HOPA Provides Plan to Address Oncology Drug Shortages

Pharmacy Times interviewed Sarah Hudson-Disalle, PharmD, RPh, pharmacy manager in the Department of Pharmacy at the Ohio State Wexner Medical Center and chair of the Public Policy Committee at the Hematology/Oncology Pharmacy Association (HOPA), and Jeffrey Pilz, PharmD, MPA, MS, BCPS, assistant director of pharmacy – medication safety and drug policy in the Department of Pharmacy at the Ohio State Wexner Medical Center and vice chair of the Public Policy Committee at the HOPA, on HOPA’s oncology drug shortages research project.

Question: What is the oncology drug shortages research project, and what were your roles?

Sarah Hudson-Disalle: My role at the time that we developed this—I was a chairperson of the Public Policy Committee for [HOPA] and really had collaborated the idea with Ali McBride, PharmD, MS, BCOP, who was one of our members of the committee at the time. As a follow up to a 2013 publication out of an American Journal of Health-System Pharmacy article that looked at oncology drug shortages in the United States, and what that impact was on clinical practice clinical trials, and health care costs after we saw that very big insurgence of drug shortages in 2011, and we wanted to just follow up on that to see where the needle fell.

So, I worked on the concept, and then bringing that part of our public policy idea of getting that back out, seeing where our members were, because we were still experiencing these drug shortages at that time. So, it was getting that setup, starting the development of the tool with Ali, and then starting the process of involving key members in our committee to get the tool out to our members, and then gathering the information, analyzing the information, and then writing the paper.

Jeffrey Pilz: Just to add to what Sarah said, the collaboration here was among several different members of the Public Policy Committee for [HOPA]. As she mentioned, this was just a follow up to a previous survey that had been completed in 2011 for the organization. So it was originally intended to start out as a sort of checkpoint to see where we've made progress between the original survey and then the updated version.

Of course, when those survey instructions and links were first sent out in 2019, we didn't know what was coming, and then we had certainly the unexpected surprises that came with supply chain interruptions during the COVID-19 pandemic. So the surveys served 2 purposes, not always in comparison to those previous metrics that we had collected, but then also, it served as a way to measure what has maybe impacted us in the oncology and cancer care profession, in terms of drug shortages during the pandemic and some of those new challenges that has come in the post-pandemic era.

So, in terms of my role specifically, I was vice chair of the Public Policy Committee, when we started writing the paper after receiving the results, and I assisted in some of the writing and then also some of the editing and therefore the process before publication.

Question: What was the scope of this project, and how many organizations participated?

This was something that was opened up to all the open membership, and we advertised it across our listservs. But we ended up having 68 unique organizations reply with their specific information.

Sarah Hudson-Disalle: The intent initially was to open this up to other organizations as well to mirror the initial survey that was done in 2011. Then with the pandemic, we really hit some barriers. There was that email surge of everything I think with supply chain in various areas around just the treatment of COVID, and how pharmacy departments across the country were dealing with things, so we were really hesitant to add to that burden. So we really did then ended up focusing in on our HOPA membership only.

Question: Following the drug shortages survey deployment to HOPA members, how did the responses shape your project?

Sarah Hudson-Disalle: Even looking at the initial survey, we really focused on treatment options as far as with chemotherapy and those agents that were used to treat various disease states. One of the things that we did expand in this survey tool was for supportive care agents. So looking at shortages with IVIG and not just like our Vinca alkaloids that would have been in the tool, and so those are things that I really felt like we had the opportunity to look at each individual drug class and see how those responses were impacted as far as different organizations were impacted, and how that aligned with options for patients in centers across the United States for how to deal with those drug shortages, how does that impact clinical trial, how does that clinical trials, how does that impact our patient care, and what did it did it have an impact on safety? So, those are the lenses that we looked at each of the results when we received them back.

Question: How did the results of the drug shortages survey help to inform HOPA's work to address issues in the field?

Jeffrey Pilz: The results really corroborate what we originally expected from this survey that most of us in the clinical practice field I think are constantly facing on a regular basis is really these struggles around supply chain interruptions and shortages overall, not just for medications, but really everything in the health care field, such as disposables, infusion supplies, PPE, etc.

What we did see from the survey results is that there is some of those long-standing problems that have caused drug shortages in the past and have continued to this day and really still need additional work to be resolved. Drug shortages are a national problem, and thus, they require really national and even international changes and solutions to really get to the point where we would no longer have to worry about them.

