Minimize Liability, Manage Risk,Ensure Patient Safety:Effective Strategies in OutpatientMethadone TreatmentWebinar
August 26, 2009
“All medical care involves themanagement of risk”- Michael Flaherty, Ph.D., 2009 RM Course Director
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Agenda
1:00-1:15 PM Welcome
Todd Mandell, MD , Webinar Facilitator
Setting the Stage
H . Westley Clark, MD, JD, MPH, CAS, FASAM,
Director, Center for Substance Abuse Treatment
1:15-1:30 PM What’s going on out there:
An insurance carrier’s perspective
Richard Willetts, CPCU
1:30-2:00 PM Managing risk and knowing the rules
Lisa Torres, JD
2:00-2:45 PM Managing risk and practice challenges
Trusandra Taylor, MD, FASAM, MPH;
Todd Mandell, MD; Lisa Torres, JD
2:45-3:30 PM Questions and dialog
Todd Mandell, MD (Facilitator)
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Thank you for supportingthis webinar session
•Substance Abuse and Mental Health Services Administration(SAMHSA) Center for Substance Abuse Treatment (CSAT)
•Opioid Treatment Provider (OTP) Risk management courseplanning committee
•OTP Risk management course faculty
•Institute for Research, Education and Training in Addictions(IRETA)
•American Association for the Treatment of Opioid Dependence(AATOD), David Szerlip and Associates, and NSM InsuranceGroup
•Those in recovery and the many professionals and families thatsupport their recovery
Please note: this presentation is not intended to substitute for actual legal or medical advise
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Housekeeping
•All participants will receive and email following this webinarwith the power point presentations and clinical toolbox.
•A survey link will be emailed to you after the webinar.
•All participant lines will be muted during the presentation soour audio quality remains high for all those participating.
•If you have a question please use the chat or Q & A functionon your screen. We will address as many questions aspossible in the last segment of the session.
Lisa Torres, JD
Managing risk and knowing the rules
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Mary T.Segment I Presenting Information
Patient Summary:
Mary T. is a 28 year old Hispanic female who presented to an opioidtreatment program on July 13, 2007.
Chief Complaint:
“I need to get clean; I’m tired and run down and I don’t want to be a drugaddict for the rest of my life because I know it’s going to kill me.”
History of Present Illness:
Mary admitted using opiates intravenously for the past five years. Hersubstance of choice is OxyContin, but when she can’t access OxyContin,she uses heroin. She began drug use as a teenager and has used otherdrugs including alcohol, marijuana, cocaine, benzodiazepines, ecstasyand LSD. She admitted smoking cigarettes, 1PPD times 15 years.
Upon intake she denied using any opiates for the past week. She admittedwithdrawal symptoms of sweats, chills, restlessness, sleep disturbance,daytime fatigue, and loose stools. However these symptoms had resolvedand she denied withdrawal symptoms for the past three days.
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Mary T.Segment I Presenting Information
Past Treatment History:
Mary admitted to several admissions for inpatient and outpatientdetoxification. Despite participation in 12 Step Meetings, she wasunable to sustain abstinence for longer than two or three months. Maryadmitted a six month period of sobriety several years ago after sherelocated to another state to live with her aunt and uncle.
Psych History:
She admitted a history of treatment for “depression” and was evaluatedby two psychiatrists within the past three years; she admitted previousprescription for Prozac, Celexa and Wellbutrin but they were ineffectiveand she had discontinued the medications. She admitted to “selfmedicating” her symptoms by increasing her drug use.
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Mary T.Segment I Presenting Information
Review of Systems (ROS):
Except for her previously noted resolved withdrawal symptoms, herROS was only remarkable otherwise for weight loss of ~ 5lbs within thepast 6 months regarding physical complaints.
Mental Status Examination:
Remarkable for feelings of sadness and depression, described asmoments of “darkness” when she “didn’t believe there was a point to hersuffering” and while she had considered overdosing, she had not foundthe “strength” to act upon it. Mary stated she found some comfort in herreligion, and the Catholic church.
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Mary T.Segment I Presenting Information
Physical Examination:
Mary was examined by the nurse practitioner. Her physical examinationrevealed vital signs within the normal limits. Her skin was smooth, warmand moist. Her arms and hands revealed scattered scarring consistentwith injection marks, but no fresh puncture wounds or abscess formationwas visible. Her sclera were mildly injected; pupils slightly dilated; nasalmucosa appeared mildly erythematous; the remainder of her focusedphysical examination was unremarkable.
Laboratory Results:
Urine toxicology screen at intake was negative for amphetamines,barbiturates, benzodiazepines, cocaine, opioids, methadone andmethadone metabolites.
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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 theassessment is difficult
Bone or Joint aches If patient was having pain
previously, only the additional component attributed to opiateswithdrawal 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 upon 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). TheClinical OpiateWithdrawalScale (COWS).Journal ofPsychoactiveDrugs, 35(2),253-259.
