Narrator: Coming up on Mayo Clinic Q&A,
Dr. Eric Tichy: The number one reason for drug shortages is
actually unknown. And this speaks to the lack of
transparency in the drug supply chain. And that's one of the
things that we aim to work on.
Narrator: Drug shortages can pose a significant threat to
public health as they can result in delayed treatment for
patients, medication rationing, and in some cases, treatment
being denied because of the lack of important drugs. Addressing
these shortages remains a top priority for Mayo Clinic.
Dr. Eric Tichy: We have created a more organized and structured
process and with the collaboration with our external
partners to help end and prevent drug shortages, we hope that
this really best prepares us to manage drug shortages that we
see in the future.
Jason Howland: Welcome, everyone to Mayo Clinic Q&A. I'm Jason
Howland sitting in for Dr. Halena Gazelka. Drug shortages
continue to be a major healthcare issue in the U.S.
with more than 200 ongoing and active shortages per year since
2018. Mayo Clinic has taken a leadership role in combating
drug shortages, including joining the End Drug Shortages
Alliance. That's a coalition that seeks to prevent drug
shortages in the U.S. Mayo was also a founding member of Civica
RX, a nonprofit generic drug company, whose goal is to reduce
shortages of essential medications that hospitals use.
Civica RX recently announced plans to manufacture and
distribute affordable insulin. Joining us today to discuss
combating drug shortages are pharmacists Dr. Eric Tichy,
Division Chair of Pharmacy Supply Solutions at Mayo Clinic,
and Dr. Mary Gilmer, Director of Pharmaceutical Supply and
Procurement from Mayo Midwest. Welcome both of you to the
program.
Dr. Mary Gilmer: Thank you.
Jason Howland: So, first off Dr. Gilmer, why are there drug
shortages right now in the U.S.?
Dr. Mary Gilmer: That's a great question, Jason. Well, let me
just start by saying that drug shortages are not new to
healthcare. But really over the last two years with the COVID-19
pandemic, the shortages have really exposed the vulnerability
of our global drug supply chain. And these drug shortages
continued to remain high, despite decades of continued and
increased awareness, effort and significant resource investment
in these drug shortage programs at the highest level. And so,
Dr. Eric Tichy: So, one of the frustrating things about drug
you know, I just want to touch on a few reasons for drug
shortages, or rationales, and there are a variety of them.
They include the supply and demand considerations and
challenges, as mentioned, that we've seen with COVID, natural
disasters like hurricanes, even including issues with
manufacturing. So, this could be the raw materials shortage, or
even the staffing challenges that manufacturing plants are
experiencing as a result of the pandemic. And then certainly, we
shortages is that the number one reason for drug shortages is
can't ignore any kind of business and regulatory changes
as a result of profit or market analysis where manufacturers may
decide to end a product line completely because it's not
profitable for them.
actually unknown. And this speaks to the lack of
transparency in the drug supply chain. And that's one of the
things that we aim to work on.
Jason Howland: So, which medications are affected. We
mentioned insulin earlier in the intro to the program, is insulin
one of them, and what are some of the others?
Dr. Eric Tichy: Absolutely, Jason. And really, let's level
set and say any medication can be on shortage. But the biggest
challenges with shortages is when we are in short supply of
our life-saving medications like insulin. These medications may
include the insulin antidotes, any kind of reversal agents, and
certainly our common injectable medications that are needed to
sustain life. So, that's really what you're speaking to. And
when these shortages affect these types of medications,
that's when our patients are most negatively impacted.
Jason Howland: How is Mayo Clinic managing drug shortages?
Dr. Eric Tichy: Well, there's high levels of stress and
frustration for everyone involved when it deals with
shortages. And so, Mayo Clinic has really acknowledged that
there's a critical need to create an organized and
structured approach to how we manage medication shortages
across our entire enterprise. So, this is involving all sites.
We have necessitated a coordination and collaboration
of teams, and this is internal and external to all of our inter
disciplinary team members. And we've developed under the
direction of the Mayo Clinic Pharmacy and Therapeutics
Committee, so our most overarching practice committee,
the Medication Shortage Management Oversight
Subcommittee we call MSMOS, and this group seeks to take a
proactive approach to ensure the effective and timely management
of medication and shortage supply concerns.
Jason Howland: And what is that proactive approach?
Dr. Eric Tichy: Absolutely. So, right down to the frontline team
members when we're experiencing, when we go at the point of
ordering any kind of supply shortage or simply when supply
doesn't meet demand. So, when we place an order for a medication,
and we do not get in sufficient quantities of what we're needing
to take care of our patients, that's when we start escalating
it and really developing the collaboration and coordination
around how we understand and identify shortages so that we
can best proactively manage them. So, that's getting
everybody on board for awareness, and any changes in
our electronic health system that we need or engaging our
formulary colleagues to understand what alternatives or
substitutes we can use. So, this is just a few of the strategies
that we use when we're talking with this MSMOS group about
creating a structured and organized approach to managing
each and every shortage we encounter.
