Description - Figure 1 - Brand Name Assessment and Review Process

Sponsor Brand Name Assessment

Step 1: Search

• Search proposed name against drug databases
• Identify any name with similarity score of 65% or above
• Search published literature for error reports

Step 2: Simulate

• Develop medication-use process map(s) for proposed name
• Test proposed name in screen-based simulations of auditory perception, visual perception, short-term memory
• Conduct medication-use process simulations encompassing prescribing, transcribing, selection, dispensing, administration and self-selection

Step 3: Synthesize

• Document names that have been identified as confusing during steps 1 and 2
• Inclusion of names in FMEA process
• Conduct FMEA
• Document results
• Prepare final report with rationale and recommendation for approval

Health Canada Review

Step 1: Initial Brand Name Review

• Screen proposed name according to general safety criteria
• Decide on the initial acceptability of the proposed brand name for continuation with step 2 of the Health Canada review

Step 2: Review

• Search proposed name against health product databases including the Drug Submission Tracking System (DSTS)
• Review sponsor's detailed LASA brand name assessment
• Request additional information, if needed

Decide on the acceptability of the proposed brand name