Hello.
My name is Deb Smith.
I'm an Improvement Consultant at Health Quality Innovators or HQI.
This educational event has been developed in partnership with HQI, the Virginia Department
of Health, and the Virginia Hospital and Healthcare Association.
I would like to draw your attention to the icons at the bottom of your screen.
There are two green icons to the right.
One is for the resources for this education, and the other is for the post-test that you
will be taking after completing the education.
Take a minute to review and download the resources.
After reviewing this pre-work, you will be ready to view the recorded education.
On completion of the recorded education, you will need to take the post-test.
You will have two chances to achieve a 70% or higher in order to receive your certificate
for credit.
I would now like to introduce your instructor for today.
Dr. Mike Stevens is an Associate Professor of Internal Medicine at Virginia Commonwealth
University, where he is also an Associate Hospital Epidemiologist, the Director of the
Medical Center's Antimicrobial Stewardship Program and an Associate Program Director
for the Internal Medicine Residency Program, where he is also the Global Health and Health
Disparities Pathway Director.
He is also in the Director of the Medical Center's Travel and Tropical Medicine Clinic.
Dr. Stevens, the floor is yours.
Thank you for that kind introduction.
I'm excited to be here today.
I want to thank Health Quality Innovators for putting together this slide deck and inviting
me to come and speak.
Also, thanks to the Virginia Department of Health, as well as the Virginia Hospital and
Healthcare Association, and the Virginia Healthcare Associated Infections Advisory Group.
I have directed the Antimicrobial Stewardship Program at Virginia Commonwealth University
since 2010.
I have no disclosures; and of course, all of this is my own opinion, what I'm saying,
over top of these great slides.
For the objectives, we're going to define antimicrobial stewardship.
We're going to talk about the benefits of having an antimicrobial stewardship program.
We're going to review guideline recommendations for implementing a stewardship program.
Describe antimicrobial stewardship strategies in the hospital setting.
Also, highlight specific initiatives to meet new regulatory requirements.
Traditionally, cost controlling arguments for antimicrobials have been proposed to justify
ASP resources.
Focusing on antimicrobial costs is dangerous, because there are natural limits to cost containment.
However, the mandates for stewardship, which we will discuss later in the slides, are a
boon to programs arguing for resources because business models can be proposed based on potential
reimbursement penalties associated with the new mandates.
I strongly encourage folks that are creating stewardship programs and arguing for justification
of resources to not to a traditional cost model based on expenditures for specific antimicrobials,
but really to look at the new mandates as a potential way to create a new business model.
Beyond cost, arguments for resources should be made based on patient safety, reducing
the emergence of antibiotic resistance, and improving the safe and optimal use of antibiotics.
We'll talk more about that.
Again, stewardship, in a nutshell, is focused on two overarching concepts.
One is reducing the emergence of antibiotic resistance, and two, improving the optimal
use of antibiotics.
Now, there are multiple different strategies that programs can deploy.
The two primary strategies are number one, antibiotic restriction, which essentially
is people have to call for approval for certain agents, and if they don't meet the use criteria,
they're not allowed to use those agents of restriction.
Then, number two is review of pre-existing antibiotic orders to assess for opportunities
to improve antibiotic use and de-escalate.
Now, by improve antibiotic use, sometimes this is not going to a narrow-spectrum antibiotic
or stopping antibiotics; but it's actually escalating therapy or starting an antibiotic.
That's an important concept, and we'll touch base on that a little bit more.
Other important strategies that are supplemental to these core strategies include things like
review of pre-existing antibiotic orders to optimize dosing, especially for narrow therapeutic
index drugs like gentamicin.
Again, those opportunities to improve use that really don't involve de-escalation.
An example of that might be somebody with fungemia, not on an antifungal, starting a
drug in that scenario.
These are all examples, and there will be multiple examples throughout this presentation
as we go through.
Other important stewardship activities include monitoring and reporting out of process and
outcome metrics.
Examples of some of these would be antibiotic prescriptions or prescribing, total antibiotic
use, number of interventions, the emergence of resistance, amongst other things.
When we talk of how to do stewardship, the CDC had released core elements of stewardship
for hospitals, nursing homes, and outpatient facilities.
Mandates really parallel these recommendations.
These are very important, and these are things that surveyors and others who are assessing
stewardship programs will be looking for.
The core elements for hospitals and nursing homes, really they involve a leadership commitment,
so there should be somebody who is accountable for the program and for program outcomes.
Ideally, this is a physician with some advanced antibiotic training or infectious disease
training, as well as a designated pharmacy leader.
Again, that accountability goes back to identifying leaders within the program.
A step back, that leadership commitment has to be at the highest level of the hospital,
dedicating resources to stewardship programs.
Drug expertise for the people who are running the stewardship program.
