Navigating FDA Black Box Warnings: Dealing with Common Comorbidities in Patients with Neurologic and Psychiatric Disorder

Black box warnings (BBWs) are the most serious warnings required by the FDA to be included in the labeling of prescription drugs when evidence of potential harm or hazard is associated with use of a specific agent. Misunderstood and potentially undesirable BBW associated with the use of antipsychotics and antidepressants make it difficult for primary care providers to be agreeable to providing treatment, including maintaining long term therapy. As new medications are released, health care providers must be aware of the role of potential BBW in therapy these medications have, along with side effect profiles, and best medication practices to ensure quality patient care.

As we continue to progress with the development of pharmacotherapies, it is important to remain up to date on newly available medications and the potential role in treatment of our patients. Often the use of agents associated with BBW is necessary, however few prescribers understand how to prescribe these agents through educated use of the product. With the use of evidence-based literature, we provide opportunities to navigate through these BBW; reducing fear from what can often be considered “sensationalized” warnings if not properly understood. This educational outreach on navigating BBW is expected to increase safe use and reduce provider avoidance due to fear of the implication of these warnings.

All participants will be required to complete the online pre-test at the time of registration prior to attending the live activity.

Program components are:

Pre-test
Lecture
Case Study Review
On-site post-test
Acheiving a passing score of the assessment post-test is not a requirement of obtaining continuing education credit; however participating in all active learning components is.

OBJECTIVES
Identify Black Box Warnings and recognize the purpose and definition of an FDA black boxed warning

Understand the role of Black Box Warnings in overall medication management that impacts patients with neurologic and psychiatric disorders

Recommend alternative strategies to ensure optimal patient safety when developing and monitoring regimens with drugs associated with Black Box Warnings