P230: Putting Guidance Into Practice: Designing Container Labels with Patient Safety in Mind
Poster Presenter
Nancy Globus
Vice President, Regulatory and Medication Safety
Syneos Health United States
Objectives
The objective of this abstract is to identify how drug product labels can put patient safety at risk and the importance of cross-functional team collaboration to translate FDA guidance into the safe package and label designs to help mitigate those risk.
Method
The link between medication errors and misleading drug labels is not always clear. But with 20+ years of experience in the pharmaceutical space, a pharmacist and drug safety expert is privy to the collaboration required to mitigate medication errors through label design.
Results
According to the FDA, approximately one third of medication errors are caused in part by product design and confusing or unclear product labels. Earlier this year, the FDA finalized guidance pertaining to the safe design of drug product container and carton labels. Through the lens of a pharmacist dedicated to medication safety, medication safety related guidelines will be translated to real-world examples of how product design and container labels can cause medication errors.
Conclusion
Through real-world experience, it's evident that product design and container labels can lead to medication errors. Poster viewers will be invited to participate in a discussion that explores this conclusion and how product and label-related medication errors can be avoided. The poster will include an interactive label design element that invites viewers to build the “perfect” label for a solid oral dosage form, a large-volume intravenous infusion solution, and a vial containing an injectable liquid. The conversation around mock label design will highlight areas where collaboration with other product team stakeholders is critical for optimal commercial, regulatory, and safety outcomes.
