advertisement

Ethical Issues in Psychopharmacology: Considerations for Clinical Practice

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.1

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.2

Psychopharmacological competency necessitates a sensitivity to ethical considerations.3 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.

Basis for ethical prescribing

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.

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

Informed consent is the legal and ethical foundation of ethical health care.4 It is predicated on the therapeutic relationship and involves the provision of information, the decision-making capabilities of the patient, and authentic voluntarism.5

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.6

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.3,5

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.3,7

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.8 Miller8 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.8

Clinical innovation

In psychiatric practice, patients commonly present with symptoms for which there are few or no FDA-approved treatments.2 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.9

Turning to innovation and, on some level, deviating from usual standards of care, entails careful thought and a clear rationale.

This approach is in keeping with that of Ghaemi and Goodwin,9 who have emphasized that clinical innovation in psychiatry should not be discouraged but, rather, should oc-cur 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.10 Over time, diligent collaboration with the primary care provider and parent for close monitoring of adverse effects and drug interactions is critically important.6

Enhancement therapies

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.11,12 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.13

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 instance, 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.1

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.

Caring for “difficult” patients

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.14 Other patients become nonadherent when their underlying illnesses are refractory to treatment or when treatment is accompanied by severe adverse effects.3 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.15,16 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.17,18

Mintz19 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.

Finally, the very act of prescribing medications may serve a myriad of defensive functions for the psychopharmacologist. For example, it may establish a sense of control, manage feelings of helplessness, control a patient’s affect, and subtly promote a patient’s dependency to avoid an experience of loss.20 Ongoing consultation and supervision for such difficult cases are key.3

Maintaining professional boundaries

Boundaries that separate professional conduct from behaviors inappropriate for a professional relationship (eg, ones that gratify the clinician rather than serve the patient) have important clinical and legal implications. Boundary violations are destructive to the beneficent aims of therapy and cause foreseeable harm to patients.21

The role of therapeutic boundaries is usually viewed in the context of psychotherapy but has relevance to other forms of psychiatric practice. Gabbard16 and Hoop and colleagues3 have highlighted the importance of paying similar attention to therapeutic boundaries in the context of medication management. An overt focus on somatic issues may obscure intense psychological and boundary issues. For example, in some patients, psychopathology may manifest in attempts to disrupt treatment. Being late for appointments, missing appointments, and requesting special favors demand the same consideration by the prescribing psychiatrist as the psychotherapist. Neglecting such clinical signs and failure to evaluate them further could put the relationship at risk for boundary crossings and violations.21

Perhaps where boundary issues are most relevant is in the split treatment relationship, where a patient is seeing a therapist for ongoing psychotherapy and a psychiatrist for medication management. Gabbard16 has described such treatment as a “fertile field for splitting” and other primitive defenses that may be damaging to the patient’s care. Frequent, open, and respectful communication with the psychotherapist helps ensure that the patient receives optimal care and that therapeutic goals are aligned.18

External influences on treatment choices

Everyday practice rarely resembles textbook medicine, and there are numerous external factors that influence medical decision making. In rural settings, practitioners may of necessity lean more heavily on psychotropic medications when other care options do not exist. In other contexts, the fact that government or commercial insurers offer limited benefit coverage may cause psychiatrists to implement care quickly and to organize treatment around only the most severe symptoms rather than optimizing all aspects of the patient’s care.

In recent years, other factors that may distort the choice of treatment have been increasingly recognized. Perhaps the most topical and controversial is the influence of the pharmaceutical industry in sculpting the practice and science of psychopharmacology, with consequences for patients, physicians, and society.22 Interactions of physicians with the pharmaceutical industry have been widely reported in the literature and lay press. Advertising, gift giving, providing incentives for the use of certain medications, and research funding have all been identified as ethically problematic.

Psychiatric educators have discussed problems that arise when commercial interests play a role in educating trainees about pharmacology and the pervasive influence of industry-sponsored faculty and research on the practice of psychiatry.23 It is becoming well-established that gifts given in the context of intensive advertising campaigns may create an unconscious bias in prescribing practices. Wazana24 analyzed more than 20 published studies and found that receipt of gifts adversely affected physicians’ prescribing behavior in several ways (eg, incorrect information about a medication, rapid application of a new drug, requests for newer medications that rarely hold an advantage over existing ones).

The scientific and ethical caliber of industry-funded research is also under scrutiny. In their pharmacoeconomic examination of published data, Baker and colleagues25 found that studies sponsored by drug manufacturers favored newer antidepressants over older antidepressants.

Conflicts of interest naturally occur in all of medicine because of the societal imperative for physicians to participate not only in patient care but also in research and as leaders and educators. These dual roles have inherent tensions that produce conflicts, because the goals of one role typically do not align exactly with the goals of the other.

Thompson26 described a conflict of interest as “a set of conditions in which professional judgment concerning a primary interest (eg, patient’s welfare) tends to be unduly influenced by a secondary interest (such as financial gain).” Thompson emphasized that it is not necessary to eliminate financial gain incentives but to prevent secondary factors from dominating the relevant primary interest in the making of professional decisions. It follows that psychiatrists who receive income from industry have, at a minimum, a potential conflict of interest in their relationship with patients and, at worst, a disruption of their ethical duty of fidelity and obligation to the primacy of patient welfare.

There have been greater efforts to explicitly manage conflicts of interest related to interactions with industry.27 Since 2004, many steps have been taken at institutional, state, and national levels to limit such relationships. Gifts and incentives physicians have received from the pharmaceutical industry have been sig-nificantly reduced.28

Conclusion

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.

