Effective Risk Management
Strategies in Outpatient
Methadone Treatment: Clinical
Guidelines and Liability
Prevention Curriculum
MODULE 6
Case Studies
Case Studies Overview
• Case Study 1 – Admission / Induction
• Case Study 2 – Take-Home Medication
• Case Study 3 – Cardiac Arrhythmia
4
Mary: Presenting Information
Mary is 28 years old
“I need to get clean. I’m tired
and run down and I don’t want to
be a drug addict for the rest of
my life because I know it’s going
to kill me.”
History of Present Illness
• Onset of drug abuse as a teenager
• Intravenous opioids during past 5 yrs
• Oxycodone, “drug of choice,” heroin substitute
• Denied use of opioid drugs for the past week and
admitted withdrawal symptoms.
• Symptoms had resolved and denies any for
past three days.
Past History of Treatment
• Several admissions for inpatient and
outpatient
• Unable to sustain abstinence longer than 2-3
months
• History of treatment for “depression”
• “Self medicating” by increasing her drug
use
7
Mary: Presenting Information
• Mary’s physical exam revealed:
• Vital signs within normal limits
• Scattered scarring on her arms and hands
• No fresh puncture wounds visible
• Mary’s UDS was negative for:






Amphetamines
Barbiturates
Benzodiazepines
Cocaine
Opioids
Methadone and methadone metabolites
8
Mary: Treatment Plan
Preliminary Treatment Plan:
• The physician’s statement for documentation of
current physiological dependence upon opioids
was completed and signed.
• Mary was recommended for admission to
opioid maintenance treatment.
9
“Red Flags”
• Diagnosis of Opioid Dependence
• Documentation of current physiological
dependence upon opioids
• UDS results
• Examine findings
11
Clinical Opiate Withdrawal Scale
Last use (OPIOIDS) :Type, Date, Time
Resting Pulse Rate:
_________beats/minute
Measured after patient is sitting or lying for one minute
0 pulse rate 80 or below
1 pulse rate 81-100
2 pulse rate 101-120
4 pulse rate greater than 120
GI Upset: over last ½ hour
0 no GI symptoms
1 stomach cramps
2 nausea or loose stool
3 vomiting or diarrhea
5 Multiple episodes of diarrhea or vomiting
Sweating: over past ½ hour not accounted for by room
temperature or patient activity.
0 no report of chills or flushing
1 subjective report of chills or flushing
2 flushed or observable moistness on face
3 beads of sweat on brow or face
4 sweat streaming off face
Tremor observation of outstretched hands
0 No tremor
1 tremor can be felt, but not observed
2 slight tremor observable
4 gross tremor or muscle twitching
Restlessness Observation during assessment
0 able to sit still
1 reports difficulty sitting still, but is able to do so
3 frequent shifting or extraneous movements of legs/arms
5 Unable to sit still for more than a few seconds
Yawning Observation during assessment
0 no yawning
1 yawning once or twice during assessment
2 yawning three or more times during assessment
4 yawning several times/minute
Pupil size
0 pupils pinned or normal size for room light
1 pupils possibly larger than normal for room light
2 pupils moderately dilated
5 pupils so dilated that only the rim of the iris is visible
Anxiety or Irritability
0 none
1 patient reports increasing irritability or anxiousness
2 patient obviously irritable anxious
4 patient so irritable or anxious that participation in the
assessment is difficult
Bone or Joint aches If patient was having pain
previously, only the additional component attributed to opiates
withdrawal is scored
0 not present
1 mild diffuse discomfort
2 patient reports severe diffuse aching of joints/ muscles
4 patient is rubbing joints or muscles and is unable to sit
still because of discomfort
Gooseflesh skin
0 skin is smooth
3 piloerrection of skin can be felt or hairs standing up
on arms
5 prominent piloerrection
Runny nose or tearing Not accounted for by cold
symptoms or allergies
0 not present
1 nasal stuffiness or unusually moist eyes
2 nose running or tearing
4 nose constantly running or tears streaming down cheeks
Total Score ________
The total score is the sum of all 11 items
Initials of person
completing Assessment: ______________
Score:
5-12 = mild
13-24 = moderate
25-36 = moderately
severe
more
than 36 = severe
withdrawal
Source:
Wesson, D. R.,
& Ling, W.
(2003). The
Clinical Opiate
Withdrawal
Scale (COWS).
Journal of
Psychoactive
Drugs, 35(2),
253-259.
Upon admission, Mary was started on
methadone.
13
Mary’s Induction Schedule
Mary’s dosing schedule per standing orders:
Day 1
Day 2
Day 3
Day 4
Day 5
Thurs.
Fri.
Sat.
Sun.(TH)
Mon.
