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Emergency Use Authorization Requirements May Offer FDA Better Window Into Medication Errors

 
• By Sarah Karlin-Smith

Unlike with traditional approvals, emergency use authorization requires medication error reports to be submitted to the FDA, offering additional insight into why they occur. 

Regeneron COVID-19 antibodies and Moderna COVID-19 vaccine
Similar packaging lead to mix-ups of Regeneron’s COVID-19 antibodies (left) and Moderna’s COVID-19 vaccine. • Source: FDA

From antibody drugs given in place of vaccines, to incorrect storage that caused products in limited supply to be discarded, the unprecedented usage of the emergency use authorization pathway for drugs during the COVID-19 emergency may be helping the US Food and Drug Administration learn more about how various drug packaging and information sheets contribute to medication errors.

Medication error reports must be submitted to the agency’s adverse event reporting system as a condition of an EUA, but...

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