Baxter made the comment in a letter posted on the US Food and Drug Administration’s (FDA) site last Friday explaining that, while it is happy to be one of the firms tasked with bolstering supplies, the effort has placed “a strain on our manufacturing facilities and distribution system.”
The company said it “has increased production of key IV solution codes in response to competitive supply issues…[but] despite our increased production, product supply remains tight.”
This was confirmed by Baxter spokeswoman Deborah Spak who told in-Pharmatechnologist.com that: “In 2013, Baxter increased production capacity of IV solutions by 3% year over year and is investing in capacity to deliver 9% growth in 2014.”
Baxter has also been rationing supplies since November in an effort to ensure that the appropriate customers receive them.
“Certain products, notably Baxter’s 0.9% Sodium Chloride Injection, USP, 1000 mL, have been prioritized for contracted customers and based on critical need, existing inventory and historical purchasing levels,” Spak told us. “We will continue to take backorders on this product and will prioritize shipments based on the customer order date.”
According to the American Society of Health-System Pharmacists , the shortage of 0.9% sodium chloride bags has also had an impact on Hospira and BBraun, though Baxter is the only producer of six different volumes of the bags and Hospira’s continuing manufacturing woes may make it difficult to help in the recovery.
The lots impacted include Sodium Chloride 0.9% in 150 mL bags, 250 mL bags, 500 mL bags, 500 mL PVC/DEHP-free bags, 250 mL PVC/DEHP-free bags, 1000 mL bags and 1000 mL PVC/DEHP-free bags.
The FDA also said the shortage is due to an increase in demand. “Baxter has these products on allocation and is working to maximize the availability of the product to meet US market demand,” the agency said.
Wholesalers and distributors of the solutions have been notified, according to the company, which also said these “steps enable Baxter to evaluate and adjust our production levels, provide predictability of demand to our manufacturing plants, establish a timeline for providing additional product; and maintain and improve our service levels for Baxter committed customers.”