Pharmacy and Pharmacology


If you have not met me
I’m Janice Hall, and I’m the manager of the
business and institutional management office and the
lead on the Human System Academy. And I’m excited about
seeing all of you all here. Some housekeeping things
just before we get started with our taping and
everything, is. Well, number one as they
say on the airplane, we’re here to do pharmacology. If that’s not the lecture
you’re here for, then you need to get off the plane. So that’s what we’re doing
here today. And we wanted to do the
safety activity to let you all know that in the event
that the bell goes off, the door right out here,
you’re going to go out this closest door, which
is right out here. And go out in the parking
lot right there to the end. And right there to the
hedge. So bathrooms, men and
women, is right outside this door to the left. You’ll see a hallway right
there that the men’s restroom. And the women’s restroom
is over there. And introducing my staff
that works for Human System Academy, Dr. Pam
Dinkins, Detra Nillins and my secretary Ruby Guerrera
are the folks that have been contacting you,
sending you the letters and keeping up with all of
you all as far as who is ready to receive their
certificates as of this coming Friday afternoon,
Dr. Dinkins will be issuing nine certificates
because we’ve had nine people who have done all
the course completion that’s necessary to get
their ROI certifications. And so I’m excited, and I
want you all to continue to be interested. And the other thing I need
you to do besides signing in and making sure that
you’ve picked up a survey, is I appreciate those of
you who have gone into Saturn and given us your
input on things that you would like to see. Because that also helps us
know what kinds of classes that people have interest
in and want us try to schedule. And so like I said, we
want to keep the Academy relevant and something
that all of our employees would be interested in. So it’s only as good as
you all make it. So I appreciate that and
thank you. Pam.>>Thank you. And good afternoon to you. Thank you, our speakers
today are Dr. Tina Bayuse and also Dr. Virginia
Wotring. I wanted to let you know
that Dr. Bayuse graduated from the University of
Maryland, Baltimore School of Pharmacy with her
Doctorate of Pharmacy in 2000. Upon graduation she
accepted a position in the pharmacology laboratory as
an employee of Wyle, supporting various
research projects, including pharmaceutical
stability research for the on-orbit medical kits. In addition, she was
responsible for the development and
maintenance of medication monographs for the Space
Shuttle and International Space Station Medical
Kits. In 2002, Dr. Bayuse became
the Lead Pharmacist for the first and only NASA
pharmacy that opened its doors in 2003. As the lead she was
responsible for the original startup for the
pharmacy, including the physical layout, policy
and procedure development for the mediation,
management and implementation of the
pharmacy practice programs. As clinical staff team
members, Dr. Bayuse and her pharmacist team work
with the JSC Clinic and medical operations group
in support of crew member and employee health. Dr. Bayuse serves as the
pharmacist consultant to the medical operations and
the health, maintenance system groups for the
on-orbit medical care including medical kit
design, medication selection and process
development. She is responsible for
leading the pharmacist team and the provision and
packing of the medications for spaceflight through
the JSC Pharmacy, as well as overseeing the
medication management of the kits. She is a member of the
operations team responsible for pharmacy
practice for remote operations including the
facility in Star City, Russia, and the same-day
landing program known as the direct return program. Dr. Bayuse serves as a
liaison between the space medical clinical and
operational pharmacy programs and the research
community. And is of January, 2012,
as a part of an integrated team with the pharmacology
discipline. Dr. Bayuse has presented
numerous topics in pharmacy practice as it
relates to space medicine. In May, 2012, she was
named an honorary NASA flight surgeon. And in 2013 she was named
an associate fellow with the Aerospace Medical
Association. Next Dr. Virginia Wotring. And I’m handling these now
so we can flow smoothly when the presentations
start. Dr. Wotring is the senior
scientist in the division of spaceflight sciences in
the University Space Research Association, and
that’s commonly known as USRA. And serves as a
pharmacology discipline lead at the NASA Johnson
Space Center Human Health and Countermeasures
Division where her role is to determine research
needs and see that the required progress is made
to ultimately ensure that medications will be both
safe and effective on NASA missions. Her currently funded
projects include an analysis of retrospective
medications of the use on spaceflight missions and
design and implementation of a new IOS-based app for
the iPad collection of medication data. Recently, she completed a
number of projects which include a newly awarded
study of pharmacokinetics in spaceflight, which will
begin soon. And also the examination
of the stability of medication stored in the
spaceflight environment and gene and protein
expression changes associated with
spaceflight. She collaborates as well
extensively with companies, academia and
nonprofits. She also hosts college and
high school summer interns at JSC, here, and was
awarded the 2012 and 2013 student career exploration
program mentor of the year award. She gives guest lectures
at local universities and has adjunct appointments
at the University of Texas medical branch in
Galveston and also the University of Houston. She received her doctorate
in pharmacological and physiological science from
St. Louis University after earning a BS in chemistry
at Florida State University. She’s published a number
of studies on ligand gated ion channels in the brain
and spinal cord. She joined USRA and
spaceflight research in 2009. In 2012 her book reviewing
pharmacology in spaceflight was published
by Springer. And the book is entitled
Space Pharmacology, Space Development Series. I present to you now
Dr. Tina Bayuse. Thank you.>>Thank you. [ Applause ] Good afternoon everybody. Ginger and I kind of
flipped a coin, and it’s we’re going to do pharmacy
practice first and then transition over into
research. And I think the slide that
will actually help with that momentum. So with that I’m going to
launch into my presentation. The objectives of today
are going to be to introduce you all to the
JSC pharmacy here on site. Kind of provide a big
picture overview of how the pharmacy services fit
into the space program. Outline the roles and
responsibilities of the pharmacist staff. Discuss issues with the
provision of drug therapy within the spaceflight
environment. Considerations of the
contents of the ISS med kits will be discussed. Medication kit packing
time, one that helps put things into perspective
for folks. And then, of course,
throughout the whole talk there’ll be examples of
unique challenges within the space medicine
pharmaceutical practice. So the JSC pharmacy
actually is relatively new. It opened March 31st,
2003. We’re located in Building
8 right now, but in 2015 we’re going to be moving
with the clinic over to Building 45. I don’t have a date yet,
but it’s sometime in 2015. There are pharmacists on
staff. We have myself and another
full-time. And then I have two
part-time per diem folks. The services that enjoy
the pharmacy are the clinic and, of course,
space medicine operations. And more and more we’re
getting involved with research. And I’m sure Ginger will
be discussing that. The physical building of
the pharmacy provides for control and accountability
of medications. And it provides the
necessary security that we need to have as if,
because it is a pharmacy onsite. We abide by all of the
federal regulations, state regulations, EPA, DEA,
USP, so having the physical facility here at
JSC is actually very beneficial of the space
program. We are more of a health
system pharmacy practice model rather than a
community pharmacy practice. And when I say community
I’m talking about like a CVS or a Rite Aid. Those folks are outside. Not necessarily hospital
because we don’t have beds for people. But we’re kind of a
hybrid. So we like to say it’s a
health system. The pharmacists are
considered part of the healthcare team for both
the clinic and medical operations. And we provide such things
like medication management for the clinical practice,
the pharmacy. There is a pharmacy and
therapeutics committee that governs the practice
of pharmacy at JSC. And that’s predominantly
for the clinic services. There is kind of an
unwritten PNT for med ops, which will probably come
more formalized in years to come. Formulary management, we
are a small facility. We have a small patient
population base. So it’s not like we can
get anything we want. So we keep it to a minimum
as to what we would treat here at JSC. Of course, prescription
dispensing. Any of the required record
keeping that is necessary for medications. Because we have treatment
areas throughout JSC and including sunny corridor,
we do go out and inspect those areas so that we can
make sure that they’re safe, that there’s no
expired medications, that things are being stored
and labeled appropriately. Of course patient
education. If you go into any
community pharmacy practice you’re going to
have the opportunity to be counseled by a pharmacist. And we do offer that. And we comply with Joint
Commission Ambulatory Care Standards. I’m sure if you’ve seen
hospital advertisements, they’re Joint Commission
certified. We follow those guidelines
because it is the gold standard, and it just
helps us to put something, pin it on something and
say this is the standard that we’re going for, for
medication practices. So as I mentioned before,
we’re not your average community pharmacy
practice. Although we may look like
