Dan Gorenstein: The U.S. is caught in a critical shortage of a drug doctors need for some of their most vulnerable patients. 

The drug known as ‘contrast media’ helps doctors diagnose a heart attack or stroke. It is used for cancer and trauma cases.

U.S. clinicians perform some 50 million scans using contrast media each year. 

The injectable liquid helps physicians see blood vessels and blockages…helping them plan surgeries, determine a patient’s cancer stage or find a source of bleeding. 

But right now, about 50% of hospitals nationwide are rationing the drug. 

That’s because there’s a manufacturing problem halfway across the globe in China. 

Drug shortages aren’t new.  

Contrast media is just one of the latest examples of vulnerability our medical supply chain has seen over the last two decades. 

Today, providing care without contrast media, and what changes are needed for the US to finally address its chronic problem with the medical supply chain.

From the studio at the Leonard Davis Institute at the University of Pennsylvania, I’m Dan Gorenstein. This is Tradeoffs.

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DG: Kierstin Kennedy compares contrast media to bandaids. 

Kierstin Kennedy: We use them everywhere, you know, like we use them all the time. And we’ve never had a shortage. 

DG: Back in April, Kierstin – the chief medical officer for the University of Alabama at Birmingham Hospital  – was surprised as she read other doctors’ posts about failing to get enough contrast media. 

KK: And I’m looking at all the responses and I was like, Wow, that’s really terrible. You know, I’m thinking like, that has nothing to do with us. We’re doing great.

DG: UAB buys contrast media from GE Healthcare. 

The company announced this spring it was limiting orders after a COVID-19 lockdown temporarily shut down production at one of the company’s facilities in Shanghai. 

A colleague warned Kierstin UAB needed a game plan, quick.

Kierstin called together hospital leaders from cardiology, neurosurgery, radiology and the emergency department. 

Kierstin’s first task was figuring out who was using the drug and how much each day.  

 KK: First thing we’ve got to do is we’ve got to figure out our utilization. And then we’ve got to compare that to what GE is telling us they’re going to send us, and that’s going to help us figure out how much we can continue to use on a daily basis.

DG: Kiersten says – initially – she took the news in stride. 

By now she and her colleagues have adapted to working with less. 

KK: We’ve been through COVID, right? Like, I am used to really terrible situations. Right? And so it’s just like, you know, this I’ve got this thing in my wall in my office that says, ‘you’ve just got to take it one effin are you kidding me? at a time’ But that is the approach, right? It’s just another fire that we need to put out. 

DG: More than 90% of the country’s total supply of contrast media comes from just two companies: GE and Bracco Imaging. 

And most hospital systems contract with one or the other, rarely both. 

Kierstin says GE told the hospital it would receive 20% of its normal shipment until production ramped back up.

The first shipment of the week never showed. The second had only a few bottles. 

KK: That was the the holy crap moment for me, you know, we’ve asked people to reduce how much they’re using, but maybe we didn’t ask them to reduce it enough because at this rate we’re only going to get a couple of bottles a week, we’re not going to make it to June 30th.

DG: That’s when Kierstin realized she needed to adjust their strategy…so doctors would have this critical tool when a crisis hit. 

KK: And the scariest thing is the patient that comes in, you know, having a stroke potentially.

DG: UAB’s comprehensive stroke center draws people from parts of Florida, Georgia, Mississippi, and Tennessee.

Kierstin says every minute counts when it comes to diagnosing and treating a stroke patient before they can lose basic functions like talking and walking. 

KK: We know that if we do this in a timely fashion, we could save, you know, brain tissue and function and keep them from being neurologically devastated. But we may not be able to do it because we don’t have contrast.

DG: Simply, the injectable dye is a go-to when the clock is ticking. 

It can pinpoint for doctors where someone is bleeding internally after a gunshot or car accident…it can show them a blockage when someone is having a heart attack.

DG: UAB, like the hundreds of other facilities hit by the GE shortage, has rescheduled elective surgeries, postponed image tests and conserved enough contrast to get two uses out of one vial.

One other essential step…. limiting the use of the drug in departments that usually don’t use it for urgent cases. 

The staff in Birmingham have managed to cut use 90%…enough they think to stretch their supply through December. 

But making sure they have enough for their urgent cases…has downside for some other patients. 

KK: We do more studies than we typically would have or the time from the patient presenting to us, getting the diagnosis and starting the treatment is longer than it usually would be. And that to me is not ideal and it’s not what we want for our patients.

DG: The extra tests can delay treatment, and potentially cost patients more money.

