August 4, 2025 • 34 mins
With sexually transmitted infection (STI) rates continuing to rise, over-the-counter testing kits are expanding access to care, and pharmacists are well-positioned to support their safe and effective use. This episode explores key facts about available OTC kits, regulatory updates, counseling responsibilities, and the potential for test-and-treat models in pharmacy practice. Join us to learn how pharmacists can contribute meaningfully to STI prevention and care.
HOST
Joshua Davis Kinsey, PharmD
VP, Education
CEimpact
GUEST
Elizabeth Skoy, PharmD
Professor
North Dakota State University
Joshua Davis Kinsey and Elizabeth Skoy have no relevant financial relationships to disclose.
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CPE INFORMATION
Learning Objectives
Upon successful completion of this knowledge-based activity, participants should be able to:
1. Identify the types and regulatory status of over-the-counter STI testing kits available to patients.
2. Describe the pharmacist's role in educating patients on the use of OTC STI kits and recognizing potential opportunities to support follow-up care or treatment.
0.05 CEU/0.5 Hr
UAN: 0107-0000-25-270-H01-P
Initial release date: 8/4/2025
Expiration date: 8/4/2026
Additional CPE details can be found here.
Mark as Played
Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Speaker 1 (00:03):
Hey CE Impact subscribers, Welcome to the Game
Changers Clinical Conversationspodcast.
I'm your host, josh Kinsey, andas always, I'm excited about
our conversation today.
Sexually transmitted infectionrates are climbing and access to
timely testing remains a majorbarrier for many patients,
making over-the-counter STI kitsan important new tool in public
(00:23):
health.
In this episode, we'll explorewhat pharmacists need to know to
support patient use, answerquestions with confidence and
help expand access to sexualhealth care.
It's so great to have ElizabethSkoy as our guest today,
elizabeth welcome.
Speaker 2 (00:38):
Thanks, josh, it's great to be here.
Speaker 1 (00:40):
Yeah, great to have you.
Thanks for taking time out ofyour summer break.
As I always joke, as I rememberas a faculty member, summer
break was not really summerbreak, it was put your head down
and get stuff done.
But thank you, I know you'revery busy, so we appreciate it.
Elizabeth has done a lot ofwork with us on lots of projects
over the years, so we're justsuper excited to have you on a
(01:01):
podcast.
I haven't had you as a guestbefore, so, on that, go ahead
and take a couple of minutes,elizabeth, to introduce yourself
to our guest, for those thatmay not know you yet.
Speaker 2 (01:11):
Yeah, thanks so much.
So hello everyone.
So I'm Elizabeth Skoy, I am apracticing community pharmacist
and I also am a faculty memberand professor at the North
Dakota State University Schoolof Pharmacy and then I also
serve as the director for theCenter for Collaboration and
Advancement in Pharmacy.
So you know, between myteaching, I teach in a skills
(01:35):
laboratory, so I teach a lot ofthat hands-on.
You know how to type, I teach apoint-of-care testing elective
and then, of course, you knowwork with pharmacies to
implement point-of-care testingelective and then, of course,
work with pharmacies toimplement point-of-care testing,
test-to-treat, providingeducation basically on pharmacy
practice.
And so, yeah, this is a reallyexciting topic and exciting time
(01:57):
in the world of at-home testingdevices, and so it's great to
be here to talk with you guysabout this.
Speaker 1 (02:09):
Awesome.
Thank you so much.
Well, without further ado,let's go ahead and move into the
content for today and let'stalk.
I always like to level theplaying field.
Just make sure that we all knowwhat we're talking about.
For today's episode, I gave thesegue earlier, but let's just
go ahead and specifically naildown what we mean when we say
OTC, sti, kit, like what is outthere, what are the purpose of
these, and maybe even talk alittle bit about collection,
(02:31):
sample types and things likethat.
Speaker 2 (02:33):
Yeah, absolutely so.
When we're talking about theSTI kit, right?
So sexually transmittedinfection is, you know, we think
of STI, that's what that standsfor.
So we think of those tests.
Up until recently we had anumber of CLIA-waived tests that
were available, and so theywere.
You know, these CLIA-waivedtests that could be done in a
(02:53):
doctor's office or even apotential in a pharmacy, in a
pharmacy in certain situationswhere there was a sample
collection, and then it'susually you know, that
point-of-care test CL, cliawaived where you get a result
pretty rapidly.
There were a few kits out therethat were maybe sold over the
counter, but how that works isthat they're actually not, you
(03:14):
don't get the results right away.
And so there were some kitsthat were for STIs that were
available over the market thatyou know you kind of did the
at-home sample collection andthen you would mail in your
results, and so there wasprobably the first I would say
over-the-counter test that wasavailable for detecting an STI
was HIV.
(03:34):
So that's been around for alittle while where somebody
could you know and that wasthrough.
Either you could do either anoral swab like an oral
collection, or you could also doa blood collection for those.
So that was one, and then morerecently we have a couple of
other tests that have come onthe market for over-the-counter,
and that is for syphilis.
(03:56):
And then there is one forfemales.
It's only approved for femalesright now over-the-counter, but
it's actually the first PCR testthat was available over the
counter, so that's kind of a newthing in itself.
And then that is testing forchlamydia, gonorrhea and
trigonitis all together.
So those are kind of the mainones out there, and again, we've
(04:18):
had the over-the-counter HIVfor a while as well.
So, yeah, I think this marketis really expanding.
I think there's been greaterinterest from some funders, like
the NIH and things like that,to expand the types of tests
that are available for publichealth and getting these tests
to the public, and so it's agreat time to see these coming
(04:42):
available to patients so theycan test at home.
Speaker 1 (04:45):
Yeah, yeah.
And one thing that youmentioned, elizabeth, I want to
go back to is you know, anyprevious ones may have been some
sort of send off and you knowthe wait response and we know
that that doesn't really makesense because, a you need to get
treated pretty quickly to takecare of things or they could,
you know it could become prettynegative very quickly.
(05:06):
And, b if you are infected, yourun the risk of continuing to
infect others and you knowwithout knowing so.
So that is, that is somethingof concern.
So the idea that these newtests are, you said, a rapid
response, right, like they'repretty within just a few minutes
or whatever- so, yeah.
Speaker 2 (05:24):
So I think that's something to call out 10 to 30
minutes, depending upon the test.
Speaker 1 (05:27):
Yeah, so with the newer ones you mentioned too,
what are the collection samplesfor those Like, what would the
patients end up having to sendoff, or utilize.
Speaker 2 (05:37):
So this is where I think you know this is really
pretty great for pharmacy.
So of course you know the bloodsample and the oral you know
for the HIV.
But then we had for the test wealso had the sample collection
for syphilis, which is usually afinger prick blood sample.
So that's how.
So at home test is a bloodsample, it's a finger prick.
And then the more recent one,the PCR test for women for the
(06:04):
three STIs that it tests forthat is actually a vaginal
sample collection and so youknow that's probably you know,
not something where pharmacy isgoing to be collecting that in
the pharmacy, right?
And so you have, you know, someof these samples were like oral
and blood.
Pharmacies you know areequipped to do that sample
collection for like a CLIAwaived.
But some of these other testsif you're doing like a urine or
(06:27):
you're doing, you know, vaginalcollection, those are usually
those samples are usually takeneither in a clinic or in a
clinic setting.
Not always, I don't want to sayso.
There's some pharmacies outthere that might be doing this,
so that's fantastic if you areequipped for that.
But generally speaking, more ina clinic setting.
And then of course now you knowit can be- for home collection.
Speaker 1 (06:48):
Yeah, yeah.
So with that though and we'llget into this a little bit more
but while we're talking kind ofabout the introduction of these
to the market and so forth,reminding our pharmacists their
role in this, there are somerestrictions as to what we can
and can't talk about and guideon and that kind of thing right.
(07:09):
Like if there is a questionabout, oh, I don't understand
this sample collection, or Idon't understand this, like it's
not, like they could open it onthe counter and us actually do
it for them, does that makesense?
Speaker 2 (07:21):
Yeah, correct, so Does that make sense?
Yeah, correct, so it gets alittle.
It gets a little.
It can be confusing when youtalk about at-home tests versus
CLIA waive tests.
Speaker 1 (07:31):
Right.
