A Look Inside DEA Investigations

A Look Inside DEA Investigations with Timothy Shea, Former DEA Administrator & US Attorney for the District of Columbia, and Jeffrey Wahl, President & Co-founder at Midas Healthcare Solutions, Inc.

Tim and Jeff have a wealth of experience. As a former DEA Administrator, a presidentially appointed position, and head of the DEA, Tim shares insights that we rarely get. He lays out quite clearly what an institution needs to do. As an experienced trial lawyer, Jeff takes us inside a courtroom of a case involving patient harm due to impairment. This a sobering reminder of how impairment on the job results in patient harm. You don’t want to miss this!

Transcript:


Terri
Today we have a lawyer. Two, actually. I’m outnumbered, a former DEA administrator and a pharmacist. This kind of sounds like the beginning of a humorous story or perhaps a nightmare for some of the pharmacy administrators out there, because the last time a lawyer and a DEA agent were in the room with you were being ranked over the coals. But let’s find out how we can potentially minimize that from happening to anyone. Well, today we have Jeff Wall, one of our lawyers and the president and co founder of Midas Healthcare Solutions, and Tim Shea, our other lawyer, and at one time the United States Administrator of the Drug Enforcement, which is ahead of the DEA, and he was a U.S. Attorney in the District of Columbia. So I want to welcome both of you. 


Jeff
Hi, Terri. Thanks so much for having us. 


Tim
Thank you, Terri. 


Terri
I’m really looking forward to our conversation today, which might go in different directions organically, but I’m just going to start us off with asking what percentage of the time would you say the DEA goes in for a routine inspection versus going into a facility because there has been a diversion or some sort of wrongdoing that has been reported? 


Tim
So I guess I’ll start there. I should say at the beginning that all of this information that I’m saying is based on publicly available information, and they’re my views at this point, not the DEA or the US. Attorney’s office or DOJ. So I just want to be clear that’s based on my experience and my personal beliefs. But I think it varies from division to division. I think there are limited resources on DEA that DEA has, although diversion is a very important aspect of our mission, and so we spend as much time as we can being proactive and trying to find problems with systems or the like. But there are a lot of cases that come to us that are referred to the DEA for investigation, and whether that’s a pharmacy or individual physicians that are overscribing or diverting the pharmaceuticals, controlled substances or hospital systems, those kind of things. 


And then there are other criminal elements and health care fraud and other stuff that the DEA does in the Diversion control division of the agency. And I think that’s a very crucial role for DEA. And we have some excellent people both in the field working on this. And every field office in the country has diversion control inspectors and agents. And then we also have a headquarters staff that regulates and operates to make sure the system is working properly. So it’s a very important job that we have been assigned under the Controlled Substance Act and we take it very seriously. 


Terri
Yeah, absolutely. And I will say that the dealings that I’ve had with the DEA, I’ve never been in a facility where they’ve come in for an investigation, but just other relationships that I’ve had or when I’ve had to reach out to ask a question about something. It’s always been a very pleasant experience. I find that they’re very reasonable people and it’s been a pleasant experience. So for what that’s worth, does substantiate. There are some great they’re tough though. 


Tim
They’re tough regulators. And being nice is one thing, but they’re not going to skimp on the rules and I applaud them for that. They do a great job. 


Terri
Right. 


Jeff
Some lectures before in programs for health lawyers. And one of the things that came out of that was the way to avoid Dyspepsia is to make sure that when you open your front door, there aren’t people with blue windbreakers with three letters on the back coming in and asking you just to collector all of your records and all of your medications. 


Terri
Very true. A little bit of a sidebar. Funny story. This was years ago. We were having lunch. It’s just this little hamburger joint, just really kind of this hole in the wall. And there were several agents that were sitting out on the patio portion eating, having a hamburger. And at one point they all stood up like rapid fire chairs falling back and they just take off. And of course he was like, what is happening? And so there was a car and the agents, I mean, one ran toward the car, one ran in front of the car, weapons were drawn, they were hanging on the car. It’s like, what is happening? They pull this guy out, they’ve got him down. Well, it turns out those agents were stopping for lunch and they had a car full of marijuana plants that were like, hanging out of the car. 


