Key Insights on Developing Investigational Drug Container Labels

FDA's Virtual Meeting on Investigational Drug Container Labels

In the latest seminar hosted by the FDA focusing on “Potential Medication Error Risks with Investigational Drug Container Labels,” stakeholders with a range of expertise came together to discuss regulations, standards, and best practices. Building on these critical topics, Leaderboard has developed five key insights and takeaways to help our partners involved in clinical studies to develop safer package labels during the investigational process.

Increase engagement.
Including a broader perspective when developing clinical trial package labels can help to better understand concerns and mitigate challenges before they occur. Especially for self-administered medications, including patients in the process while investigational drug labels are being developed may allow sponsors to include pertinent information to reduce errors.

Create a forum for discussion.
The goal is to have no medication errors in clinical trials, however, being able to share information and details on even one mistake to mitigate recurrence is a great start. Having a place where knowledge-sharing about concerns or errors can take place could reduce the chance another site repeats the same issue.

Leverage technology.
Making the investigational process less manual and increasing technological oversight can help reduce errors. Technology from using barcode scanning to expanding the use of Interactive Response Technology (IRT) could help mitigate errors and protect patients.

Take action today.
In absence of specific investigational package label instruction, the FDA recommends using the current guidance for marketed container label and package labeling titled: “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.”

Hope for the future.
Discussions like these prompt greater conversations across the globe to harmonize and standardize label information for patient safety. Leaderboard will continue to be at the pulse of guidance and regulation to help our partners bring treatments safely to market.

Reach out today to discuss how we can help you prepare for your next steps in development.

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