Risk Management: Patient Safety; Public Safety and OTP Liability

1. Risk Management:Patient Safety; Public Safety and OTP Liability Lisa Torres, JD

2. Objectives of this webinar: Provide a foundation for risk management as an ongoing process in OTP’s Focus on current patient and public safety concerns associated with induction, impairment; and take-home medication Address developments in OTP liability including liability for third party injury and death Offer strategies to help control safety and liability risks in OTP’s

3. Omissions from this webinar: Not lecturing on law or practice guidelines but using actual claims to identify trends and prepare responses Not giving legal advice specific to each OTP’s Not implying that application of these strategies or even adoption of best clinical practices will insulate OTP’s from being the subject of legal actions.

4. This webinar hopes to: • Use authentic sources to identify trends and work through actual claims to illustrate clinical and legal standards • Engage everyone by limiting seminar’s scope to a few current issues of concern to the OTP field: induction dosing; impairment & take-home • Use a hands-on approach in sharing creative, practical, actually used and cost-effective risk treatment strategies, tips and resources to inspire OTP’s to borrow those of potential value to them

5. Risk Management Explained Ideally, a process of identifying loss exposures faced by an organization & creating most appropriate response/s Often Risk Management confused with Risk Assessment, but need additional separate processes that link together to integrate a continuous culture of risk management into an organization Heart of RM: risk assessment: identification, analysis and evaluation of risks and risk treatment

6. Risk Management Cycle

7. Risk Assessment* Identification risks (loss exposure) – use OTP resources, i.e., incident reports; audits, patient complaints, accreditation response & state monitors, news from the field, etc. Analysis – of loss exposure (potential loss) in terms of frequency, likelihood & severity (of impact), Evaluation of options - prioritize risk in terms of costs in time, money, resources, goodwill, etc. *Not the same as risk management

8. Risk Control/Treatment Options • Identify risk response options that give “the most bang for the buck” through: • Prevention (reduce likelihood) e.g., to reduce patient safety complications related to induction, to assure individualized care, OTP implements new policy to discontinue use of physician’s standing orders during induction, until patient has achieved optimal dose stabilization; Narcan in OTP, etc. • Reduction of severity (contain loss after an adverse event occurs) e.g. Adopt plan to respond to families after injury/death (e.g., Sorry Works) • Loss control (reduce frequency of loss) e.g., to minimize patients from leaving treatment prematurely, conduct focus group and identify related factors. To the extent high fees are a major factor, change policies offering reduced rates to patients who require reduced services and offer incentives to encourage these patients to remain in treatment.

9. Risk Control/Treatment Options, cont. • Acceptance (do nothing; accept risk) e.g., risk of cardiac arrythmia in long term, stabilized patients too remote to warrant action • Avoidance (withdraw from activity that is the source of the risk); e.g., no longer accepting patients who use benzodiazapine • Transfer (share with other/entities who have with better resources or options) e.g., refer patients with co-occurring mental health issues to psychiatric providers • Loss control (reduce frequency of loss) e.g., to minimize patients from leaving treatment prematurely, conduct focus group and identify related factors. To the extent high fees are a major factor, change policies offering reduced rates to patients who require reduced services and offer incentives to encourage these patients to remain in treatment.

10. OTP Ideal Standard of Care* From admission, each patient receives: ongoing, documented, individualized clinical care by competent staff acting within their appropriate scope of practice, using good clinical judgment in accordance with OTP clinical practice standards and incorporating best evidence-based practices. * Borrowed from CSAT Workshop on Risk Management - 2005

11. Establishing Dependence, Withdrawal& Tolerance to Opioids • Legally (42 C.F.R. Section 8, (12) et.seq.) must be “opioid dependent” or meet exception • Not an opioid addict because patient says so … • “Street script” - buzz words/acts to receive methadone • Ask patient whether taken methadone before and to describe , “withdrawal” symptoms as experienced • Need to observe objective signs of withdrawal as only evidence of dependence (Refer to C.O.W. Scale) • Tolerance can’t be measured; it is estimated based largely on patient’s self-disclosure and proof of withdrawal.

