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Sun June 22, 2014
Shortage Of Saline Solution Has Hospitals On Edge
Originally published on Mon June 23, 2014 8:09 am
Hospitals across the country are struggling with a shortage of one of their essential medical supplies.
Manufacturers are rationing saline solution — essentially pharmaceutical-grade saltwater. The stuff is used all around hospitals to clean wounds, mix medications or treat dehydration. Now drug companies say they won't be able to catch up with demand until next year.
That leaves San Francisco General Hospital's materials manager, Reid Kennedy, in a fix. Kennedy is in charge of managing all the gloves, bandages, bedpans and IV solutions for the emergency room, medical floors and operating room.
He got a call last year from his vendor telling him it might not be able to deliver his full order.
"We were put on notice that it was going to be tight," he says, walking through the basement warehouse.
Then things got worse in January. The flu season hit much harder than expected, and sick people flooded into hospitals. Saline bags flew off the shelves to treat dehydration. Demand far outstripped supply.
But it's difficult to ramp up production, explains Capt. Valerie Jensen, the director of the drug shortage program at the Food and Drug Administration.
"To make one of these drugs is very complex, even though the drug itself is simple," she says. "It takes about three weeks to make one batch of normal saline from start to finish."
She says it's challenging to make sure saline products are sterile. If you swallow a pill with a little bit of dirt on it, you'll probably be fine. But contaminated saline injected into your vein could cause a big problem.
That's why the FDA sets strict quality standards for the facilities that manufacture saline and other IV drugs, but the agency has to find a delicate balance between safety and supply.
Some suppliers suggest that keeping up with the FDA's standards is too onerous and may be playing a part in the shortage.
"A lot of variables came together to create this," said Scott Crandall, director of medical supply contracts at Novation, a group buying organization in Texas that manages contracts for San Francisco General and 2,000 other hospitals across the country. He's been hearing from manufacturers that increased FDA scrutiny is interfering with drug production.
"During the last year, all suppliers had issues in their facilities where they had to correct certain things the FDA found," he says.
Some of those things were serious. Hospira, one manufacturer of saline, issued a recall earlier this year because of leaks in its saline bags. Manufacturer Baxter found particles in saline vials and had to recall four lots. Both companies say the recalls had no bearing on the current shortage.
But Crandall says inspections and maintenance require shutting down machines. Last winter, he says, maintenance closures "slowed production down 10 to 20 percent."
Colin Carthen is the procurement director for Satellite Healthcare, which runs 70 dialysis centers. He says Baxter told him winter weather was also a problem. Snow and ice storms in the Midwest delayed trucks headed for California.
"As the weather got worse, we began to see more and more back-order issues," he says. Each dialysis patient needs about 4 liters of saline every week to help clean his or her blood. At the worst of the shortage, Carthen felt like the lives of all 6,000 patients depended on him to find them saline.
"I called up a clinical person that I knew at like 11:30 at night and said, 'Well, what happens if we run out of saline?' Because I was really afraid," he remembers. "And they were just like, 'Yeah, it gets ugly, fast.' "
If supplies were to get really low, clinics would have to triage patients so the sickest could get treatment first. Without any dialysis treatment, toxins accumulate in the blood, and patients can die. So every day, Carthen spent hours juggling and rerouting supplies so everyone had enough.
Hospitals have developed new clinical protocols to conserve supplies during the shortage. Nurses at San Francisco General are using smaller saline bags when possible, and transitioning patients who still need hydration to drinking water from cups a little sooner than they did in the past.
The FDA is trying to mitigate the shortage by importing saline from Spain and Norway.
Both Baxter and Hospira, the top two saline producers in the country, say they are doing all they can to maximize production. Each points a finger at other suppliers for contributing to the shortage.
"We saw increased demand amid decreased product availability from competitors as the main driver," a Baxter spokesman writes in an email.
A Hospira spokesman says: "Hospira began seeing stronger demand for its saline products in late 2013 when another manufacturer began to experience manufacturing issues."
Hospira reported a 20 percent increase in U.S. sales of its injectable drugs between January and March, citing "increased volume due to competitor supply issues," in its latest quarterly financial report.
For now, the price of saline is steady. Hospitals have contracts that keep rates locked in through next year. But when those contracts expire, it's possible hospitals will pay two or three times as much.
This story is part of a partnership between NPR, KQED and Kaiser Health News.
