The Food and Drug Administration Project PAUSE will hold a workshop exploring black box warnings on antipsychotic medication instructions, especially for older adults.
The team’s directives came from this year’s appropriations bill, which instructed the US Food & Drug Administration (FDA) to “review the data regarding risks associated with the use of medicines … the antipsychotic class in older adults with mental health conditions associated with dementia and the appropriateness of the broad application of this boxed warning for all medicines within this class.”
According to a statement from PAUSE (Psychoactive Appropriate Use for Safety and Effectiveness), Congress has said that the FDA has not re-evaluated the need and value of the boxed warning included in the approved labeling of antipsychotic medications since 2008, even though there is more scientific evidence, clinical guidance changes and new medicines entering the market.
A report on the review and the workshop must be reported to the FDA within 12 months.
Project PAUSE advocates for the appropriate and safe use of antipsychotics in older adults. The team wants to make sure that measures are up to date with newer evidence. Project PAUSE has been working with the American Society of Consultant Pharmacists (ASCP) and the Alliance for Aging Research to ensure language is accurate.
Disabling behavioral and psychological symptoms of dementia — called neuropsychiatric symptoms — can include apathy, disinhibition, socially inappropriate behavior, difficulty finding one’s way, difficulty finishing basic tasks, depression, auditory and visual hallucinations, psychosis, anger, aggression, anxiety, fear, sleep issues, sundowning,delirium, mood swings, disorientation, and paranoia.
“There is a large unmet medical need in long-term care settings for the diagnosis and management of neuropsychiatric symptoms in dementia,” Sue Peschin, MHS, president and CEO of the Alliance for Aging Research, said in a statement. “Despite scientific evidence pointing towards shifts in clinical protocols since 2008, the FDA has yet to reassess the necessity and effectiveness of the boxed warning attached to the approved labels of antipsychotic medications. We’re thankful to Congress for recognizing that fact, especially as one on-label therapy for agitation in Alzheimer’s dementia has been approved by the Agency and others are in clinical development. Older adults deserve access to the most appropriate care, and we will continue to work with policymakers towards that goal.”
“This workshop is a significant step toward ensuring safe and appropriate use of antipsychotics for older individuals residing in long-term care facilities,” Chad Worz, PharmD, ASCP CEO said in a statement. “ASCP is proud to have supported this required FDA public workshop and review of pertinent data related to risk. It is crucial that black box warnings are scientifically accurate in order to promote patient safety and quality care. Additionally, ASCP will continue to engage CMS on re-evaluating its outdated quality metrics for antipsychotic use in the long-term care setting to ensure residents have access to appropriate, evidence-based care.”
Editor’s note: This story has been corrected to show the FDA will host the workshop.
