October 13, 2008
FDA database aims to limit Rx name mix-ups
FDA will initiate a pilot project to help manufacturers choose safe proprietary drug names. The project hopes to prevent mistakes made during drug administration to patients based on similarly named products.
To address that goal, FDA's pilot program will enroll manufacturer applicants on a voluntary basis, beginning no later than September 30, 2009. For the pilot project, manufacturers may submit a potential proprietary drug name to be reviewed by FDA staff. Submissions during the investigational new drug application (IND) process will be accepted only for products that have completed phase 2 of clinical development, according to the FDA concept paper. FDA will review proprietary names as part of the initial submission of an NDA, BLA or ANDA.
The FDA concept paper lists several drug naming characteristics that can cause medication errors. For instance, the FDA discourages names that incorporate or suggest a dosing interval (e.g. NameBID), since characteristics are subject to change over time, with new dosages. FDA also discourages medical or product name abbreviations, and drug names that include or suggest the composition of a drug.
US Pharmacopia, a not-for-profit public health organization that helps set standards for naming and labeling, launched a drug safety database. The “Drug Error Finder” database contains nearly 1,500 drugs the USP says have been involved in medication mix-ups.