The Risks of Drug Shortages & Timeline for Resupply

Physicians expand upon the risk of drug shortages on patient safety and discuss the possible timeline for these events.

Troy Trygstad, PharmD, MBA, PhD: Do you all have these conversations in the back room, as drug-information supply specialists, that say, 'Boy, if people really had any idea.'

Richard Montgomery, RPh, MBA: What’s going on—yes.

Troy Trygstad, PharmD, MBA, PhD: How much at risk are we, going forward? We could do everything we possibly can with FTEs [full-time equivalents] within the systems, but at the end of the day, is there a real critical risk here?

Richard Montgomery, RPh, MBA: I think we’re safer now than we were 10 years ago because of the bar coding and the backdoor things that we’re working on to get things done. I’ve been a pharmacist for 33 years, and when we’ve been dealt with drug shortages, we had to switch a product, as Erin said earlier, so we just moved it; we brought in a vial. We moved it, and we replaced it with an amplifier. It might be a different conversation; we’d put a little sticker on it, which doesn’t happen anymore—well, hopefully it doesn’t happen anymore. So I think because of the heightened awareness of safety, we’re in better shape than we were years ago. Our patients are safer going forward.

Troy Trygstad, PharmD, MBA, PhD: Because of all the management.

Richard Montgomery, RPh, MBA: Because of all the management.

Troy Trygstad, PharmD, MBA, PhD: But the structural risk is still there. It sounds as if we’re spending more resources on managing the structural risk. It still seems like a critical issue, and from a patient perspective, if I go to my dentist and they say, 'Well, we don’t have Novocain today,' I’m probably going to go back outside and get in my car.

Richard Montgomery, RPh, MBA: Well, hopefully he will call you before you get there.

Troy Trygstad, PharmD, MBA, PhD: What are some examples? There are real patient effects that occur, right? Where it’s hard to flow all the way through to the patient, and there’s nothing that could be done. Do you have some examples of those?

Erin Fox, PharmD, BCPS, FASHP: Luckily, there are not very many instances in which we’ve actually had to deny patients care. Certainly in the news around the country, we know that some hospitals have had to stop offering epidurals for laboring women, just because of the bupivacaine [Marcaine] shortage.

Troy Trygstad, PharmD, MBA, PhD: That sounds serious to me.

Erin Fox, PharmD, BCPS, FASHP: It does sound serious. It’s those types of things that can really have an impact on patients. Of course, even with all the safety systems that we have, medication errors still can occur, and so I think those are certainly risks to think about.

Troy Trygstad, PharmD, MBA, PhD: How long do these shortages last? Are they fleeting? You were saying earlier that we might have a drug shortage on Monday—we planned for it—and all of a sudden it comes in on Wednesday. That can happen, but can you also have these sort of long, extended time frames?

Richard Montgomery, RPh, MBA: Yes, depending on whom you ask—some of the companies are more transparent than others. They will talk about how there’s a full recovery, during which we are shifting materials around. I can think of instances in which antibiotics and lidocaine come and go. Some things are projected right now in the current shortage to not be fully recovered until 2020.

Troy Trygstad, PharmD, MBA, PhD: What areas do you think are at most risk for shortages?

Erin Fox, PharmD, BCPS, FASHP: It’s really anything. Any medications that are generic and injectable— those are the highest risk.

Troy Trygstad, PharmD, MBA, PhD: Why are they particularly susceptible, do you think?

Erin Fox, PharmD, BCPS, FASHP: Well, they’re harder to make, so we don’t have as many factories making them. We don’t have a large capacity in the factories that are able to make those products. They’re generic, so they’re low cost. So there are not a lot of people who actually want to make those products.

Troy Trygstad, PharmD, MBA, PhD: There’s less room.

Erin Fox, PharmD, BCPS, FASHP: There’s much less wiggle room.

Troy Trygstad, PharmD, MBA, PhD: To put that extra line in place.

Erin Fox, PharmD, BCPS, FASHP: Absolutely.

Troy Trygstad, PharmD, MBA, PhD: Less room to have the extra quality control.

