Stephen Colvill, MBA, Duke-Margolis Institute for Health Policy, spoke with the Journal of Clinical Pathways on April 2, 2024, about how collaboration, proactive strategies, and technology can help prevent drug shortages. He 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.

*This interview was conducted prior to Stephen joining the federal government. The opinions expressed in this article are the author’s own and do not necessarily reflect the views of the United States government or any agency thereof.

Please introduce yourself by stating your name, title, organization, and relevant professional experience.

I'm Stephen Colvill, and I’m an assistant research director with the Duke-Margolis Institute for Health Policy, where I lead our ReVAMP Drug Supply Chain Consortium. I'm also the executive director of RISCS, which is a nonprofit rating and certification organization for drug supply chains. I also serve as a board member of the End Drug Shortages Alliance.

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

There are a lot of steps that can be taken. It's important to delineate between proactive steps and reactive steps. In the past, a lot of focus has been reactive after a shortage happens. What changes to clinical pathways are needed, or should there be rationing of treatment? What's the best way to prioritize the patients that need product the most? All of those concerns are important.

However, it would be more effective to focus on proactive preventative measures. What can we do to prevent the shortage from happening in the first place? It's hard as an individual oncologist or even an individual organization to move the needle on a more proactive approach. That's where collaborative efforts—including collaboration and cross-functional work in your organization, collaborative efforts with other stakeholders, other oncologists, other oncology practices, and throughout the supply chain—are critical.

For example, you can work your group purchasing organization (GPO) or your wholesaler, depending on how the contracting for generic drugs works at your institution. Organizations must effectively partner with manufacturers of critical generic drugs so that there's a greater level of reliability from the manufacturer, certainty of demand, certainty of supply, and more of a collaborative partnership between the purchaser and the manufacturer. That way the manufacturer has more of a long-term incentive to continue producing these products that are so critical for patients.

Most drug shortages, including many of the most impactful oncology shortages over the past few years, have been caused by manufacturing quality issues. These issues ultimately are due to lack of investment and commitment to sustained production of quality pharmaceuticals over time, which takes a lot of investment up front for it to be paid off over many years. Participating in those collaborative efforts through your GPO or wholesaler through committed contracting programs or similar programs are important.

I'd also highlight communicative and collaborative efforts elsewhere in the supply chain like the End Drug Shortages Alliance, which I mentioned earlier. It's a group of stakeholders from across the supply chain that come together to work on solutions to combat drug shortages and it's a great network. We have a rapid response team there, for example, that works on how to respond when a shortage happens to ensure there are effective strategies put in place to not just mitigate the issue from that one particular instance, but prevent similar issues from occurring in the future. We've had leaders from manufacturers come in to that group when there's an ongoing shortage.

A collaborative approach where many individuals are coming together to work on these solutions to these problems is needed.

What are some effective strategies for community oncologists to enhance communication and collaboration with other health care stakeholders to address and navigate drug shortages efficiently?

As I mentioned earlier, there are collaborative organizations that improve awareness of supply chain disruptions that are happening now or might happen in the future that community oncologists and others can participate in. There are also various committees of the End Drug Shortages Alliance that are working to prevent future issues.

For example, I'm the chair of the Quality Committee for the End Drug Shortages Alliance and we have other committees as well. The Quality Committee is working on approaches to give better levels of insight into manufacturers that are investing in their supply chains to avoid future quality issues. For instance, we published a Quality Measures Resource Guide. It has different tools that providers and other supply chain stakeholders can use to better understand the likelihood of potential quality issues impacting the critical products that they're purchasing. The other committees are doing fantastic work as well. Anyone that participates in the End Drug Shortages Alliance can join those various committees.

From a government policy perspective, there's an important commitment to a solution to drug shortages, especially with so many pharmaceuticals ultimately being paid by the government through the Centers for Medicare & Medicaid Services (CMS), the US Department of Veterans Affairs (VA), or other avenues. So, there's really important component there.

At the Duke-Margolis Institute, we founded our revamped drug supply chain consortium, which focuses specifically on policy steps that the US government should take to promote a more reliable drug supply chain. The consortium includes a collaborative group of different stakeholders throughout the industry, from providers to wholesalers and group purchasing organizations, manufacturers, and everywhere in between.

Throughout the last year we have issued four major work products with recommendations to prevent future issues. Some of the recommendations include advancing federal coordination to prevent shortages, bolstering measurement and tracking mechanisms, identifying risks in supply chains, and putting financial incentives in place to reward manufacturers and other supply chain stakeholders. We are taking steps to promote reliable supply chains and to increase adoption of advanced manufacturing technologies that can reduce the risk of delays that result from quality issues and manufacturing and provide quality assurance.

