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