ARTICLE IN BRIEF
A new report by the Office of Inspector General cites the overuse of newer atypical antipsychotics among the elderly in nursing homes.
Newer atypical antipsychotics are being widely used off label, often inappropriately, in nursing homes, despite contraindications or adequate oversight, according to a review of Medicare claims in 2007 by the Department of Health and Human Services Office of Inspector General (OIG).
In a report released May 5, the OIG said that just over half of all Medicare claims for atypical antipsychotics by nursing home residents in the first half of 2007 — some 1.4 million claims — were “erroneous” for failing to meet the agency's reimbursement requirements. The investigation found that 10 percent of the drugs were administered in excessive doses, 9 percent were given for too long a period, 8 percent to seniors without sufficient indications for their use, and to 4.7 percent where adverse consequences indicated that the dose should be reduced or treatment discontinued.
Of 2.1 million Medicare residents in nursing homes, 304,983 had at least 1 claim for an atypical antipsychotic, and 83 percent of these were for off-label conditions; 88 percent were prescribed atypical antipsychotics for conditions specified in the FDA's box warning contraindicating their use — for example, an increased risk for mortality when used for treating behavioral disorders in patients with dementia.
Confusion, sedation, and weight gain are all risks from atypical antipsychotics, which have only been approved for treating schizophrenia and bipolar disorder, although off-label use is not specifically prohibited.
Of the 1.4 million claims filed, 726,000 failed to comply with Medicare reimbursement criteria because the medicines were either not used for an accepted indication or lacked documentation showing they had been properly administered.
After reviewing the draft report, Centers for Medicare & Medicaid Services (CMS) Administrator Donald Berwick, MD, responded in a letter to the Department of Health and Human Services Inspector General Daniel Levinson that the CMS is very concerned with overuse of atypical antipsychotics in nursing homes. Dr. Berwick said a major source of the problem lies with the current relationships between facilities, long-term care (LTC) companies, their pharmacists and pharmacies.
“We strongly believe this should be referenced in this report,” he wrote. “We are very concerned that if an OIG report ignores the causative behavior of the LTC pharmacies, and instead suggests that the problem is limited to a Medicare Part D claims payment issue, the issuance of this report may be used as a defense of this practice, and may seriously interfere with any future efforts of the OIG, the Justice Department, and the Centers for Medicare and Medicaid Services to correct the fundamental problem.”
Dr. Berwick noted that pharmacists are not required to question the necessity of any script they fill, and until state boards of pharmacy require such information and the drug industry agrees, CMS will not add any data fields requiring additional information about the appropriateness of prescribing.
Dr. Berwick also objected to the report's inference that because 95 percent of the atypical antipsychotics were used off-label, they were somehow being used improperly. Instead, Dr. Berwick wrote, “the off-label uses that are cited are still considered by law to be medically acceptable indications,” and lumping these with uses in patients contraindicated by the black-box warning “incorrectly overstates inappropriate use.”
Nonetheless, the agency admitted that steps are needed to better monitor innapropriate use. Dr. Berwick said his office will consider what actions the agency should take when handling such claims in the future.
For more than 20 years, Louis R. Caplan, MD, professor of neurology at Harvard Medical School and Beth Israel Deaconess Medical Center in Boston, has been an outspoken critic of the use of antipsychotics in nursing homes, starting with the widespread use of earlier generations of antipsychotics like the butyrophenones, especially haloperidol.
“These are medical straightjackets,” he told Neurolgy Today in a telephone interview. The problem is much larger than sedating disruptive nursing home residents, he said, noting that atypical antipsychotics are also being given inappropriately to children with behavior problems.
According to Dr. Caplan, physician oversight of the medications is largely unmonitored. “Many times, doctors only visit nursing homes once a month, yet there seems to be a general consensus that when residents, especially those with senile dementia, disrupt other residents, it is best to heavily sedate them with these drugs. But there are significant mortality and morbidity issues with the drugs that seem to be overlooked,” he said.
