Small saline-solution bags are ubiquitous in modern hospitals, cost about $1.50 each, and are the preferred method for delivering everything from painkillers and antibiotics to chemotherapy and heart drugs. The Cleveland Clinic, a top academic medical center, uses the bags to administer 350 different medicines, typical for hospitals across the country.
But supplies are running dangerously low. A long-standing problem, the situation worsened when Hurricane Maria slammed into Puerto Rico, knocking out power at factories that make the small bags for Baxter International Inc., the product's biggest supplier. Another large maker of the bags, B. Braun Medical Inc., is having problems of its own-the U.S. Food and Drug Administration is looking into reports of leaky and moldy intravenous bags. And a third, ICU Medical Inc., hasn't been able to keep up with the increased demand. The industry has also been swept up in a U.S. Department of Justice criminal probe of possible collusion and price-fixing.
"What else is going to run out?" says Scott Knoer, Cleveland Clinic's chief pharmacy officer. "I'm just scared of what's next." Hospital staffs across the country are living the same nightmare. "I find it shocking that in the richest country in the world we run out of fundamental, basic supplies," says Martha Kuhl, an oncology nurse at UCSF Benioff Children's Hospital Oakland.
It's a crisis that's been years in the making. Lacking the appeal of the latest $100,000 wonder drug, basic hospital supplies with thin profit margins are low priorities for a consolidating pharma industry that has failed to modernize outmoded factories or ramp up supply. In August, Braun Medical instructed customers to seek alternatives in the wake of what it called " unplanned production interruptions " at its IV-solutions factories.
That was three months after the FDA slapped the company with a warning letter for "repeat violations" after it failed to correct quality problems resulting in leaky and contaminated intravenous bags at its Irvine, Calif., plant. Braun didn't respond to requests for comment, but in a letter posted on the FDA website it promised improvements "in the coming weeks and months." Baxter says power has been restored at all but one of its Puerto Rico plants.
The FDA says it's working to alleviate shortages, allowing temporary imports and speeding up reviews for drugmakers seeking to make IV fluids, according to Valerie Jensen, an associate director at the FDA's Center for Drug Evaluation and Research. That may not be enough. The shortages put the system "on the brink of a significant public health crisis," the American Hospital Association warned in a Nov. 9 letter to Congress .
A bigger shadow looms over the industry. The Justice Department has launched a criminal investigation into the business practices of saline bag producers. In April, following an earlier class action alleging price-fixing, Baxter disclosed it was subpoenaed in an ongoing government probe into shortages of intravenous solutions, including saline. The investigation follows a 2015 letter from a group of U.S. senators citing reports that prices had tripled during earlier saline shortages and calling for the Federal Trade Commission to look into possible price-fixing among Baxter, Braun, and Hospira Infusion Systems- Pfizer Inc.'s former saline and IV-fluids unit, now owned by ICU Medical. Baxter says it's cooperating with the Justice Department probe.
ICU Medical says it believes the investigation focuses on a time frame prior to its ownership of the business. Pfizer says it's coordinating with ICU Medical to produce records for the Justice Department.
It's not just saline bags that are in short supply. Inventories are running low on 174 drugs, according to Erin Fox, director of the drug information service at University of Utah Health. That leaves little margin for error when an unforeseen event, like a hurricane, throws production into disarray. Other scarce hospital staples include syringes of sodium bicarbonate -the ingredient in baking soda-used for heart attack patients, and certain injected forms of morphine.
Pfizer's Hospira unit, which makes both types of products, has been plagued by factory quality-control problems for years, leading to shortages of various drugs. The factories "are taking a little bit longer to remediate than we thought," Pfizer Chief Financial Officer Frank D'Amelio said on a recent conference call with analysts, promising to fix most of the issues by the end of 2018. As a result of the problems, Pfizer's sales of injected hospital drugs declined 12 percent in the third quarter.
Finding alternatives to injectables isn't easy. While some drugs can be taken orally and others administered through a syringe, it's expensive and time-consuming to change hospitals' operating procedures. The more a workflow is changed, the greater the chances of medication errors, nurses and pharmacists say.
UW Health, the hospital system affiliated with the University of Wisconsin at Madison, is spending $1 million on alternatives to Baxter's saline bags, including renting hundreds of drug pumps that can deliver medicines via syringe and buying other drugs in premixed bags, says Philip Trapskin, UW's program director for medication use strategy.
Injected drugs are harder to produce than pills because they must be made under sterile conditions. They account for 72 percent of the country's drug shortages, according to a January report from Pew Charitable Trusts and the International Society for Pharmaceutical Engineering. The report cited factory quality-control problems and companies withdrawing from the market.
"I can't believe that one plant in only one place makes so much of a critical product that every hospital needs to function," says Fox of University of Utah Health, referring to Baxter's hurricane-hit operations. "We have all hands on deck every day. It's a logistics nightmare."
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