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Center for Substance Abuse Treatment. Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 2005. (Treatment Improvement Protocol (TIP) Series, No. 43.)

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Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs.

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Appendix D: Ethical Considerations in MAT

Medication-assisted treatment for opioid addiction (MAT) is firmly rooted in medical treatment models. Treatment decisions by MAT providers should be based on four accepted principles of medical ethics, which can be listed briefly as beneficence, autonomy, nonmalfeasance, and justice (Beauchamp and Childress 2001).

Fundamental Ethical Principles

Beneficence (Benefit)

According to Beauchamp and Childress (2001), the medical principle of beneficence emphasizes that treatment providers should act for the benefit of patients by providing competent, timely care within the bounds of accepted treatment practice. The principle of beneficence is satisfied when treatment providers make proper diagnoses and offer evidence-based treatments, that is, treatments drawn from research that provides statistical data about outcomes or from consensus-based standards of care. Beneficence is compromised when diagnoses are questionable or when outcome data do not validate a diagnosis or treatment. When MAT is carried out according to best-practice standards, the principle of beneficence is satisfied (Bell and Zador 2000).

Autonomy

Autonomy, like beneficence, springs from the ideal of promoting patients' best interests. However, whereas beneficence emphasizes the application of provider knowledge and skills to improve patient health, autonomy emphasizes respect for patients' rights to decide what treatment is in their best interests (Beauchamp and Childress 2001).

Standard medical practice places great value on patient autonomy. Usually, patients' and physicians' goals for treatment are identical, but, when they differ, physicians generally accord patients the right to make their own choices and accept the fact that patients' values may differ from physicians' values. For example, a physician might focus on extending a patient's life, whereas the patient might be more concerned with the quality of that life.

Exceptions to the principle of autonomy in standard medical practice are limited to circumstances in which patients' decisions might endanger themselves or others or in which patients may lack the capacity (because of physical or mental impairment) to make rational choices. Normally, standard medical practice does not permit an exception when patients make the “wrong” choice and the physician “knows better.” The physician may educate or perhaps attempt to persuade a patient but may not make decisions for the patient.

Nonmalfeasance—“First, Do No Harm”

The principle of nonmalfeasance emphasizes that health care providers should not harm or injure patients (Beauchamp and Childress 2001). Opioid treatment programs (OTPs) are on strong footing in terms of this principle. Before entering MAT, patients have been ingesting illicit opioids (and often other substances) and exposing themselves to serious health risks. Patients entering MAT are also at risk of arrest and imprisonment for illegal activities to support their addictions.

Once enrolled in OTPs, patients begin ingesting medications that have been manufactured in a regulated setting. The risks associated with injecting or otherwise ingesting substances of abuse produced under unknown conditions are gradually eliminated. Patients come under the care of professionals who monitor adverse drug reactions and attend to other health care needs. However, MAT carries risks of its own, including an increased risk of death in the induction phase of pharmacotherapy if medication dosage is not adjusted carefully (see chapter 5).

Justice

The principle of justice emphasizes that treatment providers should act with fairness (Beauchamp and Childress 2001). Sometimes this principle is expressed as the duty of providers to treat patients in similar circumstances equally and to use resources equitably. When treatment resources are limited, it may be unclear how to apply this principle in MAT. The principle of justice also applies when treatment providers consider the involuntary discharge of patients.

Besides emphasizing that clinicians should act fairly toward patients, the principle of justice imposes a responsibility to advocate politically and socially for resources (including adequate funding and better treatment by other medical providers) to meet the needs of patients in MAT.

Ethics in Practice

Conflict Between Beneficence and Autonomy

A conflict arises between the principles of beneficence and autonomy when a treatment provider and a patient disagree about what is in the patient's best interest and how treatment should progress. Exhibit D-1 describes such a clash in which a provider believes that stopping all illicit drug use is feasible and in the patient's best interest but the patient disagrees or cannot comply. One or both of the following questions express the source of controversy:

  • What is the proper balance between respect for a patient's autonomy and a provider's responsibility for that patient's health?
  • Should the patient or the clinician decide what is in a patient's best interests?

Exhibit D-1. Case Example

R.S., a 35-year-old man who has been in MAT for 18 months, is in his second MAT episode. The first ended when he was arrested and imprisoned for armed robbery. R.S. has not missed medication appointments but is less attentive to counseling sessions. He regularly uses alcohol and marijuana and occasionally cocaine. R.S. is unwilling to stop using alcohol and drugs. His position is that he has stopped his use of illicit opioids entirely, which was his goal entering treatment. His other drug use is his choice, and the clinic should “get off his back.”

