Shubha Bhat, PharmD, on the Role of the Clinical Pharmacist in IBD

Dr Bhat reports on the recent systematic review and RAND consensus process to define the role of the clinical pharmacist in caring for patients with inflammatory bowel disease.

Shubha Bhat, PharmD, MS, is a clinical pharmacist in the Digestive Disease Institute at Cleveland Clinic in Cleveland, Ohio. 

TRANSCRIPT:

Welcome to this podcast from the AIBD Network. I'm your host, Rebecca Mashaw, and I'm here today with Shubha Bhat, who is the IBD clinical pharmacist from Cleveland Clinic, and one of the coauthors of a recent article in the Inflammatory Bowel Disease Journal about defining the role of clinical pharmacists in the care of patients with IBD, and specifically a systematic review and a RAND consensus project that she was involved in. So thank you for joining us today.

Dr Bhat: Thank you. It's a pleasure to be here.

Rebecca Mashaw: So what prompted this review and this consensus exercise for pharmacy and IBD?

Dr Bhat: So great question, Rebecca. There is actually a growing interest in IBD bi -message now for several reasons. One, multidisciplinary teams and medical homes are becoming more integrated for IBD management as this has been shown to improve quality of care and patient equilibrium. Additionally, as IBD management continues to evolve, there are also now more, but still costly and complex, advanced IBD therapies.

The clinical pharmacists have been shown to improve clinical outcomes in other therapeutic areas such as cardiology, primary care, mental health, and so on. And so, given the complexities of medication management and IBD, pharmacists can also have an impact on this area as well. However, the roles and responsibility of clinical pharmacists within the IBD team is not well standardized or defined.

Thus, we identified this to be a gap area, and we sought to, 1, understand how clinical pharmacists are contributing to the care of patients with IBD; 2, figure out how to promote for the inclusion of clinical pharmacists as part of the IBD multidisciplinary team; and 3, provide clarity on the necessary training for this role.

Rebecca Mashaw: Could you give us a quick overview about how this project proceeded?

Dr Bhat: Yes, certainly. So to bring this project to life, we recruited a total of 6 clinical pharmacists and 6 gastroenterologists providing IBD care who also practiced alongside with these pharmacists. So an open call was sent via email to the IBD Pharmacy Practice Network. And this is a group of pharmacists that's involved in IBD management, and I'm happy to discuss more about this group in the next few minutes.

But going back to the project launch, pharmacists who were part of the IBD Pharmacy Practice Network and worked at least 3 full days a week in the IBD clinic providing clinical management to the patient were invited to participate. The selected IBD pharmacist then invited an IBD gastroenterologist whom they work closely with and since there are variations in pharmacy practice worldwide we only limited the study to participants practicing in the United States.

Rebecca Mashaw: So tell us more about the IBD Pharmacy Practice Network.

This is one of my favorite questions, and I'm always happy to talk about this group. The IBD Pharmacy Practice Network is a group of pharmacists involved in IBD management, and they're primarily based in specialty pharmacies and /or outpatient IBD or GI clinics. So I hope co found this group in May 2021, along with Michelle Becker and to IBD clinical pharmacists at the Mayo Clinic, and David Choi, who is an IBD clinical pharmacist at the University of Chicago Medicine. We originally created this group, given the lack of resources and recognition for IBD clinical pharmacists, with the aim to expand knowledge, gain recognition, and optimize medication outcomes in IBD.

I'm excited to say that we now currently have over 100 members to date, and we have actually been able to promote IBD clinical pharmacists in various capacities, including, for example, the publication and a joint partnership with the Crohn's and Colitis Foundation to host an annual IBD virtual pharmacist symposium. So Rebecca, if you don't mind, I would like to just add a shameless plug in here that if we do have any listeners that are here that haven't actually joined this group and will be interested, I'm happy to get you connected. Just send me an email at bhat@ccf.org.

Rebecca Mashaw: Very good. Thank you for that. That sounds like a very interesting group and one that's very much needed. So now back to the systematic review and the RAM consensus. How did you go about this process?

Dr Bhat: So another great question, Rebecca, but before I answer the question, I just want to say thank you for letting me take the moment to highlight the IBD Pharmacy Practice Network. I can say we're collectively very proud and excited about the group and all the progress that has been made in 2021.

So now going back to the project, we first completed a systematic review of the existing literature to understand what services pharmacists are providing the patient with IBD care, and then use these findings in conjunction with expert opinion to proceed with generating multiple statements that were focused on defining the role of IBD pharmacists in the United States for the RAND/UCLA process. So the initial statement was first done to the panel for comments before we had an introductory call, and then a complete list of statements was done circulated by an online survey and rated for appropriateness in 2 voting rounds. We also hosted moderated teleconferences prior to the first round of voting to review these statements in detail, and then again after the first round of voting to discuss the results.