Speaker 2 (07:31):
So these tests have technically, you know, a CLIA
waiver, but then once they'vedesignated by for an at-home
test in quotation marks at-hometest, then they become actually
regulated by the FDA, so they'reno longer regulated by CLIA.
Speaker 1 (07:48):
Yes, you took my question, thank you, I realized
I didn't pose that question verywell.
Speaker 2 (07:52):
I didn't know.
I thought that's maybe whereyou were going.
Speaker 1 (07:55):
Exactly where I was going.
You're answering it perfectly,so thank you so they're actually
regulated by the FDA, not CLIA.
Speaker 2 (08:02):
However, there's like this big, however, by the FDA,
not CLIA.
However, there's like this big,however, because we saw this a
lot during the COVID pandemicright when once we, if we take
as a pharmacy right, so if Itake at-home test and I collect
that sample for the patient, Ithen need to be operating under
a CLIA waiver.
(08:22):
It kind of comes back underCLIA if that makes sense, so I
can instruct a patient how to doit themselves.
But if I am doing any samplecollection or if I'm actually
interpreting the test for them,then per the you know, health
and human services, they saywell, that then goes and falls
back under CLIA because I as apharmacist and using my clinical
(08:45):
expertise and it's kind ofgoing away from that at home
classification so yeah, yeah, sothere are some.
So what we can do as apharmacist is there's a lot we
can do.
So exciting, we can talk aboutthis and I think that's why this
is an exciting podcast for ourviewers is that the first thing
that we can do is we can youwant to be recommending that
(09:08):
test, because in certain ages ofwomen and certain risk factors,
even for men, there's annualscreening is what's recommended.
So if you have somewhere whereyou're actually recommending
these for a patient, we shouldbe knowledgeable about them so
we can recommend them, we canshow them where they are and
(09:30):
then also answer questions forthem about the test.
All perfectly fine and that'sthen operating under the home.
But then if, for some reason,we would want to go further down
that path and we can talk laterabout, you know, test to treat
opportunities and things likethat, where we would actually be
potentially, you know, workingunder collaborative practice
agreement to prescribe thattreatment, the antibiotics to
(09:52):
treat those upon a positiveresult, then that, you know, is
kind of a different, differentscope.
Speaker 1 (09:57):
Different scope yeah.
Speaker 2 (09:58):
So you have to kind of understand the regulations.
So you, you know what you knowyou should be doing under the
home test.
Speaker 1 (10:05):
Exactly.
And you again, you read my mind, so thank you.
I realized, I realized in themoment that it wasn't posed well
, and then I thought, well, letme just see what she does with
it.
And you did it perfectly.
Speaker 2 (10:14):
So thank you.
Speaker 1 (10:15):
But one thing I want to point out again on that is my
whole point was, if it doesfall back on the whole CLIA
thing, you'd have to be aCLIA-waived pharmacy.
So if you're going to be doingthat, if you're going to step in
and be like, oh well, that'sjust a blood test, let me do
that for you right here, then,boom, you have to be Cleo Wave
Pharmacy.
So that is what I was gettingat was being sure that you're
(10:38):
staying within the parametersand the lines of what you're
allowed to do, based on thedifferent types of
certifications that you have atyour store.
So that was perfect, okay.
So on that, let's go ahead anddig into what are all those
opportunities for pharmacists?
So you mentioned we need to bein the know, we need to just,
you know, be able to answergeneral questions, be able to
(10:58):
guide about general samplecollection, if we're not
actually going to be the ones todo it.
But let's talk about how, likewhat are these actual
opportunities?
So one of the first ones I wantto touch on is let's talk about
how it's expanding access andit's able to keep timely and
discrete testing and, you know,trying to catch some of those
(11:19):
patients who may not show up atthe clinic, you know, at the
blood drawn, and say, oh, Ithink I might have an STI, let
me get tested, or whatever.
So let's talk about that forjust a little bit.
The expanded access, thediscrete, timely things like
that.
Speaker 2 (11:30):
Yeah, so you know, of course, we know the the
pharmacists are the most andpharmacies are the most
accessible.
You know health care providerand you know opportunity that
patients can have in the countryand so just access in general.
you might have a patient who,depending on you, know where
they are and you know how muchtransportation access they have
(11:51):
they might not even be able toget to a clinic or like a public
health site to get that testingdone, and so if pharmacies can
just have be a spot where theycan get the tests, then that's
just the first step Right, andso also I think that expanding
that access also where it's amore of a discrete spot, there's
(12:11):
been some qualitative studiesthat have been done where
patients would actually preferto pick up their test kits from
a pharmacy because unfortunatelyand I don't agree with this,
but unfortunately there is likea stigma associated with going
to like a public health or alocal public health or public
health department, because theylook at that as the place where
(12:31):
you go to get tested or treatedfor a TI, and so people don't
want to be seen going into thoseplaces or things like
that.
And then also we know thatespecially this age range you
know when you're looking at that, you know, you know later
adolescent to you know mid-20sof females that need to have
that annual testing done.
Statistically not a lot of themhave primary care providers and
(12:55):
so where they're getting that,you know very regular updates
and those check-ins to havethose that test done.
So just having that accessavailable is just having it
there where patients can accessthe test and then again do that
in the privacy of their own homeand getting those results and
then acting upon those results,I think is one thing that
(13:16):
pharmacy can definitely do.
and be, provided about that.
Speaker 1 (13:19):
Yeah, on that you bring up a good point I want to
go back to I think you might'vementioned it, but let's
reiterate these couple of newones that are over the counter.
What are the agerecommendations on that?
Who can they be sold to?
I guess Are there anyrestrictions?
Speaker 2 (13:34):
Sure, I don't believe I haven't actually read the
full package insert of either ofthem.
I don't think they necessarily.
There isn't, like a you know,an age restriction of who they
can be sold to, and so you knowit's an over-the-counter product
and so anyone can reallypurchase the product.
But there is, depending uponindividual's risk levels of you
know, their own, you know sexualactivity as well as ages, that
(13:57):
will depend upon how frequentlyyou know they should be
screening.
And then, as for the, again themore recent test, which was,
and this was the first of itskind, which has actually opened
up a pathway through the FDA forother similar tests to go to
market more quickly, so we mightsee more.
(14:17):
So at the time of this podcast,you know there's one on the
market, but by the time youlisten to this, who knows we
might have, you know, numerousones out there, yep, out there.
But Visby Medical was the firstone to release the women's.
You know three STIs thechlamydia gonorrhea and the
trichomoniasis.
So those are the three that arebeing tested under that PCR
(14:39):
test.
That's at home with the vaginalsample collection, that
particular test actually.
So it gives the positive ornegative results, but it has an
app that goes with it that talksthe user through how to do the
sample collection and how tooperate the device, through how
to do the sample collection andhow to operate the device.
(14:59):
So that's also you know aninteresting take on utilizing,
you know, smartphones andtablets and technologies, and
then actually it's the you know,through the company's website
and the information that theyprovide, is that actually the
app is the one that provides youwith the results for each of
those based off of that Yep.
Speaker 1 (15:13):
So, interesting.
Speaker 2 (15:15):
Yeah, it's an interesting take.
And again, that PCR, a PCR test, that's available.
But again, if you're ever withall these on the market too, at
any time there's a point of caretest or over the counter home
test, always just read theinformation about the test.
If the patient comes withquestions, the same thing I
(15:35):
always say with glucometersright, Like I don't, I don't
have in my mind how to use everyglucometer CGM on the market.
I don't.
But how many times have I beenlike well, let's take a look and
let's open this up and let'stalk through that.
And you can definitely evenunder the at home testing you
can do that with a patient.
You can open it up and talkthem through how to do the
(15:55):
sample collection on their own.
Speaker 1 (15:57):
And then have them do that.
Yep, and that's what you weresaying earlier with that still
quantifies as an at-home test.
Unless you do the sample, thenit brings it back under a CLIA
waiver.
So, yeah, right, so that's yeah, so great information.
And so we talked about earlier.
One of the key things forpharmacists is to be updated on
the information.
And you say one of the bestways to do that is to read the
(16:19):
package insert.
But in general, if we're goingto go into more of the test and
treat route, so let's say thatwe do have a CLIA waiver and we
are doing test and treat, we dohave the capabilities to do that
, we have it in our workflow andthat's what we're doing.
