Health Canada proposes drug name review procedures
The Health Products and Food Branch of Health Canada, which oversees the regulation of pharmaceutical and other health-related products in Canada, has published two draft guidelines on health product names. Under the proposed procedures, Health Canada will (i) screen new drug names to ensure that they are not misleading or likely to be confused with existing drug names, and (ii) attempt to reduce the risks created by confusing product names that are already on the market.
The draft guideline entitled Drug Name Review: Look-alike/Sound-alike (LA/SA) Health Product Names proposes that the government conduct a pre-market review of proposed drug names, to assess potential confusion with other product names or generic names. The draft guideline entitled Marketed Health Product Name Assessment: Look-alike/Sound-alike (LA/SA) Health Product Names proposes a process to deal with confusing product names for products that have reached the market. Both guidelines note that risk arises through potential errors in prescribing, dispensing or administration of health products. Name confusion is thought to account for one in every four medication errors.
Product manufacturers will be required to submit proposed product names for review as part of each submission for product regulatory approval. Health Canada will screen these proposed names for similarity to ensure that they are unlikely to cause confusion with other drug names. Health Canada will also review each proposed name to ensure that it is not misleading, such as where the name implies a therapeutic claim.
The pre-market approval process will involve submission of a proposed proprietary name, along with a prioritized list of alternate name choices (a maximum of two). In addition, a risk assessment and evaluation of the product's proposed name supported with studies, data and analysis is encouraged. Possible risk assessment tools may include:
- a search for similar proprietary and non-proprietary names;
- computer analysis (orthographic/phonetic);
- prescription testing studies (verbal and handwritten studies); and
- a review of medication error literature.
This name review will come in addition to that available through the Trademarks Office, by which trademarks for pharmaceutical products can be challenged.
Under the proposed post-market process for confusing product names, Health Canada will contact the producer of any drug that is already on the market and is considered to have a significant potential risk of confusion with the name of another marketed product. Health Canada will work with the manufacturer to develop a strategy to mitigate the identified risks.
Comments on the proposed guidelines may be submitted to Health Canada by November 15.
Adrienne Blanchard, Gowling Lafleur Henderson LLP, Ottawa
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