Joseph Reilly, BS, PharmD, BCGP

Joseph, do you have any final thoughts about, or takeaways from, this discussion?

Education is important for everybody. Many health care providers, including myself, always had this feeling about FMT [fecal microbiota transplant]. Is it dangerous? Will patients wind up getting sick? Where does the stool come from? Is it a mix of donors or a single donor? How much will it cost? And the whole idea of a colonoscopy with bowel prep and propofol, which I mentioned before, seems like a lot. We need to change the way we think about the natural course of 

 infection [CDI]. Hopefully, people will and explore all treatment options that are available at this point.

As far as education with the practitioners, it is about educating the patients as well. If they happen to be frequent fliers for, let’s say, as you mentioned, UTIs [urinary tract infections]. Or they go to their physician, and they say, “I have a cold,” and they’re given an antibiotic. You have to explain to patients as you’re seeing them come into your practice that it’s not important to get an antibiotic every time you go to your physician’s office. And to educate them and not to try to doctor-shop and get an antibiotic if they don’t get the right answer from their primary care physician [PCP] or whomever. It’s important not only for practitioners, but for patients or potential patients for 

 Certainly, we’re going to continue to need patient education, and I appreciate that comment. Andrew?

I am cautiously optimistic now, at this point, as to where we’re headed with CDI treatment, as we have the first FDA-approved FMT product at this point right now with seemingly more on the way. We’ve got the first one through the door, and it’s going to be a matter of seeing where things go from here. As you mentioned earlier, maybe hopefully in the next 10 years we’ll have narrowed it down to which key microorganisms are essential for restoring the microbiota. And if we see these improvements, then hopefully the treatments will continue to become more effective into the future as well.

Appreciate that. I have to say that I’ve considered myself in the past a drug pusher, if you will, in the good sense of the term. But I am excited the fact that there is now an FDA-approved fecal microbiota replacement and that’s a nice, good step forward with assurance that it’s screened and safe, for the most part. And that’s a major step for managing patients with recurrent 

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Experts provide practice pearls for educating patients on and using FMTs for the management of CDI.

Key Takeaways on FMTs in the Treatment of CDI

, there are certainly a lot of economic considerations in this population. We did a study at our hospital looking at recurrent 

. Patients who were admitted at least 3 times. Think about this, just 3 times with the admitting diagnosis being 

 infection [CDI], and we found over a couple-year period that we had 29 patients who were frequent fliers. They had come in our hospital a minimum of 3 times with 

 and kept coming back. And what we found among 29 patients, we did an economic analysis, and we found that it cost us over $2 million to treat these patients. Even with reimbursement in every case, we still lost about $1.4 million or more in this patient population. The same 29 patients. So the economics—and this is coming from…a nonprofit teaching hospital. We really have to think about this. There was a great economic impact in a small number of patients, and it makes us keep an open mind as far as what our treatment options are in these patients. In the case of the new FDA-approved live fecal microbiota suspension [live-jslm], we could be reimbursed for the product more than we paid for it and prevent future admissions to the hospital for 

,and change the outcome of a patient’s life. The big-picture view of utilizing this new treatment is very promising for us, both economically and from a patient quality of life standard.

Sounds like a win-win. I have to say your hospital is exemplary, and looking at the big picture, I would say that not all hospitals are like that. Again, it may be a struggle. I assume you have to have this put on your pharmacy and therapeutics [P&T] committee, that it has to be approved?

We approved the product through our P&T, and the initiative, the push, is to improve our antimicrobial stewardship program, to lower our 

 rates, and to create initiatives that are economically beneficial for our hospital, which is once you start saying that we can save a lot of money and improve patients’ lives, it gets the attention of administration in a hospital. So our financial analysts will take a look at the whole process and decide that this is a win-win for the hospital.

That’s great. I know traditionally, Medicare reimbursement has been linked to readmission in 30 days, not necessarily for 

 rates, per se, are determined by a calculation on what kind of testing you’re doing, what the facility is. So if your rates are high, you can get dinged for that. But so far, they haven’t talked about readmission specifically for 

 infection, which I appreciate you bringing it up because we’ve seen this ourselves. This is a major issue, and we have a referral clinic for 

 patients in our hospital. We’ve thought about making a more mandatory follow-up for patients who are seen with 

 in the hospital; as you know, patients can show up on the orthopedic ward. They can show up on the surgical ward, etc. And they’re handled by their own practitioners, per se, and the follow-up they get may not necessarily be appropriate. They may be given a prescription and told to call back if they have a problem. We think we could do better than this. And if we have a dedicated clinic where patients are funneled to this, they may not need a lot of handholding but at least referral for a call if need be. That’s something that should be thought about more in institutions.

Imagine a scenario where you have a patient who has their third episode of 

; their second recurrence. Knowing what we know now, with an FDA-approved product, what are the chances of that patient coming back within the next 60 days and being admitted to the hospital, possibly with 

? According to studies, it’s 50% or greater. So how can we not at least have a discussion with this patient that there’s an FDA-approved product out there that is effective?

I would have to say that nothing is 100%. And that patient selection for this is a big issue and that a patient who has recurring urinary tract infections [UTI], a neurogenic bladder, who gets treated for a UTI every month or so might not be the ideal patient in whom to initiate this therapy. That would be my perspective. But there are a lot of issues with this. This is clearly an effective treatment for many patients. Patient selection, however, is going to be important, and certainly this issue of asymptomatic carriage and misidentifying patients who may be colonized but not necessarily have infection due to 

, meaning they have a positive polymerase chain reaction [PCR] but yet they hadn’t been on antibiotics recently. They hadn’t been in the hospital, and they don’t respond to vancomycin or fidaxomicin. I don’t think we can expect them to respond to the FMT [fecal microbiota transplant], if you will. It’s probably a misdiagnosis. So careful patient selection for this is going to be important.