What sort of, I guess, whatsort of STIs should we be up to
date on?
Like, what are the ones that weshould make sure that we
(16:42):
understand, know you knowcertain treatments for, and
things like that?
Speaker 2 (16:46):
Yeah.
So I would say probably the youknow more common ones that
you're seeing right now are notmore common, but just you know
for treatment that you can dolike a test to treat syphilis is
a big one on the rise right now, or not more common, but just
you know for treatment that youcan do like a test to treat
syphilis is a big one on therise right now, same with
chlamydia, gonorrhea, thentrichomoniasis.
So those are the you know,probably the main ones that are
(17:06):
there for most of the CLIA wavetests and again, like for like
hepatitis C or HIV or theadenine tests, for those, uh,
they're more of a screening andso that's when you would need to
, upon a positive, they'dactually need to have like a
confirmatory a confirmatory testcompleted.
(17:26):
So that's not diagnostic.
But the ones that I justmentioned, the previous ones,
those are diagnostic and so kindof similar with which some
pharmacies and states are doingwith urinary tract infection,
where you do not have tonecessarily collect the sample
for that.
So right.
(17:46):
So, you can do a test to treat.
Again, you would need the CLIAwaiver under your pharmacy.
So you need a CLIA waiverthrough your pharmacy that you
can, you know, operate underCLIA.
But if a patient comes in witha positive test from you know,
again, we have pharmacies thathave done this with urinary
tract and they can do that alsowith, you know, syphilis or
these other tests that Imentioned they come in with a
(18:09):
positive result, then at thatpoint, if you have a
collaborative practice agreementthat allows you to do so, you
could prescribe an antibioticfor treatment for that.
So that's, I think, really,where pharmacy can take it a
step further.
So, if nothing else, be awareof the tests that are out there,
you know, on the shelf in yourown pharmacy or in the OTC aisle
(18:38):
, I should say, or see them inthe product catalog.
If you're ordering your own orrecommend this for that, then
just be aware of what they treat.
You know that they, the results,are instant.
They are a diagnostic.
They're going to give you apositive or negative result.
And then what to do upon thatpositive.
So some patients are going to,you know, go to their healthcare
professionals.
They're going to go tohealthcare provider, their
doctor or their clinic orwhatever Some might call you.
(19:00):
You know, hey, I got a positive, now what do I do?
And if you have that CPA, youcan prescribe or restate
protocol or whatever it is inyour state, if you allow for
that right to be done.
And then others, some of thecompanies are.
Even one of the companies ispiloting on their package like a
telehealth option.
So that if you get a positivelike on the box, you can pay for
(19:21):
a telehealth consult to getthat prescription.
So I think you're going to seea different varieties.
I think, it's going to dependupon what's most cost effective
for the patient.
What's if it's covered underinsurance?
Yeah, and so you know if theyhave a health savings account or
you know a payment things likethat, so it just depends upon
what's going to be mostbeneficial for the patient
(19:58):
minute to really think about it.
Speaker 1 (19:58):
I would have thought about telehealth, but that's
another way to for those, youknow, for those who are looking
for a discrete test, and thenfor looking for discrete
treatment, because, you're right, there is a stigma about you
know, going to public health forthat, or you know being seen in
your small town.
You know, oh, what are theygoing to say about me, and so
yeah, so if you're looking forthat still discrete treatment
all the way through I love theidea that there's still a health
(20:19):
option which just still allowsyou to get that treatment.
Turn right back around, go tothe pharmacy, get that filled
and just you know where youpurchase the test.
So, yeah, all great stuff.
I love it and I love the factthat you know again, with all of
this we're helping to reducesome of the stigma, we're making
things more accessible andwe're normalizing, I hope, the
ideas to normalize some of thoseconversations, some of those
(20:41):
sexual health conversations withpatients, and I'd be remiss if
I didn't talk about here how onthe rise a lot of it is in our
elderly population, in assistedliving homes and nursing homes.
That is a place where STIs areon the rise and so you know,
don't overlook that as being aplace where testing needs to
occur and treatment needs tooccur.
(21:02):
So and discussions in generalabout it.
Speaker 2 (21:05):
So yeah, yeah, and normalizing it, and I think you
put a you know, I think evenjust in general, at-home testing
has become normalized, likelet's all think back to five
years ago.
You know, if you're listeningto this, since 2025, but maybe
you know but five, six years ago.
You know, if you're listeningto this since 2025, but maybe
you know but five, six years agohow many, if we took a room,
would raise their hand and sayI've done an at-home test.
(21:25):
Like nobody probably wouldright, we'd all just be like no,
never done that.
Okay, now, now let's raise ourhands.
I mean, who has not done anat-home COVID test ever since?
Speaker 1 (21:35):
the pandemic.
Speaker 2 (21:40):
So what happened after the pandemic?
Is this just became so muchmore normalized?
Is that people had never usedone of these tests before.
They had to open up and they'rereading the insert and they're
looking at the swab and they're,you know, reading the little
pictogram and they're followingthe directions.
Well, now people have done that, and so now it's oh well it's
not so yeah it's easy, I can dothat, so now it's not so.
Um, yeah, it's easy, I can dothat, so now it's not so.
Um, such a new concept, and sopeople have come onto that also.
(22:02):
So has you know, like you said,the the convenience factor?
We live in a world where wewant to do things from the
comfort of our home, whetherit's shopping or whether that's
instead of going out to arestaurant you're ordering you
know the door dash or whateverit might be.
Uber Eats, and so we're gettingthat kind of that culture of
doing things more from theprivacy and comfort of your own
(22:22):
home as well, and so this reallyjust in general fits that
patient demand.
Speaker 1 (22:28):
Absolutely.
And you know, some couldcounter, argue and say, oh,
we're taking that role, thatimportant role, away from you
know, healthcare and testing youand whatever.
But that's where we have tomorph and change with that as
well, where we have to step upand say okay, well, now our role
is education and treatment, andthat's where we really need to
take that bigger step next, asthe pharmacist, and making sure
(22:51):
that we are setting ourselves upto do, you know, beyond the
testing, but to do the actualdiscussions and counseling and
then actual treatment options.
Speaker 2 (23:00):
So yeah, yeah, and if you have I mean again, you know
where this can even go inpharmacy.
As we're talking about this,I'm thinking a really big thing
pharmacies have been doing moreas well across the country is
oral contraceptive prescribing,and so this really fits in your.
It's that age range typicallyfemales that we're prescribing
oral contraceptives for that arecoming to the pharmacy maybe
(23:21):
because they don't have aprimary care provider.
And guess what, what a greatopportunity for us to say, oh,
by the way, just with your age,and if you are sexually active,
you should have one of theseevery year and we sell them and
I can answer questions for you,or maybe you have a handout in
your pharmacy.
I, you know, in the one of thepharmacies that I used to work
at, I used to have a handoutevery time I would.
(23:43):
You know somebody would come infor certain types of medication
.
I would usually provide themwith some education and then
also give them just something totake home to read about, about
that topic of an STI and howfrequently to be tested and
where they could be tested.
That was way before, obviouslythe you know we have these great
at-home tests now, so it's agood opportunity for us.
Speaker 1 (24:04):
Great call-outs, yeah , great points.
And you know, again, especiallylike, think about where you're
located.
Are you located where there'snot a lot of access to public
health or to clinics, or youknow minute clinics or you know
whatever.
Or are you located in a collegetown or university town?
Because, again, you know, wesee with that population they
(24:28):
typically don't have a PCP andso they're usually taking care
of themselves.
You know, like, oh, as it comesup, as whatever problem arises,
they don't really, especiallyif they're away from home,
they're certainly not going tohave established care with a PCP
, probably, you know, in a newcity or state.
So, yeah, all great points.
So now that we've kind of talkedabout the great opportunities,
(24:48):
are there any challenges thatyou can think of?
I mean, obviously we've alsotouched on some of the
challenges keeping up to datewith it, making sure that you
understand the scope of practicein your state and whatever you
know is allowed, and operatingunder CLIA waiver if needed, if
that's the route you're going,and making sure that you have
that and everything in line forthat certification.
What about any other negativeor challenges that you can think
(25:13):
of that we need to overcome inthis space?
I?
Speaker 2 (25:16):
wouldn't say necessarily challenge, but I
would just say to be aware.
