Pharmacy Director at the Huntsman Cancer Institute, Makala Pace, talks about the nationwide drug shortage that could be potentially dangerous for cancer patients.
Interview conducted by Ivanhoe Broadcast News in 2023.
Let’s talk about this drug shortage with the wiki cancer drugs. Which drugs?
Pace: There’s actually many cancer drug shortages that are ongoing at any given time. The ones that are most currently actively a concern are surrounding the drugs named cisplatin and methotrexate. There’s also a shortage of flu Derobin as well.
What are those?
Pace: All three of the medications are used to treat a variety of different specific cancer types. So there’s not just one particular cancer that’s being impacted by the drug shortage.
Why is there a shortage?
Pace: For the cisplatin and methotrexate in particular. These are older medications are usually relatively inexpensive and there aren’t many manufacturers. And there was a manufacturer who makes about 50% of all the supply of cisplatin and methotrexate for the entire United States. And they failed a quality inspection that was held by the Food and Drug Administration. And because they failed that quality inspection, they had to shut down production of the cisplatin and the methotrexate. They haven’t yet fixed their problem and they aren’t yet manufacturing those drugs again, And so that has created the shortage.
When did that happened?
Pace: I don’t have the precise date that it happened. It happened within the last year, yes. So it’s a national shortage.
That’s crazy. So, it’s just up in the air, or no one knows when they’re going to be back in that? Is it like, just no one willing to start making it?
Pace: Usually not. So there’s a lot of ambiguity about when the shortage will be resolved. Fortunately, our teams are very well positioned to manage drug shortages. This is something that we’ve been doing actually for decades. So drug shortages are not new, they are ongoing. Oftentimes the shortage will resolve for a period of time and then it becomes a shortage again sometimes for the same reason it was on shortage previously. Sometimes a new reason. Because of the ambiguity about when the product will be available we’re very judicious and managing the drug inventory that we have on hand, but making sure that every patient gets split dose that they need.
How do you ensure it doesn’t affect your patients?
Pace: So, one thing that we do is we have lots of communication that happens with the provider teams and with our inventory management teams. So collectively here at Huntsman and in conjunction with University of Utah Health, there’s over 150 pharmacy staff members that work on making sure that patients get the right drugs at the right time. Part of those groups are inventory management and pharmacy procurement and purchasing services. They will do their best to identify wholesalers and distributors so they can purchase drugs through. And those wholesalers and distributors are trying to manage requests coming all throughout the country. And so that’s one thing that they’re doing and the clinical side of things what we’ll do is we’ll communicate with providers who want to prescribe these medications and make sure that they’re aware of how much inventory we have on hand, how many patients we actively have scheduled to receive those medications, anticipations of when those inventory supplies will decrease and what we may need to do to mitigate providing as much product to as many patients as possible. Or providing an alternative therapy if that’s an option for the particular cancer and diagnosis that the patient has.
Can you talk about how a drug shortage doesn’t mean it’s completely gone?
Pace: If you think shortage, that means it’s not available ever anywhere and that’s not necessarily the case. Usually a shortage means that it’s unavailable in the quantities that we’re used to obtaining it. And the drugs often come in a variety of dosage forms, stroke dosage strengths and from different suppliers. And so maybe the shortages that we just don’t have it from all the manufacturers at the same time, or there’s only one strength that’s available instead of multiple strengths available. So it may just mean that we don’t have as a ready access to it, but there is some available somewhere. It’s just a matter of managing and mitigating, getting enough for our patient population.
So when there is a shortage like this, does the price go up?
Pace: I don’t know. It’s beyond detail that I’m able to understand. But it is something that can become a concern, of course, we do live in a free trade market where supply and demand can cause prices to go up. But it is something that is one of those things that we can try to help control, at least through legislation and those types of things. So it’s a bipartisan issue. And trying to make sure that Congress and House representatives and senators understand that they can help influence this process by putting better laws in place to mitigate how we manage shortages and what manufacturers have an obligation to and not to do when it comes to controlling drug prices.
So you guys easily get your step. It looks more like warehouses where the drug stored. Is that right?
Pace: So drugs are manufactured by a manufacturer and then the manufacturer will commonly distribute them to a wholesaler. And the wholesaler will have different warehouses or storage facilities. And then we as healthcare systems have contracts with those wholesale distributors, then provide us access to those medications. And if the medication is accessible from the wholesaler, then we can purchase it and then the wholesaler distributes it to us. And then we store it until we receive orders that are appropriate. And then we prepare and then dispense the product for the patients. So it’s very, very long stream of supply chain control. When it comes to manufacturing, storage, distribution and dispensing.
