Regulatory Requirements for Post-Acute & Long-Term Care Antibiotic Stewardship Program

Regulatory Requirements for Post-Acute & Long-Term Care Antibiotic Stewardship Program


– [Christopher] So before I jump in, I do receive funding to look at antibiotic quality improvement in nursing homes both from AHRQ and the VA. I do consult for, on a small level for a couple of companies. Zurex develops a cutaneous anti-septic and Deb Group develops a hand
hygiene monitoring system. Neither of these should be
part of my conversations today. So what I hope to get through is talk just very briefly about
the extent and consequences of antibiotic use in
skilled nursing facilities. You’ve already had a
lot of this so I won’t spend too much time on that. I talked very briefly about
the regulatory history in skilled nursing
facilities, this audience is well-aware of those so
again, you probably can teach me more about that than
I can teach you about that. We’ll talk about the new
Mega rule in some detail and then really talk
about what I think are things you’re probably
already doing that you can leverage to meet the new
regulatory requirements and then talk about some of the strategies or kind of throw me a rope approaches that you can be doing to kind of look outside your facility
to get some assistance. And I think you guys are very fortunate to have the resources in
the state that you have. You have a number of individuals and organizations that
I think are very well positioned to help you achieve these regulatory requirements. Many states don’t have
access to the resources that I think you guys have here. So why do we worry about
antibiotic use in SNFs? Well we use a lot of antibiotics in SNFs. If you stay in a SNF
for at least six months, you have about a 70%
probability of getting one antibiotic exposure. We’ve done a number of
longitudinal studies in Wisconsin facilities
and our data matches up very closely with what is published on national levels, international levels. And when we went in and looked at use we found that there are definitely hyper-utilization sub groups. About 20% of the residents
account for about 60% of the antibiotic use in SNFs. And we found our record for one year was 15 antibiotic courses in one resident. You can just think about what that’s doing to that individual’s microbiome. Now the problem we have is when we go in and look at the quality
of those antibiotic prescriptions, about
half of them are either unnecessary or inappropriate. And what I mean by
inappropriate is on the right. We tend to use a lot of broad spectrum antibiotics in this population, but most of the infections
that we’re treating in SNFs are the pus infections. Pneumonia, UTIs, skin and
soft tissue infections. And the vast majority
of those are treatable with narrow spectrum
antibiotics in most situations. And so the broad spectrum
nature of our prescribing doesn’t really match up
with the microbial spectrum that we’re often treating. And then the other thing that we find is that we’re treating these infections for far too long. So again, the pus infections,
we’ve got a mountain of evidence now that
less than a week worth of therapy is as good as
a longer course of therapy and in many cases it’s
better because it leads to fewer side effects, less
promotion of resistance, lower risk of C difficile. And so I think there’s
a lot of opportunities even if we do nothing to move the needle on avoiding antibiotic use to improve the overall quality by
focusing on drug choice and drug duration. Now all of this use has a lot of harms. And I think we’ve done
a bad job in messaging from a public health perspective. We’ve kind of focused on
resistance, resistance, resistance, this kind of population level consequence of antibiotic use. It’s a little bit like global warming, people sit there and say
yeah, it’s probably a big problem but I’m gonna still kind of drive my ATV around and guzzle gas. And I think what we really
need to be focusing on is the harms of antibiotic use at the individual resident level. And this is what we need to
spend a lot more time messaging. Antibiotics are one of
the most common drugs for adverse drug events in
skilled nursing facilities. There’s a number of studies now showing transfers to the emergency department for adverse drug events,
antibiotics are in the top three in every one of those studies. If you look at C difficile, there was a really nice study
done out in the northeast which looked at residents
started on antibiotics for suspected UTI. The vast majority of them
did not meet the gear or lobe criteria so they probably had asymptomatic bacteriuria. And what they were able to show is about 10% of those individuals
went on to develop C difficile in the two to three months after that antibiotic treatment course. So we’re triggering these C diff events with these unnecessary antibiotic use. And then the thing that is more difficult to kind of show is the
promotion of resistance. Again, we talk about resistance
at a population level, but I guarantee you
you can go into any one of your facilities and
find one or two residents where if you just map up
