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Ask the Mental Health Expert Archives 2001-2004

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Q. What kind of informed consent do you use or recommend physicians use when they start patients on atypical or typical antipsychotics?

A. The issue of informed consent with psychotic patients is always complex and troublesome for psychiatrists and other physicians. (Of course, antipsychotics are not always prescribed to psychotic individuals, and that raises still more medical-legal issues). Since I now see patients only on a consultant basis, I'm not the one who initiates the informed consent process with them--but I do advise their primary physicians on this.

The first point to keep in mind is that informed consent is a PROCESS, not a document. There are facilities that encourage the use of informed consent contracts, in which all the risks and/or benefits of the antipsychotic (AP) are spelled out, and which the patient is asked to sign. As Dr. Tom Gutheil has noted in many lectures and papers, these forms can create a false sense of security in the clinician--as if to say, "I've taken care of informed consent now." In fact, these documents appear to provide very little if any legal protection to the physician if, say, the patient develops tardive dyskinesia or a severe drug reaction and then sues the doctor.

Furthermore, patients often sign them without much real understanding. Lawyers basically tear these contracts to shreds. The best kind of informed consent--one that protects both the patient and the physician--is also the most human and genuine, reflecting a dialogue between patient and doctor over many weeks, months, and even years. This means carefully documenting in your regular chart notes what risks and benefits you have discussed with the patient; how he/she responded to this information; whether he/she understood; and your own understanding of the risks/benefits of the drug for this particular patient e.g., why, despite its potential risks, it is still the best treatment for this patient.

In my view, not every possible adverse drug reaction needs to be disclosed at the initial meeting with the patient, and acutely psychotic patients who consent to take an AP need not be overwhelmed with information they can't assimilate anyway. (I'm not dealing with the patient who refuses an AP, since that is a separate issue). Note, by the way, that the presence of psychosis does not preclude the ability to give informed consent for medication. Nevertheless, I would not immediately raise the risk of tardive dyskinesia with an acutely psychotic patient, since it is not a concern for at least the first month of treatment; however, the risk of TD must be discussed soon after the patient is stabilized, in my view, and assessed periodically thereafter with appropriate examinations.

As a rule, I would start off saying to a psychotic patient, "Joe, the medication I'm recommending is very likely to help you feel better. It's designed to help calm some of your fears, help with your thinking, and reduce the voices you are hearing. I've treated many patients with this medication, and most do well on it. You may feel a little drowsy at first, and some patients find that it gives them (for example) a little dry mouth. A few patients may feel some tightness in their muscles, which we can treat. Let me know if you have problems with the medication, or any questions. Do you understand what I've said?"

As "Joe" recovers, I will then raise more subtle side effect issues, such as the risk of TD, neuroleptic malignant syndrome, prolactin elevations, etc. I will also ask about any sexual dysfunction, abnormal movements, rigidity, etc, periodically. At each stage of the process, I will write a note documenting the discussion, the patient's questions, and his understanding. In some cases, with the patient's consent, discussion with family members and/or other treating clinicians is appropriate. This, of course, is just my personal approach. Others prefer to have a written contract, go through more side effects right away, etc.

For more details on the medico-legal aspects, I recommend reading Dr. Robert Simon's "Psychiatry and Law for Clinicians" (American Psychiatric Press, 1998).

April 2001

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