August 26, 2009

Minimize Liability, Manage Risk, Ensure Patient Safety:

Effective Strategies in Outpatient Methadone

TreatmentWebinar

August 26, 2009

“All medical care involves the management of risk”

- Michael Flaherty, Ph.D., 2009

RM Course Director

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Agenda1:00-1:15 PM Welcome

Todd Mandell, MD , Webinar Facilitator

Setting the StageH . 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 perspectiveRichard Willetts, CPCU

1:30-2:00 PM Managing risk and knowing the rulesLisa Torres, JD

2:00-2:45 PM Managing risk and practice challengesTrusandra Taylor, MD, FASAM, MPH; Todd Mandell, MD; Lisa Torres, JD

2:45-3:30 PM Questions and dialogTodd Mandell, MD (Facilitator)

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Thank you for supporting this webinar session

• Substance Abuse and Mental Health Services Administration (SAMHSA) Center for Substance Abuse Treatment (CSAT)

• Opioid Treatment Provider (OTP) Risk management course planning 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 Insurance Group

• Those in recovery and the many professionals and families that support 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 webinar

with 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 so our audio quality remains high for all those participating.

• If you have a question please use the chat or Q & A function on your screen. We will address as many questions as possible 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 InformationPatient Summary:

Mary T. is a 28 year old Hispanic female who presented to an opioid treatment 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 drug addict 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. Her substance of choice is OxyContin, but when she can’t access OxyContin, she uses heroin. She began drug use as a teenager and has used other drugs including alcohol, marijuana, cocaine, benzodiazepines, ecstasy and LSD. She admitted smoking cigarettes, 1PPD times 15 years.

Upon intake she denied using any opiates for the past week. She admitted withdrawal symptoms of sweats, chills, restlessness, sleep disturbance, daytime fatigue, and loose stools. However these symptoms had resolved and 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 outpatient detoxification. Despite participation in 12 Step Meetings, she was unable to sustain abstinence for longer than two or three months. Mary admitted a six month period of sobriety several years ago after she relocated to another state to live with her aunt and uncle.

Psych History: She admitted a history of treatment for “depression” and was evaluated

by two psychiatrists within the past three years; she admitted previous prescription for Prozac, Celexa and Wellbutrin but they were ineffective and she had discontinued the medications. She admitted to “self medicating” her symptoms by increasing her drug use.

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Review of Systems (ROS):Except for her previously noted resolved withdrawal symptoms, her ROS was only remarkable otherwise for weight loss of ~ 5lbs within the past 6 months regarding physical complaints.

Mental Status Examination:Remarkable for feelings of sadness and depression, described as moments of “darkness” when she “didn’t believe there was a point to her suffering” and while she had considered overdosing, she had not found the “strength” to act upon it. Mary stated she found some comfort in her religion, and the Catholic church.

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Physical Examination:

Mary was examined by the nurse practitioner. Her physical examination revealed vital signs within the normal limits. Her skin was smooth, warm and moist. Her arms and hands revealed scattered scarring consistent with injection marks, but no fresh puncture wounds or abscess formation was visible. Her sclera were mildly injected; pupils slightly dilated; nasal mucosa appeared mildly erythematous; the remainder of her focused physical examination was unremarkable.

Laboratory Results:

Urine toxicology screen at intake was negative for amphetamines, barbiturates, benzodiazepines, cocaine, opioids, methadone and methadone metabolites.

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Clinical Opiate Withdrawal ScaleLast 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 hands0 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 assessment0 no yawning 1 yawning once or twice during assessment 2 yawning three or more times during assessment 4 yawning several times/minute

Pupil size0 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 scored0 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 skin0 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 allergies0 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 severemore 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.

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Preliminary Treatment Plan:

The physician’s statement for documentation of current physiological dependence upon opioids was completed and signed. The patient was recommended for admission to opioid maintenance treatment because her lack of minimal family and community support which places her at high 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 3 Sat Methadone dose 50mg

Day 4 Sun (TH) Methadone dose 60mg

Day 5 Mon Methadone dose 65mg

Day 6 Tue No 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-weeks during induction process

• OTP Inspections

• Published literature review (Maxwell, 2005)

• OTP physician responsibility

• Knowledge of methadone pharmacokinetic and pharmacodynamic properties

• Individualized initial methadone dosing

• You are not alone: Physician Clinical Support System www.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 order to 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 ScheduleDay 1 Thur Dose 30mgDay 2 Fri Dose 40mgDay 3 Sat Dose 50mgDay 4 Sun (TH)Dose 60mgDay 5 Mon Dose 65mgDay 6 Tue No Show

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Mary T.Segment III: Induction

Day 2

Mary received a dose of 40mg of methadone


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Methadone Pharmacology

• Pharmacokinetics

– Long plasma elimination half-life, drug-drug interactions, individual variation, special populations

• Pharmacodynamics

– Tolerance, peak respiratory effect, cardiac conduction effects, CNS depressant and other drug interaction effects, individual variation

• “Start Low and Go Slow”

• Practitioner education

• Patient education

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A A Road-MapRoad-Map to “Steady State” to “Steady State”

0

50

100

150

200

250

300

350

400

450

1 2 3 4 5 6 7 8

ng/ml

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 Improvement Protocol (TIP) Series 43, DHHS Publication No. (SMA) 06-4214.Rockville, MD: Substance Abuse and Mental Health Services Administration, 2005,reprinted 2006.

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 withdrawal symptoms and asked to see the nurse practitioner.

The dispensing nurse advised Mary that her dose was to be increased and administered methadone 50 mg. according to the standing order protocol.

She also gave Mary her Sunday take-home methadone 60 mg. dose for Day 4. The clinic was closed on Sundays and as per regulations, the clinic customarily gave all patients Sunday take-home medication.

