Episode 66: How Standards, Education, and Certification Drive Improvement with Luba Sobolevsky, PharmD

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Transcript: How Standards, Education & Certification Drive Improvement

Amanda Brummitt: We Infuse podcast, episode number 66. Welcome to the We Infuse podcast. My name is Amanda Bremit. In every episode, we give you a seat at the table as we talk to Infusion Center owners, operators, and experts so that you can get the insight you need to run a thriving practice. In this episode, we talk with Luba Sobolevsky, founder, president, and CEO of the Immunoglobulin National Society. Luba shares how and why IGNS was created, the amazing accomplishments they’ve made, and exciting news about the creation of a Center of Excellence designation. Well, Luba, thank you so much for being here with us today. Can you start by telling our listeners a little bit about who you are and sharing your background?

Luba Sobolevsky: Sure. Pleasure. And thank you so much for having me on. I’m a, doctor of pharmacy. I got my PharmD from USC many, years ago. I started out as a clinician and, worked my way through various areas of practice and, ended up in the pharmaceutical industry. I so happened to, have landed in the immunoglobulin therapy area and spent over a decade in the pharma industry. And having had the background from the clinical side, from the industry side, it gave me a really comprehensive perspective on what was going on in our field and that, it became evident at that point that being. for being such a specialized field of therapy as IG therapy is, it’s probably only second to chemotherapy in its complexity, as well as the complexity of our patients. So, given that, the fact that we had absolutely no standards of practice for clinicians in the therapy area, now I don’t mean diagnostically speaking,

Amanda Brummitt: sure,

Luba Sobolevsky: physicians have had standards for diagnosis and dosing for a variety of disorders with immunoglobulin therapy, but we had absolutely nothing to support nurses and pharmacists that, Manage over 90 percent of what happens with the patient on this therapy. And so given the complexity of patients in the use of this product in over 70 different clinical. Indications that are evidence based and FDA approved. We had no standards, no measurable way to, to check whether someone has expertise to actually treat patients with this. a group of therapies, we didn’t have, standardized education or resources. And we expected a lot of our clinicians, we expected that they mitigate side effects, improve safety, maintain clinical outcomes, manage these patients throughout their continuum of care. These are chronically ill patients who are on IG therapy for life. We were expecting a lot from the clinicians, while as an industry we’re giving them absolutely nothing, to make that happen. and so that was the impetus, really. And that was where my career, took me.

Amanda Brummitt: Yeah. So then how, did you end up at the Immunoglobulin National Society?

Luba Sobolevsky: So that was really the junction, in my career where it became evident what was needed, what was lacking. And, it was this clarity that enabled, me and a group of clinicians to kind of get together and start assessing what was needed.

Amanda Brummitt: Wait, so you guys started the society?

Luba Sobolevsky: Yes.

Amanda Brummitt: Oh, how amazing. I didn’t know that. Congratulations. And thank you.

Luba Sobolevsky: Yes. So, at the very start of IGNS, Was this very memorable survey of around 400 nurses and pharmacists who we assessed for where they get training, whether we get they get training, what was needed, because when you’re starting something brand new, you really need to understand what the needs are in the field versus what we assume, you know, the needs are. And it was, really. Interesting, because we found out that over 90 percent of clinicians did not have any formal training in this therapy. Certainly, it’s not taught in pharmacy nursing schools. As a pharmacist, I had one hour of IG therapy coursework. Oh no. That was pretty much it. And so we as clinicians get out of our schools, pharmacy, nursing schools specifically, with really zero understanding and knowledge. And so the learning until, you know, up until the point of, IGNSS start was taking place at the workplace. And so when we ask clinicians how they. began and how they were trained and whether they were trained. Interestingly, most clinicians thought that they were being trained and they did receive education in this therapy. And so when we asked them how the two predominant ways were, they were reported as One, reading the package insert, it’s a good start. It’s a good product focused, information. It’s certainly not education or training

Amanda Brummitt: in

Luba Sobolevsky: its formal sense. And it’s not enough. And second was shadowing a superior. So the immediate question is, who trained that superior?

Amanda Brummitt: Exactly.

Luba Sobolevsky: And so when we got a group of subject matter experts, really seasoned healthcare professionals who had been in this industry for a long time, who had managed. clinical teams and were really in, involved deeply in the immunoglobulin therapy practice. We found out that there were, there were aspects of their practice that had common ground, common standards, right? And, competencies that they achieved. I think an equal percentage was Just wildly all over the place. And we realized that if a patient switches from Pharmacy A to Infusion Center B, back to another treatment center based on the pair and their preference and their lifestyle, They will be getting a completely different experience with this therapy.