Action, and action, we'll talk about what actions are within stewardship programs throughout
the deck here; but this is actually doing active stewardship, having a program that's
active.
Tracking the process and outcomes of the program and reporting these out in the appropriate
committees within the hospital, but then also to frontline providers.
Then doing education, usually tied to other interventions or other activities with the
stewardship program.
Now, when we look at the core elements in the outpatient arena, essentially they parallel
the inpatient core elements; so I'm not going to go through those in great detail.
You can see those on the slide.
Now, I will say there is an important ... Because every setting is different, the resources
in every setting are different; but these core elements really are similar no matter
what the setting you're in.
Not every program is going to adopt all of the same strategies.
The National Quality Forum released a practical playbook for stewardship programs that can
serve as an a la carte menu for programs desiring to initiate a stewardship program, and trying
to build a program around these core elements.
Again, that could be a great resource for you as you develop a program.
Now, when we talk about requirements, we talk about the mandates.
Joint Commission Survey requirements began in January 1, 2017 for acute care settings.
CMS mandates exist for long-term care facilities now.
Conditions of participation were also proposed for acute care settings, but those are on
hold for now.
The future really is a future where there will be reimbursement penalties tied to mandates
for stewardship programs.
Some of these things, in terms of what people actually will be held to, held accountable
for, are in evolution; but they seem to be really paralleling those core elements from
the CDC.
Stewardship mandates are a reality, and in my opinion, these are a major boon to programs,
because this will help with arguments for resources.
Now, looking at a stewardship committee.
Oftentimes, there will be a stewardship committee within a hospital that, although the stewardship
program has a major influence and presence on, the stewardship committee will include
individuals that aren't in that core stewardship program.
Sometimes this is a freestanding committee.
Sometimes it is a subcommittee of the pharmacy and therapeutics committee.
Ideally, you would have these folks involved on a stewardship committee.
You would have a specialty physician representing advanced antibiotic training.
Usually, this is an infectious disease physician.
Pharmacy should be at the table.
Nursing should be at the table.
You want to involve the microbiology lab.
Infection prevention and hospital epidemiology should be involved.
Individuals from information technology should be involved, and then other healthcare professionals.
Sometimes administrators, depending on the setting, should be involved.
Again, there are a number of different people who are important to have at the table, because
stewardship really touches all of these specialties, disciplines; but then also is very reliant
on these other departments within the hospital.
I will say one other thing here.
Really looking at where stewardship is going.
Ideally, stewardship programs would be embedded with, or at least tightly integrated with,
infection prevention programs in hospitals.
They use a lot of the same techniques.
They use a lot of the same technology, and they're reporting structures are not dissimilar;
so that you can really synergize when those two groups are working together.
We talk about why stewardship matters.
Well, it's been less than 80 years since the widespread adoption of antibiotics in the
1940s, and we're already talking about a post-antibiotic era.
Really, what we're talking about is a return to 19th descriptions of management of infectious
diseases.
For patients with infection with pan-resistant organisms, really those organisms, especially
gram negative organisms ... Folks that have these resistant pathogens have a really, really
very high mortality, especially if they're bacteremic.
Now, if you have an infection in a limb, say a diabetic foot infection with a resistant
pathogen, oftentimes, the best you can do is local therapy or resection of infected
tissue, sometimes amputation.
Again, this management hearkens back to the management of infectious diseases in the 19th
century.
The post-antibiotic era very much looks like the pre-antibiotic era.
This is a reality for many of our patients, now.
Really, this is the overarching impetus for adopting stewardship now, in 2017.
We'll talk a little bit more about that as we move forward.
This slide from the CDC ... When we talk about the untoward effects of
antibiotics.
Really, these compounds are not necessarily benign.
In fact, antibiotics are responsible for one in five ER visits for adverse drug events;
and they're the most common cause of ER visits for adverse drug events in people under the
age of 18.
There's a lot that's being discovered about the collateral damage of antibiotics, in terms
of effecting the microbiome.
The grossest example of this is what happens with wiping out gut flora, and then setting
up a scenario where clostridium difficile can overpopulate the gut and cause clinical
illness.
There is more and more data that we're also affecting the microbiome in other parts of
the body.
We just don't know enough about this yet; but the collateral damage may include links
to obesity, diabetes, cardiovascular disease.
There's a lot that's unknown, but they are not necessarily benign compounds.
We do know that antibiotic use leads to antibiotic resistance.
It's important to recognize that oftentimes when people become infected, they're becoming
infected with their own flora.
An example of this would be somebody developed an E. coli urinary tract infection.
That's their own population of E. coli that they acquired the infection with.
Now, if somebody is given a fluoroquinolone for some reason, their normal flora, their
E. coli can become resistant to that.
Then that antibiotic may not be available to them when they subsequently develop an
infection three, six, nine months later.
