Our guest: Hossam Gamal, PharmD, BCPS, MBA
Welcome to Drug Diversion Insights. In today’s episode, we’re diving into a critical conversation about hospital drug diversion programs and the evolving landscape of regulatory oversight. I’m joined by Dr. Hossam Gamal, an experienced Pharmacy Director who brings valuable insights into how surveyors are increasingly scrutinizing diversion mitigation efforts.
Recent trends suggest a significant shift in how facilities are being evaluated – moving beyond simply checking boxes to requiring truly meaningful diversion programs. Dr. Gamal will share his firsthand experiences with recent surveys, discussing how regulators are examining program effectiveness, the role of monitoring software, and the essential components of a robust diversion response strategy.
We’ll explore whether surveyors are equipped with the necessary technical knowledge to evaluate these programs effectively, drawing parallels to similar challenges faced in other areas of healthcare compliance. Of particular interest is Dr. Gamal’s perspective on establishing clear criteria for activating diversion response teams – a critical yet often overlooked aspect of comprehensive diversion mitigation.
This conversation comes at a crucial time when healthcare facilities nationwide are reevaluating their approach to diversion mitigation. Whether you’re a healthcare administrator, pharmacy professional, or compliance officer, today’s discussion will provide valuable insights into creating and maintaining effective diversion programs that meet increasingly rigorous regulatory expectations.
Thanks to our sponsor, MIDAS Healthcare Solutions Learn more about V.I.E.W. Waste and Return System: https://midashs.com/products/
Transcript
Terri
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Terri
Welcome back to Divergent Insights. Today we are going to discuss one pharmacy director’s experience with surveyors who seem to be putting more emphasis on a meaningful diversion program. My guest today is Dr. Hossam Gamal. Welcome, Hossam. And thank you for being willing to share what you have experienced as well as what you’ve heard from other pharmacy directors having similar experiences.
Terri
Absolutely.
Terri
I have long wondered when surveyors were gonna start holding facilities more accountable for meaningful drug diversion programs. A meaningful program is very different from a diversion program. I have seen it so many times where I have asked the facility if they have a drug diversion program and they say yes. But then you dig in to see what they have and it becomes pretty clear if it’s what I call a checkbox program rather than a meaningful program. What has been the focus of interest from surveyors that you have seen or heard about recently?
Hossam Gamal
Yeah, that’s a great question. I feel that over the years I’ve been seeing it evolving with surveyors when they come and visit hospitals. And since I worked in different hospitals, I’ve seen different perspectives from what they ask for, what they look for. And I think recently I’m seeing more and more emphasis on not only having like some kind of drug diversion software or just not. They don’t stop if you just say drug diversion software. They want to know more about what you do with the drug diversion software. Are you having meaningful, useful that drug diversion software? So, for instance, like, okay, what do you do with the drug diversion software? Do you have scores that you might monitor? Is it only for nurses? Or you also do it for anesthesia? And if you do it for anesthesia, how you track it?
Hossam Gamal
How do you talk with anesthesia? If you see or feel that there’s a problem with them? And then who gets involved in these decisions? So definitely evolve. They ask more questions. They dig deeper nowadays than it used to be.
Terri
Okay, are they saying that they are, I mean, requiring or highly recommending or, you know, dinging you if you don’t have software or are they just implying that a facility should have it? Or you can’t have a meaningful program unless you have it? Or where are the boundary lines there with the software? Because not all facilities have it. Many do it manually. I mean, I’ve worked at an institution that did it very well manually. So what are you, what impression are you getting from them in terms of gotta have it, should have it nice if you have it.
Hossam Gamal
I think at this point it’s probably not enough for them to see manual process because you can do so much with manual, but the drug diversion software take you to another level. So I wouldn’t say that they say you must have it, but there is a big emphasis that at this point you need to have something if you’re going to track anesthesia and nursing and scores. It’s very hard to do it without something. I mean, some of the automated dispensing machines, they have some ways to monitor and track some like diversion, or I would say not only diversion, but red flags, but not as detailed as the drug diversion softwares and some kind of an, if you want to call it AI. So I’m seeing more and more emphasis that show me what you have.