Amanda Brummitt: Right.

Luba Sobolevsky: And we knew that the first thing that needed to happen was that we needed to create the standards of practice for immunoglobulin therapy.

Amanda Brummitt: Absolutely.

Luba Sobolevsky: And so that was kind of, that was the beginning. That was the very, beginning with that practice survey that we did.

Amanda Brummitt: Wow. And what year did all that happen?

Luba Sobolevsky: That was 2012. Wow.

Amanda Brummitt: That is amazing. Absolutely amazing. Well, thank you for taking that jump and, doing that. so tell us, what IGNS looks like today.

Luba Sobolevsky: Yeah. So fast forwarding to 2024. IGNS now is the central standard setting, healthcare association dedicated to the field of immunoglobulin therapy and biologics. So we’ve expanded to include immune mediated disorders and therapies as it pertains to what our patients face and what our clinicians need as well. As the Standard Setting Association, of course, we create, maintain, and incorporate the National Standards of Practice, which are the only standards of practice in this, therapy space, that are legally defensible and evidence based. We, also have developed a robust credentialing program for nurses and pharmacists. It’s a way for these clinicians to achieve a prestigious credential of IG Certified Nurse, IGCN, or IGCP, IG Certified Pharmacist. Which is the only objective, measurable way to demonstrate someone’s very specialized expertise in this area. We also develop, a systematic, educational resource through online webinars and podcasts. Also, our live conferences. And we provide, overall a full suite of supporting practice based resources for any clinician in this field. So that’s, kind of, the big picture of what we do. There are four pillars, standard, certification, education, and resources.

Amanda Brummitt: Amazing. That’s a lot into just 12 years.

Luba Sobolevsky: Yeah.

Amanda Brummitt: So I’m sure there have been some huge milestones and accomplishments along the way. Can you share some of those?

Luba Sobolevsky: Sure. Well, I do think that in the just shy of a decade and a half, the four pillars we just talked about were our absolutely major milestones. I will say that in addition to that, our patient 360 arm of IGNS that we started around seven years ago is something. We are absolutely so proud of we knew that if we are, you know, everything we do at IGNS, everything we stand for has to do 100 percent with patients, making sure patients receive the best clinical care at every infusion, the safe practice that they are meeting their treatment goals and that they’re overall improving their health and quality of life. And so we began the patient 360 program as a way to determine whether changes in practice for healthcare professionals that we were incorporating along the way were actually making an impactful change on the patients.

Amanda Brummitt: That’s ambitious.

Luba Sobolevsky: Yes, it was. It is. But it continues to be the most rewarding part of what we do.

Amanda Brummitt: Yeah.

Luba Sobolevsky: And one that’s enriching, all of us as an association and as a clinical field. So currently our patient 360 program consists of a variety of, areas. One of which is our national conference for patients. It’s a two day virtual program, full of enriching sessions, with clients. Leading experts, sessions that help patients understand their disorder, understand their therapy options, ways to improve their infusion experience, ways to improve their lifestyle and quality of life with a variety of other, impactful ways like nutrition, stress management, support for, caregivers. And families and lots of other advocacy topics at the same time this patient 360 program gives us an opportunity to do research with patients and if we’ve had an annual patient 360 survey, which we publish annually at our national conference. The survey allows us to really keep kind of our finger on the pulse of what’s happening with the patients, right? And if there are any issues in their infusion experience or their treatment, we have a really great way of determining what’s going on.

Amanda Brummitt: So this is almost a real time mechanism. Where you can give meaningful intervention.

Luba Sobolevsky: Exactly. So if you think about our national conference, for example, where we have clinicians or overall our members who are clinicians, who can then see directly what the results of the patient survey is every year. And these are patients that are referred to us by our members, so whether, you know, what we think the level of practice is really isn’t that relevant if the patients are telling us a different story. Right. And in fact, there are times when we get results back that gives us pause and really are not what we expected, not what we want to see. But it also gives us. The, that push to continue to improve from the association standpoint, education, resources, topics, patch points with our clinicians, delivery of this data to them, and from the clinician’s perspective, certainly taking that internally and changing their processes.

Amanda Brummitt: Sure. And then are you guys also watching for trends in that data and then widespread re education on topics? 

