What’s Causing the Unusually High Number of Drug Shortages in the U.S. Transcript

All year long, drug shortages have disrupted hospitals and pharmacies. Medications for ADHD, chemotherapy, and diabetes, among others, have constantly been in low supply. And now, RSV treatments for infants are the latest to be affected. Ali Rogin tells us what’s driving the shortages and what could be done about it.

If you’ve recently struggled to get a prescription filled or buy certain over-the-counter medicines, you’re not alone. By late spring this year, there were 309 ongoing drug shortages in the US, the highest in nearly a decade. Experts blame supply chain gaps, manufacturing delays, and spikes in demand for the shortages, but what does that mean for doctors, parents, and patients who are caught in the middle? Michael Ganio is a Senior Director at the American Society of Health-System Pharmacists. Thank you so much for joining us. Michael, drug shortages are not that uncommon, but to have so many at one time is. What are some of the factors contributing to the situation?

Well, there are several reasons for drug shortages. What we’ve seen recently are some demand spikes, as you noted. There are weight loss medications used for diabetes. There’s unprecedented demand for those. Attention deficit and hyperactivity disorder medications, commonly known as Adderall or Ritalin, those have been in short supply because of high demand.

(01:18)
The other side of that is manufacturing delays. And sometimes it’s a disruption due to quality. It’s not a problem with the quality of the product, but it’s a process issue that has held up production. And if anyone has heard of the ongoing oncology drug shortages, things we use to treat cancers, chemotherapy drugs, those have been caused because of some of these quality issues prohibiting release of the products. So really, there are a lot of different causes, and we’ve even seen geopolitical threats to the supply chain. And of course, during COVID-19, we had supply chain disruptions across the board.

I want to talk more about the cancer drug shortage that you mentioned. How are hospitals, how are doctors dealing with that?

Yeah, these shortages are really challenging, mostly because it’s not easy to just switch between drugs. Usually, when we’re out of a drug, we have to switch regimens completely, and that means that there’s different outcomes that can be associated with those regimens. They may not be as effective. They may have different or worse side effects. And so really, there’s a decision that has to be made when deciding who gets that treatment. Is there a curative intent, is there a chance that we’ll cure that cancer, or are we doing something to try to prolong their overall survival? That may play into which patients get the drug and which ones don’t.

Let’s talk now about the antibody treatment that was approved for RSV. There are shortages there, too. How is that affecting patients?

Well, this one’s also an unusual one. This is an increase in demand causing the shortage, and actually, to say increase is a little bit of a misnomer because it’s a new drug. There’s really no precedent set as far as demand. So the manufacturer tried to project how much of the medication would be used, and it’s obvious that they did not project enough to manufacture enough to treat all of the patients that they planned to treat.

(03:05)
There are actually several things at play. You may just look at birthing numbers and wonder, well, looking at these statistics, why didn’t they forecast enough? But they had to order a lot of this drug ahead of time to know how much to make. The other variable is the fact that there is a vaccine available, and if the mother receives a vaccine within a certain timeframe, the child does not need this monoclonal antibody. So what we will hopefully see is, as the season goes on, more mothers receive that vaccine and then the infant is born protected already and will not need this antibody, but for right now, there’s a really high demand for that drug.

Now, we know there are several federal agencies involved in dealing with these shortages. The FDA has a role to play, HHS, even the Department of Defense. How can those different agencies work together to put a stop to this?

Well, they already have worked together a little bit. Back in 2018 and into 2019, several agencies worked together to develop a report on the root causes of drug shortages. Two of the root causes that are really interesting that we’re focused on are the economics of the drug shortage problem. We’re talking about a lot of older, generic sterile injectable drugs. These are difficult to manufacture because of the sterility, but they also have very slim profit margins. So there’s really not a lot of economic interest in getting into this market or expanding a portfolio into this market.

(04:25)
The other side of that is quality. When we’re purchasing the drugs, we don’t really have any insight into that quality. With our FDA system of pass/fail approval, we have to assume everything is equal. So we really have no other piece of information to base purchasing on, other than the price. That leads to a race to the bottom in pricing and it incentivizes hospitals and other providers to buy the cheapest product.

And I know that that’s something that you at the American Society of Health-System Pharmacists has been pushing to get implemented, something that would allow you to factor in quality, not just low prices. Tell me more about that, and what other solutions, on a policy level, do you think need to be implemented to avoid future drug shortages like this?

The key is providing purchasers with more information about the products we’re buying, how much investment in the resiliency of the supply chain. Are they using multiple sources for the active pharmaceutical ingredient? Do they have redundancies built into their systems? And if they do, then the market should reward that and maybe that marginal increase in price is something that providers will pay. We do know that drug shortages cost the United States healthcare system quite a bit of money. There was a survey in 2019 that estimated about 360 million healthcare dollars in the US are spent every year, just in labor costs. So the marginal increase on the price of a generic injectable is something that buyers may invest in if they know that it’s going to help resolve these shortages.

Michael Ganio with the American Society of Health-System Pharmacists, thank you so much for your time.

Thank you for having me.