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Trade disputes raise new fears around drug shortages

Jun 24, 2019

“Sometimes the panic sets in,” Lyn Lessard said. “It’s the worst part of my job.”

Lessard handles drug purchasing for Rochester Regional Health’s Unity Hospital in Greece, where drug shortages -- many caused by manufacturing and supply problems -- have become routine.

The website the University of Rochester Medical Center uses to buy drugs for its pharmacy shows many formulations are unavailable. "This drug in particular, our average daily use is 110 vials a day. That's pretty substantial when you look at the fact that we can get zero," said URMC drug shortage specialist Jen Shaw.

“It really is the new normal,” Lessard said. “You have to find something to help these patients. You can’t put this on the back burner. It’s got to be the first thing that you’re working on, all the time.”

Now, trade disputes threaten to further interrupt the supply, which is already stretched thin.

It’s not just Unity where drugs are in short supply. Jen Shaw faces the same problem at the University of Rochester Medical Center’s Strong Memorial Hospital. She’s the drug shortage specialist there.

“Every day we get a list from our wholesaler, and it tells us what didn’t come in that day. I’ll look, and I’ll start seeing, well, what can we do? How can we work with this?” Shaw said.

Shaw’s position didn’t exist until just a few years ago, when a surge in drug shortages threatened the hospital’s supply of important medications, said Curt Haas, the pharmacy director at URMC.

Now, he said, the job description is common. “Most hospitals our size have someone like Jen.”

Drug shortages ebb and flow, but they’ve been a fact of life for pharmacy workers across the country for more than a decade, according to local pharmacists and federal documents.

Lyn Lessard, purchasing supervisor at Unity Hospital in Greece, keeps tabs on drug shortages from a bank of computer monitors.
Credit Brett Dahlberg / WXXI News

“It is not uncommon for a shortage to occur,” the Food and Drug Administration says in an infographic about the issue.

National shortages have local impacts. Strong usually goes through about 110 vials of a drug called Ketorolac each day, Shaw said. It’s often used to control pain and swelling after surgery.

But right now, Shaw said, she can’t get any. “It went from thousands of vials available last week to nothing this week.”

Shaw said she heard from manufacturers that they expect to be able to sell her the drug again in mid-July. The URMC system should have enough stock to scrape by until then, she said.

In other cases, efforts to get access to a limited supply of certain drug formulations can get personal. “I definitely get after drug reps,” said Shaw. “I bust their chops.”

“Being a NICU hospital, we have a lot of premature babies here. Sometimes we play the baby card,” Shaw said.

A computer screen at Unity Hospital in Greece warns of a shortage in supplies. The manufacturer had been experiencing "delays in production."
Credit Brett Dahlberg / WXXI News

“Some of these babies are less than a pound. We just have to really stress the importance. These are our sickest, smallest patients. They can’t use an adult-size drug,” Shaw said. “It could kill them.”

In the pharmacy at Unity, Lessard said she, too, makes personal appeals to pharmaceutical companies. “I tell them, we really need this. It can be life-or-death,” she said.

The shortages can happen for a varied list of reasons. Shashi Patel, the clinical director at Unity’s pharmacy, said she tries to stay ahead of impending shortages.

“We are looking at manufacturing trends, at inspection results, at raw materials,” Patel said. “Believe me or not, we are looking at weather patterns, too.”

Damage from Hurricane Maria caused a sudden shortage in IV bags when the storm knocked out plants manufacturing them in Puerto Rico.

The FDA maintains a list of compounds that are in shortage. It’s down in length from close to 250 a few years ago, but there were still more than 100 on the list on Friday.

Placeholders show where a drug currently in shortage would be stored if it the University of Rochester Medical Center had it on hand. Haloperidol tablets are used in anti-psychotic treatments.
Credit BRETT DAHLBERG / WXXI News

Now, pharmacy leaders and industry experts say, the list threatens to grow again.

More than 80% of the active ingredients in prescription drugs sold in America are manufactured abroad, according to industry estimates. The majority of those are made in China.

And with the Trump administration demonstrating a willingness to enact trade barriers to achieve domestic and foreign policy goals, the risk of losing access to those ingredients has grown, said David Gaugh, senior vice president for sciences and regulatory affairs at the Association for Accessible Medicines.

“We monitor that very closely,” Gaugh said.

Gaugh’s organization, which advocates for greater availability of generic drugs in the United States, did not have a person working specifically on trade issues until February, he said.

“That’ll probably tell you something,” he said.

When the office of the U.S. Trade Representative came out last summer with a list of products that would be exempt from the first round of tariffs on Chinese imports, “pharmaceuticals were not on there,” said Jonathan Kimball, the person hired to address trade issues at the Association for Accessible Medicines.

“After engagement from us and other stakeholders,” pharmaceuticals were added to the exemptions list, Kimball said.

But it’s still a concern. Every round of trade discussions, he said, there’s a risk that pharmaceutical products will not be on the exemptions list.

The largest fear, though, is not that the U.S. federal government will levy new tariffs against pharmaceuticals. Gaugh said that would be antithetical to the Trump administration’s stated interest in lowering prescription drug costs.

The greater peril is that China would retaliate against tariffs on other goods by blocking pharmaceuticals from being exported to the United States.

The American Society of Health-System Pharmacists has started calling for legislation that would require federal agencies to assess the “national security threats” of relying on “foreign manufacturing of critical drugs.”

Haas at URMC  said the threat is growing, though he’s not sure relying on Chinese drug imports in the early stages of a trade war with China rises to the level of a national security risk.

“It is a bigger concern now,” he said. “Would they shut it off? Make it restrictive, subject it to tariffs? I don’t know.”

Haas and Jim Della Rocco, who directs the pharmacy at Unity, both said they have more pressing worries right now, as shortages that already exist present a greater risk to patients than potential future drug scarcities.

“Right now, it hasn’t hit in a dramatic fashion where people are running around with their heads cut off,” Della Rocco said.

Still, “We’re looking at it. We’re trying to plan for it,” he said. “It’s in the back of our minds. … Lyn’s watching it every day.”

If China were to cut off pharmaceutical exports to the United States, Haas said, “It would be catastrophic.”