Luba Sobolevsky: Yes. Absolutely. And we are able to actually note friends, very early on because we have these signals that come from this patient 360 survey. That’s a pretty robust, program. And so that’s, something that, that we are super committed to and very proud of. This patient 360 conference is completely free to our patients and caregivers. And so it’s a way for us to give back to this patient community and, and they do so much for us to, you know, educate us in ways we could never otherwise be. So this is something that, that is a lifelong commitment for IGNS. So that’s one of the major milestones for us. Another, I would say this, you know, obviously the patient focus to us is super important. But if we think about what we can do for the clinicians to support them even further, IG& S has, the largest scholarship program for clinicians who are licensed. That’s a very important distinction because, Most of the time, scholarships are awarded to students. once we have our license and we are practicing clinicians, we don’t have any opportunities to really get funding to continue our education. Meanwhile, knowing our field intimately, well, we also know that there’s. Turnover, you know, within the HCP world, there are many nurses and pharmacists who enter this field coming from different areas of practice. as we talked about a little bit earlier, there’s basically no education on immunoglobulin therapy in professional schools, nursing pharmacy. And so when someone changes their career and starts working at a specialty pharmacy or a specialty infusion company, home infusion, center, they, you can presume with a high degree of certainty, they’ve had no training or education in this field.

Amanda Brummitt: Yikes.

Luba Sobolevsky: So how do we. Continue going, taking this all the way back to the patient. How do we make sure the patient gets highest quality, safest care every time? Is it, so we’re, trying to solve for that, right? And what it’s going to take, what it has taken is us taking a stand as an association and saying, we’re going to invest into this. And so every year there’s over a hundred full scholarship attendees at our national conference.

Amanda Brummitt: Wow.

Luba Sobolevsky: Their scholarship includes not only the attendance of the conference and the pre conference seminars, but also the cost of certification to become a student. IGCN or IGCP. We provide them with an annual IGNS membership to get access to free education. We provide a variety of resources to support their practice, so it’s a kind of a full turnkey scholarship program to get someone who is new to this field all the way up to the level of expertise that we all would like them to have and that they would like to attain. And to date, we have funded over a million dollars in scholarships, in the U. S. That’s incredible. Yes. Nurses, pharmacists, and physician fellows. Oh, great. We, know that physicians, coming out of their fellowships, regardless of their area of expertise, and there are many, neurology, immunology, allergy, oncology, hematology, whatever those, fields may be. They get very little education and training, with respect to immunoglobulin specifically.

Amanda Brummitt: Yes,

Luba Sobolevsky: they know, obviously, the dosing guidelines and the treatment guidelines, diagnostic guidelines, but not what happens with the patient once the patient’s out on service. pharmacy, home infusion, centers and so forth, regardless of site of care. And so we also have a program for clinicians that, that is multidisciplinary. And I think that’s one of the key things too, that distinguishes us from many other, associations that we are multidisciplinary. So we include all healthcare professionals, pharmacists, nurses, physicians, but also That these clinicians study, learn together as they do in real life, because immunoglobulin practice is very team based, and so is our education.

Amanda Brummitt: Fantastic. So, you guys have had some incredible accomplishments. What kind of goals do you set from there?

Luba Sobolevsky: I mean, obviously, as this field expands and the IG therapy field seems to be growing, I know the companies, manufacturers are investing heavily into new clinical trials. Our, rate of diagnosis is becoming better and better population is aging. we are creating different sites of practice to support this, Therapy. And so as we continue to expand, we’re always learning and trying to figure out ways to support our clinicians and our patients. One of the newest initiatives, and this is something we are very, excited about, is the establishment of IG& S Centers of Excellence. Which is going to be a distinction that providers can attain to really stand out to differentiate their clinical services and the quality of the care they provide to patients. Up to this point, we have been providing individual clinicians with a way to distinguish their expertise through IGCN and IGCP certification. But now, within the next year, there will be a way for providers, for companies to attain a distinction as a center of excellence. And so I think that this will be instrumental in raising the bar across. The field in our practice setting,

Amanda Brummitt: we’re sure

Luba Sobolevsky: across all practice settings. So we’re very excited about this.

Amanda Brummitt: Yeah. And something objective that payers and patients and referring physicians can search for easily.

Luba Sobolevsky: Of course. It gives you a measurable way to distinguish your clinical practice, your services from someone else who may not be able to achieve that distinction. And certainly it has benefits in payer contracts and beyond. So, it both allows the providers to become more competitive, but also to demonstrate and document what that means for patients and for prescribers and their other customers, for sure.

Amanda Brummitt: That’s impressive. So Luba, I also understand you guys now have a partnership with RX Toolkit. Can you tell us about that?

