The U.S. Food and Drug Administration (FDA) issued a pair of draft guidance documents aimed at guiding the selection of proprietary names for prescription and non-prescription drugs. The best practices set forth in the guidances are designed “to help minimize proprietary name-related medication errors and otherwise avoid adoption of proprietary names that contribute to violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations,” according to the guidances.
Guidances
The prescription medication naming guidance explains FDA’s thinking on how to prescreen proposed proprietary names for attributes that contribute to medication errors. These include avoiding similarities in spelling or pronunciation, as well as avoiding listing inert of inactive ingredients as co-equal with active ingredients and avoiding the omission of active ingredient(s) when two or more are present.
The non-prescription naming guidance gives specific recommendations for how to handle any name changes for drug products that are being switched from prescription to non-prescription use.
Both guidance documents also recommend against incorporating the sponsor’s name in a proprietary name, since it increases the likelihood of confusion between different medications that may be quite similar. The guidances also detail how FDA uses its Phonetic and Orthographic Computer Analysis (POCA) software to “evaluated the orthographic and phonetic similarity of a proposed proprietary name to other names.” POCA evaluations may be conducted by the sponsor, but regardless of whether a submission includes a POCA evaluation, FDA will still conduct its own.
We covered a similar guidance in 2014, noting that medication errors account for an estimated 7,000 deaths annually, according to a 1999 Institute of Medicine (IOM) report. IOM followed this up in 2006 with a report that found major problems with naming, labeling, and packaging that resulted in patient harm.
We further noted, about the 2014 guidance: “The concept behind this draft guidance is simple: It is important for safety reasons that the written proprietary name not look like that of another proprietary name nor sound like another proprietary name when spoken. Similarity between the proprietary name of a new prescription drug and the proprietary name of an existing drug could cause a mix-up in ordering and a patient could receive one drug instead of the other.”