Methadone dose 30mg
Methadone dose 40mg
Methadone dose 50mg
Methadone dose 60mg
Methadone dose 65mg
14
Mary: Induction
Day 1
•
Mary was started on a dose of 30 mg methadone with
a standing order to increase 5 to 10 mgs daily
Day 2
•
Mary received a dose of 40mg of methadone
Day 3
•
•
•
Mary reported withdrawal symptoms
Mary received an increased dose of 50 mg
Mary given TH 60 mg for Day 4, Sunday
15
Mary: Complications
Day 4
• TH dose 60 mg
Day 5
• Mary reported no withdrawal symptoms and did not
want an increase
• Mary was noted to be slightly unsteady on her feet
• Mary given 65 mg of methadone as per standing orders
Day 6
• Mary was a no-show
• Counselor made outreach call and was informed Mary
passed away the day before
16
Mary: Autopsy
An autopsy was performed 48 hrs after Mary’s
death. The report stated:
 The Circumstantial Cause of Death due to pulmonary
edema secondary to methadone intoxication
 The forensic toxicology report indicated high levels of
methadone and methadone metabolites
17
A Road-Map to “Steady State”
450
400
350
Methadone
dose levels 300
ng/ml
250
200
150
100
50
0
1
2
3
4
5
6
7
8
Days/Half-Lives – Methadone half-life= 24-36 hours
Dose constant at 30 mg daily.
Interdose interval = 24 hrs (trough to trough)
Peak levels increase daily for 5-6 days with NO increase in dose!
Source: Payte;Center for Substance Abuse Treatment,Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs,Treatment Improvement Protocol
(TIP) Series 43, DHHS Publication No. (SMA) 06-4214.Rockville, MD: Substance Abuse and Mental Health Services Administration, 2005,reprinted 2006.
Methadone Dose “Equivalent Effect”
•
•
•
•
•
•
Day 1 Thurs Methadone dose 30mg
30mg
Day 2 Fri Methadone dose 40mg
55mg
Day 3 Sat Methadone dose 50mg
77.5mg
Day 4 Sun (TH)Methadone dose 60mg 98.75mg
Day 5 Mon Methadone dose 65mg
114.37mg
Day 6 Tue No Show
Methadone
“dose
equivalent
effect” due to
accumulative
effect of tissue
buildup
19
Induction: Summary
• Everyone is responsible for best practice and risk
management
▫ Provide a thorough, comprehensive assessment
▫ Establish diagnosis “current physiological dependence
upon opioids”
• Avoid standing orders
▫ Dear Colleague letter from Dr. Clark in Sept. 4, 2007
• Observe and document carefully
• START LOW and GO SLOW
• Respond to patient complaints and changes in status
Stan: Presenting Information
Stan is a 35 y/o AAM
• Long history of snorting heroin/oxycontin
• Titrated to methadone 120 mg
• Requested THs due to work hardship
▫ Given 5 TH doses per week by week 4
▫ First two UAs negative
Stan: Complications
• By month 3:
▫ Stan had missed several counseling
appointments
▫ 1 week later his UA is positive for
oxycodone
▫ Stan had a party and a 21 year old died after
taking Stan’s methadone
▫ Lawsuit brought against OTP
Take-Home Medication: Summary
• Follow policy and procedures
▫ Receive all TH bottles at next visit
▫ Random callbacks (quantitative)
▫ Urine drug screens on patient with expanded TH
(hardship)
• Explore alternatives to lower risk and make the
OTP work better for the patient
▫ Change hours
▫ Open 7 days
• What is the clinics responsibility to third
parties?
Glenn: Presenting Information
Glenn is a 36 y/o white male
• Methadone dose - 300 mg
• Transferred to a new program
• No cardiac history
• No other medications
• Physical Exam:
▫ Marfanoid habitus
▫ Bronchitis
▫ The remainder of exam was normal
• Father with heroin addiction
• Dose increases began at 25-35 mg
Glenn: Treatment
• November
▫ 435 mg
▫ Feeling “10% better”
• February
▫ 600 mg
▫ Feeling “30% better”
▫ Dilated pupils at trough
• March –
▫ 660 mg
▫ Feeling “50% better”
▫ Call from the ER -ventricular tachycardia (TdP)
Glenn: Complications
• Glenn continued to have repeated episodes of
ventricular tachycardia
• Over the next few days:
▫ Methadone reduced over next 4 days to 100 mg every
6 hours
▫ Glenn received an Intra Cardiac Defibrillator (ICD)
and temporary pacemaker
▫ Ongoing withdrawal symptoms
 Dose increased, but resulted in ongoing firing of ICD
Glenn: Outcome
• Ultimately Glenn’s treatment results in:
▫ 420 mg of methadone with complaints of
withdrawal symptoms
▫ Gradual increase in dose to 600 mg
▫ Dose remains at 600 mg with 1-2 episodes
monthly of the ICD firing
Torsades de Pointes (TdP): Summary
• Cases of Torsades de Pointes are rare
• Mostly associated with methadone >200 mg
• QTc may be prolonged
▫ Some have occurred with normal QTc
▫ Majority of prolonged QTc do not result in cardiac
problems
• CSAT convened a Cardiac Expert Panel in 2008 to
provide recommendations for QTc Interval
Screening in Methadone Maintenance Treatment,
final published report is pending
Torsades de Pointes (TdP): Summary
• The American Association for the Treatment of Opioid Dependence
(AATOD) recommends a thorough exam including:
▫ Patient’s history
▫ Family’s history
▫ Physical exam
• Ask your patients if they have:
• Any heart related symptoms, problems
• Fainting spells
• Palpitations
• Unexplained seizures
• Family history of any of the above
• Other drugs that can prolong QTc intervals.
• If risk factors are present, order an ECG