Luba Sobolevsky: Oh yes, this was a very exciting partnership that IG& S and RX Toolkit entered late last year. And it allows the members of RX Toolkit to access a select number of our most popular IG& S products. continuing education webinars. Oh, fantastic. So yeah, so we went through and selected, a number, I think it’s 20 webinars that would be most relevant to the RxToolkit members and shared them. And so now we have a larger population of clinicians who have access to the education and training that they really need, specifically in immunoglobulin therapy. Because we are really the only association that provides this detailed systematic education in IG and biologics as well. And so I think it’s just such a win for the RxToolkit members and it’s, we’re super excited to share those resources.

Amanda Brummitt: What a good collaboration.

Luba Sobolevsky: Yes, absolutely.

Amanda Brummitt: Let’s shift gears just a little bit and talk about what you’ve experienced in infusion practice and let us learn from your wisdom. What would you say has been your biggest challenge in the infusion space?

Luba Sobolevsky: Well, if you ask anybody about challenges in our infusion space, I think that the list kind of goes on and on.

Amanda Brummitt: I mean, you can pick 27 challenges if you want.

Luba Sobolevsky: Let’s pick the top, yeah, the top three. I think that there, I mean, obviously there are different levels of challenges, right? There’s legislation, payer, right, level. There’s the site of care issues and reimbursement. There’s the HCP nursing turnover. there’s the access to education. There’s, access to support and funding by providers, for their clinical teams to become certified, educated, attend conferences. So there’s a variety of challenges in our field. I think our field is one of the most complex, but probably within healthcare, there’s probably a resounding, kind of number of these challenges. And to me, it’s always about, you know, now what? So what do we do? How do we support practice? How do we make it easier for our field to continue to serve our patients? And that’s what we try to focus on, right? So we try to focus on assessing the needs. Right. Always, understanding what the needs, what the critical gaps are, and trying to, help meet our clinicians where they need us the most. So I’ll give you one example. About 25 years ago, IG therapy started to be utilized in the home setting. Until then, it was used in a controlled setting. And there was a lot of, this was not a, an easy transition. It’s certainly clear why it is, it can decrease healthcare costs, but there was a lot of concern about safety and, just the logistics of it and just everything to do with it was brand new and unknown. And the, obviously throughout. The years, we’ve been able to successfully as a, industry transition patients into the home setting, give them the option of flexibility. some patients continue to get treated in the infusion center. others get treated at home. Then we, experienced this entrance of subcutaneous IgG products would give, which gave patients even more flexibility. So the field has kind of shifted and changed and this was kind of the mainstay of therapy. In the recent years, with changes to reimbursement, there is a very significant flow of patients back into, AIC space. And, I mean, this is already happening, and the concern that we have, for example, one of the concerns, is that this is not a space where we’ve had a lot of immunoglobulin therapy use in the recent couple of decades. The kind of the setting of an infusion space does not provide for a one to one nurse to patient ratio as you would elsewhere and the clinicians who are currently working in these. AICs or multi specialty groups don’t really have a lot of experience with immunoglobulin. And so, just like when, with anything that’s new, it takes a while for clinicians and providers as a whole to really understand the complexity of this therapy, that you cannot treat Ig therapy as any other biologic or drug. That it has its own standards for a reason, and that we have to maintain patient safety above all else. So now our, one of our priorities is to educate the AIC space as a whole to provide more opportunities to clinicians who are in the AIC space, for example, to get the standards to HUM certified, to attend conferences, to seek out these educational opportunities. Luckily, we make it very easy through IG& S membership. All the education is free. There’s a ton of free resources. members get exclusive rights on certifications, publications, and so forth. So we’re doing. Our best to get everything, that these clinicians need, but that’s, a challenge. Whenever practice changes like that and we see it, it’s a tidal wave. we need to be right there with the clinician supporting them again to ensure the best patient outcomes.

Amanda Brummitt: Well, and you strike me as the kind of leader that you see an issue. We’re going to come up with a solution. We’re going to fix it.

Luba Sobolevsky: Well, I think IGNS’s philosophy as a whole has always been very pragmatic, right? Our standards are very practice focused, very pragmatic. Our sessions at our national conference tell you what to do, when to do it, why we’re doing it, who the best candidate for that is. So it’s very, practice focused. And yes, I think that at the end of the day, if you Know what your goals are. You know, where are you going? You’re trying to improve patient care. You’re really looking at a field at this at any problem, holistically and just trying to do the right thing for your members and patients.

