Fresh perspectives on pandemic response

While still a “card-carrying pharmacologist” today, Dr. Nicolette Louissaint points out proudly, the trained chemical engineer, with an accomplished academic background in biological and molecular sciences, has always had a superseding draw to biomedical research in the context of finding solutions for broader populations. A drive Louissaint, currently executive director and president of health preparedness and response nonprofit Healthcare Ready, believes made her transition into the world of emergency response a natural one. “It’s understanding the integration of practical challenges that are faced by communities and patients with how best to create a science- and evidence-based-led response to address those challenges,” says Louissaint, whose initial work in this area focused on HIV and ways to ensure drugs for the disease could maintain thermal stability and be safely distributed.

More crises would come calling. During the height of the Ebola epidemic of 2014, Louissant served as the senior advisor to the US State Department’s special coordinator for Ebola. She joined Healthcare Ready a year later and assumed the leadership role in 2017. The organization supports supply chains through collaboration with public health and private sectors. Last year, Louissaint was appointed to serve on FEMA’s National Advisory Council. Also with experience in areas such as health IP, trade issues, and technology transfers, she recently earned an MBA from the University of Baltimore.

Pharmaceutical Commerce caught up with Louissaint to discuss the response to the COVID-19 outbreak.

1. Healthcare Ready has a history of responding to disasters like Hurricane Katrina; how has the COVID-19 pandemic played out differently?

One of the challenges that’s a bit distinct in a pandemic is that while the recovery phase for a catastrophic hurricane like a Katrina or even a Harvey, Irma, or Maria, that tail for recovery is quite long. However, when you’re thinking about a pandemic, the response window, the amount of time when you’re in active response, is extremely long. It’s a very intensive effort that involves a lot of coordination, a lot of deep focus and information sharing, And to sustain that level of engagement in response for months on end is exhausting. It strains partnerships, it strains capacities, but it also strains resources. It’s going to pull from the resources that we would normally use toward hurricane season or wildfire season.

Being able to shift resources from one region that may not have a pressing need to a region that has a greater need is a standard part of many of the emergency response plans that are in place. The complexity, however, is when you’re thinking about a pandemic where the need is global. It’s not quite as straightforward. Especially a few months ago, there were many parts of the world that were dealing with extreme strain at the same time.

I don’t know that I would say one [calamity] is necessarily worse than the other. The acute needs that result are acute needs and if you are a patient or a member of a community and you have been severely impacted, it doesn’t matter.

2. How involved is Healthcare Ready during events like these in making sure pharmaceuticals and medical supplies get to where they’re supposed to go?

That’s a big part of what we support—the coordination across the entire supply chain. As it relates to patients, first and foremost you’re thinking about who has been impacted by the virus itself, and the medicines that are going to be needed to treat those patients. In the case of COVID-19-infected patients, you’re not dealing with a therapy or a cure, but you are dealing with treatments that may be needed to help them recover.

One very clear example is ventilator usage. Those are painful devices, and when an individual is being ventilated, there are medicines that are typically administered to deal with the pain and with sedation and things of that nature. So you really can’t just have ventilators without having ventilator-associated medicines. Those are the types of things that you think about for those individuals who are actually fighting the disease itself.

3. How frustrating was it, particularly at the height of outbreak, dealing with the reported shortage of pain drugs for these patients ?

There were some spots shortages and some challenges, but there were also a number of substitutions and products that were ramped up in production or that were procured from generic partners, including international manufacturers, to be able to assist. What happens in a scenario like that is, while there are an abundance of ventilator medicines for a normal time, it’s difficult to predict that you would need ventilator-assisted medicines prior to the pandemic. It’s not a countermeasure, it’s an assisted therapy.

But then there was also focused effort on making sure both the primary and the secondary preferred medicines that were able to safely ventilate patients were being made available, and that there was continuity in the coordination and information sharing with federal government partners as well as with the manufacturers, the distributors, the GPOs, and the hospitals—so that there was visibility in what hospitals needed and what they were ordering. And, in addition, there was guidance and discussions with the federal partners as it related to being able to allocate and distribute the product that was available based on the number of COVID-infected patients and the actual immediate need. Also important was the coordination with manufacturers to make sure that production was being ramped up and that there was some sense of what would be needed to be able to overcome those shortages.

Other key roles for the pharmaceutical supply chain, especially, involve developing medical countermeasures and the process of developing potential vaccines and therapies, and making sure that the manufacturing plans will be able to develop those vaccines and therapies in a way that allows for the necessary surge, but also doesn’t hinder capacity to continue production of products that are needed right now.

In the midst of thinking about individuals who may be infected with COVID or might be infected in the future, we’ve also got to remember that there are a number of chronic care patients that have needs for medicines every day. One of the most important components of what the pharmaceutical supply chain has had to continue to do is ensure that the medicines that these patients need to remain healthy and manage their chronic illness are available to them. That is a major priority—making sure that we’re not so focused on just surging up production of therapies or vaccines related to COVID.

4. Do you think the industry/ healthcare systems have done a good job in addressing those patient needs?

I’ve been really proud to see the way in which our partners, both public and private, have come together to do everything, from the messaging, in a manner that allows for the type of information sharing, the type of access to advocates and partners and community organizations that can help ease the navigation for patients. Helping them understand what to do if you’ve lost insurance, for example. Thinking about things like emergency refills and even explaining the difference between hoarding and stockpiling and preparedness. How many refills should they have on hand at a given time? Can we figure out ways to expedite their ability to do mail order refills and things of that nature, and having an entire supply chain be prepared to support that surge?

