Sponsors filing a drug submission must also provide a brand name assessment as part of the drug safety and effectiveness evaluation. The objective of this assessment is to evaluate the potential for a proposed drug name to be confused with other authorized products in Canada with the aim of preventing medication errors.
In an effort to standardize the brand name review process, Health Canada released a new Guidance Document for Industry – Review of Drug Brand Names, which replaces the 2013 Draft Revised Guidance Document for Industry – Review of Drug Names for Look-Alike Sound-alike (LASA) Attributes. The new Guidance will come into effect on June 13, 2015. A Frequently Asked Questions sheet respecting the new Guidance is also available here.
Notable changes in the new guidance include the following:
- Non-prescription products and natural health products are not included in the scope of the guidance1;
- Raw data to be submitted is limited to database search results (although Health Canada reserves the right to request additional material when deemed necessary);
- The orthographic and phonetic similarity threshold is lowered from 65% to 50%;
- Psycholinguistic tests are no longer required.
Brand Name Assessment Process
The sponsor must first carry out (1) an initial brand name review to determine whether the name is misleading with respect to the composition, effectiveness or safety, and then provide (2) a Look-alike Sound-alike (LASA) brand name assessment to determine the likelihood of confusion between the proposed name and authorized product names2.
The testing of LASA attributes involves a multi-step approach:
- The Search step involves searching relevant drug name and medication error databases (the Drug Product Database and the Licensed Natural Health Products Database) and identifying drug names with a combined orthographic and phonetic similarity score of 50% or more.
- The Simulate step involves assessing the confusability of a proposed name by inserting it into a variety of prescribing, transcribing, dispensing and administration scenarios and documenting the resulting failures, as well as developing a process map that outlines where and how the proposed drug will be used and who in the medication use system will come into contact with the product.
- The Synthesize step involves synthesizing the evidence obtained from the database search results and the simulations, and completing a Failure Mode and Effects Analysis to make a decision on the likelihood of confusion with the proposed name.
Health Canada will review the information submitted by the sponsor and may reject a name and request a name change if it considers that the name is likely to cause confusion with other products or is misleading. If safety concerns remain, Health Canada may refuse to issue a Notice of Compliance for new drugs or a Drug Identification Number for existing drugs.
In selecting a drug brand name, sponsors must also be mindful of the trade-mark registration process under the Trade-marks Act which focuses not on the confusability on a safety perspective, but on the likelihood of confusion as to the source of manufacture of the product.