Amanda Brummitt: Right. Well, and all the time that you’ve worked in the immunoglobulin space, what would you say has been your biggest aha moment? Something you saw that, oh, we can fix this. You

Luba Sobolevsky: Well, I really, the biggest lightbulb was truly that I think back to what we just talked about is if you know what the issue is and solve for it, that will, that’ll, that’s what you need to do. That’s what you need to focus on. when we were first starting, there were a lot of people even in our kind of among our committee members that had their doubts about, you know, does this therapy area even need its own standards? Can’t this be part of something else? And as we continue to define What I G therapy is, we continue to define what the skill set and specialized education that is needed to support it, it became very evident. So I think that moment of break it down to the basics, keep it simple, understand the need and address the need. Everything else follows, falls in place.

Amanda Brummitt: Totally makes sense. All right. What are you most excited about in the industry currently?

Luba Sobolevsky: Well, now that we talked about all the challenges, right? What

Amanda Brummitt: are you excited about fixing, maybe?

Luba Sobolevsky: Well, well, I will tell you this. I’m always excited about technology, the incredible machine learning and AI that’s, coming into this field that we already see change is changing the way we diagnose patients, the way we, look for trends in, healthcare that improve the time that, shorten the time to diagnosis for many of our patients with rare diseases. from something that is taking over a decade, even now. We published a paper recently, on immune deficiency using AI technology. And it was really astounding that this is just readily available and we can do so much good. With technology, how we reach patients that otherwise are unreachable. so there’s just, there’s a ton of, progress that’s going on right now, but I’m always, you know, I always go back to the patient, the clinician. I have to say that year after year, when I’m at our national conference, And I stand in the back of the room and I absorb who’s there and why they’re there. I’m thrilled that we have, a field where each clinician is so devoted to their patients and to improving their practice. Year over year, we continue to grow and, you know, like this year, we’re going to have probably over 1, 200 clinicians at our conference. These are folks who understand how important education and improvement in practice is and they go to conferences. And they improve their practice and they support their patients. So it’s really exciting to see that every year, over 50 percent of our attendees are brand new to IGNS as we can grow. And so while we have a, obviously a very robust return rate of our, conference attendees, 50%. are brand new. That’s exciting. And so I’m always excited about building new programs, resources, ways to support our field and just continue to serve our patients in the best way we can.

Amanda Brummitt: Sure. Yeah, that is really exciting. Well done.

Luba Sobolevsky: Thank you.

Amanda Brummitt: Well, Luba, you have been a wealth of information and you have an incredible background. That, what is one piece of advice that you would leave our listeners with?

Luba Sobolevsky: Ah, well, I think that really invest into your professional development. I, know I speak for most of us who are clinicians or who are experts, regardless of what field you’re in, right? Whether it’s business or clinical or whatever it is, I think personal growth, professional growth are really important. When we stop growing, we become https: otter. ai And so invest in your professional development, attain certification, certifications in whatever your practice setting is, right? If it’s IG, it’s I G C N I G C P. If it’s something else, go for it and grow professionally, differentiate your practice. In our area, we’re not generalists. We’re highly specialized. Prove it. Document it. Achieve it. Get educated. Get certified. Invest in yourself. I can promise you that, as an association, we will always support you, invest in you and in our, in the quality of practice, in our resources that are available to better our patients lives and our clinicians lives for that matter. but that would be, yeah, I think that all of us need to take a critical look at our career trajectory and make changes to improve ourselves and our patients. And kind of our, what we provide to our patients. I think that’s the bottom line about the patients really.

Amanda Brummitt: That is incredible advice. Well, Loubet, thank you for your time. Thank you for caring enough about the industry that when you saw a need, you gathered around bright minds and, fixed it and created this organization. And thanks for all you do for patients.

Luba Sobolevsky: Thank you so much for having me on, Amanda. I appreciate it.

Amanda Brummitt: It was so great to learn from Luba Sobolevsky of the Immunoglobulin National Society about IG treatment and just how far they’ve come. I also really appreciate that at every decision point there was a need in the industry and IG& S sought to fill it with standards, with education. with scholarships, frankly, with whatever patients and caregivers needed. Speaking of things that are good for patients and caregivers, if you aren’t familiar with the WeInfuse software platform and RxToolkit’s web based resources, I encourage you to check them out, as well as those IG courses that Luba mentioned.

These tools can save you time and money in your practice while making infusion safer for patients and caregivers. My name is Amanda Brummett and we’ll catch you in the next episode.

Guest Speakers:

Luba Sobolevsky is the Founder, President, and CEO of Immunoglobulin National Society (IgNS)