Drug shortages trigger health care worries, rationing

SALT LAKE CITY — Few, if any, patients who check into the University of Utah's Huntsman Cancer Institute for surgery or chemotherapy will give a moment's thought to whether its medicine cabinet is stocked.

But a worsening national shortage of therapeutic drugs has its pharmacy director, Scott Silverstein, anticipating the day he has to interrupt a patient's therapy to say: "We can't deliver on a drug. We can't treat you."

Providers across the United States are already having those conversations as drugs of choice ranging from cancer treatments to surgical sedatives run low or run out, forcing providers to turn to less-preferred medicines.

In some cases, patients have died for lack of the right drug.

The university's Drug Information Service (UUDIS) monitors and verifies shortages of drugs nationwide, reporting them to the American Society of Health-System Pharmacists. The society publishes this content online, helping to inform the U.S. Food and Drug Administration in decisions such as whether to allow imports.

The information has helped the university's hospitals and clinics prepare for acute shortages either by rationing drugs, using alternatives or finding other sources.

UUDIS is setting the standard for how providers can cope with a public-health problem, fueled, in part, by the recession's toll on drugmakers' profits.

"I didn't use to have to think about whether a drug would be available," Silverstein said. "Now it's getting to the point where it's what keeps you up at night."

The numbers are unprecedented, said Erin Fox, manager of UUDIS, which has been tracking drug shortages for a decade.

Fox recorded 211 drug shortages in 2010. That's up from 166 in 2009 and 70 in 2006.

"It's like disaster management daily,"said Fox, who has seen no signs of it leveling off. "We're on pace with last year. Pretty much every day, we get a new shortage."

Many of the drugs in dwindling supply are staples used every day: antibiotics, chemotherapy agents, morphine for pain relief, propofol for sedation, heparin to prevent strokes and epinephrine used in emergencies for heart attacks and allergic reactions.

About 54 percent of the shortages in 2010 were due to product quality problems, said Valerie Jensen, the FDA's associate director of drug shortages. Two of the largest manufacturers of sterile injectables, such as propofol, had product recalls last year after the FDA found particulates in the syringes.

Another 21 percent of the shortages stem from production delays, while 11 percent are caused when firms discontinue a product, usually for business reasons, Jensen said. The rest stem from increased demand, raw material shortages and manufacturing sites' consolidation or closure.

The FDA can't force a drugmaker to ramp up production. And companies don't have to warn the agency of impending shortages unless there are no known alternatives on the market.

But a summit convened in November by the American Society of Health System Pharmacists brought providers together with regulators and drugmakers to forge solutions.

"The big thing that came out of that meeting was the need for more transparency and communication," said Michael Cohen, director of the Institute for Safe Medicine Practices (ISMP) in Horsham, Penn. "It sounds so simple. But there are times when one manufacturer closes a line, when another can pick up the slack."

The FDA has a role, too, Cohen said. With the recession, generic drugmakers grew rapidly, but they faced limits on where they could purchase raw materials, much of which came from overseas. This caused the FDA to crack down on quality, "and rightfully so," Cohen said. "But maybe with no real understanding of the consequences."

Providers shoulder most of the burden, he said. "The amount of time that's being taken away from patient care is phenomenal."

In an ISMP survey last summer of 1,800 health care workers, one of four said shortages led to medication errors that could have harmed patients. One in five said patients were hurt.

Doctors in some parts of the country reported having to ration cancer and other niche treatments for which there are no substitutes, deciding whether to start a new patient on a therapy or hold off to preserve the drug for someone who had already started a cycle.

"We had a few deaths with opioids," Cohen said. Lacking morphine, hospitals had to switch to the more potent Hydromorphone, which, when given at morphine-level doses, led to overdoses.

"Hospitals need a good program in place for rapidly educating staff on how to administer atypical pharmaceuticals," Cohen said. "They need secondary purchasing sources lined up, and they need a system for notifying everyone, from administrators to physicians and nurses, of impending shortages."

Contact Kirsten Stewart at kstewart@sltrib.com.