Risk Management: Patient Safety; Public Safety and OTP Liability

1
Risk ManagementPatient 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 OTPs
• 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 OTPs

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 OTPs
• Not implying that application of these strategies
  or even adoption of best clinical practices will
  insulate OTPs 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 seminars 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 OTPs 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
  physicians 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 cant be measured it is estimated
  based largely on patients self-disclosure and
  proof of withdrawal.

12
Added Risks at Admission

• Dont know patient what other substances may be
  on board not certain of patients 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 hasnt 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/Overd
  ose from Addiction Treatment Forum, Vol. 16, 3,
  Summer 20007

16
OTP Core Liability Risks

• Failure to document patients 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 whats 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 patients written informed consent to
  voluntary treatment is the OTPs 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
  its supposed to do how it does this side
  effects and options.
• Communication must include all material risks
  that could potentially affect the patients
  decision enough information for the patient to
  be able to appreciate the risks of harm vs.
  benefits as they change.
• Consent must be voluntary cant be given while
  under pressure/threat of coersion/duress
  (consider opioid addicts state in early days of
  withdrawal and induction)

22
Informed Consent

• A patients 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., benzos, etc.
• Some medical conditions, ie. epilepsy, etc. can
  threaten to cause or result in a patients
  impairment
• Patients use of other substances, ie. alcohol,
  etc.

26
OTP Know or Should Know

• Case law is extending liability to OTPs for harm
  caused by a patients impaired driving when the
  OTP knew or should have known patient would
  drive while impaired and harm to others was
  foreseeable. OTPs 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 OTPs
  cant 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 states 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
  states boundaries. With a password, OTPs 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 OTPs intervention, OTPs
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

• Tarasoffs 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 OTPs 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 OTPs
  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.Paytes 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)