KK: There’s obviously potential harm with delaying the imaging. there’s always the possibility that we could have gotten one wrong. You know, we could have thought that this was something that could wait. And later we’re going to get a scan and we might find out that maybe this wasn’t one that should have waited…I hope that that doesn’t happen, but that is a potential risk that we know we’re taking and that represents harm to the patient because of this shortage. 

DG: Supply chain leaders at Kierstin’s hospital have struck out trying to purchase contrast media from other vendors. 

The market is tight…that manufacturers make just enough to fill their typical orders just compounds the problem.  

And Kierstin has learned something. 

KK: As a physician,  I’ve never thought to ask where our supplies come from or where they’re made. And even in this case, if someone told me, oh, we’re getting this from G.E., well, that’s that’s an American company, right? Like, I’m not thinking Shanghai,  when you say the company GE, you know, and so it was very eye opening for me. 

DG: If a basic drug like contrast media – something as ubiquitous as band aids – could fall victim to a shortage, then the country’s supply chain was way more fragile than Kierstin had ever imagined. 

KK: You know, even when we’re ordering from a company that is right here in the US, we have to know where they are getting their supplies from because that, you know, that still has downstream impacts on us. Those are things that I would have never, never thought about, never cared about before this.

DG: Over the last 20 years, more than 3,000 drugs have been in short supply in the US.

When we come back, we’ll find out why the US has experienced shortages for decades, and what’s being done about it.  

***MIDROLL***

DG: Welcome back. 

News montage: Six months into the coronavirus pandemic there is still vital gear that is in short supply…The shortages continue…Medical facilities and supply stores are just not getting enough equipment…N95 masks, gloves, gowns…a struggle to find ventilators…the wheelchairs, walkers for patients…And there’s a shortage of personal protective equipment for health care workers.

DG: Medical supply shortages have been making headlines for the past two years. 

Contrast media, a drug physicians use to test patients for strokes, heart attacks and cancer, is just the latest shortage – this one due to a covid-related shutdown at a GE plant in China. 

But, really, the US has faced shortages like this for more than two decades. And we’ve made almost no progress. 

In 2001, there were 120 drugs in short supply. In 2021, there were 114.  

Erin Fox is Senior Pharmacy Director at the University of Utah Health. 

Erin Fox: I think it does come down to really, we do not have a resilient supply chain at all.

DG: Erin has dedicated the last twenty years to finding solutions for drug shortages. There is rarely a lull in her work.  

We spoke with Erin about what makes the country so vulnerable to medical supply gaps…

 Erin, in 2009, after the H1N1 surge, it took a needle and syringe manufacturer 18 months to resume normal production levels. 

In 2017, the country faced a critical shortage of saline after Hurricane Maria devastated a plant in Puerto Rico. The list goes on and on.

What’s up with all the drug and medical supply shortages?

EF: We rely on just in time manufacturing where companies only make just enough medication. There’s no reserve on hand. Companies don’t always invest in the quality of their manufacturing. And so when they need to close to fix a problem or even just clean for a couple of weeks, you can sometimes see drug shortages that way, just because of that lack of resiliency.

DG: So, I get it, there’s an upside to just-in-time manufacturing: companies know exactly how much they need to make, they can cut  waste and improve their bottom line. But I’m betting the downside to ‘just in time’ is that it leaves hospitals and doctors vulnerable to any sort of disruption?

EF: It doesn’t account for any changes in clinical practice where people might need extra, doesn’t account for other companies having supply chain problems and needing to sell a few more units. And then when we have a pandemic or a disaster or hurricane on top of that, it just exacerbates the overall supply chain and the poor resiliency that we have.

DG: Erin, you’ve been tracking these kinds of shortages for more than 20 years. What kind of system do we have to predict and prepare for when drugs, especially ones that providers rely on every day, will be scarce?

EF: I don’t think we have a system, Dan. We have companies that are supposed to tell the FDA when they’re going to have a supply problem. But then, of course, we have everyday shortages.

DG: And as we’re trying to get our arms around the root of this problem…the FDA says 62% of drug shortages are because of quality problems.  Erin, what does  “poor quality ” mean?

EF: So a quality problem could mean there are metal shavings in a vial and the product can’t be used. Usually a quality problem is something related to the actual product itself. There could be a potency issue or a contamination issue, and so production has to stop and that product can’t be used.

DG: So you’re saying – overall – the issue is that the FDA has an information problem… essentially not enough insight into production disruptions…like when metal shavings show up in drug vials.

Over the last decade, Congress has taken a few swings at strengthening our medical supply chain.

In 2012, lawmakers required drug makers to give the FDA a heads up if they anticipated a shortage…and in 2019 Congress made it easier for hospitals to get what they needed during public health emergencies.

