Laura Weiss Roberts, MD, MA

Mental illnesses affect men and women, children and the elderly, and communities and entire nations. Neuropsychiatric disorders, moreover, are the second-leading cause of disability throughout the world. Psychiatry centers on the care of people living with these severe and burdensome illnesses, and over the past 3 decades in particular, our profession has sought advances both in the neuroscience of these illnesses and in the development of novel, evidence-based treatments-including psychopharmacological interventions.

Psychotropics are now among the most commonly prescribed of all medications, and the widened use of these agents has improved the lives of millions of individuals living with mental illness. Nevertheless, greater reliance on psychotropics has created ethical and societal concerns. Some concerns relate to the risks of pharmacological interventions, such as the paradoxical finding that depressed children who take antidepressants may have an increased risk of suicidal behavior relative to those receiving placebo. Moreover, there are potentially serious adverse metabolic effects (eg, hyperglycemia, diabetes) associated with atypical antipsychotics. There are also concerns about the widespread application (some would say overprescription) of psychotropics-a controversy that is further fueled by the fact that nonpsychiatric providers are the source of most psychotropic prescriptions in the United States.

There is no consensus that cosmetic psychopharmacology is absolutely unethical, and parallels have been drawn with plastic surgery for physical enhancement.

New ethical issues have arisen around the use of psychotropics (such as stimulants) to enhance the cognitive performance of healthy individuals. Readers are referred to a recent review of the “cosmetic” use of neuroenhancers by Geppert and Taylor.

Psychopharmacological competency necessitates a sensitivity to ethical considerations (

 Our aim here is to provide a brief overview of how psychiatrists may approach psychopharmacological treatment in an ethical manner. We first describe the basis for prescribing these agents in sound clinical practice; we then briefly cover a handful of key topics on psychopharmacological ethics.

Before a patient is offered a psychotropic medication, a thorough diagnostic evaluation and careful review of the patient’s history (including past symptoms and response to treatment) are essential. Learning what the patient’s hopes, greatest concerns, and motivations are is essential to developing an appropriate therapeutic strategy that may include the use of psychopharmacological agents to address specific target symptoms. The goal is to prescribe psychotropic medications only when they are clearly indicated and when there is a strong evidence base. In many circumstances, combined biological and psychosocial interventions may offer the greatest therapeutic benefit.

What is already known about the ethical use of psychopharmacology? 
? Psychotropic medications are among the most commonly prescribed of all pharmacological agents. Psychotropics have improved the lives of millions of individuals living with mental illness. Significant controversy exists surrounding ethical best practices in the prescription of psychotropics.

What new information does this article add? 
? This article provides an overview of the salient ethical issues that practitioners encounter.

What are the implications for psychiatric practice? 
? Psychiatrists who develop and refine their ethics “skill set” will be in a better position to anticipate and respond to ethical dilemmas as they arise in the course of their practice.

The ethical practitioner needs to keep up-to-date with empirical findings on all somatic and psychosocial treatments, including their indications, adverse effects, and contraindications. Moreover, clinicians who prescribe medications should be prepared to recommend relevant data-driven psychotherapies and psychosocial interventions that may be indicated as first-line treatment or as important adjunctive treatments-even if these must be provided by another practitioner. An ethical practitioner will also be able to engage in a trusting and grounded informed consent dialogue with the patient.

If the diagnosis is uncertain, the goals of treatment are unclear, or the clinician is not confident of what steps to take next, then consultation with another individual with relevant expertise is prudent. This is particularly true with patients who have multiple problems and perhaps multiple possible diagnoses or with those who are especially difficult interpersonally. Be prepared to document the patient’s response to treatment in a manner that may be helpful in the future and, with the patient’s permission, to communicate in a collaborative manner with others who are involved in the patient’s care-such as a psychotherapist, a primary care provider, or family members.

Informed consent is the legal and ethical foundation of ethical health care.

 It is predicated on the therapeutic relationship and involves the provision of information, the decision-making capabilities of the patient, and authentic voluntarism.

The therapeutic relationship is deeply respectful of the patient and places primacy on promoting health and alleviating suffering as the basis for any treatment recommendation. It is dedicated to beneficence and nonmaleficence (ie, seeking good and avoiding harm in the patient’s care).