all their urine cultures over a two year period of time you are going to see the effects
of antibiotic prescribing. So whenever I see a resident
who’s got candiduria, Pseudomonas, enterococcus in their urine. I know that, that individual has got a boatload of
antibiotics in the past. It just, those organisms don’t show up without a lot of antibiotic exposure. So, that’s what we’re
doing to our residents. And so again those are cases that you can kind of show to your providers that these are the harms
of antibiotic therapy. The fact that resident now
needs to be hospitalized for an intravenous course of antibiotics because of the resistance in their urine is directly a result of all that upstream historical use of antibiotic
use in that individual. So, this is unlike any other medication. So the harms that you know
we see with other drugs accrue only at the individual level. But they also accrue
at a population level, in the nursing home. Really nice study by Nick Daneman up in Canada. And what they did in
Ontario, they looked at all the nursing homes, stratified them into
high using facilities, low using facilities, and
medium using facilities. And then they tracked those residents over a two year period. Nearly 100,000 residents. And they were able to find
a very small percentage, maybe not very small,
about 20% of the residents never got an antibiotic. 75,000 of the residents
got at least one antibiotic over the two year study period. So, but they were interested
in asking the question, what was the risk to those
who never got an antibiotic being in a high utilizing
facility, low utilizing facility, medium utilizing facility. And what they found was
residents who never got an antibiotic but were
in a high using facility had a 25% higher rate
of C dificile diarrhea and other antibiotic related harms compared to residents who
never got an antibiotic but were in a low utilizing facility. So, by converting your facility
from high to low utilizing you’re not only helping
those residents who would otherwise have gotten an antibiotic, you’re helping all those other residents who never an antibiotic
in the first place. And then I think what we’re
gonna talk about today is obviously the regulatory issues. And this is a direct harm to the facility and I guarantee you that
at least in Wisconsin we’ve been utilizing the
inappropriate medication use F tag for many years
and this has resulted in a number of survey deficiencies
in facilities in Wisconsin. And if that isn’t happening in this state with the new Mega rule I suspect that it will start to happen. And then finally the
population level, again, the thing that I think we
need to de-emphasize relative to these other things, is
these residents transition back and forth from the
hospital all the time. And what we’re doing is generating the regional spread of resistance. And so being kind of a good
steward for your community is another message that we
need to be talking about here. Okay, so obviously government and public health
authorities are concerned. You’ve got a very nice talk
from the Public Health Authority at the CDC this morning. This is gonna be front
and center for the CDC and for public health authorities. So this is not going away any time soon. There’s a national
action plan to eliminate or reduce health care
associated infections and obviously the White House released this Nation Action Plan to combat antibiotic resistant organisms. And all of this public health advocacy was a direct result, or
led to the Mega rule. The Mega rule wouldn’t have happened without this type of advocacy. So you can blame Arjun [Srinivasan] for the Mega rule. He’s not here so I can say that. This is a big deal. And I think it’s freaked
a lot of people out appropriately so, but I also think that you guys are doing a lot of things already that you’re not as bad off
as you think you might be. So we’re gonna talk about that. So, you guys already know this history. Skilled nursing facilities
were originally you know designed for domiciliary care,
not to deliver medical care. We’ve kinda done a complete 180 in skilled nursing facilities
where we’re not providing a lot of medical care. Pre OBRA 1987 there was
a lot of concern about widespread abuse of residents. Again, probably overblown. And we’ve kinda done an over
correction with the regulatory issues in my opinion. We need to be a lot more
collaborative than punitive. But that’s the system we have now. If you look at kind of regulatory history infection control stewardship
wasn’t a major part of regulatory language for
most of the post OBRA period. But yet, when people
went in infection control has remained the number one or
number two survey deficiency over you know as long as I’ve
been following this field. So, it’s an area that’s of high interest to state surveyors. Again, fairly absent is
antibiotic stewardship, in Wisconsin our surveyors
took liberty with the inappropriate
medications and this is data on the right showing
that about a third to 40% of the inappropriate medication F tags are for inappropriate antibiotic use. So, our state has been
penalizing nursing homes for over use of the antibiotics
