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Developing a New Medication Safety Paradigm

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Darshan

Hey everyone, welcome to the DarshanTalks podcast. I'm your host Darshan Kulkarni. It's my mission to help patients trust the products they depend on. As you know by now I'm a pharmacist, I'm an attorney at the current law firm, and I advise companies with FDA regulated products. So if you have to think about drugs, a wonder about medical devices, if you consider cannabis or you obsess over pharmacy, this is the podcast for you. I'd love for you guys to actually subscribe, leave a comment, because these podcasts take a lot of time to sort of create and talk but a lot of fun. So if you are enjoying as much as I am, love to have you keep joining us. So please subscribe, you can always reach me at DarshanTalks on Twitter, go to our website at DarshanTalks.com. Our podcast today is actually exciting because I've actually had this guest on before, I'm very, very excited. And she is changing the rule of pharmacy in more ways and more places than you can think we had a conversation about that last time still remains true today, in fact, more so. So if you are wondering, what does the modern pharmacy do? What does modern pharmacists do? And how is the world changing? Probably you're gonna care about today's discussion. So our guest today, I don't even know what her new title is. Because apparently, there are role aspects that are changing for her. So we're going to ask her about that. She has had a major role in causing litigation and advising people on the emerging role of pharmacists. So our guest today, Aaron Fox, Aaron,

Erin

how are you? Good to see you.

Darshan

It's good to see you. So so just before we got on, you talked a little bit about how things are evolving for you. So what are you up to nowadays.

Erin

So um, you know, still have my fingers, and Frank shortages, drug safety. But I have some new roles. So I'm really excited. Our pharmacy informatics team reports to me as well as our safety and quality person. And then, you know, my, our chief pharmacy officer has taken a new role. And so my colleague and I are splitting we're doing co interim duties. And so that's, it's really exciting to have the opportunity in this new challenge.

Darshan

So let's talk about that. Because you're talking about splitting the duties of a chief pharmacy officer, before we go into that. You said your your your former boss is changing, changing roles. Where does a chief pharmacist officer go next?

Erin

So you know, I'm Linda Taylor, she's a it's just been a mentor of mine. She's, you know, gonna be ashp President, but she is deciding to kind of take a break and focus a little bit on that. And she'll be part time at our College of Pharmacy, doing some teaching that she really loves. But but i think you know, being a CSU president is probably going to keep her pretty busy.

Darshan

I would imagine. So the reason I thought that was interesting is because whenever I am, at least my working my way through pharmacy school, I always thought of the CPOE as the absolute tippy top you can go to so I but but then I know that pharmacy itself has been evolving so much with a lot of tech companies say, you know, what pharmacists actually engage with, with patients more than even physicians do. And there's an opportunity here, so I didn't know if the role of a CPOE has been evolving and has been changing. And she's sort of trying to it sounds like she's gonna lead a lot of that change. But but here's, here's my question to you. In your role as interim CTO, how do you see the changes that are coming down? And does that affect what you do on a day to day basis?

Erin

You know, I think one of the things that I'm excited about, that I'd love about working at an academic medical center is the opportunity to work a little more closely with some of our physicians, to really on some, not only just cost savings measures, but but safety measures too. And so, you know, over the years, I've been, you know, had the opportunity to work with so many different types of physicians. And I think with this new role, it gives me a little more strategic way to maybe make things happen a little bit more quickly.

Darshan

So you talk about being in basically control, working with physicians, which is a very clinical role. You talk about cost and you talk about safety. Obviously, a lot of these have been handled in many ways it's sort of pharmacies operated. But as you come in, what is the first thing you focused on, and then what is the first thing your toe CPOE, if you will focused on,

Erin

you know, in a way, a lot of what we've been doing hasn't changed that much. In part because we, we did have opportunities before, when when our boss was most, maybe traveling a little bit more, but before COVID, she would give us the opportunity to split up her meetings and things like that. So, you know, some of the roles are familiar. But but others are a little less. So we are working through new goals for our pharmacy department for this year. So getting the the kind of the strategic roadmap from our C suite, with with and then thinking about how, how we connect to to those goals.

