Transcript Risk Management in Opioid Treatment Programs

Risk Management
in OTPs
Balancing Risk Management with
Good Treatment
(aka: Remember The Serenity Prayer)
David Kan, MD
Medical Director, Opiate Replacement Therapy Clinic
San Francisco VA Medical Center
Overview
Practice and Malpractice
DWM - Driving While on Methadone
Disability Forms
Inductions
Practice & Malpractice
Malpractice – The 4 D’s
Dereliction of
Duty
Directly leading to
Damages
Malpractice
DUTY
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Is this your patient?
If someone is not your patient you cannot
be sued for negligence
Physicians can still choose whom their
patients will be
Some exceptions
Malpractice
DERELICTION
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A breach or violation of the standard of
care is a necessary element
What is Standard of Care?
Malpractice
DIRECTLY
The breach of the standard of care
must directly cause injury to the
patient.
 Aka: “proximate cause”
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Malpractice
DAMAGE
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Must be injury to the patient that can be
proven
Injury must have directly resulted from
substandard care
Relevant Legal Principles
Burden of Proof  Plaintiff
Standard of Proof  Preponderance of
Evidence
Statute of Limitations  Two years in
California (as of January 2003)
Standard of Care
Reasonable Medical Probability
Standards of Care
Legal
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Federal Code
 42 CFR Part 8, 8.11-8.12
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CCR, Title 9
Regulatory Bodies
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JCAHO
CARF
Clinical Guidelines
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CSAM Guide
TIPS
Common Standard of Care
“to do what a reasonable physician would do
with the same or similar patient under the
same or similar circumstances”
CONTRIBUTORY NEGLIGENCE
vs.
COMPARATIVE NEGLIGENCE
Contributory Negligence
e.g., in North Carolina:
Plaintiff has contributed to bringing
about the harm.
Any amount of contributory
negligence bars recovery by the
plaintiff.
Comparative Negligence
e.g., in California:
The allocation of responsibility for
damages incurred between plaintiff and
defendant
The reduction of the damages
recovered by the negligent plaintiff in
proportion to his or her fault
Types of Errors
Errors of fact - UNFORGIVING
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Failure to obtain relevant data, e.g., past
records, ask appropriate questions.
Errors of judgment - FORGIVING
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Acted in good faith and exercised requisite
care in obtaining necessary information
and arriving at diagnosis and treatment.
Good Practice
General Recommendations
Consult, Consult, Consult
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Reasonable physician with similar patient,
similar circumstances
Consultation meets this test
Document
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Best Defense
NEVER ALTER RECORDS
Standard of Documentation DOES NOT
EQUAL Standard of Care
Good Practice
General Recommendations
Protocols and Procedures
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Diversion Control
Consents
Contact Risk
Management or
Loss Prevention
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Prior to bad outcome!
NEVER talk directly to
plaintiff’s attorney
Be honest with your
attorney.
All communications go
through your attorney.
What Do These People Have
In Common?
DRIVING UNDER
THE INFLUENCE
OTP Legal & Liability
Concerns
California DUI Law (%BAC)
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(.01%–.04%) Possible DUI
(.05%–.07%) Likely
(.08% Up) Definitely DUI*
 >.01% Definite DUI under age of 21
Breathalyzers in OTPs
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Very Common
Protocols for Dose Adjustments
OTP Legal & Liability
Concerns - Criminal
Drugged Driving (DUI)
1.
2.
3.
Laws that require the drug to render driver
“incapable of driving safely”
Laws that require the drug to impair the driver’s
ability to operate safely, or require driver to be
under influence of intoxicating drug”
Per se laws that make it criminal offense to have
drug(s) in one’s body while driving
Laws Vary State by State
Slide Courtesy: Katie O’Neill, Esq, AATOD 2007
OTP Legal & Liability
Concerns
California Law (CVC 23152)
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It is unlawful for any person who is addicted to the use of
any drug to drive a vehicle.
It is unlawful for any person who is under the influence of
any alcoholic beverage or drug, or under the combined
influence of any alcoholic beverage and drug, to drive
a vehicle..