12. Added Risks at Admission Don’t know patient; what other substances may be on board; not certain of patient’s tolerance level Patients’ responses to methadone vary considerably given different metabolism; rates of absorption, digestion and excretion which in turn are influenced by body weight and size, other substance use, diet, co-occurring disorders, medical diseases and genetic factors. Methadone remains in body tissues longer than its peak effect disguising potentially toxic build up, especially when tolerance hasn’t been built up.

13. Balancing Act Docs treating for opioid addiction must balance risks of under-medicating (patient will not be relieved of withdrawal) and over-medicating (patient will be sedated, impaired) Risk of under-medicating is that patient will resort to illicit substances, self-medication to seek relief Risk of over-medicating is overdose, or patient impairment to the extent driving becomes dangerous and a foreseeable risk of safety to others.

14. RM Strategies to Maximize Medication Safety at Induction • High variation between patients and unverifiable information warrants: • 1. Highly individualized care in dosing, etc. • 2. Enhanced monitoring for first five days or until stabilization (all OTP staff monitor for signs of: withdrawal vs. overmedication, impairment) • 3. Improve language and communication to inform and educate new patients about severity of

15. RM Strategies to Maximize Medication Safety at Induction, cont. • Include and engage patient in minimizing risks associated with induction dosing via Education • Include “Strategies for Reducing Overdose Deaths” – a list of vital information to educate patients and relatives or friends and the chart, “What to Watch For – Signs/Symptoms of Overmedication/Overdose” from Addiction Treatment Forum, Vol. 16, #3, Summer 20007

16. OTP Core Liability Risks Failure to document patient’s receipt of “individualized care” Failure to review OTP policy/ies, procedure/s and practices to determine whether they are effective in protecting patients’ safety and protecting against foreseeable harm to others OR Failure to correct policies, procedures and practices that are ineffective Ignoring “red flags” – incidents that are outside realm of “usual and customary” Failing to consider what’s “reasonable” and “foreseeable ? LOGIC MODEL Failure to communicate to patients the risks regarding true and full disclosure of their use of other substances including prescribed medications, medical histories, other medical providers,conditions, etc.

17. Malpractice Elements A duty owed – legal duty of health care provider to provide care and treatment of a patient; A duty breached – the provider did not meet the “relevant standard of care”* The breach was the proximate cause of the injury; Damages in the sense of pecuniary or emotional (no injury, no claim). * Established and supported by various sources such as SAMHSA/CSAT Treatment Improvement Protocols (43), Clinical Practice Guidelines, peer reviewed research and professional specialty publications, etc.

18. LEGAL STANDARDS • Established in fed regulations (42 C.F.R. Section 8.12 et.seq.), state, local statutes/regulations and case law • Compliance with legal standards is critical but will not insulate an OTP from liability; and it only evidence of having met legal standard/s, not of having met the clinical standard /s of care and duty owed to patients, etc. • However non-compliance is strong evidence of not having met legal or medical standards of care.

19. Strategies: Controlling Induction Risks HEIGHTENED PATIENT MONITORING THROUGH STABILIZATION: Given many “unknown” factors of new patients at induction, in light of the increased likelihood of harm; Integrate patient and his/her family into the safety net Encourage patients to engage family members from the beginning and, whenever possible to give OTP permission to discuss over-medication, etc. with a designated person; Have family members know to call OTP with questions ; Identify and remove dis-incentives for patients and their families to fully disclose poly-substance use, misuse, abuse (rewarding or encouraging honesty)

20. Strategies: Controlling Induction Risks, continued • Identify and remove dis-incentives for patients (and their families) to fully disclose poly-substance use, misuse, abuse (rewarding or encouraging honesty) • Align everyone, including all OTP staff to be diligent about identifying all potential danger signs & symptoms (i.e., red flags, etc.) of methadone and taking appropriate action thereon.