So different states havedifferent regulations for
reporting STIs to public health,and so if you do have.
Especially if you're doing likea test to treat, right where
someone's coming in with thepositive and you have that test
to treat, where then you canunder a CPA protocol or whatever
practice laws within your stateyou can prescribe a treatment
(25:39):
for that STI, then you shouldalso just make sure you know
your state laws, that sometimesyou do have to report these to
public health and so alsoletting the patient know upon
that that you will have to.
you know if you undergo this,that you'll have to be reporting
it.
Speaker 1 (25:55):
Yeah.
Speaker 2 (25:56):
That's one thing.
Oh, go on.
Speaker 1 (25:59):
I was just going to say we don't have to talk about
specifics because that would getinto bias and everything.
But have you heard about costs,like are these cost effective
or are they fairly expensive?
Speaker 2 (26:10):
Yeah, so I mean I was looking at some of the costs of
them and again I think it justcan it really depends and it
varies for the because I also sobehind the scenes for someone
who does a lot of test to treatand point of care testing and
working with pharmacies to getthat up and running.
I'm really familiar with thecost of some of these tests.
Before they went home test andI was like, oh my gosh, how is
(26:33):
anyone ever going to afford that?
But, they've actually beenpretty, pretty reasonable.
So for the blood test, for forthe syphilis, for instance, over
the counter I've seen somewherearound and again like I'm not
price, but I'm just saying likeif you probably google this.
You're probably gonna find about30 ish dollars, which isn't bad
(26:53):
and then as and then the visbymedical that I've seen over the
counter, it's like through theirapp it's about 150.
So but if you think about that,you know if you have a patient
that has, you know, maybe highdeductible plan or you know,
health spending account andthat's not covered, and you know
(27:16):
, for a lot of them it might becovered as a preventable.
But if it's not, because it's alab or whatever, that might be
a much more economical and costeffective, even by going to the
pharmacy and then getting atreatment it might be more
economical than going insomewhere, although I will say
too that a lot of public healthdepartments do offer that
testing for free.
So there again, just be awarethat's another thing you can do
(27:37):
as pharmacy.
Just be kind of aware of theresources in your community, in
your area.
I know some states even, andeven some college campuses will.
They have numbers or contactsyou can, and they'll get a test
mailed to them for free throughlike grant funding or through
the state funding as well.
So if you ever have a patientthat is interested and can't
afford that, I would recommendto reach out to some of those,
(28:00):
like a local public health or astate public health department,
to see if there's anyopportunities for that.
Speaker 1 (28:05):
That's great and we always I feel like I always give
a call out to our communityhealth worker program and the
fact that if you have atechnician cross-trained as a
CHW or a community health worker, you know they're going to know
what the ins and outs are inthe community, the opportunities
, the different ways in whichthey can get a patient connected
.
So that's something else.
(28:26):
Yeah, I you know.
And also we were talking aboutpricing when doing comparisons.
It also could be you know howmuch is someone willing to pay
for the ease of it being ontheir time, like what if it's a
Saturday evening?
Or what if they're going out oftown and they, you know they
don't have time to go get labdone and then whatever.
And so that whole buying thetest and doing the telehealth
and filling their prescriptionor, you know, doing it in-house
(28:48):
with you, if you have acollaborative practice agreement
to treat, you know it could, itcould be worth it to them
because, for whatever reason,you know timing and such.
So yeah.
Okay, well, last thing before wewrap up.
Well, next to the last thing,I'll ask you this and then I'll
ask you the very last question.
But before we do that, I knowjust from your expertise, I want
(29:09):
to pick your brain on this.
As you mentioned, you've beeninvolved with getting test and
treat stuff up and running andeverything.
You know one of the biggestpushbacks we always hear, and I
totally get it.
I've been there, I've owned astore, I've worked in, you know,
for other companies.
I get it Timing, you know likeI just I don't have time.
I just don't have time.
I don't have time to do this.
Do you have any nuggets or anytips or tricks about how to work
(29:32):
in these types of things, likeif you, you know it'd be so easy
to just see someone out there,they figured it out, they
purchased it, whatever, just letthem walk because they probably
know what they wanted anyhow.
But you know, how can we, howcan we see those instances, take
advantage of them and really,really make a time for that?
Any kind of tips and tricks onthat?
Speaker 2 (29:52):
Yeah, I would just say that, first of all, these
are at-home tests, and so you'renot doing the sample collection
.
And so that typically is whatcan, sometimes depending upon
the type of test, but that cantake time.
The patient's you knowinformation or you know whatever
you know, intake forms orwhatever like that that could be
(30:14):
time to develop or patienteducational materials.
There have been actually it wasactually not too long ago, but
it was through the University ofPittsburgh and I had come
across.
I love toolkits, I'm a toolkitjunkie Like I.
Just I absolutely love a goodtoolkit for pharmacy and we've
done a lot within our center forhelping pharmacies and toolkits
(30:35):
and kind of giving everythingthey need.
And so the National Associationof County and City Health
Officials actually did acollaboration with pharmacy on
STI treatment and they actuallyhave available a complete
toolkit for pharmacies and soyou can have like printable
materials.
for some of these it's allpublicly available because it
was through a federal or federalgrant and it was with the
(30:58):
University of Pittsburgh as well, but testing and has
educational materials.
So it even has a patient intakeform.
So if that's something that's alot of pharmacies.
I've had get kind of hung up onthat a little bit and I've
worked with it's like oh well,how do I collect the information
and how do I?
Oh, like that, just seemsreally overwhelming, and it can
be.
It can be really a lot, and sowhy recreate the wheel when
(31:20):
there's some of these reallygreat resources?
that are out there for you.
So it's a tidbit, I would say,put that in the back of your
pocket if you're ever interestedin that.
But also, as you mentioned too,of really relying on our
partners of, like our communityhealth worker or technicians of
you know, getting thatinformation, gathering that
information and really afterthat, if you're just answering
some questions for the patientwhich we do anyway and that's
(31:42):
part of our normal workflow aswell as you know prescribing the
treatment and counseling on themedication.
It's really I would say it's notmuch more than a prescription
you know a regular prescriptionand you're probably going to
make more money on it.
So to be honest with you,unfortunately, in the way that
things are right now in theworld of pharmacy and
reimbursement.
Speaker 1 (32:08):
Yep, no, totally makes sense.
That's exactly what I wanted.
Speaker 2 (32:09):
I love, I love the idea.
Speaker 1 (32:09):
I'm also a nerd and a toolkit junkie so, like,
anytime you can get like like, Istill like to print things and
no, it's not great for the, forthe, you know, for everything,
for environment, but I love tolike hold something and like
open up a package and get all mygoodies and everything.
So, yeah, I'm totally with youon that.
I love that idea.
So tell us again who the, the,the company, tell us again where
that kit can come from.
Speaker 2 (32:30):
Sorry, yeah.
So the kit came from theNational Association of County
and City Health Officials, sothat was the granting partner.
And then it was from and maybesome of your listeners even here
are familiar with that, but itwas also from the University of
Pittsburgh.
School of Pharmacy was acollaborator on that and they
have an article in the Journalof American Pharmacy Association
(32:54):
on that toolkit development andsome really great resources.
So shout out to them for doingan excellent job on that and
providing a resource topharmacies.
I love it when people do greatwork and they share that with
others.
Speaker 1 (33:08):
I love that I love when, again, there's no reason,
like if they took the time andcreated the wheel.
I love when they share itbecause there's no reason for us
to recreate it, so it's great,awesome, okay, well, final
question.
Now for sure, as I always liketo ask our guests, the name of
our podcast is Game Changers.
So, elizabeth, what do youthink the game changer is here?
What's our overall take homepoint from today's episode?
Speaker 2 (33:32):
I think the overall game changer is that our rising
STI rates in the US are a publichealth concern and for the
first time we have accurateat-home tests with immediate
results for our patients to helpincrease access to treatment
and increase access just toscreening in general and
(33:52):
prevention of spreading ofdisease.
And I also think that it'sanother opportunity for pharmacy
, who probably wasn't doing youknow you're not going to be
doing probably a vaginal samplecollection in the pharmacy, but
now we still have an opportunityfor a test to treat now with
this because we have an at-hometest, so I think that's
(34:14):
definitely a game changer for us.
