Generic/Brand Drug Shortages & Medical Professional Impact

Troy Trygstad, PharmD, MBA, PhD, et al, consider the impact drug shortages have on generic versus brand drugs, and the preventive role of the FDA and frontline workers.

Troy Trygstad, PharmD, MBA, PhD: You’d think, in a natural marketplace, you’d have stuff that’s patented from a single source, which would be a risk. You would think, conventionally, that…the generic market space would have multiple players. But actually, it’s been a bit of the opposite. You’re describing, when we get into gene therapies, enzymes, and specific medication for a specific population, an international supply chain. We’re getting very specific patient populations. What does the frontier of work look like 10 years from now?

Richard Montgomery, RPh, MBA: Hopefully I’ll be retired by then. It’s going to be a whole new world. You’re going to have your basic medication, and I don’t think they’re going anywhere. For the specific disease states, things are going to become very precise now that gene therapies are advancing. I’m not going to take any part antidepressants. There’s definitely going to be a lot of play in this area.

Troy Trygstad, PharmD, MBA, PhD: What’s the role of the FDA in all of this?

Erin Fox, PharmD, BCPS, FASHP: The FDA does a great job of regulating our drugs to make sure that they’re safe, but it can’t force manufacturers to make products, no matter how lifesaving they are. There’s not a lot it can do once the shortage begins. It can prevent shortages if drug companies tell it ahead of time, when it can actually make a difference. Then it can prevent shortages. We don’t actually find out about those. I wish we had more transparency into what happened and which shortages were prevented. They do prevent quite a few. Overall, on any given day, the FDA can’t actually make the manufacturers do their jobs and make high-quality products.

Troy Trygstad, PharmD, MBA, PhD: What is the literal role? Approvals?

Erin Fox, PharmD, BCPS, FASHP: Sure. It’s also regulation and inspections.

Troy Trygstad, PharmD, MBA, PhD: What else?

Erin Fox, PharmD, BCPS, FASHP: Those are really the primary roles in making sure that our drug supply is safe. The FDA is going to inspect the raw material suppliers, and if there’s a change and it’s contaminated, it is going to provide a citation. Sometimes that leads to a shortage, but it’s better than having unsafe product.

Troy Trygstad, PharmD, MBA, PhD: The role is safety, not abundance.

Erin Fox, PharmD, BCPS, FASHP: Sure. The FDA can’t actually control abundance.

Troy Trygstad, PharmD, MBA, PhD: That makes sense. Erin, you’re at the University of Utah. Just like most health systems, there’s a diversity of workforce. Give us some thoughts about what it’s like for those frontline workers dealing with a shortage. What is the practical impact on their practice?

Erin Fox, PharmD, BCPS, FASHP: That’s a great question. For our prescribers, they’re not really as impacted as many of our other team members. Sometimes they do have to use an alternative. Sometimes they have to be willing to use a different concentration or a different volume. Our nurses are definitely impacted. Some days they might see a syringe; some days they might see a vial. It’s very difficult to keep them apprised from all the changes that are needed to provide the same product to our patients. I would say our pharmacists are the ones who take the brunt of the workload of managing shortages.

Troy Trygstad, PharmD, MBA, PhD: This sounds like the environment I work in from time to time. If you’re in a community pharmacy, you have no idea what’s going on in the background. At the back of the office, you have pharmacy technicians and pharmacists trying to forecast what’s coming and manage their inventory. What are some of those details, so that it doesn’t affect prescribers as much?

Erin Fox, PharmD, BCPS, FASHP: A great example is when we were impacted by Hurricane Maria and we couldn’t get out small-volume saline bags. We had to figure out quickly which products used most of those small bags. We came upon our antiemetics prior to chemotherapy infusions. What we ended up doing was changing our dexamethasone bags to dexamethasone syringes; it sounds like an easy fix, right? The patients were going to get the same product. There was going to be no change to the providers, but I will tell you that we had to hand touch 700 different templates in our electronic medical record that took 100s of hours to accomplish.