Patients in MAT who stop their opioid abuse but not their abuse of other substances (i.e., “noncompliant” or “nonresponding” patients) are a major research focus. The literature is replete with studies of strategies, such as contingency contracting (see chapter 8), that use patients' dependence on their treatment medication to compel their compliance with treatment-related mandates. These strategies “are based on the assumption that patients have the necessary skills to produce drug-free urine samples but often lack sufficient motivation” (Iguchi et al. 1996, p. 315). Examples of mandates enforced by contingency contracting include adoption of and adherence to a drug-free lifestyle (Iguchi et al. 1997), attendance at additional therapy-related sessions (with or without a significant other) (Iguchi et al. 1996; Kidorf et al. 1997), and performance of employment-related tasks (Kidorf et al. 1998). Training in substance abuse treatment provides treatment providers with an awareness and understanding of patients' tendencies toward denial, minimization, and rationalization of their substance use. A working familiarity with such studies provides treatment providers with a reasonable basis to choose beneficence over autonomy when they conclude that they know better than patients what is in patients' best interest.

The conflict between beneficence and autonomy is not unique to MAT, but it is especially acute in MAT because of the fundamental power imbalance between treatment providers and patients. Patients in OTPs depend on their medication and may fear the effects of withdrawal from it. That dependence gives providers (and the principle of beneficence) the upper hand. Patients who refuse to comply with provider views of what is in their best interests risk administrative discharge or other sanctions. Until recently, only an OTP could provide patients with medication, ensuring the OTP's hold over patients. Often no other facility exists from which to obtain MAT.

Why do treatment providers in OTPs lean toward the principle of beneficence and away from the principle of autonomy in their approach to patients? The following factors may apply:

  • A longstanding, complex regulatory system that favors a rule-governed perspective in OTPs
  • Belief that patients in denial cannot act in their best interests
  • Disagreement about goals between patients and treatment providers
  • Attention to community concerns
  • Effects of noncompliant patients on staff, patients in compliance, and new patients
  • Discomfort with the disease model (see below)
  • View of patients in MAT as failures
  • Limited research examining the precept that complete abstinence is in patients' best interests.

Clinicians Who Are Uneasy With the Disease Model

MAT providers generally embrace the concept of addiction as a chronic relapsing disease; however, unlike medical professionals treating other chronic illnesses, some providers appear uncomfortable with the idea of alleviation of symptoms without cure (Hunt and Rosenbaum 1998, p. 202). These providers might draw on lessons from physicians caring for patients with other chronic diseases. How do they deal with noncompliant patients who fail to alter their diets or lifestyles, for example? Based on the disease model underlying comprehensive maintenance treatment, total abstinence may be unrealistic in the short run for some patients. When OTPs refuse to recognize that immediate abstinence is unrealistic and punish patients for the continuing but reduced presence of symptoms, they are not defining addiction as a disease. The long-term goal is always reducing or eliminating the use of illicit opioids and other illicit drugs and the problematic use of prescription drugs; but, in the short run, patients should be supported as they reduce their substance use.

Research suggests that many patients are aware that they may relinquish their autonomy when they enter MAT. A study about the attitudes of patients receiving methadone found that many see OTPs as institutions that control and punish more than they help—OTPs are agents of conventional society (Hunt and Rosenbaum 1998).

Some Patients' Perspectives

“[C]lients often felt that the relationship between themselves and their counselors was less focused on therapy than power; less about psychological growth, getting help and a sense of well-being than about social control, conforming to rules and regulations, and punishment.” (Hunt and Rosenbaum 1998, p. 209)
“[Study participants] were also aware and fearful that having once adopted the culture of the clinic they would become dependent on it, and more significantly on the goodwill of individual counselors. This dependence was particularly troubling to them because of the increasing insecurity of subsidized slots. Many users expressed concern about once having entered the system and accepting its lifestyle with little or no warning they would be ejected from it. … [M]any study participants felt, precisely because of the asymmetrical relationship between the client and the clinic, the staff used this as a way of exacting compliance.” (Hunt and Rosenbaum 1998, pp. 200–201)

In the opinion of Bell (2000, p. 1741), “Patients need protection because many are reluctant to complain because they have a sense of powerlessness and do not want to jeopardize their treatment.” Providers at OTPs should be aware of any bias toward the principle of beneficence and away from the principle of autonomy. Rather than assuming that the tilt toward beneficence is always correct, treatment providers and administrators should ask themselves in each case whether they are striking a proper balance between these two fundamental principles.