The information-sharing element of informed consent stresses the importance of communicating accurate, appropriate, and balanced information regarding the risks and benefits of treatment and treatment alternatives-including the risks and benefits of no treatment. Moreover, information sharing should incorporate the attitudes and values of the patient to the fullest extent possible.

It can be difficult to know how much information to bring into the discussion with the patient. More often than not, the “reasonable person” standard guides how much information to share-in other words, what would a reasonable person need or wish to know to make a decision? If the likelihood of benefit is great and the adverse effects are limited and far less burdensome than the illness itself, then the information to be shared will be far less than if the promise of benefit is small and the adverse effects are extensive, very burdensome, or severe. In particular, if adverse effects of treatment are rare but are life-threatening, they should be made explicit in the consent dialogue.

Furthermore, informed consent requires that the patient have sufficient decisional capacity to understand the question at hand. The assessment of decisional capacity is a clinical judgment of the patient’s ability to provide an informed, voluntary decision. The evaluation of decisional capacity involves careful exploration of 4 elements:

• The patient’s capacity to communicate and thus his or her ability to express a preference

• The patient’s capacity to understand relevant information

• The patient’s capacity to think through choices in a rational manner

• The patient’s capacity to appreciate the nature of his illness and the recommended treatment in the context of his life

The final element of informed consent is voluntarism, ie, the patient’s ability to act in accordance with an authentic sense of what is right for him, in light of his own life context and belief system.

Voluntarism is contingent on the patient’s developmental level; consider whether his illness affects his ability to discern his preferences, whether there are psychological or cultural factors that shape his sense of being free to make the decision, and whether the context supports autonomous decision making. A child, for instance, will be less able to offer an authentic, uncoerced decision than an adult, and a prisoner with mental illness who resides in a locked facility will be less able to offer an authentic, uncoerced decision than an outpatient with mental illness who resides in a community setting.

The capacity to provide consent is always measured in relation to a specific decision. High-stakes decisions-those that involve risk to the patient or to the community, for example-are held to a higher, more rigorous standard. A distressed inpatient with psychotic symptoms and a history of self-harm who demands to leave the hospital should meet an exceptionally high standard for informed refusal of treatment in comparison with the patient who declines to have his blood drawn for a routine cholesterol check. The consequences of the first patient’s decision could be grave, whereas the second patient’s decision is unlikely to threaten life and well-being.

Other aspects of the informed consent process and criteria for ethical involuntary treatment are discussed extensively elsewhere.

High-risk pharmacotherapy clearly necessitates a very careful informed consent process. The clinician must understand all clinical alternatives and the emerging empirical literature that may have bearing on the patient’s case. Before talking with the patient about the treatment decision, it may be prudent to consult with expert colleagues.

The decision needs to be presented to the patient in a balanced manner. The patient needs to be allowed to weigh the risks and benefits in the context of his life. Facilitating collaborative decision making-such as involving the patient’s loved ones and discussing all options, including the risks of not treating-is key. Frequent follow-up and monitoring are also necessary.

A pregnant woman potentially in need of psychotropic therapy presents an example of high-risk pharmacotherapy; the psychiatrist must consider the well-being of the mother and the risk to her fetus if therapy is undertaken or discontinued. The principles of autonomy-beneficence, nonmaleficence, and justice-can guide clinicians in finding ethical approaches to providing care under such circumstances.

 emphasizes the importance of relational ethics, ie, an emphasis on the perspective that the well-being of the patient and her baby are intertwined rather than at odds.

Clinicians also need to anticipate and reduce the risks of ethical dilemmas that arise at the onset of care. Preventive ethics includes proactive discussions about family planning when treating women of childbearing age, before they become pregnant.

In psychiatric practice, patients commonly present with symptoms for which there are few or no FDA-approved treatments.

 Clinical innovation is needed to help patients. By definition, clinical innovation poses an ethical risk because it involves the application of interventions that have not been well or sufficiently proved in a research setting.

Turning to innovation and, on some level, deviating from usual standards of care, entails careful thought and a clear rationale, as described in the ethical decision tree in 

This approach is in keeping with that of Ghaemi and Goodwin,

 who have emphasized that clinical innovation in psychiatry should not be discouraged but, rather, should occur under ethical conditions. Clinical innovation should be based on a scientific hypothesis. In addition, clinicians should report their observations, such as unexpected psychotropic effects, so that they can be evaluated by the scientific community. Throughout treatment, a high standard of informed consent-along with other safeguards essential to clinical practice-should be maintained.