Hossam Gamal
Not definitely saying you must have it, but it will be very nice to show that you have something like a drug diversion software that help you identifying and monitoring control substance and drug diversion.
Terri
Okay. Yeah, that makes sense. And I wonder too if it’s a different. I mean, it may be inspector, surveyor, independent, dependent. Surveyor dependent, but it’s probably. It may vary if they’re coming into an institution that has had an issue and that’s why they’re there. Right. So then it’s like, oh, you, what do you have? You better do better because that’s why we’re here in the first place. Versus it’s just a routine inspection. It’s time for your accreditation and they’re asking questions. But as far as they know, you haven’t had any problems. And if you have a system and you can fully explain what you’re doing, then it might be more of a, you know, it’d be nice if you had software, but so far you had.
Terri
Haven’t had a problem.
Terri
So. Okay, sounds like you’re doing something.
Hossam Gamal
And I think you make a great point because there was more than one instance that I was in the position that there’s an issue. And then they are here to see what you did and how did you know and how are you going to know in the future if there’s an issue or not versus just a regular inspection. And they are just looking off on what you have. And it’s like, okay, it looks like they have something. So that’s a different way for them to look at things. And when you have an issue, I have a feeling that most of the people that I talk to, director of pharmacies and manager, they end up having something at the end, they will end up having a software.
Terri
Okay, all right. Well, I think it’s great that they’re taking more of an active interest in it because it is such an important thing. And unfortunately, you know, it’s expensive and it takes dedicated resources and some facilities won’t put it in play or an active program in play until there’s a problem. Right. So I think it is nice that they’re taking an active interest, but I would hope that it also means with all of the questions and follow through that they’re doing, do the surveyors seem in general knowledgeable one the topic of diversion and what goes in to an effective program? And then after we talk about that, we’ll talk about the software. But I recently did a podcast with a defense lawyer who has represented several physicians, and he’s also worked with, you know, nurses and pharmacies and stuff in the past.
Terri
His focus now is with physicians. But as part of that interview, we talked about that regulatory agents don’t necessarily fully understand prescribing from a clinical perspective, which really impacts his clients as physicians. So the same thing plays out here, right. If you’ve got a surveyor that doesn’t really understand what an effective diversion program looks like, they know that you should stop diversion. Right. So are you finding that they seem pretty knowledgeable about what a robust program looks like should entail?
Hossam Gamal
I had experience with pharmacist surveyors and I can tell you that the pharmacist surveyors, they know what they’re talking about. They know what is that drug diversion? I would say committee, what is drug diversion software? What is drug diversion and control substance monitoring should be looking like? So they definitely have the knowledge. Is it the knowledge like the one that is doing the job day today? Maybe not. But they have enough knowledge to ask questions and make sure that you are on the right track. And if you are not, then it’s a problem.
Terri
Yeah, yeah, that makes sense. You can’t get too much past the pharmacist surveyors. If we get a nurse in, we can kind of talk our way around things. Right. Because not. Not to insinuate that, you know, they’re not smart it’s just we’re in. We live in two different worlds. So, you know, they don’t know our world and, like, we don’t know their world either. So it’s a little bit easier to talk our way around things. So what about when it comes to the software itself? You know, the questions in general are probably, you know, what are you doing? How can you monitor? Do you find that they have pretty good. I mean, there’s more than one software out there that they work a little bit differently, although they ultimately have the same goal.
Terri
Do you find that they’re pretty knowledgeable about the software and how it works?
Hossam Gamal
So I did work with at least two different pharmacist surveyors, and I did work in different hospitals that have different softwares. And just to go back to your question about the software and if they are required or not, out of five hospitals that I worked in the last few years, all of them at this point have some kind of drug diversion software, one version of the other, one name or the other. But they do have it now, and it’s based on maybe a system that had an issue somewhere else, and they decided to roll up a drug diversion software everywhere in their system. Or it could be a small hospital that heard about something, or they had an issue with drug diversion and they ended up buying or getting a consultant. They got. They got the drug diversion software.
