Informed Consent in Neuropsychosocialpharmacology

by Abilash Gopal, Darlyn Pirakitikulr, and Harold J.Bursztajn, M.D.

Psychiatric Times, November 2005:59

As medications continue to improve and specialized medications proliferate, it consent and privacy, it is essential that patients be guaranteed both informed consent and privacy, especially in time-pressured managed care environments (Bursztajn and Brodsky, 1999). The physicians must spend time educating the patient to be a partner in decision making. Informed consent and privacy, stead of becoming less important, are all the more important for the patient to give an adequate history so that medication can be effectively prescribed. Informed consent is a process with clinical, ethical, legal and risk-management dimensions (American Medical Association, 2004; Gutheil and Appelbaum, 2000). True informed consent depends on the patient having the privacy conducive to bringing up all considerations relevant to reducing and managing clinical uncertainty.

Both therapeutic nihilism, which exaggerates the uncertainty attendant to decision making, and therapeutic overconfidence, which denies the uncertainty, need to be avoided. Both patient and doctor, overlooking biopsychosocial interaction, can fall prey to the notion that there are single causes responsible for pathologies and that these pathologies can be corrected with the right treatment (Bursztajn et al., 1990). The idea that neuropsychopharmacology can guarantee results or provide a quick fix needs, more than ever, to be addressed, without succumbing to fatalism that rationalizes bad clinical habits.

Neuropsychopharmacology is not some new phrenology. Rather, there are a variety of biopsychosocial explanations for the myriad factors associated with any given pathology. In effect, when patient and doctor are empowered by an informed consent process, the therapeutic alliance that emerges results in what we can call neuropsychosocial-pharmacology.

In this more realistic conception of psychopharmacology, both biological and psychosocial factors matter. Depth of understanding and prudent prescribing are critical standards for the profession. Absolute certainty about either the etiology or treatment of suffering is disavowed from the outset in psychopharmacological decision making. The same is true for therapeutic nihilism, whereby the patient is abandoned once the prescription is written. Instead, relevant information is gathered with the recognition that there may be no perfect solution to the problem at hand. Psychopharmacology practice is a dynamic and collaborative decision process that requires communication, planning, education, observation, feedback and adjustment (Bursztajn et al., 1990). This approach removes the physician from the role of either an omnipotent, all-knowing technician or a careless drug-dispenser and prepares patients to enter into a collaboration with their physician.

The real clinical opportunity afforded by informed consent is transforming the uncertainty that is part of the complexity of decision making into the doctor-patient alliance (Gutheil et al., 1984). For the doctor, informed consent need not be a formality. It can be a process that illuminates the path to proper healing. For the patient, informed consent is an opportunity to feel empowered as a participant in one's own treatment

Unfortunately, however, informed consent is sometimes looked upon as merely a legal mandate: a momentary nuisance. Instead, patients need to be aware of the danger of not taking psychoactive drugs as directed, and they need to be sufficiently educated to allow for informed self-observation and communication of symptoms, responses and side effects. Finally, they need to be empowered to work with their psychiatrists to develop a treatment program that will meet objectives and is compatible with the patient's attitudes and lifestyle. Thus, in order to satisfy the three legally stipulated components of informed consent-information, voluntariness and competence-patient and doctor can build an ongoing therapeutic alliance. Assured of the clinician's involvement and support, the patient is more likely to carry out the treatment plan and less likely to retaliate (Bursztajn and Brodsky, 1998). With this model of informed consent, then, the dual objectives of good patient care and protection from litigation can be accomplished together.

Special Considerations

Psychodynamically informed prescribing of psychoactive substances distinguishes psychopharmacology from mere pill-dispensing. This means understanding the patient's suffering in terms of both their disease and their individual character (Freud, 1916; Shader, 2003). It is crucial that such informed prescribing be accompanied with sufficient patient and family education to optimize the benefit/risk ratio of the precribed substance. Moreover, the prescribing of psychoactive medications brings many challenges to the informed consent process. Issues of vulnerable populations and special classes of drugs both contribute to the complexity of informed consent.

People who use alcohol or other drugs as a means of coping constitute an important class of vulnerable populations. Using patients who consume excessive alcohol as an example, obtaining informed consent from such patients is complicated both by the acute and chronic effects of alcohol on their judgment and by dysfunctional coping patterns such as denial. Patients who are sober during examination may consent to the administration of psychoactive substances. Nonetheless, particularly because of their susceptibility to relapse, these patients need to be meaningfully educated as to the negative side effects these drugs may have when consumed with alcohol. In addition, newly sober alcoholics may suffer from transiently impaired judgment as a side effect of detoxification. This problem may greatly affect a physician's ability to obtain meaningful informed consent

To address this problem, it helps to begin with a clinical assessment of executive functions and memory. This can be done in conjunction with the informed consent process by asking patients, once informed, to review their understanding of the risks and benefits of the medication they are taking. Doing so again during follow-up visits is helpful as well.