But as we’ve been talking about, those policies have fallen short, to say the least. Why? 

EF:  None of the policies have really targeted those quality problems at the manufacturing level. And so there’s no law that any drug company has to make any product, no matter how life saving it is. And none of these policies can force a drug company to improve their quality or to make something that we really need.

DG: Alright, the next stop on our historical tour of medical supply chain legislation comes in 2020 when Congress passes the pandemic response legislation known as the CARES Act.

What did the CARES ACT do?

EF: So the CARES Act with regard to shortages, companies, in addition to telling the FDA they’re going to have a shortage, they’re also supposed to tell the FDA how long they expect it to last. So kind of that expected duration, that’s really important for planning ahead and trying to prevent shortages. The CARES Act also gives the FDA the authority to ask those companies to make a backup plan, to have some kind of business continuity plan, so that they can keep making drugs.

DG: Despite real progress – in the form of more information – the information is really just trickling in…and we’re still seeing shortages like with contrast media.

And now we’ve got President Biden trying to address this problem. 

He’s called for supply chain reviews and strategy development. He created a Task Force, and the White House hosted a national forum.

Does any of this matter?

EF: So it has definitely been a flurry of activity. And what I see is that those activities are helping to identify the gaps that still need to be closed. And quite a bit of that is around transparency, really understanding which products are most vulnerable. I don’t think we know that yet. Part of that is, is due to some of that lack of transparency in the supply chain.

DG: Alright, so Biden is poking around. But even that is tough because of this lack of basic information about how and where our drugs are made. 

EF:  You know, drug companies are not forbidden from sharing that information. They’re just choosing not to. Drug companies are allowed to say, what is a proprietary trade secret or not. The FDA is not allowed to share proprietary secrets. So if a company says this is our trade secret for how we make this drug, the FDA cannot reveal that without a change to the law. 

DG: Yes, if the FDA had more information on how manufacturers operate and where they are, we could better anticipate production disruptions for other drugs made in Shanghai, for example.

Erin, you were part of a really prestigious team assembled by the National Academies of Sciences, Engineering, and Medicine to recommend how to improve the U.S. medical supply chain. Which of the seven recommendations you issued  should be implemented immediately?

EF: At the end of the day, we really need to know what we’re buying and really target our money, our scarce resources towards the highest quality products we have…Right now when we buy medications at our health system and this occurs at health systems all over the country, the only information you have is price…We know that the FDA sees very clear differences in the manufacturing sites and between manufacturers, but those aren’t communicated to buyers…It’s either on the market or off the market. 

DG: So if buyers–hospitals, doctors and pharmacists– could see the quality rating system the FDA sees, how would that work?

EF: So if I’m going to buy a drug and I have two choices, one is a B plus and one is a C minus. The C minus is probably going to be cheaper and the B plus will cost more. So if I’m going to spend more money on this drug, then I want to make sure that I choose the one that has a higher quality. I’m going to spend a little bit more and not have a recall on that product and hopefully not have a shortage related to a quality related issue.

DG: If i’m following you, you’re saying it’s less likely a B plus drug–a drug with a higher quality rating– would suffer from a shortage?

EF:  From a quality related shortage. If we’re just going off of quality ratings, I mean, We can’t 100% eliminate shortages because things will happen. Hurricanes happen, disasters happen, unforeseen things happen. But if a company has a backup plan, maybe has six months of safety stock to give themselves a runway to get through a shortage. All of those things could contribute to a higher quality score and decrease the number of quality related shortages that we have.

DG: So the thinking is if hospitals and doctors were motivated to buy drugs with higher quality ratings, drug and device makers would be incentivized to improve their quality. 

On average, we are seeing about 100 new drug shortages each year. If we had a public quality rating system AND required companies to disclose information about where their products were made, what kind of impact would that have??

EF: I would think that we would get at least a 30-to-50% decrease in the total number of shortages.

DG: Asking companies to share trade secrets seems like it would be a hard sell to business leaders.

Could we see a decrease in drug shortages, if we had a public quality rating system for drug manufacturers, and not the companies’ proprietary information ?

EF: Well, that’s hard because we need both. We have a rating system that’s not public. It exists. We need Congress to say that that can be public. But we also need Congress to force the companies to tell us just a little bit more about their products. We should know just as much about our drug products as at least we know about our food.

DG: And until that changes, we’re going to continue to see shortages.

EF: We will.

DG: Erin, thanks for taking the time to talk to us about it.

EF: Thank you.

DG: I’m Dan Gorenstein, this is Tradeoffs.