Of course, that takes a lot of time and effort, and different competing parties really having to come together and collaborate from those different sides of the industry in the regulatory body and health care frontline practice. So what would happen here is that we at least can advocate for some of the changes on more of a local level within our professional organization, with our representatives, on the manufacturing side, and a lot of that revolves around transparency. If we have the transparency of where something is made, how much in terms of extra capacity that's available, and when there's a shortage, what intensity is it, how much product is available on the market—that allows us on the front end to do a lot more work to plan accordingly, not necessarily hoard supplies, but then maybe order up just what we need at the time without exacerbating the shortage and be able to still maintain that same level of patient care that we would like.

Whereas otherwise, if we're just given the information that something is at shortage, we really are left without additional steps to move forward. In terms of what we would do from HOPA’s end, we can advocate for a lot of the things that are in our issue issues brief around direct shortages. That includes some recommendations, including not only advocating for more transparency, but then some of the long-standing changes that may happen at that national level. So things like rewarding for quality for manufacturing, trying to advocate to have faster, more expedited processes, especially at the regulatory level if there is a need to import items or allowance of items, especially even moving things from like an investigational drug trial status to being put out to the general population.

So I think there's some challenges that still exist. But if we have more of the momentum behind this, there's more tension to it, through seeing the impact that it has on patient safety and efficacy, that helps us really drive home the message of why it is important to tackle some of these drug shortage issues.

Sarah Hudson-Disalle: Also, I mean, those are very high-level points. Probably the other really important point I think is for pharmacy as a profession is the involvement of the pharmacist in the patient care team. We know that oncology care is very complex, and there's a lot of moving parts that are there and drug shortages threaten patient safety, causes treatment delays in those chemotherapy regimens, changes in dose, or those combinations can put a risk for our patients of how we're doing that. So really ensuring that a pharmacist is a part of that care team and that they are helping to navigate, if there's a drug shortage, what drugs are being used in place of fill in the blank of whatever it would be, but ensuring that pharmacist is an integral part of that team. So I think that's really at an even more finite level, and really at our local and national levels, applying those other needed solutions that need to happen.

Jeffrey Pilz: I was just going to add the results really reaffirmed that the biggest challenge that took short is those sterile injectable products that are less than typically $9 a dose. So really inexpensive generics that are long-off patent, those are the highest risk, especially when there's also silos, there's only one active pharmaceutical ingredient source or there's only one manufacturer of the finished product.

Question: What are next steps following the HOPA Drug Shortages Issues Brief in HOPA's plan to address these issues?

Sarah Hudson-Disalle: So one of the pieces is to advocate for various legislation that would be brought forward, serving as a voice as the oncology experts in the field and having a seat at that table and helping our elected representatives understand the importance of additional funding or making sure that there are key places for the safety of our manufacturing pipeline.

As well as even to, in those value-based cares, ensuring there’s a pharmacist that's involved with that. And so, there's different ways that our organization can advocate for these solutions. And I think that we've, as an organization, have stepped up when that's occurred to make sure that we know that electric representatives are going to come in and ask for HOPA as far as their opinion on what's going to happen, as well as support any legislation that might be brought forward that can be a solution.

Question: Any closing thoughts?

Jeffrey Pilz: Already, pharmacists are challenged when making clinical decisions for their patients and thinking about the safety, efficacy, and the cost of the product or financial toxicity. And drug shortages, really add a fourth element to that: Is the product available, is something that we would need to treat these patients in the manner that we would like to, we're following guideline driven recommendations is that really optimal product available, is the optimal regimen an option for this patient. So certainly, working towards correcting drug shortage issues is a long way to try to help prevent us from having to make those decisions that aren't in the best interest of the patient safety, efficacy, or financial status.

Sarah Hudson-Disalle: Probably the last thing that that I would add, those oncology drug shortages present unique challenges, that many times there's not alternatives for those treatments that are available. I think further support for policy actions are needed for economic incentives that Jeff brought up, and just to help to return to more of that stable and consistent oncology drug supply is just so critical on undoing that, so I'm like the broken record, but making sure that we have pharmacists that are part of patient teams to make sure that that safety of the patient is front and center. And we will partner together to make sure that patients get the care they need.