At the same time, care must be taken to avoid using stereotypes (e.g., the drug-seeking addict) to make treatment decisions. We can probe deeper to understand exactly what drug use means to patients. This will engender a trusting doctor-patient relationship and allow patients to find the personal strength to work through their vulnerabilities in a healthy way. Considering dual or multiple diagnoses can help to further individualize treatment (Berk et al., 2004). By establishing an open line of communication and exploring multiple meanings and diagnoses as tools for deepening our understanding of the patient's suffering, we can collaborate with our patients in arriving at a number of satisfactory treatment choices (Bursztajn and Brodsky, 1998).

Patients with personality disorders form another vulnerable population. These patients sometimes present themselves as victims of family, parents, the law and previous physicians (Bursztajn et al., 1991). In particular, individuals with the classical antisocial personality may misrepresent themselves in order to satisfy ulterior motives, such as avoiding prison or continuing criminal activities from a hospital setting. Physicians need to be particularly wary when dealing with these patients to avoid the misadministration of psychoactive drugs. Corroborative information obtained tactfully from patients' families can be especially helpful to evaluate this possibility. Observation in group psychotherapy can likewise be helpful, while allowing for close observation of social dynamics.

Individuals with borderline personality traits can present a special challenge to obtaining informed consent, as it may be difficult to ascertain their state of mind. Moreover, these individuals often demonstrate impulsivity and affect instability. Thus, not only is the initial process of informed consent difficult when working with these patients, but it is also a challenge to make sure that a treatment program involving psychoactive medication is properly followed. Here, part of the informed consent process can be to share the knowledge that some patients can sometimes feel so desperate that they can be their own worst enemies: “How can we help you not become your own worst enemy when taking medication, as you've often done so in other areas of your life?” Promising too much in the course of informed consent sets the stage for later disillusionment and abandonment, whereas committing oneself too little feeds the patient's hopelessness and despair.

Other vulnerable populations include neurocognitively impaired or demented patients and some elderly patients (Bursztajn et al., 1991). Neurocognitively impaired patients suffer from brain dysfunction, which can impair cognitive capacities, such as judgment, orientation and memory, and amplify adverse effects. These conditions may make it necessary to obtain informed consent from a legal guardian. A similar situation exists with certain elderly patients. However, it is important to make a clinical determination of competency, particularly since not all elderly patients are actually incompetent. Here again, family and social supports can play a helpful part in making the informed consent process meaningful and effective (Bursztajn et al., 1991).

The prescription of drugs that, although helpful for anxiety or pain relief, are potentially abused underscores the danger of a superficially conducted informed consent process (Bursztajn and Brodsky, 1998). Patient ignorance of the pros and cons of any medication compromises treatment efficacy and places the responsibility for the outcome solely on the physician. By contrast, physicians who engage patients in a dialogue about the risks associated with such drugs can allow patients to share in the uncertainty of clinical situations. The patient will then share the responsibility for making wise decisions (Bursztajn and Brodsky, 1998).

Therapeutic Discretion

Not all side effects of a medication affecting complex systems can be known. Recent reports, such as the controversial link between some classes of antidepressants and suicidality (Lapierre, 2003), indicate the need for a dynamic conception of informed consent and for continuing physician and patient education.

Rather than mention every imaginable possibility, it is more helpful to tactfully inform patients who are beginning new medications that some risks become apparent only with widespread or long-term uses. Moreover, risks and benefits are dynamic and may change as the patient changes. It is a common misperception that physicians rely on one authority, such as the PDR, for prescribing drugs. The PDR is simply a list of reported side effects and cannot capture the particular vulnerabilities of any individual patient. Moreover, to inundate patients with an exhaustive list of all possible side effects may merely result in making them anxious and aversive. Instead, the physician must seek a balance between the extremes of patient ignorance and hypersensitivity due to information overload.

Physicians need to use their judgment as to how much information will help their patients and how much will simply make them over-anxious. Whereas patients should have access to all information about possible side effects, only those side effects that are relevant for a particular patient should be emphasized. This discretion will allow the informed consent process to advance a patient's treatment. At the same time, it will alert the patient to bring to the physician's attention any unfamiliar effect that may emerge, rather than communicate to the physician only those side effects that have already been discussed.

