More than one-quarter of all patients in nursing home facilities receive antipsychotic medications, according to the Centers for Medicare and Medicaid Services. Antipsychotic medications have many legitimate uses, such as treatment for schizophrenia, delusions, and hallucinations; however, many nursing facilities continue to use them as an off-label solution for dementia (and the behavioral and psychological symptoms associated with dementia).
The U.S. Department of Health and Human Services found in 2011 that 83 percent of Medicare claims for antipsychotics were used for off-label purposes. Back in 2005, the Food and Drug Administration required manufacturers of atypical antipsychotics to include a warning about the increased risk of death when used by an older person with dementia-related psychosis. In 2008, the warning was extended to all antipsychotics, and a Health and Human Services report showed that nearly 90 percent of antipsychotic users qualified as “off-label use.”
Nursing home staff often use powerful antipsychotic drugs to calm down dementia patients, despite being dangerous and ill-suited to Alzheimer’s or other types of dementia.
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A federal initiative to reduce the use of antipsychotics in nursing homes has had limited effects. The initiative, started by the Centers for Medicare and Medicaid Services, kicked off in March 2012 with the goal of reducing antipsychotic use by 4 percent by the end of 2012. When the country fell short of that target, the goal was pushed back one year. But as of July 2014, use of these dangerous and powerful medications have not been reduced by any significant margin.
The National Partnership to Improve Dementia Care in Nursing Homes has documented the use of antipsychotics in nursing homes by state. While the use of antipsychotics for long-stay residents has indeed decreased in the last few years, the decrease has been small and slow. The data shows no more than a 4 percent decrease in off-label use of antipsychotics.
Drugmaker Johnson & Johnson has faced civil and criminal charges for aggressively marketing antipsychotic drugs to nursing home facilities for off-label use. The U.S. Department of Justice argued that from 1999-2005, Johnson & Johnson subsidiary Janssen Pharmaceuticals marketed Risperdal to control dementia behaviors, despite the Food and Drug Administration’s rejection of the drug for dementia patients.
The $2.2 billion Johnson & Johnson settlement was one of many government cases against pharmaceutical companies for marketing off-label uses. The Department of Justice settled with Eli Lilly over marketing of Zyprexa, AstraZeneca over sales of Seroquel, and Abbott over Depakote.
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Off-label use is not universally a bad thing; certain medications have had success treating cancer despite lack of approval from the FDA. However, the use of antipsychotics in nursing homes is another story. Antipsychotics are used in an almost-routine fashion in nursing homes, and they are often treated as a convenient solution to a patient’s confusion or behavioral issues.
The American Society of Consultant Pharmacists recommends that the use of antipsychotics in nursing homes should include:
- An appropriate indication for use
- A specific and documented goal of therapy
- Ongoing monitoring of the resident to evaluate effectiveness in achieving the therapy goal and the development or presence of adverse effects from the medication
- Use of the medication only for the duration needed, and at the lowest effective dose