Transcript Resident lecture on controlled substance 10.25.16x

I have no conflicts of interest to disclose
LEARNING OBJECTIVES
1. Describe data for efficacy for opioids
2. Review alternatives to controlled substances
for chronic pain
3. Explain the framework for safe prescribing
4. Describe how to use CURES database
5. Explain medication assisted treatment (MAT)
for opioid abuse disorder
CASE 1
Your first patient of the day is a 50-year-old woman with a seizure disorder who has
been suffering from chronic knee pain due to severe degenerative arthritis.
Physical therapy and regular use of first acetaminophen and later non-steroid antiinflammatory drugs (NSAIDs) were previously successful in managing her
symptoms, but over the past few months she has become increasingly disabled
due to knee pain and is having difficulty walking.
Corticosteroid joint injections were only transiently helpful, and she has been applying
topical NSAID gel to the area as well with minimal improvement.
You referred her to an orthopedist for evaluation and joint replacement surgery was
recommended, but she strongly prefers a non-operative approach. She is tearful
during the visit and asks for “something stronger” to get help get rid of her pain.
HOW EFFECTIVE ARE OPIOIDS FOR
NONCANCER CHRONIC PAIN?
• Meta-analysis by Martell et al. (Martell, 2007) after 16 weeks of
continuous use for chronic back pain, opioids = no better
analgesia than a placebo or non-opioid control ([95% CI, −0.49 to
0.11]; P = 0.136)
• Authors of that meta-analysis noted that the majority of the
included studies were of poor quality and no study looked at
opioid efficacy beyond 16 weeks.
EFFICACY OF OPIOIDS FOR CHRONIC PAIN
Drug Class
Average Pain Reduction
Opioids
30-40%
Tricyclics/AEDs
30-60% for neuropathic pain
Acupuncture
Approx.10%; difficult to interpret
data, but appears additive with
other therapies
CBT/Mindfulness
30-60%
Exercise/ PT
30-60%
Massage
30-40% for LBP, additive benefit
with other therapies
EVIDENCE BASED MEDICINE?
• Cochrane Review: Opiates provide moderate reduction in
subjective pain scores in short-term follow-up, weak evidence
• There is no evidence of significant functional improvement or QOL
scores
• 23% rate of discontinuation 2/2 SEs
• Data quality is poor
• Few long-term efficacy trials
• Exclusion of patients with history of substance use disorders and
uncontrolled disease
• Pharma sponsorship
• Studies not powered to detect serious, adverse effects
RISK: BY THE NUMBERS
• More than 3% of adults now receive long-term opioid therapy
for chronic non-cancer pain
• Approximately, 17,000 people die every year of overdoses
involving prescription painkillers
• The number of overdose deaths from prescription painkillers
is now greater than those of deaths from heroin and cocaine
combined
• About 18 women die every day of a prescription painkiller
overdose in the US
• Non-Hispanic white women ages 45 to 54 have the highest
risk of dying from a prescription painkiller overdose
http://www.cdc.gov/homeandrecreationalsafety/rxbrief/
http://www.cdc.gov/homeandrecreationalsafety/rxbrief/
SIDE EFFECTS
• Constipation (40%)
• Nausea (30%)
•
Vomiting (15%)
•
Dizziness (20%)
•
Somnolence/sedation (30%)
•
Itching (15%)
•
Opioid-induced hyperalgesia
•
Hypogonadism
•
Abuse and dependence
•
Death from unintentional overdose
TRAMADOL
• Tramadol is a controlled substance
• It has abuse potential
• It has street value
• It is not safer than other opioids
• In fact it interacts with SSRIs, TCAs and other drugs
• Treat it the same as all other opioids
DRUG SCHEDULES
I: high potential for abuse, high potential for abuse: heroin, LSD, marijuana, ecstasy
II/IIN: high potential for abuse, may lead to severe dependence.
