Industry insiders have criticised new draft US Food and Drug Administration (FDA) guidance on choosing proprietary drug names, saying simulation studies involving doctors, nurses and pharmacists are time-consuming and unhelpful.
Susan Proulx, President of Med-ERRS, a safety consultancy owned by the Institute for Safe Medication Practices (ISMP), told in-Pharmatechnologist.com that simulation studies – where medical professionals act out writing down and processing prescriptions for proposed drug names – should be removed from FDA guidelines .
The draft document – due to be finalised later this summer and currently taking comments – advises pharma developers to run experiments testing proposed drug names in a mock-up of a clinical setting, involving doctors, nurses, assistants and pharmacists. The aim is to test whether the mooted names could be misheard or misread and confused with another drug.
Settings should approximate real life by “using ruled or unruled paper, prescription pads, computer order entry, and telephone orders” and “varying factors such as background noise, handwriting samples, different ink colours, directions for use, and different voices/accents,” says the FDA’s draft guidance.
Proulx told us simulations her firm had run for clients had proved “very time and labour-intensive” and showed up no significant problems with names that had not been caught in the earlier part of the project from database searches.
Med-ERR’s president said she supported the other recommended screening method in FDA’s guidance: computerised database searches which compare the similarity of proposed names to ones already on the market.
Drug companies can use the FDA’s Phonetic and Orthographic Computer Analysis (POCA) programme to query the names against the FDA’s own drug lists and RxNorm (over-the-counter drugs). The process can identify conflicts with pending products which the general public is not yet aware of. Drug names are given a percentage score indicating their similarity, which the FDA uses in its decision.
Proulx told us although the FDA “has probably gone a bit too far in what they’re requesting sponsors to do” she understood the need to make the submissions process clearer.
The drug industry is “really unhappy” with the FDA’s current way of judging names, she said, which is perceived as inconsistent. “FDA lives on a pendulum swing. Right now they’re at the point in the pendulum where they are hypersensitive and they keep rejecting names.
“Also the FDA will say that people must do a certain thing but they don’t seem necessarily consistent in their application. Some names are rejected, and other surprising names get through that sound like they could be marketing.”
The FDA rejects drug names if they could cause confusion and risk medication errors.
It disallows names which sound too much like another drug already on the market, or refer to some but not all of the drug’s active ingredients. References to dosing intervals (such as “24-hour”) or the drug delivery system (“Extended-Release”) are discouraged, as these attributes may change in future.
Aside from preventing errors, the FDA frowns on names which imply a drug has properties which are not supported by scientific evidence. The FDA said it “likely would object to a proposed proprietary name that contained the prefix ‘best’or that sounds like ‘best’because it implies superiority over other currently available therapies.”