OBJECTIVES

To evaluate labels of 13 drugs with narrow therapeutic indices (NTI) to assess whether information on drug administration is documented consistently between brand-name and AB-rated generic drugs.

METHODS

Drug labels in XML format were downloaded from the DailyMed website. Twenty four drug label sections were identified as sources for information on drug administration. A semantic natural language processing approach was used to extract this information and subsequently indexed as AB-rated brand-generic drug label pairs. We assessed the consistency of information in the generic drug label sections as having either “no difference”, “minor difference” or “major difference” when compared to the brand-name drug label. Differences that do not convey the same information as the brand drug were defined as major. Sections with a “major difference” were further categorized as either “no information”, “less information” or “more information”.

RESULTS

A total of 150 brand-generic drug label pairs representing seven formulations were evaluated. Of these, 48% had inconsistent information (major or minor difference) in ≥1 label section(s) of the generic drug label when compared to the brand name drug label. Of the 51 drug label pairs with a “major difference”, the generic drug label had either no information (43%), less information (20%) or more information (37%) relative to the equivalent brand drug label. [INFORMATION FOR PATIENTS SECTION] (11%) and [STORAGE AND HANDLING SECTION] (10%) had the greatest number of brand-generic drug labels pairs with a “major difference”.

CONCLUSIONS

Drug labels are the primary tool used by FDA to communicate essential information for safe and effective use of NTI drugs. Majority of generic drug label sections showed relatively small differences. Despite FDA’s mandate that generic drug labels are the same as brand drug labels, bioequivalent drugs may differ in drug administration information. The combination of proactive monitoring and innovative technologies are needed to enable ongoing label compliance.