HOST: Captain Mary Kremzner, U.S. Public Health Service
PHARMACIST #1: Commander Jaewon Hong, U.S. Public Health Service
PHARMACIST #2: Lieutenant Commander Beth Carr, U.S. Public Health Service
CAPT Kremzner: What’s in a name? When it comes to new pharmaceutical products, plenty. Before any drug reaches the market, its name is thoroughly examined to identify misleading or potentially confusing names.
Hi, I’m Captain Mary Kremzner and this is Drug Info Rounds, brought to you by the pharmacists in the FDA’s Division of Drug Information.
I spoke with two FDA pharmacists, Commander Jae Hong and Lieutenant Commander Beth Carr who will explain the screening process for proposed proprietary drug names.
Which division within the FDA is responsible for reviewing and approving new product names?
LCDR CARR: That’s the purview of the Division of Medication Error Prevention and Analysis, or D-M-E-P-A—in consultation with the Office of Prescription Drug Promotion. DMEPA may seek input from other pertinent review disciplines as well.
CAPT KREMZNER: And this process also applies to some OTC products as well, correct?
CDR HONG: Yes. OTC products that are submitted under a New Drug Application or Abbreviated New Drug Application are reviewed in the same manner as prescription products. However, DMEPA does not review proposed names for products marketed under an OTC monograph, for products from a distributor, or for products repackaged for distribution to wholesalers and retail outlets.
LCDR CARR: The Office of Prescription Drug Promotion’s focus is rather different. They look for names that might imply to the consumer or healthcare professional that the product has a unique effectiveness or composition that could lead someone to draw an overly positive conclusion about the products benefits.
They assess whether a name might somehow overstate the product’s efficacy, imply minimized risk, broaden product indications or make unsubstantiated superiority claims.
CDR HONG: OPDP is focused on limiting promotional aspects of proprietary names, whereas DMEPA’s focus is on safety. It compares proposed names to existing ones and determines the likelihood for confusion in the market. They analyze the name to determine if it can be misleading in any way.
LCDR CARR: They use various computational methods, analyses and public databases to find the names of marketed products. They scrutinize a name’s spelling, its appearance when scripted, and its pronunciation when spoken.
Similarly spelled names may have greater likelihood to sound similar to one another when spoken, or look similar to one another when scripted.
There’s a particular association between handwritten communication and name confusion, which can lead to medication errors. That’s why DMEPA closely examines the orthographic appearance of a proposed name using several different legible handwriting samples.
Since spoken communication of medication names is common in clinical settings, the pronunciation of the proposed proprietary name is compared to the pronunciation of other product names to reduce errors.
CAPT KREMZNER: LCDR Carr, will you discuss more about the potential problems that can occur with names that have been vetted and approved by the FDA after they reach the market?
LCDR CARR: Yes, even with our rigorous review process, the potential for unexpected confusion exists. It could be necessary to change a proprietary name of a product that is already on the market.
And this is why we strongly encourage healthcare professionals to report drug names that have in any way contributed to medication errors. This way we can apply the lessons learned from the failures to our premarketing review process.
CAPT KREMZNER: Healthcare professionals can report these and other medication errors easily on FDA’s MedWatch website: www.fda.gov/medwatch