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.
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).
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
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.
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
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.
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