Antibiotic use definitely can lead to antibiotic resistance.
Resistance cuts across all microorganisms.
Any organism that can be infected by antimicrobials, can develop resistance.
This is a problem across the board.
It's with gram positive organisms like staph aureus, with malaria, with tuberculosis.
Of particular concern in 2017, is resistance in gram negatives; because there's a paucity
of new drugs in development for these resistant gram negative organisms.
The CDC, really probably is an underestimate of the total morbidity associated with antibiotic
resistant infections.
23,000 deaths per year.
Over 2 million illnesses caused by from antibiotic resistant pathogens.
Now, again this is probably the tip of the iceberg, because the future estimates are
much higher than this.
It's estimated by 2050, there will be 10 million deaths per year from antibiotic resistant
infections.
That's a death every three seconds.
That's more than are projected to die from cancer in 2050, which is 8.2 million people.
This is a crisis.
It's a crisis now.
We're really seeing the tip of the iceberg in terms of resistance; but we need to do
something, or this is only going to get worse and worse.
We talk about stewardship initiatives.
We talked about this a little bit earlier in the slides.
The key strategies include restriction of antibiotics, and then post-antibiotic order
review with provider feedback.
One of the things that we're looking at on this slide in antimicrobial criteria for use.
What does that mean?
Essentially for every antibiotic, but especially those that are restricted, there should be
very transparent, clear criteria for use; so providers know when to use the drug optimally.
They know when to call for approval, when they should not, what the alternatives are.
It's very important that folks always receive guidance on what is the most optimal antibiotic
to use for any specific condition.
We'll talk more about that.
That really falls under the supplementary strategies.
Again, those include dose optimization, the deployment of local treatment guidelines,
among other key strategies.
Talking a little bit more on restriction and preauthorization.
Throughout the slide deck, you're going to see numerous examples of these different restriction
strategies or different strategies under the specific stewardship strategy.
These are a few examples.
They may or may not be appropriate for your setting.
They're certainly not comprehensive.
There are numerous different ways that these could be deployed, depending on your setting,
local resistance profiles, what are considered the key antimicrobials, and that sort of thing.
Stewardship, one of the key stewardship tools, again, is restriction.
Restriction is very powerful because antibiotic selective pressure really has to do with exposure
to those antibiotics.
If patients are exposed to those antibiotics, they are less likely to develop resistance.
That's sort of the bottom line.
If you control the use of the agent, you're exposing people to the antibiotics only when
really, truly appropriate.
Some examples here would be for agents that are associated with high mortality when used
inappropriately, like Tigecycline.
Things that are very narrow spectrum, but potentially high cost, like Daptomycin.
Then things that really should be held in reserve for last resort, as last resort agents,
for really resistant infections.
Things like Colistin, and some of the newer drugs that are coming out that have some activity
against the resistant gram negatives.
When we talk about criteria for use again.
We talked about this a little bit before.
This again, is to be transparent with when these drugs will be approved, when they should
not, what the alternatives will be.
Just being very clear about all of these things for frontline providers.
This really overlaps with treatment guidelines, which we'll talk more about.
Some examples of criteria for use.
Some folks might say for Daptomycin, "Well, we're only going to approve this when somebody
has a MRSA infection, and they're failing Vancomycin, or there's a high Vancomycin MIC
to that isolate."
For Linezolid, maybe only if there's worsening pneumonia, secondary MRSA that's been documented,
and they've already failed Vancomycin.
Another potential example would be using Echinocandins when you have documented, invasive candida
infection with things that are resistant to Fluconazole.
Again, these are examples.
These are not meant to be the only potential ways to develop criteria for use, and these
may or may not be appropriate for your setting.
These are examples, again, of how you would create these within a program.
When we talk about antimicrobial dosing and monitoring protocols, this is a supplementary
strategy.
When I say supplementary, that doesn't mean that it's less important.
It's just usually the other core strategies are adopted first.
This can be very important, especially for narrow therapeutic index drugs with high potential
morbidity.
A prototypical example of this would be aminoglycosides, especially gentamicin.
These can be of enormous value when adopted in a comprehensive stewardship program.
Oftentimes, this is being driven by the frontline work of pharmacists involved in stewardship
programs.
Antimicrobial dosing and monitoring protocols.
Again, this is an extension of the last slide.
These should be available to providers and specific to the institution, where appropriate
and widely available; so we'll know exactly for what drug what would be the right dosing
for any given sort of category of renal insufficiency, or depending on what type of renal replacement
therapy a patient is receiving.
Now, talking about antimicrobial dosing and [MOD 00:20:21] protocols ... When we talk
about preoperative antimicrobial prophylaxis.
This is really what we call low-hanging fruit for antimicrobial stewardship programs.