Terri
So somebody, I guess, decided to try to rob them while they were eating a hamburger. But it’s like, oh, that’s kind of interesting. We saw them in action for just a moment there. Kind of wondered why they stopped for a hamburger, though. Yeah, good undercover guys. Okay. Yeah. So when the DEA comes in response to an event, then in a facility, do they also just proceed as if it is a routine inspection? I mean, that’s what I’ve heard. That’s where people kind of get in trouble. They’ve come in for another reason, but now they’re going to do a full inspection as to what they would do. Is that true? Is that what happens? 


Tim
Typically, each case is different, but there’s some very complex but important regulations under the CSA that DA enforces that include reporting requirements, notification requirements, systems for dispensing and wasting of controlled substances. And those are what they’re going to look at very carefully and if there are any problems with that, they’re going to dig even further. So I think those are key elements. And you’ve seen that in several cases that DA has done in terms of, for example, in hospital systems and all that. If there is a system wide problem and lack of enforcement either systems that are not adequate or the lack of enforcement of systems that are in place, those are going to be problems for any type of institution and they’re going to look at. It may seem a mundane thing to record and to document and report certain activities that involve controlled substances, but that’s crucial. 


Tim
I mean, you think of DEA. You mentioned that example you had at the hamburger store. But people think of DEA and going after El Chapo and Pablo Escobar and the rest. And that does happen. And we do have very activities that can make TV shows like Narcos, but we also have an important role in diversion. And to me, that was very important aspect of the job was to support what we do in the field and to make sure that these entities, whether it’s a hospital or pharmacy or whether that are entrusted with controlled substances allowed by the federal government under the Controlled Substance Act, do what they’re supposed to do with those controlled substances. Because what happens if they don’t is that these drugs get diverted and it contributes to the horrific drug abuse problem we have in this country. And we’ve seen the rise of fentanyl in the last three or four years. 


Much of the problem is related to fentanyl disguised, for lack of a better term, in the form of legitimate pharmaceuticals like Oxythern and others. And that is a problem. And whether it’s legitimate drugs being diverted or these kind of counterfeit drugs, I think it’s important they all contribute to this problem and DEA is going to be attacking it from all sides. 


Jeff
Terri there’s an interesting parallel between the important information that Tim just said and not from a regulatory standpoint, but from an accreditation standpoint. So I’ve had the same conversation with friends and colleagues who are on the Joint Commission and they have gone on record to say when they come in and do an audit or an assessment of a healthcare facility, the first thing they look at is controls on controlled substances. Obviously, that’s the big push with the DEA. That’s within their jurisdiction. But the Joint Commission looks at the control or lack of control over controlled substances as kind of a bellwether for how a hospital or healthcare institution is handling everything else. Interesting, many of these folks have said when we see an inadequacy or vulnerability or failure to comply with the CSA or any of the promulgations of any other regulatory bodies with controlled substances, they start turning over every rock. 


They look at every type if they go into every department because if you can’t control your controlled substances, you can’t really control anything because they’re obviously the most heavily regulated aspect of a hospital. 


Terri
Right. Interesting. 


Jeff
Pervasive assessment rather than a targeted assessment. 


Terri
Right. Yeah, that makes sense. And that’s really interesting. I’m curious, did they share with you? Do they then pick up the phone and call the DEA as well? Or do they keep it compartmentalized? 


Jeff
I have not heard that they called anyone. I think that would probably create some friction between the hospitals that they’re assessing for accreditation. I don’t think they want to be whistleblowers. I think part of what they want to do is fix the problem so that the DEA does not have to come on site. I think they want to identify the issues and then help to solve them. Yeah, no, that’s a great but I think the approach might be somewhat different. 


