Tuesday, June 10, 2008

With Precautions, Psychiatrists Need Not Shun off-Label Prescribing

Fear of lawsuits should not stop psychiatrists from prescribing medications for off-label indications as long as they make patient-centered decisions based on evidence and talk to patients about risks and benefits.

By focusing on patient care and providing appropriate informed consent, consultation-liaison psychiatrists can protect themselves from liability lawsuits regarding the use of antipsychotics and other medications for indications not approved by the Food and Drug Administratio (FDA). So said experts who led a workshop for consultation-liaison (C-L) psychiatrists at APA's 2008 annual meeting in Washington, D.C., in May.

Off-label use includes prescribing medications not only for unapproved indications, but also for unapproved dosages and patient populations, some of which may be subject to specific warnings by the FDA, said Ramaswamy Viswanathan, M.D. He is the director of the C-L Psychiatry Department at the State University of New York Downstate Medical Center in Brooklyn, N.Y. Intravenous infusion of haloperidol and the use of antipsychotics to treat dementia-related agitation are only two notable examples.


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