If you have ever witnessed a loved one with dementia experiencing a violent delusion or a physical outburst it can be one of the most frightening moments for not only you, your loved one, but also for the people around them. It can not only jeopardize the health and well being of themselves and their care givers but of anyone who happens to be in the vicinity.
In many memory centers and secured dementia units in assisted living facilities and nursing homes, physical outbursts associated with dementia are common. The use of anti-psychotics and other prescribed medications that help control behavior is often a standard of care. However, the Office of the Inspector General sites in a recently published report titled “Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents” released on May 4, 2011 that more than 20% of the Medicare claims for atypical antipsychotics were used in a population that has not been approved by the FDA (Food and Drug Administration).
Off-label use is dangerous
According to the report, this use of antipsychotics in nursing home patients over the age of 65 with a dementia diagnosis, including Alzheimer’s Disease, accounts for 1.4 million antipsychotic drugs claims submitted to Medicare during the review period (January-June of 2007) The problem is not only has the FDA not approved the use of this category of drugs for elderly dementia patients, but they have instituted the agencies strongest warning. This black box warning alerts doctors and patients to the fact that the use these atypical antipsychotics, such as Risperdal and Zyprexa, in elderly patients with dementia could increase their risk of death.
The black box warning on these drugs stems from a cumulative study that found that patients 65 and older with dementia were more than two times more likely to die while taking the medications than those without dementia. Dr. Daniel Carlat, psychiatrist and CNN contributor explained that the cause of death for these patients was heart failure and pneumonia, the two most common causes of death for any dementia patient.
Off-label use accounts for one in five prescriptions in this class in nursing homes
Daniel Levinson, Inspector General, Department of Health and Human Services, wrote, “The report found about 305,000 nursing home residents (about 14%) had Medicare claims for atypical antipsychotic drugs. Of these, about one in five residents was prescribed these antipsychotics in a way that violated government standards for their use. For example, residents were on a drug for too long, or at too high a dose.”
Levinson blames pharmaceutical companies for misrepresentation and illegal marketing tactics of the off-label use of these drugs to doctors and skilled nursing facilities. He says there needs to be more accountability for pharmaceutical companies who promote off-label uses in order to increase their sales.
Although Carlat agrees that pharmaceutical companies have “in many cases, illegally manipulated our (psychiatrists) prescribing habits,” he disagrees with Levinson’s opinion and many aspects of the report. He believes that such drugs are crucial to treatment. Carlat writes, “When these drugs are successful, they soothe the inner turmoil that makes life intolerable for these patients, improving their quality of life dramatically.” Carlat added that there are currently no medications FDA-approved for the agitation associated with dementia, which affects nearly half of all those patients diagnosed with some form of the disease.
What can families do?
Levinson suggests that families and caregivers should be vigilant in understanding the medication regimens prescribed for their loved ones. They should be the voice for their ailing family member who may be unable by question the need for these types of drugs. But, Carlat cautions, “Physicians are not prescribing these medications in order to do harm to their patients. They are using them because there are no better options. Antipsychotics, by helping patients to be calm, are humane treatments for patients who are reaching the end of their days.”
The question remains, do the benefits of using these off-label drugs outweigh the risk. This can only be answered on a case-by-case basis with medical efficacy and ethics being weighed at every step.
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