These subdivisions SHALL NOT APPLY to a person who is
participating in a narcotic treatment program approved
pursuant to Article 3 (commencing with Section 11875) of
Chapter 1 of Part 3 of Division 10.5 of Health and Safety
Code
Opiate Replacement itself is not PER SE impaired driving
OTP Legal & Liability
Concerns - Civil Liabilities
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Negligence Lawsuits by Injured
Parties against:
 Patients
 OTP
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Defending Liability for Patients
 Demonstrate legal use of methadone
 Confirm patient was stabilized on dose
 No impairment of functioning 1,2
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Cognitive, Psychomotor
1. Lenne et al, “The effects of the opioid pharmacotherapies methadone, LAAM and buprenorphine, alone and in combination with alcohol, on simulated
driving.” Drug Alcohol Depend. 2003 Dec 11;72(3):271-8
2. Baewert, et al: “Influence of peak and trough levels of opioid maintenance therapy on driving aptitude.” Eur Addict Res. 2007;13(3):127-35
OTP Legal Responses
Limiting Patient Liability
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DUI Toolkit
Advance Consent, prepared literature, don’t drive orders
Limiting OTP liability
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Appropriate dosing / treatment decisions
Patient education
Monitoring of driving risks
IN SPECIFIC
Taking keys?
(Risk of False Imprisonment)
Disability Forms
ADA Title I and V Section 12114c
Drug addiction may be a "disability" if it
"substantially limits one or more ... major life
activities." 42 U.S.C. Section 12102(2)
Current use of illegal drugs does not make
“qualified individual with disability”
Can be qualified individual with disability
Workplace Drug Testing
Workplace Drug Testing
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Is not considered a medical examination
Methadone usually NOT Tested
Alcohol Testing
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Is considered a medical examination and thus must meet
need and necessity
Individuals with current alcohol-related disorders are
protected under the ADA
ADA does not conflict with DOT or other
Federal Regulation
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ADA trumps state/local law when conflict arises
Addiction and ADA
Brown v. Lucky Stores, 246 F.3d 1182
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Employer permitted to terminate an alcoholic employee for
violating a rational rule of conduct even if the misconduct
was related to the employee's alcoholism
Hernandez v. Hughes Missile Systems Co.,
DJDAR 6518 (9th Cir. June 11, 2002)
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Hernandez fired after Cocaine+ on Utox
Hernandez went to rehabilitation
9th Circuit ruled that Hernandez was qualified individual with
disability and history of addiction alone even related to
reason for termination was not grounds not to rehire
Induction Issues
Induction Issues
Induction Protocols:
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Plusses – standardization, efficient
Minus – standardization, efficient
MD Evaluation?
 Sufficient but not Necessary
 Trained Staff
 Monitoring
Induction Issues
How Much is Too Much?
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Methadone
 Cannot Lever dose to amount/type of drug
used
 Federal/State Limits on 1st day
 Don’t forget long half-life (8-59hrs)
 Most methadone deaths happen during
induction in non-tolerant pain patients
 Untreated opiate withdrawal itself is almost
never fatal
Induction Issues
How Much is Too Much?
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Buprenorphine (2-32mg q day)
 Safer profile due to partial agonist
 Less Clinical Experience
 Caution with Benzodiazepine / Sedatives
 Also long half-life
 Illegal to use short acting opiates in context of
opiate treatment (either detox or induction)
 AGAIN – Untreated opiate withdrawal itself is
almost never fatal
Dose Increases
How Much is Too Much?
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CFR requires blood level measurements be
available
Clinical Assessment
Urine Toxicology
Sedation in Groups
 Rule-out other causes first
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Long Half Life
Dose Increases
How Much is Too Much? (cont.)
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Long Half Life
Patients are not sensitive to acute
methadone dose changes 1
However, patients at higher doses may
require higher dose escalations
(proportionately) 2
1. Robles E Sensitivity to acute methadone dose changes in maintenance patients.
J Subst Abuse Treat. 2002 Dec;23(4):409-13
2. CSAM Guidelines for Opiate Treatment Programs, 2008