Dear Dr. Mossman:
Some of my older patients with dementia develop severe behavioral disturbances, and when other treatments don’t work, I sometimes use second-generation antipsychotics (SGAs) to help them cope better. But I worry about the liability I might face because of the “black-box” warning about prescribing SGAs to these patients. How can I minimize the legal risks of doing this?—Submitted by “Dr. K”
“Black-box” warning. The phrase sounds scary, and it’s meant to frighten you—or at least get your attention.
However, the FDA has put boxed warnings on all antidepressants and many other psychotropic drugs. This doesn’t mean you should quit practicing psychopharmacology. Instead, the FDA just wants you to hesitate and be careful when you prescribe certain drugs in certain situations. One such situation is using SGAs to address behavioral problems that often occur in older persons with dementia.
When it comes to prescribing SGAs for patients with dementia, you can respond to your fear of the “black box” with something that isn’t scary at all: doing what’s best for your older patient. In this article, we’ll explain how, as we cover:
- the scope of the clinical problem
- what a “black-box” warning is
- the significance of the boxed warning for SGA use for dementia-related behavioral disturbances
- how to minimize medicolegal liability when prescribing SGAs.
Aging boomers
As the “baby boom” generation enters its 7th and 8th decades, psychiatrists should expect to treat many older individuals who have dementia and behavioral problems. In the United States, approximately 4 million individuals age >60 have dementia,1 and this number will rise rapidly in the next few years.2 Rates of dementia-related agitation and aggression range from 20% to 80%.3,4 Such behavior—always distressing to patients, family members, and caregivers—can lead to physical injuries, increased caregiver burden, premature institutionalization, physical restraint, and over-medication.
No medication has received FDA approval for treatment of dementia-related agitation. Currently, doctors try a variety of medications, such as memantine, cholinesterase inhibitors, anticonvulsants, and selective serotonin reuptake inhibitors.5 Nearly one-third of nursing home residents with dementia receive antipsychotic drugs.6 Thus, despite the “black-box” warning, SGAs commonly are prescribed to cognitively impaired older persons for behavioral agitation and/or psychosis.
What’s a ‘black-box’ warning?
Almost every prescription drug has dozens of possible adverse effects. “Black-box” warning is a colloquialism that refers to the FDA’s format for describing particularly important potential complications or precautions necessary when prescribing a drug. (For the official definition of a “boxed warning, “ see Box ).7
Regulatory definition of ‘boxed warning’
Certain contraindications or serious warnings, particularly those that may lead to death or serious injury, may be required by the FDA to be presented in a box on the drug’s prescribing information. The box must contain, in uppercase letters, a heading inside the box that includes the word “WARNING” and conveys the general focus of the information in the box. The box must briefly explain the risk and refer to more detailed information in the “Contraindications” or “Warnings and Precautions” section for more detailed information.
Source: Reference 7
Understanding the warning
In April 2005, the FDA mandated a boxed warning for SGAs after placebo-controlled studies showed a significantly higher death rate—mostly from cardiovascular accidents or infections—in geriatric patients who received SGA treatment for dementia-related psychoses.8 The warning does not forbid you from using SGAs when treating older patients with dementia—but you must think carefully about this off-label treatment (ie, prescribing SGAs for an indication that is not FDA-approved).
In patients with dementia, medical conditions may be expressed as behavioral problems that should be addressed with behavioral therapies or appropriate medical therapy ( Table 1 ).9,10 You can feel better about starting SGA therapy if a thorough medical, cognitive, and functional workup has ruled out nonpsychiatric reasons for disruptive behavior.9,11,12 The workup should look for cardiovascular, cerebrovascular, pulmonary, and metabolic risk factors, along with medication side effects.
If medical and situational problems are ruled out, or if aggressive, assaultive, or disruptive behavior threatens the physical safety of patients or others, careful consideration of therapeutic alternatives may show that SGAs are the best treatment choice. Once this decision is reached, clinicians can minimize legal liabilities in several ways.
Table 1
Questions to ask before starting SGAs for dementia-related behavioral problems
| Questions | Comments |
|---|---|
| Is the behavior dangerous? | Nonviolent behavior (eg, foul language, inappropriate voiding, hoarding, or refusing to bathe) can be addressed with nonpharmacologic interventions |
| What about treatable medical problems? | A demented person’s behavioral outbursts may stem from pain (ingrown toenail, acid reflux), misinterpretations caused by hearing or vision problems, delirium from infections or drug interactions, etc |
| Would a nonpharmacologic approach work? | Possibilities include eliminating environmental stressors, increasing interpersonal attention, more frequent reorientation, or music or art therapy |
| SGAs: second-generation antipsychotics | |
| Source: References 9,10 | |