Massoomi said the subsequent expiration date extension for Duo Dote has alleviated concerns about running out of the product, which is placed throughout the Omaha area."We have, currently, 15 hospitals in the community of Omaha that have these kits, [and] they are stockpiled within the key fire departments," Massoomi said.FDA officials last September announced that although its authorities under PAHPRA don't extend to the use of Duo Dote outside of CBRN emergencies, the agency "will not take enforcement action with regard to the storage or use for insecticide poisoning" of specific lots of the product when it is used up to one year after the labeled expiration date.
He said it's appropriate to apply the extended expiration date to medications stored at those locations, because they are temperature- and humidity-controlled environments.
But he said the new dating won't be applied to Duo Dote autoinjectors kept in emergency vehicles, which lack such controls.
BETHESDA, MD —When residents of the Omaha, Nebraska, area suffer from pesticide poisoning, a provision in a recent federal law may help ensure the availability of lifesaving medications when they are in short supply.
The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, or PAHPRA, included new authorities for FDA to extend the expiration dating of medical countermeasures for use during chemical, biological, radiological, or nuclear (CBRN) emergencies, including pandemics and other natural disasters.
"But more importantly, we've used it quite a few times in our community for firefighters who have been exposed to toxins.
Cyanide is in the burn off from chemicals in normal buildings, such as from furniture.
Massoomi said extended expiration dating for medical countermeasures isn't just about improving the nation's readiness for terrorist attacks or other major events.
"It's unfortunate that we just think of them as CBRN agents, not realizing that there are other things that they can be used to prepare for, just everyday natural disasters that occur," he said.
And we've actually used it to help a couple families that had smoke inhalation and had high levels of cyanide." He said he would like FDA to use its new and previous authorities to look more broadly at expiration date extensions and provide guidance on the issue to pharmacists and other clinicians.
"My hope is that it will allow them to expedite [the resolution] of some of the critical shortages—not only of medical countermeasures, but just in general," he said.
But she said surveyors would expect to see some sort of documentation from FDA, such as an e-mail, letter, or website posting that describes the expiration date extension.