Transcript
Chris Nelson: Listeners, welcome to U Rising. I'm Chris Nelson, host of this episode and chief university relations officer.
Today I'm talking with Erin Fox about recent and ongoing prescription drug shortages, from antibiotics to chemotherapy and ADHD drugs. Erin is an adjunct professor of pharmacy and the associate chief pharmacy officer at University of Utah Health. She is the go-to expert for national media on this problem, and I'm excited to have Erin share her insights with us.
Welcome to U Rising, Erin.
Erin Fox: Thanks so much for having me.
Chris Nelson: So, let's get right into it. Currently, how many active drug shortages are you and your team monitoring right now?
Erin Fox: We are watching about just over 300 active and ongoing drug shortages. Some of those began even in 2012, but some of them began more recently.
Chris Nelson: Is this a new phenomenon or how long do drug shortages go back? Have they always existed? Are we just getting better at tracking them? What has changed, if anything?
Erin Fox: We've been tracking drug shortages here at University of Utah since 2001 nationally. Before that, we had a really good system of tracking locally, but that national tracking didn't really get started until 2001. FDA began a little bit earlier. They had a Y2K plan to monitor some drug shortages, and those team members from that Y2K plan formed FDA's drug shortage team.
Chris Nelson: What are some of the prescription drugs currently in short supply that listeners might be familiar with?
Erin Fox: You know, people might've heard of some chemotherapy shortages, basic chemotherapy like cisplatin or carboplatin. People might also think about lidocaine injection. So, this is something that if you go to the doctor's office because you need to get some stitches, if you have a quick mole removed, lidocaine is really used everywhere.
Erin Fox, an adjunct professor of pharmacy and associate chief pharmacy officer at University of Utah Health, oversees prescription drug shortage monitoring and is the go-to expert for national media on this problem.
Chris Nelson: And even saline has been in short supply at different points of time.
Erin Fox: It has and that sounds ridiculous, right? How can something that is just salt and water be short? But we've definitely had shortages of saline.
Chris Nelson: What's the criteria for declaring a shortage of any specific prescription drug? Is there a uniform shortage criteria or does it vary based on the drug?
Erin Fox: Yeah, that can get confusing because there are a couple of different definitions. So, the FDA uses a different definition than my team and I use for our national work. But, you know, we have really more of a patient-focused definition where if a drug isn't available and the pharmacy has to change the way that it's prepared or dispensed or a provider has to use an alternative or a patient just has to go without therapy, that's our definition of a shortage. And we verify those shortages directly with manufacturers. So, we're not talking about a really quick back order of two or three days. These are usually pretty long-term shortages.
Chris Nelson: So, this is a loaded question, but I'll ask it. What are the root causes of these drug shortages? And I know there's probably not a singular one, but how would you explain that to a lay audience?
Erin Fox: In most cases, we don't actually get to know the true reason for a shortage. Drug companies are not required to publicly disclose that information. They do disclose it the FDA, and that has been law since 2011. So, what we have are some aggregate data from FDA, and they tell us that in more than two-thirds of the cases of any shortage, it's a quality problem at the manufacturing facility.
Chris Nelson: Interesting. What are the roles of hospitals and pharmacies and supply chain? So is the root cause at the manufacturing level, is there ever a shortage based on just supply chain or certain hospitals keeping too much of something? Or is that . . .
Erin Fox: Sure. Hoarding comes into play. You know, everyone wants a tool to help them predict shortages. Why do they want that? So they can find out earlier and buy more. In some cases, we see an increased demand. We saw that at the start of COVID, when hospitals were starting to stockpile medications expecting a huge influx of patients. Sometimes hospitals just, you know, forget to order something, but that's pretty rare to have a long-term shortage just because someone forgets to push a button. It's usually some kind of more systemic problem within the entire supply chain.