Just one more way for us to helpimprove the lives of our
patient and increase publichealth.
Speaker 1 (34:21):
That's great.
That's great.
Well, thank you so much.
We have time for today.
Elizabeth, Thank you so muchfor spending your afternoon with
us.
I really appreciate it.
Speaker 2 (34:30):
Yeah, absolutely.
Thanks for having me.
It's always a pleasure.
Speaker 1 (34:33):
If you're a CE Plan subscriber, be sure to claim
your CE credit for this episodeof Game Changers by logging in
at ceimpactcom.
And, as always, have a greatweek and keep learning.
I can't wait to dig intoanother game-changing topic with
you all next week.
Hey CE Impact subscribers, Welcome to the Game
Changers Clinical Conversationspodcast.
I'm your host, josh Kinsey, andas always, I'm excited about
our conversation today.
Sexually transmitted infectionrates are climbing and access to
timely testing remains a majorbarrier for many patients,
making over-the-counter STI kitsan important new tool in public
(00:23):
health.
In this episode, we'll explorewhat pharmacists need to know to
support patient use, answerquestions with confidence and
help expand access to sexualhealth care.
It's so great to have ElizabethSkoy as our guest today,
elizabeth welcome.
Speaker 2 (00:38):
Thanks, josh, it's great to be here.
Speaker 1 (00:40):
Yeah, great to have you.
Thanks for taking time out ofyour summer break.
As I always joke, as I rememberas a faculty member, summer
break was not really summerbreak, it was put your head down
and get stuff done.
But thank you, I know you'revery busy, so we appreciate it.
Elizabeth has done a lot ofwork with us on lots of projects
over the years, so we're justsuper excited to have you on a
(01:01):
podcast.
I haven't had you as a guestbefore, so, on that, go ahead
and take a couple of minutes,elizabeth, to introduce yourself
to our guest, for those thatmay not know you yet.
Speaker 2 (01:11):
Yeah, thanks so much.
So hello everyone.
So I'm Elizabeth Skoy, I am apracticing community pharmacist
and I also am a faculty memberand professor at the North
Dakota State University Schoolof Pharmacy and then I also
serve as the director for theCenter for Collaboration and
Advancement in Pharmacy.
So you know, between myteaching, I teach in a skills
(01:35):
laboratory, so I teach a lot ofthat hands-on.
You know how to type, I teach apoint-of-care testing elective
and then, of course, you knowwork with pharmacies to
implement point-of-care testingelective and then, of course,
work with pharmacies toimplement point-of-care testing,
test-to-treat, providingeducation basically on pharmacy
practice.
And so, yeah, this is a reallyexciting topic and exciting time
(01:57):
in the world of at-home testingdevices, and so it's great to
be here to talk with you guysabout this.
Speaker 1 (02:09):
Awesome.
Thank you so much.
Well, without further ado,let's go ahead and move into the
content for today and let'stalk.
I always like to level theplaying field.
Just make sure that we all knowwhat we're talking about.
For today's episode, I gave thesegue earlier, but let's just
go ahead and specifically naildown what we mean when we say
OTC, sti, kit, like what is outthere, what are the purpose of
these, and maybe even talk alittle bit about collection,
(02:31):
sample types and things likethat.
Speaker 2 (02:33):
Yeah, absolutely so.
When we're talking about theSTI kit, right?
So sexually transmittedinfection is, you know, we think
of STI, that's what that standsfor.
So we think of those tests.
Up until recently we had anumber of CLIA-waived tests that
were available, and so theywere.
You know, these CLIA-waivedtests that could be done in a
(02:53):
doctor's office or even apotential in a pharmacy, in a
pharmacy in certain situationswhere there was a sample
collection, and then it'susually you know, that
point-of-care test CL, cliawaived where you get a result
pretty rapidly.
There were a few kits out therethat were maybe sold over the
counter, but how that works isthat they're actually not, you
(03:14):
don't get the results right away.
And so there were some kitsthat were for STIs that were
available over the market thatyou know you kind of did the
at-home sample collection andthen you would mail in your
results, and so there wasprobably the first I would say
over-the-counter test that wasavailable for detecting an STI
was HIV.
(03:34):
So that's been around for alittle while where somebody
could you know and that wasthrough.
Either you could do either anoral swab like an oral
collection, or you could also doa blood collection for those.
So that was one, and then morerecently we have a couple of
other tests that have come onthe market for over-the-counter,
and that is for syphilis.
(03:56):
And then there is one forfemales.
It's only approved for femalesright now over-the-counter, but
it's actually the first PCR testthat was available over the
counter, so that's kind of a newthing in itself.
And then that is testing forchlamydia, gonorrhea and
trigonitis all together.
So those are kind of the mainones out there, and again, we've
(04:18):
had the over-the-counter HIVfor a while as well.
So, yeah, I think this marketis really expanding.
I think there's been greaterinterest from some funders, like
the NIH and things like that,to expand the types of tests
that are available for publichealth and getting these tests
to the public, and so it's agreat time to see these coming
(04:42):
available to patients so theycan test at home.
Speaker 1 (04:45):
Yeah, yeah.
And one thing that youmentioned, elizabeth, I want to
go back to is you know, anyprevious ones may have been some
sort of send off and you knowthe wait response and we know
that that doesn't really makesense because, a you need to get
treated pretty quickly to takecare of things or they could,
you know it could become prettynegative very quickly.
(05:06):
And, b if you are infected, yourun the risk of continuing to
infect others and you knowwithout knowing so.
So that is, that is somethingof concern.
So the idea that these newtests are, you said, a rapid
response, right, like they'repretty within just a few minutes
or whatever- so, yeah.
Speaker 2 (05:24):
So I think that's something to call out 10 to 30
minutes, depending upon the test.
Speaker 1 (05:27):
Yeah, so with the newer ones you mentioned too,
what are the collection samplesfor those Like, what would the
patients end up having to sendoff, or utilize.
Speaker 2 (05:37):
So this is where I think you know this is really
pretty great for pharmacy.
So of course you know the bloodsample and the oral you know
for the HIV.
But then we had for the test wealso had the sample collection
for syphilis, which is usually afinger prick blood sample.
So that's how.
So at home test is a bloodsample, it's a finger prick.
And then the more recent one,the PCR test for women for the
(06:04):
three STIs that it tests forthat is actually a vaginal
sample collection and so youknow that's probably you know,
not something where pharmacy isgoing to be collecting that in
the pharmacy, right?
And so you have, you know, someof these samples were like oral
and blood.
Pharmacies you know areequipped to do that sample
collection for like a CLIAwaived.
But some of these other testsif you're doing like a urine or
(06:27):
you're doing, you know, vaginalcollection, those are usually
those samples are usually takeneither in a clinic or in a
clinic setting.
Not always, I don't want to sayso.
There's some pharmacies outthere that might be doing this,
so that's fantastic if you areequipped for that.
But generally speaking, more ina clinic setting.
And then of course now you knowit can be- for home collection.
Speaker 1 (06:48):
Yeah, yeah.
So with that though and we'llget into this a little bit more
but while we're talking kind ofabout the introduction of these
to the market and so forth,reminding our pharmacists their
role in this, there are somerestrictions as to what we can
and can't talk about and guideon and that kind of thing right.
(07:09):
Like if there is a questionabout, oh, I don't understand
this sample collection, or Idon't understand this, like it's
not, like they could open it onthe counter and us actually do
it for them, does that makesense?
Speaker 2 (07:21):
Yeah, correct, so Does that make sense?
Yeah, correct, so it gets alittle.
It gets a little.
It can be confusing when youtalk about at-home tests versus
CLIA waive tests.
Speaker 1 (07:31):
Right.
Speaker 2 (07:31):
So these tests have technically, you know, a CLIA
waiver, but then once they'vedesignated by for an at-home
test in quotation marks at-hometest, then they become actually
regulated by the FDA, so they'reno longer regulated by CLIA.
Speaker 1 (07:48):
Yes, you took my question, thank you, I realized
I didn't pose that question verywell.
Speaker 2 (07:52):
I didn't know.
I thought that's maybe whereyou were going.
Speaker 1 (07:55):
Exactly where I was going.
You're answering it perfectly,so thank you so they're actually
regulated by the FDA, not CLIA.
Speaker 2 (08:02):
However, there's like this big, however, by the FDA,
not CLIA.