Hossam Gamal
So just wanted touch, like, just make sure that I’m giving you that observation. From my experience, when it comes to the surveyors knowing some details about the software that I would say probably the two that I spoke to, they do know some details about the software. Like, for instance, one of them, we’re talking about the drug deliverance software and what we’re doing. And then we started talking about anesthesia and then said, okay, what do you do for anesthesia and how you track them? Because the software that you have, they have a score that can create a score for them and you might be needing to do this and this. So it made me feel that it’s not that they just know a name, they know more details about it.
Hossam Gamal
The other one, I wouldn’t say that he had the same level of details, but over time and over the survey, definitely he got better and he kept asking more questions in details about the drug diversion software that we use.
Terri
Okay, all right. Yeah, it’s interesting. I’m glad you mentioned about the facilities that you’ve been in and that they have the software. I was looking, reading an article today. It was from 2023, though, on the survey of how many hospitals reported that, you know, responded to the survey that have the software, and it’s certainly the numbers have gone up since a few years prior to that, but still, I’m trying to remember what the number was. I feel like it was either just under or just over.50% of those that responded said they had it. Don’t quote me on that. But so you have seen in your experience, everybody has something.
Hossam Gamal
Yeah, I would say like you mentioned back in 2018, probably none of these hospitals had the software. Okay, probably maybe one. But moving forward in the last three, four years, one after the other, are getting something and making sure that the control substance drug diversion monitoring program is getting where it needs to be.
Terri
Okay, all right, so that’s good to hear. So it’s not. It’s more than just a checklist check. We got software. They seem to be taking it seriously and trying to improve and build upon that program.
Hossam Gamal
Yes, for sure.
Terri
Okay. All right, Interesting. When you and I spoke last, you indicated that an area that is critical for a diversion program is a defined criteria for activating the diversion response team. And I agree with that. So let’s talk about that a little bit. Are there lessons learned? Were you know, in any of these places that newly had the software and were newly implementing things? What kinds of things did you do? What kind of lessons did you learn? Any recommendations for those that are kind of getting started on that? Because I, I do think it is. It is a bit. There’s no one size fits all. Every case is different. And a lot of it I think sometimes comes down to, I think we should escalate this one. Right. I mean, you can try to put a checklist of things together.
Terri
If this, this, then activate, but it doesn’t always work. So what have you found?
Hossam Gamal
It’s very tricky to put the criteria. And I think it needs to be something that evolve over the time, especially if it’s something implemented new in a system organization or a hospital. Because when you think with the team about what and how we should escalate or activate a response team, you put all the different ideas into a paper and then you talk about it and you approve it. And then when you start going live and you see cases like, I wonder if to high scores is enough to activate.
Hossam Gamal
I wonder if someone that we are monitoring on a watch list, if they show up on like two times, I wonder if that score that we are putting as a trigger is the correct score or if it should be higher because you don’t want to grab all the noise and get distracted from what needs to be done because sometimes it gets overwhelming. So, lessons learned. I would say make sure that you pick if you are going to have like some kind of a score as a trigger for the activation, make sure that it’s scored that is meaningful, not just a score, because that’s one thing that we learn.
Hossam Gamal
If you choose a lower score and try to say, I just want to make sure that we see everything, then you get lots of noise and it’s a lot of work and sometimes it doesn’t get you anywhere. Yeah, another. Go ahead.
Terri
Well, I was just going to say, I want to clarify, when you’re talking about a score, are you talking about the score that the software itself gives you or are you talking about, okay, so the score the software itself gives you and then activating the diversion response team, did that typically look like, okay, let’s do a deep dive based on that score or. Or was it going off of that score and then we’re going to take to interview and that type of thing?
