FDA safety alerts: Getting the response right!

Abstract

The Food and Drug Administration (FDA) has issued more than 350 safety alerts for drugs and biological products, since January 2008. Approximately 12% (40) of these alerts were regarding medications indicated for the treatment of neurologic or psychiatric disorders. FDA safety alerts are intended to improve patient safety by providing the medical community with timely new safety data and actionable information that may impact treatment choices by both healthcare providers and patients. Communication of the safety alert to health care professionals also generally provides a summary of the data that serves as the basis for the alert, although often unpublished and not accessible for in depth review by decision makers. Health care providers and institutions are expected to orchestrate a response to these alerts that is in the best interest of delivering safe care to patients. Responses may range from dissemination of new information, policy development, or changes in selection or use of a drug or medication class. As mental health care delivery systems vary widely in size, patient population, infrastructure and financing, and resources (personnel and technology), responses to safety alerts may also vary to same degree. We were interested in identifying commonalities for failures and successes, in the experiences of clinical pharmacy specialists in mental health settings responding to safety alerts.