FDA to launch drug name review pilot project
FDA will initiate a pilot project to help manufacturers choose safer 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, as well.
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 drug release 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. During the proprietary name review process, FDA will screen names against a stem list created by the US Adopted Names Council, evaluate names for orthographic and phonological similarities, and conduct simulation studies, among other things.
US Pharmacopia (USP), a not-for-profit public health organization that helps set standards for drug naming and labeling, launched a drug safety database for health care professionals and patients in August. The “Drug Error Finder” database contains nearly 1,500 commonly used drugs the USP says have been reportedly involved in medication mix-ups.
Drug name mix-ups are responsible for one-quarter of the 1.5 million Americans estimated to be harmed each year from medication errors, the Associated Press reported in September. The Alzheimer's drug Reminyl changed its name to Razadyne after two deaths occurred over mistakes with the similarly-sounding drug Amaryl, a diabetes medication.
The problem received national attention after actor Dennis Quaid's children nearly died from a massive dose of Heparin due to label similarities between Heparin and Hep-lock, a lower-dose form of the blood thinner.
The FDA pilot project will be conducted under the auspices of the Prescription Drug User Fee Act – a part of the FDA Amendments Act of 2007 – signed into law by President Bush in September 2007.