now for a number of years. So, 2016 is when the Mega
rule was first released. A lot of it is being
implemented in phases. The final phase is to be
implemented this fall. Which requires that all facilities have an infection preventionist
with dedicated training beyond their terminal clinical degree and all of you theoretically
should have an antibiotic stewardship program in
place as that was required to be implemented last fall. So like everything related
to survey the Mega rule is just the tip of the iceberg. It’s the interpretive
guidance that kind of dictates things so when the Mega rule is released there wasn’t a lot detail on what to do. So the interpretive guidance is really there to kind
of help us piece out what do we actually need to
be doing at a facility level. The thing to remember is that
the interpretive guidance is modeled after the CDC core elements. So if you’re not familiar
with this document please get a copy, keep
it in your facility. It has a nice checklist,
Salman and his group are doing assessments that
are modeled on a lot of this. And so, you’re technically
following the core elements if you’re engaging with Salman’s group in doing the assessments and the training. But this is a good document
to be familiar with. It has a checklist associated with it. Again, you probably already
utilizing some modified form of a checklist already. As a result of Salman’s group’s efforts. But this is a really nice
way to kinda see are we in line with regulatory language or not. So what are the specific
elements detailed? So one, they wanna see leadership support. They wanna see that a
facility has protocols and or policies in place that address each of those bulleted
elements that I’m gonna go into some of those in detail. Now the thing in this last
bullet that I want you to pay attention to. This has not gotten as much attention as I think it needs to. But they wanna see clear documentation of indication, drug, dose and duration. If you can’t show that
in your documentation you will get a survey
citation, I guarantee you. So, working with your providers, working with your staff to make sure that this part of documentation
is clear in your records. And again, they don’t
say where it needs to be. It could be in the physician order. It could be in the nursing notes. It could be somewhere else. But this needs to be
somewhere in the record. And if you don’t have
that, I guarantee you the surveyors will hit you. Now we published this article in JAMDA. It is a draft antibiotic
stewardship policy. It goes line by line through
the interpretive guidance to kind of address those
elements in the policy. If you don’t have a stewardship policy this is a great place to start. You can kind of plug and
play with the document. It’s also probably a good article to read to see if you already have a policy. Does my policy have all of these elements? This’ll be very useful during a survey if you’ve got a policy like this. Okay. So Yoda, he is where I go
to all of my sage advice. We’re kinda learning on the
fly how to do stewardship in long term care, I’ll
be perfectly honest. We’ve borrowed a lot of things
from the hospital setting because there haven’t
been a lot of good studies done in long term care facilities. So, a lot of what we recommend kinda comes from best practice in hospitals. That being said, I think
a lot of what we see in the core elements and the
rate interpretive guidance its pretty common sense. You know, just best practice. And so, I don’t think
it’s too far out there. So, there must be a medical director who is upset with this slide. So unfortunately this is the current state in most nursing homes. You’ve got the DON and
the IP doing all the work and again I apologize to
the pharmacists in the room. Pharmacy and the medical
directors have not been very engaged in antibiotic
stewardship in nursing homes. And many times the medical director can be your worst offender. And that’s really problematic. So, I think one of the
first things you need to do is take stock of what are
your leadership resources, both medical director wise and pharmacy wise in your facility. And see how can you
leverage those individuals more effectively to support
antibiotic stewardship. Most people are not sociopaths. Most of the people wanna help, and what they need to hear
is what do I need to do. So, coming to your medical
director and saying you know it’d be great if you could give an in service to the nursing staff about when they should be thinking about ordering a urinalysis. They will be generally
delighted to say oh yeah I can give a talk on that. The medical director is really
useful for helping deal with problematic other
prescribers in the facility. It’s not a comfortable
thing for them to do but that’s why they’re there. And so, asking them you know
to talk with a colleague who is really out of bounds is a start, but going to them and saying you know Doctor so and so
continues to use this drug that’s unnecessarily broad this patient gets C
diff three times a year you know, giving them data
and actionable recommendations to go back to their colleague will help them do their
