A worsening shortage of IV saline solution, one of the most common products used in hospitals, is causing concern among healthcare providers having trouble locating saline products during this increasingly severe flu season.
Increased demand from hospitals due to the ongoing flu season and a planned routine shutdown of one manufacturer's factory for maintenance are major causes of the shortage, which began surfacing in the fall.
Some pharmacists say the shortage also reflects the lack of resiliency in the supply chain.
“All it takes is a few flu admissions and a small recall and not enough forecasting before a year-end closure and all of that together can create a shortage,” said Erin Fox, director of the University of Utah Drug Information Service.
The saline products in short supply are sodium chloride 0.9% injection bags. Saline solution is an example of a product that is not stockpiled in the supply chain. When one company reports a shortage for a “just-in-time” product, it also can trigger shortages from competing manufacturers as hospitals seek out alternative sources of supplies.
Baxter International, which temporarily shuttered its plant for planned maintenance in December, and Hospira produce about 90% of the saline products used in the U.S. B Braun Medical is the other U.S. producer of saline products.
“When there is an unexpected spike in demand from those typical patterns, manufacturers have to adjust production levels, which can take time,” said Tareta Adams, a spokeswoman for Lake Forest, Ill.-based Hospira. “With capital-intensive products such as IVs, we have a limited ability to produce higher volumes, and we are maximizing production to serve as many hospitals as we can.”
Hospira expects “improved availability of some of the saline products by the end of February.” A Baxter spokeswoman said the Deerfield, Ill.-based company is working with regulators to identify alternative options to alleviate demand. Until the shortage eases, the three companies—Baxter, Hospira and B Braun—are temporarily allocating saline products based on need to hospitals and other healthcare providers.
Saline products have not been in short supply during past flu seasons, pharmacists and regulators said.
“We've not had this type of issue where all three firms are facing increased demand,” said Valerie Jensen, associate director of the Food and Drug Administration's drug shortages program. “All three manufacturers are aware and are working to get supplies out as quickly as possible.”
On Jan. 17, the FDA notified providers about the shortage and attributed the shortage to an “unusual spike in demand.”
Flu activity remains high. Hospitalizations and deaths, both of which are indicators of severity, continue to rise, according to the Centers for Disease Control and Prevention.
While not all flu patients visiting hospitals or clinics may need an IV saline solution, more than half of the flu patients in 2013 were older than 65 and are more likely to be hospitalized and dehydrated, according to Bona Benjamin, director of medication use quality improvement for the American Society of Health System Pharmacists.
The shortage is challenging because there are not easily exchangeable alternative products, Benjamin added. Hospitals, in some cases, can use oral hydration products, smaller bags or alternative fluids such as dextrose containing certain concentrations of sodium chloride. If hospitals have access to sterile chloride injections, which are also in short supply, they may be able to compound solutions.
“Our sense from reports is that this is a very, very serious situation,” she said.
Ongoing drug shortages remain a concern for hospitals and providers despite fewer new shortages. There were 140 new shortages in 2013, compared with 204 in 2012 and 267 in 2011, according to the University of Utah Drug Information Service.
But the number of active shortages remains high. There were 288 active drug shortages in the fourth quarter of 2013, with each quarter of last year having 294 to 299 active drug shortages.
To alleviate other shortages, the FDA has allowed temporary importation of products from outside the U.S. Jensen said the agency continues to work with Baxter, B Braun and Hospira but has not ruled out taking other regulatory steps.
“If that ends up being a source overseas that can help with the situation temporarily, that's something we're definitely exploring,” she said.