Dr. Caplan admitted that he is unsure whether the drugs are being prescribed by visiting psychiatrists or physicians. “But it is doubtful that anything can be done about the practice because nursing homes tend to operate as a closed, self-supporting system.”
Part of the problem is economic, he added.
“Nursing homes just do not have the money to properly manage problem residents, even though there are safer sedatives and tranquilizers, especially quetiapine fumarate. But I suspect they are not being used as much because they tend to be shorter-acting, and nursing homes are opting for the more potent antipsychotic because they last longer. Other options they could be using are anti-convulsants like valoproic acid and trileptal, which also act as mood stabilizers,” he told Neurology Today.
Nonetheless, Dr. Caplan said that some atypicals might be warranted if administered in lower doses. “I am not sure about seroquel. It is an atypical but it has a different side affect profile, and it can help reduce hallucinations, especially at low dose,” he told Neurology Today.
To date, the US FDA has approved eight atypical antipsychotic drugs for treating schizophrenia or bipolar disorder, including aripiprazole, clozapine, olanzapine, olanzapine/fluoxetine, paliperidone, quetiapine, risperidone, and ziprasidone.
At the time of the review, FDA had approved all of these drugs for use in the psychiatric treatment of schizophrenia and/or bipolar disorder, but many patients filing claims had neither diagnosis and were being treated off-label.
“I think that it is important to look at this from a different perspective,” said Anil K. Nair, MD, chief of neurology and director of several clinical trials in dementia at the Alzheimer Center at the Quincy Medical Center, Quincy, Massachusetts.
“The underlying assumption the OIG has taken is that atypical antipsychotic drugs alone are dangerous to nursing home patients, but this is based on incomplete data. Studies have show that cheaper alternatives (typical/conventional antipsychotics and benzodiazepines) are likely as or more harmful than atypical antipsychotics to cause death in this population. There are no FDA approved medications for use for aggression and violence in dementia, therefore all drugs are used off-label in this situation,” he told Neurology Today in a telephone interview.
“This report selectively collected data on the expensive atypical antipsychotics, without considering the potential harm from using cheaper conventional antipsychotics or benzodiazepines,” he noted.
“Moreover, the risk of using atypical antipsychotics can be presented to patients in two ways. In fact, the absolute risk of heart attack death increased by only a small number, about 4 deaths instead of 2 for every 1,000 patient-years, but the same information appears more dramatic when presented as relative risk that is doubled.”
“The study also compares a healthier group needing less antipsychotics to a less healthy group, which may also account for some of the increased risk,” he told Neurology Today.
“We are speaking about older patients whose quality of life and independence is a key factor in the few remaining years of their lives, and it is important to prevent them from being a burden to their caregivers. Drugs should only be used when nonpharmacologic approaches have failed to adequately control behavioral disruption. When used appropriately, these medications are effective treatments for dementia to help control aggressive or violent symptoms, thereby maintaining their dignity and reducing caregiver burden.”
Dr. Nair said he feels the report is more about “how not to pay for these medications than about patient risk or considerations of a humane unrestrained life,” noting that the Medicare may be indirectly advocating for the use of older agents which have significantly greater risks. “I see significant conflict of interest when a government entity responsible for payment (one that is also trying to save money), comes up with a report critical of higher-cost atypical antipsychotics but continues to pay for cheaper and more dangerous conventional antipsychotics and benzodiazepines in the same population,” he said.
OIG REPORT ON ANTIPSYCHOTICS USE IN NURSING HOMES
- 14 percent of elderly nursing home residents had Medicare claims for atypical antipsychotic drugs.
- 83 percent of Medicare claims for atypical antipsychotic drugs for elderly nursing home residents were associated with off-label conditions, including the treatment of agitation in dementia, depression, personality disorders, and autism; 88 percent were associated with the condition specified in the FDA boxed warning — increased risk of mortality when used for treating behavioral disorders in patients with dementia.
- 51 percent of Medicare atypical antipsychotic drug claims for elderly nursing home residents were erroneous, amounting to $116 million.
- 22 percent of the atypical antipsychotic drugs claimed were not administered in accordance with CMS standards regarding unnecessary drug use in nursing homes.