番茄社区

Shortages of iohexol and iodixanol intravenous contrast media products have been reported after a GE Healthcare production facility in Shanghai experienced an unexpected, temporary shutdown last month during a COVID-19-related lockdown in the city. Though the preeminent supplier is back up and running, it to right the resulting shortage.

Accordingly, hospitals across the U.S. are on high alert, with many enacting conservation plans that involve difficult decisions about which patients to prioritize.

IV contrast allows radiologists to better read imaging tests like x-rays and CT scans, but it's also used in procedures like heart catheterizations, and by doctors providing emergency care, such as for heart attack or stroke.

"COVID has surprised us every time we thought we had it nearly conquered," Nancy Foster, vice president of quality and patient safety policy at the American Hospital Association (AHA), told 番茄社区. "This is just one more surprise in the batch, and it's a troubling one because it is so important for some of these emergency cases."

Those patients need to be diagnosed rapidly in order to preserve function, she said. "It's really critical."

Unfortunately, "most of the hospitals and health systems with whom I've spoken to are now at a point of rationing contrast media," she noted.

Clinical leadership teams are meeting to discuss which patients and studies should be prioritized, Foster said, as well as which patients could receive alternative imaging that would give the clinician as much information as they would need to make a diagnosis.

Hospitals are also looking at strategies in which they can use the tools they have to "ensure that every drop of contrast media is effectively used," she added, including repackaging single-use packaging under sterile conditions in the pharmacy to preserve quality and cleanliness, packaging a smaller allotment, and combining extra doses to create an additional one.

"For some patients, they are making the hard choice that they are going to have to delay their scans until the supply gets better," Foster said. "Those are hard, hard conversations to have with patients."

At a time when hospital leaders had hoped to resume more normal operations, and when health experts have continued to warn against an increase in sicker patients as a result of non-COVID care that's been put off during the pandemic, the thought of delaying testing is especially alarming.

"There is a little bit of hardship for the hospital, but what we really care about is the hardship for our patients," Foster said.

At the University of Alabama at Birmingham (UAB), leaders worked quickly to to help address the shortage.

Laura Kowalczyk, JD, MPH, vice president of supply chain management at UAB Medicine, told 番茄社区 that supply has been cut by 80%, noting that she has communicated the situation as dire to clinical teams.

Though hospitals and health systems have experienced shortages of different supplies throughout the pandemic, the difference with the current shortage is the severe constriction in the supply chain due to such a large supplier having their manufacturing go down, she said. "It takes a long time to ramp it back up."

As the shortage continues, clinicians are making sure that the most serious patients are prioritized.

"The first thing we look at is patient acuity level, and the second thing we look at is whether there are reasonable alternatives," Kierstin Kennedy, MD, interim chief medical officer for UAB Hospital, told 番茄社区.

Radiologists at UAB have also been working to determine the minimum amount of contrast needed in certain instances, so as not to waste any, she said.

"From a clinical standpoint, as a physician, I have not experienced anything like this," Kennedy noted. "In some ways, we cannot catch a break. We just got through the PPE shortage."

Overall, many hospitals and health systems that are reliant on GE Healthcare have been affected, Foster said. On top of this, as some GE customers have reached out to a limited number of smaller manufacturers, their supplies have also been strained as a result.

Foster said that she has personally heard most frequently from hospitals or health systems that traditionally see a high number of patients in need of emergency care, or those that serve as the primary cardiac or stroke center in their community.

The AHA first became aware of the shortage towards the end of last month, when members that are GE Healthcare customers received a letter that stated that their orders would not be able to be completely filled.

"We're talking about a major part of the market having been stymied by the shutdown of the plants in China," Foster explained.

In the meantime, GE Healthcare has expanded production capacity at its Cork, Ireland manufacturing plant. In Shanghai, capacity is expected to increase to 50% by May 13, with continued improvements over the coming days and weeks.

"Our priority is delivering for our customers and their patients, and we are working around the clock to expand capacity of our iodinated contrast media products," a spokesperson for GE Healthcare told 番茄社区 in an email. "After having to close our Shanghai manufacturing facility for several weeks due to local COVID policies, we have been able to reopen and are utilizing our other global plants wherever we can. We are working to return to full capacity as soon as local authorities allow."

In an April 19 letter reviewed by 番茄社区, GE Healthcare addressed the situation with its customers, stating that it was working to optimize production around a fewer number of product units, and that it was temporarily rationing orders of iohexol. It further noted that it had invested more than $240 million over the past 5 years to increase its global manufacturing capabilities, and that it would continue to invest in that area.

Having a better understanding of where major corporations are sourcing raw materials or important ingredients "is a conversation we've had with several of the federal agencies, as we're thinking through how you would bolster the supply chain to make it more robust and durable during times of emergency and high use," Foster said.

"This will be another item on that list," she added. "There are apparently only a couple of places in the world where contrast media are manufactured. If one of those places goes down ... then it's hard to believe that the others could make up for that."

The AHA has also been reaching out to insurers, in part because it wants to make sure payers are "keenly aware" of the impact of the shortage on provider decision making. In terms of prior authorizations, insurers look to make sure the right study is being done, "which is a good thing normally," Foster noted. "But if they're going to make sure, they too have to understand the challenging conditions in which we're working."

For instance, an MRI in place of a CT scan with contrast might be a good alternative in certain situations. "It's not that we're trying to upgrade the test, [we're trying] to get the right diagnosis at the right time," she said.

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