Risk Management in OTPs Balancing Risk Management with Good Treatment (aka: Remember The Serenity...
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Transcript of Risk Management in OTPs Balancing Risk Management with Good Treatment (aka: Remember The Serenity...
Risk Management in OTPs
Balancing Risk Management with Good Treatment(aka: Remember The Serenity Prayer)
David Kan, MDMedical Director, Opiate Replacement Therapy Clinic San Francisco VA Medical Center
Overview
Practice and Malpractice DWM - Driving While on MethadoneDisability FormsInductions
Practice & Malpractice
Malpractice – The 4 D’s
Dereliction of Duty Directly leading to Damages
Malpractice
DUTY 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 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”
Malpractice
DAMAGE Must be injury to the patient that can
be proven Injury must have directly resulted
from substandard care
Relevant Legal Principles
Burden of Proof PlaintiffStandard of Proof Preponderance of EvidenceStatute of Limitations Two years in California (as of January 2003)Standard of CareReasonable Medical Probability
Standards of CareLegal Federal Code
42 CFR Part 8, 8.11-8.12 CCR, Title 9
Regulatory Bodies JCAHO CARF
Clinical Guidelines 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 Failure to obtain relevant data, e.g.,
past records, ask appropriate questions.
Errors of judgment - FORGIVING 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 Reasonable physician with similar
patient, similar circumstances Consultation meets this test
Document Best Defense NEVER ALTER RECORDS Standard of Documentation DOES
NOT EQUAL Standard of Care
Good Practice General Recommendations
Protocols and Procedures Diversion Control Consents
Contact Risk Management orLoss Prevention
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) (.01%–.04%) Possible DUI (.05%–.07%) Likely (.08% Up) Definitely DUI*
>.01% Definite DUI under age of 21
Breathalyzers in OTPs Very Common Protocols for Dose Adjustments
OTP Legal & Liability Concerns - Criminal
Drugged Driving (DUI)
1. Laws that require the drug to render driver “incapable of driving safely”
2. Laws that require the drug to impair the driver’s ability to operate safely, or require driver to be under influence of intoxicating drug”
3. Per se laws that make it criminal offense to have drug(s) in one’s body while driving
Laws Vary State by StateSlide Courtesy: Katie O’Neill, Esq, AATOD 2007
OTP Legal & Liability Concerns
California Law (CVC 23152) 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
Negligence Lawsuits by Injured Parties against: Patients OTP
Defending Liability for Patients Demonstrate legal use of methadone Confirm patient was stabilized on dose No impairment of functioning 1,2
Cognitive, Psychomotor
OTP Legal & Liability Concerns - Civil Liabilities
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 DUI Toolkit Advance Consent, prepared literature, don’t drive
orders
Limiting OTP liability 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 Is not considered a medical examination Methadone usually NOT Tested
Alcohol Testing 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
ADA trumps state/local law when conflict arises
Addiction and ADA
Brown v. Lucky Stores, 246 F.3d 1182 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)
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: Plusses – standardization, efficient Minus – standardization, efficient MD Evaluation?
Sufficient but not Necessary Trained Staff Monitoring
Induction IssuesHow Much is Too Much? 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? 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? CFR requires blood level
measurements be available Clinical Assessment Urine Toxicology Sedation in Groups
Rule-out other causes first Long Half Life
Dose Increases
How Much is Too Much? (cont.) 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):409-132. CSAM Guidelines for Opiate Treatment Programs, 2008