An elderly resident refuses to get dressed. When approached he lashes out, and if he's touched he tries to bite. He has alienated family and frightened aides; his health is declining. He's prescribed an antipsychotic, an off-label industry standard for combating the agitation that can accompany dementia.
But recent studies, warnings, and lawsuits have begun to change the way care providers-and the public at large-regard these drugs. In June the Food and Drug Administration required manufacturers of the 11 "typical" antipsychotics, the first-generation antipsychotics that include haloperidol (Haldol), to add a black box to the label warning of a higher risk of death in older adults with dementia. Three years ago a similar warning was placed on the labels of the "atypical" antipsychotics, the second-generation drugs that include quetiapine (Seroquel) and eight others. In light of these warnings, the rate at which these drugs are prescribed to older patients with dementia has raised concern. In 2007, the Centers for Medicare and Medicaid Services reported that in 2001, 39% of nursing home residents had been prescribed an antipsychotic; the agency also reported that 21% of those taking antipsychotics don't have a psychosis diagnosis.
Although the warnings don't mean the drugs are contraindicated in this population, several studies in the past year have highlighted potential hazards with off-label use (see Antipsychotics and Dementia: Recent Studies, below). In addition, states are fighting what they say are unscrupulous marketing practices. In October Eli Lilly agreed to stop marketing olanzapine (Zyprexa) for off-label uses after reaching a $62 million settlement with 32 states and Washington, DC. The states claimed that Lilly marketed the drug while hiding data about its adverse effects, including an increased risk of diabetes.
"People get on these medications and they never get taken off, even if the behavior dissipates," says Ann Kolanowski, professor of nursing at Pennsylvania State University. "We need to look at pharmacologic interventions as a help during a crisis, not as something to be used chronically." Kolanowski is focusing on nondrug means of quelling disruptive behavior as principal investigator for the Quality of Life Project, a four-year National Institute of Nursing Research- funded study of the effect of recreational activities on nursing home residents with dementia.
The Quality of Life Project will test the effectiveness of activities targeted to a resident's interests before dementia appeared. "Let's say we have an older woman who may be introverted but she's also very curious," Kolanowski says. "We get an old purse, fill it with trinkets, and put it next to her. She can sit for 45 minutes rummaging through it, and she's happy about it." For more outgoing residents, Kolanowski is testing the effectiveness of scavenger hunts and physical activities such as bowling.
Many people assume that most nursing homes don't use such nondrug approaches because they're understaffed. But Kolanowski says a staff's "knowledge and skill" are more important than its size. She advocates training all staff, from nursing directors to nurses' aides, on the importance of recognizing "triggers," such as physical discomfort, that prompt problem behaviors.
Also, she says that because nursing homes are required to periodically evaluate the necessity of all prescribed medications, inappropriate prescribing of antipsychotics to people with dementia is "probably more of an issue out in the community, where it isn't regulated." She says that nurses, regardless of setting, should question physicians' orders for these drugs, as well as encourage the use of diversionary activities.
Joy Jacobson
Managing Editor
Antipsychotics and Dementia: Recent Studies
Ballard C, et al.PLoS Med2008;5(4):e76. British researchers randomized 165 patients with Alzheimer's disease to continue receiving an antipsychotic for 12 months or be switched to a placebo. They found that withdrawal of the drug, for most patients, "had no overall detrimental effect on functional and cognitive status."
Douglas IJ, Smeeth L.BMJ2008;337:a1227. British researchers studying 6,790 patients who had had a stroke and been prescribed at least one antipsychotic found that the "risk of stroke in patients receiving antipsychotics seems to be greater in those with dementia than in those without."
Rochon PA, et al.Arch Intern Med2008;168(10):1090-6. Among older adults with dementia treated with typical or atypical antipsychotics, the rate of serious adverse events within the first 30 days of therapy was three or four times higher, respectively, than among those taking placebo.
Setoguchi S, et al.J Am Geriatr Soc2008;56(9):1644-50. Researchers investigating the cause of death in older adults who had received either typical (n = 12,882) or atypical (n = 24,359) antipsychotics found "a significantly greater risk of all-cause mortality" in patients with dementia than in those without and that patients taking typical antipsychotics had a "significantly greater risk of dying" from cardiovascular causes than did those taking the atypical drugs.
World Health Roundup
Contamination of milk powder with melamine in China has caused urinary tract dysfunction in more than 54,000 infants in China and been linked to the deaths of four. The World Health Organization reported that infants were being treated for urinary tract problems, renal tube blockages, kidney stones, and acute kidney failure after ingesting infant formula adulterated with melamine. More than 14,000 infants have been hospitalized.
Melamine, a synthetic chemical used to make cleaning products, glues, and pesticides, cannot be used in foods in the United States. High in nitrogen, it raises the apparent protein content of foods. China has said the compound was added to disguise the dilution of milk by some unscrupulous dealers that collect the raw milk produced by the country's numerous dairy farmers. It was reported in late October that melamine may have been added to livestock feed, affecting chicken and pork products, as well as eggs, frozen yogurt, liquid milk, biscuits, candy, and drinks. Melamine-tainted pet foods sickened many U.S. dogs and cats last year.
The U.S. Food and Drug Administration announced that because all companies authorized to sell infant formula in the United States have certified that their products do not contain milk from China, there is no known threat of contamination. But the agency is urging consumers to avoid infant formula possibly imported from China, such as that available in Asian markets or over the Internet. A list of recalled products is available at http://www.fda.gov/oc/opacom/hottopics/melamine.html.
High rates of asthma in children may be linked to abuse, according to a report in the American Journal of Respiratory and Critical Care Medicine. A household survey of 1,200 children in two metropolitan areas in Puerto Rico showed that of the 6% with a history of physical or sexual abuse in the previous year, 51% had a diagnosis of asthma (compared with 39% of nonabused children). The researchers suggest the higher rate may be caused by exposure to stress and violence, which studies have linked to childhood asthma. They recommend screening child abuse victims for asthma and remaining aware of the possibility of abuse among children with asthma.
Jennifer Moser