One of the most common comments I hear from users of Electronic Medical Records (EMR) systems is associated with “alert fatigue” from unwelcome drug interaction notifications. Many users tell me that they are flooded with unavoidable but unnecessary alerts that interrupt their workflow, decrease productivity, and make the important alerts harder to see. Clinicians find themselves clicking through the alerts as quickly as possible which defeats the purpose of clinical decision support.
In today's fast-paced healthcare industry, electronic health record (EHR) and other healthcare information system vendors need smart, current drug data that will enable their systems to drive patient safety and improve healthcare -- without generating a flood of annoying alerts that will only be ignored. Lexicomp has recently included new functionality that can alert users with the appropriate Black Box Warning where appropriate in the current workflow. (Note: The Lexicomp solution Lexi-Data referenced in this post has been replaced by newer Medi-Span solutions as of January 2013.)
In the most simple terms, an FDA Black Box Warning is the strongest warning that the US Food and Drug Administration (FDA) puts on a drug. It means that you should pay close attention to the drug's usage because there are some potentially extremely harmful or dangerous threats to your health that the already FDA approved drugs could pose.
The other side of the coin, however, is that an FDA Black Box Warning means that despite the FDA's knowledge of these harmful, serious and sometimes deadly side effects that they are still leaving the FDA approved drug on the market for you to be able to take and potentially experience these harmful side effects. In theory, these FDA Black Box Warnings are designed for both the doctor who is prescribing the drug to be aware of the problems and for you as the consumer to be more aware.
The warning is placed in a prominent 'black box' on the package insert of an FDA approved drug so that people and their doctors can be more aware of it, but few doctors ever see the pill bottles and the vast majority of consumers realistically aren't going to go through the amazingly large amount of technical and medically detailed information on a package insert. This can lead to doctors note being aware of a serious alert which can have serious consequences. With Lexicomp’s inclusions of Black Box Warnings within their medication database, the warnings can be provided to the physician during the prescription process where they are most needed.