Issues for Discussion

 

1.         Describe the advantages and disadvantages of evaluating all proprietary drug trade names for potential confusion vs. taking a risk-based approach.  Is it possible to triage the drug names into groups that may be handled differently based on case specific findings? 

 

 

2.         Based on the discussion of the study methods presented today, identify the critical design elements of each method that should be included in good naming practices.  Are there any methods that should be discounted as not being potentially effective or useful tools?

 

 

3.         In addition to the methods discussed today, are there are other methods that should be considered? 

 

 

4.         Under what circumstances should a field test (in a real world prescribing

environment) be required?   Is any one method alone sufficient as a screening tool or should a combination of methods routinely be employed (e.g., behavioral testing and orthographic/phonographic testing)?

 

 

5.               Describe the circumstances, if any, when it would be appropriate to approve a proprietary drug name contingent on a risk-management program being in place?