Shortage Effects on Clinical Trials and Future Hopes

Physicians briefly discuss the effect of drug shortages on clinical trials and consider the future of medical supply management.

Troy Trygstad, PharmD, MBA, PhD: Have you ever had a circumstance—you come from a research institution—have either of you had a circumstance where you were engaged in a clinical trial and a drug shortage affected a clinical trial?

Erin Fox, PharmD, BCPS, FASHP: Absolutely. And that is 1 of our planning pieces when we’re making a plan for our organization: Are any of our clinical trials going to be impacted by this specific product? In some cases.

Troy Trygstad, PharmD, MBA, PhD: Because they’re ongoing and it could disrupt them.

Erin Fox, PharmD, BCPS, FASHP: Right, and in some cases, they need a specific NDC [national drug code], and so in some cases, if we can get the same product but a separate NDC, we’ll try to preserve the clinical trial from being impacted. But the manager of our investigational drug service is on our daily huddles about shortages because it’s that important.

Troy Trygstad, PharmD, MBA, PhD: So I’m imagining the great Carnac the Magnificent from Johnny Carson’s The Tonight Show. What sort of activities do you engage in? Do you Magic 8 Ball what’s coming next? What sort of data and tools do you use to figure out what might be coming? Is it sentinels, weather balloons? What does it look like?

Richard Montgomery, RPh, MBA: I talk to the wholesalers about this all the time because it drives me nuts because a shortage will come out, and we’ve got to go to drug B or drug C or drug D, and they’ll come out and go, 'What’s your anticipated usage?' It’s like, 'Guys, you know what, we were buying of this. We’re going to buy this much of it or this much or whatever. You guys figure it out, but we need it, and I don’t have the time or the resources to pull all that data in and make a calculation and put it on a nice spreadsheet and tie it up with a bow and send it.' So I think that’s part of the stuff that drives me nuts is the wholesaler piece. Sometimes they go, 'Well, no, it’s not us, it’s the vendor,' and sometimes we get into just-in-time inventory with them, as well. That’s 1 of the things that keep me up at night.

Erin Fox, PharmD, BCPS, FASHP: Sure, yeah. I call those fake shortages. We have enough shortages.

Troy Trygstad, PharmD, MBA, PhD: Fake shortages.

Erin Fox, PharmD, BCPS, FASHP: Yes, yes, fake shortages.

Troy Trygstad, PharmD, MBA, PhD: That made news.

Erin Fox, PharmD, BCPS, FASHP: It did, right? We have enough shortages right now to manage without a fake shortage because our wholesaler or somebody didn’t do their job and purchase a product that actually is available. We’re managing many, many shortages over here. We don’t need these fake shortages. So sometimes that’s increasing our pars.

Troy Trygstad, PharmD, MBA, PhD: What are pars? This is not golf.

Erin Fox, PharmD, BCPS, FASHP: Sure—how much you normally would keep in stock.

Troy Trygstad, PharmD, MBA, PhD: Ah, OK.

Richard Montgomery, RPh, MBA: Your maximum, the maximum level.

Erin Fox, PharmD, BCPS, FASHP: Minis and maxes, like when you would reorder something.

Troy Trygstad, PharmD, MBA, PhD: Your calipers.

Erin Fox, PharmD, BCPS, FASHP: Yeah. So you might need to increase that, and we have many, many discussions with our wholesalers about what is your par for this. You need to keep a week’s worth on hand.

Troy Trygstad, PharmD, MBA, PhD: But it sounds to me like what you’re describing is that not only do you need this forecasting and anticipation of what might be coming—reading the tea leaves, if you will—keeping abreast of what’s going on in manufacturing, but also that…it has to be a community of folks that behaves ethically as well in some ways, right? So you can’t have one system-hoarding. What’s that community of good behavior look like, or do you have some bad actors from time to time?

Richard Montgomery, RPh, MBA: Yeah. We have bad actors within our own system. They will go out and grab stuff up.

Troy Trygstad, PharmD, MBA, PhD: I’m reminded of when there was the Relenza shortage…and when you’d have physicians pull it off the shelf for their own personal use. Does stuff like that go on pretty frequently?

Erin Fox, PharmD, BCPS, FASHP: I mean, it can happen. People are human, and the first thing that people do when they see something that’s short is that they try to get as much of it as they can. And to Rich’s point, that’s not always the best.