Darshan

So So how do you go about making a strategic roadmap? Is it really something that the C suite just goes, and we need you to do this? Or is it a negotiation? And I recommend to a certain extent, everything's in negotiation. But if you are weighing it, is it really the hospitals going? We are the academic medical center to be more accurate as going, these are the things we really need to happen. So how does that get weighed? How does that even play itself out?

Erin

Yeah, so I haven't gotten to be at the table for those super high level discussions. But, you know, here here in our organization, we have kind of kind of kind of three main main goals. So we have patient experience, we have safety and quality, and we have financial strength. And so really, each year, the roadmap for what we want to focus on really does fall within those buckets. You can, you know, you could be a frontline pharmacist and think, Well, those things don't have that much meaning to me. But we think about well, one one goal this year is to help with our patient throughput, you know, how do we help our discharge process and get patients discharged more quickly, so that so that we can, you know, have room for for folks coming out of LR, and pharmacists have a big role? They're in that discharge process? And how can we even you know, work two to three days ahead at the time of admission to set them up well for a good discharge at the end of their stay.

Darshan

But it's so interesting, because one of the things I was going to ask you when you said your three goals are patient experience, safety and quality and financial strength. My first thought was sleep no clinical, that's the that's the first thing I would have thought every academic medical center will be focusing on. And what the way you answered back to me was interesting, because you basically said clinical just permeates all through all.

Erin

It does. Yeah, yeah. If we're not taking good clinical care of our patients, then then we can't exist. So you know, it really, really that clinical has to be at the top.

Darshan

Now. Is that because you're not going to academic medical center? Or do you think like the smaller hospitals that are out there going, you know, what, we're really in this in the business of dispensing? And we need to make sure that the drug goes out from the pharmacy gets to the patient's bedside as quickly as possible, like, Oh, do you think it's a difference in perspective? Or is it just that's where the practice of pharmacy is right now.

Erin

I hope that's sort of the practice of pharmacy is right now, I have not had the opportunity to work outside of actually this organization. So I'm very inbred that way I try to expand and try to expand my network and, and try to learn as much as possible. But that day to day exposure, you know, I've worked here for almost 25 years, so yeah.

Darshan

Okay. Um, so that really raises the next question to me, when you talk about financial, financial strength, he talks about safety and quality. As you know, I do a lot of work with life sciences companies, as well. And one of the things that pops up is this idea of medical affairs, and they're supposed to be helping hospitals and, and pharmacists and physicians, hopefully do a better job in terms of kalamandalam about their, their drugs and and sort of educating them. Here's my question, and I'll sort of speak to it on multiple levels. As a pharmacist, I did 20 years of pharmacy in multiple, multiple hospitals. I can count on one hand the number of times a medic met a person from medical affairs, and that was always because either the hospital didn't think it was appropriate for us to meet them. I was more frontline. That just wasn't my role. It could have been a variety of things. But from your perspective, from your vantage point, how often have you used As bad as a resource?

Erin

That's a good question. And, you know, I know the medical affairs folks are not always focused on sales, or they're not supposed to be.

Darshan

Question, but yes,

Erin

but it often does seem. And I've kind of mixed bag, you know, I've talked to companies that that do a good job that are willing to listen to so you know, understanding that you might have restriction criteria for for a new product, you might not want to roll out your product 100%, you might want to do some pilots do some education. But there are companies that understand that process, there are also companies that kind of come in with a party line that say, you know, you should switch to this right now for all of your patients. And they don't understand even just some of the challenges in making a switch in an academic medical center, and how much effort and time that takes.

