1. Minimize Liability, Manage Risk, Ensure Patient Safety: Effective Strategies in Outpatient Methadone Treatment Webinar August 26, 2009

2. “All medical care involves the management of risk” - Michael Flaherty, Ph.D., 2009 RM Course Director

3. 3 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)

4. 4 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

5. 5 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.

6. Lisa Torres, JD Managing risk and knowing the rules

7. 7 Mary T. Segment I Presenting Information Patient 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.

8. 8 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.

9. 9 Mary T. Segment I Presenting Information 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.

10. 10 Mary T. Segment I Presenting Information 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.

11. 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.

12. 12 Mary T. Segment I Presenting Information 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.

13. 13 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

14. 14 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

15. 15 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 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

16. 16 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

17. 17 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

18. 1818 A Road-Map to “Steady State” 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 levels

19. 19 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 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

20. 20 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

21. 21 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. 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

22. 22 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. 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

23. 23 Mary T. Segment VI: No Show Day 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 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

24. 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 “dose equivalent effect” due to accumulative effect of tissue buildup

25. 25 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.orgwww.ireta.org Starting 3 pm EST, August 27 th, 2009 you can watch this same webinar “on-demand” at www.ireta.org free and CEU’s are available through registrationwww.ireta.org

26. 26 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

27. 27 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. The University of Pittsburgh, as an educational institution and as an employer, values equality of opportunity, human dignity, and racial/ethnic and cultural diversity. Accordingly, the University prohibits and will not engage in discrimination or harassment on the basis of race, color, religion, national origin, ancestry, sex, age, marital status, familial status, sexual orientation, disability, or status as a disabled veteran or a veteran of the Vietnam era. Further, the University will continue to take affirmative steps to support and advance these values consistent with the University's mission. This policy applies to admissions, employment, access to and treatment in University programs and activities. This is a commitment made by the University and is in accordance with federal, state, and/or local laws and regulations. For information on University equal opportunity and affirmative action programs and complaint/grievance procedures, please contact: William A. Savage, Assistant to the Chancellor and Director of Affirmative Action (and Title IX and 504 Coordinator), Office of Affirmative Action, 901 William Pitt Union, University of Pittsburgh, Pittsburgh, PA 15260, (412) 648-7860. 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.