Much of pediatric psychopharmacology is inherently innovative because children’s mental health issues have received little attention or research. Moreover, there is often a limited scientific database to guide evidence-based use of medications in children with mental illness. The neurodevelopmental impact of exposure to psychotropic medications is as yet unknown. However, not treating the symptoms of mental illness, especially when they are severe and interfere with healthy development and sustenance of emotionally important relationships, has potentially devastating consequences for the child.

The prescription of psychotropics for children and adolescents includes key safeguards that should be carefully documented. First, the patient should have an appropriate evaluation that encompasses psychiatric and medical areas and that includes basic considerations, such as measures of physical growth, as well as laboratory testing. This evaluation may be performed through a team approach with a pediatrician. Before undertaking treatment, the practitioner should engage the parents and, to the extent possible, the child in an informed consent process that explains the illness, the proposed treatment and the alternatives, and the anticipated outcomes of each. The consent information must include FDA black box warnings.

Beyond the parents’ consent, the youngster should be informed about the basics of the illness and treatment options, and assent should be sought. This assent can be revisited as the young person matures. The treatment approach may require revision if the patient no longer provides assent. In recent years, the rights of the “mature minor” who possesses sufficient cognitive and emotional ability to provide informed consent for mental health and substance abuse treatments have been emphasized.

 Over time, diligent collaboration with the primary care provider and parent for close monitoring of adverse effects and drug interactions is critically important.

The historical premise of clinical care is to heal, relieve suffering, and aid in the remission of symptoms. As in other specialties of medicine, psychiatrists are now faced with the ethical considerations that accompany the use of psychotropic medications with the intent of enhancement, rather than treatment. So-called cosmetic psychopharmacology has drawn much criticism.

 There is less controversy in using psychotropic agents to treat minor depression or subclinical anxiety that may evolve into more severe illness. However, the use of medications to address symptoms such as fatigue or tension in individuals in high-demand roles or to improve cognitive performance in noncognitively impaired individuals is under scrutiny. Across all disciplines of medicine, there is no consensus that this is absolutely unethical, and parallels have been drawn with plastic surgery for physical enhancement.

New ethical standards for enhancement therapies are necessary if the use of psychotropic medications for enhancement is to become accepted practice. These new standards will necessarily entail, at a minimum, a thorough exploration of the patient’s expectations of medication benefits, the known benefits and risks of the proposed treatment, and a clear understanding of available information based on clinical and research experience. The clinician should understand the previous treatments used (including psychotherapy) and should define the overall goals for the intervention. Wherever possible, look for an evidence base to support the use of psychotropics for the condition at hand and mon-itor patients closely for the risks and benefits associated with such approaches.

Note that the logic behind clinical innovation is not quite met under the circumstance of enhancement therapy because of the first precondition-establishing a true clinical need. Moreover, the risks and burdens that accompany the intervention may be far greater than the baseline state of the individual. For in-stance, stimulant use may unmask latent bipolar disease or disrupt normal physical development in a child or adolescent. Similarly, use of anxiolytics for tension may give rise to addiction and harmful drug interactions. For these reasons, many believe that the mainstream practice of psychiatry has no place for enhancement therapies and that “cosmetic” treatment approaches produce excessive and ineffective polypharmacy and the associated negative sequelae for patients.

This position is less firmly held with psychosocial interventions, such as cognitive-behavioral therapies to enhance performance in, for example, sports or examinations. Well-informed patient “consumers” are increasingly likely to advocate for the application of these therapies in everyday life. Consequently, the use of psychopharmacological agents beyond historical clinical indications is predictable and efforts should be undertaken to develop appropriate, clinically and ethically sound guidelines for this emerging practice.

Clinical care is complex and challenging under the best of circumstances, and it becomes much harder when treating patients who express self-destructive, hostile, overly dependent, or acting-out behaviors.

 Other patients become nonadherent when their underlying illnesses are refractory to treatment or when treatment is accompanied by severe adverse effects.

 Psychopharmacotherapy may be essential for patients with multiple problems but also may pose new and unexpected ethical concerns.

Even when focused on somatic treatments, mental health clinicians must understand fundamental intrapsychic and interpersonal dynamics that may shape the care of the patient.