Darshan

So what I'm hearing you say is that the, some companies are educated and sort of, what's the word? I forget what the right term for it is, but smart enough to recognize that this is a process. Others are just a party line, and you will all switch over because our overlords are telling you that that is what must happen. And obviously, the ones who lose out are probably the second group, mostly because it's not easy to do. That is what I'm hearing. But But let me ask you a second version of that, which is something you hinted at which I think is brilliant, which is my perspective, when I was a pharmacist in in hospitals, was that anyone from industry is quote, unquote, painted, for lack of a better term. So to me, the meaning of a sales rep versus a medical affairs person is the same thing. Truth is, as you pointed out, that's not true. But that was the perspective, at least, when I did it. A, Is that still the perspective? Be? Is that perception evolving? Or is there just lack of education on that? How does that play out?

Erin

You know, I think I think this perspective is changing a little bit. But again, it really does vary company by company, you know, you, you can talk to medical affairs folks who are, you know, physicians or pharmacists are have a good clinical background, and they really understand it, sometimes you end up talking to PhDs who are brilliant, and they can tell you everything about you know, the pharmacology of a product, but they, you know, just look at you like, you know, like you're speaking a different language, when you talk to them about time it might take to make an epic order set and, you know, get things built properly. And for a smart pump things, things like that. So it's it's variable.

Darshan

It's variable. Okay, fair enough. So So I find that perspective valuable. So so thank you for that. Let me ask you a different version, a different set of questions. Going back to your original three, you talked about the patient experience, you talk about safety and quality, you talk about financial strength, those three sort of goals you go for. What I also want to talk about is the drug shortages piece that came in. And one of the things that keeps coming up and as I have more and more conversations, is the idea of and we've done this for literally decades, but drug compounding, as in your new role. How do you view drug compounding, either internally if you're making a product or externally? And is there a difference in perspective, if you will, let's start with the first lesson. There was a compound question internally when you're compounding for, for the shortages that you might have. How do you handle that? How do you perceive that? And do you do you think that it should be manufacturers making a Do you think that for the most part, we've got the quality down at the hospital level?

Erin

So I think it's variable i will tell you that which is it's such a

Darshan

it depends.

Erin

I didn't think about going to law school at one time. No, I think so. So for our organization, we've invested a tremendous amount of money and time and training and and people resources into being able to compound well whether that's just day to day compounding and mixing things or or if we're trying to, you know, kind of get through a shortage. So we devote a tremendous amount of work there. So I I feel like we're in good shape on that end. In general, though, unless it's something where we're trying to maybe split up a vial into multiple doses. We're not we're not doing high risk compounding, you know, powder to liquid to get through a shortage. We are much more likely to use an alternative. Use a more expensive product if we need to. Just Just because that's about It's not our expertise. Um, so yeah,

Darshan

that's kind of interesting to me. So what you said is, you try to avoid it, you just rather switch products because of the risk of poses. Do you again, I'm asking you, I'm speaking to you not in your role as a, as an interim CEO at your hospital, but just in general, as a pharmacist, do you think some hospitals don't have the budgets? Therefore, they are taking on those greater risks? And how do you advise them as a pharmacist level? on how to address those concerns? Or their thoughts around shortages? Because they still have to be they have the same problems, but not the budget to fix it?

Erin

Sure. Sure. That's, that's such a good question. And I, I think about an example in my head of the sodium bicarbonate injection shortage, okay, so simple to compound, right? We have the raw materials, it's, but should you should you go down that road, you know, in our case, we really decided we're not going to compound it, we were going to conserve a little bit. And then we're going to just going to use alternatives. I think. If you don't have the resources, that's when you you might want to start looking at an outside compounding pharmacy. Especially if you don't have the, you know, sometimes it's just a tremendous amount of capital. You know, if you need to get new clean rooms, new hoods, if your organization doesn't have that money to invest, it doesn't matter if you have the knowledge if you don't also have the equipment. And so, you know, for those folks, I would, I would definitely recommend looking into outsourcing.

