FDA - Product Design to Minimize Medication Errors

The U.S. Food and Drug Administration has produced a new guidance for industry of interest. It is titled “Safety Considerations for Product Design to Minimize Medication Errors.”

The introduction reads:

The recommendations in this guidance apply broadly to the development of drug and biologic products. Accordingly, this guidance is intended for sponsors of investigational new drug applications (INDs); applicants of new drug applications (NDAs), biologics licensing applications (BLAs), abbreviated new drug applications (ANDAs); and manufacturers of prescription drugs marketed without an approved application or over-the-counter (OTC) monograph drugs. This guidance provides a set of principles for using a systems approach to minimize medication errors relating to product design and container closure design and thus enhance patient safety.

The recommendations in this guidance document are intended to provide best practices on how to improve the drug product and container closure design for all prescription and non-prescription drugs and biologic products regulated by the Center for Drug Evaluation and Research (CDER), which are referred to collectively in this guidance as products. The guidance also provides examples of product designs that have resulted in postmarketing medication errors…”

The document can be accessed here: FDA

Posted by Dr. Tim Sandle