As accustomed as U.S. health care workers have become to drug shortages in recent years, news in January that there was a shortfall of intravenous (IV) 0.9 % normal saline solution caught many by surprise. How could the health care system of one of the richest countries in the world be running short of one of medicine’s most basic and usually ubiquitous supplies?
Baxter Healthcare Corp (Deerfield, IL), the nation’s principal supplier of normal saline solution, triggered the shortage by shutting down its line dedicated to the production of one-liter bags for two weeks in December without first ramping up its inventory. It soon realized that it would be unable to “catch up” with demand, which was higher than average, it claimed, due to a bad flu season. Baxter began switching over other production lines to make up the shortfall, and other companies followed suit. “It became like a game of musical chairs,” remembers Regine Villain, the Chief Supply Chain Officer at MUSC, “because they were trying to respond to the market and they had to shut down a production line making 250-mL bags in order to make more one-liter bags, leading to further shortages. In the spring, the U.S. Food and Drug Administration (FDA) took measures to ease the crisis, approving U.S. distribution of normal saline from Baxter's production facility in Spain and from Fresenius Kabi's production facility in Norway, both of which were inspected to ensure that they met FDA standards.
Upon learning of the shortage in early January, Villain informed clinical leadership that it could have hospital-wide ramifications. A multidisciplinary committee of administrators, clinicians, pharmacists, and supply chain specialists was created to manage the situation. Barton L. Sachs, M.D., MBA, CPE, who at that time was serving as Interim Chief Medical Officer, and Chief Executive Officer Patrick J. Cawley, M.D., MHM, FACHE, immediately apprised the MUSC clinical community of the shortage and offered the committee’s recommendations on how to reduce its effects. These included the institution of safe conservation measures (e.g., the use of oral vs IV hydration when appropriate) and the substitution of other formulations of saline for those in short supply. A chart created by MUSC’s Pharmacy Services provided guidance on which substitutions were appropriate in which clinical scenarios.
While the multidisciplinary committee was working hard to control demand, David Habib, M.D., Associate Chief Medical Officer for Supply Chain, and Villain were trying to maximize supply. They set up weekly meetings with Baxter to learn of any new developments and to ascertain the exact number of units they could expect that week of each saline formulation. This level of detailed follow-up allowed for the creation of a database showing precisely how many units of each saline solution would be available for MUSC clinical use that week. Based on this information, the committee refined its recommendations, which were communicated to clinicians via email by Chief Quality Officer Danielle B. Scheurer, M.D., MSCR.
MUSC’s quick and multilayered response has served as a model for other institutions. The chart it created to inform physicians about acceptable substitutions was shared with a number of health care groups for dissemination to their members, including the South Carolina Health Care Association; the United HealthSystem Consortium; and Novation, a group purchasing organization.