Chris Nelson: So, you deal with this every day, but for somebody who, you know, occasionally goes to the doctor, they get a prescription, they just expect to go to the pharmacy. Can you take us behind the scenes, the role of the FDA and the role of the manufacturers. You know, FDA obviously approves, regulates the drugs and the manufacturers produce it, but what is happening behind the scenes that people who are just, you know, going to the pharmacy to pick up that medication just may not see or even know.
Erin Fox: There's a lot of steps. So, the FDA does regulate the drug companies and what they're allowed to manufacture, but from there, the FDA really doesn't have a lot of power over the drug companies. They can't force any company to make any critical drug, no matter how lifesaving it is.
So really the drug companies, we have a very free market system in the U.S., so the drug companies are manufacturing drugs, they're usually choosing the ones that are the most profitable for them to make, or ones that they have good experience in making. Those drugs are made, then they're usually shipped to a wholesaler, where a hospital buys small amounts, maybe every couple of days, maybe once a week, if it's a really small clinic, maybe only once a month. But that overall supply chain can get really fragile when a manufacturer has a glitch. A lot of times the manufacturer only makes just enough and they're only making it just in time.
So that means a manufacturer on any given day doesn't have, say, a six-month safety stock to make up the difference in case there's a glitch. They might have one month. But if they have a manufacturing problem that takes them eight months to solve, that's where we see those gaps. And these are very inexpensive, low-cost drugs. The drug companies aren't making any money on these drugs, and so they don't have that incentive to really make any extra. They almost have an incentive to make just enough and if there's a shortage, they don't lose any money, but patients pay the price. And that's what’s so frustrating about this issue.
Chris Nelson: So, it's interesting. So, the more the generic ones have the higher prevalence of the storages, whereas is it a patent on a drug? Is that what you . . .
Erin Fox: Yeah.
Chris Nelson: So, the companies who still have their patent are probably making plenty of that because they're still making a lot of revenue.
Erin Fox: Right. So, drugs that are still branded, brand name under patent, those companies have a lot of incentives to have a backup plan and to have that safety stock, maybe even have a couple locations where they make a product and to really invest in their manufacturing lines.
A generic supplier, often they're making 30 or 40 different drugs on a single manufacturing line. If anything happens to that manufacturing line, it affects a large number of products. And again, they're really not making a lot of profit on those drugs. So, the drugs that we generally see in short supply are hard to make, things that are injectable, that you have to keep sterile and particle free and that have been generic and around for a long time.
Chris Nelson: So, Erin, where are most prescription drugs made? Are they made overseas? Are they made in the United States? How does a drug become a drug? What's that manufacturing process look like?
Erin Fox: You know, manufacturing is very global, and so there certainly are drugs that are made overseas but a lot of the drugs that are in short supply right now are actually made in U.S. factories. It's kind of a misconception that all of these shortages are due to drugs being made overseas and if we had more factories in the U.S., it would resolve everything. Certainly, you could think of a geopolitical argument for onshoring more drug production, but would it help solve shortages? It would not.
Chris Nelson: And like you were saying, the drugs are manufactured but a lot of the raw materials are coming from different places.
Erin Fox: They are. Raw materials do come from mostly from India and China. We don't always know the exact amount. And again, that's another thing that drug companies are allowed to keep as a trade secret, where their raw material comes from and which companies making it.
Chris Nelson: Alright, so we give you all the power in the world, how do you solve this problem? How do you prevent these shortages?
Erin Fox: I would love to have a magic wand and give purchasers of drugs something else to rate a medication on besides just a pass-fail system that it's on the market or not on the market. What has happened with generic drugs is that FDA says that they're all equal. And so that's great, but unfortunately the FDA sees that there really are differences behind the scenes. When all drugs are equal, the only thing you have to compete on is price, and you get a race to the bottom on prices, and that's where you get people dropping out or taking shortcuts on their quality. And so, I would like to see a rating system, maybe a letter grade system, where perhaps payers only pay for, let's say, B+ grade and above. That would really incentivize the manufacturers to invest in their supply chains and purchasers, you know, I’m in charge of our $600 million drug budget. I would like us to spend that money on the highest quality products.
