Daniel Wermeling: Depending on the year, Kentucky is either first or second worst in the nation
for opioid overdose mortality. There are at least a thousand deaths in Kentucky that are
related to opioids. In our state, it’s mostly let’s say 80% prescription opioids, 20%
heroin, but heroin is growing.
Opioid addiction is not just something you think about with poor people or inner city
people, it actually cuts across a wide swath of almost all socio-economic places. This
became apparent in Kentucky first in Northern Kentucky where the death counts were starting
to really rise, and the ambulances were making daily runs from these cities taking overdosed
individuals to the emergency room.
One of the strategies, then, is naloxone distribution there, and St. Elizabeth’s Healthcare System
has adopted this as something they need to do for their community. That’s where I grew
up was in Edgewood. And so it sort of hits home when I see it there. The alarm signals
were being sent from a lot of different places, including Kentucky—in our government and
the federal government—that there’s a major issue here and it’s getting worse.
Naloxone’s been approved since 1971. And so you would find that in post-operative recovery
rooms and emergency rooms, and in the kits of paramedics who work in ambulances. The
drug can only be given by an injection, so it requires a needle. When you awaken someone
from an overdose, they’re not quite “there” yet; so they can be combative, aggressive,
agitated, and needles around agitated people then become a hazard.
So this is naloxone injection. It’s in a small glass vial, if you will, with a rubber
stopper, and it goes inside this container, which the front end you can see is a needle
with a needle shield. So this would be for intramuscular or intravenous injection.
Our ambulances here in Fayette County have this as a standard for administering a lot
of different drugs, naloxone can be one of them. It’s the same type of syringe with
the exception that there’s not a needle on the tip. You still have the same drug cartridge.
Take the caps off, put it in. So this has a fitting on the end of it that fits right
on here and screws on. Now you’ve turned an injection into a nasal spray. Medical literature
shows from the paramedics that this works pretty quickly. You have to do all kinds of
things to put it together, and if you’re addled, or nervous, or excited doing all these
things, and remembering what to do and how, can be challenging. The thing with this is
that it’s very dilute.
If you bought a commercial nasal spray product with a unit-dose metered pump, it delivers
10 times more potent, concentrated solution. The mist would then coat the inside of the
nose and the drug would be absorbed and within in minutes usually people are awakened and
start breathing on their own.
What I proposed to NIDA, then, was to make a unit-dose disposable nasal spray so a paramedic
or a family would have this prescribed as if they were going to have an EpiPen to take
home. NIDA’s providing some funding, we’re providing some funding, and then the partner
Reckitt Benckiser is providing funding to complete the development and launch of the
product commercially. If the FDA should approve it, then the rights to the product would be
transferred to Reckitt Benckiser and they would commercialize it because they have all
those resources in place.
This is what I tell people, like my students is that “I use almost everything I ever
learned, I’m just not an expert at it.” So you want to find the experts for the various
disciplines. I sort of try to do it thinking backwards. That if you had the doctor, the
nurse, and the pharmacist how would they prescribe this? How would they use it? How is it paid
for? What do they need to do and what systems have to be in place to allow them to do it.
And so that’s part of what I think about and write about is, how do we do that for
this particular product?
The research part was really the initiation of this as the result of understanding that
we had an unmet need in Kentucky, but it also was an unmet need for the nation.
The second part is that we were conducting service, trying to get the laws in place so
that doctors can prescribe and families could have access to the medicine. We’ve written
numerous papers about this, both at the state and federal level in peer-reviewed journals.
There are now 24 states in the country that have a law that allows a physician to write
an “unusual prescription” for naloxone, because medical law, which is governed state-by-state,
not federally, requires that the physician have a physician-patient relationship to prescribe.
So I could write a prescription for you, but you can’t save yourself. And so a third
party also has to be authorized to give you a medicine.
That was something I was involved with in Frankfort to help get that law structured
and to testify before committees and the like to get that law passed. And so now it’s
legal in Kentucky to do this, but it’s not been well implemented yet because this is
a very unusual practice, most doctors have never heard of doing this.
The educational component is that we had students who were on rotations, or wanted an independent
problems course, actually write and draft some of the educational materials. So those
now have been developed and are distributed.
In the end, that’s what this whole thing is about: it’s “how you do solve the problem?”
You can sort of subdivide this into smaller problems, but one was “how do you satisfy
the unmet medical need?” and then “how do you put this into practice?”