II narcotics: hydromorphone, methadone, morphine, fentanyl, codeine
IIN stimulants: amphetamine, methamphetamine, methylphenidate
III/IIIN: potential for abuse, less than sched II, may lead to dependence
III narcotics: products < 90mg/codeine: Tylenol III, buprenorphine
IIIN: ketamine, anabolic steroids such as Depo-testosterone
IV: low potential for abuse: alprazolam, carisoprodol, clonazepam, diazepam, temazepam, tramadol
V: lowest potential for abuse: cough preparations w/ limited quant of codeine
Robitussin AC, Phenergan c/ codeine, pregabalin
MODALITIES FOR CHRONIC PAIN
Pharmacologic
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NSAIDS
Tylenol
TCAs (nortriptyline)
SNRIs (venlafaxine, duloxetine)
Gabapentin
Topical lidocaine ointment
Topical capsaicin
Muscle relaxants
Tramadol/Opioids
Physical
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Alternative Medicine
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Acupuncture
Massage
Yoga/Meditation
Physical and Occupational Therapy
Joint injections
Epidural steroid injections
Surgery
Heat or ice
Home exercise program
Cognitive and Behavioral
•
•
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Gardening
Therapy for comorbid depression and
anxiety
CBT
SAFE APPROACH TO CONTROLLED SUBSTANCE USE (1)
• 185 patients in chronic pain clinic
• Prediction tool
• 17/18 low risk = no aberrant bhvr
• 40/44 high risk = aberrant bhvr
Scoring (risk)
0–3: low; 4–7: moderate; ≥8: high
Webster LR, Webster RM. Predicting aberrant behaviors in opioid-treated
patients: preliminary validation of the Opioid Risk Tool. Pain Med. 2005 NovDec;6(6):432-42. PubMed PMID: 16336480.
• Aberrant behaviors:
• abuse
• use of additional opioids than
Rxd
• Requested refills instead of
clinic visit
• Canceled clinic visit
• Solicited opioids from other
providers
• Unauthorized ER visits
SAFE APPROACH TO CONTROLLED SUBSTANCE USE (2)
• Use of Treatment Agreement
• Recommended for all patients on Controlled Substance for
chronic non-cancer condition
• REQUIRED FOR ANY PATIENT USING FOR GREATER THAN 90
DAYS
• CURES Report
• Check before writing ANY prescription
• OK to give multiple scripts once stable for three months
• Urine and serum toxicology
• At least twice per year
• Collect in clinic and then send to lab
CURES
• California’s Prescription Drug Monitoring
Program
• Legislature passed that ALL providers must
have registered for CURES by July 2016
• CURES 2.0 no longer requires notary
• Show all controlled substances filled at a
pharmacy with name, dose, quantity,
prescriber, refill number
CURES (2)
• The data is only as accurate as what pharmacies upload to
• CURES.
• Pharmacies are required by law to upload data within 7 days.
Some
• Load within 24 hours, others take 7 days.
• CURES enters the pharmacy data into the system within 4 hours.
• Currently, the VA and Military pharmacies are not entering data
into CURES.
• Methadone clinics do not report to CURES.
CURES (4)
Only 3 mandatory entries:
• a. Last Name
• b. First Name
• c. Date of Birth
CURES (5)
• After reviewing, place label on CURES report
and scan into record
• Also reference that you reviewed it in your note
• Coming soon: ability to document that patient
has agreement, notes to other providers
SAFE APPROACH TO CONTROLLED SUBSTANCE USE (3)
• Get imaging studies and laboratory tests upfront to be clear what
you are treating
• Consider baseline utox before initiating therapy
• Max out all other therapies first
• Make sure there are no contraindications to use
• Heavy etoh use, active substance abuse
• Start low and go slow
• Use lowest dose and lowest frequency
• Avoid methadone (high risk of overdose and death)
• Avoid mixing with other sedatives such as benzodiazepines given
risk of overdose and death
SAFE APPROACH TO CONTROLLED SUBSTANCE USE (4)
•
Know your goal (be explicit and include it in Treatment Agreement)
• Being able to walk dog or dancing at dance class or exercising once a week
•
Require use of other modalities
• Tell patient they must also go to PT, Wellness Center , specialty appointments etc
to ensure more than just a pharmacologic approach
• Stop medications if they are not adhering to agreement
•
Don’t be afraid to stop!
• If patient is not improving functionally (not just pain score), then advise that
opioids may not be appropriate modality
• Set parameters
• We’ll try this for 3 months and if you’re not able to walk 3 blocks, then we’ll stop
• Treat it like an epilepsy medication; you are constantly re-evaluating for efficacy
• This doesn’t have to be forever
INTERPRETING URINE TOXICOLOGY SCREEN
What is on standard utox?