Joseph Reilly, BS, PharmD, BCGP, reviews the positive economic impact of use of live-jslm for treatment of CDI in a hospital setting.

Economic Implications of FMTs on CDI

Finally, measures to prevent and control the spread of 

 infection [CDI] are equally as important as treating it. How can we prevent the spread of CDI in health care settings? It’s another big topic, but just briefly, how good are we at doing this, and what are some important things to know about prevention of CDI spread in hospitals?

One of the big things for preventing the spread of CDI within the hospital is focusing on that horizontal transmission, so that’s one of the first things that we can help providers with. The ways that we do that in the hospital are going to be the contact precautions, making sure that providers, nurses, and everyone are going into these rooms with the appropriate gowns and gloves, and monitoring the surfaces at that point as well. Once they’re wearing that, it’s about making sure they remove it while they’re within the room when they’re leaving. Also, using soap and water to wash your hands afterward, not an alcohol-based hand wash at that point.

The spore nature, so you’re not walking into one room, picking up a spore and then all of a sudden walking over to the next room of a patient who is immunocompromised or who has ulcerative colitis, and setting them up for a subsequent 

 infection as well. That’s one of the things, but we also need to focus on the…terminal room cleaning that we do as well. So it is making sure that we are washing these rooms down with bleach or hydrogen peroxide solutions. Also, UV light or radiation tends to be another method that has been utilized as well to clean these rooms after a patient with 

What about the role of antimicrobial stewardship in preventing CDI, any thoughts on that?

I have thoughts about that every day at work, every day.

 rates, and the indiscriminate use of antibiotics is certainly a problem. Patients will come in with community-acquired pneumonia and oftentimes will receive 3 different antibiotics from different classes initially before they’re put on whatever they receive, which is often combination therapy. It’s difficult to get providers to adopt the mindset that not everything is a bacterial infection, that viruses cause a lot of upper respiratory tract infections. They want to be safe sometimes and just say, let me throw antibiotics at this patient…. They leave them on it, nobody wants to stop it. Antimicrobial stewardship is required; it’s essential to decrease the rates of 

 and something that all hospitals need to address.

When I think about antibiotic stewardship obviously the concern is overuse of antibiotics and developing resistance, and it cuts across many different areas. Sometimes antimicrobial stewardship for preventing 

 infection is a bit different, and sometimes it’s across purposes, if you will, with other antimicrobial stewardship practices. Is there anything specific your hospital does for 

, now we’re calling it antibiotic stewardship. We take a look at antibiotics that we think are more likely to cause 

. We try to crack down on our use of clindamycin. We have patients on vancomycin and piperacillin and tazobactam, and you’ll see clindamycin was added because they fear aspiration pneumonia. We try to decrease the use of broad-spectrum antibiotics unnecessarily. We restrict those antibiotics, definitely clindamycin and also the quinolones. We try not to use quinolones in the first line. It also helps us that we have higher resistance rates with the quinolones, especially for 

, the indications that they want to use them. So restricting the use of those antibiotics, educating our providers about the development of 

, is a targeted action we’ve taken over the last few years.

Thanks, any other comments about antimicrobial stewardship?

Within the hospital we’ve covered most of that to where it’s making sure that when someone is on antibiotics, it’s always for the appropriate reason at that point. To make sure that we’re not overreaching, which, as infectious disease providers, it’s something that we see on a regular basis—we’ll get called and they’re on carbapenem plus vancomycin. And we have to guide people back down to maybe cephalosporin or sometimes maybe not even needing antibiotics. It’s as if they have got them on them for the sake of it. But one of the more interesting things is not only providing the education to hospital providers, but also providing that to outpatient providers. That is going to be a big thing and a bit of a challenge going forward with antibiotic stewardship. Because a lot of the times that we see these individuals with 

 in our clinic, as you noted earlier, it’s that you have a dentist who gave clindamycin for the sake of giving clindamycin, or amoxicillin-clavulanic acid for the sake of giving amoxicillin-clavulanic acid, even though there is not a good indication for the use of it in that manner. So we have seen, over the past couple of years, this change in the clinical epidemiology of 

, where we’re noticing more community-associated infections and a decrease in the hospital-associated infections. That’s going to be one of the frontiers that we need to start addressing from that stewardship standpoint going forward.

Experts comment on the measures that need to be taken to prevent or control the spread of CDI in the healthcare setting.

Preventing the Spread of CDI in the Healthcare Setting

There's still some hesitancy to use FMT among clinicians in patients. What kind of education is needed to overcome this barrier?

To speak with those providers that don't have a lot of experience with patients who have recurrent 

 and explain the whole burden and what the patient is going through and how easily they can be treated with FMT. That prevents the recurrence, again, and it prevents that whole horrible cycle that the patient goes through. Speak to them about not just doling out antibiotics at the drop of a hat. That's important. If we speak to more dentists who tend to throw it out there, orthopedic surgeons tend to throw it out there. Whether they need it or not, they give it preop; they give it postop. A lot of that education to those particular physicians is important.

Also to go on with that, on the other side of the clinician, it’s going to be the patient as well because we have run into a lot of different patients that we’ve seen at our clinic. They hear the word fecal and some treatment and they shy away from that at that point and say, ‘I don't want something like that,’ as well. So, it’s a bit of educating the patient about the fact that this isn't brand new. This is stuff that has been studied in great detail at this point and has been around for decades to where we have developed a greater understanding. The most important thing: it's FDA approved at this point as well and those are important things to pass on to each patient.

Candace Cotto, RN, and Andrew Skinner, MD, discuss barriers to use of FMTs in managing CDI, highlighting clinician and patient education.

Joseph Reilly, BS, PharmD, BCGP

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