Darshan

So you talk about outsourcing, you talk about it, because you're right. And in retrospect, that's the most obvious solution, right? Go to someone who actually has those, and maybe you pay a little bit more for it, but it gets you to where you need to be right now. Two questions out of that, my first question is, when you have the shortages, you obviously, obviously try to adjust for it by my compounding, which takes a lot of effort and money and stuff of that to do has that affected reimbursement at all, as far as you can

Erin

tell? Um, you know, not that I can tell, and because the majority of the shortages that we face where we probably would compound are in the inpatient setting, where in most cases, you're getting reimbursed on that D or D bundle. And so it's it's not really where you're going to have to ask for a prior authorization to allow for for a compounded drug that that way, so haven't seen it impact reimbursement that way.

Darshan

I guess the question I was wondering is, has there been any discussion or any kind of lobbying around the cost of the DRP bundle itself being increased because of adjustment to the to the actual processes it takes to deliver on that big bundle? But what I'm what I'm hearing you say is not yet.

Erin

I haven't seen it yet. But I think we need to do it. And not just not really focusing in on that very specific example of compounding. But thinking about how did we get into a situation where so many generics where the prices just been driven, so low, a big part of that incentive is that hospitals have a very, you know, slit, really slim margins on those drgs. And so they're trying to buy the lowest cost products. And as the cost gets lower and lower, the manufacturers don't have the money to reinvest in quality. And so then we end up with poor quality products recalls shortages.

Darshan

So you talk about poor quality products recalls the shortages, which I think is 100% part of the problem. So if that's true, um, our alternative is either you make it in house to adjust for it, or you go to a compact of like a five, a three or five or three beam who might make it for you. I guess my question for you at that point is how do you choose a external vendor who can do it at a really high quality but we know that manufacturers cannot meet that same quality so how do you sort of reconcile that?

Erin

It's so hard, it's so hard. We absolutely need more more information on that. You know, you can look on FDA website and you can see the the inspections, but but you never see the loop cut, there's no closure. To know if the manufacturer really did fix the things that FDA suggested they fix. All you have is their word for it. So yeah, I think it is very, very difficult, I think. Certainly, you know, professional organizations and GPOs often have different guidances to help organizations try to make it choice for an outsourcer, you could go visit. But again, if you don't have the skill set to know what to look for, it might look like a great place. You know, I knew people that, you know, had visited some of the compounding agencies that have been closed and they thought things things looked great. So it's it's very tricky. It's very tricky.

Darshan

So that's, I think that's exactly right. It's so tricky how, when you're making these decisions, how do you choose your preferred outsourcing facility? if you will? Do you? It's, and please correct me if I'm wrong, what I what I heard you say was that what ideally what should happen is that you should audit them. But But you may not have the resources, you may not have the expertise. So what do you do right now? Do you sort of just go, we look at the FDA, and we hope that they're doing a good job and base based on battery, what's your process.

Erin

So and this is gonna sound terrible, but because we spend so much resources to in, in source we actually don't purchase from an outsourcing company at all.

Darshan

So that's really interesting.

Erin

So so we just don't, um, I think, you know, if if we did, certainly, we would have to, you know, we would, we would try to look at, look at all the available information. But in our case, we put kind of all our eggs in our own insourcing basket and really tried to, you know, keep all of our equipment, all of our people everything at the highest level we can.

Darshan

So let's address that than that. Because that sounds fascinating that you've actually managed to pull it all in house. I mean, I thought at least the opioids is something you'd be buying from outside, but it sounds like you guys have figured this piece out. So So how do you maintain quality? And just to be clear, this is a general perspective, this does not represent your current facilities or anything like that. So if FDA listening in that is that is not what this represents. So So when you're looking at and maintaining the quality within your internal compounding pharmacy, how do you ensure that it meets the highest quality? What is your process?