Hossam Gamal
Yeah. So as an example, the way that it can be done is, okay, here are the different categories. So let’s say it’s a low risk, medium risk, high risk. And then under the low risk, what are the triggers for the low risk? For instance, we are going to maybe have two or three different triggers. Score is for. I’m just going to throw some numbers. The score is four. If someone has a score of four for two months, that’s a low trigger. If someone was triggered for that higher score for two months, that’s a trigger. And then maybe other things on the low, and then you go to the medium, and then you say, okay, if someone is triggering three times on a score, then we go to the medium.
Hossam Gamal
And then you need to also put in place, okay, what are we going to do if it’s medium and what are we going to do if it’s low? If it’s low, maybe just review with the manager or director of the floor and see if there’s any red flags or not. If it’s medium, what we are going to do is that we are going to activate the response team, for example, and then talk and have a discussion between the people involved in the response team. Who are those people that are going to be activated? Is it pharmacy nursing? Is it going to be hr, someone from executive team? So all these decisions need to be put in place so that you have some kind of guidance for the team on what needs to be done. And how and when.
Hossam Gamal
And then if the team is going to end up meeting to discuss one of the cases that we have, what is the next step? Are we just going to monitor? Are we going to have a meeting with the individual nurse, anesthesia or pharmacy, whoever the person is, and if that’s the case, what are the next steps? Or are we just going to monitor and see if that person is. If it’s just like red flags, but it’s not something alarming.
Terri
And I would guess that somewhere in that piece of the activating the diversion response team will be that deeper dive into the transactions. Right. Because I think we all know that the number might be based on some factors that we can easily explain once we start looking at the transactions.
Hossam Gamal
I think that’s why it’s very important to create some kind of activation but also be open minded and be willing to change them if need to. Because the one example that comes to mind that we had someone that was triggering for example, for two months and then on the third month triggered again. When we did the deep dive, we found that, well, it was triggering one medication because that medication, the pocket was full and it was just creating an error showing that the patient is triggering trying to access the cubic or the drawer, when in fact it was not. Okay, it was just an error in the automated dispensing machine.
Terri
Right, right. Yeah. And I think that’s really important. People cannot forget that the software is great and it gives you a really good look at things, but you have to be careful how you interpret things as well. Right. And so I think that is another advantage of that diversion response team because it’s more than one person looking at it and you want to remain unbiased, but you can really kind of take the data and raise the alarm and you know, any which way you want. Right. I was
just talking to someone recently that was performing an audit and at.
Terri
First it was like, whoa, look how.
Terri
Much higher the dispenses are of this drug, you know, for this person. And as were working through it’s like, okay, well let’s just see, you know, you’re in the middle of the month, so it’s five for this month. What was it last month? And so when you looked at, you know, take the whole three months together and they’re more kind of in the middle of the pack. Look at the last two weeks of just this month and they’re like, whoa, way ahead. Right. Okay, let’s look at each individually. Let’s look at how much they dispensed. It’s like, you know, it’s pretty much the same number, but now they’re just at the top of the pack.
Terri
So when you originally thought, whoa, we have a big problem, well, when you break it down, it’s like, we might not have a big problem, but to go from whoa to maybe there is no issue here. Right. But we have to be really careful how we use the information because we can. I mean, if we have a bias or if we don’t know what we’re doing, we can skew it really any way we want.
Hossam Gamal
Definitely true. And that’s why I feel it’s very important to, number one, to make sure that it’s a lot of work. When we start doing those deep dives, those are necessarily before making any decisions. But those deep dives, they take time and they take energy. So making sure that you have resources to do them and they are dedicated and they know understand what they’re doing without bias. It’s very important. Key having also our nursing leadership and anesthesia, if they are involved, to be open minded. And it’s a big learning curve for them. So our steam changes over time. Like, no, there’s no way that this person versus Let me take a look. I think there’s something going on here. It evolves with them understanding more and more about what’s going on and why we’re doing it.
