The purpose of a container label on a prescription biopharmaceutical product is to communicate the contents of the package and any pertinent information needed for the safe and effective use of the product to the end user. In the United States, the actual text and placement of the text are both governed by the U.S. Food and Drug Administration (FDA), with input from other standard-setting organizations, such as the United States Pharmacopeia (USP). The basic rules are set forth in the Code of Federal Regulations (title 21, part 201); however, compliant medication labels can still fall victim to confusing elements that can lead to medication errors — that’s where Addison Whitney comes in.
Preventing medication errors with label guidance
To help mitigate potential medication errors, our medication safety experts collaborate with our visual designers to create aesthetically pleasing, safe medication labels that comply with regulations. We incorporate the FDA’s recently finalized Guidance for Industry, which had been in draft form since 2013. It is one of several published documents specifically dealing with preventing medication errors and how a product’s name, design, container label or packaging configuration can contribute to those errors.
The history of the Guidance traces back to the Institute of Medicine’s 2006 report “Preventing Medication Errors,” as well as the commonly cited statistic that medication label and package issues cause or contribute to approximately one-third of medication errors. Some of these issues include:
- Confusing placement or expression of the product name, dosage form and strength or concentration
- Confusion between different strengths of the same product
- Confusion between different products manufactured by the same company
- Label clutter and difficult-to-read text
- Use of error-prone symbols or abbreviations