COMMENTARY

'Frustration and Disbelief' Over Drug Shortages

Robert Glatter, MD; Paul Biddinger, MD

Disclosures

January 03, 2020

This transcript has been edited for clarity.

Robert D. Glatter, MD: Drug shortages have the potential to adversely affect health outcomes by leading to delays in treatment regimens or alternative drug therapies. According to a US Food and Drug Administration (FDA) report released in October, a staggering 163 drugs made this list. One of the key shortages involves heparin. Other recently identified medications in critical supply include epinephrine; morphine; and intravenous fluids, such as normal saline.

Here to discuss the critical issues underlying current drug shortages, likely causes, and possible solutions is Dr Paul Biddinger, associate professor of emergency medicine at Massachusetts General Hospital (MGH) and chief of the Division of Emergency Preparedness and director of the MGH Center for Disaster Medicine. Welcome back, Dr Biddinger.

Paul Biddinger, MD: Thank you so much.

Glatter: To begin, I want to get your take on the recent shortages that you've been facing at your hospital, specifically the types of medications and what you're doing at MGH to address this critical issue.

Biddinger: We've been facing some significant drug shortages at MGH, and I would say that the two most notable are intravenous heparin and intravenous immunoglobulin (IVIG). Both have been substantial enough that we had to activate our hospital's emergency operations plan.

Part of the challenge for these two drugs in particular is that their uses and indications span a large number of specialties and services (including nephrology, dialysis, cardiac surgery, cardiology, interventional radiology, and others). When drugs are so important and in such short supply, we try to make sure that we serve patients equitably in the most medically sound fashion we can. This requires us to bring together a huge number of experts and really marshal a lot of resources to respond effectively.

Glatter: In your meetings with other clinicians and departments, how are they reacting to this in terms of patient care? The patients are affected. What are we doing to make amends? How do we substitute other therapies?

Biddinger: I think the universal reaction is frustration and disbelief that in 2019, the idea that these core medications that we rely on to save lives can be in shortage—it just doesn't make sense. One of my colleagues here at the hospital said this is a little bit like McDonald's running out of ketchup. You just can't believe it's happening.

Our providers are (and as you want them to be) advocates for their patients. Recognizing that we can't do business as usual, we've tried a number of strategies. First, we identify opportunities to eliminate waste. When a patient would come up to the cath lab from the emergency department (ED), there would be a bag of heparin spiked and ready to go even though the patient was already on heparin from the ED. We can make some gains eliminating waste, and that's good for everybody.

Much of what we've had to do, unfortunately, involves substitution or adaptation strategies. We identify alternative therapies that are equivalently safe, but we have to use medications that are either less familiar to clinicians or much more expensive. In certain circumstances—and this is more relevant to IVIG, where the clinical indications are less strong—we unfortunately have to prioritize and cannot offer the medicine to some patients who used to receive it.

Glatter: Do you think this affects healthcare outcomes in terms of complications or length of stay indirectly?

Biddinger: Yes. It absolutely affects the cost of healthcare—there's no question about that—both in terms of person-hours (for clinical staff, purchasing staff, pharmacy employees, and others) and the higher cost of these alternative drugs. We're monitoring clinical outcomes extremely carefully in our health safety reporting system, and we are trying to track overall outcomes.

So far, I'm pleased to say we have not noticed any decrement in safety or outcomes, but it's a worry when you have clinicians using drugs they're less familiar with and in different kinds of formulations. That's always a challenge. We are trying to combat that with our experts, and we've come up with many additional tools, just-in-time training, and online resources.

Glatter: Do you advise your clinicians to quickly report these shortages when they occur? For those on the front lines, is that something you've made clear?

Biddinger: We try to find the shortage before the clinicians notice it. Among our purchasing department, our materials manager, and our pharmacy leadership, they often see it, but it's not in the typical sources that you might see. The FDA has a website that lists drug shortages, but we often see drugs going on shortage or back-order allocation long before they are listed on the FDA website.

Glatter: In your opinion, what are the root causes of these shortages? The FDA certainly came up with their list. Do you agree with this, or do you have any changes?

Biddinger: I think it's a couple of things. The authors of the FDA report tried really hard to dig into the drug shortage situation. Economically, as they pointed out, not only is there a lack of incentive for multiple manufacturers to be in these low-profit-margin drugs, but also we have moved to an economy of just-in-time inventory, where no one has a warehouse of anything. As we use a product, it's being manufactured on the other side for economic gain.

For such drugs as heparin, and other drugs that have been in shortage that are essential (including atropine and bicarbonate), there are no stockpiles. There is no margin of safety. Any little hiccup in the system related to plant manufacturing or shortage of a raw ingredient, or any other perturbation in the system means that, at the end of the day, we can't give the medication to patients. That's what I think is unacceptable.