Erin

Yeah, so you've got it, you've definitely got to devote resources to it. And and that's people, as well as some kind of a tracking system, you know, are you you know, are you you know, doing all the cleaning? Are you doing all of the the testing are you doing, you know, everything to meet 797, we desert our facility, we actually have a full time technician devoted to literally just making sure that we are compliant with all of our 797 measures. That is their entire job. So, you know, certainly they're working in collaboration with with a lot of other folks. But if you don't have the the people resources, and you're not willing to put that time into it, you know, you also have to have some relationships with other companies. As far as you know, sending samples out for sterility testing, stability testing, you've got to do that as well. And so, you know, managing all of that, again, takes takes the resources and time. And so that's to me, how you would set up a system of having quality is first and foremost being willing to invest in resources that would take

Darshan

so so obviously, what it sounds like is if I was starting my own bad, my own academic medical center, or if I was a small hospital, and I wanted to start something of this, it starts by getting a buy in from your C suite, if you will, and saying, look, this is gonna be helpful, at the very least, it's going to be helpful for our patients, because we'll be able to meet their needs. The second part of that same question will then be, we also think it'll save you money, because let's be honest, they aren't going to give you this if you can't save the money. So if that's true, you need to come up with a budget. So how do you go about getting that budget? And obviously, I'm speaking in general terms, but do you go about by saying, look, this is what our competitors have done? This is what we had consultants Come out, come in and give us a pricing? Or, or do you sort of go, we we have internal expertise, and we've done this for dog years? And we think based this is what this is what we think at minimum cost us based on our own experience. So do you use consultants or do you use outside vendors and and sort of, how do you how do you build that, that base of support,

Erin

I think you can use a combination, depending on you know, where your C suite is at. I think you'd also talk about just the general regulatory guidance that you're required to follow even if you don't intend to compound for shortages or do some extensive compounding, where you might outsource outsource that, you're still going to need some level of, of equipment and expertise if unless you intend to waste a lot of product. And so you can, you can talk about that, that ROI you might get on, you know, not not wasting product, being able to do it yourself, I think you also can talk a little bit about the regulatory uncertainty of the outsource companies, you know, you could say, well, you know, here are two options, you know, this is what we we know that these are the items that we could be in control of, these are the potential risks, if we outsource, there will be unknowns, there, there will be things you cannot control. And so I think kind of laying those options out for your C suite, so that they can make an informed decision, if they want to invest the resources is probably the best way to do it.

Darshan

Okay, so So you've, you've got the buy in, um, you, you then probably have to construct the slps that go along with it, you have to construct the Create, the specific quality measures are going to, you're going to use how often you learn that auditing yourself,

Erin

oh, gosh, we we do audits monthly to make sure that that we're following. And then, you know, I can think at our organization, we are DNV incentive Joint Commission, and so they come every year, and so it's just kind of a constant readiness. But we also have to be prepared that our Board of Pharmacy could come in at any time as well and audit to 797. So it's, it's more of a constant readiness. You know, and in a way I think the academic medical center helps you with, with being people being okay with those audits, you know, everyone's used to learning and you know, kind of being tested, and it's, it's just, this is a part of what we do. If you can kind of ingrain those audits into your culture, then then I think that helps set you up for success.

Darshan

So do you find? And again, I'm not gonna pick on any organization, do you find that some organizations that audit, you're better suited for that role than other organizations? And if so, do you? Do you think that it makes sense to have a more centralized process of doing that in terms of external organizations auditing you for the function?

Erin

I think that's where your answer, but I think it depends. It depends on your it's, I think, you need to pick the auditing strategy that best fits your organization, you know, is it Do you have like, like, at our organization, we actually have an external to our department, but internal to our organization, people who are, you know, ISO trained auditors, that that can come in and do that. But if your organization doesn't have that, then it might make sense to outsource it. But it would be important to choose an auditing company that has the has the experiences to match your your experiences, if someone is only used to auditing a very small community hospital, you wouldn't want to send them in to, to, you know, very large, you know, oncology cleanroom.

Darshan

I guess I'm sorry, I should I should have been clear, I was referring primarily to government organizations or quasi organizations, you find that a State Board of Pharmacy slash a Jayco slash mean, the other organization that go along with it? Are they all equally qualified in your experience to audit pharmacies and has that and that's why I don't want to name which specific organization because overall, what is your experience been with that?

