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"Novel" antipsychotic medications represent major progress in treating patients with the most serious mental illnesses, but as with so many medical advances, people need to be aware of potential dangers before they decide to take that next large step. Psychiatrists are beginning to learn that prescribing one of these new drugs comes with legal risks and policy implications not spelled out in the long list of cautions contained in the prescribing information.
The great appeal of novel antipsychotics is that their efficacy is equivalent to that of the previous generation of such drugs, but cause far fewer side effects. They are, however, considerably more expensive, often costing 10 times as much as the older medications.
Have the new drugs, then, changed standards of care to the point where psychiatrists who opt to prescribe an older anti-psychotic incur a liability risk-should a patient develop tardive dyskinesia, for example-that they did not previously confront? Do psychiatrists place themselves in legal jeopardy if they use an older antipsychotic and fail to inform patients and families about the new, less risky ones? Must there be a specific indication before they can prescribe an older drug?
These were among the complex legal implications of the novel antipsychotics addressed by psychiatrists Douglas Mossman, M.D., and Douglas Lehrer, M.D., at an APA annual meeting session in Toronto in June. They suggested that the answers to the questions are not yet obvious.
Prior to 1994, when risperidone was introduced, psychiatrists had few options when choosing an antipsychotic; they could select from three or four phenothiazines, which had little effect on negative symptoms of schizophrenia, such as apathy and alogia. Clozapine became available in 1990, but the reluctance of third-party payers to cover the cost of the expensive new drug and its risk of agranulocytosis, which made weekly blood tests necessary, kept the older drugs as the first-line treatment for most people with schizophrenia, Mossman pointed out.
Risperidone and its more recent cousins, olanzapine and quetiapine, "dramatically changed prospects for patients with psychotic disorders," said Mossman, a professor of psychiatry and director of the forensic psychiatry program at Wright State University School of Medicine in Dayton, Ohio.
But these medications have a downside-their cost. "Were the new drugs sold for the same prices as older compounds, psychiatrists would have little reason to hesitate about which type of drug to choose," he noted. "For patients with new-onset schizophrenia or for those without a good reason to [be given] a conventional agent, evidence weighs heavily on the side of making novel antipsychotics the first choice." But since third-party payers are obligated to heed their budget constraints, and they pay for the use of most medications, psychiatrists and others may be under pressure to use older antipsychotics first.
Having decided to prescribe a conventional antipsychotic, psychiatrists should be careful to explain to patients and families what factors led them to choose that medication rather than one of the new compounds. This action is particularly crucial, Lehrer said, in light of the Osheroff case in which a private psychiatric hospital, Chestnut Lodge, was sued by a profoundly depressed patient who was treated with psychoanalytically oriented therapy and not given any medications. When no improvement was evident after several months of inpatient care, he was transferred to another hospital, which treated him with antipsychotics and antidepressants, to which he responded. The case was settled in 1987 prior to trial.
Lehrer, an assistant professor at Wright State and chief medical officer at a public psychiatric hospital, noted that at publicly funded facilities psychiatrists are more apt to confront a policy that requires older antipsychotics to be the first-line treatment. Psychiatrists and administrators will have to wrestle with the ethical and legal quandaries that arise when a patient insists on one of the novel antipsychotics, he said.
Psychiatrists also need to assess whether the introduction and proven efficacy of the new drugs has changed the standard of care for schizophrenia to the extent that even proper use of an older drug could cause legal liability regarding tardive dyskinesia risk, Lehrer pointed out.
He cited a January letter from Steven Hyman, M.D., director of the National Institute of Mental Health, to the federal government's chief Medicaid official, Sally Richardson. Hyman suggested that relying on older antipsychotics to save on drug costs could be a "false economy." The letter points out that "the potential cost of lawsuits that may result when patients now are started on standard antipsychotic medication (rather than new atypicals) and later develop persistent tardive dyskinesia" would quickly surpass the cost savings enjoyed by prescribing older medications.
The APA practice guidelines for schizophrenia treatment, published in 1997, do not devote much space to the novel antipsychotics, since published research at that time was sparse and does not anoint the new drugs as standard initial therapies, Lehrer noted.
But beyond cost issues, Lehrer said that psychiatrists need to ask a "more fundamental question," namely, "could a patient or his family sue a psychiatrist or agency successfully for using older neuroleptics?"
"My sense," he continued, "is that most U.S. psychiatrists would not state that use of a conventional antipsychotic drug as first-choice therapy is malpractice, although many U.S. psychiatrists do maintain that failure to respond to one conventional antipsychotic is sufficient reason to move to trials of atypical agents."
As for medicolegal concerns related to indications for the use of a particular new or older drug, Lehrer and Mossman agreed that "one can only speculate" about how courts will come down on the issues. Only older compounds allow for long-acting injection, for instance, and injections may be the only way to ensure compliance among uncooperative patients.
A second area where specific indications are at issue in medication choice involves patients displaying negative symptoms that persist after conventional drugs have been given. To sue successfully in such a case, a patient, they suggest, would have to be able to prove that "his doctor's failure to offer him [a novel antipsychotic, which can alleviate negative symptoms] was a deviation from the prevailing standard of care."
Unfortunately, the answers to these legal conundrums will mostly have to await the outcome of malpractice lawsuits against psychiatrists who angered patients by opting for one or another antipsychotic medication.