Because when stay-at-home orders were coming in March, we saw a lot of patient rushing to their pharmacies to try to get those emergency prescription refills and figure out how much of their refill they could get. That puts a strain on the supply chain as well because of the number of individuals that are dependent on chronic care maintenance meds.

5. You mentioned the toll these coordinated efforts can have on partner relationships. Among distribution channels—manufacturers, wholesalers, retail pharmacies, FEMA, etc.—has there been a “banding together” type of mindset that has carried through?

Absolutely. It’s all about being able to coordinate and not just among competitors that are within the same part of the supply chain, but truly across the supply chain. There’s been a real desire that we’ve seen from manufacturers, distributors, GPOs, pharmacy partners, ancillary care health system providers, collectively, working together. Because some of it is about sharing what they’re seeing. How can we shine a light on our perspective so you know what we need, or we can explain the things that we need you to search on in a way that makes sense and was helpful?

That coordinated activity got most mobilized in February and March, and we’ve been able, from the Healthcare Ready side, support it. There’s definitely been a real spirit of partnership. I’ve seen partners across the supply chain lean into working together to tackle an issue more than the opposite.

6. As discussed, there was an initial reaction to the pandemic of higher demand for pharma products. How did distributors balance that need with making sure they were protecting their own workers and drivers?

One of the most important things that we’ve all had to remember is how much the situation has evolved. At the beginning of the pandemic, when we were thinking about stay-at-home orders and there were also some states that had geographical restrictions, requiring, basically, that if [distributors] go into the state or if they cross state lines or are near a hospital, they are required to then self-isolate or quarantine for 14 days. With that, you’re thinking about the challenges for distributors, especially not having enough drivers; they can’t afford for every driver to have to self-isolate after a single delivery or a day of deliveries.

So we had to work on everything from clarifying that type of a mandate or request in order to make sure that either there were exemptions that were in place for drivers or that it was clear how they were going to be able to monitor symptoms or what was truly being expected of them. There were a lot of discussions regarding [personal protective equipment]utilization based on the science of understanding what the appropriate level of PPE would be for a delivery driver if they are making contact with the hospital, if they’re delivering to a secondary site. Also what the appropriate disinfection and sanitation practices would be for a DC or warehouse. We did a lot of work making sure that we were sharing the information that became available from the CDC, but also that our distributor partners had an opportunity to review and ask very specific questions that would have been unique to distribution.

We wanted to make sure that as the response surged, that it was as easy as possible for them to know what was required. We needed to also, from our vantage point, make sure that we were educating our government partners to understand that we need federal, state, and local coordination on these issues related to DCs, specifically distribution, because there are many times where products will be moving across multiple states.

One thing that I saw all of our distributor partners do, which was commendable, was work with their customers to make sure that they had ironed out processes for what deliveries would look like, what the cadence of those deliveries would be, where the drivers were approved to make deliveries,  etc. The goal was to make sure that they were protecting their drivers but also protecting their customers. By having better control over that handoff and that actual worker protection, they were able to protect their workers and drivers in a way that I think made it much easier for us to sustain ongoing deliveries and distribution throughout the entire response.

7. Might these experiences and practice adjustments lead to a new business model in pharma distribution?

I don’t know what the future holds. There’s so much uncertainty right now. But I think what has been made clear is the capacity that the entire supply chain has, and the vastness of their resilience plans and the need to be able to have recovery and resilience plans that coordinate across the sectors. Everything from the way in which AmerisourceBergen worked with the federal government to help move [emergency-use drug] remdesivir at their direction, to the

way in which GPOs like Premier were able to make sure they were coordinating and sharing insights they were getting at the hospital level with the federal government. It’s taking that insider capacity from the healthcare side, and using it to improve the way in which we’re taking care of communities and patients in response.

It’s important to remember we saw uprisings and civil unrest across the country in response to the killings of Breonna Taylor, George Floyd, and Ahmaud Arbery. We saw the need to maintain logistics in cities that may not have had an access and reentry point  for COVID, but did have a blockade up because of unrest and protests. Things  are happening at the same time, and it’s a reminder that you don’t have a plan or create a capability for just one type of hazard. What you do is make sure that that capacity can actually work across multiple hazards.

8. As preparation for the distribution of vaccines and/or therapies for COVID-19 ramps up, is there a preferred approach that Healthcare Ready supports?

What we support are around principles rather than a specific plan. We support making sure that science is guiding the distribution plan and that we are leveraging existing capacities to be able to move the product. We’re also supportive of the work that the National Academies is doing on behalf of the CDC to be able to determine equitable allocation and distribution of vaccines. That is a very complicated set of issues related to coordinating just how you determine across a range of ethical- and equity-based issues, how to allocate a vaccine once one becomes available and what principles should you use as a guide. We’re very supportive of the National Academies as they’re looking to help create some guiding principles and a framework for that.

Science will be the guide. As we learn more about the potential vaccines and we understand which are likely to be approved and then are ultimately approved, there will be a distribution plan that accompanies that. There are a number of partnerships that have been forged, even in assistance ramping up for production, which will certainly change the speed at which product becomes available and needs to be pushed out. We’re watching that all very closely.