Erin

You know, thing, it's, it's variable. Sometimes you'll get people that are very experienced and may come from, you know, this is a new role for them that they become from a pastoral of, of working in the hospital. You can also get auditors who are very inexperienced, and so it depends,

Darshan

do you find yourself educating them? And do you find part of your role is not just educating them on what you do, but what pharmacies do and and what I'm specifically thinking of is, let's say the FDA walked through the door. One of the big when I talk to my clients, one of the things they talk about is FDA looks at us as essentially a manufacturer they don't understand the functioning of a pharmacy. And we struggle with with not just explaining that, no, we we recognize we do batches but but this is in a very different For my different scenario, and how does that play out for you overall, what I'm really sort of trying to figure out

Erin

I think there's a there's there's a good balance, it's almost, it's almost like being in a deposition, right? Do you want to say too much? Or do you want to just answer the question? I think you can, you can try to educate, but it may backfire. Or it may, it just may fall on deaf ears, because they're, they're really not they, if they have a set of tasks that they're going to check off, they can't change those tasks, no matter how much you want them to, or educate them.

Darshan

So make sense. Um, I do want to be respectful of your time. We usually aim for these will be our 20 minutes or so 2030 minutes, we're already over. So based on our discussion, if you were gonna ask our audience a question, what question would you ask them?

Erin

I would love to know how they pick an outsourcing pharmacy. I'm fascinated now. I'm fascinated with this topic.

Darshan

Sounds perfect. So the question for the audience's if you're a pharmacist, or you are a hospital or the like, how do you pick your own outsourcing facility? Awesome. We are going to ask you two rapid fire questions. This month, what challenge you

Erin

I'm thinking about having a new role, having new reports to meet that is a challenge.

Darshan

Okay. And this week, what was the best part of your job

Erin

this week, um, you got I got to I got to be in our vaccine clinic again. So that's that's always that's the best, huh,

Darshan

I'm surprised that I keep hearing the vaccine clinics are so busy and difficult. And you that's your favorite part of your your week. This I'm I'm kind of reconcile those two.

Erin

It's, it's really fun because we are at our at our large clinic that we have at our main hospital. It's it's all volunteers, you know, different staff. So you get to see anesthesiologists, you get to see, you know, nurses that you may or may not have seen for four years. In some cases. It's, it's fun to see people in person and get to talk with them. And then it's it's really fun to see the excitement on a patient's faces when they know they're getting their shots. Some are nervous, you know, but we do a lot of you know, congratulations. You know, it's it's just, it's nice.

Darshan

That's awesome. So, just to sort of bring this all together, we we talked a little bit about your your changing roles to being a coast chief firearms officer, we talked about the priorities that come along with it, which is including shortages, safety, informatics, safety and quality, and how you're basically splitting your duties with your co chief pharmacy officer. You talk about what does a CPO sort of graduate into and that becomes becoming the ashp President, not too shabby. Then, then we talked about just what does the role of a CTO include, which includes things like working with physicians, managing costs safety. We talked a little bit about medical affairs, we talked about the perspective and the evolving perspective around medical affairs. And then we talked about compounding and we talked about what is the perspective on whether we're in sourcing or outsourcing, we talked about in your role in your specific hospital, we talked about patient experience, safety and quality and financial strength, all being the driving factors. Obviously, the thing that struck out to me is clinical sort of flows through all of them. We talked about one of the difficulties in terms of using outsourcing facilities and he talked about just the FDA does audits. We don't really know what actually happened at the end of them. You talked about some of the advice that's given by GPOs and the like, you talked a little bit also around how you actually insource everything why you did that what choices you made, and and the testing and the sterility and stability testing that you that you really need to get into just to make all that happen. Um, I think that covers it that I miss anything.

Erin

Great summary, conversation with you. Thank you,

Darshan

and thank you so much. It's just so much fun. It was a pleasure having you on let's let's hope we get you back on soon again.

Erin

Thank you.

Erin

This is the DarshanTalks podcast, regulatory guy, irregular podcast with host Darshan Kulkarni. You can find the show on twitter at DarshanTalks or the show's website at DarshanTalks.com

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