Incorporating Dosage Strength into Packaging Design & Labeling Requirements

August 19, 2014

By Pamela Davol, Clinical & Regulatory Project Manager

Last year, the Center for Drug Evaluation and Research (CDER) released the draft guidance Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors. It was written with the intent to provide guidance on using packaging design and labeling to determine medical dosage strength. The guidance acknowledges that the use of colored labels can be effective in drawing the user’s attention to important information, but emphasizes that the color is more of a supplement to—rather than a replacement for—the information gained by actually reading the label. For this reason, CDER cautions that all labels must be properly evaluated to minimize the occurrence of medication errors. In order to facilitate successful employment of packaging labels and increase the likelihood of product approval, we recommend the label and color configuration plan be developed using formative usability evaluations and be reviewed by the FDA before final usability validation of the product.

Prior to these steps, the early color and label configuration plan would benefit greatly from preliminary research, such as early iterative human factors evaluation with consideration to intended users and use environments. These efforts would provide information about preexisting color schemes and established mental models, and could highlight environmental conditions that may impact color identification and interpretation. The CDER guidance touches on these areas as potential sources of use-error if packaging design and labeling is used improperly.

Once the plan for color and layout are in place, formative usability studies may be executed to develop an initial configuration plan. Use-errors and close calls observed during the study would then drive edits to the next round of label design and style choices. Subsequently, a small formative follow-up study is recommended to confirm that any modifications to the preliminary design do not introduce new use-errors or increase occurrence of known use-errors before moving forward with usability validation of the product for marketing approval.

It is at this point that the final proposed configuration plan, along with formative usability data, is submitted to the FDA for review prior to IFU and full product usability validation studies. The result of this review may be a request to change the label and color configurations; however, that risk is minimized if prior evaluations demonstrate that the users are able to interpret between labels, colors, and their associated dosages. In addition, preparing and submitting the configuration plan prior to usability validation allows the marketing and regulatory groups to communicate beforehand, avoiding unforeseen disputes later in the process.

If the developer opts out of early iterative user and environmental analysis (as we caution against), there is an increased risk that the FDA will recommend changes to colors. These recommended changes will be suggested if colors are too similar across dosages, do not present sufficient reading contrast (between labeled text and background), or if they bear too close of a resemblance to another product line.

After the label and color configuration plan is approved, the usability validation evaluation can be conducted with considerable confidence that the product will not need to undergo further modifications, which may require repeating the usability validation process. In our experience, the combination of early research, formative usability evaluations, and an upfront FDA review results in the most successful FDA submission reviews with fewer complications and delays in acquiring marketing approvals.