LYNN NEARY, HOST:
Hospitals across the country are struggling to deal with a shortage of one of their most essential medical supplies - saline solution. It's a product used throughout the hospital during surgery, for dialysis, with medications. Drug companies are rationing it and say they won't be able to catch up with demand until next year. From member station KQED in San Francisco, reporter April Dembosky explains why saltwater is so hard to come by.
APRIL DEMBOSKY, BYLINE: Reid Kennedy walks through the basement of San Francisco General Hospital. He's in charge of managing all of the gloves and bandages and bedpans that pass through here. He stops at a special backroom with a combination lock.
REID KENNEDY: IV solutions are under lock and key because they go in people's bodies.
DEMBOSKY: This is where the hospital keeps its precious saline supply.
KENNEDY: And saline is huge - hugely popular. It's just used everywhere. It's used in wound management. It's used in medication delivery. It's used hydration. It's used just everywhere.
DEMBOSKY: The patients upstairs wouldn't know it, but Kennedy is dealing with a serious shortage of saline. He first got a call last year from his supplier telling him they might not be able to deliver his full order.
KENNEDY: We were just put on notice that it was going to be tight.
DEMBOSKY: Then things got worse in January when the flu season hit.
KENNEDY: It knocked us out.
(SOUNDBITE OF DOOR SLAMMING)
DEMBOSKY: But we're talking about salty water here. Can't drug companies just whip up some more?
VALERIE JENSEN: To make one of these drugs is very complex, even though the drug itself is very simple.
DEMBOSKY: That's Valerie Jensen, the director of the drug shortage program at the FDA. She says drug companies are already making as much saline as they can.
JENSEN: They only have so many lines that can produce these drugs. And those lines are running 24/7, but they're just not able to meet the total demand.
DEMBOSKY: What makes saline production so complicated is making sure it's sterile. Injecting saline into a vein with the slightest contamination can cause big problems. But the FDA has to strike a delicate balance between safety and supply. The shortage seems to be caused by multiple factors. Scott Crandall is with Novation, a group buyer in Texas that manages saline contracts for San Francisco General and 2,000 other hospitals. He's been hearing from manufacturers that increased FDA scrutiny is interfering with drug production.
SCOTT CRANDALL: During last year, all of the suppliers had issues within their facilities where they had to correct certain things the FDA found.
DEMBOSKY: Some of those things were tiny technical infractions. But some of those things were serious. Hospira, one manufacturer of saline, issued a recall earlier this year because of leaks in its saline bags. Before that, drug company Baxter found particles in its saline and had to recall four lots. Both companies say recalls had nothing to do with the shortage. But Crandall says inspections and maintenance require shutting down machines.
CRANDALL: It slowed their production down 10 to 20 percent - are the numbers we're being told.
DEMBOSKY: Winter weather was a factor, too. Colin Carthen is Satellite Healthcare's procurement director. He says Baxter told him that snow and ice storms in the southeast were delaying trucks headed for California.
COLIN CARTHEN: As the weather got worse, we began to see more and more backorder issues.
(SOUNDBITE OF MEDICAL EQUIPMENT)
DEMBOSKY: Carthen oversees the saline supply for 70 dialysis centers across the U.S., including this one near San Francisco. This afternoon, a handful of patients sit in rows of vinyl recliners receiving treatment for kidney failure. Each dialysis patient needs about four liters of saline each week to help clean their blood. At the worst of the shortage, Carthen felt like the lives of all 6,000 patients depended on him to find a way around the shortage.
CARTHEN: So I called up a clinical person at 11:30 at night and said what happens if we were to run out of saline because I was really afraid about what might happen. And they were just like yeah. It gets ugly fast.
DEMBOSKY: If supplies got really low, clinics would have to triage patients so the sickest got treatment first. Without any dialysis treatment, toxins accumulate in the blood and patients can die. That's why Carthen says every day he spent hours juggling and re-routing supplies so everyone had enough. The FDA is trying to mitigate the shortage by importing saline from Spain and Norway. For most hospitals, the price of saline is a steady. Hospitals have contracts that keep rates locked through next year. But when those contracts expire, it's possible hospitals will pay two or three times as much. For NPR News, I'm April Dembosky in San Francisco.
NEARY: This story is part of a partnership between NPR, KQED and Kaiser Health News. Transcript provided by NPR, Copyright NPR.