Antipsychotic drug use since the FDA black box warning: survey of nursing home policies

J Am Med Dir Assoc. 2011 Oct;12(8):573-577. doi: 10.1016/j.jamda.2010.04.005. Epub 2010 Oct 2.


Objectives: To use a nationwide survey to assess changes in antipsychotic utilization patterns and usage policies in nursing homes (NHs) in the United States since the introduction of the black box warning by the FDA.

Design/setting/participants: A survey was distributed online and was completed by 250 directors of nursing of NH. The directors of nursing answered questions concerning policies about and use of antipsychotic medications.

Measurements/results: The most commonly reported intervention to manage symptoms in residents with dementia since the black box warning was to lower doses of antipsychotics. Over half of facilities report obtaining more frequent psychiatry/psychology consults. One-hundred seven facilities have a policy regarding informing family members of residents about the black box warning. Most facilities (63.6%) with a policy require family to sign consent. In the NH setting, the presence or absence of a policy did not correlate with the reported change in use of antipsychotics or types of alternative interventions.

Conclusion: Notably, a large number of NH facilities have policies regarding informed consent on the use of antipsychotics. However, in our study, the rate of use of antipsychotics did not change in many facilities since the black box warning. In addition, having a policy did not correlate with decreased antipsychotic use or with use of alternate agents or nonpharmacologic methods to address symptoms. The results of this survey suggest that NH administrators should worry less about the legal exposure of using antipsychotics and focus on actions that result in improved patient care.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antipsychotic Agents / adverse effects*
  • Antipsychotic Agents / therapeutic use*
  • Dementia / drug therapy
  • Drug Labeling*
  • Health Care Surveys
  • Humans
  • Nursing Homes*
  • Organizational Policy*
  • Practice Patterns, Physicians' / statistics & numerical data*
  • United States
  • United States Food and Drug Administration


  • Antipsychotic Agents