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Audit: Common psychiatric meds can be deadly for elderly

California Watch
Christina Jewett
May 11, 2011

A federal audit found widespread and costly prescribing of antipsychotic drugs to seniors in nursing homes, often in "off-label" uses that can be deadly for elderly patients with dementia.

The report released Monday by the Health and Human Services Inspector General's Office shows that 88 percent of the second-generation antipsychotic drugs prescribed at U.S. nursing homes are for patients with dementia, despite a government warning that such patients face an increased risk of death on such drugs.

The report, accompanied with a strongly worded column by the Health and Human Services inspector general, also comes down clearly on one side of an ongoing debate in California over the use and safety of antipsychotic medications.

Such medications are prescribed daily to 24,000, or about a fourth, of the 99,000 nursing home residents in the Golden State, federal data shows.

Inspector General Daniel Levinson called the findings about prescriptions to dementia patients “alarming.” The Food and Drug Administration in 2005 issued its strongest “black box warning,” saying that prescribing atypical antipsychotic drugs to seniors can increase their risk of death. Those drugs were developed to meet the needs of patients with rare and severe mental conditions, such as bipolar disorder and schizophrenia.

Off-label prescribing is not illegal and is left to physician discretion, although the Justice Department has cracked down on drug companies for off-label drug promotions.

The report was based on a review [PDF] of nursing home patient medical records from the first half of 2007. The findings include:

  • Fifty-one percent, or $116 million worth, of claims for the medications were “erroneous,” meaning they were not given to patients or did not meet Medicare nursing home prescribing guidelines. 
  • About 83 percent of claims were for “off-label” uses, meaning they were given to patients for conditions other than the serious mental disorders the drugs were developed to treat.
  • Of the 2.1 million elderly nursing home residents, 14 percent had a prescription for an atypical antipsychotic drug between Jan. 1 and June 30, 2007.

Levinson referenced multi-million-dollar Justice Department settlements that pharmaceutical companies have paid for marketing antipsychotic drugs for conditions they are not meant to treat. He also called on families to “ask questions about medications that their loved ones take, learning the reasons for their use, proper dosages and possible side effects.”

“Government must uphold patient safety standards established for nursing homes and combat off-label promotion of these powerful and potentially lethal drugs,” Levinson wrote.

While Levinson, a prominent national authority, expressed serious concern about the use of antipsychotic drugs, the issue is hotly debated in California.

The California Advocates for Nursing Home Reform have launched a public-education “Campaign to Stop Drugging,” focused on the prescription of antipsychotic medications to seniors.

The group has published a guide for the public, held a conference with elder advocates and attempted but failed to pass state legislation calling for more rigorous informed consent regarding the death risk of such drugs.

Anthony Chicotel, staff attorney for the reform group, said the inspector general report signifies an opportunity to transition from fact-finding to action.

“Anytime anyone takes a hard look at this, they find terrible things,” Chicotel said.  “They need to focus attention away from just looking and focus on finding solutions.”

The advocates’ efforts, though, are frequently at odds with the trade group that represents nursing homes, the California Association of Health Facilities, which responded to the anti-drugging campaign with its own website dedicated to defending such prescribing to seniors.

The website notes: “Misleading and exaggerated information regarding the use of psychoactive medications in nursing facilities abounds across the Internet and in the news media.”

It also features a statement by a physician, Dr. Karl Steinberg, who says such prescribing can be “a great benefit.”

“I take issue with sensationalistic, one-sided media coverage of this topic, and with the mischaracterization of the use of antipsychotics to keep patients in bed or to sedate them so heavily that they are virtually comatose,” Steinberg wrote. “While there may be some overuse of antipsychotics in the dementia population by a few providers, I believe the great majority of antipsychotics are prescribed to reduce the distress of the patient, and to improve their quality of life.”