A Method of Addressing Proprietary Name Similarity for US Prescription Drugs

Abstract

There is an increased risk of medication error and harm to a patient whenever 2 or more drug product names appear alike in sound, look, or meaning. Any ambiguity of the proprietary name (“trade” or “brand” name) of a drug product can lead to errors in ordering, dispensing, or administering medication. A drug’s name is a critical identifier, and correct product identification is important to the responsible administration of medicine. This article describes a series of tools created for regulatory reviewers to enhance the review of proprietary names under current federal regulations, with the goal of encouraging further innovation toward the goal of medication safety. These tools include measures of orthographic, phonetic, and semantic similarities and are designed be used together with the existing computerized measures of similarity. It is the hope that highlighting the importance of medication error reporting for the safety review process will further encourage health care professionals to provide adequate and detailed reporting regarding medication errors, which will lead to improvements in the overall safety review process.