Methadone Dosing ScheduleDay 1 Thur Dose 30mgDay 2 Fri Dose 40mgDay 3 Sat Dose 50mgDay 4 Sun (TH) Dose 60mgDay 5 Mon Dose 65mgDay 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 director not 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 and that 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 her feet at the dispensing window.

The dispensing nurse recommended to Mary to adhere to the standing order protocol for a further increase in her dose and Mary was given methadone 65 mg.


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Mary T.Segment VI: No Show

Day 6 Mary’s counselor made an outreach telephone call to her apartment building due to her no-show status for dosing. The counselor was advised during that call that Mary had passed away the day before. When she was found by her landlord that morning, she appeared to have fallen asleep on the couch. She was not breathing and her lips were blue. An ambulance was called and she was pronounced dead at the hospital emergency room.


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Mary T.Segment VI: No ShowDay 6

A subsequent autopsy was performed within 48 hrs of Mary’s death. As the Circumstantial Cause of Death, the autopsy report stated cardiopulmonary arrest due to pulmonary edema secondary to methadone intoxication, history of opioid prescription drug and heroin abuse.

The forensic toxicology report indicated high levels of methadone and methadone metabolites. No other drugs were reported.


Methadone Dose “Equivalent Effect”

• Day 1 Thur 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 65mg114.375mg

• Day 6 Tue No Show

Methadone “dose equivalent effect” due to accumulative effect of tissue buildup

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Thank you for your time and your attention

• Please tell a friend about our next webinar rebroadcast dates for live Q&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 through registration

http://www.ireta.org/

http://www.ireta.org/

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Faculty and Planning CommitteeAnthony Campbell, RPH, DO, CDR, USPHS – Planning CommitteeMedical OfficerSubstance Abuse and Mental Health ServicesCenter for Substance Abuse TreatmentDivision of Pharmacologic Therapies

Eric Ennis, LCSW, CACIII – Planning CommitteeAmerican Association for the Treatment of Opioid Dependence, Risk Management Committee Chair Senior Instructor of PsychiatryDirector of Adult Outpatient ServicesAddiction Research and Treatment Services (ARTS)University of Colorado Denver

Michael T. Flaherty, PhD – Course DirectorInstitute 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 CommitteeProject DirectorPrescription Drug Misuse and Abuse ActivitiesHealth and Clinical Services DivisionDB Consulting Group, Inc.

Todd Mandell, MD – Core Faculty/Webinar FacilitatorMedical Director, Vermont ADAP

David Szerlip – Planning Committee/Core FacultyDavid Szerlip & Associates, Inc.

Trusandra Taylor, MD, FASAM, MPH – Core FacultyMedical DirectorJEVS Human Services

Lisa Torres, JD- Core Faculty

Holly Hagle, MA – Planning Committee/FacultyTraining and Education OfficerInstitute for Research, Education and Training in Addictions – IRETA

Eric Hulsey, DrPH – Course EvaluatorScientific DirectorInstitute for Research, Education and Training in Addictions – IRETA

Tiffany Kilpatrick, CGMP – Planning CommitteeRegional Program DirectorGreat Lakes Addiction Technology Transfer Center (Great Lakes ATTC)Jane Addams College of Social WorkUniversity of Illinois at Chicago

Kristine Pond – Planning CommitteeLogistics Coordinator Institute for Research, Education and Training in Addictions – IRETA

Sabato (Anthony) Stile, MD – Planning CommitteeAssistant Professor of PsychiatryUniv. of Pittsburgh School of MedicineMedical DirectorSPHS BH Addictions Program, Medical DirectorUPMC Behavioral Health Associates and EAP Solutions

Monica Velazquez – Planning CommitteePublic Functions SupervisorGreat Lakes Addiction TechnologyTransfer Center (Great Lakes ATTC)Jane Addams College of Social WorkUniversity of Illinois at Chicago

Alan A. Wartenberg, MD – Planning Committee/FacultyMeadows Edge Recovery CenterRhode Island

Richard Weisskopf – Planning CommitteeState Opiate Treatment AuthorityIllinois Department of Human ServicesDivision of Alcoholism and Substance Abuse

Richard Willetts, CPCU, ARM – Planning Committee/Core FacultyProgram DirectorNSM Insurance Group

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ACCME DISCLAIMER STATEMENT • The information presented at this CME program represents the views and opinions of the individual presenters, and does not

constitute the opinion or endorsement of, or promotion by, the UPMC Center for Continuing Education in the Health Sciences, UPMC / University of Pittsburgh Medical Center or Affiliates and University of Pittsburgh School of Medicine. Reasonable efforts have been taken intending for educational subject matter to be presented in a balanced, unbiased fashion and in compliance with regulatory requirements. However, each program attendee must always use his/her own personal and professional judgment when considering further application of this information, particularly as it may relate to patient diagnostic or treatment decisions including, without limitation, FDA-approved uses and any off-label uses.

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ACCME Continuing Education Credit• This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation

Council for Continuing Medical Education (ACCME) through the joint sponsorship of the University of Pittsburgh School of Medicine and IRETA. The University of Pittsburgh School of Medicine is accredited by the ACCME to provide continuing medical education for physicians.

• *The University of Pittsburgh School of Medicine designates this educational activity for a maximum of 2.5 AMA PRA Category 1 CreditsTM. Each physician should only claim credit commensurate with the extent of their participation in the activity.

FACULTY DISCLOSURE• Faculty for this activity have been required to disclose all relationships with any proprietary entity producing health care goods

or services, with the exemption of non-profit or government organizations and non-health care related companies. • No significant financial relationships with commercial entities were disclosed by the full webinar faculty.

Documents

August 26, 2009