Drug Labeling & Packaging: Design & Review

Labeling and packaging-related medication adverse events continue to be one of the most frequent types of voluntary reports submitted to the ISMP National Medication Errors Reporting Program (ISMP MERP).

Visual label similarities leading to mix-up, confusing or absent presentation of important information on medication labels, and error-prone product packaging, have frequently contributed to medication errors, and in some cases, serious patient harm.

Engagement Description:

Our experts can design medication labels, or evaluate the labeling and packaging that your team has created for potential safety issues.

Ideally, error-prone labeling and packaging should be caught prior to the launch of a new product to minimize harm and expensive revisions. However, Med Safety Board can help remediate safety issues at any point in the life cycle of a product, including post-market implementation.

This service offering can be tailored to meet your specific needs and can range from a single label to a suite of labels within a product line, or even an entire portfolio of products, whether for prescription medications, biologics, or over-the-counter products.

Download an overview of this offering >

Project Considerations:

• Overall appearance and readability of the labels, including placement on the actual container
• Placement and prominence of critical information
• Readability and understanding of key information needed by the end user to properly use the medication
• Use of potentially confusing terminology, abbreviations, symbols/icons, and dose designations
• Size and prominence of product logo or corporate dress
• Readability, understanding, and/or positioning of expiration dates, lot numbers, and barcodes
• Potential for look-alike confusion with other similar products in a company’s line
• Label and packaging match the dosing of the product
• Packaging is appropriate for the route of administration