Medication Safety

Safety Review of Trademarks

Lilly undertakes a thorough safety review of trademarks for its products before they are introduced to the public before patient use. This review includes many of the steps outlined in the Concept Paper developed by the FDA for the PDUFA IV proprietary name Pilot Program. It includes a thorough search of several relevant databases of product names for look-alike or sound-alike similarity that might result in confusion that could lead to a medication error.

In addition, prescription simulation studies are undertaken in the U.S. and several other countries to identify possible look-alike/sound-alike problems including look-alike issues that may arise in handwriting of prescriptions. A modified failure mode and effects analysis is undertaken on any product names identified during this process to determine the likelihood of a medication error. Several companies interested in patient safety have developed well-tested methodologies to accomplish the above, which Lilly uses in conducting its review.