However, there's like this big,however, because we saw this a
lot during the COVID pandemicright when once we, if we take
as a pharmacy right, so if Itake at-home test and I collect
that sample for the patient, Ithen need to be operating under
a CLIA waiver.
(08:22):
It kind of comes back underCLIA if that makes sense, so I
can instruct a patient how to doit themselves.
But if I am doing any samplecollection or if I'm actually
interpreting the test for them,then per the you know, health
and human services, they saywell, that then goes and falls
back under CLIA because I as apharmacist and using my clinical
(08:45):
expertise and it's kind ofgoing away from that at home
classification so yeah, yeah, sothere are some.
So what we can do as apharmacist is there's a lot we
can do.
So exciting, we can talk aboutthis and I think that's why this
is an exciting podcast for ourviewers is that the first thing
that we can do is we can youwant to be recommending that
(09:08):
test, because in certain ages ofwomen and certain risk factors,
even for men, there's annualscreening is what's recommended.
So if you have somewhere whereyou're actually recommending
these for a patient, we shouldbe knowledgeable about them so
we can recommend them, we canshow them where they are and
(09:30):
then also answer questions forthem about the test.
All perfectly fine and that'sthen operating under the home.
But then if, for some reason,we would want to go further down
that path and we can talk laterabout, you know, test to treat
opportunities and things likethat, where we would actually be
potentially, you know, workingunder collaborative practice
agreement to prescribe thattreatment, the antibiotics to
(09:52):
treat those upon a positiveresult, then that, you know, is
kind of a different, differentscope.
Speaker 1 (09:57):
Different scope yeah.
Speaker 2 (09:58):
So you have to kind of understand the regulations.
So you, you know what you knowyou should be doing under the
home test.
Speaker 1 (10:05):
Exactly.
And you again, you read my mind, so thank you.
I realized, I realized in themoment that it wasn't posed well
, and then I thought, well, letme just see what she does with
it.
And you did it perfectly.
Speaker 2 (10:14):
So thank you.
Speaker 1 (10:15):
But one thing I want to point out again on that is my
whole point was, if it doesfall back on the whole CLIA
thing, you'd have to be aCLIA-waived pharmacy.
So if you're going to be doingthat, if you're going to step in
and be like, oh well, that'sjust a blood test, let me do
that for you right here, then,boom, you have to be Cleo Wave
Pharmacy.
So that is what I was gettingat was being sure that you're
(10:38):
staying within the parametersand the lines of what you're
allowed to do, based on thedifferent types of
certifications that you have atyour store.
So that was perfect, okay.
So on that, let's go ahead anddig into what are all those
opportunities for pharmacists?
So you mentioned we need to bein the know, we need to just,
you know, be able to answergeneral questions, be able to
(10:58):
guide about general samplecollection, if we're not
actually going to be the ones todo it.
But let's talk about how, likewhat are these actual
opportunities?
So one of the first ones I wantto touch on is let's talk about
how it's expanding access andit's able to keep timely and
discrete testing and, you know,trying to catch some of those
(11:19):
patients who may not show up atthe clinic, you know, at the
blood drawn, and say, oh, Ithink I might have an STI, let
me get tested, or whatever.
So let's talk about that forjust a little bit.
The expanded access, thediscrete, timely things like
that.
Speaker 2 (11:30):
Yeah, so you know, of course, we know the the
pharmacists are the most andpharmacies are the most
accessible.
You know health care providerand you know opportunity that
patients can have in the countryand so just access in general.
you might have a patient who,depending on you, know where
they are and you know how muchtransportation access they have
(11:51):
they might not even be able toget to a clinic or like a public
health site to get that testingdone, and so if pharmacies can
just have be a spot where theycan get the tests, then that's
just the first step Right, andso also I think that expanding
that access also where it's amore of a discrete spot, there's
(12:11):
been some qualitative studiesthat have been done where
patients would actually preferto pick up their test kits from
a pharmacy because unfortunatelyand I don't agree with this,
but unfortunately there is likea stigma associated with going
to like a public health or alocal public health or public
health department, because theylook at that as the place where
(12:31):
you go to get tested or treatedfor a TI, and so people don't
want to be seen going into thoseplaces or things like
that.
And then also we know thatespecially this age range you
know when you're looking at that, you know, you know later
adolescent to you know mid-20sof females that need to have
that annual testing done.
Statistically not a lot of themhave primary care providers and
(12:55):
so where they're getting that,you know very regular updates
and those check-ins to havethose that test done.
So just having that accessavailable is just having it
there where patients can accessthe test and then again do that
in the privacy of their own homeand getting those results and
then acting upon those results,I think is one thing that
(13:16):
pharmacy can definitely do.
and be, provided about that.
Speaker 1 (13:19):
Yeah, on that you bring up a good point I want to
go back to I think you might'vementioned it, but let's
reiterate these couple of newones that are over the counter.
What are the agerecommendations on that?
Who can they be sold to?
I guess Are there anyrestrictions?
Speaker 2 (13:34):
Sure, I don't believe I haven't actually read the
full package insert of either ofthem.
I don't think they necessarily.
There isn't, like a you know,an age restriction of who they
can be sold to, and so you knowit's an over-the-counter product
and so anyone can reallypurchase the product.
But there is, depending uponindividual's risk levels of you
know, their own, you know sexualactivity as well as ages, that
(13:57):
will depend upon how frequentlyyou know they should be
screening.
And then, as for the, again themore recent test, which was,
and this was the first of itskind, which has actually opened
up a pathway through the FDA forother similar tests to go to
market more quickly, so we mightsee more.
(14:17):
So at the time of this podcast,you know there's one on the
market, but by the time youlisten to this, who knows we
might have, you know, numerousones out there, yep, out there.
But Visby Medical was the firstone to release the women's.
You know three STIs thechlamydia gonorrhea and the
trichomoniasis.
So those are the three that arebeing tested under that PCR
(14:39):
test.
That's at home with the vaginalsample collection, that
particular test actually.
So it gives the positive ornegative results, but it has an
app that goes with it that talksthe user through how to do the
sample collection and how tooperate the device, through how
to do the sample collection andhow to operate the device.
(14:59):
So that's also you know aninteresting take on utilizing,
you know, smartphones andtablets and technologies, and
then actually it's the you know,through the company's website
and the information that theyprovide, is that actually the
app is the one that provides youwith the results for each of
those based off of that Yep.
Speaker 1 (15:13):
So, interesting.
Speaker 2 (15:15):
Yeah, it's an interesting take.
And again, that PCR, a PCR test, that's available.
But again, if you're ever withall these on the market too, at
any time there's a point of caretest or over the counter home
test, always just read theinformation about the test.
If the patient comes withquestions, the same thing I
(15:35):
always say with glucometersright, Like I don't, I don't
have in my mind how to use everyglucometer CGM on the market.
I don't.
But how many times have I beenlike well, let's take a look and
let's open this up and let'stalk through that.
And you can definitely evenunder the at home testing you
can do that with a patient.
You can open it up and talkthem through how to do the
(15:55):
sample collection on their own.
Speaker 1 (15:57):
And then have them do that.
Yep, and that's what you weresaying earlier with that still
quantifies as an at-home test.
Unless you do the sample, thenit brings it back under a CLIA
waiver.
So, yeah, right, so that's yeah, so great information.
And so we talked about earlier.
One of the key things forpharmacists is to be updated on
the information.
And you say one of the bestways to do that is to read the
(16:19):
package insert.
But in general, if we're goingto go into more of the test and
treat route, so let's say thatwe do have a CLIA waiver and we
are doing test and treat, we dohave the capabilities to do that
, we have it in our workflow andthat's what we're doing.
What sort of, I guess, whatsort of STIs should we be up to
date on?
Like, what are the ones that weshould make sure that we
(16:42):
understand, know you knowcertain treatments for, and
things like that?
Speaker 2 (16:46):
Yeah.
So I would say probably the youknow more common ones that
you're seeing right now are notmore common, but just you know
for treatment that you can dolike a test to treat syphilis is
a big one on the rise right now, or not more common, but just
you know for treatment that youcan do like a test to treat
syphilis is a big one on therise right now, same with
chlamydia, gonorrhea, thentrichomoniasis.