job more effectively. So, lead them to the water so to speak. I think for the pharmacist
again, a lot of this is driven by what’s in
your contract language for your facility. So, when you’re
renegotiating your contract or you’re talking with your administrator about how can we leverage our consultant pharmacy more effectively thinking about trying to incorporate some of that into your contract language with your consultant pharmacy I think is a very useful suggestion. And a lot of times those
pharmacists want to help and so again, figuring
out what they can do to help in the facility for
a limited amount of effort. Take advantage of them. Don’t feel like you need to carry the burden all on your own. So, this is just data kinda summarizing what is visually projected
on the left hand side. I think when you look at,
from a structural perspective a lot of facilities don’t
have prescribing guidelines. I think that this could
be a very useful tool to codify you know when
are we going to send a urine culture, how
are we gonna treat UTI? How are we gonna treat pneumonia? That can kind of be a
straw man argument you know when a provider comes in and is you know prescribing gazilla-cillin all the time you know saying we don’t
treat UTI’s in this facility with those broad spectrum antibiotics. And again, when I was talking over lunch I think if there’s one type of infection to kind of focus your efforts on initially urinary tract infection is obviously the highest yield in my opinion. So, how can the medical director help, I’ve already talked a
little bit about this. I think role modeling is really important and so if your medical
director’s is your worst offender politely drawing their
attention to the fact that they’re the worst offender. Sometimes they don’t know. Usually they know, but
sometimes they don’t. You want them engaged
in your QAPI meetings. And you want them reviewing and developing policies and procedures. And again, I think a really
useful tool is to get them engaged in doing staff eduction. And then, I’ve already
talked about helping them manage the negative
deviants in your facility. Yep (laughing) so, the antibiogram, and I asked
this question at Dan’s [Dikema] talk I think’d be very powerful. So, knowing what your resistance
rates are in your facility particularly for certain high utilized classes of medication. So fluoroquinolones come
to mind very rapidly. If 60% of your urine
isolates are resistant to fluoroquinolones that class of drugs should not be used empirically
in the treatment of UTI in your facility. And so getting that data, showing it to your medical director and saying, would you be in agreement with saying we’re not gonna
use fluoroquinolones first line is you know there’s effort
to aggregate that data. Sometimes your labs can help
you collect this information. And you’ll be meeting a regulatory requirement by doing this. Because the regs say you
need to track antibiotic use. And you need to track
antibiotic related outcomes. And so, if you can kind
of show the surveyor when they come in, hey you know we look
at the resistance rates of all of our urine cultures and this is the
fluoroquinolone resistance rate the Bactrim rate et cetera in addition to your MRSA and C diff rates you’ve met that regulatory requirement to track an antibiotic related outcome. Again, this is something
I talked about at lunch. I can’t tell you how
important nursing assessments in communication to providers is. This is where you wanna
invest a lot of resources and efforts because it’s not gonna only help with stewardship it’s gonna help with
everything else you do in the nursing home. So getting a good consistent
reliable SBAR process in place is really important. Talking with nursing
staff, how they communicate to providers a change in condition, are they sending unconscious messages, we really need to test
and treat this resident. Or I’m getting pressure from the wife or the daughter and now I’m asking you
to start an antibiotic. So I’m just kind of pushing
the pressure downstream. We need to be cognizant of how we interact with one another and putting
some emphasis on this at the nursing staff
level is really important. This is data from a Wisconsin facility showing how a engaged
enthusiastic medical director can drive practice change. In this facility they started looking at their microbiology data because
they had an MRSA outbreak. They recognized that
they had a lot of issues with Enterococcus, Candida in their urine. And they’re like, we are
prescribing a lot of antibiotics. And we’re creating this. So he sent out a dear doctor letter, that’s what he called it. To all of his colleagues
with the micro results and with suggestions for practice change. Avoiding unnecessary antibiotics
for change in condition, using more narrow spectrum
antibiotics for UTI. And they dropped their
antibiotic use by a third with just the dear doctor letters. They didn’t do anything else except aggregate some micro data and send out a dear doctor letter. And so this was very powerful for this facility. How can the pharmacists help? Well again, I think the
pharmacists need to be engaged in the QAPI meeting. Where you know, prescribing