Troy Trygstad, PharmD, MBA, PhD: It’s a natural human reaction, right?

Erin Fox, PharmD, BCPS, FASHP: It’s natural, but then you might be stuck with a product that you can’t even use in your system. We’ve certainly seen examples of that even in our own organization where someone buys up some hydromorphone, but it’s a really weird concentration, and now we have to figure out a plan for how to use that up. It happens, but…I’m an optimist, and I think most people do want to do a good job and do want to do the best for their patients.

Troy Trygstad, PharmD, MBA, PhD: Within your community of pharmacist leads, are there folks, actors in and around that exacerbate problems?

Richard Montgomery, RPh, MBA: Yeah, and we know who they are, and we’ll get to them first. One of the other important things is communication. Executive, hospitals will compete, but pharmacies are small. We know each other. We work with each other. We go to conferences together, and we talk. So, when we get the doctor that comes in or the nurse practitioner that says, well, I got it at hospital X. They have it down the street—why don’t you guys have it? Well, you know what, they don’t have it, because we talked to them this morning. That’s how we kind of keep everybody together. I think it’s keeping open lines of communication and being honest.

Troy Trygstad, PharmD, MBA, PhD: So you’ve got a community of folks with the honest rule of communicating with each other in the marketplace as purchasers. That sounds to me that it might be at risk of a teacher’s lounge effect from time to time. Do you sort of gripe and you get to the bar at a conference and go, “Hey, this is happening or this person or this manufacturer,” because it sounds to me, again, it’s a bit of a social circle for all of you in this unique space.

Erin Fox, PharmD, BCPS, FASHP: Yeah, I think it is odd. Sometimes when shortages are mentioned in a conference or anything and if I’m in the room, people will point to me, and I didn’t create the shortages, but I think they know how focused I am on that problem. I think it is, like anything, we talk about our challenges and drug shortages are a really frustrating challenge, and so we do talk about it.

Richard Montgomery, RPh, MBA: And clinical pearls: “Hey, what are you guys doing?” I know people. I can pick up the phone in other organizations and say, 'Hey, this shortage is coming. What are you guys doing or what have you seen? What are you hearing?' Because some people have straight lines to vendors that I may not have access to. So I think it’s the sharing part and the open communication. We’re all in it together. We’re here to take care of our patients, and that’s what we try to do.

Troy Trygstad, PharmD, MBA, PhD: So, Erin, you get a phone call from the administration tomorrow. They say, 'We want you to move to DC. We’re starting a new position in the suburbs out at the FDA, and it’s the FDA czar for drug shortages, and you can do whatever you want.' What would you do?

Erin Fox, PharmD, BCPS, FASHP: I said I would help them on a consultative basis, but FDA can’t fix this problem. This is industry’s problem to fix. FDA can help. I do help FDA and other government agencies when called upon. I fly to DC very regularly to help out with those meetings. But, on the whole, this is not FDA’s problem to fix. So I will say, 'I will help you consultatively, but you don’t need me there in DC at FDA.'

Troy Trygstad, PharmD, MBA, PhD: Is there a need for an organization? So USP [United States Pharmacopeia] is private, correct? There are a lot of private entities that figure out how to self-regulate markets or help stabilize markets. Any possibilities there?

Richard Montgomery, RPh, MBA: They’re publicly traded companies. Some are family owned. Unfortunately, it’s capitalism where they need to make a dollar, but they need to make a safe product. And sometimes those 2 don’t intersect. So, yeah…I think it needs to come from within, and the industry needs to step up. And some people need to take the lead on the industry side and say, “Hey, this is bad. This can’t keep happening.”

Erin Fox, PharmD, BCPS, FASHP: And I do think I’m very encouraged. So FDA’s current drug shortage task force that they’ve recently formed actually includes many other government agencies. Folks like CMS are there at the table along with FDA, and so right now we actually have, in many places in pharmacy, regulations contradicting each other. And so we’ve had the opportunity to have those discussions. Results from that task force won’t be available until the end of 2019, but I think it’s good that FDA and Commissioner Scott Gottlieb have gotten a larger table of folks to think about this problem.

Troy Trygstad, PharmD, MBA, PhD: Well, I want to thank a great panel that we’ve had today. Thanks for joining us on Pharmacy Times® Peer Exchange yet again, and we’ll see you next time.