Ethical and Legal Considerations

Abstract

In this chapter, the four basic principles of biomedical ethics are discussed in relation to clinical decision-making for patients with SUDs and their families: (1) beneficence, (2) non-maleficence, (3) respect for autonomy and (4) justice. Examples focusing on decisions particular to medication treatment for OUD are presented. Stigma is considered. Additionally, some of the regulatory frameworks that affect substance use are reviewed, including current laws to expand access and availability of naloxone for opioid overdose reversal, the Harrison Narcotics Tax Act of 1914 and the Controlled Substances Act of 1970. The Narcotic Addict Treatment Act of 1974 and the Drug Addiction Treatment Act of 2000 (DATA 2000), under which opioid agonist treatments have been delivered in the United States are explored. Patient confidentiality laws such as 42 CFR Part 2 are also examined.

Review Questions

• 1. A 47-year-old African-American male who works 6 days a week in construction and a 23-year-old female Latinx patient both present to an opioid treatment program seeking maintenance treatment for their opioid use disorder. Which of the following principles of biomedical ethics is most likely to be used when offering treatment options equally among patients with substance use disorders?

  • A. Beneficence

  • B. Justice

  • C. Non-maleficence

  • D. Insurance

  Correct answer: B. Justice. Justice is the medical ethical principle that requires that treatment options are fair to all patient populations and that they remain in compliance with federal and state regulations. Beneficence and non-maleficence are other medical ethical principles unrelated to equity of treatment. Insurance is a distracting answer, and not a medical ethical principle.

• 2. A 35-year-old female construction worker residing in a suburban area is unable to commute to the methadone OTP for her opioid use disorder. She found a general medicine practitioner who is authorized to prescribe buprenorphine in a local community clinic. Which of the following legislations allowed physicians (MD or DO; and later nurse practitioners and physicians’ assistants) to obtain a waiver from separate registration requirements for Schedule III, IV, and V medications approved by the FDA to treat opioid use disorders?

  • A. Narcotic Addict Treatment Act of 1974

  • B. Harrison Narcotics Tax Act of 1914

  • C. Drug Addiction Treatment Act of 2000

  • D. Affordable Care Act of 2010

  Correct answer: C. The Drug Addiction Treatment Act (DATA 2000) amended the Narcotic Addict Treatment Act by allowing physicians (MD or DO; and later nurse practitioners and physicians’ assistants) to obtain a waiver from separate registration requirements for Schedule III, IV, and V medications approved by the FDA to treat opioid use disorder. The Harrison Narcotics Tax Act of 1914 does not regulate the clinical independence of individual providers. The Affordable Care Act of 2010 is a distracting answer.

• 3. A 27-year-old male fast food worker is concerned he may not make his shift on time if he starts methadone maintenance treatment for his opioid use disorder. He fears he may be fired from his job and questions would arise if he requests a later start time. Which of the following consequences of stigma should be addressed when probing for patient concerns regarding treatment?

  • A. Positive stereotypes

  • B. Improved self-image

  • C. Status loss and discrimination

  • D. Acceptance and impartial treatment

  Correct answer: C. If the patient’s employer finds out he needs a later start time to start treatment for an opioid use disorder, they will know he is using opioids. Link and Phelan describe status loss and discrimination as the consequences of stigma when a person is labeled with an undesirable characteristic. Positive stereotypes, improved self-image, acceptance, and impartial treatment are the opposite of experiences related to stigma.

• 4. An 18-year-old female with a history of heroin injection drug use recently completed a residential treatment program. When returning home, she used her regular heroin dose and experienced an overdose. Fortunately, her parent called 911 and first responders arrived in time to reverse the overdose. Which of the following legal interventions have helped reduce opioid overdoses in the United States?

  • A. Expansion of naloxone access

  • B. Rockefeller Drug Laws in New York State in 1973

  • C. Title 42 of the Code of Federal Regulations Part 2

  • D. Law 30/2000

  Correct answer: A. The expansion of naloxone access has directly reduced opioid overdoses by increasing the availability of an overdose reversal drug in the community. Rockefeller Drug Laws raised criminal penalties for the sale and possession of drugs, primarily heroin. Part 2 is a distracting answer, and is related to privacy laws. Law 30/2000 has helped reduce opioid overdoses in Portugal.

• 5. A 39-year-old male with 5 years of methadone maintenance treatment recently lost insurance coverage. If a substance use treatment program is subject to both 42 CFR Part 2 and HIPPA Privacy Rule, can they disclose a medical record number to obtain authorization for referring an individual to another healthcare provider?

  • A. Yes, the medical record number can be used to identify the patient by sources external to the program.

  • B. Yes, even though the medical record number can identify the patient, it is important to not delay the referral while waiting for patient consent.

  • C. No, a medical record number is considered protected health information.

  • D. No, one must contact legal counsel for assistance before reaching a decision.

  Correct answer: C. Under the Privacy Rule, a program may not use or disclose protected health information, which includes information that may identify a patient such as the medical record number. The other options are distracting answers.