So those are the you know,probably the main ones that are
(17:06):
there for most of the CLIA wavetests and again, like for like
hepatitis C or HIV or theadenine tests, for those, uh,
they're more of a screening andso that's when you would need to
, upon a positive, they'dactually need to have like a
confirmatory a confirmatory testcompleted.
(17:26):
So that's not diagnostic.
But the ones that I justmentioned, the previous ones,
those are diagnostic and so kindof similar with which some
pharmacies and states are doingwith urinary tract infection,
where you do not have tonecessarily collect the sample
for that.
So right.
(17:46):
So, you can do a test to treat.
Again, you would need the CLIAwaiver under your pharmacy.
So you need a CLIA waiverthrough your pharmacy that you
can, you know, operate underCLIA.
But if a patient comes in witha positive test from you know,
again, we have pharmacies thathave done this with urinary
tract and they can do that alsowith, you know, syphilis or
these other tests that Imentioned they come in with a
(18:09):
positive result, then at thatpoint, if you have a
collaborative practice agreementthat allows you to do so, you
could prescribe an antibioticfor treatment for that.
So that's, I think, really,where pharmacy can take it a
step further.
So, if nothing else, be awareof the tests that are out there,
you know, on the shelf in yourown pharmacy or in the OTC aisle
(18:38):
, I should say, or see them inthe product catalog.
If you're ordering your own orrecommend this for that, then
just be aware of what they treat.
You know that they, the results,are instant.
They are a diagnostic.
They're going to give you apositive or negative result.
And then what to do upon thatpositive.
So some patients are going to,you know, go to their healthcare
professionals.
They're going to go tohealthcare provider, their
doctor or their clinic orwhatever Some might call you.
(19:00):
You know, hey, I got a positive, now what do I do?
And if you have that CPA, youcan prescribe or restate
protocol or whatever it is inyour state, if you allow for
that right to be done.
And then others, some of thecompanies are.
Even one of the companies ispiloting on their package like a
telehealth option.
So that if you get a positivelike on the box, you can pay for
(19:21):
a telehealth consult to getthat prescription.
So I think you're going to seea different varieties.
I think, it's going to dependupon what's most cost effective
for the patient.
What's if it's covered underinsurance?
Yeah, and so you know if theyhave a health savings account or
you know a payment things likethat, so it just depends upon
what's going to be mostbeneficial for the patient
(19:58):
minute to really think about it.
Speaker 1 (19:58):
I would have thought about telehealth, but that's
another way to for those, youknow, for those who are looking
for a discrete test, and thenfor looking for discrete
treatment, because, you're right, there is a stigma about you
know, going to public health forthat, or you know being seen in
your small town.
You know, oh, what are theygoing to say about me, and so
yeah, so if you're looking forthat still discrete treatment
all the way through I love theidea that there's still a health
(20:19):
option which just still allowsyou to get that treatment.
Turn right back around, go tothe pharmacy, get that filled
and just you know where youpurchase the test.
So, yeah, all great stuff.
I love it and I love the factthat you know again, with all of
this we're helping to reducesome of the stigma, we're making
things more accessible andwe're normalizing, I hope, the
ideas to normalize some of thoseconversations, some of those
(20:41):
sexual health conversations withpatients, and I'd be remiss if
I didn't talk about here how onthe rise a lot of it is in our
elderly population, in assistedliving homes and nursing homes.
That is a place where STIs areon the rise and so you know,
don't overlook that as being aplace where testing needs to
occur and treatment needs tooccur.
(21:02):
So and discussions in generalabout it.
Speaker 2 (21:05):
So yeah, yeah, and normalizing it, and I think you
put a you know, I think evenjust in general, at-home testing
has become normalized, likelet's all think back to five
years ago.
You know, if you're listeningto this, since 2025, but maybe
you know but five, six years ago.
You know, if you're listeningto this since 2025, but maybe
you know but five, six years agohow many, if we took a room,
would raise their hand and sayI've done an at-home test.
(21:25):
Like nobody probably wouldright, we'd all just be like no,
never done that.
Okay, now, now let's raise ourhands.
I mean, who has not done anat-home COVID test ever since?
Speaker 1 (21:35):
the pandemic.
Speaker 2 (21:40):
So what happened after the pandemic?
Is this just became so muchmore normalized?
Is that people had never usedone of these tests before.
They had to open up and they'rereading the insert and they're
looking at the swab and they're,you know, reading the little
pictogram and they're followingthe directions.
Well, now people have done that, and so now it's oh well it's
not so yeah it's easy, I can dothat, so now it's not so.
Um, yeah, it's easy, I can dothat, so now it's not so.
Um, such a new concept, and sopeople have come onto that also.
(22:02):
So has you know, like you said,the the convenience factor?
We live in a world where wewant to do things from the
comfort of our home, whetherit's shopping or whether that's
instead of going out to arestaurant you're ordering you
know the door dash or whateverit might be.
Uber Eats, and so we're gettingthat kind of that culture of
doing things more from theprivacy and comfort of your own
(22:22):
home as well, and so this reallyjust in general fits that
patient demand.
Speaker 1 (22:28):
Absolutely.
And you know, some couldcounter, argue and say, oh,
we're taking that role, thatimportant role, away from you
know, healthcare and testing youand whatever.
But that's where we have tomorph and change with that as
well, where we have to step upand say okay, well, now our role
is education and treatment, andthat's where we really need to
take that bigger step next, asthe pharmacist, and making sure
(22:51):
that we are setting ourselves upto do, you know, beyond the
testing, but to do the actualdiscussions and counseling and
then actual treatment options.
Speaker 2 (23:00):
So yeah, yeah, and if you have I mean again, you know
where this can even go inpharmacy.
As we're talking about this,I'm thinking a really big thing
pharmacies have been doing moreas well across the country is
oral contraceptive prescribing,and so this really fits in your.
It's that age range typicallyfemales that we're prescribing
oral contraceptives for that arecoming to the pharmacy maybe
(23:21):
because they don't have aprimary care provider.
And guess what, what a greatopportunity for us to say, oh,
by the way, just with your age,and if you are sexually active,
you should have one of theseevery year and we sell them and
I can answer questions for you,or maybe you have a handout in
your pharmacy.
I, you know, in the one of thepharmacies that I used to work
at, I used to have a handoutevery time I would.
(23:43):
You know somebody would come infor certain types of medication
.
I would usually provide themwith some education and then
also give them just something totake home to read about, about
that topic of an STI and howfrequently to be tested and
where they could be tested.
That was way before, obviouslythe you know we have these great
at-home tests now, so it's agood opportunity for us.
Speaker 1 (24:04):
Great call-outs, yeah , great points.
And you know, again, especiallylike, think about where you're
located.
Are you located where there'snot a lot of access to public
health or to clinics, or youknow minute clinics or you know
whatever.
Or are you located in a collegetown or university town?
Because, again, you know, wesee with that population they
(24:28):
typically don't have a PCP andso they're usually taking care
of themselves.
You know, like, oh, as it comesup, as whatever problem arises,
they don't really, especiallyif they're away from home,
they're certainly not going tohave established care with a PCP
, probably, you know, in a newcity or state.
So, yeah, all great points.
So now that we've kind of talkedabout the great opportunities,
(24:48):
are there any challenges thatyou can think of?
I mean, obviously we've alsotouched on some of the
challenges keeping up to datewith it, making sure that you
understand the scope of practicein your state and whatever you
know is allowed, and operatingunder CLIA waiver if needed, if
that's the route you're going,and making sure that you have
that and everything in line forthat certification.
What about any other negativeor challenges that you can think
(25:13):
of that we need to overcome inthis space?
I?
Speaker 2 (25:16):
wouldn't say necessarily challenge, but I
would just say to be aware.
So different states havedifferent regulations for
reporting STIs to public health,and so if you do have.
Especially if you're doing likea test to treat, right where
someone's coming in with thepositive and you have that test
to treat, where then you canunder a CPA protocol or whatever
practice laws within your stateyou can prescribe a treatment
(25:39):
for that STI, then you shouldalso just make sure you know
your state laws, that sometimesyou do have to report these to
public health and so alsoletting the patient know upon
that that you will have to.
you know if you undergo this,that you'll have to be reporting
it.
Speaker 1 (25:55):
Yeah.
Speaker 2 (25:56):
That's one thing.
Oh, go on.