data, culture results, infection rates are being reported. They clearly play a role in developing facility policy and procedures. So if you’re looking
for how to standardize the treatment of UTI the
pharmacist can be very helpful in saying these should
be our first line drugs in our facility. This is how they should
be dosed and adjusted for renal function, et cetera, et cetera. They can also help put
together pocket cards things of that nature. So they can be extraordinarily helpful in developing some of these strategies. I think they can be very useful in some of the tracking and reporting. So again, one of the
regulatory requirements is you need to be tracking
some antibiotic use measure, so the pharmacists can help. Now if you have electronic filling data and they have an IT or informaticist who can pull that data
that makes it really easy. But it’s still pretty challenging to work with long term care pharmacy data. That being said, if you don’t have that type of resource having kind of an antibiotic event card that the front line staff fill in and submit to the IP who can kind of aggregate that. Because they’re doing that anyways for their infection rates. So you’re taking advantage
of front line staff to collect some of the
data the IP is aggregating. Or the pharmacist is aggregating it. And then that’s being reviewed
at some regular interval. If you’re doing those things, tracking antibiotic use, tracking an antibiotic outcome, documenting you know that you the indication, drug, dose, duration and that you’re doing some education to staff and facilities. You have largely met the
regulatory requirements for stewardship. Now, I would argue you
don’t wanna stop there. But if you’re doing those
kind of four things, you’ve largely met the
regulatory requirements. So, when we looked at our
facilities in Wisconsin the vast majority said they were tracking some type of outcome. I would argue that they
weren’t trending it which is really important to see where you were last year to where I am now. They could tell me what
they had in the last month. But they couldn’t tell
me whether they’d been going down, staying the same, going up. So, in addition to tracking it, you need to trend it,
visualization of your numbers is really useful, very powerful for people like medical
directors and providers to see. A lot of times the people
who were looking at it were the IP and the DON, medical director often didn’t see this data in our facilities. So that’s a crime. The medical director should
always be seeing this data. So I’ve talked a little
bit about this already. So they wanna see use. They wanna see outcomes. Arjun referred to the
appropriateness piece. And again that’s still
really difficult to do. But I think it can be very
valuable if you can get there. So, what do I mean by utilization
versus appropriateness. Just pay attention to the
top two bullets on the left. Antibiotic start and days of therapy. I think those are gonna be the
most useful measures to you. The days of therapy I find to be the most useful measure. One because it’s similar to what’s being tracked in hospitals, and at some point if nursing
homes start to engage more consistently with
NHSN getting comfortable and familiar with the
days of therapy measure I think will be valuable. The other advantage, it
also gives you a sense of what your duration of
prescribing is in your facility. Antibiotic starts give you no information on duration of therapy. So even if you don’t move the needle at all on antibiotic starts, but you go from an average
of 14 days of prescribing to eight days of prescribing. Your days of therapy
will drop in a major way but your antibiotic starts
won’t change at all. So, if most of your improvement efforts are focused on duration of therapy you probably don’t wanna be just using an antibiotic start measure
if that makes some sense. Now, appropriateness
again really complicated. Most of you are already probably familiar with McGeer criteria or Loeb criteria. And a lot of times I see
facilities reporting out the number of UTI’s that were treated that met McGeer criteria. And the number that didn’t
meet McGeer criteria. So, you are already
tracking appropriateness of antibiotic therapy if
that’s what you’re doing in your facility. Now, if that’s too complicated to do. And let’s say again you’re
looking at duration of therapy then track the number of events that are more than seven days versus those that are
less than seven days. And so, you’re trying
to get that percentage that are less than seven days up, and the percentage that are
more than seven days down. If you have a particular drug that you know you have problems with. Fluoroquinolones. The proportion or percentage
of antibiotics starts that were quinolones is
another appropriateness measure that you can be tracking in your facility. So again, I’m not gonna
sit here and tell you which measure you need to use. You need to use one at least, according to the regs. But I would argue that you wanna look at what are my problem areas. What do I want to affect
in a positive way. And make sure that you’re designing your tracking measures around that. And make sure you’re
