Erin R. Fox, PharmD, MHA, BCPS, spoke with the Journal of Clinical Pathways about steps health care stakeholders can take to mitigate the impact of drug shortages. She participated as a panelist in a session titled “Promising Practices to Reduce the Impact of Drug Shortages on Cancer Care” at the 2024 National Comprehensive Cancer Network annual conference.

Transcript:

Erin Fox, PharmD: Hi, my name is Erin Fox. I am a clinical pharmacist. I'm the associate chief pharmacy officer of shared services at University of Utah Health.

What are some effective strategies to enhance communication and collaboration among health care stakeholders, such as pharmacies, wholesalers, and regulatory agencies, to address and navigate drug shortages efficiently?

Dr Fox: That's such a great question because communication and understanding which supplies you can get and when you can get them is so important to making a clinical plan for patients.

One of the things that my team and I do is we provide a lot of content on which drugs are short, which specific NDC numbers, so the specific size or strength formulation of a product. We put all of that up on a public website. It's the ASHP website, ASHP.org.

And we try to help communicate that availability to anyone who's looking for shortage information. So I think FDA also has a drug shortage website. Our site is a little bit different in that we can provide information about alternatives and also safety issues focused for clinicians on how they can really mitigate the potential harm to their patients. But I would say, you know, communication is the most important thing and I think it's the thing that's usually the most lacking in a shortage situation.

Usually you'd have no early morning system, you don't know a shortage is coming. Once you do find out about a shortage, it can be hard to find out when you will be able to get product again and how much product you'll be able to get. I think those are things that wholesalers can work on. Pharmacies can also work on that. Pharmacies sometimes hoard product. They play some very large number of orders in the hope that they might get some, but sometimes they actually get all of them.

And, you know, there may be health systems out there with one- or two-years supply on hand just because all of their back orders came in on time. So I think wholesalers can really help by making sure that health systems can get enough allocation so that they're not trying to hoard, but at the same time, not letting health systems buy, say, one or two years’ worth at the same time.

What proactive steps can these stakeholders take to mitigate the impact of drug shortages on patient treatment plans and ensure continuity of care?

Dr Fox: I think the best thing you can do is to try to work on a plan ahead of time before you have a shortage. So understand who is going to be communicating about shortages, who is going to be updating information, and how you're going to make decisions if you do have to go into that unfortunate case of rationing care.

So I think if you can decide on all of those roles, who's playing which role ahead of time, things will go much smoother when you do have a shortage. It's almost like treating it like emergency planning, where you would practice for an emergency to happen. Drug shortage is kind of like an emergency as well.

And so you would wanna practice those roles ahead of time if you can, at a minimum have some guidance or policies in place, just to help people feel a little bit more comfortable and also prevent rework. People may be very stressed out, kind of in panic mode, and you don't want multiple people all working on the same tasks at once.

So really, everyone understanding their role in the shortage process can be really helpful in having a good outcome for your patients and your organization.

Given the financial implications of drug shortages on both patients and health care facilities, what recommendations do you have to optimize resource allocation and minimize the economic burden while maintaining high-quality cancer care delivery?

Dr Fox: So unfortunately, a lot of the expense with drug shortages is all of the extra work that's required to manage those shortages. Whether that's, you know, people working late on the phone with manufacturers trying to get supplies, moving stock around. Sometimes you do have to use a more expensive product.

And so again, I think it's having that plan in place of understanding when you might need to get a new reauthorization, talking with the insurance companies to make sure that they understand that there's a shortage and that they might need to approve a different product or a brand name product in some cases.

All of those things can go aways to try to mitigate the overall financial impact of shortages. I will say though, most of the shortages are a very low cost drugs. We rarely have shortages of very expensive brand name products, and so again a lot of that expense comes from labor costs of trying to spend extra time ordering product or getting back orders in.

What role do you see technology and data analytics playing in anticipating and managing potential shortages of chemotherapy and other essential cancer therapies?

Dr Fox: You know, hopefully data analytics can improve so that wholesalers have a better understanding of what an organization's true need is and that can help them set better allocations.

You know, right now in some cases a wholesaler, if you can't buy a product for three months, you have had zero purchase history to them. And so your allocation might go to zero as well. And so there's a lot of improvements that can be made as far as data analytics around shortages that way. I think we could also get more visibility about where products are along the supply chain, which health systems might have more product, which wholesalers might have more product, which companies have product available, all of that could certainly be improved with better data analytics.

In light of the unpredictability of drug shortages, can you share insights into establishing contingency plans and alternative treatment options to ensure patients receive timely and appropriate care even during periods of supply disruption?

Dr Fox: So I think it's important to have a good understanding of all of your patients and what their regimens are, you know, where patients are along their treatment journey. That will help you understand if you maybe need to start a patient on a regimen that could provide the same effect but may not contain those shortage products. I think it's really important also to understand if you are going to allocate product, you know, again, being very clear if certain patients are going to get one product that they kind of stick with that and that you move patients to an alternative regimen, trying to do that not in the middle of their course. So again, mapping out the total doses that your patients are going to need on those shortage products. And yeah, I think that's the best potential solution there.

And that's also a really great segue into the data analytics. How can better data analytics help, certainly for a clinician's office or an organization's office. Those better data analytics can help them understand which patients are on which regimens and how much product they actually need to finish those courses. So all of those things combined can help.

And again, having that plan in place ahead of time, understanding who is doing which role can also be really helpful in mitigating potential patient harm.

Is there anything else you'd like to add, any final thoughts?

Dr Fox: You know, I think drug shortages can be very scary for patients. It's hard enough to have cancer, but then on top of it, it's very hard to be worried if your treatment is available or not. And so I think, you know, cancer centers should have a community communication plan for patients, understand that patients will have these questions, especially if shortages are in the news, and be willing to provide them with information to calm their fears, or just understand about what's going to happen, especially if they're being switched to a different regimen, talk to them about why the switch is happening and if you feel like their outcome will be the same.