– Family history of substance abuse
– Legal history (DUI, time in jail)
– Mental health disorders
• Patient who is showing engagement with process
Initiating opioid treatment: How?
• Therapeutic trial in the harm/benefit
paradigm
– Set specific, functional goals
– Refer back to those goals to assess benefit
• Which medication?
– Long/short acting
– Strength
– Formulation
– Abuse potential
Informed consent
• Communication of risks, potential benefits,
goals/expectations, and treatment and
monitoring plans
• Written agreements or ‘contracts’
– Educate patient about safe opioid use
– Clearly define acceptable behavior
Opioid treatment agreements
Tone is important:
“This is so you know what to expect from us
and what we expect from you”
“This is about keeping you safe”
“We do this for all patients”
What should be in your OTA?
• What patient can expect of the practice:
– A good faith effort to manage patient’s pain
• What practice can expect of patient:
–
–
–
–
–
–
–
–
–
–
–
No unsanctioned dose escalation
No early refills
No replacement for lost or stolen prescriptions
Single prescriber
Safeguard meds and no sharing
Keep regular appointments
Follow-through with referrals and adjuvant treatment
No use of illicit drugs or non-prescribed controlled substances
Urine drug testing
Whom/When to call for refill
If agreement not followed, may taper opioids off and/or refer to
addiction treatment
Monitoring: the 5 A’s
1. Analgesia – 11- pt Numeric Rating Scale
2. Activities of daily living (function) – ‘Your goal
was to get back in your walking routine. How
is it going?’
3. Adverse effects: constipation, sedation, etc –
ASK!
4. Addiction/overuse – Is the patient
oversedated? Does pt think he is addicted?
Does the patient use other illicit drugs?
5. Adhering to the treatment agreement
CT prescription monitoring program
www.ctpmp.com
Log of every scheduled medication filled in any
Connecticut pharmacy
Sortable by patient
1-2 week lag time
Urine drug testing
• Identifies more misuse than self-report or
physician impression
• Which test to order?
– Immunoassay is screen
– Gas chromotography/mass spectroscopy for
confirmation – would recommend doing this any time
you get an unexpected result
• Always ask and document recent intake before
sending test
How to discuss UDT
“This is our routine practice.”
“We want to ensure your safety.”
UTox8
• Federal “5”
–
–
–
–
–
Marijuana
Cocaine
Opiates
PCP
Amphetamine/
methamphetamine
• Plus
– Methadone
– Benzodiazepines
– Barbiturates
Interpreting UDT
• Common errors:
– Standard Utox8 does not include oxycodone or
fentanyl: you must include tests of medications
patient is prescribed
– In most cases, oxycodone will NOT cause opiate
assay to be positive; however, it can in high doses.
Therefore, you MUST do confirmatory testing
– Hydrocodone metabolizes to hydromorphone so pt
who takes hydrocodone may frequently have +
hydromorphone on opiate GC/MS.
Responding to problems
• Reassess
• Document findings and plan
• Structured risk management
– Short courses and follow-up
– Frequent UDT and/or pill counts
• Referral to pain or addiction specialist
• Taper off opioids
Stay in the harm/benefit
paradigm
• Explain how patient’s behavior or the
outcome of the treatment is not in line with
the treatment agreement.
• Firm but empathic -- you will still work with pt
on pain treatment and primary care
• Pt is not bad; treatment is not effective, not
safe, not appropriate.
• Benefits no longer outweighing harms.
“Cannot responsibly continue prescribing
opioids as I feel it would cause you more
harm than good.”
Case
57 M w/ chronic low back pain for 15 years after being
thrown out of a jeep
• After 8 weeks pt still experiencing significant pain that is
negatively affecting function; you start opioids (MSContin
15 mg TID titrated to 30 mg TID) to good effect:
improved pain and function
• One month later, routine UDT positive for cocaine
What was done/should have been
done in advance
• Comprehensive approach to high-quality
management of chronic pain
• Treatment agreement: discussion with pt
about risk and benefits
• “Fair warning” that UDTs would be done
• “Fair warning” that + UDT might mean
discontinuing opioids
• Practice-wide decision about how
treatment agreement violations handled
What to do now?
• Get GC/MS confirmation of any unexpected result
• (if confirmed) Talk to patient, reveal result of test, ask
him why he used
• Show empathy but do not allow patient to dispute results
• Show empathy but do not allow patient to shift blame: ‘I
did it because my pain was out of control/you are not
treating my pain’
• Based on practice policy, either begin opioid taper or
‘second chance’ with close monitoring (1-2 week follow
up with UDT)
• Consider addiction referral based on your assessment
Opioid Management: Summary
• If prescribed, opioids for chronic pain must be
part of a comprehensive pain management plan
• Treatment agreements are useful to keep
everyone on the same page
• Patients must be monitored for the 5 As
• Know the tools available to you for monitoring
and how to use them
• Opioids should be continued when effective and
safe, discontinued if ineffective or unsafe
• Use this harm/benefit paradigm to help you
communicate with patient
• Document
Thank you
Managing opioids in Primary Care
Brief Visits
Joint
Commission
Mandate to
Manage pain
Desire to
relieve
suffering
Patient
Expectations
Complicated
Patients
Resources
not meeting
demand
Fear of
feeding into
addiction/
safety
problems
Fear of
Bibliography
•Caudill-Slosberg et al. Pain (2004)
•Davis WR, Johnson DB. Prescription opioid use, misuse, and diversion among street
drug users in New York City. Drug and Alc Dep. 2008;92:267-276.
•Fleming MF et al. J Pain. 2007
•Katz NP. Patient Level Opioid Risk Management. PainEDU.org Manual. 2007
•Olsen Y et al. J of Pain (2006);
•Passik J Opi Manage 2005
•R.K. Portenoy, “Opioid Therapy for Chronic Nonmalignant Pain: Current Status,” in H.L.
Fields and J.C. Liebeskind, eds., Progress in Pain Research and Management (Seattle:
IASP Press, Vol. 1, 1994): at 267.
•Monitoring the Future
•National Survey of Drug Use and Health
•Drug Abuse Warning Network
•TEDS
•Zacny JP, Galinkin JL. Psychotropic drugs used in Anesthesia Practice: Abuse Liability
and Epidemiology of Abuse. Anesthesiology. 1999;90(1):269-288.
Addiction
(Abuse/Dependence)
Prescription Drug Misuse
Aberrant Drug Related Behaviors
(ADRB)
A spectrum of patient behaviors
that may reflect misuse
Total Chronic Pain Population
Adapted from Passik. APS Resident Course, 2007
Outline
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•
Case
Context
Achieving balance
Initiating opioid treatment
Informed consent and agreements
Monitoring and documentation (the 4 As)
Responding to problems
Opioids for chronic pain
• Increasing use for musculoskeletal
pain: 1980 to 20001
• 6% of all primary care visits in 20012
1. Caudill-Slosberg et al. Pain (2004); 2. Olsen Y et al. J of Pain (2006);
Sources of misused opioids
• 19% directly from a doctor
• 56% given for free by a friend or relative
– 81% of those friends/relatives received
them from a doctor
• 9% bought from a friend or relative
• 4% from a drug dealer or stranger
http://oas.samhsa.gov/nsduh/2k6nsduh/2k6Results.pdf
Increasing opioid misuse,
morbidity, mortality
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•
•
•
incidence misuse1,2
admissions for addiction treatment3
ED visits4
overdose deaths5
1. MTF; 2. NSDUH; 3. TEDS; 4. DAWN; 5. CDC