Effective Strategies in Outpatient Methadone Treatment: Legal and Clinical Issues

1. Effective Strategies in Outpatient Methadone Treatment: Legal and Clinical Issues April 2, 2010

2. Audio and Q & A options • Option 1 – Using your computer headphones and/or speakers is preferred.                           • Option 2 – If you do not have that equipment available, you can listen to the webinar by calling 1-800-882-3610, code 8353003. • To avoid background noise, please mute your phone. • On a regular phone you can do this by dialing 61# to mute your handset and 60# to unmute your handset • Problems? Call for technical assistant at 1-800-504-5379. • If you have a question or comment, please use the Q & A tab on your computer screen

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

4. Today’s Webinar will be hosted by S.A. Stile, M.D. and Lisa Torres, J.D.

5. Faculty • Lisa Mojer-Torres, J.D., is an attorney specializing in civil rights and health care law. For the past fifteen years, she has represented people who experience discrimination related to substance addiction. She is nationally recognized as an advocate for “consumers” of substance addiction treatment and recovery services, representing this constituency at multiple venues. She is currently employed by the Division of Addiction Services for the State of New Jersey. • S.A. Stile, M.D., is a Psychiatrist, specializing in the treatment of Patients with Addiction and Co-Occurring Disorders. He is employed by the University of Pittsburgh Medical Center. He previously was Medical Director of the NATP at St. Francis Medical Center, the Suboxone Detoxification out-patient program for SPHS and is the Consultant to the UPMC-Mercy In-patient Detoxification Unit in Pittsburgh.

6. Today’s Webinar Agenda 10:00 - 10:45 • Welcome to the SAMHSA/CSAT webinar – Sabato (Tony) Stile, M.D. • Impairment from a Legal Perspective – Lisa Torres, J.D. 10:45 - 11:30 • Impairment from a Clinical Perspective - Sabato (Tony) Stile, M.D. 11:30 • Webinar adjourned

7. ImpairmentPatient Safety; Public Protection and OTP Liability Lisa Torres, J.D.

8. Objectives of this webinar: Introduce the issue of patient impairment in the OTP Identify the sources of impairment Impairment assessment instruments Managing loss exposure associated with patient impairment Policies and procedures regarding impairment OTP responses to suspected patient impairment OTP liability for injuries involving an impaired patient

9. Impairment – A Severe Risk Exposure • There are many consequences of mixing other medications with methadone.* • Impairment is among the most severe interaction; • Trends show “impairment” as an increasingly likely factor in more frequently filed claims by third parties against Opiate Treatment Programs * OTP’s and patients should familiarize themselves with reliable, updated sources for methadone interactions with other drugs. (SeeAddiction Treatment Forum’s website www.ATForum.com).

10. “IMPAIRMENT” • “Impairment” is the diminishment of a person’s faculties so that his/her senses (ability to see, hear, walk, talk, judge distances, etc.) are compromised, below the normal/acceptable level, as set by the state. • Whether someone is “legally impaired” depends upon the particular degree of diminished capacity and the activity involved. Both are established via regulation and/or case law and will vary by state.

11. In the Context of Risk Management An impaired patient presents potential danger to him/herself and to others if he/she does not restrict his/her activities to those which he/she can do safely, and without significant risk of harm. Regardless of source of impairment, impaired individuals are prohibited from operating heavy machinery including automobiles. Identifying impairment in a patient is typically grounds to support the refusal to medicate. Suspicion of patient impairment can and (as per this Webinar) should trigger a set of preemptive actions aimed at avoiding and minimizing the risk of potential harm.

12. Sources of Impairment in Methadone Patients • A methadone maintenance patient, who has achieved optimal dose stabilization is not impaired. • However, a newly induced patient who has not matched or built up tolerance and whose “optimal” dose hasn’t been established can be impaired. • Certain substances and medications taken in combination with methadone can also cause a patient to become impaired (drug-to-drug interactions). • Alcohol and benzodiazepine are among the most common substances taken with methadone that warrant heightened scrutiny for impairment.

13. Analysis of Impairment as a Risk • During induction, patient impairment is common and should be anticipated. • Loss associated with patient impairment is more probable in patients whose urinalysis indicates continued poly-substance use. • For patients who drive long distances to and from the OTP, loss becomes even more probable. • Loss associated with automobile accidents often involve third parties and can be severe.

14. Establishing an OTP “Tone of Impairment Awareness” • Educate all patients regarding various sources and potential consequences of impairment; • Inform patients of OTP policy (i.e., No Tolerance for Impairment) and procedures for responding to reasonable suspicions of (i.e., deferring or denying methadone dosing); • Total OTP community effort to observe & report signs, symptoms and information regarding impairment in order to determine safest, most appropriate course of action.

