Laura Bray, MBA, spoke with the Journal of Clinical Pathways at the 2024 National Comprehensive Cancer Network annual conference about her experience as a patient advocate with Angels of Change and the key drivers impacting drug shortages.

Please introduce yourself by giving your name, title, and affiliation.

I'm Laura Bray, chief changemaker at Angels for Change.

Can you share with us a bit about your personal journey and how it has influenced your role as a patient advocate?

Angels for Change is the nation's only patient advocacy nonprofit on a mission to end drug shortages. I founded Angels for Change in 2019, after my own child faced three life-saving drug shortages during her pediatric cancer journey.

The shock and fear of my child not getting her protocol-driven medications because of a broken supply chain led me to first try to find it for her. Then I looked to start an organization that could help any patient, physician, or facility facing life-saving drug shortages. Patients are at the heart of why Angels for Change exists. My patient, my daughter—at the time she was 9 years old—is why we're here. Remembering what it felt like as a caregiver to feel that hopelessness and fear drives our work.

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?

First, there needs to be spaces to have dialogues, to have collaboration. The pharmaceutical supply chain is deeply fragmented. In fact, there's a philosophy called limited visibility by design, which means sometimes through regulations, laws, and contracts, we have built a system that has limited visibility. The reason why it's called supply chain and not supply management or supply organizational structure, is because it must be a chain that's connected all the way from the very beginning of production and suppliers to the end consumer. Any brokenness in that chain at any point breaks the movement of supply.

However, there are sometimes valid reasons why we purposefully limit the visibility of the supply chain and break it. These include for intellectual property reasons, personal and private information, and the movement of medicines across borders. At the same time, we still want the chain to be linked and purposefully connected.

When we faced our first drug shortage, my daughter's drug shortage, there was no space in the entire nation dedicated to that work of ending drug shortages. And so, we needed a patient advocacy organization dedicated to having these conversations, with the patient at the center from the beginning and connected until the end.

We also needed a place for industries and policy makers to have these conversations.  How do we ensure there is enough supply? What do we do during a disruption? How do we make sure that there are early warning systems and there's transparency? And how do we work together to increase the redundancy and to make sure quality is infused, not just in the product quality, but in the quality of patient care? All of those conversations have to happen. There was no place in the entire system to have that. It had to be built.

We founded Angels for Change to begin having patient-centric design and lean into the stakeholders and ask, how are we going to ensure patient access? We also worked with industry stakeholders to launch the End Drug Shortages Alliance to provide them with a place to have these conversations.

We wanted to provide an avenue for public, policy, industry, private, and nonprofit patient advocacy to have conversations all together. And so, we launched our summit, which is the only supply chain conference in the country devoted to drug shortages and the patients who rely on those medicines. We also work with the Duke-Margolis Center to revamp the US’s supply chain. The center looks at policy, and Angels of Change is part of the advisory board. We also work with the API Innovation Center (APIIC), which is the advanced manufacturing consortium for active pharmaceutical ingredient (API).

So how do we foster collaboration? Now that we have places to have these conversations and collaborate, we need to begin moving work forward using action and patient care as the outcome measure, not just reliability or resiliency.

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

It starts by recognizing the four key drivers to drug shortages. First, the lower the cost, the more likely something is to be in shortage. These shortages do not happen in the blockbuster large cost medicines. Instead, the majority of shortages are in these very low cost, generic medicines. For instance, in oncology, providers and their patients are being impacted significantly because they rely on generic injectables and often there's no suitable alternative.

We like to think about these drugs as the salt and pepper of our health care system or the oil and vinegar and water. You can have a kitchen without caviar, but you can't have a kitchen without salt and pepper and olive oil. And so, these low-cost products are less reliable and resilient because they are hit by drug shortages more often, and that is disrupting patient care.

Low cost is a driver. What can purchasers do? What can facilities do? You can make sure that you're building redundancies in low-cost medicines. And those redundancies could be additional supply, but also making sure to buy at a sustainable price.

The second key driver of drug shortage is consolidation. If something is really low in price, the market has consolidated and maybe there's only one manufacturer in the entire market or in mainly one geographic region. That consolidation means if something breaks in any one of those places, we're all struggling. So, what can purchasers do? Encourage multisourcing, encourage the market to not consolidate, encourage manufacturers to produce in different places, and encourage distributors to order from multiple manufacturers.

The next driver of drug shortage is complexity. The more complex the drug is to make, the more likely it will be in shortage. This is why cancer patients are uniquely harmed by drug shortages. Not only are their drugs more likely to be in shortage and there's no suitable alternative, but they're so complex to make, which can lead to bigger manufacturing challenges.

The last key driver is quality assurance. The biggest predictor of a future shortage is actually a past shortage. If there was a shortage because of a very low-price product, it will likely be in shortage again. What we can do as a society is say, these medicines are too important to allow us to have them be unreliable. We've got to do whatever we can, both short term and long term, to make them more available, more redundant, and more resilient.

If you're an individual facility, when the market is healthy and when you can order supply, make long -term partnership decisions with your suppliers, not short-term pricing decisions. In a unhealthy market where it's broken and it's scarce, Angels for Change hosts the nation's only drug shortage crisis line and we have a global supply sharing network. We can help your patients at your facility get emergency supply. Call us, and let's work together to find a solution. It's not just for one patient or just your patients. When we're building solutions, we're building it for the entire US. The earlier we know that there are challenges, the earlier we can build solutions for everybody. Call Angels for Change. You can always do that before you have to mitigate patients when the market's broken.

That's the reactive, unhealthy stuff. But in the proactive, when the market is healthy, if you see these essential life-saving, complex medicines that are really cheap— and I'm talking about less than a cup of coffee or a Big Mac—we probably need to be infusing sustainability and partnership in every conversation today to keep it healthy.

What overall message did you hope to convey to the audience during your talk?

Drug shortages exist. They're a true and real systemic crisis. They've been born on the backs of physicians and pharmacists doing herculean efforts reactively for decades, and patients bear the burden and the risk. No one individual member of society is going to solve it.

If we want to solve this, we must work together. We're all going to have to change a little bit. Doing the same thing we've done for 20 years is going to give us the same results and the situation is getting worse. We're at a 20-year high of medicine shortages, including essential medicine. We cannot keep doing what we're doing.

I want you to know you're not alone. Angels for Change is here, but we are going to have to work together. I like to call it the culture of the willing. Come to the table with multistakeholder solutions and collaboration. Full systemic change is what is necessary, and our patients deserve it.