So after all of these efforts, we were then able to generate a list of final statements that the panel was in agreement with. And then we could use the findings to define IBD clinical pharmacist roles and provide a framework for embedded clinical pharmacists and IBD care.

And what were those key findings?

Dr Bhat: So from the systematic review, we identified that the overall number of publication pertaining to the clinical pharmacist role and IBD was mostly limited and generally pertain to the pharmacist role and impact primarily with thiopurine initiation of monitoring, also medication adherence, and then lastly, biosimilar switching.

So despite the limited literature, the panel was able to identify the following roles and responsibilities to be appropriate for IBD clinical pharmacists and this included medication education, medication initiation and monitoring, therapeutic drug monitoring, biosimilar management, health maintenance review, and transitions of care.

I will say that one of my favorite memories from this project with the panel's discussion on real-world versus ideal state, recognizing that IBD clinical pharmacists can be a limited resource, and that depending on the practice patient volume, it may not be feasible for IBD clinical pharmacists to provide these services to every single patient with IBD.

So in considering the real-world setting, the panel deemed that the IBD clinical pharmacists are most impactful when they're involved in caring for patients, particularly on complex treatment. And some examples of those include immunomodulators, biologics, and small molecule therapy.

One of the interesting discussions that the panel also had was focused on the training of pharmacists involved in caring for patients with IBD and it was deemed that this cohort should be residency-trained and board certified.

Rebecca Mashaw: Could you speak a bit more about that effort to have pharmacists trained, residency trained and board certified? Is that going to be difficult to implement and what kind of changes are going to be needed to make that happen?

Dr Bhat: Certainly. So Rebecca, just to provide some background context, clinical pharmacists typically complete 1 to 2 years of residency training and once they're specialized they can actually go on to obtain board certification to further demonstrate their expertise. And the specialization opportunities for clinical pharmacists have significantly grown over the past few years. And pharmacists now have the option to complete residencies and obtain board certification in several therapeutic areas. And this includes, for example, cardiology, critical care, emergency medicine, infectious disease, and even oncology. So a lot of opportunities across the board.

Unfortunately gastroenterology and hepatology is not a dedicated specialty area for pharmacists at this time. And I'm hoping that this will change in the next few years now that pharmacists are becoming recognized as important members as part of the care team. So based on the current offerings, the panel did say that a 1-year postgraduate residency training in either general pharmacy, ambulatory care, or specialty pharmacy would be appropriate. And that for pharmacists embedded in the IBD or GI clinic, board certification and ambulatory care would be appropriate.

But I think we can say that overall there's still an area of need. I will say that generally the therapeutic focus around GI and hepatology and pharmacy school is generally underemphasized and direct patient care opportunities during residency may be lacking or insufficient. However, one of the positives is that there is growing awareness about the needs of pharmacists’ inclusive IBD education.

And for example, the Advances in IBD or AIBD this year in December 2024 will actually be featuring a pharmacist track as part of the conference for the first time. And this is another opportunity that I'm super excited about.

Rebecca Mashaw: What can you tell us about the agenda for that training? That is very exciting development.

Dr Bhat: So yeah, so just to give you a little bit of perspective, Rebecca, so the tracks at AIBD have generally been focused on pediatric, nursing, and surgery. However, we're excited that there's actually going to be a pharmacy for this track and for the agenda for this year. We're actually going to take a step back and talk about clinical pharmacy services in general.

So how do you go about justifying for these positions, what exactly can pharmacists do, and why you should be integrating them into your practice. And then we're actually going to pivot a little bit and talk about some of more of the medication complexities that we typically see in our practice. So this includes the use of combination or dual advanced therapy and IBD.

And then lastly, medication access is a big part of our job. So we're actually going to be talking about how to access these therapies and how to utilize patient support programs. So I'm hoping there'll be a good turnout, but I'll be excited again that there's a growing attention and focus now on the fact that IBD pharmacists are important to include in these educational initiatives. And I think that there's just more opportunity for us across the board.

Rebecca Mashaw: I would imagine a lot of that opportunity is because of the many new medications that have been approved in recent years. That has made the whole picture of of pharmacy for IBD that much more complex, hasn't it?

Dr Bhat: Yeah, it's definitely a lot of complexities in the treatment that we're dealing with, ranging anywhere from the baseline screenings that are required to the actual administration. So in terms of the spacing, even the route of the administration is now a little bit more complex. We have the medicines that are writing off with an intravenous or IV dosing, and then it will eventually transition to a sub-q formulation. So yes, a lot of complexity across all our medicines.