Future Challenges

As medicine evolves over time, there will be new challenges to the informed consent process. At present, we are witnessing many changes in the accessibility of medical information to patients. One such change is the advent of widespread direct-to-consumer advertising. In addition, the Internet is a vast resource for patients to research treatment options. Thus, patients will be exposed to a great amount of information from different media sources. In the future, informed consent will likely involve asking patients what they have learned about medications from other sources.

The sexual side effects of newer drugs pose another challenge to informed consent. It is not enough simply to assume that because patients do not complain of sexual side effects they do not suffer from these effects. Fear, guilt and shame are powerful influences. In addition, medications that treat sexual side effects of psychotropics, as well as those that may sexually disinhibit patients (e.g., bupropion [Wellbutrin]), suggest the need for psychopharmacologists to be psychodynamically informed. A supportive, psychodynamically informed approach can be especially helpful for putting patients at ease. Patients can then explore potentially conflicting sexual side effects such as libido inhibition and disinhibition.

Another layer to this issue is the set of rules governing doctor-patient confidentiality as dictated by the Health Insurance Portability and Accountability Act (HIPAA). The new HIPAA requirements may themselves need to be addressed in order for patients to feel comfortable enough to freely discuss the most intimate of side effects. It has been recognized by both federal and state supreme courts that the success of psychotherapy depends on the belief that the relationship between doctor and patient is private (Althaus v Cohen, 2000; Jaffee v Redmond, 1996). Indeed, confidentiality in communications between a patient and doctor is the foundation on which effective psychotherapy can be carried out. It is only in such an atmosphere that patients can feel comfortable divulging the details of their condition so healing can begin. Such confidentiality is as essential to the practice of psychopharmacology as it is to the practice of psychodynamically informed psychotherapy.

Nonetheless, in 2002, in the guise of increasing the efficiency of health care delivery, the secretary of the U.S. Department of Health and Human Services published amended regulations to the HIPAA Act of 1996. The Standards for Privacy of Individually Identifiable Health Information (2002) eliminated the requirement that an entity covered by the regulations obtain patient consent for the use or disclosure of a patient's health information. Such entities include third parties such as insurers and HMOs.

In effect, the amended regulations eliminate the expectation of patient-doctor confidentiality. Together with the time pressures of clinical practice, this can contribute to an atmosphere of doubt, anxiety and distrust between the patient and doctor, which is a huge impediment to effective and safe treatment. When patients are not comfortable disclosing all the details of their condition to the doctor, the physician may be unable to make an accurate diagnosis. This is particularly dangerous when the administration of psychoactive substances serves as part of the treatment regimen. In order for these drug to

be effective, a physician must have access to all the details of a patient's condition. In view of the double stigma of genetically inherited illness and mental illness, protecting patient privacy by obtaining informed consent will be essential for both valid research and the recognition and utilization of the efficacy of newly developed psychotropic medications (Bursztajn et al., 2003).

The amended Standards (2002) raise serious questions as to whether conditions for such trust can continue to exist. When patients are aware that their health information may be disclosed to third parties without their consent, they are likely to become more anxious-consciously or unconsciously-about sharing the details of their illness. The physician is then forced to act on incomplete information-a particularly hazardous situation when potentially powerful psychoactive drugs are involved.


Informed consent processes allow patients and doctors to shoulder the burden of uncertainty together. Thus, when properly conducted, these procedures can be the cornerstone of a healthy doctor-patient alliance. In addition to protecting against litigation, they can illuminate the path toward effective treatment. Psychiatrists who understand and value the informed consent process instead of treating it merely as a legal mandate will find themselves empowered to develop deeper therapeutic alliances with their patients.

Finally, physicians must take care to adapt to the new challenges to informed consent that continually arise. In the face of all these factors, it is our responsibility as clinicians to uphold the informed consent process. Psychiatrists in particular, as physicians with training and expertise in a comprehensive, multidimensional yet integrated approach to human suffering are well-positioned to practice and teach this process, even when practicing neuropsychopharmacology. In so doing, we can create lasting doctor-patient alliances that make meaningful treatment possible, thus practicing neuropsychosocialpharmacology.

Mr. Gopal is a student at Tufts University School of Medicine.
Ms. Pirakitikulr is a premedical graduate of Princeton University.
Dr. Bursztajn is co-director of the program in psychiatry and the law at Harvard Medical School.