In Addiction Medicine ETHICS AND THE LAW July Financial Disclosures

The ASAM Board Exam Study Course in AddictionMedicineJuly 2021ETHICS AND THE LAWJacqueline Landess, MD, JDClinical Assistant Professor of PsychiatryMedical College of WisconsinMilwaukee, WIForensic PsychiatristMendota Mental Health InstituteMadison, WIFinancial DisclosuresBrian Holoyda, MD, MPH, MBAForensic PsychiatristMartinez Detention FacilityMartinez, CAFull Spectrum Health ServicesLas Vegas, NV1Jacqueline Landess, MD, JDNo Disclosures2AgendaThe ASAM Board Exam Study Course in AddictionMedicine1. Ethical Principles2. Informed Consent3. Privacy and Confidentiality4. Ethical Prescribing5. Special TopicsJuly 2021Financial DisclosuresBrian Holoyda, MD, MPH, MBANo Disclosures34Ethical PrinciplesEthical Principles Autonomy: self‐determination, self‐governance, moralindependence Beneficence: actionsshould promote patientwell‐being Example: A patient with asevere heroin use disordersees PCP who refers him toinpatient detox andcommunity recoveryresources Example: Patient withrecurrent upper GI bleedrefusing voluntary inpatientaddiction psychiatryadmission561

Ethical PrinciplesEthical Principles Non‐maleficence: do noharm (or as little asnecessary) Fairness in decisions Equal distribution of resourcesand new treatments Medical practitioners upholdlaws Example: Providing comfortmeasures for a patientundergoing heroindetoxification7Justice: Example: Advocating for apatient rejected from inpatientaddictions treatment when theinsurance provider deems it “notclinically indicated”8Ethical Principles Respect for people:treating people in amanner that acknowledgestheir intrinsic dignity Truth‐telling: honesty,sharing information9Complex EthicalScenario 40‐year‐old femaleanesthesiologist Taking opioid medicationsmeant for patients, replacingwith saline Has used oral opioids on thejob but denies problems Asks you to notify nobody10Audience Response Question #1Which of the following is NOT true regarding informedconsent?A. It must be given voluntarily.B. An individual must possess decisional capacity.C. Patients with psychosis cannot give informed consent.D. It involves the disclosure of information between thephysician and the patient.11Informed Consent Voluntariness Information disclosure Decisional capacity122

Voluntariness Freely given Coercion: punishment or excessiverewards Persuasion Influence Context‐dependent Risk of infringing SUDs treatment in custody Drug court Inpatient treatment13 Nature of illness and proposedtreatment Risks/benefits Alternatives Consequences of foregoing treatment “Reasonable person” standard High standard of disclosure Addictive medications (opioids) Harmful medications (disulfiram) Dangerous medications(methadone)14Decisional Capacity Communicate a choice Understand the relevant information Appreciate the situation and itsconsequences Reason about treatment options “Sliding scale” approach Potentially impaired Intoxication Substance‐related neurocognitiveproblems Dual diagnosis15For Those LackingCapacity Durable power of attorney forhealthcare decisions (DPOAHC):form identifying surrogate decision‐maker if one becomes incapacitated Advanced directive/living will:written statement expressingspecific wishes, does not designatehealth care POA Guardian/conservator of theperson: person appointed to makecare decisions when patient isincapacitated16Pearls There are various ethical principles underlying medicineand addictions treatment that may come into conflict The process of informed consent requires voluntariness,information disclosure, and decisional capacity Certain treatment settings have the potential to infringeon voluntariness17Information DisclosurePrivacy andConfidentiality Privacy: patient’s right toprotection of sensitiveinformation Confidentiality: clinician’sobligation to protectsensitive information 42 CFR Part 2:Confidentiality of Alcoholand Drug Abuse PatientRecords HIPAA183

42 CFR Part 2 – Covered Programs Individual, entity, or identifiedunit within a general medicalfacility that provides SUDsdiagnosis, treatment, orreferral for treatment Medical personnel/staff in ageneral medical facility whoseprimary function is provision ofSUDs diagnosis, treatment, orreferral for treatment42 CFR Part 2 – Federal Assistance Conducted in a federaldepartment or agency Supported by federal funds Carried out under a license orregistration from federalgovernment Medicare providers Authorization to conductmaintenance treatment orwithdrawal management Registration under ControlledSubstances Act to dispense asubstance used in treatment ofSUDs1920DisclosureHIPAA (‘96), Privacy Rule (‘00) Part 2 programs may only releasepatient information with the patient’sconsent Exceptions include:1.2.3.4.5.6. All PHI protectedMedical emergencyError in manufacture, labeling, or sale of aproduct under FDA jurisdictionResearchValid court order with subpoenaCrimes committed on part 2 programpremisesReporting suspected child abuse orneglect Exceptions related to medical operations and publicinterest/benefit SAMHSA working to revise 42 CFR Part 2 Failure can result in criminal penalty (afine)2122CSA Regulation/ClassificationControlled Substance Act (1970) DEA licensure requirement Schedule I: illegal, no medical use (cannabis, MDMA,methaqualone) Schedules II‐V: addictive potential II: cocaine, meth, methadone III: ketamine, testosterone IV: benzos, zolpidem V: diphenoxylate, gabapentin Classification and regulation Manufacturing Distribution Exportation and sale23244