putting most of your effort around where you’re gonna be tracking or trying to make improvements. If those aren’t aligned, it’s
gonna be really difficult to say whether you’re having an impact. So again, if most of your efforts gonna be on duration of therapy you wanna be using a
days of therapy measure and you may wanna look at
that percentage of treatment course that’s greater than seven days. So, the other thing is leverage pharmacy. They may be able to help
you track some of this data in a low intensity way. Particularly if they can
access electronic resources. And they might be able
to help you figure out how to stratify your data, or visualize your data
in a more effective way. I’ve already talked about this idea. Use your frontline staff to do some of the initial primary data collection. So, in the battle days of
hospital infection prevention we used to have infection
cards that the nurses would fill out whenever there was a healthcare
associated infection. They would hand it to the ICP and the ICP would aggregate the data. But the front line staff were filling out the information on the event. There’s some issues with that approach. But you could see how
this could be scaled up more effectively if
your ICP is going around and spending most of his or her day tracking down data on infections they can’t go out there and do education. And kind of reinforce best practice. And so, helping them collect data I think’d be very useful. And finding ways to integrate this into infection surveillance. So if your facility’s
already tracking UTI’s then, just add on the
antibiotic information into that surveillance activity. They’re already in the record, they’re already looking
at this information. So just add it to their
infection tracking form. And figure out ways to
turn that into a measure that you’re reviewing in your QAPI meeting reviewing with your medical director. If you don’t have the ability
to do this consistently on a monthly basis then take a cross sectional approach. Every three months we’re
gonna do a deep dive into you know specific
aspects of prescribing. So, for the next two
weeks we’re gonna look at every antibiotic use
and we’re gonna detail why they were started,
what agent was started, what was the duration of therapy. You will learn a lot from just doing that. Even if you’re not doing it monthly. And again, you’re meeting
the regulatory language if you’re doing that. They don’t tell you how
to do surveillance, okay? Again, I’ve already
said make sure you align your tracking with your quality
improvement initiatives. Make sure you’re trending your data and then the other thing
that I would say is be careful about comparing
yourselves to external data particularity if you
don’t know the methodology by which those data are developed. So bench marking is a very powerful tool, but it only is useful if
your apples are their apples. If you’re comparing apples and oranges you can get led down the garden path. And then what I would
say is education is still our most frequently used tool. It is specifically in
the regulatory language. So you need to be doing
some type of education to your nursing staff and your providers. You need to do both. Again they don’t say what. They don’t say how much. But you need to have documentation that you provided education to nursing staff and providers on that. And then, I know that
I’m running late here. The antibiogram is mentioned specifically in the interpretive guidance. They don’t say you have
to have an antibiogram although a lot of
facilities have interpreted that as saying they need
to have an antibiogram. What they say is you need to be tracking an antibiotic [use] outcome. An antibiogram is a way of doing that. They don’t say you must
use an antibiogram. So if getting an antibiogram
is really challenging, I wouldn’t lose too much sleep about this. If you’re getting an antibiogram
just to have an antibiogram and you’re getting the
hospital’s antibiogram or you’re getting a regional
aggregate antibiogram I will tell you that’s not very useful. It’s fine to throw up
in front of a surveyor and say I’ve got an antibiogram but you really don’t know
anything about the resistance in your facility if it’s
the hospital’s antibiogram or the region’s antibiogram. You really need to know
your facilities antibiogram. So if you can get that facility
level data, very useful. But, if it’s really challenging then I would pick some things and just say you know we’re
gonna look at MRSA C diff and fluoroquinolone resistance
in our urine cultures. And now you’ve met the
regulatory language. And it’s actually useful
to you because now if you can go back to
your providers and say, 60% of urinary isolates are
resistance to quinolones, we need to stop using quinolones, that’s actionable information that you’ve brought
back to your providers. Alright, I’m not gonna spend any time on the external resources cause
you already have access to a lot of resource,
and I suspect the other providers will talk about that. So I will stop there.

Add a Comment

Your email address will not be published. Required fields are marked *