Despite strict government warnings and national initiatives cracking down on administering antipsychotic drugs to older people with Alzheimer’s disease and other dementia, dangerous abuses persist. The practice is particularly pernicious when it occurs in nursing homes, behind closed doors, where the most vulnerable residents are rarely informed or allowed to give meaningful consent before being drugged.
The Center for Medicare Advocacy, a nonprofit law organization, recently issued an alert after analyzing the continued overuse of antipsychotics in nursing homes. It found that in 2016, more than 270,000 nursing home residents are still being liberally drugged with them even though the overwhelming majority of them have not been diagnosed with any type of psychosis. The Center decried it as elder abuse and “a national scandal.”
Nursing home residents are medicated in alarming degrees with alarming doses of anti-depressants, anti-anxieties, antipsychotics, sedatives, and hypnotics—all belonging to the family of “psychoactive” drugs, also called anti-psychotics, psychotropics, or psychotherapeutics. Whatever their label, they work on the brain in various ways to change a person’s mood, behavior, or personality. Most of them also decrease the level of consciousness, acting as a type of “chemical restraint.”
While there are justifiable and therapeutic uses for these drugs, particularly for individuals with bipolar disorder or schizophrenia, they’re frequently misused and abused in nursing homes, where a majority of the residents are prescribed one or more of them, usually to calm those who are agitated or combative—and considered problematic patients.
But the powerful drugs, acting alone and in interaction with other drugs, have a long list of common side effects—including tremors, anxiety, confusion, insomnia, immobility, delirium, kidney and heart failure, and violent behavior. Another common effect, oversedation, often greatly increases the risks of falls and fractures. And in some people, those diagnosed with Alzheimer’s and other types of dementia, psychoactive drugs can even cause death.
Ignoring the Warnings
The risk is so real that in 2005, the Food and Drug Administration (FDA) issued warnings to prescribers and distributors and then imprinted the drugs with one of its rare black box warnings.
It states:
Elderly patients with dementia-related psychosis treated with conventional or atypical antipsychotic drugs are at an increased risk of death.
Antipsychotic drugs are not approved for the treatment of dementia-related psychosis. Furthermore, there is no approved drug for the treatment of dementia-related psychosis. Healthcare professionals should consider other management options.
Perversely, however, the use of such drugs in care facilities actually increased after the FDA’s dire warning.
Digging deeper, in 2011, the Inspector General of the Department of Health and Human Services released a report titled “Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents.” It focused on “atypical” drugs—or those in a second generation, such as Abilify and Risperdal—developed to have fewer side effects than the original antipsychotics; in reality, they were found to have “different” side effects rather than fewer. It also concentrated only on drugs administered to residents 65 and older who spent more than 100 days in a nursing home and billed costs to Medicare over a six-month period.
Among the study’s findings:
14% of those residents had billed for such drugs—at a cost of $309 million
83% of the claims were for “off-label” conditions—or those not medically approved
88% were related to dementia—a use specifically warned against in the FDA black box warning
51% of the claims were “erroneous,” either not used according to accepted medical standards or not documented as administered to residents, and
22% of the drugs claimed were provided in doses or durations that exceeded federal standards.
The Centers for Medicare and Medicaid Services (CMS), the federal agency charged with overseeing nursing home care, responded to the news in the usual way federal agencies do: It created a bloated working group, the National Partnership to Improve Dementia Care in Nursing Homes. The partnership of federal and state agencies, nursing homes, other providers, advocacy groups, and caregivers convened to improve comprehensive dementia care reported a drop in the use of antipsychotics—from 23.9 percent in 2011 to 17.4 percent by the end of 2015. It is important to note, however, that the data is self-reported by nursing home staff—and that dangerously drugging well over a quarter million residents still constitutes an epidemic of elder abuse by most definitions. Another fact: Anti-psychotics can work swiftly to kill people with dementia; it’s likely many did not survive the 100-day period included in the statistics.
Unnecessary and Underhanded
Multiple investigations have uncovered that some nursing homes commonly prescribed the maximum dosages of the drugs to drive up the amount they are able to bill Medicare, whether or not residents needed them. And “need” is another operative buzzword, as facility-related doctors often prescribe the dangerous drugs over the phone, without personally examining the resident or being aware of other drugs in his or her regimen. Prescribing more may be the easy fix when no one is sure what else to do.
Adding to the complicated picture are lawsuits against several drug companies for promoting the drugs for uses not approved by the FDA, and for paying kickbacks to doctors and long-term care pharmacy providers for prescribing them. One of the largest, against health care giant Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, was settled for $2.2 billion in 2013. In that case, company drug reps were found culpable of urging physicians and other prescribers with elderly patients to use Risperdal and other antipsychotic drugs to treat symptoms such as anxiety, agitation, depression, hostility, and confusion—without mentioning that the FDA had then only approved them to treat schizophrenia. There was also no mention that Risperdal by then was known to pose serious health risks to older patients.
In addition to running the disingenuous marketing campaign, the drug company paid “speakers fees” to doctors who wrote Risperdal prescriptions and paid millions of dollars in kickbacks to Omnicare, Inc., the nation’s largest pharmacy specializing in dispensing drugs to nursing home patients. (Omnicare was again in the news in October 2016, agreeing to pay more than $28.1 million to the federal government to settle a whistleblower lawsuit alleging it sought and received tens of millions of dollars in kickbacks to CVS pharmacy.)
Advocating for Proper Use
Knowing that the problem of drugging is real, huge, and persistent underscores the need for caregivers and savvy medical providers to be proactive.
California Advocates for Nursing Home Reform (CANHR), a nonprofit advocacy organization, has long been at the forefront of the fight to end drug abuse in nursing homes. It operates a website dedicated to the cause, The Campaign to Stop Chemical Restraints in Nursing Homes, which includes a spreadsheet listing the current use of psychoactive drugs for named nursing homes in every state. It also publishes a downloadable guide, “Toxic Medicine: What You Should Know to Fight the Misuse of Psychoactive Drugs in California Nursing Homes” that contains information useful to caregivers and advocates in California and other states.
CANHR offers the following advocacy tips for nursing home residents or their representatives when a doctor or staff member proposes the use of psychoactive drugs.
You do not have to accept a doctor’s recommendation to use psychoactive drugs.
Do not give consent if the doctor has not directly examined the resident to determine the need for the drug.
Antipsychotic drugs can be deadly. Don’t consent to their use unless you are certain that all other care and treatment options have been exhausted.
Insist that the doctor or nursing home provide written information on adverse consequences of the proposed drugs, including black box warnings.
Carefully review and consider the written information before making a decision.
Consider seeking a second opinion from a trusted physician or advocate if you have doubts about giving consent.