Risk Management in OTPs

1. 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

2. Overview • Practice and Malpractice • DWM - Driving While on Methadone • Disability Forms • Inductions

3. Practice & Malpractice

4. Malpractice – The 4 D’s Dereliction of Duty Directly leading to Damages

5. 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

6. Malpractice • DERELICTION • A breach or violation of the standard of care is a necessary element • What is Standard of Care?

7. Malpractice • DIRECTLY • The breach of the standard of care must directly cause injury to the patient. • Aka: “proximate cause”

8. Malpractice • DAMAGE • Must be injury to the patient that can be proven • Injury must have directly resulted from substandard care

9. 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

10. Standards of Care • Legal • Federal Code • 42 CFR Part 8, 8.11-8.12 • CCR, Title 9 • Regulatory Bodies • JCAHO • CARF • Clinical Guidelines • CSAM Guide • TIPS

11. Common Standard of Care “to do what a reasonable physician would do with the same or similar patient under the same or similar circumstances”

12. CONTRIBUTORY NEGLIGENCE vs. COMPARATIVE NEGLIGENCE

13. 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.

14. 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 Comparative Negligence

15. 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.

16. 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

17. 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.

18. What Do These People Have In Common? DRIVING UNDER THE INFLUENCE

19. 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

20. OTP Legal & Liability Concerns - Criminal Drugged Driving (DUI) • 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

21. 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 combinedinfluence 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

22. OTP Legal & Liability Concerns - Civil Liabilities • 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 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

23. 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)

24. 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

25. 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

26. 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

27. Induction Issues

28. Induction Issues • Induction Protocols: • Plusses – standardization, efficient • Minus – standardization, efficient • MD Evaluation? • Sufficient but not Necessary • Trained Staff • Monitoring

29. Induction Issues • How 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

30. 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

31. 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

32. 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):409-13 2. CSAM Guidelines for Opiate Treatment Programs, 2008