What does the FDA do about this?
Pace: So the FDA is under obligation to make sure that drugs are manufactured under safe and quality manufacturing processes. They can’t mandate the different manufacturers make specific drugs. That is something that’s up to the manufacturers. So their job is to make sure that the products that are produced by the manufacturers are quality products. In this particular instance with methotrexate and cisplatin when they did an inspection about large facility that was responsible for producing 50% of all the supply of that product. They found that they weren’t meeting quality measures and so they had to halt production of those products because quality wasn’t being done, which could potentially put the patient’s at risk for receiving those products.
I was reading that they also look for, maybe other countries.
Pace: Yes. So that’s something that the FDA has been doing. Cisplatin has actually been approved to come in from, I believe from China. The challenge with that is that it has packaging that’s all in Chinese. And so the FDA is stepping up and is doing what they can to translate that labeling into English so that we can understand what is in that product. That it is really the cisplatin that we believe it is to be in. So the FDA has recently said that we can use imported product for cisplatin in particular. They’re working on identifying something potentially for methotrexate, but that hasn’t happened yet.
So are there fears that if this one manufacturer doesn’t start making it? Or it’ll just run out?
Pace: There is always that concern is always present, but usually there are other manufacturers that do make it. For now we’ve been able to mitigate the shortage with cisplatin and methotrexate because there are other manufacturers that have continued to produce and make the supply. One challenge is that they haven’t been able to totally ramp up and I guess match the production of the previous facilities. So while they’re not taking on more of that production, they have been able to maintain some production, so we are able to continue to receive some supply. The challenge has come in that everybody wants same supply. And so a lot of the manufacturers and the distributors have started developing allocation processes. And so we work very closely with them. So for example, just this week with cisplatin, we were asked to. Can you look ahead for the next couple of weeks and tell us how much cisplatin you need. You tell us how many patients, how much you need. And then we’ll look at what our allocation suppliers and determine if we can meet your needs. And so I’m in the process right now of working with our clinical teams to look ahead to see who’s plan to receive cisplatin over the next few weeks to make sure that all of those patients that we’ve identified can get drug.
It sounds like whenever there’s a drug shortage, you really don’t let it affect the patients, right?
Pace: No, we do everything we can so that the patient is not impacted as much as possible. First and foremost, the patients come first here at Huntsman and at University of Utah Health, we want them to get the right medication at the right time. Fortunately, in some situations there are alternatives that are available. Cancer is dynamic, There’s lots of different opportunities for some cancers to use different alternative therapies and then other mitigation strategies such as switching to an alternative dose or perhaps maybe saying specific regimen may say you get this every three weeks. Is it safe and considered effective if maybe we go every four weeks instead? Those are conversations that we would engage with our providers and the prescribers to say, Hey, our supply might be getting a little tight. Here’s the options we want to provide it to everybody. Here’s a patient that we might think could we could do something different? Do you agree or disagree? And so it’s really a joint conversation amongst our pharmacy group and our clinicians.
Is there anything like that patients can do or they need to do or if they’re worried about it, what should they do?
Pace: So we always encourage patients to advocate for themselves. So if they have questions, they can ask direct questions of the providers and ask them specifically, I hear my medication was on shortage. Am I going to be able to get it? So they can ask direct questions that’s always encouraged. They can also find the information in the public domain and in the public space. So there is a website that is considered the quintessential website for drug shortage management. It’s managed through ASHP, which is the American Society of Health System Pharmacists. It’s a public website, public domain, and actually our Drug Information and Support Service Group here at University of Utah Health manages that webpage. So we are considered experts and drug shortage management. And they can look on that webpage and it provides information on maybe why the shortage is happening if that information has been shared and potential release dates of new products and those types of things. And then the last thing that patients can do is that they can make sure that legislation in Congress is aware of their concerns. And so Utahns can go to Utah.gov and identify who their specific state and local and regional representatives are and ask them to advocate for appropriate shortage. Measures be placed at the federal and at the state level so that drug manufacturers have inappropriate obligation to meet patient needs.
Is there anything else that you want to add that I didn’t ask?
Pace: I think just the reassurance that we know cancer patients have a lot on their minds. The last thing that they should need to worry about is can they get the medication that they need. If they have a cancer diagnosis that requires a drug on shortage, we’re going to do everything we can to get that medication to them. And balancing that with availability of stock, potential alternative options, making sure that every patient gets the best care possible. Is there anything you would like to say?
END OF INTERVIEW
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