(Mis)informed Consent

December 20, 2011

Over the years, the practice of medicine has become less of an art, and more a process of crossing T’s and dotting I’s.  “Treating the chart” has become, in many ways, more important than treating the patient, and it seems that the pen—or, rather, the electronic medical record—has emerged as a more valuable tool than the stethoscope or reflex hammer.

For psychiatrists, one of the pesky little details of any office visit is obtaining “informed consent.”  Most commonly, this is the document—signed by the patient—stating that he/she has been fully informed of the reason they’re being prescribed a medication, the potential risks of taking said medication, and any possible alternatives.  Most private insurers and hospitals, and all Medicaid programs, require this documentation in the charts of patients seeing mental health specialists, and (at least in my experience) these documents are frequently sought in chart audits.

What do I mean by “pesky”?  Put briefly, the process of obtaining informed consent can be time-consuming, and some doctors worry that it might actually interfere with treatment.  In a 2004 survey, for instance, 44% of psychiatrists reported that “informed consent … increases patients’ anxiety.”  With respect to antipsychotics, nearly 20% of psychiatrists in the same study admitted “it is good practice to withhold information about tardive dyskinesia from some patients.”  As a result, patients are often poorly informed about the meds they take.  In a 2001 study of psychiatric inpatients in Scotland, fewer than half knew the reason they were receiving medication, the side effects of those medications, or even remembered getting an explanation from staff.  (But, according to the survey, far more than half were “happy to take all medications”!!)

I was recently asked for some suggestions on how to improve the medication-consent process in my outpatient clinic.  I must admit, the current process is atrocious.  Our forms are 10+ years old, with general descriptions of each class of medication (and, of course, they lack any drug introduced in the last decade); and they have that “photocopy of a photocopy” appearance, with faded margins and text at a crooked angle.  But hey, no big deal—they’re just papers to sign and stick in the chart, basically.  In the community clinic where I work part-time, the process is even more rudimentary: we have one generic form with no drug names or descriptions; the front-desk staff asks each patient to sign the form before each visit, and afterward I simply write in the name of the medication(s) I’ve prescribed.

In thinking of ways to improve the process, I’ve come to realize that it may provide an opportunity for some meaningful change in our treatment approach.

First of all, there’s no excuse for not describing the potential adverse effects of the drugs we use, but we must be cautious not to trivialize this process.  Most psychiatrists I know, for example, have a readymade “speech” about the potential for rash with Lamictal, or weight gain with Zyprexa, or sedation with Seroquel.  (See this post at Shrink Rap—and its comments—for more on this perspective.)  But if the patient hears this as just a “speech,” it’s less likely to be meaningful, just like the pre-flight safety lectures you hear on airplanes.  I advise my students and residents to pretend they’re prescribing to their spouse, parent, or child, and give all the information they would want to hear about each new drug.  (This includes how to stop the medication, too.)

Second, just as important as the potential adverse effects, I believe that patients need to hear more specific explanations of how the drug might actually provide some benefit.  All too often we give a feeble explanation like “this Prozac should make you feel better in a few weeks” or ” Valium might calm your nerves a bit” or “since you haven’t responded to your antidepressant, here’s some Abilify to help it along.”  We owe it to our patients (and to ourselves) to provide more detailed explanations.  To be sure, most patients don’t need to hear a molecular mechanism, complete with pKa values or details of CYP450 metabolism, but we ought to have this information in our heads, and we must know how we’re using this information to treat the patient in front of us.  When a patient asks how an antipsychotic might help their depression, or why an anticonvulsant might help stabilize their mood, we must give an answer.  (And if no good answer is possible, we need to rethink our treatment plan.)

Third, it is equally important to discuss treatment options with a patient.   When patients ask “is there anything else I can do or take?” the ensuing discussion might extend the appointment by a few minutes, but it always leads to a more collaborative dialogue (unless, of course, the patient is fishing for a Xanax prescription or a month’s supply of Seroquel to sell for cash).  A discussion of alternatives often gives an indication of what the patient wants, what the patient values, and how we can best promote the patient’s recovery.

Finally, the informed consent process really should be extended to non-psychiatrists who prescribe these agents.  Primary-care docs routinely prescribe antidepressants, benzodiazepines, psychostimulants, and mood stabilizers (and, of course, my personal favorite, “Seroquel for sleep”), without a discussion of risks, benefits, and alternatives, or (in most cases) a signed consent form.  Heck, even gastroenterologists prescribe Reglan, which is as likely to cause tardive dyskinesia as many of the antipsychotics we use in psychiatry, and pain specialists are fond of Cymbalta (an SNRI with some potentially nasty withdrawal effects) for “chronic pain.”  These providers should recognize the potential risks (and mechanisms) of psychotropics, just as psychiatrists do, and share them with their patients.

So even though we might look at obtaining informed consent as a “necessary evil,” we should instead look at it as a way to enhance treatment.  If nothing else, this would force us to think about what we do and why we do it.  It would enable us to honestly evaluate the true benefits and risks of what we prescribe, and maybe steer us in a different—and healthier—direction.

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