Hossam Gamal
But again, working in a facility where I had resources enough seen and I check on them every now and then and the resources that they had is growing. Instead of having one contour substance coordinator, they have two now and they know what they’re doing. They handle, they do the deep dives versus if you don’t have the resources and you struggle to spend all the time to do those deep dives.
Terri
Right. Yeah. And if you don’t have the resources and the tendency then is to pass more on to the nurse managers or whoever the manager is of, you know, whatever licensee you’re looking at. And then it falls apart there too. Right. Because they don’t know what they’re looking at. And then it’s like you’re bothering me again, you know, and it’s these done that months ago. Exactly. Crying wolf again. Yes. Yeah. No, you’re right. And it is, you know, I, I’ve sat in diversion response teams where different disciplines are represented. And you know, somebody starts with this might be a stupid question, but because they’re looking at it completely differently. Right. Maybe they’re not clinical and so they need you to explain Something to them. But it turns out, no, it’s not a stupid question at all.
Terri
It was something that the rest of us just took for granted. But as soon as they said it out loud, it’s like, oh, yeah, let’s look into that. That would be really interesting to get the answer to that question. And it makes a difference in the investigation. Yeah. Okay, well, this is good, I think. Are there any number one piece of advice that you would give to people, really anything that, you know, people that maybe don’t have a solid program, people that recognize they have a problem, but they just haven’t had time to look into what they want to do about it, or they’ve got software and they’re pretty new to it, they’re just trying to build their program.
Hossam Gamal
I would say the one big thing that comes to mind is to making sure that your admin executive team is on board. They understand and they know what needs to be done and why it needs to be done and what kind of risk the facility can be put in if something happened or if the program is not as solid as it should be. Because unfortunately we’ve seen it and we’ve seen it on the news. Some places they don’t have those programs or they have just the basic program and they end up being in a big trouble. And then even financially it puts a big burden. So making sure that you have some buy in from executive team, admin team, and then by that second thing is making sure that you have the resources.
Hossam Gamal
Pharmacy cannot do it by themselves unless they have the resources and that understand how to do it. And then without the support of some kind of a team that is not only living in pharmacy, I don’t think that this program will be successful. It has to be bigger than pharmacy because it’s not just about pharmacy.
Terri
Yeah, yeah, that makes perfect sense. And thinking about something where the surveyors or what’s your software and more people getting it’s probably like back in the day before barcode scanning came along, nobody scanned, right. And then institutions started getting it and started scanning, but not everybody had it. Now if somebody makes an error and they didn’t scan, they bypassed the scan, they’re going to be in big trouble. Because that was the expectation, Right. There’s no excuse. The scanners are there, everybody’s doing it. So software is probably starting to maybe get to that point. If you have a case and a situation and you didn’t have software, then it’s like it’s kind of the standard now. Why don’t you have it? And the assumption then is you wouldn’t have had this problem had you had the software.
Hossam Gamal
Very true.
Terri
Which may or may not be true.
Hossam Gamal
Yeah. But I mean, this is a very good example of another way to prevent mistakes and error. And then the other one that comes to mind is also like an IV workflow management, having some kind of software and making sure that the. The medications are scanned and there’s a way to track those medications also definitely prevent mistakes and errors. So it’s all these tools that over time we add to our workflow and put in place to prevent drug diversion, to prevent medication errors, and to protect our patients.
Terri
Yeah. All in the name of patient safety, medication safety, and taking advantage of those. The technology. Yeah, that all makes sense. All right, thank you very much, Sam. I really enjoyed the time talking through this, and I think it’ll be really interesting for our listeners to hear that surveyors are definitely putting more emphasis on this.
Hossam Gamal
Thank you so much, Terry, for having me.
Terri
Thank you.
Terri
A special thanks to our sponsor, Midas Healthcare Solutions. If you’re attending the Nadi Healthcare Diversion Summit in New Orleans on April 7th 8th, be sure to stop by their exhibit to discover their innovative technology. Midas offers solutions for med surge areas, procedure suites and pharmacies. Visit www.midashs.com to schedule a demo and learn more about their technology.