Troy Trygstad, PharmD, MBA, PhD: That part of the world has changed quite a bit. Twenty years ago, you might have moved some things around and taken out a pencil and made note of it, right?

Richard Montgomery, RPh, MBA: Right.

Troy Trygstad, PharmD, MBA, PhD: So a change in a drop-down menu in a large multistate system is no small matter these days, correct?

Richard Montgomery, RPh, MBA: Correct.

Troy Trygstad, PharmD, MBA, PhD: What does that feel like and look like?

Richard Montgomery, RPh, MBA: That’s the biggest part. We’ve moved to an era of patient safety, which is a good thing, but the background work that goes into providing that safe environment is immense. A simple national drug code [NDC] change will take hours to change because you’ve got to alter so many order sets and automate dispensing cabinets. On your shelf, if you have people off the shelf when they order, you have to change the shelf labels; otherwise you’re going to order the product that’s out. My other point is, we did the same thing with our push meds versus our small-volume parenterals, divvying out vials that you may not use; there are strict guidelines for this. You get a certain amount of vials depending on the quality of your intravenous room, beyond the use date.

Troy Trygstad, PharmD, MBA, PhD: This sounds like an engineering feat to me.

Erin Fox, PharmD, BCPS, FASHP: It really is. It’s so frustrating that we have all of these great hardware and software systems to support our patient safety, yet all of those systems are really set up to use the same product all of the time. Even a tiny change switching 2-mg vials of morphine into syringes requires a ton of work.

Richard Montgomery, RPh, MBA: Automated dispensing cabinets as well. At times you have to reengineer your cabinets—which were designed to hold vials—so they can house syringes. It has to be in a controlled setting because morphine, for example, is a narcotic. You can’t just put them in a tower somewhere because they fit. This reengineering is a clinical feat.

Troy Trygstad, PharmD, MBA, PhD: Are you training your teams with extra types of training, like lean training or supply-chain management?

Richard Montgomery, RPh, MBA: We are. We also look to our vendors for help. Our cabinet vendors come in, and they do a good job of helping us figure out strategically what to do. Our drug manufacturers also come in to help us set these up because they know it’s an issue.

Troy Trygstad, PharmD, MBA, PhD: I’m a new graduate of pharmacy school, Erin, and I’m looking at residencies. I’m done with my first-year residency. You have to make your pitch for your drug information and shortages.

Erin Fox, PharmD, BCPS, FASHP: Drug shortages are an interesting problem. I’ve been interested in them for years because it’s solving a specific clinical problem. Folks who only want to do the clinical portion are not going to like working on drug shortages because you have to think about the operations. It’s thinking about how you can make things safer for not just 1 patient but all of the patients in your health system. A lot of medication-use policy is that way too. We do a lot of that in our program. I will say that as interesting as drug shortages are to work on, they probably are the leading cause of health care waste in our systems.

Troy Trygstad, PharmD, MBA, PhD: What kinds of waste? Describe the specifics.

Erin Fox, PharmD, BCPS, FASHP: Think of all this work that’s being done.

Troy Trygstad, PharmD, MBA, PhD: Extra time and people.

Erin Fox, PharmD, BCPS, FASHP: It’s mainly people. I think of Rich’s team working to rearrange all of their cabinets. I think of our informatics team and everything they’re not doing to optimize the system because they have to change the size of lidocaine [Lidoderm]. All of that work to use our products is a tremendous amount of waste. I would love it if I never had to think about drug shortage again.

Troy Trygstad, PharmD, MBA, PhD: It sounds like a lot of maintenance. These aren’t exception handlings. They are just the norm. There is always an omnipresence of drug shortages. It sounds as if it’s this maintenance activity that’s maybe taking away from others. How do we move forward with other types of clinical processes?

Erin Fox, PharmD, BCPS, FASHP: I think of our technicians who are working on shortages, and how they could be taking medication histories…instead. Our clinical pharmacists are thinking of plans on how to take this little amount that we have and use it more wisely. They should be working on clinical plans for their patients; it’s a waste.