We have to build more safety into the system. We would never accept a car that is absolutely maxed out at a speed of 40 miles per hour, because there are times you have to just go a little faster. We have to ask the same of our pharmaceutical manufacturing and distribution system.

Glatter: The United States is dependent on other countries, such as China, to manufacture heparin. How do we bridge that issue, which is certainly a discussion in and of itself?

Biddinger: Absolutely. Obviously, it's a global economy and things come from all over the planet for our different manufacturing processes. Just as we look at our technology and other critical infrastructure sectors from a security lens, we should really be doing the same with some of our basic manufacturing.

And again, it's not to say that everything should be manufactured domestically—I don't think that's possible for us to do. We really have to look at critical vulnerability and identify adaptation strategies so that we can respond more effectively when we see hiccups, as we did with the swine flu epidemic in China, which raised concerns about an interruption to the heparin supply.

Glatter: Have there been any thoughts about going back to using cow lungs or sheep intestines for heparin? Obviously, mad cow disease in the 1990s made that a safety issue.

Biddinger: Exactly. For a long time, as you know, it wasn't permitted. Recently, the FDA has said that they will expedite any manufacturer's applications to start making heparin from a cow source, but as far as I'm aware, no one has actually submitted an application.

Glatter: Are you aware of any shortages on the horizon that haven't been identified yet by the FDA?

Biddinger: Drug shortages seem to come out of nowhere, and we're actually a little bit gun-shy at this point, because something that seemed fine yesterday becomes a problem today. I think there are other shortages out there. Again, I think the entire medical supply chain is stretched as tightly as it can possibly be stretched.

We have heard some concerns about sterilization of certain medical equipment, and ethylene oxide plant closures. So that's not exactly a drug shortage, but it is very much a medical supply issue that we're waiting to see how it will evolve in the coming weeks and months.

Unfortunately, on the basis of all the factors we've seen recently, we know there will be more drug shortages, which means we're going to have more crises for which we're going to have to adapt.

Glatter: Obviously, these shortages affect all types of physicians and healthcare providers because we are talking about oncology patients, patients with sepsis, and patients undergoing heart surgery. The ramifications are so broad that this discussion has to include everyone.

Biddinger: Absolutely. And IVIG was probably one of the strongest examples of that. The indications for IVIG span allergy, immunology, hematology, oncology, transplant, and many other clinical uses. Some of these uses are clearly lifesaving, for which there is no alternative therapy, and some may be a little less strong and not lifesaving, but very much allow people to effectively live how they wish.

This puts us in a terrible position of having to save medication for someone who needs it in a lifesaving indication, but we are unable to offer it to someone whose life is going to be very adversely affected when we can't give the medicine.

Glatter: Exactly—like life-threatening situations, such as anaphylaxis when we have an epinephrine shortage, which is obviously a situation that no one would ever want to experience. Clearly, this is an ongoing problem.

Biddinger: And 10 or 20 years ago, if you turned to either one of us and said, "Hey, can you imagine a time when the US healthcare system won't have epinephrine," it would have been laughable. But sadly, no one is laughing right now.

Glatter: Many of the shortages involve older drugs with low profit margins. In a nutshell, how do we incentivize companies to make these critical medications? It seems like that's really what this comes down to.

Biddinger: I think there will have to be a combination of incentives and requirements. Back to approaching this from a health security lens, certain medications that are absolutely essential for lifesaving medical treatment have to have certain manufacturing distribution requirements where there is a margin of safety. We would need a 20% buffer that gets us through a plant closure or a supply chain issue.

I think there's no way around it. And yes, that is going to have an effect on healthcare costs, but the alternative is that we can't save lives—and that really is untenable. In an era where sometimes we can afford drugs that cost $50,000-$100,000 a dose, if we're going to raise the cost of epinephrine by $0.02 or $0.03 to get that safety margin, that really seems well worth it to me.

Glatter: To wrap up, did you have any take-home points for our viewers?

Biddinger: I think there are a couple things. When hospitals and healthcare providers face these kinds of shortages, they really should approach it as a system. They need to treat the shortages like the emergencies they are and make sure to work across the institution with their colleagues so that they make the best use of a limited supply that they can.

The other is political. The vast majority of Americans don't know that this is a real issue and don't know how thinly the supply chain is stretched. Working with legislators to come up with solutions and to make sure this is a public issue is really important for us to make a meaningful change.

Glatter: Great. I really appreciate your time. This is such a critical issue for all of us. Thanks again.

Robert D. Glatter, MD, is an attending physician at Lenox Hill Hospital in New York City and assistant professor of emergency medicine at Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. Glatter is an editorial advisor and hosts the Hot Topics in EM series on Medscape. He is also a medical contributor for Forbes.

Paul Biddinger, MD, is an associate professor of emergency medicine at the Harvard Medical School. He is also a director at the Center for Disaster Medicine and vice chairman of the department of emergency medicine at Massachusetts General Hospital in Boston, Massachusetts.

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