Terri
Right, okay. All right. That’s great information. When the DEA goes in a response to a diversion and they go into a facility and let’s say that they do find things are in order because we all know, right, we’re not going to prevent diversion 100%. They’re very clever. They’re finding new ways all the time. Every facility, even with a solid program, needs to be diligent, constantly looking. And you learn from every case that you may have of what your gap was or how they found a workaround. But there are facilities out there that are doing a solid job on mitigating the risk. And if somebody gets past them and it ends up in the DEA’s hands, does the DEA typically are they more forgiving? They go in, they look, the records are all locked up tight. They’re doing what they’re supposed to do, and somebody found a way around it. 


So does the DEA handle that differently than they would if they found someplace that’s just not compliant and obviously people were going to be able to find ways around. 


Tim
Right. They have to make an assessment at some point. When they do these cases, they work with the United States Attorney’s office in that location. So it depends on if they end up presenting the case to them. So I think the two things that they’ll look for is number one, is there a systemic problem? Do the systems not work? And if the systems are broken, that’s a huge problem because that means that whether you’re doing the right thing or not, you’re going to lose and not have you’re going to have diversion. The second thing is, do you have systems in place that are adequate, but they’re not being enforced or there’s problems with it, that’s going to be a problem as well. And then they look at the results. If you have a system where you have people, for example, you have healthcare professionals in a hospital system that have been known drug users and have a substance abuse problem, and then they’re allowed to continue to interact and to use and to dispense and waste controlled substances, that’s a problem because you’re setting the system up for failure. 


So one or two problems that they see or minor issues are not going to be as problematic as having a systemic problem or a problem where the system isn’t being enforced. That’s how they’ll view it. 


Terri
Right. You just said something I want to have you clarify. You said if you have someone that has a known problem and they’re allowed to work, there’s two cases, right? If there’s somebody that you suspect and you don’t take action, you kind of, oh, I think it’s practice, sweep it under the rug, what have you, but you’ve been alerted that there might be a problem. And then there’s the case of somebody that has potentially gone through the recovery program and has come out on the other end and it’s been a couple of years, they’ve done their due diligence and you allow them to reintegrate with some monitoring in place and some controls. When you say that person that you’ve allowed to work, are you talking about those reintegrated people that we’ve gone through the process and they’re in recovery and they’re continued to being monitored?
If they were to have a relapse, is the facility more at risk than they would have been the original time before they brought them in? You understand what I’m saying? 


Tim
Yeah. No, I do. I think the question I mean, you added a condition there, which is being surveillance after there’s a known risk, that often doesn’t happen. So if you don’t have surveillance after you’ve identified somebody as having a substance abuse problem, that’s going to be problematic for the institution. And so that’s where you’re going to have heightened scrutiny of what they’re doing as an institution. So I think nobody wants to bar people for life from working, but I think at the same time, you’ve got to put adequate control so that you don’t have drugs like fentanyl. And I mean, these are dangerous drugs that are diverted. Dangerous for the people that are using them, for the healthcare professionals that may be abusing them, or if they’re distributing them as well as using them to distribute them to other people. I think that’s a problem. 


So I think it depends. I mean, there have been cases where we found in hospital settings that the hospital has known that somebody handling controlled substance has an abuse problem, but there’s been no surveillance afterwards. They’ve been allowed to go back to the same job. So that’s where you’re going to have a problem. 


Terri
Yeah. No, I know. My approach is always when I perform an audit and it’s just clear, oh, boy. It’s like immediate off the floor until we can finish. Some are not as cut and dried. There’s a little bit more conversation that needs to be had to figure it out. But yeah, once you think, you know, then immediately they’re off the floor from a patient safety perspective. 


Tim
I think that’s common sense, but it happens all the time. That’s the problem. That’s why to enforce it. 