Other Conflicts Among the Four Principles of Medical Ethics

Involuntary discharge

An OTP's decision to discharge a patient against his or her wishes calls into question all four ethical principles. Involuntary discharge appears to breach practitioners' duties to put patient health first, do no harm, and respect patients' wishes, as well as to avoid harm to the community from reintroducing the effects of untreated opioid use (especially criminal behavior and potential disease transmission). Yet an OTP often must balance the interests of individuals facing discharge with those of other patients, staff, future patients, and the larger community and society.

Threats to safety

When a patient commits or threatens an act of violence against another patient (on OTP premises) or against staff (on or off OTP premises), comes to treatment armed with a weapon, or deals drugs at or near an OTP, that patient poses a threat to the safety of the program, its staff, and its patients. Involuntary discharge of such a patient, although not in his or her best interests, takes into account the OTP's ethical responsibility to the rest of its patients (current and future), its staff, and others. The consensus panel believes that patient behavior threatening the safety of patients and staff or the status of the program in the community is grounds for patient discharge. OTP administrators may need to make difficult judgments about what constitutes threatening behavior (especially in light of deficits in interpersonal skills and possible untreated co-occurring disorders) and evidence of drug dealing. But an OTP's responsibility to provide good treatment for its other patients—indeed, its responsibility to remain a viable resource in the community—requires that these limits be set and enforced.

Failure to pay

Involuntary discharge for failure to pay treatment fees presents a more difficult ethical issue involving the limited financial resources of many patients and the uneven public funding of MAT. Patients discharged for inability to pay or because their OTPs have lost funding might have been doing well, and terminating treatment, in most cases, will halt their recovery or precipitate relapse (Knight et al. 1996a ). Although involuntary discharge for failure to pay fees appears to violate the principles of autonomy, beneficence, and nonmalfeasance, the unfortunate reality is that OTPs must operate within fiscal constraints. If OTPs continue to deliver uncompensated care, they may face financial ruin—a consequence that would jeopardize treatment for all patients (including those who continue to pay). Nonetheless, OTPs considering patient discharge for nonpayment should address the principle of nonmalfeasance, at least in part, by mitigating harm to patients, for example, by working out payment schedules, assisting with access to insurance or other funding sources, or facilitating transfer to lower cost facilities. In 2003, the American Association for the Treatment of Opioid Dependence (AATOD) released new recommendations addressing involuntary withdrawal from treatment for nonpayment of fees (www.dmhas.state.ct.us/opioid/withdrawal.htm).

Failure to respond

Another difficult ethical issue occurs when an OTP proposes to discharge a patient involuntarily for failure to respond to treatment. No matter which principle the OTP follows, it will fail to uphold another—perhaps even the very principle it is seeking to uphold. An OTP has at least two choices, and all four ethical principles are implicated.

To discharge. When an OTP discharges a noncompliant patient, it risks violating the principle of beneficence because discharge might lead to a poorer health outcome for that patient and perhaps repercussions for the community. Indeed, because research has shown that discharge from MAT leads to poor outcomes, by pursuing the principle of beneficence to its logical conclusion of involuntary discharge, the OTP may be putting a patient's health at greater risk. The OTP may be violating the principle of nonmalfeasance as well, especially if it is unaware of the possible consequences of involuntary discharge.

Involuntary discharge of noncompliant patients often occurs when OTPs have waiting lists. When limited slots exist—because of the limits of public sector funding or regulatory caps on slots—and applicants are waiting for treatment, pressure mounts to discharge patients who are not fully compliant with treatment regimens. Concerns about the fairness of continuing to treat a patient who is unwilling or unable to take full advantage of treatment appeal to the principle of justice.

Not to discharge. Arguably, when treatment providers do not discharge noncompliant patients but continue treating them, they risk violating the principle of beneficence because they are not providing care they believe will promote patient health. By ignoring the effect noncompliant patients have on the therapeutic milieu for other patients, providers are violating the principle of beneficence for those other patients. Treatment providers who continue to treat noncompliant patients also violate the principle of justice by denying treatment to potential patients on the waiting list.