I'd be excited about the treatment advance as a whole. But I think, again, this justifies, this even provides more justification as to why a pharmacist should be part of the team.

Rebecca Mashaw: How does this new vision of the pharmacist role in IBD differ from what's going on today, from your present reality?

Dr Bhat: Excellent question, Rebecca. And I'm hoping that the manuscript will be a first step to setting the foundation for what IBD clinical pharmacists can provide for patients with IBD. As evidenced by the growing membership numbers of our IBD Pharmacy Practice Network, there is a growing recognition about the benefits that IBD pharmacists can bring to the multidisciplinary team and for patients. However, these roles are not necessarily standardized across practices or even recognize this opportunity for pharmacists to either participate in or take the lead on.

So just to give you an example, though I believe that there's like a heavy association between IBD pharmacists and the prior authorization process and this makes sense because pharmacists generally have a good inherent understanding of the insurance system, and they know how to optimize medication as such. However, the actual physical task of doing the prior authorization form is super administrative in nature, and so I don't necessarily think that this is the great best use of a pharmacist time. Instead, we should be involving the clinical pharmacist in the appeal or peer-to-peer process, because this often requires more of a clinical rationale or justification.

And so to summarize, although it's great that more clinical pharmacists are becoming involved in IBD care, they may not necessarily be practicing at the top of their license. And so I'm hoping that this manuscript will hopefully provide the directions and guidance on how IBD clinical pharmacists can be integrated into the clinical practice to further optimize patient care and outcomes.

Rebecca Mashaw: You also called for additional studies to demonstrate the impact of clinical pharmacists alongside those of the gastroenterologist and the rest of the multidisciplinary team on patient outcomes in IBD. Do you have such studies in development?

Dr Bhat: So I am, hopefully, I'm hoping so. There are a few studies that I would like to conduct in this area, you know. However, one of the challenges, Rebecca, is that there's a few complexities that come up we're doing these types of studies.

For example, like the type of outcomes that we should focus on is not as concrete in IBD as it may be for example in hypertension or diabetes where we're targeting for like a goal blood pressure or a hemoglobin A1C target. I know clinical remission would be a great endpoint but as we all know this is not necessarily like the primary outcome to focus on because you can still have active disease, even in the absence of symptoms.

The other thing I know, like, we also focus a lot on endoscopic improvement or remission. However, this is not, like, always a standardized data point that may not be, like, readily available, or it could indicate, like, active inflammation. So, again, these endpoints are not a clear cut of some of the other endpoints that we use in other therapeutic areas.

Another complexity, Rebecca, that I'm seeing with these types of studies is that because IBD clinical pharmacists are working as part of team-based care, it also would be challenging to directly extrapolate the outcomes, specifically to the pharmacists alone. So I think overall there's a lot of complexity from a study design and a methodology perspective, but I think the studies are needed and I know this is an area of interest because the justification of an IBD pharmacist in practice would be further supported if we had this type of data and evidence.

Rebecca Mashaw: To justify adding that person or persons to your staff. And that's got to have some facts and figures along with it, right?

Dr Bhat: There you go, you got it exactly on the head, yeah. And I think also would further add some complexity to the total justification piece, we're actually like starting to see more members as part of the multidisciplinary team. So then the next question that I commonly hear after people ask, okay, do I have pharmacist? It's actually how do we differentiate between a pharmacist and an advanced practice provider? So there's a lot of like overlap between the two roles for sure. And if you're tight on budget, which always seems to be the case in most situations, how do you then justify picking what type of provider or what type of support staff are you going to add onto your team then?

Rebecca Mashaw: Any final thoughts that you'd like to share with other IBD professionals?

Dr Bhat: I hear frequently from my colleagues about wanting to learn more about this role and again, how to justify for and include IBD pharmacists in their practice. For my personal experience, there's still a lot of education to be done about IBD pharmacists in general, their training and what resources and services they can provide. But once the team gains this exposure, the IBD pharmacists often becomes an invaluable member of the team, and then the team generally cannot imagine functioning without this resource. So it is my hope that overall, that there's going to be an increase in awareness and resources for IBD pharmacists and that this continues to grow and that we eventually reached a point where the inclusion of an IBD pharmacist on the team is just natural and that this becomes a standard of care for all patients with IBD.

Rebecca Mashaw: Well thank you so much for sharing your insights with us today and we'll be interested to see what happens with your additional research.

Dr Bhat: Sure and again I hope that for all the pharmacists listening on the line, please attend the IBD 2024 this year. I think we got a lot of good initiatives and a potential opportunity just waiting for us out there.

Rebecca Mashaw:  That's wonderful. Thank you so much.