The U.S. is facing a nationwide shortage of intravenous bags just as flu cases accelerate, forcing many hospitals to use more time-consuming ways to administer drugs and to weigh a halt on elective procedures and clinical trials.
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Some hospital officials said they have only a day or two of supplies and worry whether they would be able to handle an influx of patients as the influenza virus ramps up. Forty-six states are seeing widespread flu activity, according to the Centers for Disease Control and Prevention, putting this year on par with 2014-15, which was the most severe flu season in recent years.
The availability of saline IV bags has plummeted because a major manufacturer in Puerto Rico, Baxter International Inc., was affected by the hurricane that slammed its plants on the island, while production problems hit another key manufacturer of the bags this year. The Food and Drug Administration said Thursday that production at Puerto Rico plants remains fragile.
"It might as well be a Third World country," said Erin Fox, senior director of drug information services at the University of Utah, which tracks nationwide drug shortages. Hospitals, she said, are now administering medications using syringes instead of IV bags because of the shortage.
Those methods have more side effects, Ms. Fox said. "It's happening every day," she said. "And it will have more of an effect as hospitals get into delaying electives or clinical trials."
Baxter said its two IV plants in Puerto Rico now are hooked up to the electrical grid but that power is "intermittent" and that the plants have backup diesel generators in place. In a statement, the company said it is "making progress on the road to a full recovery" of operations and expects "to return to more normal supply levels for products made in Puerto Rico in the coming weeks."
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A Baxter spokesman added that there isn't normally enough industry capacity to ramp up the supply of small IV solution bags for hospitals to quickly make up for a major disruption like a hurricane.
A large hospital can go through hundreds or thousands of IV bags a day, depending on patient volume.
The bags vary in size and are filled with saline solution, or salt water. Smaller-volume bags are often used to deliver medications that must be diluted before they go into a patient's bloodstream via the IV. Hospitals facing a shortage of these smaller-volume bags have in some cases used larger ones, which are sometimes used for hydration.
There have been shortages in the IV market in recent years, even before the hurricane. In August, B. Braun Medical Inc. told customers about "unplanned production interruptions" and advised them to seek alternative sources of IV products. Three months earlier, the FDA had warned B. Braun about customer complaints of "visible particulate matter and leaking intravenous bags" and noted good-manufacturing violations the agency identified over several years.
Another factor may be at play, too. A Baxter filing last May with the Securities and Exchange Commission suggested the U.S. Justice Department is investigating possible collusion among manufacturers of intravenous solutions, and any effects that communications among companies had on pricing and shortages. Baxter has said it looked forward to explaining to the DOJ "the background and history of these issues."
Market-research firm IBISWorld estimated Baxter holds 44% of the U.S. IV solutions market, followed by Hospira Inc., now part of ICU Medical Inc., with 31%, and B. Braun with 10%.
Massachusetts General Hospital in Boston has nurses spending as long as 35 minutes delivering medications using IV syringes, known as an IV push. Instead of a four-to-five day supply of bags, the hospital now has one or two days' worth. The hospital is so concerned it is looking at using glass bottles for patients instead of the IV bags.
"If the influenza virus or catastrophic event breaks out, that would stress us more. In some ways, it's unprecedented," said O'Neil Britton, Mass General's chief medical officer. "It raises fear we may have to make choices about not doing some things and delaying elective procedures."
Officials at Catholic Health Initiatives, which offers care in 100 hospitals across 17 states, said it is possible they would have to delay elective procedures until the shortage abates.
"It's hard to overstate the public-health crisis," said Craig Frost, vice president of clinical pharmacy services at Catholic Health Initiatives. "It's a fundamental part of patient care."
Some county governments are approving emergency-disaster declarations so they would be able to get federal help if the crisis worsens.
The FDA has worked with producers to bolster the supply to U.S. hospitals, though officials say shortages were worsened by some hospitals' hoarding of IV fluid bags. The bags' producers are now connected to the electrical system in Puerto Rico and are ramping up production.
FDA Commissioner Scott Gottlieb said shortages at mainland U.S. hospitals "will improve over the next two months."
Some hospital officials said they had hoped the shortage would be lessened by now, after Hurricane Maria raked Puerto Rico and crippled plants owned by Baxter.
Many hospitals, however, say they aren't seeing any uptick in supplies and that the shortages are so acute that the problem can't be abated soon, particularly with small bags used to dilute and deliver drugs to patients in such short supply.
Health leaders are pressing federal regulators and Congress to adopt new measures aimed at ensuring a steady supply of critical treatment products. For example, groups such as the American Hospital Association, American Society of Anesthesiologists and American Society of Clinical Oncology are urging Congress to look into whether it is OK that some medications are allowed to be made at a single plant, according to a letter to some lawmakers. They also are pushing to get regulators more information about the cause of shortages and congressional incentives to get more manufacturers involved in producing specific critical products such as IV saline and drugs.
The AHA also wants the FDA to seek out and approve new suppliers in the U.S., and it wants the three major current makers to increase supplies in the future. Shortages have persisted off and on in recent years, even before the hurricane.
Congress has taken little action so far. The House Energy and Commerce Committee's Oversight and Investigations Subcommittee held a hearing in October focused on public health preparedness in the wake of Hurricanes Harvey, Irma, and Maria, and the subcommittee continues to examine the issue of shortages.
Bonnie Levin, assistant vice president for pharmacy services at MedStar Health, which encompasses 10 major hospitals around Washington, D.C., and Maryland, said "there is still a significant shortage of IV bags of all sizes." But, said Dr. Levin, her hospital group has coped by moving patients to oral and other therapy as fast as possible.
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(END) Dow Jones Newswires
January 07, 2018 13:36 ET (18:36 GMT)