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Mary T.Segment I Presenting Information
Preliminary Treatment Plan:
The physician’s statement for documentation of current physiologicaldependence upon opioids was completed and signed. The patient wasrecommended for admission to opioid maintenance treatment becauseher lack of minimal family and community support which places her athigh risk for relapse.
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Mary T.Segment II: Dose Titration Schedule
Mary’s dosing schedule per standing orders:
Day 1 Thur Methadone dose 30mg
Day 2 Fri Methadone dose 40mg
Day 3SatMethadone dose 50mg
Day 4Sun (TH)Methadone dose 60mg
Day 5MonMethadone dose 65mg
Day 6TueNo Show
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CSAT Guidance“Standing Orders”
•Dear Colleague Letter – September 9, 2007
•Risks associated with initial methadone dosing and the first two-weeksduring induction process
•OTP Inspections
•Published literature review (Maxwell, 2005)
•OTP physician responsibility
•Knowledge of methadone pharmacokinetic and pharmacodynamicproperties
•Individualized initial methadone dosing
•You are not alone: Physician Clinical Support Systemwww.PCSSmentor.org
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Mary T.Segment III: Induction
Day 1
Mary was started on a dose of 30 mg. methadone with a standing orderto increase 5 to 10 mgs daily up to a maximum dose of 80 mg.
There were no symptom indications to guide the dose increases.
Methadone Dosing Schedule
Day 1 Thur Dose 30mg
Day 2 Fri Dose 40mg
Day 3 Sat Dose 50mg
Day 4 Sun (TH)Dose 60mg
Day 5 Mon Dose 65mg
Day 6 Tue No Show
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Mary T.Segment III: Induction
Day 2
Mary received a dose of 40mg of methadone
Methadone Dosing Schedule
Day 1 Thur Dose 30mg
Day 2 Fri Dose 40mg
Day 3 Sat Dose 50mg
Day 4 Sun (TH)Dose 60mg
Day 5 Mon Dose 65mg
Day 6 Tue No Show
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Methadone Pharmacology
•Pharmacokinetics
–Long plasma elimination half-life, drug-drug interactions, individualvariation, special populations
•Pharmacodynamics
–Tolerance, peak respiratory effect, cardiac conduction effects, CNSdepressant and other drug interaction effects, individual variation
•“Start Low and Go Slow”
•Practitioner education
•Patient education
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A Road-Map to “Steady State”A Road-Map to “Steady State”
Days/Half-Lives – Methadone half-life= 24-36 hoursDose 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 ImprovementProtocol (TIP) Series 43, DHHS Publication No. (SMA) 06-4214.Rockville, MD: Substance Abuse and Mental Health Services Administration, 2005,reprinted2006.
Methadonedose levels
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Mary T.Segment IV: Complication - Withdrawal Symptoms
Day 3
Mary reported to the dispensing nurse that she was experiencing withdrawalsymptoms and asked to see the nurse practitioner.
The dispensing nurse advised Mary that her dose was to be increased andadministered methadone 50 mg. according to the standing order protocol.
She also gave Mary her Sunday take-home methadone 60 mg. dose for Day4. The clinic was closed on Sundays and as per regulations, the cliniccustomarily gave all patients Sunday take-home medication.
Methadone Dosing Schedule
Day 1 Thur Dose 30mg
Day 2 Fri Dose 40mg
Day 3 Sat Dose 50mg
Day 4 Sun(TH) Dose 60mg
Day 5 Mon Dose 65mg
Day 6 Tue No Show
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CSAT Guidance“Take-home doses”
•“Dear Colleague Letter” – January 28, 2008
•Medical Director responsibility for all decisions
•Eight-point criteria in § 291.505(d)(6)(iv)(B) and 42 CFR,8.12(i)(2)
•Accreditation Guidelines 2007
•Clinic closure for business, Sunday, state and federal holidays
•Alternative arrangement for patients determined by the medical directornot to be appropriate candidates
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Mary T.Segment V: Titration Resumed
Day 5
Mary reported that she was no longer experiencing withdrawal symptoms andthat she did not want an increase because she did not want to be like those“other patients on high doses”. Mary was noted to be slightly unsteady on herfeet at the dispensing window.
The dispensing nurse recommended to Mary to adhere to the standing orderprotocol for a further increase in her dose and Mary was given methadone 65mg.
Methadone Dosing Schedule
Day 1 Thur Dose 30mg
Day 2 Fri Dose 40mg
Day 3 Sat Dose 50mg
Day 4 Sun (TH)Dose 60mg
Day 5 Mon Dose 65mg
Day 6 Tue No Show
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Mary T.Segment VI: No Show
Day 6
Mary’s counselor made an outreach telephone call to her apartmentbuilding due to her no-show status for dosing.
