There is no remedy in sight for America’s drug shortage.
The number of new shortages has dropped steadily over the past two years from a high of 267 in 2011, mostly due to a reporting requirement that allows regulators to get ahead of anticipated problems and intervene, according to the University of Utah’s Drug Information Service.
But unresolved shortages from years past are pushing up the total number of drugs in short supply.
The U.’s tracking service reported 273 active shortages in the fourth quarter of 2011. By the end of 2012, active shortages reached 299, a number exceeded in the first quarter of 2014.
“We now have 305 active drug shortages. It’s a crazy amount. We’ve never followed this many before,” said Erin Fox, a clinical pharmacist and manager of the Drug Information Service. For 13 years, the service has monitored and publicly reported shortages via the American Society of Health-System Pharmacists (ASHP).
Most squeezed are central nervous system drugs, antibiotics and intravenous saline solutions, Fox said.
“Saline is a standard supply used for everything. It’s almost like running out of bandages,” she said. “One of the physicians asked me if we were going to be short on air next.”
Chemotherapy drugs also are a chore to keep stocked, along with nitroglycerin injections, a first-line therapy for patients with chest pain.
“Not every hospital is impacted by all of them at once,” Fox said. “Most hospitals are dealing with 100 to 150 [shortages] at any time.”
The lack of drugs or use of inferior alternatives have resulted in about a dozen deaths nationwide, according to the Institute for Safe Medication Practices. None are known to have happened in Utah, Fox said.
And while hospitals are generally able to cope by counting doses and rationing supplies, the pains they take are costly, to the tune of hundreds of millions annually — and help keep the problem from public view.
“It’s such a critical manufacturing failure, and in any other industry I think it would get a lot more attention. But as health care providers it’s our job to protect patients, so we end up making the problem invisible,” Fox said.
The cause of shortages varies. About 30 percent are due to manufacturing failures, 9 percent are based on mismatched supply and demand and 6 percent stem from a business decision. Only 4 percent are due to shortages of raw materials, according to a Drug Information Service investigation.
Industry consolidation and a “just-in-time” inventory system used by drugmakers to avoid having to discard unused medicines also plays a role.
There are three saline producers in the U.S., two of which own 40 percent of the market, said Don Williams, material manager for Intermountain Medical Center. “So when Hospira and Baxter have manufacturing problems it doesn’t take long to affect the entire country.”
Intermountain didn’t feel the saline crunch, which was limited to Baxter International customers. Intermountain uses Hospira and has the added benefit of having its own distribution center. While some health centers only have space for a week’s supply, Intermountain can stock 30 to 40 days worth of saline.
“That’s our normal stock,” stressed Williams, noting hoarding is disallowed by suppliers during times of shortages and the resale of supplies is illegal.
Getting to the root of the problem, however, will also require an investment by drugmakers who have let manufacturing plants deteriorate, Fox said.
The saline shortage started in mid-January, following a Baxter recall of four lots of saline and a dextrose injection due to particulate matter found in the solutions. FiercePharmaManufacturing reports the company also recently had to recall a tube-fed nutrition product for the same reason, and was issued a warning letter by the U.S. Food and Drug Administration (FDA) for plants in Jayuya, Puerto Rico, and Marion, N.C.
Meanwhile, Baxter continues to pay dividends to its shareholders. The FDA is working with other manufacturers, Hospira and Braun, to meet demand for saline and is bringing in saline supplies from Norway.