that if you stop by Building 8. Because we’re in-house,
it’s considered close loop. So for our folks,
particularly for spaceflight, they get what
they need from the pharmacy. It’s also on-orbit, and it
comes back to the pharmacy. So their care is
continuous with us. That is very similar to
being in a hospital floor moving from one floor to
the next. Except in our case it’s
down here to up there. We have, that allows us to
have a timely response to the space medicine
community. Because we are dedicated
over here, we are not having to deal with
regular people. And because we are
dedicated to the JSC scope, the standard of
pharmacy practice has also been carried up to the
on-orbit medication kits. So again, like I said
again, it’s that continuous thing. So I like to use the
iceberg as an analog. Some people are very
visual. Dispensing prescriptions
is what most people think that when you talk about a
pharmacist, a practice, that’s what we do. However, just like the tip
of the iceberg is only visible one night is
visible, there’s a lot that we do that is pretty
much unseen. And here at JSC, or within
space medicine, it’s even more, more of a, excuse
me, more of a need to recognize below the water
surface because we do have a unique environment with
spaceflight. We do have unique
situations. And, of course, that means
that we do have a unique pharmacy practice. So this is just a graphic
that I like to put up to show kind of the areas
that we support. Of course we support
clinic operations here at JSC. The big one that I want to
focus today and the one that’s probably more
interesting to a lot of the folks in the room with
the medical operations spaceflight side. And then I want to touch
on the research part that we’ve been working on with
Ginger. And then I’m going to turn
it over to her. We do have some agency
support off to the side because we do periodically
get questions from NASA headquarters. And through our branch we
make sure that they get the right information. Has anybody read Safe
Passage? Okay. Of course you have. The part that I want to
highlight is the gold part. And this is part of the
executive summary. And it reads, the standard
of clinical care for a healthcare system for
astronauts should be equivalent to the best
clinical care available on earth for those problems
that occur before, during and after a mission. For us, that’s equivalent
to making sure that we do, we practice pharmaceutical
care here at JSC. So what is pharmaceutical
care? It’s the responsible
provision of drug therapy. And I’ll explain the
provision of drug therapy in a minute. For the purpose of
achieving definitive outcomes to improve a
patient’s quality of life. So that’s what you would
expect if you were terrestrially based. It makes sure that you
either cure a disease, eliminate or reduce the
symptoms. Stop or slow down a
disease process. Or, of course, prevent the
disease process. And of course
terrestrially, pharmacists play a major role in this. So for space medicine, if
you transfer that over, what we want to make sure
is that we can eliminate or reduce crew member
symptomatology. Stop or slow long-term
effects of microgravity. Or prevent them from even
happening in the first place. But I would argue that the
stakes are higher here within this practice
because it’s not just about the crew member or
the patient. It’s about the mission. So what is the provision
of drug therapy, so that we’re all on the same
page. It’s to achieve the
desired but beneficial effect with minimal
adverse effects. And that’s important to
remember throughout this talk. With minimal adverse
effects. Pharmacokinetics and
pharmacodynamics, Ginger is going to really delve
into. But just to give you a
quick introduction, PK, which is what we lovingly
refer to as pharmacokinetics, is how
the body acts on the drug. PD, pharmacodynamics, is
how the drugs act on the body to produce the
desired effect. One without the other,
they coincide. So when you start talking
about research, you kind of need to think about
both. Another way to look at it
is that the onset, intensity and duration of
a therapeutic response elicited by a medication,
which is PD, depends on the rates of absorption,
distribution, metabolism and elimination of PK. And those are the four big
milestones to make sure that you have a good PK
picture. We also are concerned
about pharmacovigilance, which is basically the
science related to assessing, detecting,
assessing and understanding of potential
adverse effects with medications, long-term and
short-term. Which is perfect for our
practice of medicine, right. And then pharmaceutics,
how drugs can be delivered to the body. It’s a little bit
different in microgravity sometimes. And I’ll go through a
couple of those. So in order to do drug
therapy, provisional drug therapy, well we have some
responsibilities. And I’m going to quickly
go over those. Medication accountability. Inventory management is
one of our hallmark signs. And I will tell you that
non, that we are nonexempt from DEA regulations
on-orbit. So if we do need to trash
something, we do have to follow the regulations
that the DEA has set. They’ve given us a waiver
to witness the destruction. So nice of them. However, we still have to
do all the recordkeeping and filing with the DEA
when it is destroyed. Supply chain management is
a big deal. We ship a lot of things to
Russia so that it can be launched. Making sure that it’s cold
chain appropriate, room temperature appropriate,
for shipping outside of JSC and of course, within
JSC, is one of the things that we’re responsible for
making sure. And then if there is an
excursion, how we can quickly address it. Whether or not research
supports the use of it, or research supports that we
need to discard it and start over. Pharmacy is involved
heavily in appropriate selection and use of
medications, both terrestrially for the
clinic as well as on-orbit. Of course we do the
therapeutic monitoring for medications, which looks
at potential drug, drug interactions, drug food,
drug allergy. And of course, we can’t
really talk about anything these days without having
a financial awareness of what that looks like. So we make sure that we
are being very diligent about the cost of
medications. Which means we don’t want
to be wasting medications because it didn’t ship
appropriately. It’s not just the cost of
the drug, it’s all the resources that go involved
in getting it over there. Frontline collaboration
with our healthcare providers. Sound alike, look alike,
that’s a phrase that you could hear in community
practice and hospital pharmacy. So we want to make sure
that what we’re packing for our crew members get
limited amount of training in the medical kits. That the names and the way
they are looked, the way they are packaged, don’t
confuse them. Drug stability. We have a unique
situation. We can’t always
refrigerate things. And because of the size of
medication kits, we usually have to repackage. So does that affect
stability? We don’t know. Drug information for both
our patients, our clinical and our nonclinical staff. We do have international
partners, which means they have the choice of flying
their personal international medications,
which means we’d like to know what they are. And what’s contained in
them so that we can make sure that if something
were to happen, our US crew surgeon that might be
on console, is well aware. So that takes a little bit
of research on our part. Medication design support,
I’ve already mentioned. Any technology updates
that come through pharmaceutics,
pharmaceutical wise, new, excuse me, new drug
delivery systems, finding substitutions for obsolete
systems. Because we have an
understanding of what the med kits look like, it’s
very easy for us to say yeah, that might work. That might not work. Based on the size of the
kit. Reformulations of
medications can really trip some people up. And then we’ve had a lot
of withdrawals from the market. A lot of shortages from
the market, which I’ll get into. And some restrictions. So having the pharmacist
as part of the team, that’s kind of our job to
make sure that the right drug is covered for what
they need. Drug recalls. We actually have a big one
right now that we’re dealing with in the
pharmacy and it’s for IV saline. It affects medications
everywhere, and we’ve actually had to quarantine
medications that were on-orbit before and
resupply them as quickly as we can. They, what that involves
for us, because we do have a pharmacy management
system, we just plug in what we need to plug in as
far as a part number of a drug. And it tells us where we
dispense that to and what lot number we dispense. So we can very quickly
make a determination as to who has got what. Getting it up on orbit,
that’s a whole other conversation. But at least we can
identify and let the physicians know quickly if
it’s something that they need to be concerned
about. Most of the recalls that
we get don’t impact our services. So we don’t bother
everybody with all the recalls that we get. People would stop paying
attention to us if we did. Drug shortages. Lord, this one’s been
eating our lunch for the past couple of years. Daily vigilance is
required. We’ve had numerous drug
shortages that have almost impacted our on-orbit
kits. And at the 11th hour we
were able to secure some from another vendor. And it was able to be
packed. So I’m happy to say that
we’ve never had a medical kit on-orbit that’s had a
drug that wasn’t there because it was shorted. However, in 2012 we came
pretty darn close. Eighty-six percent of the
medications in our on-board medical kit
required an action by the pharmacist to make sure
that it actually was in the med kit. It got better in 2013. I think it went down to
35%. But it’s cyclical with the
national shortages that come out. And that’s a big one
because it doesn’t just impact, not being in the
kit. But if we have to make a
change, and we use a different size or a
different strength, which is like the last resort
for us because it affects downhill. It can impact, we want to
make sure that we’re not talking about sound alike,