21. Elements of Informed Consent: In Methadone Maintenance Treatment • A patient’s written informed consent to [voluntary] treatment is the OTP’s program physicians’ responsibility under 42 C.F.R. Section 8.12(e)(i). • Patients’ consent represents competency to understand and appreciate what methadone is; what it’s supposed to do; how it does this; side effects and options. • Communication must include all material risks that could potentially affect the patient’s decision; enough information for the patient to be able to appreciate the risks of harm vs. benefits as they change. • Consent must be “voluntary”; can’t be given while under pressure/threat of coersion/duress (consider opioid addicts’ state in early days of withdrawal and induction)

22. Informed Consent A patient’s signature on an informed consent form is evidence that informed consent was obtained, however, it is not a substitute for the informed consent process. Consider duress of being in opioid withdrawal; coercive nature of having to sign a consent form prior to being “dosed”, etc. Patient consent is ongoing: would a reasonable person wish to alter treatment decisions based upon more or different information; if so re-new consent.

23. Elements of Informed Consent in Opioid Treatment Nature and purpose of methadone Benefits, risks and side effects of methadone Alternatives to methadone, (safer, with less side effects; etc., ie., Suboxone, Naltrexone etc.) including option of no medication/treatment Informing patients of restrictions, patients’ responsibilities, policies and procedures and potential impact upon treatment, expecially consequences of fee arrears.

24. Pharmacoviligence Pharmacological science relating to detection, assessment, understanding and prevention of adverse effects, including long and short term side effects of medicines. Used as a clinical standard potentially defining duty to verify patients’ use of prescribed drugs and to identify (and possibly prevent) dangerous drug-to-drug interactions or otherwise cause a patient to become impaired and give rise to foreseeable third parties. Instruments: use of internet technology to obtain drug-to-drug interactions

25. Multiple Sources of Impairment Initial induction dosing; over-medicating, prior to stabilization; Drug-to-drug interactions can cause impairment, i.e., benzo’s, etc. Some medical conditions, ie. epilepsy, etc. can threaten to cause or result in a patient’s impairment; Patients use of other substances, ie. alcohol, etc.

26. OTP Know or Should Know… Case law is extending liability to OTP’s for harm caused by a patient’s impaired driving when the OTP “knew or should have known” patient would drive while impaired and harm to others was foreseeable. OTP’s charged with knowledge when evidence was ignored (ie., recent urine screens, reports of patient stumbling or unable to keep eyes open on medication line); Duty to other non-patients born out of case law Tarasoff; no interception attempted; breach of duty OTP’s can’t afford to “bury heads in the sand” – should ask patients about transportation to OTP and whether alternatives means are available, etc.

27. Impairment Strategies to identify and screen for use and abuse of other substances that cause impairment and would place certain patients at higher risk (urine screens; prescription monitoring, closer observations, etc.) Strategies/tools to help identify patients who drive long distances to the OTP; OTP has duty warn patients of risks of driving while impaired and to disclose its duty to report to Motor Vehicles suspected and potential impaired drivers (see each state’s law)

28. Duty to Report/Prescription Monitoring Several states impose a legal duty to report “suspected” impaired drivers to the Dept. of Motor Vehicle; Prescription monitoring is an internet based data bank of all prescriptions written within a state’s boundaries. With a password, OTP’s can access these data banks to verify whether and which medications patients are prescribed in order to identify potential drug-to-drug interactions

29. Legal Standard: Impaired DriversTo the extent an impaired or suspected impaired patient conduct can be influenced by an OTP’s intervention, OTP’s should have a policy, procedure and practice in place to do so. • If the medical staff suspects you to be impaired so as to impose safety risk to yourself or others, you will not be medicated and will contact your safe designated driver or partner to escort you safely home until such time as you appear unimpaired. • If you deny having or being impairment, you may request confirmation via immediate field sobriety testing or drug screening tests, however if actual impairment cannot be immediately confirmed, and you insist on driving or otherwise operating a heavy vehicle/ machinery in such a way that you are placing yourself or others in a state of potential harm, the OTP will first warn and then fulfill its legal obligation to report to the department of Motor Vehicles for their determination.

30. Third Parties • Tarasoff’s duty to warn strangers, third parties who are prospective victims and imposed a duty to protect others from foreseeable risks of harm/injury • Potential harm to pedestrians and other drivers that is foreseeable (and too potentially severe to ignore); Third parties can sue for injuries caused by the actions of OTP patients.

