Indications for Use: Psychotropic Drugs for BPSD
To meet CMS F605 guidelines, prescribing a psychotropic drug requires an “adequate indication for use”. Current practices in neuropharmacology provide guidance. Four drugs that are FDA-indicated for managing symptoms like agitation in Alzheimer's are underused in nursing homes.
Under F605, new CMS guidance stipulates that nursing home care providers must prevent the unnecessary use of psychotropic medications and keep residents free from chemical restraint. When a psychotropic medication is warranted for Behavioral and Psychological Symptoms of Dementia (BPSD), and after exhausting all nonpharmacological interventions, selecting an evidence-based medication is crucial.
Adequate indication for use
CMS standards state that to meet the standard for “adequate indication for use,” a practitioner must identify and document a clinical rationale, explains the blog, CMS New Guidance: Psychotropics & Gradual Dose Reduction, F605. The indication for use can be backed by manufacturer’s recommendations, clinical practice guidelines, standards of practice, medication references, or the medical literature.
Memantine and several acetylcholinesterase inhibitors are FDA-indicated for symptom management in Alzheimer’s and other dementias. Known neuropathology builds a foundation for understanding why and how they work.
What causes agitation?
A neurology-forward approach recognizes that dementia is a form of neurodegenerative brain disease. Agitation can occur because of neurotransmitter dysregulation, explains Elizabeth Crocco, MD in her video, Pharmacological Management of Agitation & Aggression in Alzheimer's and Related Dementias.
More specifically, “There's an imbalance between the executive control and emotional drive due to dysregulation in the prefrontal cortex and the subcortical nuclei that provide neurotransmitters. The main culprits are the neuroadrenergic and serotonergic systems, and indirectly, dopaminergic, and it results in hyperactivity or deficits that lead to agitation,” she says.
This is why drugs that modulate various neurotransmitters are of interest in dementia care, she explains.
Acetylcholinesterase inhibitors + memantine
Acetylcholinesterase inhibitors increase levels of acetylcholine. This neurotransmitter is “essential for processing memory and learning” and is “decreased in both concentration and function in patients with Alzheimer's disease,” explains Francis in his discussion of neurotransmitter disruption in Alzheimer’s. This understanding forms the basis for using an anticholinesterase inhibitor in clinical care. Examples are donezipril (Aricept), rivastigmine (Exelon), and galantamine (Razadyne).
Another component of Alzheimer’s symptomatology stems from “overactivation of N-methyl-D-aspartate (NMDA) receptors by glutamate,” Francis notes. This is why an NMDA receptor antagonist such as memantine (Namenda) can be effective in “correcting neurologic abnormalities associated with Alzheimer's disease”.
Notes a GuideStar blog, “The medications—acetylcholinesterase inhibitors plus memantine—are known to improve cognition, function, and behavioral and psychological symptoms of dementia (BPSDs).” The two are complementary.
This evidence-based approach is underused in nursing home care, found GuideStar research about nursing home practices. Using these medications can improve clinical outcomes for residents living with dementia.
Four drugs that are FDA indicated
Acetylcholinesterase inhibitors “are FDA-indicated for the treatment of Alzheimer's and Parkinson's" and can be “very helpful when started early for preventing agitation,” says Dr. Crocco. She adds that “donepezil, rivastigmine, and galantamine are all indicated for mild, moderate, and severe dementia of Alzheimer's.”
When FDA names a condition in “indications and usage” for a drug, this means that it is “supported by substantial evidence of effectiveness based on adequate and well-controlled studies” (FDA).
Memantine is also “indicated for the treatment of moderate to severe dementia of the Alzheimer's type,” according to the FDA.
SSRIs
Another category of drugs that can offer benefits in dementia care is Selective Serotonin Reuptake Inhibitors (SSRIs). These are classified as antidepressants; they increase levels of the neurotransmitter serotonin. Citing research, Crocco says that SSRIs such as citalopram can be helpful even when people don't have depression or anxiety; they can reduce psychosis and agitation. This is a lower-risk option, as compared with antipsychotics, she adds.
Evidence-based care
When medications are warranted to address symptoms of dementia, GuideStar Eldercare may use a combination of an acetylcholinesterase inhibitor plus memantine. As clinically indicated, they may advise cautious use of SSRIs. These applications are supported by evidence. (To explore the research, visit the GuideStar Clinical Resource Library.)
Choosing FDA-indicated options and applying evidence-based research are ways to meet the “adequate indication for use” standard in CMS F605, supporting compliance. Importantly, says Dr. Steven Posar, CEO of GuideStar, evidence-based care leads to better clinical outcomes.