look alike. That we don’t have a
potential of error in administration. So if we fly something
that was five milligrams and all of a sudden we had
to double it because that was the only one that was
available, making sure that the crew knows that
that was, so it’s not a good thing. We just try not to do
that. That’s the last resort. Lord, that keeps me up at
night. But the therapeutic
difference is if there’s unfamiliarity with the
crew and the crew surgeon because they get trained
on the med packs as well. The time gap that occurs
between the crew training and the kit contents when
they’re packed is a big thing that we need to
consider. By the time we pack, some
of our crew members are already in Russia. So that could change, you
know, we’ve had to send notes to the training
group so they could send notes to the crew surgeon
and the crew so everybody was on the same page. Changes to the paper,
procedures, checklists, anything like that, we try
to avoid. And then of course we have
to be vigilant about resource assessment, up
mass, if there’s going to be more trash, if there’s
going to be more time for the crew. And then the last thing we
want is a delay in treatment because that
could definitely affect the mission outcome if
treatment was needed. So what are some of the
considerations for medical kits volume? We have a finite space. It’s basically a binder
that we can use. Mass, the amount of trash. So we try to eliminate all
this extra packaging, you know, the tamper-resistant
things that you guys see on eye drops. That’s a foreign object
debris on-orbit. So we have to take that
off at the time of packing so that QA knows that it’s
a brand new bottle. And then we shrink wrap it
with the HMS team to make sure that the crew knows
that it hasn’t been tampered with. Stability is a big one,
and Ginger I’m sure is going to go into that. Sterility. We cannot, we do not have
resources onsite, nor legally could we, accept
medications that were repackaged from like a
vial into a syringe because of expiration
date. But onsite we don’t have
the resources to do sterile prep. So sterility is a big one. And then pharmaceutics
issues. A couple of years ago we
went through a med kit redesign. And everything in the kit
looked like a little syringe. And those syringes went
away. The market said, we’re not
going to do this anymore. We have some drugs that
are in this, but you can’t get empty ones anymore. It’s kind of a USP
requirement now. So we went about looking
for alternatives. And the most flexibility
that we could get would be the vials. You can see my lovely
little drawing of a vial there. What happens in
microgravity because we did the C9 flight, all the
fluid sticks to the glass. So if you were to go to
put in a needle, into the air, you’re not going to
get anything. So we had to come up with
a way, and training was involved in the flight, to
get the crew to be able to withdraw the contents of a
vial. This picture down here,
bottom right, the Afrin bottle, like an Afrin
bottle, you know, has got a spray mist. One G it sprays fine. Zero G it comes out like a
stream. So all that’s going to do
is go in somebody’s nose and down their throat and
not be effective at all. But we were able to find
another version so that it was a meter dose spray. So everything that we do
now that’s nasal prep is make sure that it’s a
nasal meter dose spray. And it comes out as a mist
then and does what it’s supposed to do. But for the longest time,
even on Shuttle, they used to repackage them in these
tiny little bottles. And it wasn’t really going
anywhere. Except down their throat. This is a real dirty
version of a pack, med packing kit. And just for your
awareness, pack, the process starts about eight
weeks prior to pack. It depends on the vehicle
that we’re flying on. So right there in the
bottom right, if we’re flying on a Soyuz, it’s
about eight to nine weeks before launch. So 8 plus 8 is 16. And if it’s a SpaceX or
orbital flight it’s between 6 or 7 weeks, so
15 weeks. So anywhere from 16 weeks
to, I’m sorry, 14 weeks to 16 weeks is the window
that we have backing it up from the launch date. We are fortunate in that
our HMS surgeon has signed a protocol so that these
are the contents of the kit. We know the contents of
the kit. We know that they’re going
to have to change. We don’t want to write a
prescription each time. So we have a protocol that
allows us to work with the HMS team. They identify the drugs
that we need to resupply based on use or expiration
date. And then it gets sent to
us via order. So it actually saves a lot
of time from having to get a prescription from our
surgeon. We review it and make sure
if there’s any drug shortages, any packaging
issues. And shelf life is the
driver for us. Cost is a factor, but if
something is more expensive but we have the
expiration date that we need and it prevents a
launch earlier, a repack earlier, then yeah we’re
going to go with the more expensive drug because in
the long run it’s going to save more money. We have, I mentioned the
pharmacy management system actually keeps track of
everything. And the one thing that I
haven’t mentioned yet is we make sure that
toxicology gets the contents and the inactive
and active ingredients. And I’ll go into that in a
second. And then we actually pack
with HMS and QA. And it’s all based on
drawings that they have. So I mentioned that the
timeline begins about four months prior to a Soyuz
launch. And then the packs go into
that locker right there. So really on orbit you’re
looking at a resupply of every nine months based on
expiration date. Because so much of the
expiration date is chewed up on the ground getting
it ready. Excuse me. I do not want you to read
this. It’s just to show we do
have crew-specific iMacs, which is crew-specific
medications. That involves more steps
because it’s crew-specific. So it has to be driven by
the physician. Because it’s not a set
list of medications each time, it does require us
to review it and compare it to anything they’ve had
in the past. Anything that’s on the med
kit that might interact with it. And then if there are
shortages, we have to deal with that. If there’s expiration
dating, then we have to deal with that. And packing off to the
side there, there’s complete. This process starts about
19 weeks prior to a Soyuz launch. Right now we’re only
flying iMacs with the crew, which means it would
always be on a Soyuz. I don’t know if that’s
going to change in the future. But that’s where we are
right now. It allows basically this
whole 19 week window allows pharmacy three
weeks to do the meat of the work before packing. And then packing happens
about launch minus 11 weeks to 9 weeks here and
then gets shipped over. So of course, highlighting
patient safety and mission success is kind of like an
underlying theme for us. And I already mentioned
pharmacovigilance. But one of the other
things that we are kind of charged to do is make sure
that there’s, any adverse events the medications are
mitigated as much as possible. Looking at pharmaceutical
countermeasures that might be coming through the
pipeline, that might be part of research. If they are part of a
research study, whether or not that interacts with
the medications that they’ve been prescribed in
their iMac. There’s a clinical
practice guideline within the clinic for circadian
distinct or any changes, and we work with the crew
surgeons for that to make sure that the folks that
are part of that program are getting the right
medications for their sleep shifting. And then drug tolerance
testing. We do it for the
astronauts, flight directors and flight
controllers. So basically your OSHA or
your Occupational Health reasons. And it looks at potential
hypersensitivities to drugs that they may not
have had before. And makes an awareness to
the crew member of how they may feel taking that
medication. And then of course, if
it’s a sleeping medication, that’s really
important to us. One of the things that I
haven’t addressed is the fact that the common
beliefs are the pharmaceuticals that we
use are the same in spaceflight as they are
terrestrially. That’s an assumption that
we’ve made. And whether or not the
integrity of the medications, the stability
of them, has been unchanged within
spaceflight. So those are the common
beliefs. And I’m not going to go
too much into this because this is Ginger’s thing. But just so that you know,
the drug is administered, it’s absorbed,
distributed, metabolized, eliminated. Clinical response,
toxicity or efficacy. It could go either way. Or it could be
sub-efficacious, and then you just have to have this
thing rolling around in your bloodstream. So it’s a big unknown
within spaceflight, because we do know of the
physiologic changes. And any one of these spots
could be a problematic. We just don’t know. Changes of hydration,
motility, fluid distribution, paddock
function, any one of those could throw this out of
the whack. And again, Ginger is going
to go more into detail. So the challenge that we
have as clinician within the pharmacy. Because there’s ultra-body
systems that are well documented, the impacts of
kinetics and dynamics are not part of the FDA
approval process for our special population. So we don’t have anything
to go back to terrestrially. There is posibility of
data for PKPD. Minimal studies have been
done, and the studies that have been done can’t
necessarily be extrapolated to all
medications. You cannot compare one
class of drugs to another class of drugs. As a matter of fact you
can’t compare some of the drugs within the same
class to each other because of the way that
they work. So we do know that the
changes in the body that are not well researched
with regards to PKPD. And stability of
medications is largely an unknown. And Ginger is going to
talk about that. So because of that, and a
couple of other things, we got involved with Ginger’s
group as an integrated team member. I think it was actually
directed by Dr. Davis at one point.>>I think so.>>So the point is for us