Jason Howland: So, Dr. Tichy, how do drug shortages affect
patients?
Dr. Eric Tichy: Well, because of the work that Dr. Gilmer's team
does, and so many of our clinicians at Mayo Clinic, we
like to think that the impact on the patient's themselves is
minimized. So, we really do a great job of finding alternative
therapies, we do things to conserve the products that we
have to make sure that we are taking care of those that are
sort of most urgently needed. When the shortages are severe,
it can actually lead to delays in appointments. So, when the
COVID pandemic first occurred, one of the reasons why the
entire economy locked down was that they wanted to give the
health system time to sort of prepare for what they expected
was a big influx of patients. So, I would say that 99% of the
time, these never affect the patients themselves. There are
some rare instances, though, where it could lead to delays of
therapy or using alternative medications.
Jason Howland: So, what alliances or partnerships is
Mayo Clinic involved in to best prevent or end these drug
shortages?
Dr. Eric Tichy: So, I'm glad you emphasize the end drug
shortages, because I think a lot of what we've talked about thus
far is really sort of mitigating the impact of a shortage. And
our goal is really to get further upstream and actually
end them and stop them from happening. So, we do a lot of
advocacy with the government and different regulatory agencies.
Anytime someone says they want to, you know, help end or manage
drug shortages, we're always interested in what that
opportunity is. So, Mayo Clinic has made a couple of big
investments. One is that we were a founding member and investor
in Civica RX, which is a generic manufacturing company that is
focused on critical medications, mainly used by hospitals. And
our goal there is really to turn these critical drugs into a very
highly reliable supply, similar to what you see with like basic
utilities like water and electricity, that you can rely
on them, and that if they go down, it's for a very short
period of time, and we have strategies to replace them. And
then most recently, we've joined the End Drug Shortage Alliance,
which is a coalition of many different stakeholders. So,
there's patient advocacy groups, there's manufacturers,
distributors, and health systems similar to ours that are all
participating in this to sort of, so we can speak with one
message to end drug shortages.
Jason Howland: Can you talk a little bit more about Civica RX
and the work that's underway? So, you mentioned it's a generic
Dr. Eric Tichy: Correct. So, Civica is a generic drug
manufacturing company. It's based in the U.S. So, part of
the strategy is actually onshoring production of these
medications, because of the national security issue that
that actually brings up. And I think the country really
understood that at the beginning of the pandemic when so much of
our medical supplies were produced offshore, and we
actually had seen some countries doing sort of protectionist
measures to make sure that their populations had access to some
drug manufacturer?
of these medical supplies, including drugs. And it was a
big wake up for the United States that we really
strategically needed to onshore production of these products.
So, Mayo Clinic had actually helped start Civica, about two
years before the pandemic. And then as a result of the Cares
Act, Civica RX received about $200 billion of funding from the
U.S. government to build a manufacturing facility in the
United States and Civica will start rolling products off of
their manufacturing lines sometime in 2024. So, it is a
bit of an involved process, but it's, you know, something that
really will make a materially significant impact towards
ending drug shortages.
Jason Howland: Well, we're just about out of time. But my last
question to both of you, how long do you think these drug
shortages will continue to persist?
Dr. Eric Tichy: Well, drug shortages were uncommon 20 years
ago, and in the last 20 years they have become increasingly
common. And my hope is that we could get back to where we were
20 years ago, where drug shortages were rare, similar to
what we see with utilities. And I think that the pandemic has
created a unique opportunity for us because of the attention it's
brought to the importance of supply chains. And a lot of
organizations are really recognizing this as a problem
and making investments to prevent drug shortages. So, do I
think you can 100% eliminate them? I think that might not be
realistic. But I do think we can get to where we were 20 years
ago, where drug shortages were very uncommon and drug supply
was very reliable. Dr. Gilmer, what are your thoughts on this?
Just to speak to what Dr. Tichy had shared, we absolutely hope
that we have created a more organized and structured
process, and with the collaboration, as Dr. Tichy had
mentioned, with our external partners to help end and prevent
drug shortages. We hope that this really best prepares us to
manage drug shortages that we see in the future.
Jason Howland: Fantastic. Unfortunately, we're all out of
time. But I'd like to thank our guests today, Mayo Clinic
pharmacists, Dr. Eric Tichy, and Dr. Mary Gilmer. Thank you both
for joining us.
Dr. Eric Tichy: Our pleasure.
Dr. Mary Gilmer: Thank you.
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