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Bulletin

What's In a Name?

Fasken
Reading Time 2 minute read
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Life Sciences Bulletin

In December 2011, the US Food and Drug Administration (FDA) reported that at least one serious injury occurred when a topical wart remover, Durasal (salicylic acid 26%), was dispensed to a patient following eye surgery instead of a topical corticosteroid, Durezol. Prior to this incident, the FDA issued a notice that several other cases of confusion between Durezol and Durasal had been reported.

Instances of drug confusion due to look-alike or sound-alike drug names continue to be reported in Canada as well. For example, in November 2011, Health Canada released a notice regarding potential confusion between the anticoagulant, Pradax, and the antiplatelet drug, Plavix. In 2011 alone, there were five reported Canadian cases involving mix-ups between the two drugs, with at least one case of confusion resulting in patient harm.

In addition to patient harm arising from medication errors due to similar drug names, cases of drug name confusion can have significant implications for drug manufacturers, such as the suspension of drug sales by Health Canada, delays in having drug submissions approved, and potentially significant costs associated with renaming drug products (e.g., re-labelling, repackaging, etc.).

In order to mitigate the potential problems due to drug name confusion, including medication errors, Health Canada provides guidance on naming practices. For example:

  1. Proprietary drug names should consist of only one word and should avoid qualifications by letters or numbers;
  2. Brand names and generic names for drug products that contain different medicinal ingredients should be easily distinguishable; and
  3. Care should be taken when adding a prefix or suffix to modify the name of another drug in order to indicate a product line extension. Sponsors should be prepared to furnish Health Canada with a rationale as to why it is unlikely that the proposed drug name will give rise to safety or efficacy concerns.

Drug manufacturers should take note of Health Canada's suggestions in order to avoid both pre- and post-market regulatory complications.

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