Because of the impact of Hurricanes Maria and Irma on Puerto Rico’s drug manufacturing, hospitals face an ongoing shortage of IV fluids manufactured there.
“Hospitals across the country are reporting shortages of IV fluids, particularly sodium chloride 0.9% injection bags—a type of saline bag,” said FDA Commissioner Scott Gottlieb, MD, in a statement.
The saline IV fluids, which are used to inject drugs intravenously in hospital and outpatient settings, have been intermittently in shortage since 2014. “However, despite our best efforts, the situation in Puerto Rico has greatly exacerbated this supply issue,” Gottlieb said.
FDA is working closely with the federal government and Puerto Rican authorities to help stabilize the overall medical products manufacturing sector.
The agency is temporarily allowing the importation of IV saline products from facilities outside of the US. FDA is also encouraging the expansion of production at existing facilities to meet shortfalls and expediting its review of new product applications that will help address the shortage.
Hospitals should also review recommendations by the American Society of Health-System Pharmacists (ASHP) and the University of Utah, according to FDA.
ASHP’s "Small-Volume Parenteral Solutions Shortages" document provides an outline for potential actions for organizations and healthcare professionals to consider in managing the shortage.
The organization’s recommendation for pharmacists include:
• Purchase imported product. FDA has allowed Baxter to import small-volume parenterals (SVPs).
• Transition to premixed solutions where possible. Consider either purchasing frozen products or storing compounded products in the freezer to maximize beyond use dates in order to reduce waste.
• Consider conversion for a limited list of products to alternative point-of-care activated systems (Vial2Bag®, Add-Vantage, or Mini-Bag Plus).
• Consider compounding and dispensing medications that may be administered via IV push in ready-to-administer concentrations packaged in syringes.
In addition to assisting Baxter in getting its Puerto Rico production back online, the agency recently approved IV solution products from Fresenius Kabi and Laboratorios Grifols. “Both companies are expected to increase production of saline products in the coming weeks. We believe steps like these will help to improve the shortage situation over time,” Gottlieb said.