Package and Label Safety Evaluation

Using the PREVENT-ERR® model, The Medication Safety Board provides packaging and labeling evaluations. These evaluations may be performed in response to specific regulatory requirements or to support sponsor-generated requests for label changes.

We apply various tools and techniques, including elements of Failure Mode and Effects Analysis (FMEA), to “error-proof” the written and associated graphics information on items including:

• Medication bottles and cartons
• Ampules
• Vials
• Syringes
• Dosing cards
• Titration kits
• Medication-containing patches

The Medication Safety Board also collaborates with human factors engineers to further ensure the safety of packaging and labeling. By developing and performing simulation studies in settings that mirror the actual locations where these products might be found, potential risks and system failures can be identified.