The counselor was advised during that call that Mary had passedaway the day before. When she was found by her landlord thatmorning, she appeared to have fallen asleep on the couch. She wasnot breathing and her lips were blue.
An ambulance was called and she was pronounced dead at thehospital emergency room.
Methadone Dosing Schedule
Day 1 Thur Dose 30mg
Day 2 Fri Dose 40mg
Day 3 Sat Dose 50mg
Day 4 Sun (TH)Dose 60mg
Day 5 Mon Dose 65mg
Day 6 Tue No Show
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Mary T.Segment VI: No Show
Day 6
A subsequent autopsy was performed within 48 hrs of Mary’s death. Asthe Circumstantial Cause of Death, the autopsy report statedcardiopulmonary arrest due to pulmonary edema secondary tomethadone intoxication, history of opioid prescription drug and heroinabuse.
The forensic toxicology report indicated high levels of methadone andmethadone metabolites. No other drugs were reported.
Methadone Dosing Schedule
Day 1 Thur Dose 30mg
Day 2 Fri Dose 40mg
Day 3 Sat Dose 50mg
Day 4 Sun (TH)Dose 60mg
Day 5 Mon Dose 65mg
Day 6 Tue No Show
Methadone Dose“Equivalent Effect”
•Day 1 ThurMethadone dose 30mg30mg
•Day 2 FriMethadone dose 40mg55mg
•Day 3 SatMethadone dose 50mg77.5mg
•Day 4 Sun (TH)Methadone dose 60mg98.75mg
•Day 5 MonMethadone dose 65mg114.375mg
•Day 6 TueNo Show
Methadone“doseequivalenteffect” due toaccumulativeeffect of tissuebuildup
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Thank you for your timeand your attention
•Please tell a friend about our next webinar rebroadcast dates for liveQ&A are September 1, 2009 and September 23, 2009 from 1 – 3:30 pm(est.) to register visit www.ireta.org
•Starting 3 pm EST, August 27th, 2009 you can watch this same webinar“on-demand” at www.ireta.org free and CEU’s are available throughregistration
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Faculty and Planning Committee
Anthony Campbell, RPH, DO, CDR, USPHS – Planning Committee
Medical Officer
Substance Abuse and Mental Health Services
Center for Substance Abuse Treatment
Division of Pharmacologic Therapies
Eric Ennis, LCSW, CACIII – Planning Committee
American Association for the Treatment of Opioid Dependence,
Risk Management Committee Chair
Senior Instructor of Psychiatry
Director of Adult Outpatient Services
Addiction Research and Treatment Services (ARTS)
University of Colorado Denver
Michael T. Flaherty, PhD – Course Director
Institute for Research and Education in Addictions –
IRETA and the Northeast Addiction Technology Transfer
Center (Northeast ATTC)
Executive Director/Principle Investigator
Carl-Henry J. Fortune, MPH – Planning Committee
Project Director
Prescription Drug Misuse and Abuse Activities
Health and Clinical Services Division
DB Consulting Group, Inc.
Todd Mandell, MD – Core Faculty/Webinar Facilitator
Medical Director, Vermont ADAP
David Szerlip – Planning Committee/Core Faculty
David Szerlip & Associates, Inc.
Trusandra Taylor, MD, FASAM, MPH – Core Faculty
Medical Director
JEVS Human Services
Lisa Torres, JD- Core Faculty
Holly Hagle, MA – Planning Committee/Faculty
Training and Education Officer
Institute for Research, Education and Training
in Addictions – IRETA
Eric Hulsey, DrPH – Course Evaluator
Scientific Director
Institute for Research, Education and Training
in Addictions – IRETA
Tiffany Kilpatrick, CGMP – Planning Committee
Regional Program Director
Great Lakes Addiction Technology
Transfer Center (Great Lakes ATTC)
Jane Addams College of Social Work
University of Illinois at Chicago
Kristine Pond – Planning Committee
Logistics Coordinator
Institute for Research, Education and Training
in Addictions – IRETA
Sabato (Anthony) Stile, MD – Planning Committee
Assistant Professor of Psychiatry
Univ. of Pittsburgh School of Medicine
Medical Director
SPHS BH Addictions Program, Medical Director
UPMC Behavioral Health Associates and EAP Solutions
Monica Velazquez – Planning Committee
Public Functions Supervisor
Great Lakes Addiction Technology
Transfer Center (Great Lakes ATTC)
Jane Addams College of Social Work
University of Illinois at Chicago
Alan A. Wartenberg, MD – Planning Committee/Faculty
Meadows Edge Recovery Center
Rhode Island
Richard Weisskopf – Planning Committee
State Opiate Treatment Authority
Illinois Department of Human Services
Division of Alcoholism and Substance Abuse
Richard Willetts, CPCU, ARM – Planning Committee/Core Faculty
Program Director
NSM Insurance Group
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