For at least the past six months, hospitals and pharmacists across the country have had to acclimate to having less saline IV solution on hand than ever before. And, while manufacturers say the stock has improved since retreating from the height of flu season, experts warn a major catastrophe could signal a crisis.
The bags of .9 percent sodium chloride solution are widely used in hospital and pharmaceutical operations. The solution hydrates patients who come to the emergency department. It’s used to flush wounds. Dialysis centers cleans their patients’ blood with it. Pharmacists use it to mix antibiotics and other liquid drugs.
“We started having problems back in November,” said Debra Reed-Powell, operations manager of Parkland Health & Hospital System’s Materials Resource Department. “We kind of knew something was going on. We didn’t know exactly what it was, then the 1000-milliliter bags stopped showing up. Then last January, we were like, ‘hold up, what’s going on.’ And that’s when the information started coming out.”
Late last year, the three manufacturers of the solution notified the Food and Drug Administration, which monitors drug shortages, that they anticipated having trouble meeting demand. A shortage, especially one that’s now lasted nearly half a year, wasn’t on their radar, however.
Baxter HealthCare Corp. and Hospira Inc. are the primary stateside manufacturers approved for distribution. B. Braun Medical Inc. also produces some saline, but not as much as those two.
When identifying a cause, the conversation often starts with the words “manufacturing problems.” Parsing that phrase reveals disparate reasons: In December, Baxter voluntarily recalled 50 mL and 100 mL bags of sodium chloride solution after particulate matter was found inside the bags, which could block blood vessels and cause a stroke or heart attack. In February, Hospira recalled 1,000 mL bags of saline solution “due to the potential for solution to leak at the administrative port of the primary container.”
Then the brutal winter made distribution difficult. And once the flu season started, Baxter reported “unprecedented demand.” In a letter sent to its customers, Hospira cites “this year’s flu season” and “industry supply constraints” as the reasons for its shortfalls.
According to a survey of pharmacy directors conducted in February by the American Society of Health System Pharmacists, the shortage has impacted 76 percent of U.S. hospitals and healthcare facilities.
“It’s dire in that the manufacturing is just barely keeping up with the orders,” said Scott Crandell, senior director of medical sourcing at Novation, the Las Colinas-based company that serves as a middleman between healthcare providers and drug manufacturers. “If there’s one more hiccup in manufacturing, I would consider it a dire situation. Right now we’re not telling the market that it’s a total emergency because we don’t want to cause panic.”
The FDA has allowed Baxter to import saline solution from its plant in Spain. Fresenius Kabi US is shipping in product from its plant in Norway. The FDA says it performs the same quality measures on those that it does on what’s made in America.
“At 400,000 units, it was a drop in the bucket so to speak and at a much higher cost,” Crandell said of the Norwegian shipment. “But that’s one alternative, to buy this product that’s being imported. It’s not a perfect option but it does help a little bit.”
In an email, Baxter spokeswoman Christy Noland said the company has begun divvying out its inventory to hospitals based on critical need, existing inventory, and historical purchasing levels.
“We are prioritizing clinical access to these products on an equitable basis to continue to meet patient needs,” Noland wrote.
And so, hospitals are adapting. At Parkland, Reed-Powell said the system gets a weekly allocation from Baxter. When it came just twice a month, she said dwindling supply at its warehouse prompted Parkland to negotiate with the company to get it switched to weekly. She now does daily allocation updates to better manage the supply and says the strategy is working.
Parkland has not run out of saline, she said.
Meanwhile, Crandall says more of Novation’s healthcare clients are rethinking the way they use the solution. They’re using different sized bags and giving patients water who can swallow instead of an IV. Hospitals are beginning to work collaboratively between departments to better share what they have, he said. They’re also identifying substitutes that can help offset the amount of IV fluid needed.
Erin Fox, director of the Drug Information Service at the University of Utah, said she’s seen some caregivers teaching colleagues oral hydration methods they learned in the Peace Corps just in case: “It’s just so odd to think about,” she says.
“It’s being choosy about which product you’ll use and which size of the product you have at any given time,” she said. “It’s a huge workload on hospitals and on the health systems to just do that daily adjustment.”
Fox’s employer helps advise the federal government about drug shortages. The saline shortage is indicative of much broader implications about America’s supply of this essential drug, she says.
“That a few little glitches can result in such a profound shortage really shows the weakness in our supply chain and how fragile it is,” she says. “What if we really did have a terrible flu season and we didn’t get enough of the treatment that we needed?”
According to the Centers for Disease Control, the flu season peaked the week of December 28 and began its descent in early January. It also wasn’t as severe as the year prior, although CDC data shows that hospitalization rates among patients 18 to 64 years old were higher than the past three previous seasons.
But Fox stresses her point: “I don’t think there are places that are fully back up to stock,” she said in an interview late last month. “Every hospital around the country is doing an incredible amount of work to do all that counting up and seeing what delivers you’re going to get and what deliveries got canceled. It’s hours and hours of work being spent on this. You have to wonder, at some point something’s got to give.”
The FDA and the companies say they’re working diligently to avoid reaching that point. Noland said Baxter has increased its capacity by 3 percent in 2013 and is “investing in capacity” to raise it another 9 percent by the end of 2014. Hospira said it has “maximized production” of its IV saline products.
Meanwhile Crandall, of Novation, believes collaboration and communication will ease the pain of the shortage. The company, which he said has “45 to 50 percent” of the nation’s hospitals as contracted clients, helped facilitate $49 billion in healthcare-related contracts last year. It has the connections to bring the right players into the right room.
And so, Novation organized a symposium at the Joule Hotel from Monday to Wednesday of this week for manufacturers and its members to discuss the shortage and ways to overcome it. A press call is scheduled for Wednesday afternoon.
“There’s a lot of communication that’s needed and we’re doing a lot,” Crandall said. “The industry could do more, that’s probably the other message. We’re just as frustrated as everyone else. We can’t control this, but we want to take a very mature approach to figuring this out.”
But still, the reality remains that the shortage isn’t likely going anywhere anytime soon. To end her email, Noland, the Baxter spokeswoman, was positive yet grounded to the realities of the shortage: “While the customer experience has improved greatly since January, the overall market is still at capacity and any supply interruption could possibly further impact the market.”