The national emergency declaration promulgated by President Donald Trump and the Trump administration on Friday, March 13 allowed for the Department of Health and Human Services (HHS) to permit the relaxation of a variety of regulations in U.S. healthcare, including strictures on hospital bed capacity, restrictions around licensure and approvals for telehealth capabilities, and provisions for federal intervention to address supply chain issues for hospitals and clinics, in the face of the surging COVID-19 coronavirus pandemic.
Advocacy leaders at the Charlotte, N.C.-based Premier Inc. have been hard at work interfacing with the federal government around hospital and health system supply chain issues in recent weeks. Among those leaders is Soumi Saha, PharmD, senior director of advocacy at Premier, has been focusing laser-like on issues around supply chain, and has been working to ensure that all the personal protective equipment (PPE—masks, gowns, etc.) and ventilators that will be needed in hospitals, clinics, nursing homes, and other patient care organizations, will be available to those patient care organizations, as the COVID-19 pandemic hits the U.S. healthcare delivery system like a tsunami.
Recently, Ms. Saha spoke with Healthcare Innovation Editor-in-Chief Mark Hagland regarding her and her colleagues’ advocacy efforts in this area, and her insights on the public health crisis. Below are excerpts from their interview.
At the highest level, how are you looking at and framing the current supply chain situation?
We’re looking at three main buckets in the healthcare system: acute care, non-acute care, and pharmacy. In the acute-care setting, the primary concern remains PPE. The primary focus is still on masks, primarily the N-95 and surgical masks, and gowns are the secondary concern right now.
Can you quantify the level of shortages involved?
Premier has data that’s three weeks old, based on a survey of our member hospitals and patient care organizations that we conducted three weeks ago. We’re re-releasing a survey today to find out the constraints, per the past three weeks. Giving you numbers from three weeks ago would be misaligned. What we have been able to quantify is that, in hospitals with live COVID patients, their utilization of PPE has increased five- to seven-fold.
What levels of shortages are you seeing around the different types of PPE?
When we visited three weeks ago, the primary concern was the N-95 mask. The primary difference is, in surgery, the outer layer is not permeable, because of the increased risk of splashing in surgery, but the traditional N-95 mask is permeable. So with a shortage of N-95 masks, hospitals started using surgical masks, and that created a ripple effect. So with the CDC [the federal Centers for Disease Control and Prevention] allowing for the use of industrial surgical masks and outdated surgical masks, that helped temporarily. But with the EU [European Union], India, South Korea, Thailand, and Taiwan, limiting their export, we have to find a way to increase the supply of masks.
So last Wednesday, the President announced a memorandum permitting the government, Department of Labor, to increase the domestic manufacturing of masks. It allows World War II-esque manufacturing capabilities, where the government can require industry to manufacture things. We’ve been working with the government to find out how this will work. The good news is that PPE manufacturing is much more resilient than pharma. Three main steps: step one, you’ll an expedited FDA [Food and Drug Administration] regulatory approval process. Step two, is committed volume. And step three is a secure and controlled, and efficient, distribution channel.
Why committed volume is so important is that there are manufacturers with capacity, willing to commit their diaper lines to masks, for example, but they don’t want to commit to doing this but end up holding the bag at the end of the day, that’s unfortunate. So Premier, we’re saying, we’re willing to commit to a guaranteed level of purchase for providers, to give these manufacturers the security and confidence they need to enter the marketplace. Distribution is also important: we need an efficient way to move these products to providers, and we’ve said we can help facilitate distribution channels; we want to leverage what exists today. Don’t want to have to create new distribution channels.
Are you optimistic about the prospects of creating these pipelines relatively quickly?
I hope to be optimistic; we cannot be in a situation where supply and demand do not meet. We have a little bit of time, because most hospitals have at least two weeks of supply on hand, which is good. We have a little bit of time to act to ramp up production in the US, and I’m hopeful that we an create an action plan that will work.
We’re also actively monitoring the drug supply chain. I don’t think the average consumer doesn’t realize that Italy is the number-three producer of active pharmaceutical ingredients after China and India, the actual drug ingredients.
What about the issue of ventilator manufacture?
The survey I mentioned that’s going back out to our membership today includes questions about ventilators as well as hospital beds. Ventilators are challenging. There’s currently an eight-week lead time to purchase ventilators from the largest manufacturers. We’re also hearing different numbers about the stockpile; we’re hearing numbers varying anywhere from 4,000 to 12,000, in terms of ventilators sitting in the strategic national stockpile. We’re trying to assess that situation.
Did the emergency declaration address the manufacture of ventilators?
No, only of masks—using general term “respirators,” which means masks. We understand there’s going to be a domestic memorandum coming soon on drug manufacture. There may be an additional memorandum on ventilators and hospital beds. We’re working with the government, helping them to collect data.
How many hospitals did you survey three weeks ago, and how many did you survey today?
The original survey included a little over 300 hospitals, and all were Premier member hospitals. This next version is being sent to all hospitals nationwide.
When will the data be made available?
The goal is to get it out late tonight or tomorrow morning as soon as we can get it programmed form HHS. And by the end of this week, we should have some really good solid numbers to share.
