March 26, 2014
The national shortage of normal saline, which was a result of the confluence of manufacturing shortages and increased demand, has impacted medical facilities nationwide.
Baxter issued a letter in mid-March outlining the company’s approach to the addressing the shortage, noting that it “established temporary allocation processes and other distribution controls to drive consistency in the supply stream and ensure access to products.”
Among the steps the company has taken to address what it calls “unprecedented demand” are as follows:
- In place of monthly ordering, weekly ordering will become the temporary norm. Monthly orders will be divided into weekly allocations, beginning March 25. When placing Tuesday orders, amounts lower than the weekly allocation will be combined with the order the following week. Orders exceeding the weekly allocation will be automatically canceled.
- A review and cleanup of back orders begins March 24, resulting in a number of cancellations of back orders.
- After completion of the cancellations, Baxter will have reports with information regarding what has been canceled, what will be fulfilled, and the specific allocation amounts for your facility. Customer service representatives can provide you with this information.
- The best way to receive your full amount is via the same product channels you’ve used thus far.
Baxter noted in its letter, “While we are hopeful that you will begin seeing improvements in product availability by the end of April, given prevailing market conditions, a definitive timeframe for full return to historic service levels is uncertain.”
According to Michael Cohen of www.philly.com, the three manufacturers and market share are as follows: Baxter (45%), Hospira (45%), and B. Braun (10%). He also cited the maintenance shutdown at Baxter, which was scheduled in advance, as a contributing factor.
Capt. Valerie Jensen of the FDA told Medscape that the organization became aware of the shortage in late 2013. Given the act signed into law July 2012, The Food and Drug Administration Safety Innovation Act, a task force on drug shortages was created to help the FDA to prevent and mitigate drug shortages. As a result of a presidential executive order, the FDA reported that it has seen a six-fold increase in companies’ self-reporting potential shortages.
Capt. Jensen cited manufacturers experiencing delays that they self-reported to the FDA. But the companies did not anticipate the delays resulting in shortages. But by mid-January, the demand rose to levels higher than anticipated. Although influenza typically drives the increase in demand, this year has seen a number of other triggers, she added. “Hospital demand in general has just been high this year, as we are hearing from manufacturers,” Capt. Jensen said.
1. Scudder L, Jensen V. Critical intravenous solution shortages. Medscape. 2014 Feb 20.
2. Cohen M. Critical IV solution shortage affecting US hospitals. www.philly.com. 2014 Jan 27.
3. U.S. Food and Drug Administration. Strategic plan for preventing and mitigating drug shortages. October 2013.
4. Baxter Healthcare Corporation. Letter addressed to customers. 2014 Mar 12.