to be able to communicate her doing her research
thing. Us doing the clinical ops
thing and making sure that we’re on par with each
other. We understand each other’s
issues. And that we can help each
other out in either telling the story or
getting the story funded. She mentioned, or her bio
mentioned the medication use evaluation. We’ve started that, which
is the goal of that is to be able to better provide
clinical care for our astronauts, better provide
information to the HMS teams about packing and
how to, what we need to pack. And of course, the bigger
exploration mission question mark that we know
is coming. We have provided support
to the epidemiology group in way of drug
information, classes of drugs, how they sometimes
categorized their data. And supporting one of
Ginger’s previous studies. And we have been asked to
be kind of a subject matter expert for clinical
pharmacy ops and various other areas. And that’s just a couple. So the more integrated we
get with Ginger, the more we get pulled into other
stuff. Which is all fantastic. It’s supposed to be that
way. And I think that was part
of Dr. Davis’ vision. And the slides are not
advancing. Okay. So spaceflight and
pharmacy practices has unique challenges. We talked about
international medications that sometimes aren’t even
available in the states. Sometimes the packaging
isn’t even in English. So that’s a big deal. PKPD unknowns. I talked about the
pharmaceutics, fluid dynamics. I did not talk about the
excipient’s concerns. Right now in station we
have a one gram limit on all alcohols. Which doesn’t sound like a
lot. It doesn’t sound like a
big deal. But when you talking about
creams and eye drops and ointments and anything
that might have an alcohol, that kind of
counts towards the one gram for all station. And that counts anything
that’s going on in research. So we’re very aware of
that. And so when we have to get
something that we don’t normally stock because
that brand is no longer available, we make sure
that we really look at it. And sometimes, give them
materials folks the heads up that something’s coming
their way and kind of grease the wheels a little
bit just so they’re not completely taken off
guard. And we’ve had to work with
them and the crew surgeons to make changes to
medications because of that alcohol limit. Drug administration I
mentioned. You know, if you can’t get
stuff out of a vial the routine way, it’s a
problem. Market availabilities. I talked about shortages. That’s a big one. We have multiple
disciplines for our common goals. We’re working with
engineering folks. We’re working with
physicians. We’re working with
nursing. Training folks. And each one of them has
their own perspective on what they bring to the
table for healthcare. And sometimes making sure
that we’re all speaking the same language is a
little bit challenging. But we work through it. And then of course
regulatory compliance. I mentioned that the DEA
did not give us a waiver for trashing in orbit. But this also gives us
some unique opportunities, something that you’re not
going to really find elsewhere. Medication use evaluation
and management from a pharmacotherapeutic
perspective, want to make sure that the folks that
are using those medical kits are getting what they
need to get out of them. So if there’s a drug in
there that’s not being used, and the reason for
it isn’t really something that should consider
anymore, then why bother having it in the kit. It just takes up space. Shelf life improvements. If there is a need for it,
we don’t know yet. Packaging might be an
issue. And of course stability
testing support that we can offer Ginger’s group. Continuous evaluation for
performance improvement and risk mitigation. For us that’s a big one. Remember, we said that we
want to make sure that the crew is safe and that the
mission is not impacted by a medication. So we’re always looking
for ways to either streamline the process so
that we can maybe, for example, shorten the
window from when we get a medication request to when
it gets over to Russia for launch. Or whether or not there’s
a new clinical practice guideline for something
that we need to make sure we have a medication for
on board. And then I just mentioned
the research integration. Having the ops perspective
with the research perspective I think has
really been good for both of us. So, with that, are we
taking questions now or at the end?>>I would say probably,
if it’s unique to your piece, which I have a
question of my own.>>Okay.>>Are you over, because
White Sands is part of JSC, and they have a
clinic there, are you pharmacists for them as
well, and do you, when you get your inventories, ship
the stuff to them or they do something different
there?>>They do something
different there because they have pharmacists are
only licensed in the state that they practice.>>Okay.>>But we are contractor
pharmacists. So we can’t oversee them. They have a consultant
pharmacist that comes in and helps them do what
they need to do. Now we have streamlined
and helped to streamline some of their purchasing. But it doesn’t get shipped
to us and then shipped to them because it cuts into
our rules as far as being a distributor. And we’re not licensed as
a distributor. Yes.>>So how do you get
injected medication out of a vial in space?>>They, Melinda came up
with this really cool technique called slinging. So you kind of, I mean
it’s a technique. You kind of have to
practice it to get some sort of centripetal force
so that it pulls it down. It’s one of the reasons
why we chose not to use, the point of that actual
flight, was to see if we used spikes instead of a
needle. If you use a spike in it,
could you get the stuff out? Well no because the spike
can’t be moved. So we learned something
very valuable. And in an effort to try
and be patient safe and go needleless, it actually
wouldn’t have worked. So by using the needle,
they can kind of chase it if they had to. We try and get prefilled
syringes wherever possible, because
obviously that’s more convenient for everybody
involved. But we, when the med kit
redesign came about we wanted to build in
flexibility because we’ve had so many shortages with
prefilled syringes. It’s better to have a vial
that, you know, that they chase around the liquid
with than try and then not have the drug at all. But it was something that
we wouldn’t have, we didn’t expect at all. Yes.>>Would some of the drugs
that you use clinically in bottles, the bottles seem
to be quite large for the amount of drug content
that’s actually in that. Because of the space
flight environment and mass and the cost and
stuff that have to be involved in that, have you
ever had to reduce the size of the vials and
has that made a difference. Because then you’ve not
got as much surface area for the fluid, or the drug
to be in.>>Okay, so it’s two parts
to answer that question. The first part is we
cannot, because of rules of regulations for
pharmacy practice, we can’t sterily do that. So we couldn’t take
something from a 10 a mil vial and put it in a 5 of
mil vial and slap a label on it. It impacts a whole bunch
of other things downstream. Wherever possible we try
to make sure that they have the smallest
available vial. However, we found that the
single dose vial, the tiny little ones, are actually
harder to get out because then you’re having to use
multiple vials to get whatever you need. So it’s kind of a
tradeoff. We try and make sure that
we have the best option available. And that’s where that
shortage, you know, impacts comes from. The med kits contents are
set up right now with best case scenario. And prefilled syringes are
where we’d like to be. Now some things are only
available in one size. So it is, it is what it
is. Yes.>>So you mentioned that
there is a one gram limit of alcohol on board. Why exactly is that?>>It’s an environmental
reason. I’m not exactly sure what
the impact is, but it’s an ECLS rule that we
find out by accident. Materials called us, so. Yes.>>As far as the patient
private information, are there any unique
considerations for your pharmacy compared to
terrestrial?>>No. Everything that we do, I
mean, patient privacy of course everybody has to
follow patient privacy. So there’s nothing really
different. I mean Ginger can speak to
that a little bit more. We’re not really allowed
to talk about stuff that’s not been published, you
know, in the general forum, from what I’ve been
told. I mean other folks may
have different. But because we’re the
clinical pharmacy god of the house, I can’t get up
in front of a panel and say, well anecdotally
this, that and the other, because it hasn’t been
published. So that was our direction. And do you want to, well
when you get miked you can answer.>>We’ll go there.>>Okay. Did that answer your
question? Okay. Yes sir.>>Do you find that
medicine expires faster or they have different
expirations being in space than they do on the
ground?>>Well that’s where
Ginger’s latest research is coming. We don’t really know yet. And I actually suspect
that lower earth orbit isn’t going to be the
answer for us. I actually think that once
we fly outside of that, we’ll have more of an
impact, just based on some of the conversations we’ve
had. Shuttle, no, it was 14
days, you know. But station, you know, the
drugs that we get from the market only have about a
year, 18 months, maybe 2 years, that come from the
distributors and the wholesalers. So that’s usually the rate
limiting step is what we actually get in-house
before we can pack it.>>It could probably be an
impact on a Mars mission.>>Absolutely. Absolutely. And I’m sure Ginger is
going to talk about that, yeah, yeah. I can only, legally right
now, I can only pack what we have information for. And so that’s one of the
big things that’s a concern for me is if we
don’t have data and all of a sudden we’re being
asked, well can you stretch it? That’s a little bit of a
hitch for us. But I’m hoping that we can
get some good research to at least maybe start that
conversation. And then we can always
work with the FDA later if we needed to. But right now to go to
