FDA Update on IV Saline and Amino Acid Shortages

PUBLISHED: Jan 9, 2018
Relevant to: Ambulatory Care, Critical Access Hospitals, Dialysis Facilities, Home Health, Hospice, Hospitals, Long Term Care, Medical Office, Pharmacy

The US Food and Drug Administration (FDA) has issued an update on the continued efforts to mitigate the IV saline and amino acids for injection shortages exacerbated by Hurricane Maria. According to the FDA, a key area of focus for the FDA remains addressing the IV saline shortage, which has impacted patients, health care providers and hospitals. Based on the information the FDA is receiving from the companies, it is expected that the shortage of IV saline fluids will improve in early 2018, with continuing improvements in the weeks ahead. Just before the holidays, Baxter – a leading producer of IV saline fluids – announced that all of their facilities in Puerto Rico have returned to the commercial power grid.

The FDA’s drug shortage website remains the best source of information for product availability. The website includes a list of manufacturers with products in shortage, and the current availability and estimated shortage duration for the products. In most cases, the manufacturers, based on historical need, are allocating IV saline products to health care providers until supply is improved.

The FDA is continuing to encourage hospitals to consider clinical recommendations for managing the shortage of these IV fluids, including recommendations issued by the American Society of Health-System Pharmacists (ASHP) and the University of Utah. The recently released guidance, Small-Volume Parenteral Solutions Shortages (link below) provides an outline for potential actions for organizations and health care professionals to consider in managing the shortage. The FDA is also continuing to pursue efforts to increase supplies of IV saline while product availability concerns remain. This includes approval of IV saline products from additional companies like Fresenius Kabi and Laboratorios Grifols.

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