Black Box Warnings A to Z
Black Box Warnings
A to Z
Emory S. Martin III, PharmD BCPS
Vice President, Pharmacy Services
Scott & White Healthcare
1
Objectives
Following the presentation, the participant will: ? Be able to quantify the typical frequency of
prescribing drugs that have a black box warning (BBW) ? Be able to list the common categories of prescribing practices in violation of BBWs ? Be able to navigate and use the FDA's on-line tool for communicating new drug safety information ? Be able to identify 10 significant BBW drugs and how to avoid the BBWs
2
INTRODUCTION
3
What is a BBW?
4
BBW ? More than a Precaution; Less than a Contraindication
US FDA Labeling Cautions ? Precaution: Consideration must be taken in special
situations/patient groups ? Warning: Serious adverse events that have been
observed and potential safety hazards ? A "Black Box Warning" or "Boxed Warning" is the
strongest warning the FDA issues ? Contraindication: Drug should not be used in a
specific situation because risk much greater than possible benefit
5
................
................
In order to avoid copyright disputes, this page is only a partial summary.
To fulfill the demand for quickly locating and searching documents.
It is intelligent file search solution for home and business.