them and say we don’t have any data, can we extend
shelf life? They’re going to laugh at
us.>>How do you inventory
the meds? Do they have a barcode, or
do you just get the whole pack back and you look at
what’s missing? To tell what the crew
really took. Or do they.>>For the station, yeah. That’s a work in progress. Right now there’s a
project for RFID in one of the packs. And it was actually, it
actually came out of one of the research gaps from
a different group. And we got pulled in
because it’s ultimately going to impact how we
pack. It was supposed to launch
on SpaceX 5, but then the equipment that was going
to be able to read it wasn’t launching until
five months later. So it’s got pushed off. Right now it’s based on
what people tell the ground. So most of our resupply is
based on expiration date. We very rarely get stuff
where we get a call down saying hey, it’s been
used, we need to resupply it. Because we have quantities
in such that we should never get to that point. But it has happened.>>For a non-narcotic
drug, do you have to verify what came back? And do you have to destroy
them, or just concider it waste?>>So for non-DEA drugs we
get nothing back right now. So the program has made
the decision that they’re not going to return
anything. So everything gets
trashed, which is unfortunate for a research
perspective. We have in the past gotten
things back, and we’ve turned it over, most of
it, if not all of the packs, over to research
for stability. It’s of course, I don’t
want to steal your thunder, but it’s like one
time point there’s not ground control. It’s an opportunity to do
something with those medications. Ideally it would be nice
to get them back, one for inventory because we
wouldn’t be asking the crew to go off and do this
exercise to make sure that we have a count for it. And two, it allows us to
be able to turn stuff over to research. You know, the onesies
twosies that we’ve been getting back are difficult
until you can see kind of a trend. And each mission is
different. Each timeline that they
have, and each solar event that they’re, you know,
experiencing, is different. So it would be nice to be
able to get them all back. But I don’t make those
decisions. Sadly. Anything else? Okay I appreciate your
time guys. Thank you so much for
coming out. [ Applause ]>>Seriously, where did
the mouse go? Yes it’s not bad. It’s not bad. Tina, did you make my
mouse disappear?>>We can see it.>>It’s on the television. But if you move it all the
way to the right or all the way to the left, it
will reappear back on the laptop.>>Ah, brilliant. There I am. Okay. Okay, can everybody hear
me alright? Alright so I’m going to
pick up where Tina left off. And she did a really good
job of setting things up for my story. When I tell people that
I’m with the pharmacology lab or the pharmacology
discipline at JSC, the first thing that people
say every time is NASA has a pharm lab? And I especially get this
from young students, pharmacy or pharmacology
students, who hear about my job. And they’re like, there’s
a job like that? How cool. And how did you find out
about it, and how do I get into it? Well, I didn’t know NASA
had a pharm lab until 2009. Which is when I was
looking for a job, and I found this job advertised
in the back of science. At which point I had to do
a little bit of research to find out why NASA had a
pharm lab. And maybe I’d want to work
there. So I quickly had to
educate myself on what goes on with
pharmaceuticals and spaceflight. And if you think about
going on a trip, if you go on a trip, you might take
medicines. You might take the
medicines that you know you take every day,
routinely, or you might take medicines to prepare
for some kind of thing that you expect might
happen. And that’s what
spaceflight is. We’re going on a little
trip. We pack ahead of time for
the things we know we’re going to want and for
things we think might happen. And the first time this
came up, and you know, you don’t really do this when
you’re going out for two hours. You do this for longer
duration trips. So the first few
spaceflight missions, there weren’t any
medications. But by the time in 1963,
by the time we got up to 35 hour journeys, people
thought, you know, maybe we should be taking some
medicines with us. And at this point they
packed preloaded auto injectors with a pain
reliever and a motion sickness treatment. I don’t know if either
were used, but they were packed. And those were the first
pharmaceuticals in flight. Now things are different
in microgravity, and that sounds really simplistic
and stupid, but it comes down to make a huge
difference in all kinds of things. Tina was telling you about
filling a syringe and the challenges there. So everything that you can
think of can be different in spaceflight. Like flame, it doesn’t,
there’s no rising air current. So flame in space is
different. And there’s some great
videos that our crew members have done with
experiments on that subject. You should look them up. Carbonated beverages. We don’t take those with
us anymore because, I don’t know how well you
can see it here, but that’s a bubble of a
carbonated cola drink there. There are air pockets
trapped inside it. In a glass, right, the air
bubbles come up to the top. They rise. But in microgravity they
don’t. The gas is trapped inside. So you’re actually
consuming more gas, and you don’t have the
separation of gas and liquid in your stomach
either. Which I’m told makes for
some uncomfortably messy burps. So no carbonated beverages
in space. So you have to apply that
kind of thinking to just everything on the
missions. Things can be different. And when folks started
investigating what happens to the human body in
spaceflight, and this has been going back since
early days, we’ve been finding out of a lot of
different parts of physiology that are
altered in the spaceflight environment. One of them is an overall
upward shift of body fluids. And I know we have a lot
of doctors in the audience. Your body has a number of
mechanisms to compensate for gravity by pushing
fluids up. Rather than having all of
your fluids pool in your six-foot-tall, or in my
case five-four, hydrostatic column. We have features,
especially in the lower parts of our body that
helps move fluids up. All of those features are
still active when you go to microgravity. So there’s a net movement
of fluid up. And this can even, we
think, move some fluids maybe out of the
circulatory system. It causes an unloading on
the cardiovascular system, what changes some things
in various reflexes. We can get changes in salt
handling that go in with all of those reflexes. So this very quickly
becomes incredibly complex because of the very
complicated way that your physiology has adapted to
handling water and salt and responding to gravity
and everything. It’s all connected. And it’s not just limited
to the cardiovascular system. We know that decreased
gravity disrupts the sense of balance. And some of the other HSA
talks are given by the discipline leads of these
other areas I’m going to mention. So you may get to see more
about them. We have space adaptation
system syndrome issues where people may feel
nauseous or even vomit, particularly in the first
few days of flight or the first couple of days after
transitioning back to earth. This particular syndrome
drives some number of medication usage by our
crew. We have a loss of bone
mineral density that seems to increase with time
spent in microgravity. People experience body
pains, and we think this may be due to expansion of
vertebral discs or rather lack of compression of
vertebral discs. People complain of head
congestion kinds of issues. It may be related to the
fluid shifting. We’re not really sure
about that yet. Circadian rhythms are
certainly disrupted. There’s an absence of the
normal cues that would help you set your body
clock. So all of these
physiological issues have led to quite a number of
reports of various medical complaints in space. And these are all
published. On your right side is some
space shuttle lists and based on the ISS, this
list. In large, well largely,
these are things that would happen to any adult
ambulatory healthy population. You know, the occasional
little infections, irritations, nothing that
would be considered terribly problematic. But those instances have
driven usage of medications that Tina
packs them to get for them to take when they need it. And this is all shuttle
data. Very shortly, everybody
cross your fingers for me, I should have a new
publication doing a similar examination on ISS
medication use. But, well spoiler alert,
it’s not all that different for station. You still have to read the
paper though. Sleep is a driver of a lot
of medication use. Or rather insomnia is a
driver of a lot of medication use. Headaches, congestion,
space adaptation syndrome. A little GI complaints,
back pains, EVAs, people sometimes complain of a
physical pain, muscle aches and strains after an
EVA. Largely related to the
hard suit that they’re operating in. Apparently it’s really
hard work to wear that suit and do stuff. So, yeah, for all these
reasons, NASA has a pharm lab. And we have a mission
that’s related to Tina’s. We want to make sure that
the flight surgeons have good information about how
the pharmaceuticals they’re using to treat
their patients will work in the extreme conditions
of spaceflight. Which means that, and I’m
going to go all the way to the end, so as a
pharmacologist, it’s my job to know the
pharmaceutical’s mechanism of action. That’s normal. That’s what I do. But it gets a little
weirder here at JSC because we have to factor
in, how did the spaceflight environment
change the physiology of the person you’re giving
the medicine to? And we have to think about
whether the spaceflight environment did anything
unusual to the drugs themselves. Now this means that we do
experiments. And we can’t do every
experiment on an astronaut in flight. It’s just no feasible. We use a number of
different models. And some of the talks here
