Federal regulators are turning up the heat to reduce the alarming quantity of dangerous, costly, and unnecessary anti-psychotic drugs prescribed to seniors to quell dementia-related anxiety—not just in nursing homes, but in hospitals too.
Nearly nine out of 10 times in which these drugs, such as risperidone (Risperdal), are given to Medicare beneficiaries, they are for uses that regulators have not approved, an Office of Inspector General's report said last May.
And it's not just risperidone. The U.S. Food and Drug Administration has approved eight drugs, Aripiprazole, Clozapine, Olanzapine, Olanzapine/Fluoxetine, Paliperidone, Quetiapine, Risperidone, and Ziprasidone, to treat schizophrenia and acute manic and mixed episodes associated with bipolar disorder, but specifically says the drugs are not approved to treat dementia-related agitation or psychosis in seniors.
Dangers include increased chance of death, life-threatening nervous system problems, movement disorders, high blood sugar and diabetes, and low blood pressure. Other risks include increased rates of pneumonia and pressure ulcers.
Medicare Calls for 15% Reduction
Now Medicare officials are launching multi-pronged initiatives to reduce the use of anti-psychotic drugs in their beneficiaries. They're calling for a 15% reduction of their use in nursing homes, and are planning efforts affecting acute care facilities as well.
Though the OIG report focused on nursing homes, a closer look reveals that the use of these drugs often begins, is maintained, or is increased within hospitals. In any case, hospital leaders should be concerned that wherever these drugs are used, they can increase 30-day mortality and 30-day readmission rates.
Bad outcomes, even if they occur post acute care discharge, could result in a sizeable percentage of Medicare DRG revenues getting sliced from hospital reimbursement.
As federal and some state initiatives unfold in coming weeks, be prepared for some startlingly ugly revelations about how the healthcare system and pharmaceutical manufacturers customarily treat this behaviorally fragile population.
Physicians, hospitals, and pharmacy services should all start by looking in the mirror to assess their practices: Are these drugs truly necessary, or are they being used as a chemical restraint to keep patients from disturbing other patients or bothering staff? There are many alternatives, but I won't go into them here.
"A Medical Straightjacket"
"In the hospital in my experience, unfortunately it's the most overused drug... a medical straightjacket," says Louis Caplan, MD, senior neurologist and expert in neurologic pharmacology at Beth Deaconess Medical Center in Boston.
"Anybody who's a little hyperactive or agitated—and they're usually agitated for a medical reason, which is they're sick, in pain, or have an infection—you give them these drugs and it makes them less responsive. You're less able to get a history or examine them. And then it wears off, there's a rebounding of excitation and hyperactivity, so (they're given) higher and higher doses, and sometimes it takes days or weeks to wear off," Caplan says.
Rather, Caplan says, "tender loving care" of patients can go a long way to calm them down. "But here the problem is that nurses are now so forced to get on the computer and put all these things in the record, they're not doing as much bedside nursing, staying with the patient."
During the 14 years he was chief of neurology at Tufts Medical Center, haloperidol was banned, "and we didn't have a problem," he says. Haloperidol was not named in the OIG report, but is another common drug that does not have FDA approval to treat behavioral problems in older adults with dementia.
Haloperidal and resperidone, "should never be given to old, sick people, and if it were all thrown in the river, it would be better for patients, although worse for the fish," Caplan says.
ICU Staff "Not Neurologically Sophisticated"
A big problem is the use of anti-psychotics in the elderly treated in intensive care units, Caplan explains. "The people running the ICUs are not neurologically sophisticated, so that they don't pay as much attention to neurospsychological aspects. They would much rather look at computers and see blood gas levels and do imaging rather than examine patients neurologically," Caplan says.
Because hospitals are segmented, the people who take care of patients in ICUs don't follow patients afterwards, so they don't see the longer-term effects of these drugs, he says.
Often, a hospital physician's prescription follows a patient to a nursing home where their use is never re-assessed. Family or patient consent for the use of these drugs, required in many states, is often never obtained.
Consider recent developments giving this issue more attention:
CMS's Plans
The Centers for Medicare & Medicaid Services is under pressure to improve its claims processes for use of these 10 anti-psychotic drugs. In its report last May, the OIG said that over a six-month period ending June 30, 2007, "over 726,000 of the 1.4 million atypical anti-psychotic drug claims for elderly nursing home residents did not comply with Medicare reimbursement criteria."
- As noted, CMS has rolled out an initiative calling for a 15% reduction in the use of anti-psychotic medications in nursing homes by year's end. [CMS video.] Recommended strategies include lower staffing ratios, use of non-pharmacological agents, and at the very least, lower dosing for 72 hours after a patient's episode. Surveyor inspection training to identify noncompliance with federal guidelines is undergoing an update.
- CMS intends to make it clear in an upcoming campaign that nursing homes aren't their only target. Shari Ling, MD, CMS deputy chief medical officer, said in a statement:
"We know that the overuse of these kinds of drugs is not a sector- or setting-specific problem, and we look forward to teaming our long-term-care colleagues with other caregivers across the continuum to make a positive difference in how we as a health community at large care for patients with behavioral issues, particularly those with dementia."
- Last week, jurors in an Arkansas state court determined that Johnson & Johnson and a subsidiary engaged in false or deceptive acts when it sent letters to 6,000 doctors saying its drug Risperdal was safer than competing drugs. The state wants to fine the pharmaceutical company $1.25 billion and awaits a judge's determination. This is the third verdict against J&J on this issue, following decisions in Louisiana and South Carolina. State officials said J&J pushed the drug for unapproved uses in the elderly even after being told by federal regulators to stop.
- States and advocacy groups are getting involved as well. The California Advocates for Nursing Home Reform issued a report, "In a Stupor: What California’s Antipsychotic Drug Collaborative Reveals About Illegal Nursing Home Drugging," documenting that one in four nursing home residents receives anti-psychotic drugs for purposes the FDA does not approve.
In a commentary last May, Inspector General Daniel Levinson wrote, "the most potentially troubling finding of the study is this: Researchers found that 88% of the time, these drugs were prescribed for elderly people with dementia," an unapproved use, and the very population at increased risk of death from these drugs. And, he added, "Many pharmaceutical companies have improperly promoted these drugs to doctors and nursing homes for years."
The challenges of managing dementia patients is something most of us would rather not think about. But these reports present a stunning array of issues that compel us to take another look.