Sen. Herb Kohl (D-WI)

Three Senators have proposed legislation that would further regulate the administration of antipsychotic medications to nursing home residents.

The bipartisan bill, proposed Tuesday, would require nursing home staff to obtain informed consent from a resident or their legally designated representative acknowledging the potential risks and side effects associated with the antipsychotic medications. These prescription medications often are prescribed to elderly nursing home residents who experience aggressive or agitated behavior as a result of Alzheimer’s or other forms of dementia.

The bill is an amendment to an existing Food and Drug Administration bill, S. 3187 and proposed by Sens. Herb Kohl (D-WI), Chuck Grassley, (R-IA) and Richard Blumenthal, (D-CT). It addresses growing concern about the safety of prescribing antipsychotics for “off label” use. Medications such as Risperdal and Haloperidol are only officially approved to treat mental illnesses such as schizophrenia.

“This amendment responds to alarming reports about the use of antipsychotic drugs with nursing home residents,” Grassley said in a statement. “It’s intended to empower these residents and their loved ones in the decisions about the drugs prescribed for them.”

The legislation also follows a 2011 Office of the Inspector General report that uncovered widespread overuse of these medications in nursing homes despite “black box” warnings about them from the FDA. That report stated that more than half of the 1.4 million claims for atypical antipsychotic drugs totaled $116.5 million and did not comply with Medicare reimbursement criteria.