Erin Fox, PharmD, BCPS, FASHP: Yes. If you have an extra line, you’re probably going to try to make something more profitable than the lidocaine vials or morphine vials.

Troy Trygstad, PharmD, MBA, PhD: Right.

Erin Fox, PharmD, BCPS, FASHP: Certainly hospitals have tried to bargain down prices of generic injectables over the years. Now we’re at the point when some companies even talk about how they might be underwater with what it costs them to make a vial of something to sell to a hospital. They’re actually selling it for a lower cost now. They make up that cost by selling other products—but that’s why we don’t have as many players and additional capacity in this market right now.

Troy Trygstad, PharmD, MBA, PhD: Have you ever had an example when you said this is a critical supply, and there are substitutes for it, and you’re going to use those substitutes because you really want to make sure you’ve got 10 units of this or 50 units of that? Take penicillin, for example: We’ve got only this therapy that’s going to work for these folks, so we’re going to make sure that we’ve got that in stock.

Richard Montgomery, RPh, MBA: It’s probably more in your specific disease states. Oncology is one that comes to mind the most. We’re going to make sure we have these drugs. There are specialists who make sure that the kids have their drugs, sometimes at the expense of the adult having an alternative.

Troy Trygstad, PharmD, MBA, PhD: So populations in special-disease states.

Erin Fox, PharmD, BCPS, FASHP: Sure.

Richard Montgomery, RPh, MBA: Yes.

Troy Trygstad, PharmD, MBA, PhD: We’re certainly getting into precision medicine, pharmacogenomics, and gene therapy. That sounds like a bit more of a risk if I’ve got a smaller population and fewer manufacturers for a specific, hard-to-manufacture product.

Erin Fox, PharmD, BCPS, FASHP: I think the key difference, though, is with a very specific, special product that might be used on only a small number of patients, that there are very high profit margins.

Troy Trygstad, PharmD, MBA, PhD: So you’ve got room.

Erin Fox, PharmD, BCPS, FASHP: So there’s room to have redundancy in your supply chain. With generic injectables, there’s no incentive to have room for redundancy.

Troy Trygstad, PharmD, MBA, PhD: That’s a great point.

Erin Fox, PharmD, BCPS, FASHP: Or any backup plans. There’s no incentive at all.

Troy Trygstad, PharmD, MBA, PhD: As the resident health economist on the panel, I would say that the incremental cost of production is low compared with the price point, which is less of a problem because you’re going to have backups. You’ve got room in that margin. To your point, the generics are harder to manufacture, you’ve got less room for storage, and the cost of the next unit is closer to the price point—those are the products that are most at risk.

Erin Fox, PharmD, BCPS, FASHP: It also takes so much time to come to market if you think about it. If you wanted to build an injectables factory right now from scratch, it would take 2 to 3 years.

Troy Trygstad, PharmD, MBA, PhD: Lead time.

Erin Fox, PharmD, BCPS, FASHP: A huge amount of lead time. This is why there’s no flexibility and resiliency in our current supply chain, because other companies can’t easily make up the difference.

Richard Montgomery, RPh, MBA: And it’s not just building the building. Then you’ve got to validate all the processes within the building. There’s your engineering piece that comes into this, and your FDA comes in and wants to make sure you built a brand-new plant with shiny, new equipment—but you’ve got to make sure it works. You’ve got to make sure what’s coming off that line is sterile, and you’ve got to make sure that the public is safe. So you’re probably looking at 5 to 6 years before you can actually get a product out there.

Troy Trygstad, PharmD, MBA, PhD: I’m reminded of the saying that, despite all our frustrations with our legal system, it’s still the best system available. It sounds a little bit like we have a lot of frustrations. We can make some improvements, but at the end of the day, to your point, we’ve got safe products going out in the millions every day. We can do better, but we’ve got people on the front lines like yourselves working on this every day.

Richard Montgomery, RPh, MBA: My personal opinion is, I’d much rather have something never come out than have to be recalled, because recalls are horrible. You’ve got to track it down to the patient level, which is almost impossible. You’ve got to pull stuff back. You’ve got to sequester it and then just cross your fingers and hope that nobody got hurt.