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    Drug shortage help on horizon


    While hospitals continue to face IV saline shortages after two hurricanes significantly damaged infrastructure in Puerto Rico, the situation should improve early this year.

    Related: Drug shortages likely after hurricanes

    “Based on the information we’re receiving from the companies, we expect that the shortage of IV saline fluids will improve in early 2018, with continuing improvements in the weeks ahead,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

    Nearly 4 months ago, Hurricane Maria struck the island, knocking out power. Then, shortly after, Hurricane Irma dealt a second damaging blow to its infrastructure.

    However, Baxter, a leading producer of IV saline fluids, recently said that all their facilities on the island have returned to the commercial power grid.

    Related: Why 2016 drug approvals fell

    “Moreover, all the other companies that manufacture products that were on our initial list of drugs that we considered critical and at risk of potential shortages – because the drugs were largely or entirely manufactured in Puerto Rico—are now on the power grid. Many of these companies report to us that their production is increasing,” Gottlieb said.

    Pharmaceutical manufacturers are allocating IV saline to health care providers until supply is improved, according to FDA.

    Hospitals should also consider clinical recommendations for managing the shortage of IV fluids, including those issued by the American Society of Health-System Pharmacists (ASHP) and the University of Utah. Plus, the new guidance, "Small-Volume Parenteral Solutions Shortages", provides an outline for potential actions for organizations and health care professionals to consider in managing the shortage.

    In addition, FDA is “continuing to pursue efforts to increase supplies of IV saline while product availability concerns remain. This includes our approval of IV saline products from additional companies like Fresenius Kabi and Laboratorios Grifols,” Gottlieb said.

    Plus, ICU Medical, which previously manufactured IV amino acids, is planning to return to the market early this year.

    “Given the improvements we’ve seen over the last few weeks, I’m optimistic that supplies of IV saline and amino acids will increase over the next few weeks and the stress of the shortage will begin to abate, even if the shortages will not be fully resolved immediately,” Gottlieb said. “That said, the production situation in Puerto Rico remains fragile.”

    Read more: Saline shortages: A 3-step action plan


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