Chris Nelson: Sounds good. I'll have to find that magic wand for you.
Erin Fox: I would love that.
Chris Nelson: Take me into the life of a hospital pharmacist. Again, until I worked in health care and saw the amazing in-patient pharmacists, and this is not a knock in any way at local pharmacists, but I show up, the medicine's always there, but you're in a hospital, you're in a critical moment and that drug is short. What does that look like for those hospital-based pharmacists? What amazing efforts are they going behind the scenes that people probably just have zero idea or appreciation for?
Erin Fox: You know, one example that I like to talk about is what happens when crash cart medications are short? So, this is, like on TV, people are calling a Code Blue or, you know, crash. And you have a tray with a very set number of medications and they're in a set formulation. A lot of those have been short. We can usually get a substitute, but instead of it being a pre-filled syringe, it's a vial or maybe three vials. And in that emergency situation, you're so used to just grabbing that pre-filled vial and being able to hand it over to be administered to the patient. When you have to manipulate three or four vials to make a dose, yes, you can get the same dose, but you're in an emergency situation and it's not great. So, we do have pharmacists all over in clinical areas and that is frustrating. I will say that at University of Utah Health, we invest a lot of effort upfront so that people are aware when we do have a shortage. We try to provide some lead time so that it's not an immediate emergency.
Chris Nelson: Is it calling other hospitals? I mean, are pharmacists wheeling and dealing behind the scenes or is that not how that works?
Erin Fox: No, I mean you can try to do that a little bit, but really nobody is going to have enough stock on hand to really help make a difference.
Chris Nelson: Right. It is a universal shortage everywhere for the most part?
Erin Fox: Exactly. So sometimes what you can do is if your wholesaler is out, you can try to order it directly from the drug company and sometimes they will have some and they'll ship it to you. Unfortunately, that usually only works for larger health systems because drug companies are usually only set up to send maybe, like, a pallet instead of maybe 25 vials.
Chris Nelson: So, one of the things that is affecting drug shortages, and we just had a recent story about this in the news, cyberattacks on pharmacies. So, what is that, that seems like kind of a tangential threat to drug shortages as well. What was university's experience with that and how are things now?
Erin Fox: Yeah, this is a big problem to have kind of a switch that communicates between insurance companies and medical claims. It affected entire health systems, pharmacies especially because most people are used to paying a copay and that switch is the thing that tells the pharmacist how much that copay should be. We're back up and running. We were able to switch to a different company, but if you rely on a copay card, some of those haven't been able to switch over.
Chris Nelson: A little bit of sticker shock for some patients.
Erin Fox: A little bit of sticker shock, sure. Yeah, you know, people aren't used to seeing that their inhaler costs almost $600. The bright side of Covid was, and I think why I am more optimistic about shortages right now is because of there are more supply chain stories, like COVID, normalized the supply chain story. Before that, I would talk to reporters, but they only really wanted us to talk if they could dig up a patient that was harmed, right, or talk to a doctor who was mad about it. Now they'll just talk about it in general and that is such a switch, and I think it is moving the discussion forward.
Chris Nelson: Yeah, a dumb question, but I get the just in time as needed manufacturing process, is it partly because medications lose their efficacy? Or is that really not, I mean, can you store these things for a decade?
Erin Fox: Most of these injectable products that are in glass vials. They have a two- to three-year shelf life. But when you're making 30 different drugs on your manufacturing line, some of those are profitable and some are not profitable. And so you're turning them out and then you make a batch. And if you have to go back and make more of that batch, it's either going to impact another drug, plus there's cleaning time. So, yeah, again, there's no incentive to have extra since they don't make any money on it. But things like Humira, these branded products, there's never been a shortage of those products.
