Antipsychotic Medication Use for Individuals with
PDF Version of DQA 09-015
(PDF, 42 KB)
|| April 17, 2009
Homes NH 04
|| Otis Woods, Administrator
Division of Quality Assurance
Antipsychotic Medication Use for Individuals with Dementia
The purpose of this memo is to address the current federal Food and Drug
Administration (FDA) Public Health Advisories on antipsychotic medication
use for the treatment of behavioral disorders in elderly individuals with
Alzheimer's disease, dementia or other organic brain syndrome.
The FDA issued Public Health Advisories for all antipsychotic
medications. The advisories can be accessed at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/
These advisories are a response to various studies that indicated increased
mortality when antipsychotics were used for the treatment of behavioral
disorders in elderly individuals with Alzheimer's disease, dementia or other
organic brain syndrome.
The advisories highlight FDA requirements for manufacturers to include a
Boxed Warning in medication product labeling that describes the mortality
risk and notes that antipsychotics (e.g., aripiprazole, olanzapine,
quetiapine, risperidone, clozapine, ziprasidone, haloperidol and
thioridazine) are not approved for the treatment of behavioral disorders in
elderly individuals with dementia.
Federal and State regulations establish various requirements related to
medication use, some of which are very specific to antipsychotic use. These
regulations have not changed.
The Division of Quality Assurance (DQA), as part of the nursing home
survey process, investigates the use of antipsychotic medications for
behaviors in residents with Alzheimer's disease, dementia or other organic
brain syndrome. Through the investigation, surveyors determine compliance
with the various antipsychotic medication regulations.
DQA surveyors apply standards of practice for behavior treatment. In
applying those standards, the following questions are considered by
surveyors when antipsychotic medications are used for behaviors related to
Alzheimer's disease, dementia or other organic brain syndrome:
- Was the behavior persistent?
- Was the behavior harmful?
- Were other environmental, psychosocial or medical causes of the
behavior ruled out?
- If a behavior was persistent and harmful; if other environmental,
psychosocial and medical causes were ruled out; and, if an antipsychotic
medication is used, does the antipsychotic improve the behavior and is
the antipsychotic used for the shortest time possible?
- When antipsychotic medication is used for behaviors, can the facility
show that it is monitoring for benefits and risks? This includes
training staff to identify and document the effects of the medication on
the resident and the practice of follow-up communication within the
- Has the facility discussed the risks and benefits of the medication
with the resident and/or the resident's power of attorney or guardian?
In addition to this focus area, DQA surveyors may also investigate other
areas. For instance, the facility's Medical Director is responsible for care
coordination and resident care policies within the nursing home. Pharmacy
Consultants are responsible for assisting facilities in the identification
of medication-related problems.
When there are problems with the use of antipsychotic medications, DQA
surveyors may look into whether facilities worked with their medical
director and pharmacy consultant to develop and implement plans of care or
policies related to antipsychotic medication use for behavioral disorders in
residents with Alzheimer's disease, dementia or other organic brain
It is important to remember that, for most behaviors, antipsychotic
medications have, in some cases, not been shown to be any more effective
than a placebo. If an antipsychotic medication is used for a single resident
behavior without first conducting a complete assessment, it is likely that
there was not an adequate indication for the use of the antipsychotic. When
there are not adequate indications for medication use, the medication may be
considered unnecessary and the nursing home is at risk of violating state or
federal rules or regulations.
Existing regulations have not changed with the FDA advisories. When
antipsychotic medication is used for dementia-related behaviors, facilities
must discuss the use of antipsychotic medication with the residents'
families, consultant pharmacists, medical directors and physicians before
starting or making any changes with antipsychotic therapy.
Similarly, before starting or making any changes with antipsychotic
therapy, facilities should document their consideration of all the standards
related to antipsychotic medication use for residents whose behaviors are
the result of Alzheimer's disease, dementia or other organic brain syndrome.
When antipsychotic medications are used for behavior treatment, a monitoring
plan that evaluates the medication's effectiveness and side effects must be
Medication monitoring is essential for the determination of effectiveness
and requires appropriately trained direct care staff to recognize the side
effects that may result from the medication. Communication between nursing
staff and the facility's medical director and pharmacy consultant is,
therefore, critical to ongoing antipsychotic medication monitoring within
If you have specific information regarding the use of and the ongoing
monitoring of medications that contain the FDA black box warning, please
contact Douglas Englebert, RPh, Pharmacy Practice Consultant, at (608)
266-5388, or e-mail him at: firstname.lastname@example.org
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