The nation’s hospitals were already in the grip of a saline solution shortage when hurricanes interrupted production at plants in Puerto Rico. Now, B. Braun, one of three main suppliers, is halting production at a plant for maintenance, a move it acknowledges will make a bad situation worse.
In a letter released (PDF) by the FDA, B. Braun told clients that it would halt production at a plant in December to do “critical maintenance,” a move that will exacerbate availability of the essential product through the first quarter of 2018.
The company said it has planned for the production halt all year.
“However, unplanned production interruptions have resulted in significant decreases in supply of product necessary to meet current demands of our customers. The December shutdown will further strain our inventory levels.”
The company did not say what the unplanned interruptions were, but the FDA told B. Braun in a warning last year that repeated problems suggest the company needs to assess its production throughout its global network.
The saline shortage, which had dogged hospitals since at least 2014, was exacerbated when hurricanes Irma and Maria wreaked havoc on pharma plants in Puerto Rico. That included three facilities where Baxter International, another of the big three saline producers, makes small volume presentations, or “mini-bags,” of sodium chloride.
Baxter said in its earnings report last month that its three plants in Puerto Rico remain in “limited production,” but that the FDA is allowing it to temporarily import some products from its facilities in Ireland, Australia, Canada and Mexico to help feed demand in the U.S. market. The FDA also is allowing B. Braun to import extra supplies from Germany.
The shortage is complicated by the fact that not all saline is the same. As one source explained, some chemo drugs can be presented only in DEHP-free bags because of a serious interaction, while some patients are sensitive to saline with sodium hydroxide.
“We have been able to get what we need to avoid disruptions in patient care, but the mix of products is not ideal and there are no guarantees we will continue to get the supplies we need,” Philip J. Trapskin, who manages medication supplies for the University of Wisconsin-Madison’s health system told the New York Times recently.