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Risk Management:
Patient Safety; Public Safety
and OTP Liability
Lisa Torres, JD
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
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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.
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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
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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
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Risk Management Cycle
Define Scope
and Frameworrk for
OTP’s Risk Management
Strategy
Communication
Throughout OTP
Risk Awareness
Monitoring &
Ongoing Review
Risk Assessment:
Identify risk(s)
Analyze
Evaluate
Risk Treatment
Identify options
Develop Plan of Action
Approve &
Implement
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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
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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.
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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.
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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
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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
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withdrawal.
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.
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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.
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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
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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
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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.
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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.
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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.
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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)
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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.
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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)
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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.
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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.
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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
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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.
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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.
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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 27
(see each state’s law)
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
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Legal Standard: Impaired Drivers
To 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
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determination.
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.
•
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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.
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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..
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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
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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)
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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” MethadoneDrug 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
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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.
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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
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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)
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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.
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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
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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)
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