May 23, 2012
U.S. Senators Chuck Grassley, R-Iowa, Herb Kohl, D-Wis., and Richard Blumenthal, D-Conn., today filed an amendment seeking to combat the costly, widespread and inappropriate use of antipsychotics in nursing homes.
“This amendment responds to alarming reports about the use of antipsychotic drugs with nursing home residents,” Grassley said. “It’s intended to empower these residents and their loved ones in the decisions about the drugs prescribed for them.”
While the Food and Drug Administration (FDA) has approved antipsychotic drugs to treat an array of psychiatric conditions, numerous studies conducted during the last decade have concluded that these medications can be harmful when used by frail elders with dementia who do not have a diagnosis of serious mental illness. In fact, the FDA issued two “black box” warnings citing increased risk of death when these drugs are used to treat elderly patients with dementia.
The amendment to S. 3187, the Food and Drug Administration Safety and Innovation Act would require the Health and Human Services Secretary to issue standardized protocols for obtaining informed consent, or authorization from patients or their designated health care agents or legal representatives, acknowledging possible risks and side effects associated with the antipsychotic, as well as alternative treatment options, before administering the drug for off-label use.
The amendment also calls for a new prescriber education program to promote high-quality, evidence-based treatments, including non-pharmacological interventions. The prescriber education programs would be funded through settlements, penalties and damages recovered in cases related to off-label marketing of prescription drugs.
For more information on psychiatric abuse of the elderly – click here