31. Take Home Medications - Law Federal Regulations permit OTP’s to circumvent usual take-home criteria (rather stringent) for all patients on Sundays and holidays when the OTP is closed. However, this regulation does not absolve OTP’s of their standard of care and duties to patients and foreseeable third parties. Still have duty to make sure all patients handle medication responsibly and meet other criteria.

32. Comparative vs. Contributory Negligence Contributory negligence – a defense in negligence suits wherein the plaintiff was barred from bringing suit if negligent at all; Most states mandate that plaintiff cannot be half (50%+) or more than half responsible (51%+) to file a complaint (modified comparative fault system), but can otherwise have liability apportioned out among and between plaintiff and defendants, Several states today have “pure comparative negligence” case law and/or statutes that allow plaintiffs to bring negligence suits but then to apportion liability according to relative fault..

33. INDUCTION TOOLKIT • Initiate additional admission criteria (or conditions of admission) that inform patients prior to admission about patients’ responsibilities in partnering to help control risks associated with induction dosing, impairment (due to poly drug misuse) and take-home medications; • Explore use of Narcan for overdose reversals; • Include use of phone calls to monitor new patients throughout the day

34. INDUCTION TOOLKIT, cont. • Restrict new admissions to Mondays – Thursdays, early enough to allow for 4-5 hour induction dose observations. • Institute home phone call monitoring to all new patients for first five days minimum; • Distribute, read, discuss and review pamplet, “Follow Directions: How to Use Methadone Safely”, U.S. Dept. Health & Human Services/SAMHSA publication (Appendix)

35. INDUCTION TOOLKIT, cont. • Make sure patients and their housemates know to respond immediately when palpitations, dizziness, lightheadedness or fainting. NEVER LET HIM/HER “SLEEP IT OFF”. Distribute to patients’ and families “Addiction Treatment Forum” Vol 16, #3, Summer 2007, Strategies for Reducing Overdose Deaths and What to Watch for – Signs & Symptoms of Overmedication/Overdose (Appendix) • REFER to “Addiction Treatment Forum” Methadone-Drug Interactions, (3rd/2005 [4th] Edition) for thorough resource for methadone and medications, illicit drugs & other substances (Appendix) • Clinical Suggestions for Minimizing Methadone-Drug Interactions • Drug Interaction Resources on the Internet - atforum.com

36. INDUCTION TOOLKIT, cont. • Consider “time management” training specially tailored for OTP physicians, medical directors and other healthcare professionals for time saving strategies to assure adequate chart documentation to substantiate individual patient care. • Distribute and review Dr. J.T.Payte’s “Methadone Induction Guide” (Appendix) • Incorporate patients’ family members, significant others in education, participation in preventing safety risks, etc.

37. TOOLKIT: IMPAIRMENT/DRIVING Initiate new questionnaire that records the mode, route and total miles of transportation to and from the OTP each day, and work, where applicable for each patient. • Include whether public transportation would be a possible option in an emergency and the names and phone numbers of two persons who could be counted on as “designated driver” in case alternative means were needed

38. IMPAIRMENT TOOLKIT, cont. • Explore use of standardized field sobriety tests and drug impaired driving assessments • Proactive planning to develop policies and procedures for intervening when impairment is suspected (see above)

39. Consent as a Risk Transfer Option • A tool to “transfer” some of the risk back onto the patient who, after all, retains control of behavioral risk(s) (Check with State laws/regs.) • Patient agrees to refrain from driving automobile if the OTP determines probable impairment to a point where unsafe to drive and to avoid a foreseeable risk of harm to driver and members of the public, driver surrenders keys for safe transportation alternative.

40. TAKE-HOME TOOLKIT Monitor patients’ take-home medications by imposing a “bottle re-call or call back” procedure where patients are randomly asked to come in with their medication; Conduct random home safety inspections Use of lock or storage boxes – make patients pick-up medications in the boxes (although risk of making patients targets of those who would steal or purchase) Random checks to make sure lock boxes function

41. Screening for Sources of Third Party Take-Home Tips • Screen patients who have children in their home; increased diligence about protecting them from harm; assuring safe use of medication. • Do not drink medicine in front of children; they tend to mimic older people • Screen for patients who are using/abusing substances and are more vulnerable /higher risk to sell medication; (have been cases where patients who sold medication were charged criminally)