Over the past year, there were a number of notable developments in matters relating to branding and naming of pharmaceutical products in Canada. Most recently, on March 6, 2014, Health Canada released the details of its draft revised guidance document on the regulatory issues associated with the naming of drug products, which will amend the 2006 Guidance on Look-alike/Sound-alike Health Product Names. The new guideline will be formally released in June 2014, and will provide a one year transition period before implementation, giving pharmaceutical brand owners notice in order that they may prepare for compliance with these new rules on naming from a regulatory standpoint.
Names that Look alike/Sound alike: New Guidance will be released June 2014
On March 6, 2014, Health Canada released details of its draft revised Guidance for Industry – Review of Drug Names for Look-alike Sound-alike (LASA) Attributes. The aim of the policy is to avoid medication errors that can arise from similarities between health product names.
The revised guidance was developed in response to requests from industry for clarifications and more detailed direction on LA/SA drug names than what exists in the 2006 Guidance. The revised draft guidance document was published on February 19, 2013 and was open for consultation until April of 2013. The details of the revised draft guidance (further revised from the consultation document released in February 2013) were provided in a Health Canada webinar on March 6, 2014, although there is no formal publication as yet.
The draft revised guidance identifies significant specific and heightened requirements. For example, the review process will entail three essential steps for product sponsors:
Search: This step involves searching the “relevant drug name and medication error” databases. The information retrieved during this step provides an initial list of drug names that merit further scrutiny.
Simulate: This 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. A process map must be submitted outlining where and how the proposed brand name drug will be used, based on indications and who in the medication use system will come into contact with the product.
Synthesize: At this stage, the database search results, together with the simulations, generate evidence necessary to help make a decision about the likelihood of confusion with the proposed name. A failure mode and effects analysis (FMEA) is conducted based on the information gathered through the ”search” and “simulate” steps, and serves to further identify any confusion with the proposed name.
Health Canada will review all information in respect of the proposed name. It will also complete a search of its own Drug Submission Tracking System to identify any names in the submission process that give rise to concern due to the potential for confusion. Health Canada may reject a name that is likely to cause confusion with other health products, or is misleading with respect to the therapeutic effectiveness, composition or the safety of the product.
In terms of timelines, if the review period is to be more than 180 days, there will be an assessment within 90 days of the date the submission is filed; a final assessment will be conducted 30 days before product approval to ensure no other names have been approved recently with a potentially confusing name.
Other significant changes resulting from industry consultation of the February 2013 draft guidance include:
- Removal of non-prescription drugs from the application of the Guidance;
- Removal of the need for psycho-linguistic testing;
- Sponsors may use any drug search engines they deem appropriate. Health Canada will continue using Phonetic and Orthographic Computer Analysis (POCA);
- The threshold for similarity is lowered from 65% to 50%. The 50% threshold is consistent with what the US FDA uses;
- Removal of the requirement for the involvement of patients in simulations and FMEA; and
- Removal of the requirement to submit all raw data to Health Canada, however, all search results from DPD and LNHPD must still be submitted.
The new guidance is expected to be published in June 2014.