The Archives of  General Psychiatry published an article this month entitled, “Metabolic Testing Rates in 3 State Medicaid Programs After FDA Warnings and ADA/APA Recommendations for Second-Generation Antipsychotic Drugs.”

The retrospective analysis examines how frequently the recommended metabolic testing for second generation antipsychotic drugs (SGA’s) was performed in Medicaid patients in 3 different states. The conclusion was that the monitoring was not being done nearly as frequently as recommended. Less than one-third of patients treated with these medications, which can cause metabolic syndrome,  undergo serum glucose or lipid monitoring.

Obviously this is not good news. In recent years, we’ve learned that the risks associated with SGA’s is higher than originally thought. My intent in this post, though, is not to focus on this study itself as much as to examine an ethical dilemma related to it that I have never heard discussed.

What I’ve been wondering: Is it ever appropriate to prescribe SGA’s to severely mentally ill patients who have no financial means to obtain the necessary blood monitoring tests? I’ll explain.

A few years ago I provided psychiatric services to patients at several different public community mental health centers in several different counties of my state. These patients all had Medicaid or no insurance. Indigence was ubiquitous. If the medications I prescribed to a particular patient were not covered by Medicaid, then I would typically provide the patient with free drug samples from our sample closet (medications procured from the pharmaceutical reps).

Not uncommonly I would treat patients with serious mental illnesses such as schizophrenia, schizoaffective disorder, bipolar disorder, and major depression. I often used SGA’s, and I when I did so it was frequently to treat psychosis in such patients. This was during the time just before the SGA monitoring recommendations were published. Since many of these patients had no insurance coverage or money to pay for laboratory monitoring, I simply didn’t do it. I easily justified this practice to myself because they were seriously impaired by mental illness, I had a treatment that usually helped them to function better, and the risks of the medications were thought to be less than we realize they are today.

I did not have the opportunity to provide services in that setting after the SGA monitoring guidelines were released. The risk/benefit analysis has shifted, but the SGA’s are still life-saving medications for the seriously mentally ill. Since then I’ve often wondered what the right thing to do is for those patients today, those with psychosis whose lives are in shambles without medications yet who do not have the means to obtain the appropriate blood tests.

The purists will insist that the medications should never be prescribed unless the appropriate monitoring can be done, but those of us on the front lines of medicine understand that clinical practice is never that simple.

In some patients, using the older first-generation antipsychotics dodges the metabolic monitoring issue, but then the risk is of tardive dyskinesia, not necessarily a great trade-off, particularly in persons likely to need life-long pharmacotherapy. Also, some patients will not have the means to pay for the older antipsychotics, and it will be more likely that the SGA’s will be readily available to them via samples or indigent medication programs.

In indigent, seriously mentally ill patients who clearly have the decision-making capacity to make good informed decisions (admittedly not always the case in this population), would it be sufficient to do thorough informed consent about the potential side effects and recommendations for blood monitoring, weigh and measure the patient often (this is part of the monitoring anyway and is free), teach them to look for symptoms of diabetes, and then document all of this thoroughly?

I think that in select cases the most ethical answer will be to do just that. However, this approach should be the exception and not the norm.

I don’t have the answer here. This is a real dilemma. What are your thoughts?

Photo Credit: Sectionz via Flickr

From Psychiatric Times: “Medicare Prepares Reversal on Covering All Antidepressants and Antipsychotics”

The all-or-none nature of this concerns me. While it may be less important that all drugs from the antidepressant and antipsychotic classes are covered, if these classes lose their Medicare Part D “protected status,” the fallout not only for Medicare recipients but for all insured patients could be significant.

Photo credit: Psyberartist