 Psychiatrists must have a sophisticated awareness of the antecedents of maladaptive behaviors and be able to respond to the “difficult” behaviors in a manner that places patient well-being first. The ability to respond in this way requires that psychiatrists perceive the difficult behavior as a clinical sign, not unlike a skin lesion or high blood pressure. By viewing whatever is “difficult” about the patient in this way, the clinician is more likely to be compassionate and less likely to react without thinking or to inadvertently collude with or enable the pathological condition of the patient.

 has described different personality styles and offers suggestions on how to adapt prescribing styles accordingly. For example, the patient who has a dismissive attachment style or is quick to reject others will benefit from a prescribing physician who pays greater attention to explicit communication about the treatment, sets clear treatment expectations, invites the patient to identify personal treatment goals, and prioritizes the establishment of a robust therapeutic alliance before offering psychotropic medication.

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Excellence in psychopharmacology demands sensitivity to the associated ethical considerations. The key considerations of psychiatry are both complex and dynamic, and psychiatrists who develop and refine their ethics skill set will be in a better position to anticipate and respond to ethical dilemmas as they arise in their practice.

Ethical Issues in Psychopharmacology

Ethics is an endeavor. It refers to ways of understanding what is good and right in human experience. It is about discernment, knowledge and self-reflection, and it is sustained through seeking, clarifying and translating. It is the concrete expression of moral ideals in everyday life. Ethics is about meaning, and it is about action.

In psychiatry, ethics is about the use of specialized expertise to prevent and alleviate the suffering of mentally ill individuals. Ethics in this context is unusually complex. This is partly due to the specific form of suffering that defines mental illness: the distortion of cognition, feeling, perception and behaviors and the erosion of relationships, societal role and sense of self. Mental illness affects these most basic of human qualities and, accordingly, psychiatrists enter their patients' lives in ways that are distinctly personal and distinctly powerful. The goal of treatment in this context is to relieve suffering through the transformation of the thoughts, experiences, behaviors and relationships of ill individuals. Psychiatrists' therapeutic repertoire thus encompasses skills that range from attentive listening to compassionate, insistent intervention. For these reasons, the care of people with mental illness raises extraordinarily difficult ethical questions about our understanding of personhood and about the principled use of power in clinical care.

Ethical practice in psychiatry is informed by philosophical bioethics concepts, by sound ethical skills and, increasingly, by evidence (Figure) (Appelbaum and Grisso, 1995; Grisso and Appelbaum, 1995; Grisso et al., 1995). There are several bioethics concepts that are central to psychiatry. 

 is the full regard for an ill individual's values, life experience, autonomy and dignity. 

 is the commitment of the clinician to serve faithfully the well-being and best interests of the patient without divided loyalties. 

 is the duty to do good by alleviating suffering and by working to enhance the life of the ill person, whereas 

 is the duty to avoid and minimize harm. 

 is closely linked to these principles, in that a professional should apply specialized expertise in the care of the patient, without stepping outside of one's scope of knowledge and skill. 

 relates to the obligation to protect information disclosed by patients or observed in caring for patients without their explicit permission or a legal imperative to disclose it. 

 is the duty to tell the truth and to assure accurate understanding. 

 is the equitable distribution of resources and burdens in the context of health care and research. Finally, 

 is the responsibility of the psychiatrist to live according to the shared rules governing society and, when necessary, to seek changes in the law. These ideals translate into safeguards such as therapeutic boundary-keeping; informed consent; confidentiality protections; clinical peer review and monitoring; access to emergency care; and the duty to report, duty to warn and duty to protect.

Beyond this conceptual basis, there are several essential ethics skills in psychiatric practice (Table). The first of these is the ability to identify ethical features and conflicting values present in a patient's care. Balancing the wishes of concerned parents against the confidentiality needs of their adolescent child or thinking through the need for medication for an agitated, distressed, decisionally compromised patient who is experiencing significant psychotic symptoms requires sensitivity to a number of underlying, conflicting ethical pressures.

The second skill relates to the clinician's capacity for self-observation in seeking to help and minimize harm to mentally ill patients. This proficiency is certainly essential in preventing boundary transgressions and violations in treatment, but it is also important in avoiding diagnostic errors of overemphasis or underemphasis. This second skill is also important for clinicians in recognizing when they are in situations that are uncomfortable and may signal latent ethical problems in the care of a patient.

The third skill is the ability to discern one's areas of clinical expertise and to work within one's appropriate scope of practice, except in unusual circumstances (e.g., in emergencies or in rural communities). A corollary to this skill is the commitment to ongoing education to assure that one can provide appropriate care to one's patients in relation to community and national standards. 

