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What drug is currently in shortage? What is most likely to be the result of a drug shortage? Why are there drug shortages? What is health care rationing? Our guest is Julie R. Gralow, MD, chief medical officer and executive vice president of the American Society of Clinical Oncology. AMA Chief Experience Officer Todd Unger hosts.
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Speaker
- Julie R. Gralow, MD, chief medical officer and executive vice president, American Society of Clinical Oncology
Transcript
Unger: Hello and welcome to the AMA Update video and podcast. Today we're talking about drug shortages, specifically why they're happening, how to prevent them and what physicians can do to help their patients. Our guest today is Dr. Julie Gralow, who testified before Congress about this issue earlier this year. Dr. Gralow is the chief medical officer and executive vice president at the American Society of Clinical Oncology in Alexandria, Virginia.
I'm Todd Unger, AMA's chief experience officer in Chicago. Dr. Gralow, welcome.
Dr. Gralow: Thanks, Todd, and thanks for discussing this important topic.
Unger: Well, these days, it seems like every week we're seeing headlines about a drug that's in short supply. Dr. Gralow, have drug shortages actually become more common these last few years than they once were or not?
Dr. Gralow: Well, ASCO first started getting involved in drug shortages well over a decade and a half ago. So they've been going on for a long time. But in 2023, there were 125 drugs on the drug shortages list kept by the FDA and the American Society of Health Systems Pharmacists.
And this past year, 2023, 2024, in oncology, we had shortages of two drugs that were critical to treating many kinds of cancers that were the most severe shortages I've ever seen in terms of the length, the duration of the shortage, the depth of the shortage, just how little was available, and the number of patients impacted. We estimated almost half a million cancer patients were impacted.
Unger: Wow, and that is just cancer patients, so to speak. You mentioned 125 different drugs. Talk to us a little bit about which ones continue to be most impacted.
Dr. Gralow: The drugs at most risk are in a category that we call sterile injectables, and they're virtually always generic. They're off patent at the point that they become vulnerable. Many of these drugs cost about $5 a vial. The two chemo drugs—cisplatin, carboplatin—we had the severe shortages over the last year cost $15 a vial.
The profit margin is so low due to once the patent expires, there's this race to the bottom of other manufacturers coming in, undercutting, undercutting, and it causes manufacturers to leave the market. So it's really the generic, sterile injectables that are most vulnerable.
Unger: Now, I totally understand that scenario that you just painted there. Are there other underlying issues that cause this kind of shortage to keep happening?
Dr. Gralow: It's a combination of failures in our market. Also, quality issues, not so much quality in the final product, the drug, but in the manufacturing plant that's not kept up to date. And then there are supply chain problems. For sterile injectables, we have this emphasis on low prices above other considerations.
We have slim profit margins, and there was a facility in India that caused this whole recent cisplatin, carboplatin shortage. It was cited for quality issues. And then we found out what a downstream effect there was, how much of the cisplatin, carboplatin came in one way or another from the raw materials that were in India.
Unger: Well, given all these issues, it's probably safe to say that drug shortages are not going away any time soon. So what can physicians do to help their patients when they're affected by a shortage like this?
Dr. Gralow: It's so complicated. We jumped in at ASCO and provided a web page that had clinical and ethical guidance to help our members in making these decisions of what to substitute, who to choose to keep the drugs, and who needed to switch to something else. We also, the web page included information on the latest drug availability, such as when a lot from China was approved to come in, as well as all of our congressional activity.
And we've also involved our members in hundreds of meetings with lawmakers in DC to try to fix the problem, if you will, at least what we can fix from a legislative standpoint. So we're working with our members to keep the topic top of mind in Congress.
Unger: Gosh, I just can't imagine what it would be like to be on the patient end of this and have this kind of problem, especially when you need treatment. But I have to imagine that it also weighs really heavily on physicians, too. How does it feel to be a physician when you're in a situation like this?
Dr. Gralow: Well, it's horrible for patients and their families, and it's horrible for the whole health care team, the physicians, the nurses, everyone. That's why we actually issued some ethical guidance on how do you make decisions about what is actually rationing drugs and in some cases having to reserve these drugs where the intent would be curative instead of palliative.
So for some patients, these drugs offer the best chance of cure, and for others, going without them could mean poorer outcomes, reduced survival, increased side effects. And these drug shortages impact disproportionately rural areas and those with fewer socioeconomic resources. So it is tough. We heard from our members just these horrible decisions, impossible choices, if you will, that had to be made.
Unger: Well, obviously, this is a problem that's got to get addressed. From what you've told me, there are real changes to the supply chain that need to occur. What do you think the most immediate changes need to be made?
Dr. Gralow: Think in the shortest term, the immediate term, one, we need to develop a maintain a list of our real critical drugs, including those that have already been in shortage. One of the biggest predictors of a drug that goes into shortages that it's previously been in shortage and then drugs at risk of shortage. And we need to maintain this list so that we're paying attention.
And then the other thing we can do in the short term is we need better, clearer communication channels so that health systems can be notified immediately. I told you, we have over 100 drugs on our drug shortage list. Now, some of them, it's not going to be severe. They're on the list for reasons that are just because one manufacturer is shut down. For others, there's a real risk.
And so our current list of drug shortages doesn't tell you why the drugs are in shortage or how severe or what the problem is or how long we expect it to be. So clearer communication channels and then an eye kept on the critical drugs are two things we can do in the short term.
Unger: Well, Dr. Gralow, thank you so much for joining us today and spotlighting this very important issue. For the folks out there, if you found this discussion valuable, you can support more programming like it by becoming an AMA member at ama-assn.org/join.
That wraps up today's episode and we'll be back with another AMA Update. Be sure to subscribe for new episodes and find all our videos and podcasts at ama-assn.org/podcasts. Thanks for joining us today. Please take care.
Disclaimer: The viewpoints expressed in this video are those of the participants and/or do not necessarily reflect the views and policies of the AMA.
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