It can be highly complex in terms of doing this right, and monitoring our people using
the right drug at the right dose at the right time, and doing the right type of intraoperative
re-dosing.
However, there's potential enormous benefit to patients and institutions in reducing surgical
site infections when this is deployed correctly; and these things are all very well laid out.
The next slide really gives you an example of this from the surgical care improvement
project, which really we're not talking a whole lot about anymore; but it does provide
some guidance as to drug doses recommended for surgery.
However, there's a comprehensive guideline for this from [Bradford 00:21:21] et al. that's
also available, that can tell you exactly what antimicrobials you'd use per condition
and procedure, and spells out the right dosing and intraoperative re-dosing.
Again, these are potential major targets for stewardship programs, especially stewardship
programs looking for early wins.
When we talk about other supplementary strategies, one of these -again, somewhat low-hanging
fruit, but with potential enormous benefit- is IV to PO switch protocols for drugs with
high oral bioavailability.
These can be done in a relatively simple fashion; but it's automated at the level of the pharmacy,
once these protocols have been adopted locally.
Then, when we talk about local treatment guidelines.
These can be of enormous utility to providers.
What I will say here is really stewardship programs should partner with frontline providers
wherever and whenever possible, and should be viewed as a asset in the optimal treatment
approach to infectious diseases in these patients.
One of the ways stewardship programs can avail themselves to frontline providers is to create
things that make their lives easier.
Everyone is trying to do the right thing in terms of addressing these infectious diseases,
and people love local treatment guidelines.
Now, the value of these over national guidelines is that they can actually account for local
antibiotic resistance via the local antibiogram.
We'll talk about that in a slide or two.
Then also, will pull in the institution's formulary.
You're able to actually tailor your guidelines to very specific recommendations that are
going to be meaningful to your frontline providers.
You can create these really for a host of different conditions.
At VCU, we have comprehensive treatment guidelines, which encompass probably about 40 separate
guidelines at this point.
They're available on our internet site, but also as a mobile smartphone application, and
are available to our providers that way.
Now, you don't need to do that sort of thing to have a major impact.
If these things are available at the point-of-care, then they will be of value.
Again, you're going to want to pull in your frontline clinicians when you're creating
these guidelines.
Then, you're going to want to monitor how often they're being used, and then their impact
to frontline providers.
This is an example of one of our meningitis guidelines for our antibiotic guide.
Yeah.
Then moving forward, talking about the antibiogram.
Antibiogram data is critical for forming local empiric antibiotic use.
Again, this is really why there needs to be a very strong partnership between stewardship
programs, their microbiology laboratories, and their information technology services.
Now antibiograms, just in a nutshell, typically these can be done in different ways.
Usually facilities get these at the facility level, which encompasses about a year's worth
of data looking at specific organisms and drugs, looking at resistance across a population
of organisms for that year.
There's different ways to do this.
If you are able to, you can get very much more nuanced data, down to the unit level.
You can do it for more discrete time periods.
The more nuanced, the better; with the understanding that if you have too few isolates, it's difficult
to draw inferences from what you're seeing.
However, these can be of enormous benefit when you are creating local treatment guidelines.
One example.
Yeah, if you see that your E. coli population has 25-30% fluoroquinolone resistance, those
probably aren't good agents to be using when your providers are doing prostate biopsies
for instance.
That means over one in four of the patients who are receiving this, are not receiving
adequate antimicrobial prophylaxis.
As you see shifts in your antibiogram over time, this will affect what you choose to
use for prophylaxis; but then also for empiric treatment of various conditions, including
sepsis.
Again, antibiograms are very important.
Now, when we look at the untoward affects of antibiotics ...
To summarize, mandates are here, and they represent great opportunities for programs
to advocate for resources, especially [FT 00:26:19] support or monetary support for
physicians and pharmacists is crucial.
All providers have a role to play with stewardship, however.
Frontline providers should be aware of how dire the resistance crisis is and adopt some
of the techniques that stewardship programs are providing for them.
Some of those could involve the utilization of local treatment guidelines, partnering
with stewardship programs to address specific issues, the source of things.
Beyond this, frontline providers should take an antibiotic timeout, really daily; but at
a minimum of every 48 hours to ask, "What is being treated, and what should the duration
of therapy be, and can I de-escalate therapy?"
These should be questions that providers are asking, for all of their patients receiving
antibiotics, daily.
Again, the frontline provider should partner with stewardship programs to address antibiotic
use and resistance.
In conclusion, antibiotic resistance crisis is real and it's getting worse, especially
for gram negative organisms.
If we don't change our approach to antibiotic prescribing, these life-altering drugs will
not be available to many of our patients moving forward.
We all have a role to play in optimizing antibiotic use and reducing the emergence of resistance.
Not just people that are active participants in stewardship programs, but especially frontline
providers.
Thank you, Dr. Stevens.
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