INTERPRETING URINE TOXICOLOGY SCREEN (2)
• What is on standard utox?
• Amphetamines, barbiturates, benzodiazepines,
cocaine, PCP, and the opiates morphine and codeine.
• Etoh and Marijuana are not checked on our screen.
• Hydrocodone, hydromorphone (contained in
vicodin/norco and dilaudid respectively) may be
detected if taken consistently but at low
concentrations are not detected.
• Drugs that are NOT detected include methadone and
oxycodone (contained in percocet).
INTERPRETING URINE TOXICOLOGY SCREEN (3)
 For patients on methadone, “Urine Methadone and Metabolite” lab
test should be checked at least twice per year.
 For patients on Hydrocodone/hydromorphone, the test “Serum
Hydrocodone and Metabolite, Quantitiative can be ordered.
 For Oxycodone, the test “Serum Oxycodone and Metabolite,
Quantitiative” can be ordered as a drug screen.
 False positive amphetamine screens can occur due to cross reactivity
with drugs such as pseudoephedrine.
 False positive cocaine screens are unlikely due to test
characteristics.
FALSE POSITIVE RESULTS ON UDS
CASE 2
You have been prescribing oxycodone to a 35-year-old mason with
chronic back pain resulting from a work-related injury and are
seeing him for routine follow-up.
Despite your very low suspicion for prescription drug misuse, at your
preceptor’s suggestion you order a urine drug screen
(immunoassay).
The results come back the following day and show the following:
Cocaine: negative, Amphetamines: negative, Benzodiazepines:
negative, Opiates: positive.
CASE 2 (CONTINUED)
Studies have repeatedly shown that physicians are very poor at predicting
which of their patients will misuse, abuse, or divert prescription opioids.
In one study of patients clinicians thought were not at risk for misuse of
medications, 60% had urine drug tests showing illicits or the prescribed
drug was not found (Bronstein, 2011).
Furthermore, comorbid drug misuse is common and patients will often be
less than forthcoming with this information to their prescriber.
In another study of 801 patients receiving opioid therapy for chronic pain
from 235 different PMDs, 24% of the urine drug tests were positive for
an illicit substance and 46% of patients with positive toxicology testing
denied illicit drug use even when they were guaranteed anonymity
(Fleming, 2007).
TAKE HOME POINTS
• The evidence for use of opioids in chronic non cancer pain is
weak.
• Try to use other modalities, both pharmacologic and nonpharmacologic.
• If you do use opioids, you MUST sign a Treatment Agreement,
check CURES report and perform urine toxicology screens.
• Make a firm plan for how you will know your patient is benefitting,
such as improved functionality.
• Don’t feel trapped by opioids. You can stop them if you feel the
risks become greater than benefit or if your patient is not
engaging in the rest of the care plan (eg weight loss, exercise) or
showing aggressive behavior around prescribing.
MEDICATION ASSISTED TREATMENT (MAT)
• If you suspect a patient has opioid use disorder then
refer to DPH SAPC
• Methadone is one form of MAT but there is another as
effective form, buprenorphine-naloxone (Suboxone)
that can be prescribed by certain licensed physicians
• Support our patients with addiction and link them to
appropriate care
QUESTION 1
What modality is as or more effective than opioids for chronic back pain?
A. Yoga
B. Mindfulness
C. Accupuncture
D. A & B
E. None of the above
QUESTION 2
When must ALL providers be signed up for CURES?
A. Deadline has passed
B. April 2016
C. July 2016
D. January 2017
QUESTION 3
What should you do before starting a patient on a controlled substance for noncancer chronic pain?
A. Check CURES
B. Sign Treatment Agreement
C. Check a urine toxicology screen
D. Agree on what functional end-point will be used to determine if working
E. All of the above
ARE OPIOIDS EVER A GOOD IDEA?
They may be. But…
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Doses > 100mg/day = highest risk of adverse events and death
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Methadone = 6-8hr analgesic half life but 72hr overall half-life
-
ER/LA form should not be given until tolerance develops to
opioids , >1wk
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Negotiate goals, Sign treatment agreement, use u-tox, use
CURES
QUESTIONS?