FDA Guide on Drug Product Designs to Reduce Med Errors

FDA has published a guidance on Safety Considerations for Product Design to Minimize Medication Errors that provides a set of principles for using a systems approach to minimize errors relating to product and container closure designs for all prescription and nonprescription drugs and biologic products.



 

The guidance also provides examples of product designs that have resulted in postmarketing medication errors. “Many medication errors can be avoided at the design stage by drawing on lessons learned from past medication errors and by conducting proactive risk assessments before marketing,” it says. However, the document does not describe how to conduct, document, and submit risk assessments, or how such assessments will be evaluated by the agency.



 

Additionally, FDA says this is the first of three planned guidances to minimize or eliminate hazards contributing to medication errors at the product design stage. The second guidance will focus on minimizing risks associated with the design of drug product container labels and carton labeling, and the third will focus on minimizing risks when developing and selecting proposed proprietary names.