have been about those different models. We can use bedrest, and
that has been used for some issues, particularly
testing bone loss drugs, certain cardiac issues as
well. Muscle atrophy. We’ve just started using
HERA as a new model. They’ve been testing some
software for me that we’re about to start on flight. A simple tool that runs on
an iPad for an astronaut to record their own
medication usage. What they took? Why they took it? How well they thought it
worked, you know, perceived efficacy. Report many side effects
there as well. So we’ve been testing
software in the Hara environment. We can do a few things to
model particular features of the spaceflight
environment. And one of them is to make
people sick. These kinds of studies
have been going on for decades. Rotating chair sorts of
experiments have been used with a lot of motion
sickness treatments to try and test efficacy of
dosages and side effects and whatnot. Right now there is a study
doing something like this, along with a learning
protocol. This is, Barry Young is
the PI. It’s an NSBRI-sponsored
study. His hope is to develop a
combination of a learning protocol with a reduced
dosage of a medication. So by training people,
maybe we can help them use less medication. Which leads to fewer side
effects. We can also use culture
systems to measure things that go on at the cellular
or biochemical level. And this happens a lot
over in Building 37. We can’t do everything in
ground analogs because we can’t perfectly model the
spaceflight environment. So sometimes we have to
use spaceflight. But that involves huge
limitations, huge limitations. We’re using human subjects
and very valuable and important human subjects
who have very busy lives up there. We need to use
non-invasive methods whenever we can. Experiments need to be
nontoxic, and that’s every part of the experiment. Every solution you’re
going to use to do anything has to be
approved by the tox folks. We need everything to be
lightweight and small. Any plastic materials
involved have to not degas something toxic in a
closed environment. We need low power
consumption. We need to arrange the
protocol of the experiment to not impact the crew’s
schedule very much. And no matter what
happens, your experimental end is going to be small. On any given mission we
may have two or three individuals sign up to
participate in a certain experiment. You know, your maximum
number would be what 500 people if we had everybody
ever sign up. And from, for a
pharmaceutical study, that’s small. That 500 is small. You know, in the clinical
trials world we run 3,000 people at a time through
things. So this is a really
different world as far as end goes. Nevertheless, things can
happen. Crew members can take
blood in flight, and they do. They can even do their
own. And we have freezers to
store the samples. We can separate out serum,
and samples can come back. Lately Dragon has been
bringing back samples. And we’re really happy to
see that. There are also
opportunities for crew members to perform
measurements in flight themselves rather than
returning a physiological sample to earth for us to
examine. The ultrasound equipment
has been used heavily in this regard, and we’re
working on developing some new kinds of things, lab
on a chip kinds of models where you can do a finger
stick and have capillary action pull blood right
into one of these little ports. The chips can be designed
with preloaded bindery agents. Usually anybody-driven
tests. So we can use those, the
binding capacity of anybody to measure a given
analyte. These kinds of things are
kind of being developed right now. And we’re working on
finding a good commercial partner to start getting
some of these kinds of capabilities on board. Initially we’re looking at
replacing, well like aiming at a CBC kind of a
test, a suite, first. And then we’ve got a long
list of analytes, both clinical and research
analytes that we’re interested in enabling in
the future. And it’s probably going to
be something like a different kind of chip,
just have different preloaded chips that they
could use. Now missions now, now
we’re just talking about having a one year mission
that’s beginning. Six months has been
routine for the past few years. In early days, things were
really different though. People were going on
missions that lasted a few days. Maybe up to two weeks. And at that point I think
your thinking is different. It is like a camping trip. So you can, if you think
you’re going to need headache pills you put
them in a zip lock bag in your pocket. And you take some, you
take a whole lot of power bars with you and some
water. And you just go. And you work hard, and you
don’t complain much about lost sleep. It’s a camping trip. That’s your mentality. But when you’re staying
there working for six months or a year at a
time, I think we have to switch gears a little bit. And maybe even more than a
little bit. So we’ve been thinking
about ramifications for long-term health. And about improving
behavioral health and performance for
individuals while they’re going through this. Which leads us to a whole,
well a long list of things that we need to be
concerned about. And like I said, I came to
space research in just 2009. It wasn’t that long ago. And I had the opportunity
at that point to learn a little bit about medical
operations and about how Tina’s group was working. And to think about
everything that we might need for long duration
missions. And to just make a list. What don’t we know? What do we know, what
don’t we know? And there’s an awful lot
we don’t know. And it’s not because we’re
stupid. It’s because nobody else
has ever needed to know before. These are new kinds of
questions. So among the things that
we don’t know are what are the crew members using? And how much and why? And do they feel like it’s
working? We don’t really know that. There’s a little bit of
information embedded in the medical records. But the information that’s
in the medical records was not collected with these
questions in mind. So they didn’t do from my
point of view a very good job of collecting that
information. They were concerned with
taking care of the health of their patient. So that’s where they were
focused, as they should be. We also have open
questions about the stability of medications. And somebody already said,
do the medications degrade differently in space than
they do here. We really don’t know. We’ve taken a look at a
few examples that we’ve been able to get returned. CHS and Tina worked very
hard to get some samples returned, that I’ve had
the opportunity to analyze. And that’s another paper
that’s going to be out soon. So right now I really
have, I only have a few examples and a few time
points. But I don’t see anything
that would make me concerned about
medications being stored on the ISS. Things are not degrading
or showing signs of degradation before their
expiration dates. So right now, of the very
small group of medications we’ve looked at, we’re not
seeing any signal flags. Pharmacokinetics, Tina
already told you what that is. Absorption, distribution,
metabolism and excretion of medicines. How your body handles the
drugs that are put into it. I mentioned the fluid
shift feature of being in microgravity. I don’t think you have to
understand a whole lot of physiology to imagine that
if a bunch of fluid in your body is shifted from
where it normally is, that this could affect how you
absorb and distribute a medication. And where we’ve got some,
we’ve got an experiment that’s going to be
starting in a couple of years to examine this in
flight. We also look at
Pharmacodynamics. So all the medications
that, all the reasons that a medication might be used
in flight. You know, is the
medication finding its target site correctly? Is it interacting with the
subsequent biochemical pathways properly. You know, is everything
the same or is it different? We don’t know. Now as far as the usage
goes, I gave you a heads up about this. So my study is called dose
tracker. And we’re, we’re pitching
to crew right now. We’re going to use this
for a few months for each particular crew member who
volunteers to be in the study. And it’s voluntary. It’s a research study. We’re going to use this
for a few months on the ground and collect some
information on that particular individual. How often they treat
headaches. How often they use sleep
medications. And what kinds of side
effects they usually get? Do they get a tummy ache
after they take an aspirin, you know, things
that are unique to that individual. Then we’ll have them use
this dose tracker application to record
their medication use in flight. And we’ll be able to
compare that person’s medication usage in flight
and on the ground. At the same time, so
that’s an effort to collect a more complete
set of data from a research perspective in a
prospective fashion. We’re also working with
Tina’s group in the pharmacy to look at what
data already have been collected in the past, on
past missions. LSAH has been going
through medical records and PMCs and every place
they can to pull out information that is in the
records from previous missions. And put together a big
awful table, a big awful table for us to comb
through. To see if we can find,
well whatever patterns we can find. And we just got that
dataset, what, the end of July. And we’ve been trying to
figure out an approach. I think we’re getting
there, and maybe we’ll figures something out
soon. But we’re doing what we
can to patch things together there. In the world of stability,
there have been a few different efforts at a few
different times. And right now we have, we
kind of have three different tactics going on
right now. We’ve got, we’ve got some
analyses of flight-aged medications. So that’s what I was just
talking about. Some of these medications
that we have not analyzed personally in-house. I think we’re going to be
able to offer to external investigators who are
specialists in certain areas and have them
analyze things. Which is really cool. It allows us to
collaborate more with chemists in the outside
