Seasoned observers will know the US FDA has been developing its naming policy for API salts – which combine an ionisable drug and a counter-ion– since December 2013 following the implementation of the US Pharmacopoeia's (USP) monograph.
Last week, the regulator published its final guidance on the subject, deciding that new drugs will be named after their API alone – ‘newdrug’ and not ‘newdrug hydrochloride’ according to the FDA example – to minimize potential confusion.
The FDA said the policy “should help avoid medication errors that could result from a mismatch of established name and strength” also suggesting it “will make it easier for healthcare practitioners to calculate an equivalent dose when transferring patients from one dosage form to another.”
The guidance will apply to all new drugs, although the FDA said it will make exceptions on a case by case basis if the fact the ingredient is a salt is therapeutically important. Approved medicines will not be impacted unless there are specific safety concerns.
Medication errors
According to FDA data, more than 95,000 medication errors have occured in the US since the year 2000. While it has no solid figures, the agency belives a significant proportion of thses mistakes are related to the drug name.
The FDA takes such concerns into consideration when reviewing the 400 or so drug name and labels submitted by drugmakers each year. The agency rejects around 100 each year for reasons of appropriateness, similar spelling to another currently marketed product, ambiguity in a drug name and/or identifier, or simply beacuse the proposed name is misleading.