The US Food and Drug Administration (FDA) is allowing Baxter Healthcare Corporation to temporarily import intravenous (IV) saline from its manufacturing plant in Spain to help ease an ongoing IV fluid shortage in the United States. The agency is also permitting the importation of a saline product from Norway.
The temporary easing of restrictions on imports on these products is intended to help ease an ongoing shortage of IV fluids. A recent JAMA article noted the shortage had affected two-thirds of US hospitals as of February, and outlined how hospitals and other health care facilities are coping with the shortage. Many are taking extraordinary measures to minimize patient harm, such as giving water or alternative fluids to patients who are capable of drinking rather than IV fluid. About half of the hospitals reported that efforts to conserve IV supplies were preventing patient harm from the shortage. However, the hours involved in regularly calling suppliers and carefully managing supplies costs the hospitals valuable staff time, even when patients are not harmed.
Temporarily allowing the import of saline from Baxter’s Spanish facility will not end the IV fluid shortage, but may ease disruptions in the availability of 0.9% saline, according to the FDA. The agency has inspected the saline plant in Spain to ensure that it can meet the agency’s standards for safety and quality.
Importing pharmaceuticals from other countries has become an increasingly common strategy for drug makers, with most drug ingredients used in US drugs now coming from China and India. However, serious quality problems have occurred, such as the importation of adulterated raw material for heparin into the United States, which resulted in major recalls of the product in 2008. Many foreign countries lack the regulatory capabilities of the FDA. The FDA has slowly been growing its workforce in countries like China and India, but still is unable to inspect all foreign facilities.
On a recent visit to India, FDA Commissioner Margaret Hamburg, MD, emphasized the need for drug makers who wish to export drugs or ingredients to the United States to meet US standards. One major Indian drug and drug ingredient manufacturer, Ranbaxy, was targeted by the FDA in January. The agency barred the use of pharmaceutical ingredients produced at the company’s plant in Toansa, India, in FDA-regulated products, and required 2 of the companies’ other factories to comply with FDA standards.
Categories: Patient Safety/Medical Error