Investigational drug labeling variability.

Area of Science:

• Pharmaceutical Sciences
• Clinical Pharmacy
• Regulatory Affairs

Background:

• Investigational drug labeling lacks standardized regulations, leading to content and layout inconsistencies.
• Variability in labeling increases the risk of errors in drug handling, from storage to administration.

Purpose of the Study:

• To evaluate the conformity and variability of investigational drug labels.
• To assess the utility of an automated script for label analysis.
• To identify factors influencing the ease of locating the kit number on labels.

Main Methods:

• A systematic evaluation of 27 investigational drug labels using an 87-criterion checklist, including conformity to Canadian regulations.
• Comparison of internal and external labels, and labels from American and European sponsors.
• Development of a Python script for automated label description and a pharmacist survey on kit number visibility.

Main Results:

• External labels largely complied with regulations, while internal labels frequently omitted expiry dates and sponsor details.
• Significant differences were observed in label criteria based on container type (internal vs. external) and sponsor location (e.g., European sponsors used more bold characters).
• Label characteristics like word count and empty space were correlated, and a higher proportion of empty space improved kit number visibility.

Conclusions:

• High variability exists in investigational drug labeling, with critical information frequently missing from internal labels.
• Automated script analysis proved effective, suggesting further development for improving label readability and reducing error risks.
• Harmonized international guidelines are essential for standardizing investigational drug labels and enhancing patient safety.