world. We’re looking at packaging
materials and packaging methods to see if we could
increase the useful life span. Right now, the gold
standard in the pharmaceutical industry is
to use foil, foil blister packs. So it’s that Mylar-looking
stuff on both sides. That is, it’s really
impermeable to humidity, to light, to oxygen. It’s really, it’s awesome
for all that kind of protection. We have no idea what
happens in a radiation environment with it. But it’s the best thing on
the ground. Now from a packaging
perspective from Tina’s point of view, it’s
miserable. Just miserable. There’s all this trash. It’s relatively heavy. Yeah, it’s terrible. Just terrible. So we’re trying to figure
out what we could do that would be both protective
and feasible for flight. And the answer is not
obvious. We’ve also got an SBIR out
there. This investigator from
Real Time Analyzers is in phase two of his SBIR. He’s building, he’s
building a device that I fantasized a while back
and convinced management to post an SBIR for. And it seems to be
working. You can do a lot as far as
analyzing a medication with various kinds of
thermal or optical techniques. And this company is using
near infrared. They can shine at a
sample. And the spectrum they get
back. You can identify a
substance from its spectrum. Homeland Security is using
this all the time now at ports of entry and
whatnot. They can open a 55 gallon
drum of white powder, like what it is? Is it baby milk, or is it
anthrax? What is it? And industry has come up
with little hand-held scanners where someone who
doesn’t know anything about science can just
shine on the white powder. And if the scan, if the
squiggle, if the trace of bumps matches something
that’s in the library that’s in the machine,
they can identify it. So they can tell you, does
it match baby milk? Or does it match anthrax? You know, they can do
that. So for this project we’re
aiming at doing the same thing with the
medications. We’ll have the scanning
capability, and we’ll build up a library of the
medications we pack in good shape, and the
medications we pack in degraded shape. So when you do a scan, the
idea is a crew member, on year of their mission, the
medicines are getting kind of old. Is it safe to take or not? They can scan it and see
if it matches the good spectrum or not. And you know, so that
would allow them a little control over what they’re
doing. You know, how we’ll
implement it isn’t known yet. First we’re trying to
figure out if we can, if we can actually make this
work on the ground. And they’re doing that it
looks like. For those of you who go to
the investigator’s workshop in January, he’ll
be there with an update of their progress this year. So that’s covered
stability. For PK, we really don’t
know if the spaceflight environment alters
pharmacokinetics. We’re investigating that
now. This is a new study that
was selected in the last NRA. And I’ve been working
recently. There were some
feasibility issues from the point of ISSMP about
implementing the study the way we had proposed it. I think we’ve worked that
out now, and we’re going to be moving forward. We’re going to give crew
members a select number of medications and have them
perform serial blood draws and bring samples back
down to earth and analyze them. Just as you would with a
standard PK study on the ground. We’re going to have the
same crew members perform this before their flight
and after their flight, as well as during their
flight. So we can compare and see
if there is a spaceflight associated change. That’s really what we’re
looking for. The pharmacodynamics
aspect of this study are going to be in the area of
sleep. There aren’t a whole lot
of PD kinds of things that you can measure in a
non-invasive way. But sleep is a good one. We can tell when someone’s
sleeping, when they’re awake, there’s actigraphy. There’s a lot of different
ways to do that. So we’ve intentionally
chosen some medications for this study. One is a sedative, is a
hypnotic drug that people use to help them sleep. A couple others that we’re
using are known to have soporific side effects. So we’re hoping to collect
a little bit of PD data on how well they work. I also do, in the world of
PD, I look out for some of the other disciplines that
are in health and human countermeasures. We have experts in muscle
and bone and the immune system and what not. And you’ve all been
hearing lectures from all of them. In many cases, there are
countermeasures proposed for whatever problems are
in that discipline, that involve a pharmaceutical. So I try and be a good
partner to all these people with what medicines
they are using now or proposing to use in the
future. So one thing we’re doing
with the bone group, they’ve already done some
studies with Alendronate in flight and seeing very
good efficacy with that. But as you probably know,
there are lots of other bone loss treatments out
there. They have not yet been
tested in space. And I’m keeping my eye on
what’s going on with them as people on earth are
taking them. Bisphosphonates have a
pretty common reflux side effect, which sometimes
we’ve talked about being concerned about that in
spaceflight. If you don’t have the
influence of gravity, you might be more susceptible
to reflux kinds of issues. So we’re thinking it’s
possible that we might see that side effect more
often. So it might be a good idea
to have some backup plans. So I’ve been watching
Denosumab and some of the PTH-derived drugs as well,
come through the clinical trials testing program,
hit the market and have adverse events reported in
the FDA system. We’ve got, we’ve got a
short list that we’re looking at here. There’s, I guess because
of the market share, the huge market share for this
particular kind of drug, there’s a lot of activity
in the drug development world with these kinds of
drugs. Not every realm is that
active. We also think about basic
science results and how they could affect what is,
what’s happening clinically. So there have been basic
science results with various microorganisms,
potentially infectious microorganisms, that seem
to become more virulent when they’re in a
spaceflight environment or in a rotating tissue
culture system that gets used on the ground a lot. So imagine a bad day. You’ve been infected with
a salmonella or something that’s spaceflight-altered
so that it’s more virulent. And you’re given an
antibiotic. Well does the antibiotic
work on that microorganism that has been altered? We don’t know. So I’ve been partnering
with the microbiology group at JSC who does a
lot of work in collaboration with Arizona
State on addressing this issue. Can we do some testing of
the antibiotics who carry on microbes that have been
altered in this way? So that’s ongoing. We’re also looking at
medications to treat space adaptation syndrome. And I mentioned Larry
Young’s study already. The medications that are
used to prevent nausea and vomiting are generally
associated with some unpleasant side effects. So if they’re going to get
used at all, we’d really like to reduce the dose. So this study that’s aimed
at reducing the dose by using a learning/training
kind of method, we’re hoping is going to work
out well. We also keep our eye out
for new clinical issues, the VIP problem hasn’t
been terribly well-defined yet. But we’ve had two
activities in this area. One is to investigate the
possible treatment options for this. The one that seems obvious
is Diamox, that would be used on earth for these
kinds of symptoms. It’s associated though
with an elevated risk of kidney stones, which we
don’t really want to give to people who are at an
elevated risk of kidney stones. So there’s a problem
there. So I’ve been searching
clinical trials for new drugs in this kind of area
as well. We’re also examining,
through the medication use evaluations with the
pharmacy, what affected crew members have used. A lot of vision changes
can be associated with medication use. So this small study that’s
in progress is trying to look at whether symptoms
associated with VIP could actually be caused, at
least in part, by some of the medications that
people are taking. If it’s not, that’s great. We want to rule that out
so people can move on to what the real answer is. Muscle atrophy occurs in
spaceflight. And we have the muscle
expert right here in the audience. We have been watching for
them a developing class of compound, selected
androgen receptor modulators. I don’t know if you’re
familiar with them or not. We know that testosterone
and other kinds of sex hormones can increase
muscle mass. We know that. We’ve all seen in the news
where it can go horribly, horribly wrong and be very
detrimental to individuals. The pharmaceutical
industries are developing more selective agents to
perform particular activities in different
areas of the body. The trouble with something
like a sex hormone is that there is a receptor for it
in nearly every tissue in the body. And so using the parent
hormone can cause a lot of effects that you might not
want. By targeting, if you’re
lucky enough that there is a unique kind of receptor
on the tissue that you’re interested in, in this
case it would be a muscle selective receptor of some
type. If we could target a drug
to that particular receptor isoform, we could
have our drug act only on that tissue. Which is exactly what
these studies are aiming at. And there’s been some
really good pre-clinical work done. They’ve got some beautiful
studies out now where muscles in mice have been
shown to recover from disuse atrophy. Very beautifully, without
having effects on the reproductive system in the
animal or in the brain or anything else. I’m thinking that this may
be a really good solution. But because we’re still at
the mouse stage of experimentation, it’s
going to be a while before anything is in the clinic
I think. Another avenue that’s kind
of way off in the future is the idea of taking a
medication to protect individuals from
potentially damaging radiation exposure. It may be that exposure to
radiation is going to be the limitation as far as