I'd encourage anyone to check out the work we're doing at Duke-Margolis and other similar collaborative organizations.

What role do you see technology and data analytics playing in helping community oncology participate and manage potential shortages of chemotherapy and other essential cancer therapy?

Data and technology are integral to solving this issue, but those are kind of nebulous terms. Data on what? Who should generate the data and what sort of insights should the data provide? Those are all really critical questions.

An important thing to keep in mind about data and technology is it can help to enable multidimensional communication. With this type of communication, there's a shared effort to do a full holistic evaluation of the supply chain and identify risks and where supply chains are strong.  Currently, how the supply chain works is that there is one stakeholder communicating in a linear fashion with one other stakeholder. For example, an oncologist talks to a pharmacist in the organization and the pharmacist might talk to a wholesaler. The wholesaler might talk to a manufacturer and the manufacturer might talk to one of their upstream suppliers of active pharmaceutical ingredient or something like that. That's an example of linear communication, and all these different assessments of supply chain reliability occur at different nodes in the supply chain.

The US Pharmacopia (USP) has done some great work in this area. They're involved in founding a new drug shortage task force with other oncology related advocacy organizations. They recently had an event where they shared a lot of the work they're doing, including developing a medicine supply map and  a vulnerability score program. Both projects use artificial intelligence and machine learning to evaluate many different data points across many different areas of this supply chain, including proprietary data that USP has to identify vulnerabilities and compare the likelihood of shortages between different manufacturers or different drugs. Purchasers can use the information generated from that tool to contract with more reliable suppliers and partner with them over the long term. There's a lot of other organizations working in this space as well.

Different types of models of data analytics on supply chain that help evaluate the likelihood of shortages are needed to ultimately drive purchasing and usage toward more reliable suppliers and reward them for their reliability.

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

There are financial implications of drug shortages on both patients and health care facilities. The economic burden from shortages is important and impactful on patients. Also, from a financial perspective, there's research coming out on the financial ramifications of the major oncology shortages last year.

For example, there was a recent study completed by University of California, San Francisco (UCSF) on the cisplatin shortage that looked at the cost of care of substitute treatments and how much more expensive those treatment regimens are. The cost for a course of treatment ranged from $30 000 to $70 000. That's kind of the magnitude that we're talking about here. There are huge increases in costs that come from potentially having to go to more expensive sources of supply.

And we're talking about shortages of generic drugs that are really inexpensive. Cisplatin is like $10 or $20 a dose or a vial. These are lower margin, lower priced generic, and older generic injectable products that typically go into shortage.

We can find effective solutions that promote more reliability for those drugs, and if they come with some incremental costs, that incremental cost is likely not significant in the grand scheme of things. It’s important to keep that in mind when considering preventive steps. Such costs might be participating in a committed contracting models or sourcing from more reliable suppliers that might have a little bit higher up-front cost on a per unit basis. And that's a challenge, of course. Everyone's strapped from an economic perspective right now. However, when we factor in the downstream or later effects of having a shortage, it starts to make a lot of sense to participate in these up-front costs compared to the huge expense that comes down the road from having to source alternative therapies that are more expensive or losing out on demand.

Ultimately, preventative steps will be more cost effective in the long run, which we see in other areas of health care too. The question remains, what are the right preventive steps to take? That's where the collaborative organizations that I mentioned earlier can help with participating in a committed contracting model with your GPO or wholesaler and finding ways to use data and technology to identify more reliable suppliers. Those strategies are all really critical.

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

There is a level of unpredictability with drug shortages, but really there's a lot of predictability with it too. When we look at the drugs that are going in shortage, they're primarily older, generic, injectable products that are relatively inexpensive. And there's a lot of oncology products that fall in that category, especially now with quite a few products having lost patent exclusivity 10 or 20 years ago.

Any product that's been around for 20 to 30 years as a generic and is low price has a high likelihood of a future shortage. It could be on shortage next month or next year, or maybe three years down the road, but there's a high probability right now based on fragility in the supply chain of future shortages.

So, taking steps to get ready for when potential future shortages might happen is important. It’s critical to think about what you're going to do to change clinical pathways, if that's necessary. But the best thing to do is take some of those preventive steps that I mentioned earlier, so that those shortages don't happen. However, there has to be some fundamental changes in how the generic drug market works and how contracting for generic drugs works to get to a place where drug shortage are not likely to occur.

It’s critical to find ways to partner collaboratively with others in the supply chain through your GPO and/or your wholesaler and find reliable manufacturers and effective ways to identify who those reliable manufacturers are.