OTPs should decide how to respond to treatment noncompliance based on factors and principles discussed above and patients' specific circumstances. No single decision is correct in all cases. The OTP has an ethical responsibility to consider these principles and the effect of discharge on patients and the program.

Take-home privileges

The decisions a medical director makes about take-home privileges, although not as stark as those related to involuntary termination, also require that all four ethical principles be weighed. Patients are usually interested in increasing their autonomy and ability to carry out normal daily activities by reducing visits to their OTP for medication, but the medical director must consider what is safest for patients. Take-home medication privileges might benefit a patient by reducing his or her exposure to an OTP's less stable patients and making it easier for the patient to lead a normal life, by providing an incentive to further enhance recovery, and by expressing a program's confidence in the patient's progress. However, increased take-home privileges may pose a risk to a patient of overmedication and lethal use and to people in the community of drug diversion or accidental life-threatening ingestion by intolerant individuals (e.g., children). Federal regulations governing OTPs require that a medical director deciding whether to allow or increase patient take-home privileges consult the principle of nonmalfeasance by considering the risk of harm to patients or others (42 Code of Federal Regulations, Part 8 § 12(i)(2)).

The longstanding concern with methadone diversion also is rooted in the principle of justice. OTPs are under considerable public scrutiny. If an OTP gives take-home privileges to irresponsible patients and those patients, their family members, or others in the community are harmed, the OTP's operations may be restricted or the OTP might be shut down. When an OTP closes its doors, its responsible patients—and the staff and ultimately the community—suffer. Therefore, it is important to consider a patient's behavior carefully—not just the time in treatment—before allowing take-home medication.

A word about due process

The decision to discharge a patient involuntarily or adjust take-home privileges might require that a treatment provider or administrator resolve factual disputes or differences in interpretation between a staff member and a patient or between two patients. It is important that an OTP provide a forum so that patients can receive a fair hearing on their versions of disputed events, including a review of the evidence and proposed sanctions. Some States require additional due-process procedures.

Ethics: Conclusion

OTP staff members can avoid or minimize some ethical dilemmas by remaining aware of sources of potential conflict, keeping ethical principles in mind, familiarizing themselves with the ethical standards of their profession, and discussing potential conflicts with patients and other staff members. The goal always is reducing or eliminating the use of illicit opioids and other illicit drugs and the problematic use of prescription drugs. Exhibit D-2 presents the canon of ethics adopted by AATOD. Exhibit D-3 provides Internet links to the ethical guidelines of other treatment-centered organizations.

Exhibit D-2. AATOD Canon of Ethics

• Ensure that patients are treated with compassion, respect, and dignity regardless of race, creed, age, sex, handicaps, or sexual orientation.
• Retain competent and responsible personnel who adhere to a strict code of ethics, including but not limited to prohibiting of fraternization with patients, exploitation of patients, and criminal behavior.
• Subscribe to the treatment principles published in TIP 43, Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs, which serves as a resource in making therapeutic decisions.
• Provide patients with accurate and complete information regarding methadone treatment, the nature of available services, and the availability of alternative treatment modalities before admission and throughout the treatment process.
• Ensure that discharge from treatment is conducted in accordance with sound and medically acceptable practice. The patient is assured of due process if the discharge is administrative in nature.
• Provide a safe and clean environment for patients and staff that is conducive to the therapeutic process.
• Remain in compliance with the required Federal, State, and local operating standards.
• Take all necessary and appropriate measures to maintain individual patient records and information in a confidential and professional manner.
• Strive to maintain good relations with the surrounding community, and pursue every reasonable action to encourage responsible patient behavior and community safety.

Exhibit D-3. Ethical Codes of Selected Treatment-Oriented Organizations and Their Web Sites

American Medical Association's Code of Ethics
www​.ama-assn.org/ama/pub/category/8600​.html
American Nurses Association's Code of Ethics
nursingworld​.org/ethics/chcode.htm
American Psychological Association's Code of Ethics
www​.apa.org/ethics
Mental Health Counselors' Code of Ethics
www​.counseling.org
National Association of Alcohol and Drug Abuse Counselors' Code of Ethics
www​.naadac.org
National Association of Social Workers' Code of Ethics
www​.socialworkers.org/pubs/code/code.asp
Public Policy of the American Society of Addiction Medicine, Principles of Medical Ethics
www​.asam.org/ppol/Principles​%20of%20Medical%20Ethics.htm
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