Wednesday, August 15, 2018

FDA: Hurricane Maria worsened supply of IV bags to deliver antivirals

By on February 1, 2018

SAN JUAN – Food and Drug Administration Commissioner Scott Gottlieb acknowledged in a written statement Thursday that this flu season has been challenging  because of an ongoing IV bag supply issue due to the impact of Hurricane Maria in Puerto Rico.

This year’s worse-than-normal flu season “and workarounds deployed by health care providers in the wake of this shortage have increased demand for saline and other products” used to hydrate and deliver medications via intravenous routes.

“As we have shared over the last few months, throughout the country, there is still a shortage of IV saline bags, which have long faced supply problems. These supply problems were aggravated by the impact of Hurricane Maria on the medical products manufacturing sector in Puerto Rico, which affected volume IV bags. Although the shortage of saline is improving, this year’s worst-case flu season and the alternative solutions deployed by healthcare providers as a result of this shortage have increased the demand for saline and other products,” he added.

To address the public health issue, the FDA extended the expiration dates of certain products and has been working with manufacturers such as Baxter and B. Braun to import products from their foreign facilities. The agency is also getting more data on potential supply gaps and identifying the specific products needed.

Puerto Rico manufacturing, pharma affected by lack of electric power

The products include large volume saline bags typically used to hydrate patients; small-volume IV saline bags (generally in 50 and 100 ml sizes) that are often used to deliver other medicines; as well as empty IV containers of varying sizes that are being used by many health care providers to compound their own IV saline solutions by filling these empty containers.

“The hurricanes and flu season have underscored the importance of preparedness and connectivity across the agency, the industries we regulate, as well as distributors and health care providers to best serve patients that need access to these critical products,” Gottlieb said.

 

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