It means that we must be scrupulous in justifying the use of these medications in elderly patients and must always include careful documentation in the medical record.

The study you mention (Wang et al, 2005) analyzed 22,890 new users of both conventional and atypical antipsychotics who were over 65. My own reading of the article is that death rates among elderly patients started on conventional antipsychotics were at least as high as those started on atypicals, actually, significantly higher than that of atypicals in the period soon after initiation of the drug, but with the comparative death rates of subjects on conventional and atypical antipsychotics converging with time. The causes of death had been predominantly cerebrovascular in the pooled FDA studies of elderly patients taking atypical neuroleptics, but the causes of death were not available to the investigators in this most recent study; however, the authors speculated about the role of anticholinergic reactions, extrapyramidal effects and cardiac conduction delay in the death rate, all of which effects may be more frequent in the conventional or first-generation drugs. Thus, the risks of using antipsychotic medications in elderly patients are real and unavoidable, and cannot be circumvented by a shift from atypical antipsychotics to haloperidol, thioridazine, etc., drugs which themselves are now expected to receive similar "black box" warnings.

As a practical matter, medical record documentation should include the following three elements:

1. Justification. Start by stating your awareness of "black box" warnings about atypicals and also the recent data suggesting excess death rates in elderly patients on conventional neuroleptics. Then, if there is a specific indication, e.g., diagnosis of schizophrenia or clear psychotic disorder, this should be noted. If the drug is being prescribed for behavioral complications of dementia, this fact should be acknowledged, followed by a statement to the effect that the patient's degree of suffering outweighs the risks of starting the medication, and/or that other non-neuroleptic medications or nonpharmacological behavioral interventions have already been tried or are inappropriate. In general, the closer to standard psychotic indications, the easier it is to justify the use of neuroleptic medication, and the better the clinical effect that is likely to be seen. On the other extreme, wandering or slapping a homecare worker or nursing aide can be vexing behaviors but are not adequate indications for the use of antipsychotic medication. For single-dose uses, such as sedation for closed MRIs, I would recommend using benzodiazepines and not antipsychotics, particularly in emergency department settings where patients's drug histories are sometimes not available; recall also that elderly patients starting neuroleptics for the first time in their lives may be at greatest risk.
2. Statement about dosing and side effect monitoring. You should note that you are starting at the lowest dose which can be administered to assure tolerability, and that you will monitor the patient on a regular basis for all possible side effects.
3. Explanation to patient, family members or healthcare proxy. Here you should document the fact that you notified the patient or his representatives about the warnings and offered a full explanation of the same justifications described in #1 above. I would also add a statement, preferably a quote, confirming the assent of the responsible decision-maker.