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FDA's Plan to Ease IV Saline Shortage Includes Expiration Date Extensions

Allison Inserro
FDA Commissioner Scott Gottlieb, MD, announced new steps Tuesday to address the growing shortage of supplies related to IV saline fluids in the wake of the damage to Puerto Rico after Hurricane Maria, including asking companies to submit data to extend expiration dates. The tight supply of saline products has been worsened by an increased demand for saline as a result of the worse-than-typical flu season.
The FDA announced new steps Tuesday to address the growing shortage of supplies related to IV saline fluids in the wake of the devastating damage to Puerto Rico after Hurricane Maria.

The tight supply of saline products has been worsened by an increased demand for saline as a result of the worse-than-typical flu season.

FDA Commissioner Scott Gottlieb, MD, said one of those steps includes asking companies to submit data to extend expiration dates, so that some products nearing their expiration within hospitals could be used. Updates will be posted on the FDA’s drug shortage website.

He also said the FDA is looking at additional potential import sites for both small and larger volume IV saline bags. Approval of IV saline products from additional companies, specifically Fresenius Kabi and Laboratorios Grifols, is expected to result in increasing product supply in the next several weeks. Small volume IV saline bags, or those in 50 and 100 ml sizes, are often used to deliver other medicines like antibiotics to patients, while larger volume sizes are typically used to hydrate patients, like those suffering from the flu.

“We continue to expect that the shortage of IV fluids will improve in the coming weeks and months,” said Gottlieb in a statement. “In addition to working with manufacturers to ensure that their Puerto Rico facilities can operate at full capacity, we’ve worked with manufacturers such as Baxter and B. Braun to import product into the US from their foreign facilities including most recently from a Baxter facility in Brazil.”

Gottlieb said the FDA has heard from facilities  “that only have a few days’ worth of supply on hand; as well as institutions that have to ration diminished stores of these products.”

He said the FDA is monitoring the demand for empty IV containers as an alternative to filled bags. These empty containers are regulated by the FDA as class II medical devices. They are manufactured by some of the same companies as the filled bags as well as other medical supply manufacturers. With the shortage of filled bags, facilities are turning to the repackaging or compounding of IV saline fluids and using empty IV containers. In turn, Gottlieb said these containers too, are running low, and there are concerns that these supplies could tighten further.

Gottlieb said health care organizations and hospitals should contact FDA directly if they aren’t receiving the products they need.

How is your hospital or facility coping with the shortage of these or other drugs or supplies? AJMC.com would like to hear from you. Contact AInserro@ajmc.com or via Twitter @allisonnj

 
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