The fourth skill is the ability to apply a formal ethical decision-making model in response to an ethically complex patient-care situation. Different models have been proposed and possess various strengths. Jonsen and colleagues (1998) suggested a clinical ethics decision-making strategy that places primacy on beneficence and involves four major components in order of importance: 1) clinical indications; 2) preferences of patients; 3) quality of life; and 4) contextual features. Beauchamp and Childress (2001) proposed an analysis approach that examines the roles of the four main ethics principles of beneficence, autonomy, non-maleficence and justice. Hundert (1987) proposed a strategy in which conflicting values are made explicit and are resolved through prioritization and clarification.

Fifth is the ability to anticipate and work responsibly through high-risk ethical situations, such as reporting suspected abuse, hospitalizing patients against their preferences or caring for an especially difficult patient. In such situations where the clinician must intentionally use power in a manner that encroaches upon usual rights of individuals in order to assure safety, every effort must be made to do so respectfully and in a manner that minimizes the invasiveness and burden of the intervention.

The sixth skill is appropriate use of consultants (e.g., clinical or ethical specialists) and information resources (e.g., clinical data, codes of ethics, legal guidelines) to clarify ethical choices.

Finally, ethical psychiatric practitioners will have the skill of building in additional protections (e.g., advance directives, alternative decision-makers, confidentiality safeguards) for individuals who are especially vulnerable due to illness or circumstance.

In recent years, there is an increasing emphasis on empirical evidence in shaping ethical practices in psychiatry. Examples include the positive role of education in protecting confidentiality in small communities, strategies for enhancing informed consent processes, the creation of empirically derived and validated tools for assessing the clinical decision-making capacity of mentally ill people, the influence of pharmaceutical marketing in clinicians' choices, and the effectiveness of training interventions in enhancing clinicians' ethical problem-solving skills. With the intensified focus on measurable skills in diverse competence domains, including ethics and professionalism, data-driven, performance-based testing in psychiatry residencies and specialty certification exams is also growing.

It is clear that ethical ideals, skills and evidence-based approaches map nearly exactly upon excellent clinical care practices for mentally ill patients. This is the essence of the field of clinical ethics, which is the application of insights from the multidisciplinary field of bioethics to address morally important aspects of everyday care for individual patients. The ethical dimensions of patient care are inseparable from other aspects of clinical excellence, in meaning and in action. In this approach, ethics is not extrinsic or supplemental: it is an endeavor fundamental to the care of the mentally ill and to the work of the psychiatrist.

Appelbaum PS, Grisso T (1995), The MacArthur Treatment Competence Study I: Mental illness and competence to consent to treatment. Law Hum Behav 19(2):105-126.
 

Beauchamp TL, Childress JF (2001), Principles of Biomedical Ethics, 5th ed. New York: Oxford University Press.
 

Grisso T, Appelbaum (1995), The MacArthur Treatment Competence Study III: Abilities of patients to consent to psychiatric and medical treatments. Law Hum Behav 19(2):149-174.
 

Grisso T, Appelbaum PS, Mulvey EP, Fletcher K (1995), The MacArthur Treatment Competence Study II: Measures of abilities related to competence to consent to treatment. Law Hum Behav 19(2):127-148.
 

Hundert EM (1987), A model for ethical problem solving in medicine, with practical applications. Am J Psychiatry 144(7):839-846.
 

Jonsen AR, Siegler M, Winslade WJ (1998), Clinical Ethics, 4th ed. New York: McGraw-Hill Inc.
 

Dyer AR (1988), Ethics and Psychiatry: Toward Professional Definition. Washington, D.C.: American Psychiatric Press Inc.
 

Roberts LW (2002), Informed consent and the capacity for voluntarism. Am J Psychiatry 159(5):705-712.
 

Roberts LW, Geppert C, Bailey R (2002), Ethics in psychiatric practice: essential ethics skills, informed consent, the therapeutic relationship, and confidentiality. J Psychiatric Pract 8(5):290-305.
 

Roberts LW, McCarty T, Roberts BB et al. (1996), Clinical ethics teaching in psychiatric supervision. Academic Psychiatry 20(3):72-184.

Psychiatrists must identify ethical conflicts that arise among their practice, personal beliefs, and the needs and beliefs of the patient.

Laura Weiss Roberts, MD, MA

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