Saline Shortage Feared With Hurricane Season Threatening Production

(Bloomberg Businessweek) -- Three years ago, when Hurricane Maria devastated Puerto Rico, it crippled Baxter International Inc.’s ability to manufacture saline solution, an essential hospital supply. With another hurricane season threatening the island, Baxter says it will do better if disaster strikes again, even in the midst of the coronavirus pandemic.

As the Atlantic hurricane season gets under way, the looming confluence of bad weather and a deadly global pandemic has the medical world increasingly on edge. Hospitals rely heavily on saline solution-filled pouches to deliver medications such as antibiotics and painkillers, as well as to hydrate patients. Baxter, which dominates the saline market, makes most of those clear bags in Puerto Rico, drawn there by tax incentives, as are dozens of other drugmakers.

This year, as the pandemic rages in the U.S. and strains hospitals, forecasters expect hurricane season to be much more active than normal. The National Oceanic and Atmospheric Administration predicts as many as six major hurricanes, double the number in an average year.

Lessons learned from Maria have helped Baxter build “a more resilient supply chain,” says Lauren Russ, a spokeswoman. The company has invested $1 billion in its manufacturing network and has won clearance from the U.S. Food and Drug Administration to make saline in other countries should the need arise, Russ says. After Hurricane Maria, the FDA allowed Baxter to import saline made in the company’s facilities in Australia, Canada, Ireland, and Mexico. In addition, Baxter now immediately ships newly produced saline bags from Puerto Rico to the U.S. mainland rather than holding supplies there. “With those two strategies in place, we’re feeling comfortable,” says Sam Calabrese, chief pharmacy officer at the Cleveland Clinic, one of the largest hospitals in the country.

Ohio isn’t a Covid-19 hot spot like Florida or Texas. Still, some critical medications are in short supply following months of treating Covid-19 patients. The state’s pharmacy board granted a waiver that allowed the hospital to make its own versions of some drugs, including the painkillers hydromorphone and fentanyl.

Elsewhere, the virus has stretched the supply chain for drugs needed to care for Covid-19 patients, creating shortages of sedatives, antibiotics, and pain medicine. At the same time, China, a major pharmaceutical producer, curtailed output as the virus spread there.

A similar fate hasn’t befallen saline yet, but supplies “remain a concern to the U.S. government because of the increased demand for their use with Covid-19 patients,” Jonathan White, director for the division of recovery in the Office of the Assistant Secretary for Preparedness and Response, said in an email.

Saline is one of many older, generic drugs that have low profit margins and a dwindling number of providers. Baxter makes the bulk of the country’s regular small saline bags, although a few other companies provide limited supplies.

In late June, the American Society of Health-System Pharmacists, a pharmacy organization that tracks shortages, flagged low supplies of saline bags that don’t contain polyvinyl chloride, known as PVC, or a chemical called DEHP. The special PVC/DEHP-free bags are needed, particularly for pediatric patients, to mix infusions of specific drugs, mainly certain chemotherapies, the sedative lorazepam, and drugs to prevent organ rejection after transplant, says Erin Fox, a drug shortage expert at the University of Utah. Some makers of PVC/DEHP-free bags are conducting hourly reviews of supplies to ensure they have enough saline on hand to meet demand.

That’s just the kind of situation that keeps disaster experts up at night. “There are still a lot of variables,” says Nicolette Louissaint, executive director of Healthcare Ready, a nonprofit organization formed after Hurricane Katrina pummeled New Orleans in 2005. That, she says, makes “it difficult to know if we are sufficiently prepared.”

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