human beings going on spaceflight missions. If we could, if we could
remove that limitation, it would be wonderful. So can’t we just take some
antioxidants to stop it? I get asked this on a
really regular basis. There’s so much in the
news now about blueberries and other fruits and
vegetables and curcumin and turmeric and curry and
just, everybody has a solution, right. Just take antioxidants. Well, it turns out that
the redox balance in your body is really very
sensitive. And it is a balance. If you slam the system
with a lot of antioxidants, your pushing
the balance in one direction. And that direction is not
always good. And in fact there have
been studies where a lot of antioxidants have been
given to cancer patients. And we see that people die
faster. It doesn’t happen every
time with every kind of tumor, but it has been
noted. So just delivering a big
load of antioxidants is not the answer. Now it could be a part of
the answer. Or there could be certain
antioxidants. Or I don’t know yet. We’re watching some of
these in trials now. And certainly there are no
human populations in the same situation that our
astronauts are in. Getting a very, very low
dose over a relatively long period of time. From a wide variety of
radioactive sources. The ground groups that are
being tested are cancer patients who are getting
radiotherapy. There is a big drive to
produce a co-therapy that could be administered with
radiotherapy to help protect these individuals
from the radiation they’re getting limit their side
effects and perhaps triggering of subsequent
tumors that are radiation-derived as well. So there’s a lot of
activity in the pharmaceutical world in
that area. We have no idea how well
it will inform what we’re doing because our
situation is so different. But it’s something we
think about. So you can feel free to
contact me directly with any questions. A lot of the information
that I showed you about the topics that we’re
investigating and studies that are funded right now
by NASA are on this human research group web page. And they go into detail
about particular topics. And here’s mine at the
human research roadmap. And I’ll entertain any
questions you have now.>>So early on in your
presentation you had a chart showing various
types of medication use on the shuttle, as well as the ISS. I’m just curious, have you
studied the relative frequency of the need for
those medications on earth versus spaceflight. Are they mostly the same? Or some jump up.>>So that’s the
discussion part of my new paper. So you’re going to love
it. You’re going to love it. So, that is kind of a
natural question. Is it any different? And it’s a little bit
tough to make the comparisons because our
population of people is, they’re very healthy. They’re very healthy
adults. And most studies that are
conducted about medication usage and the general
population, they look at the general population. So they include old people
and sick people and, yeah. So making those direct
connections are a little tricky. I’ve been able to use, I
found a couple of populations that may be
good comparisons, or at least better than the
general population. One is a crew on
submarines. So they live in a closed
environment for months at a time, like our crew do. They tend to be healthy. So in, they have rigorous
schedules. They don’t have circadian
cues. There are quite a number
of things that are like our crew members. But they are also some
significant differences. They have very few women. They only started women on
these submarines very recently. At least the US did. Their crew tend to be
significantly younger, 10 to 15 years younger on
average than ours do. And not as well educated
as ours. In general, though, again,
another spoiler alert, our crews aren’t using
medications really any differently than anyone
else. They are using sleep
medications a little more. And that’s really the
biggest difference.>>What about headaches? Does that tend to be
generally in par with our population?>>That one is really hard
to tell. Really hard to tell. Because even if you’ve
enrolled people in a study about medication usage,
when you ask them to write down everything they took,
over the counter stuff for a headache, they don’t
always think that’s important enough to write
down. So you know you’re getting
an error in data, and you know which direction it’s
in. And we see this with our
crew members too. It might not have been
noted because it didn’t seem like a big deal. Also, since headaches are
relatively common, people think of it as, oh, that’s
really common. So nobody wants to know
about that because it’s just not important. It’s almost like normal. It seems too normal. So we know we’re missing a
lot of information there. Both in the general public
and our population. Yeah.>>We still have folks
that, even in a clinical trial, that take a placebo
that report that they get a headache. So, you know, it’s a
placebo. It’s basically a sugar
pill, and they’re reporting the side effect
was a headache. So it would be very
difficult to keep up with that.>>And that gets further
compounded by a side effect, a noted side
effect of nearly every headache remedy, is
headache. It’s true. Go look it up. But, you know, headache is
a reported side effect of nearly every medication
that’s produced. Is that.>>Is that real?>>Because headaches just
happen to people. Or is it really
drug-derived? We’re not really sure. We’re not really sure. For things that are so
very common, it’s hard to tell what’s real and
what’s not. What else?>>Ginger, I assume that,
PK and PD are different in 40 to 50-year-old average
age astronauts than they are in younger earth
everyday people. So do you have to take
that into consideration when you’re looking at a
new drug. And then what does space
life do on top of that older individual. I assume that’s a factor
in.>>So the age of our
astronauts isn’t that much older than the people who
would be used in clinical trials. As long as they’re healthy
and don’t have any kidney or renal failure, they’d
be classed as adult, normal healthy adults. Probably not an issue. There are some medications
where indicates a very narrow therapeutic index
we might be concerned. But the drug kit that
flight medicine has chosen is really, really good
about avoiding those kinds of medications if at all
possible. So they’re making smart
choices about how to avoid these kinds of problems. Yes.>>So I understand these
kits are premade and there’s standard stuff in
the kit. What do you do if you have
a crew member who comes along and they say, well
on the ground I usually take this. And you say, oh that’s not
on my kit. Is that just, you don’t
get that, or do you, can you add new things in just
quickly. Or how does that.>>That was a
crew-specific iMac that I mentioned, yeah.>>Okay.>>So that they have
everything.>>So you can accommodate
everybody.>>Right. Right.>>Right so.>>Within a three kilogram
limit.>>So each individual
who’s flying has the opportunity to continue
using their routine medications when they go
on their mission. And I’m told they can even
do things like, if you personally identified one
sleeping, one insomnia treatment that you prefer,
even though you don’t take it all the time but you
know you prefer it, you can carry some of that for
instance. Or if you prefer to treat
your headaches with aspirin versus ibuprofen,
you can carry you some aspirin. You can make some personal
choices about your healthcare in flight. Yeah, there’s a mechanism
for that.>>And there’s also a
mechanism that if we see enough of a trend of the
personal packs wanting the same thing that’s not in
our med kit, we can move it into the med kit to
free up some space. And so that’s all part of
the work that we do with HMS and the crew surgeons.>>And one of the things.>>Both of them happen
more regularly than>>Right, now that we have
the medication usage.>>Right.>>Yeah, hopefully we
should be able to inform those decisions a little
bit better by looking at what people are really
using.>>That long pole in the
tent though is the process time it takes to make
those changes. So that’s something that
folks really do need to pay attention to. Because if we do need to
act quickly and make some changes to the med kits
because a new clinical reason needed, you know,
it shouldn’t take a year to 15 months to get it put
in the system and packed and ready to go. But that’s a process
problem.>>What else? In the back.>>Are there any specific
medications that you know that you cannot take up?>>Anything refrigerated.>>Right. Right. So we can only carry
things that require room temperature storage. If storage is anything
other than room temperature, we cannot. There are some
medications, especially the liquids and ointments
and whatnot that contain too much alcohol. What else?>>Anything that would
foam. So like an injectable
medication that might be used in a cardiac event.>>Things in a.>>If it’s shaken, it can
foam.>>Things in a delivery
device that’s not going to work in microgravity. That would be another one.>>Right.>>What else? Nothing else? Well thank you all for
attending. I appreciate your
attention. [ Applause ]>>Thank you Drs. Wotring and Bayuse. Again, thank you all for
being here today. A couple of things for
you. We have surveys that we’ve
asked you guys to take. We want you to complete
them and will walk around, or stand here
and then you hand them to those persons as you’re
leaving. The other thing is that on
next week we have another lecture series in case
you’re interested, and this is hosted on the SA
web page. All of our lectures are
posted there. It’s going to be on kidney
stones. It’s next Tuesday at 10:00
in the same location. And that’s going to be our
last seminar series for this year. We’re going to break for
the holidays. But already we’ve got four
more seminars scheduled for January and February. So that information will
be posted to the web very soon also. So thank you again for
your attendance. And please turn in your
surveys please. Thank you. We appreciate your
feedback.

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