15. Identification of Patient Impairment Opportunities to identify patient impairment in the OTP: • Direct observation by security or other staff who observe and interact with patients prior to dosing, e.g., fee collection, UA’s, appt. scheduling, etc. • Dosing nurses are the most important resource in identifying patient impairment via interaction and observation before dosing for specific symptoms (heightened observation during induction); • Counselors have benefit of patients’ current and past substance use histories, ie., UA’s, etc.

16. Maximize Cooperation from Patients In Identification of Patient Impairment Most underused resource: information from patients. 1. Include patients in developing policies and procedures regarding impairment in the OTP; 2. Remove disincentives & punitive consequences for identifying patient impairment, including patient’s own; 3. Create incentives for patients to share true information about patient impairment.

17. Identifying Impairment: Reasonable Inquiries • Regular inquiry/ies directly to all patients as to what other substances and medications they are currently or have recently taken (e.g., in counseling and @ dosing window, etc.); • For new patients and patients known to be struggling with alcohol/substance abuse, (ie. those with positive drug screens, etc.) verbal inquiry/ies may not be sufficient to identify impairment (or to meet legal “reasonable action” standard).

18. Risk Treatment Options for Impairment Related to Induction 1. Accept or assume all/some of the risk – no or limited affirmative treatment. Accept risk that new patients will experience impairment (either withdrawal symptoms or somnolent, lethargic) until tolerance is built or matched. OR Limit risk by making patients remain at OTP for full first day; then reducing hours to half day, etc. and imposing a call-in process to check patients for first few days of induction. 2. Avoid risk by abandoning or eliminating source of risk. Insist all inductions be done in-patient or only accept patients who are stabilized and are tolerant to their methadone dose.

19. Risk Treatment Options, continued Mitigation (Control Loss) - reduce frequency, likelihood, severity and/or impact of impairment related loss: A. Implement OTP-wide policy of “No Tolerance for Impairment in Patients”; B. Remove disincentives & punitive consequences for identifying patient impairment, including self; C. Create incentives for patients who share true information about patient impairment. D. With input from patients, establish a policy and procedure for responding to suspicions of impairment

20. Mitigating Impairment Risks • Defer dispensing of patient’s medication until OTP is confident patient is not impaired; • Refer to procedures if impairment risk remains; • At closing, take reasonable action to assure patient is transported safely home; 4. If patient is intending to drive away from OTP, AMA (unmedicated but [potentially] impaired), consider whether OTP has legal obligation to report same to local law enforcement, DMV, etc. (ie, call anonymously from cell phone, etc.)

21. Legal Standards for OTP’s- Negligence, Malpractice & Third Parties Four elements of [common law] negligence (malpractice is negligence by professionals) 1. A duty owed – legal duty to act within legal standard of care owed to patients [and others who may be injured if duty is breached, i.e., foreseeable victims of injury/harm; 2. A duty breached – failure to meet the “relevant standard of care” (supported by various sources; expert testimony, peer-reviewed research, guidelines, etc.); 3. The breach was the proximate cause of the injury;*** Damages - (if no compensable injury, no claim). ***”Causation” is a major hurdle to overcome to get to trial

22. Third Party Liability • Tarasoff is a classic case that first extended the duty to warn strangers, who are prospective victims and imposeda duty to protect others from foreseeable risks of harm/injury • Risk of potential harm to impaired driver, passengers, pedestrians and other drivers (and their passengers) is foreseeable (and too potentially severe to ignore) those “third parties” who are injured can file a complaint or otherwise hold the OTP legally responsible for injuries caused by the actions of its impaired patients.

23. Summary of the Legal Standard • OTP’s must take proper /all precautions and use reasonable care to ensure that a patient is not impaired prior to administration of methadone • OTP’s must take all reasonable precautions to inform the patient of the side effects of medications prescribed or dispensed (a function of patient consent) AND to prevent the impaired patient from driving (may include reporting to local police/highway safety patrol &/or Dept. Motor Vehicles)

24. Once Impairment is IdentifiedLegal Duty to Take Action • Means OTP’s can’t bury head in sand and claim protection from a lack of knowledge. When OTP ignores evidence of impairment (obvious, in “plain sight” or observed by others), OTP is charged with that knowledge in that it should have known AND it should have taken reasonable actions to intervene to prevent the impaired patient from driving. • Liability of the OTP Does not extend to patients who become intoxicated after leaving the OTP without providing OTP any indication or reason to suspect.

25. OTP Knew or Should Have Known… Case law is extending liability to OTP’s for harm caused by a patient’s impaired driving when there were plenty “red flags” from which to reasonably conclude patient would drive while impaired; OTP’s held liable for “medicating” despite knowledge (actual or inferred) that patient would drive while impaired or failed to take affirmative action to prevent. OTP’s charged with knowledge when evidence was ignored (ie., urine screens, reports of patient stumbling or unable to keep eyes open on medication line); What would a “reasonable” physician do?

