FDA guides on product design to prevent medication errors

April, 2016
The US FDA has published new guidance on considerations when designing pharma products in order to minimise medication errors.

The safety consideration guidance - which can be viewed at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM331810.pdf  provides valuable insight into the US regulator's thinking when it comes to designing product containers and closures that enhance patient safety.

While not directly related to anti-counterfeit and product safety, it describes a systems-based, risk assessment approach that should be considered at the earliest stage in the product design process, alongside other safety feature considerations.

Two additional guidance documents are planned - one covering drug product container labels and carton labelling and a third aimed at minimizing risks when developing and selecting proposed proprietary names.

"Drug product design features that predispose end users to medication errors may not always be overcome by product labelling or health care provider or patient education," says the guidance.

"It is therefore preferable to eliminate, or minimize to the extent possible, these hazards from the product design." Securing Industry