Jeff
Right. The ultimate goal of all of this is to protect the patients in those healthcare institutions. And I’ve worked on several civil matters, not prosecutions, where health care providers were diverting and were not putting those medications into commerce. They were using them, and in fact, using them on the job close to the time when they were surreptitiously obtained under the guise of being for a patient, with tragic consequences to patients, nurses who are working in an intensive care unit who literally have one patient responsibility. Because the ratio in an ICU is usually one to one. And self administering fentanyl at the time, they were also depriving their patients of that fentanyl, which is patient abuse sort of at its root, but also coming back in such an impaired state that they can’t perform even routine nursing care on those patients, resulting in morbidity and mortality. 


Terri, I think you might have heard one of my lectures about one of the cases where one of my clients ultimately was paralyzed because a nurse who had taken fentanyl on the job administered a medication that should have gone into one of five intravenous access ports into a spinal drain, which had been marked as spinal drain. The line said spinal drain. It was virtually impossible to do that, and the institution covered up for it. And you asked a question before about, does the de look upon an institution that tries to mitigate in advance in the civil world if a hospital denies that they have a diversion problem? In this instance, they denied it for four years up until the trial. It made it a lot worse. 

So I spent four years of taking depositions and asking every person who was involved in the care of this patient management and the c suite whether this nurse exhibited behavior that was indicative of diversion in hundreds of different ways, changing the chart, manipulating things, and every answer was unequivocally.  This is diversion. This is the behavior of a diverter. Yet they officially didn’t admit that they had a diversion issue, and it cost them one of the other issues that in addition to the harm that Jeff described, one of the things that the DA would look at, and their job is to is that this is if this continues, that this happens, it’s an it’s. It’s a matter of public trust in the healthcare system. And when people learn about these kind of diversions and whether people die or people are hurt or damaged in the hospital, that’s a public trust issue that DEA has to address. And I think that’s been cited as reasoning in some of the cases DEA has brought forward, especially in the hospital setting. 


Terri
Yeah, absolutely. 


Jeff
We talk about the UTSW case because it’s in the public sphere and for your viewers, Terri, two RNS, I think, a year apart had pulled some fentanyl from the Pixis dispensing cabinets and had self administered, and each one tragically died in a hospital bathroom from the same consequence of an overdose. That case, it became notorious, not initially because of the DEA investigation, because that didn’t start until three years after the events. It became notorious because someone tipped off the Dallas Morning News and it became an above the fold story. And that’s what ultimately got the DEA to investigate for three years. So, yeah, the lack of public trust is enormous. And in most towns and cities, you have choices as to where you obtain your health care as a patient consumer. And when you hear bad news about impaired health care providers or lack of controls over opioids within a hospital, you’re going to go to the hospital down the street. And it’s a huge public trust issue, and it’s a huge economic issue for health care. And if health care has an economic problem, we all pay the price for that. 


Terri
Yeah. And I know there’s some things you can and can’t talk about with that case, but does that mean that the facility itself never reported those two deaths? It wasn’t found out until it was leaked to the media. 


Jeff
Yeah, I’ve studied this case extensively because it’s a really good window on how hospitals and the DEAl with each other. And again, this is all public information they did not report. And part of the reason they had such a substantial financial penalty, and I call it a honeymoon period with the DEA thereafter, I think it was three or four years, was that they failed to self report. And I’m going to defer to Tim on the obligations of a healthcare system when they are aware of overdosing healthcare providers to the point where they die. 


Terri
You have to report Joint Commission too, right? I mean, there’s some reporting requirements there, too, right? 


Jeff
Tim, what’s your thought about that? 


Tim
Well, I’m not going to talk about that particular case because part of it was during my tenure. But I will say in general, that the self reporting is important. I think it shows an acceptance of responsibility. And both the prosecutor and the DEA are going to look at that and how they’re trying to remediate the problem once they found out what the problem was. It’s not going to forgive some systemic problems or lack of enforcement during the process. But it is going to be important to look at as opposed to someone who or some entity that tries to just fight it the whole way and not recognize the problem because DA wants to solve the problem as well as enforce the law and meet out punishment. Because in the end, these cases serve two purposes when they correct an existing problem with an existing institution, but they also serve as the deterrent to others going forward, I assume. 