Ethical Prescribing Patient risks SUDs Diversion Exacerbation of comorbidmedical or psychiatric illness Practices to address Urine drug testing Medication contract PDMPs25Universal Precautions1. Make a diagnosis withappropriate differential2. Psychological assessment (riskof addictive disorders)3. Obtain informed consent4. Treatment agreement5. Pre‐ and post‐interventionassessment of pain level andfunction26Audience Response Question #2Which of the following is NOT an example of misprescribing?A. Providing a patient opioids at a dangerously high dose.B. Providing a prescription for 3 months of opioids followingan uncomplicated outpatient surgical procedure.C. Providing a friend a prescription for Ativan for no medicalpurpose.D. Providing a patient a prescription for Ativan for short‐termtreatment of anxiety, only to later learn via your state’sPDMP that she had received multiple prescriptions in thelast week from different providers.27Legal Consequences Misprescribe: inappropriate rationale,dose, quantity CSA: “unlawful for any person toknowingly or intentionally manufacture, distribute, or dispense, orpossess with intent a controlledsubstance”1. Knowingly2. Without legitimate medical purpose3. Outside the course of professionalpractice State medical board sanctions Civil: malpractice Criminal: CSA, murder28Recent Case Joel Smithers, D.O. Opened practice in 2015,made 500,000 Schedule IIprescriptions Led to death of WV woman 800 federal drug charges(unlawful distribution) Given 40‐year sentence in09/2019 and 86K fine296. Appropriate trial of opioid therapy /‐ adjunctive medication7. Reassess pain score and level offunctioning8. Regularly assess 4 A’s: analgesia,activity, adverse effects, aberrantbehavior9. Periodically review diagnosis andcomorbid conditions10. DocumentationPrescription Drug Monitoring Programs 49 states (MO pending),D.C., Guam Mitigate abuse/diversion Models Non‐mandated use Proactive reporting Mandated use Criticisms Inadequate informationcollection Ineffective utilization inclinical settings Limited interstatesharing Mixed data oneffectiveness, differs bystate305

Addiction & the Law: Special TopicsPearls Confidentiality of substance abuse treatment is governed by 42 CFRPart 2, HIPAA, and the Privacy Rule The Controlled Substances Act of 1970 established the DEA regulationand classification of addictive drugs and criminal penalties fordistribution of drugs There are various models of ethical prescribing that generally involveinformed consent, regular assessment and dose planning, andappropriate clinical documentation PDMPs, though potentially helpful, differ in their implementation andeffectiveness31 AdolescentsPregnant patientsJustice‐involved populationsCivil commitment & substance useAmericans with Disabilities Act (ADA)Impaired Physicians32Audience Response Question #3A 15‐year‐old patient comes to you requesting treatment for alcoholuse disorder. Which of the following scenarios most likely requiresguardian informed consent before initiating treatment?ADOLESCENTS,ADDICTION & THE LAW33A.B.C.D.E.She is a mature minorShe is marriedShe is serving in the militaryShe has run away from homeShe is experiencing severe withdrawal34Legal Standards: MinorInformed Consent 35Mature Minor Doctrine Age of majorityMinor’s ability to consent General medical care Mental health Substance use disordersEmancipation Legal Marriage, military Other forms Mature minors Have children High school graduate DefinitionAssessment of maturity: Age & maturity Emotional capacity Intelligence Risk of procedure/treatment Benefit to minorInformed consent assessment: Risks of forgoing treatment Long term consequencesBrain development, impulsivity & “charged”environments366

Consent for Inpatient Substance TreatmentLallemont et al. (2009)Minor Consent for SUD Treatment Laws vary by state Minimum age of consent can range from age 12‐16 May be able to consent to some services but not others Detox Outpatient Inpatient Parental notification may still be required3738Adolescent Autonomy,Privacy & Confidentiality Parental involvement Confidentiality can be preserved Insurance & privacy39Pearls State laws vary regarding minor consent requirements andmay allow for a mature minor to consent Adolescents usually have the greatest autonomy to consentfor substance use disorder treatment compared to othermedical treatments When treating an adolescent patient, involve parents ifpossible while preserving the adolescent’s confidentiality40Legal Consequences OfSubstance Use In Pregnancy PREGNANCY, SUBSTANCE USE& THE LAW 41Criminal Feticide laws (38 states) Chemical endangerment of a child(Amnesty) Direct criminalization of use duringpregnancyCivil Child welfare (23 states DC) Civil commitment (3 states)427

Reporting Requirements to Child WelfarePearls(Jarlenski, Guttmacher. Org) Mandated reporting of child abuse/neglect Standard: Reasonable belief or suspicion for abuse Prenatal drug use & Substance Exposed Newborns Clinical & ethical problemsGuidelines Inform of any mandated reporting requirements & limits ofconfidentiality Obtain informed consent before drug testing (ACOG)43 A person who uses substances during pregnancy can besubjected to civil or criminal penalties in many states Mandated reporting requirements of perinatal substance usevary across states Obtain informed consent before drug testing, includingnotification of reporting requirements44Audience Response Question #4Approximately what percentage of women who areincarcerated in jail have a substance use disorder?JUSTICE‐INVOLVED POPULATIONS45A. 25%B. 33%C. 50%D. 75%E. 90%46The NeedStatistics 6.8 million under supervision orincarceratedHistory of incarceration in theU.S.SUDs & incarceration 75% will relapse within 3months of release (SAMHSA)MAT INCORRECTIONS Over 50% with active SUD 75% of women have SUD 10‐ 15% receive treatment 100x more likely to die ofoverdose within 2 weeks ofrelease (BJS, Binswanger)Barriers Lack of education Substituting “one drug foranother”/abstinence mentality Diversion concerns CostLack of community providers to startor continue MATBUT, more pilots across the U.S.Wikimedia.org47488