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WINTER 2007
High Rates of Prescriptions Given for Unproven Uses
by Sam Fahmy

A University of Georgia study has found that three-quarters of people prescribed antidepressant drugs receive the medications for a reason not approved by the federal Food and Drug Administration.

This practice, known as off-label prescribing, is legal and intended to give physicians the flexibility to prescribe the drugs that are best suited to their patients’ needs. And while study authors Dr. Hua Chen and Jack Fincham acknowledged that there are legitimate uses for off-label prescribing, they said that in many cases physicians write off-label prescriptions based on limited or anecdotal evidence.

“Most off-label drug mentions have little or no scientific support,” said study co-author Jack Fincham, A.W. Jowdy Professor of Pharmacy Care at the University of Georgia College of Pharmacy. “And when I say most, it’s like 70 to 75 percent. Many patients have no idea that this goes on and just assume that the physician is writing a prescription for their indication.”

The researchers, whose results appear in the June 2006 issue of the Journal of Clinical Psychiatry, examined data on drugs prescribed to 107,000 Medicaid patients. They found that 75 percent of antidepressant recipients, 80 percent of anticonvulsant recipients and 64 percent of antipsychotic recipients received at least one of these medications off-label.

Chen, an assistant professor at the University of Houston who led the study when she was a doctoral student at UGA, said a greater emphasis on evidence-based medicine, which relies on data rather than anecdotal evidence, would ensure greater safety in off-label prescribing.

The researchers also urge physicians to tell their patients when and why they prescribe a drug off-label and encourage patients to be their own best advocate and to ask questions about the drugs their doctors prescribe.

“Physicians have the right to prescribe any medication off-label,” Chen said, “but they also have the responsibility to inform patients that this medication is being used off-label.”

For more information contact Jack Fincham at jfincham.uga.edu or Hua Chen at hchen20@uh.edu.