Chris Nelson: So, the University of Utah is known nationally as this place that tracks these drug shortages. You do media nationally almost every day. How did we get that reputation? Why is the University of Utah known for tracking drug shortages?
Erin Fox: So, there are two websites that people can go to get drug shortage information. One is FDA and one is the American Society of Health Systems Pharmacists and University of Utah has provided all of the data for that ASHP, American Society of Health System Pharmacists, website since 2001. Media hasn't always been my favorite thing to do. I can't say that it's still my favorite thing to do, especially TV. That's not my, I love a podcast. It's great.
Chris Nelson: I know. We just sit here and look at each other.
Erin Fox: So good! But, you know, I will say that early on I saw some stories about drug shortages where the facts were wrong and I knew they were wrong. And I actually went to our public relations folks and asked, can we ask for retraction? Can we do something? It's so frustrating that this reporter put this wrong information out there and people might think that's true. And it was great because our public relations folks, who I love dearly, looked at me and said, ‘You know what, Erin? We asked you if you wanted to talk to that reporter, and you said, no.’ And it's true. I wasn't comfortable talking to the media. And so, what I did was I thought, okay, I really care about getting the right information out there, and so I will invest in learning how to talk to the media, and that's what I've done.
Chris Nelson: Interesting. How big is the team that you oversee now that does the tracking of the drug shortages?
Erin Fox: You know, we have about four people that really spend most of their days on drug shortages.
Chris Nelson: Wow. So you kind of answered this, but I am curious, so you trained to be a pharmacist. How did you come to this job? What was your pathway to pharmacy? And did you always want to be a pharmacist?
Erin Fox: No, you know, I always liked science. So, I got a biology degree here from the U, graduated, I worked at ARUP in the laboratory. Didn't really like that. Wasn't seeing a path to grad school and Ph.D. in an area that I was super passionate about. A friend of mine was taking some early pharmacy classes and I went and took one with him, and I really liked it. I really liked how you're helping people, but it's also very science based. I love how you are always learning. There's always a new drug approved that you have to learn more about and I really enjoy that.
Chris Nelson: Where did you go to pharmacy school?
Erin Fox: I went here to the U, University of Utah. Three degrees from the U.
Chris Nelson: University of Utah, three degrees.
Erin Fox: Yeah.
Chris Nelson: Excellent. Alright, last question, and I'm curious if there's anything consumers can do, but what advice do you have for consumers?
Erin Fox: I would say don't panic. It's really easy to get scared, especially if you have cancer or a loved one with cancer. And you see news stories about cancer chemotherapy shortages. In most cases, patients are not going without the drug. There's a lot of effort that goes on behind the scenes to try to stretch doses, use alternatives that are just as effective. So don't panic.
And then if it's like a pill or a tablet, it's okay to shop around at a different pharmacy, but have that relationship with your pharmacist and ask them because they might be getting some in the next day. And so, if you move your prescription around too much, you kind of might get out of line. But my best advice is don't panic. In most cases, very few patients are actually going without shortages. It's usually just pain and suffering inside the pharmacy system.
Chris Nelson: Are you hopeful for the future? Are things getting better? Do we have more work to do? What's next?
Erin Fox: Last spring, I had the opportunity to testify for a senate committee. And I will say that this is the most congressional interest that I've seen in over 20 years of tracking national drug shortages. So, I'm a little bit hopeful, but at the same time, it's a really hard problem to solve that rating system that I talked about, FDA is not super in favor of that because they don't want people to think that there are differences between generic products. And so, I think until we can get at that rating system, we will still have direct shortages.
Chris Nelson: Erin, thank you for being my guest on U Rising.
Erin Fox: Thanks, Chris.
Chris Nelson: Listeners, that's it for today's episode. Our executive producer is Brooke Adams, and our technical producer is Robert Nelson. I'm your host Chris Nelson. Thanks for listening.