The nation's top drug compliance official says the Food and Drug Administration is working to combat the drug shortages that have plagued hospitals.
Nearly 70 products were in short supply as of Monday evening, from popular products like Nasonex to crucial drugs, like those needed by physicians treating cardiac arrest, according to the FDA.
Cynthia Schnedar, director of the Office of Compliance for the FDA's Center for Drug Evaluation and Research, told suppliers and group purchasing executives at the 2015 Healthcare Supply Chain Expo on Monday that the agency is encouraging manufacturers to increase their output.
About 37% of drug shortages are the result of factory issues, Schnedar said. Other major reasons for shortages include difficulties accessing raw materials, manufacturing delays and capacity issues. Some shortages are resolved over the calendar year.
Shortages of sterile injectables—including antibiotics, cancer medications and anesthetics—experience some of the most persistent shortages, she said, and are often related to issues with sterility, bacterial or fungal contamination, visible particulates in the medication or crystallization, among other reasons.
Schnedar said there's no simple fix for the shortages because the manufacturing processes and chemical makeup of drugs are so complex, and problems that are the root cause of shortages often affect multiple products at once. Plus, manufacturers don't necessarily have an incentive to ramp up production if they are not likely to make a profit.
The FDA can take several steps to help manufacturers avoid or resolve shortages, Schnedar said, including allowing for the manufacture of medically necessary products with additional safety controls. The agency can also: request other firms to raise their production of a product if it's made by multiple companies; expedite reviews for new manufacturing sites or changes to product information; and even allow temporary importation from otherwise unapproved sources in rare cases, she said.
“We simply cannot require a company to continue making a drug, to make more of a drug, or [tell it] how much of the drug to make or who to sell the drug to,” Schnedar said.
Shortages reported each year appear to have decreased recently, with 251 reported in 2011, 117 in 2012, and 44 in 2013, as well as 2014. There are nearly 70 this year, but they could resolve themselves before year's end.
“We're making progress in mitigating critical shortages, but many challenges remain,” Schnedar said. “A single shortage of a critical drug is simply unacceptable. We have a strategic mission, we're working hard, but we cannot solve the drug shortages problem alone. We need the industry commitment to a culture of quality manufacturing, and we're working hard to make that happen.”
The FDA declined to make Schnedar available for an interview following her talk. The Healthcare Supply Chain Association, which hosted the supply chain exposition, has made drug shortages one of its top priorities.
“We take this very seriously, and our customers do as well, and we are taking an active role to mitigate the problem as best as we can, knowing there are some things we can't manage,” said Todd Ebert, former CEO of St. Louis-based GPO Amerinet, who took over as president and CEO of the Healthcare Supply Chain Association this summer.
