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Ask the Mental Health Expert Archives 2001-2004

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Whether to Medicate

Q. I am medical director of a mental health unit at a community hospital. We are having several discussions regarding whether the new atypical antipsychotics, ziprasidone and aripiprazole, should be on our formulary and available to our patients.

We are considering intramuscular ziprasidone in both the agitated patient and in the patient who is receiving intramuscular antipsychotic medication on an involuntary basis. We are confronted with the conflict between their high cost and their perceived safety. Specifically, does the standard of care in psychiatry now require that we make available the newer antipsychotics when a patient requires antipsychotic medication on an emergent or involuntary basis (pursuant to court order)?

A. You are raising a number of separate but related questions, all of them complex and important! To the best of my knowledge, the emerging national standard of care in clinical psychiatry does not absolutely require psychiatrists to prescribe the newer (atypical) antipsychotic agents in any context, emergent or non-emergent, voluntary or involuntary--but, your own state may have specific legislative or regulatory requirements that supercede such a general standard.

On that point, you should probably consult with your hospital's legal department. That said, there's no question but that most experts strongly favor the atypicals as agents of first choice. Furthermore, the emerging standard of care probably does require psychiatrists, at a minimum, to inform psychotic patients of (1) the risks and benefits of standard antipsychotics; and (2) the availability of the newer agents, as well as their risks and benefits. (Informed consent, of course, is often not applicable in the emergency room setting, as you well know, when other judicial rulings may apply; e.g., those exceptions detailed in the Rogers v. Okin decision. For details, I recommend Dr. Robert Simon's excellent book, Concise Guide to Psychiatry and the Law).

A very good review of these issues (Mossman & Lehrer, Psychiatr Serv 51:1528-1535, December 2000) summarizes the situation very well: "Recent data on antipsychotic prescription practices and court decisions issued through September 2000 suggest that proper use of the older drugs is not a deviation from the standard of care. However, case law suggests that psychiatrists have a legal obligation to tell patients about novel antipsychotic agents, even if they continue to prescribe conventional neuroleptics."

In light of this, I don't believe that the standard of care absolutely requires that these newer agents be used in the emergency setting--it might, however, require that once stabilized on a conventional antipsychotic (neuroleptic), the patient be informed about the atypicals and, if necessary, referred to another facility that could provide atypical antipsychotics. (Failure to so inform the patient might pose considerable medicolegal risks if, say, that patient went on to develop tardive dyskinesia--though that would be very unlikely with short term neuroleptic use).

Again--your state DMH may have its own regulations that override emerging national standards. Furthermore, if a patient already has an existing "Rogers guardianship" in place that restricts his court-ordered medication to one or two of the atypical agents, your facility might face legal difficulties if it could not, or would not, provide these atypical agents.
The other issue you raise--that of the cost effectiveness of older vs. newer agents--is partly a matter of the type of patient (emergent or non-emergent) and how long he or she is being treated. Most of the recent studies, as you undoubtedly know, have found that in the long-term (12-24 months), the tablet cost of the newer agents is largely compensated for by the reduction in overall costs, due mainly to reduced rates of hospitalization; see, for example, Rosenheck et al: A comparison of clozapine and haloperidol in hospitalized patients with refractory schizophrenia. N Engl J Med 337:809-815, 1997.

But such reduced long-term costs would not necessarily apply to a patient seen once or twice in the emergency room, and who required immediate sedation with an antipsychotic. For example, in the ER setting, haloperidol would clearly be much cheaper than olanzapine or risperidone in the short-term (1-2 days), and would probably be just as effective--though the atypicals would probably be better tolerated. For more information on national trends, you might want to consult the Bazelon Center of Mental Health Law (http://www.bazelon.org/) to see if they have more detailed information on this issue. I hope this is of some help.

June 2003

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