[At the time of this writing], Dr Roberts is Katharine Dexter McCormick and Stanley McCormick Memorial Professor and chairman and Dr Jain is a postdoc-toral medical fellow in the department of psychiatry and behavioral sciences at the Stanford University School of Medicine. Dr Roberts reports that she is the owner of Terra Nova Learning Systems (TNLS); she has received federal funding for competitive, peer-reviewed research grants and competitive, peer-reviewed small-business grants and contracts; she serves as a consultant for federally funded scientific projects with collaborators across the United States. She does not receive direct funding from pharmaceutical companies for her work. Dr Jain reports no conflicts of interest concerning the subject matter of this article.

References

1. Ghaemi SN. Toward a Hippocratic psychopharmacology. Can J Psychiatry. 2008;53:189-196.

2. Geppert CMA, Taylor PJ. Should psychiatrists prescribe neuroenhancers for mentally healthy patients? Psychiatric Times. 2011;28(3):1, 6-9.

3. Hoop JG, Layde J, Roberts LW. Ethical considerations in psychopharmacological treatment and research. In: Schatzberg AF, Nemeroff CB, eds. The American Psychiatric Publishing Textbook of Psychopharmacology. 4th ed. Arlington, VA: American Psychiatric Publishing, Inc; 2009:1477-1495.

4. Kuther TL. Medical decision-making and minors: issues of consent and assent. Adolescence. 2003;38:343-358.

5. Roberts LW, Dyer AR. A Concise Guide to Ethics in Mental Health Care. Arlington, VA: American Psychiatric Publishing; 2004.

6. Roberts LW. Informed consent and the capacity for voluntarism. Am J Psychiatry. 2002;159:705-712.

7. Dell ML, Vaughan BS, Kratochvil CJ. Ethics and the prescription pad. Child Adolesc Psychiatr Clin N Am. 2008;17:93-111, ix.

8. Miller LJ. Ethical issues in perinatal mental health. Psychiatr Clin North Am. 2009;32:259-270.

9. Ghaemi SN, Goodwin FK. The ethics of clinical innovation in psychopharmacology: challenging traditional bioethics. Philos Ethics Humanit Med. 2007;2:26.

10. Belitz J, Bailey RA. Clinical ethics for the treatment of children and adolescents: a guide for general psychiatrists. Psychiatr Clin North Am. 2009;32:243-257.

11. Kramer PD. Listening to Prozac. New York: Penguin; 1997.

12. Cerullo MA. Cosmetic psychopharmacology and the President’s Council on Bioethics. Perspect Biol Med. 2006;49:515-523.

13. Stein DJ. Cosmetic psychopharmacology of anxiety: bioethical considerations. Curr Psychiatry Rep. 2005;7:237-238.

14. Groves JE. Taking care of the hateful patient. N Engl J Med. 1978;298:883-887.

15. Mohl PC, Lomax J, Tasman A, et al. Psychotherapy training for the psychiatrist of the future. Am J Psychiatry. 1990;147:7-13.

16. Gabbard GO. Deconstructing the “med check.” Psychiatric Times. 2009;26(9):48. http://www.psychiatrictimes.com/display/article/10168/1444238. Accessed March 11, 2011.

17. Gabbard GO: Psychodynamic Psychiatry in Clinical Practice. 3rd ed. Washington, DC: American Psychiatric Press; 2000:134-143.

18. Roberts LW, Hoop JG, Dunn LB, et al. Ethics and Professionalism: An Overview for Mental Health Clinicians, Researchers, and Learners. Arlington, VA: American Psychiatric Publishing; 2008.

19. Mintz DL. Teaching the prescriber’s role: the psychology of psychopharmacology. Acad Psychiatry. 2005;29:187-194.

20. Brockman R. Medication and transference in psychoanalytically orientated psychotherapy of the borderline patient. Psychiatr Clin North Am. 1990;13:287-295.

21. Jain S, Roberts LW. Ethics in psychotherapy: a focus on professional boundaries and confidentiality practices. Psychiatr Clin North Am. 2009;32:299-314.

22. Jain S. Understanding Physician-Pharmaceutical Industry Interactions: A Concise Guide. New York: Cambridge University Press; 2007.

23. Jain S. Key aspects of physician and pharmaceutical industry relationships for trainees. Acad Psychiatry. 2010;34:98-101.

24. Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA. 2000;283:373-380.

25. Baker CB, Johnsrud MT, Crismon ML, et al. Quantitative analysis of sponsorship bias in economic studies of antidepressants. Br J Psychiatry. 2003;183:498-506.

26. Thompson DF. Understanding financial conflicts of interest. N Engl J Med. 1993;329:573-576.

27. American Board of Internal Medicine; American College of Physicians-American Society of Internal Medicine; European Federation of Internal Medicine. Medical professionalism in the new millennium: a physician charter. Ann Intern Med. 2002;136:243-246.

28.Campbell EG, Rao SR, DesRoches CM, et al. Physician professionalism and changes in physician-industry relationships from 2004 to 2009 [published correction appears in Arch Intern Med. 2010;170:1966]. Arch Intern Med. 2010;170:1820-1826.

29. Haroun AM. Ethical discussion of informed consent. J Clin Psychopharmacol. 2005;25:405-406.

Ethical Issues in Psychopharmacology: Considerations for Clinical Practice

This article originally appeared in:

Psychiatric Times

It is reprinted here with permission.