Speaker 1 (25:59):
I was just going to say we don't have to talk about
specifics because that would getinto bias and everything.
But have you heard about costs,like are these cost effective
or are they fairly expensive?
Speaker 2 (26:10):
Yeah, so I mean I was looking at some of the costs of
them and again I think it justcan it really depends and it
varies for the because I also sobehind the scenes for someone
who does a lot of test to treatand point of care testing and
working with pharmacies to getthat up and running.
I'm really familiar with thecost of some of these tests.
Before they went home test andI was like, oh my gosh, how is
(26:33):
anyone ever going to afford that?
But, they've actually beenpretty, pretty reasonable.
So for the blood test, for forthe syphilis, for instance, over
the counter I've seen somewherearound and again like I'm not
price, but I'm just saying likeif you probably google this.
You're probably gonna find about30 ish dollars, which isn't bad
(26:53):
and then as and then the visbymedical that I've seen over the
counter, it's like through theirapp it's about 150.
So but if you think about that,you know if you have a patient
that has, you know, maybe highdeductible plan or you know,
health spending account andthat's not covered, and you know
(27:16):
, for a lot of them it might becovered as a preventable.
But if it's not, because it's alab or whatever, that might be
a much more economical and costeffective, even by going to the
pharmacy and then getting atreatment it might be more
economical than going insomewhere, although I will say
too that a lot of public healthdepartments do offer that
testing for free.
So there again, just be awarethat's another thing you can do
(27:37):
as pharmacy.
Just be kind of aware of theresources in your community, in
your area.
I know some states even, andeven some college campuses will.
They have numbers or contactsyou can, and they'll get a test
mailed to them for free throughlike grant funding or through
the state funding as well.
So if you ever have a patientthat is interested and can't
afford that, I would recommendto reach out to some of those,
(28:00):
like a local public health or astate public health department,
to see if there's anyopportunities for that.
Speaker 1 (28:05):
That's great and we always I feel like I always give
a call out to our communityhealth worker program and the
fact that if you have atechnician cross-trained as a
CHW or a community health worker, you know they're going to know
what the ins and outs are inthe community, the opportunities
, the different ways in whichthey can get a patient connected
.
So that's something else.
(28:26):
Yeah, I you know.
And also we were talking aboutpricing when doing comparisons.
It also could be you know howmuch is someone willing to pay
for the ease of it being ontheir time, like what if it's a
Saturday evening?
Or what if they're going out oftown and they, you know they
don't have time to go get labdone and then whatever.
And so that whole buying thetest and doing the telehealth
and filling their prescriptionor, you know, doing it in-house
(28:48):
with you, if you have acollaborative practice agreement
to treat, you know it could, itcould be worth it to them
because, for whatever reason,you know timing and such.
So yeah.
Okay, well, last thing before wewrap up.
Well, next to the last thing,I'll ask you this and then I'll
ask you the very last question.
But before we do that, I knowjust from your expertise, I want
(29:09):
to pick your brain on this.
As you mentioned, you've beeninvolved with getting test and
treat stuff up and running andeverything.
You know one of the biggestpushbacks we always hear, and I
totally get it.
I've been there, I've owned astore, I've worked in, you know,
for other companies.
I get it Timing, you know likeI just I don't have time.
I just don't have time.
I don't have time to do this.
Do you have any nuggets or anytips or tricks about how to work
(29:32):
in these types of things, likeif you, you know it'd be so easy
to just see someone out there,they figured it out, they
purchased it, whatever, just letthem walk because they probably
know what they wanted anyhow.
But you know, how can we, howcan we see those instances, take
advantage of them and really,really make a time for that?
Any kind of tips and tricks onthat?
Speaker 2 (29:52):
Yeah, I would just say that, first of all, these
are at-home tests, and so you'renot doing the sample collection
.
And so that typically is whatcan, sometimes depending upon
the type of test, but that cantake time.
The patient's you knowinformation or you know whatever
you know, intake forms orwhatever like that that could be
(30:14):
time to develop or patienteducational materials.
There have been actually it wasactually not too long ago, but
it was through the University ofPittsburgh and I had come
across.
I love toolkits, I'm a toolkitjunkie Like I.
Just I absolutely love a goodtoolkit for pharmacy and we've
done a lot within our center forhelping pharmacies and toolkits
(30:35):
and kind of giving everythingthey need.
And so the National Associationof County and City Health
Officials actually did acollaboration with pharmacy on
STI treatment and they actuallyhave available a complete
toolkit for pharmacies and soyou can have like printable
materials.
for some of these it's allpublicly available because it
was through a federal or federalgrant and it was with the
(30:58):
University of Pittsburgh as well, but testing and has
educational materials.
So it even has a patient intakeform.
So if that's something that's alot of pharmacies.
I've had get kind of hung up onthat a little bit and I've
worked with it's like oh well,how do I collect the information
and how do I?
Oh, like that, just seemsreally overwhelming, and it can
be.
It can be really a lot, and sowhy recreate the wheel when
(31:20):
there's some of these reallygreat resources?
that are out there for you.
So it's a tidbit, I would say,put that in the back of your
pocket if you're ever interestedin that.
But also, as you mentioned too,of really relying on our
partners of, like our communityhealth worker or technicians of
you know, getting thatinformation, gathering that
information and really afterthat, if you're just answering
some questions for the patientwhich we do anyway and that's
(31:42):
part of our normal workflow aswell as you know prescribing the
treatment and counseling on themedication.
It's really I would say it's notmuch more than a prescription
you know a regular prescriptionand you're probably going to
make more money on it.
So to be honest with you,unfortunately, in the way that
things are right now in theworld of pharmacy and
reimbursement.
Speaker 1 (32:08):
Yep, no, totally makes sense.
That's exactly what I wanted.
Speaker 2 (32:09):
I love, I love the idea.
Speaker 1 (32:09):
I'm also a nerd and a toolkit junkie so, like,
anytime you can get like like, Istill like to print things and
no, it's not great for the, forthe, you know, for everything,
for environment, but I love tolike hold something and like
open up a package and get all mygoodies and everything.
So, yeah, I'm totally with youon that.
I love that idea.
So tell us again who the, the,the company, tell us again where
that kit can come from.
Speaker 2 (32:30):
Sorry, yeah.
So the kit came from theNational Association of County
and City Health Officials, sothat was the granting partner.
And then it was from and maybesome of your listeners even here
are familiar with that, but itwas also from the University of
Pittsburgh.
School of Pharmacy was acollaborator on that and they
have an article in the Journalof American Pharmacy Association
(32:54):
on that toolkit development andsome really great resources.
So shout out to them for doingan excellent job on that and
providing a resource topharmacies.
I love it when people do greatwork and they share that with
others.
Speaker 1 (33:08):
I love that I love when, again, there's no reason,
like if they took the time andcreated the wheel.
I love when they share itbecause there's no reason for us
to recreate it, so it's great,awesome, okay, well, final
question.
Now for sure, as I always liketo ask our guests, the name of
our podcast is Game Changers.
So, elizabeth, what do youthink the game changer is here?
What's our overall take homepoint from today's episode?
Speaker 2 (33:32):
I think the overall game changer is that our rising
STI rates in the US are a publichealth concern and for the
first time we have accurateat-home tests with immediate
results for our patients to helpincrease access to treatment
and increase access just toscreening in general and
(33:52):
prevention of spreading ofdisease.
And I also think that it'sanother opportunity for pharmacy
, who probably wasn't doing youknow you're not going to be
doing probably a vaginal samplecollection in the pharmacy, but
now we still have an opportunityfor a test to treat now with
this because we have an at-hometest, so I think that's
(34:14):
definitely a game changer for us.
Just one more way for us to helpimprove the lives of our
patient and increase publichealth.
Speaker 1 (34:21):
That's great.
That's great.
Well, thank you so much.
We have time for today.
Elizabeth, Thank you so muchfor spending your afternoon with
us.
I really appreciate it.
Speaker 2 (34:30):
Yeah, absolutely.
Thanks for having me.
It's always a pleasure.
Speaker 1 (34:33):
If you're a CE Plan subscriber, be sure to claim
your CE credit for this episodeof Game Changers by logging in
at ceimpactcom.
And, as always, have a greatweek and keep learning.
I can't wait to dig intoanother game-changing topic with
you all next week.
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