26. OTP Duties Associated with Impairment Duty to inform (consent process) Duty to affirmatively warn Duty to observe whether patient is impaired Duty to assess/monitor newly admitted Patients and those known to abuse substances Duty to take reasonable investigatory steps to determine whether patient has/had a poly-drug problem; Duty to intervene: delay, defer or refuse dispensing methadone Duty to assess whether patient poses a foreseeable risk of danger to self and to 3rd parties and to act reasonably to prevent same Duty to report potentially dangerous (AMA) situations involving impaired driver/driving (to Police &/or DMV)

27. Impairment Assessment S.A. Stile, M.D.

28. Common Triggers for Assessment Index of Suspicion: (Reason Documented) • History of recent prior episodes • Induction • Smell of Alcohol, or +BAC • +UDS, on site • Reports from other patients • Staff observation • ANY STAFF/ALL STAFF/ALL PATIENTS • Behavior reveals Altered Mental Status

29. Clinical Perspectives Do a Mental Status Assessment • Do an Assessment for indicators of intoxication from opiates, sedatives and/or stimulants • Assess also for Withdrawal from opiates, sedatives or stimulants- COWS, CIWA-AR • Don’t assume it’s always from substances • DOCUMENT

30. Acute Stimulant Intoxication-signs Adrenergic: Dilated pupils Diaphoresis (profuse sweating)--often with chills Hypertension (elevated blood pressure) Tachycardia (increased heartbeat), with or without arrhythmia and chest pain Hyperthermia (elevated temperature) Bruxism (teeth grinding) Tremors Seizures--mostly for cocaine users

31. Intoxication • Opioid toxicity characteristically presents with a depressed level of consciousness • Opiate toxicity should be suspected when the clinical triad of CNS depression, respiratory depression, and pupillary miosis are present. • Drowsiness, conjunctival injection, and euphoria are seen frequently.

32. Diagnostic criteria for 292.89 Sedative, Hypnotic, or Anxiolytic Intoxication (cautionary statement) A. Recent use of a sedative, hypnotic, or anxiolytic. B. Clinically significant maladaptive behavioral or psychological changes (e.g., inappropriate sexual or aggressive behavior, mood lability, impaired judgment, impaired social or occupational functioning) that developed during, or shortly after, sedative, hypnotic, or anxiolytic use. (1) slurred speech (2) incoordination (3) unsteady gait (4) nystagmus *** (5) impairment in attention or memory (6) stupor or coma

33. Considerations • Could be Medical cause • Drug-Drug interactions - from other Doctors • Substances are common causation • Impairment is the issue, even if accidental

34. Special Note on Prescribed Medication • Regardless of your Policy on prescribed medication, e.g. Benzodiazepines, Opiates, Psychotropics, if their use is involved in the current state of impairment, it is the impairment you must first deal with. • The Treatment plan can then be amended to deal with the longer term issues, based on your policy.

35. Some Process suggestions What do you do? • As a clinic policy, No toleration of impairment AND Policy is communicated • Preparatory consents in case of episode-involve the family, with prior consents • Documentation occurs, whenever there is index of suspicion, from start • Privately discussed • Reflected in the treatment plan

36. Choices • Medicate • Medicate and Monitor • Do not Medicate and further Monitor • Do not Medicate, arrange for transport home

37. Examination • Observation-Index of suspicion • Engagement in respectful conversation • Decision on whether to further test • Explanation of reasons for testing-(Script?) • Always maintain Privacy and Confidentiality • Results Should be reflected in Treatment Plan (THs) • Specific Testing-MOCA, BAL, UDS, Neuro

38. Memory • Immediate • Recent • Remote

39. Orientation • Time • Place • Person • Situation • Space (figure, signature, sentence)

40. Psychomotor Status • Unconscious/Stuporous • Conscious but Drowsy • Some PM retardation • Alert • Hyperactivity • Cooperative • Combative

41. Mood and Affect • Euthymic-Dysthymic-Manic • Angry-Irritable-Hostile • Calm-Anxious-Panic • Elated

42. Speech • Spontaneous • Slow-Deliberate • Slurring • Rapid • Illogical

43. Eyes/Gait • The horizontal gaze Nystagmus (HGN) • Pupils constricted-Dilated-Uneven-Reactive the walk-and-turn the one-leg stand Romberg Test Finger to nose

44. Vital Signs • Temperature • Pulse • Respirations • Systolic BP • Diastolic BP

45. Summary • All Staff and patients have a role in the index of suspicion • Policy, communication, consents • Script, documentation tool, TRAINING • CONFIDENTIALITY • Document Process, alter Treatment Plan • Make choices consistent with Safety for ALL

46. Thank you for your time and attention! Visit www.ireta.org to: • View a recording of this webinar starting Monday, April 5th after 5 pm EST. • To view more educational events on Effective Strategies in Outpatient Methadone Treatment • Access the Clinical Toolbox – with links to the ppt. and clinical tools discussed on this webinar