And what happens in a lot of these cases, they see the UT case and others and other systems will look at that and say, what’s our exposure here? And are we doing it right? So that’s really the purpose of a lot of criminal cases anyway, and that’s deterrence is a huge rationale for having these big things. I will mention one thing in that case, though. In many of these cases where you see once a system is involved with the DEA and with the US attorney’s Office, like this case where you had a three year, I would call, probationary period afterwards you’re seeing some of the language in there. It says basically obey the existing law, which sounds innocuous, but if you think about it, if they violate anything in that three year period, that’s a second offense and your penalties are going to double. It’s going to be a very serious problem. 


So once you get tangled up in these kind of issues or these kind of investigations or reviews by a regulatory agency like the DEA, it could be problematic down the road for a long time and cost a lot of money. I mean, the UT case alone was 4.5 million, which was huge. So I think DEA did a good job investigating that case, and I think it’s one that should serve as a message to other hospital systems that they’ve got to make sure their controls are in place. 


Jeff
Terri, to your point about notification as a responsibility under the CSA, I pulled the press release that was put out to announce this resolution. And the US attorney from the Northern District of Texas, the district that had Dallas in it when they announced this resolution, he noted that the behavior of this hospital and I have lots of friends there. I know you do too. So we’re not trying to vilify that it’s an educational goal for all of your viewers. They exhibited a, quote, almost shocking disregard for its obligations under the Controlled Substance Act, which probably had something to do with their failure to report two deaths of healthcare providers from diversion. I would suspect that would be a reason for characterizing it that way. 


Terri
Right? Yeah, well, it’s the acknowledgment of wrongdoing with anything, right? When we offend somebody, if we don’t take ownership for it, I tell my kids, stop blame shifting, take ownership for it. And that’s the beginning of showing that you really want to make amends or to change or whatever it is that needs to be done. And you talk about the public trust thing. That is a big thing. And when I meet somebody and they, oh, what do you do for work? And I tell them and sometimes I wonder if I’m telling them too much or if it’s a good thing that I’m telling them. Because the look of shock on their face when they find out that healthcare professionals can be involved in this type of thing potentially while they’re taking care of them or their loved ones is a little overwhelming to them. And I just had a family member that went in for some surgery and I spoke to him the morning of and he’s like, hopefully it all goes well. 


And I said, I’ll be praying for you, it all goes well, blah, blah. And he goes, yeah, and just pray that nobody’s taking my drugs. It’s like, oh my gosh, I’ve given him one more thing to worry about. When really the biggest percentage is not doing this. But they do need to be aware because sometimes it’s the patient that lets somebody know that there’s just something wrong going on. 


Jeff
It’s remarkable that I have similar conversations with healthcare providers and many of them are naive to how pervasive the problem actually is. And there have been some statistics in the industry that estimate that there are about 4000 diversions of controlled substances within healthcare institutions on a daily basis. When you think about it, and this is from an informed source at one of the Adm companies, that means that two thirds of American hospitals, because there are about 6000 hospitals, have a diversion every day. 


Terri
And is that of controlled substances? 


Jeff
Yes, controlled substances. 


Terri
Wow. 


Jeff
Which is remarkable. Yeah, it’s frightening. 


Terri
That is frightening. So yeah, bottom line, facilities say, oh no, we don’t have that here. We haven’t found anything. It’s like, well then you need to start wondering what’s going on. Well, tell me, how does a settlement agreement work? I mean, a lot of that all that legalese and this and that. Walk us through that kind of in general. 


Tim
Well, they take a couple of forms. The one in the case that Jeff referred to that wasn’t one that was entered into the court record and enforceable by a court. It was an agreement between the parties, basically. So in the civil context, the US attorney’s office has to sign off on it. They’re the chief legal advisor to the DEA. And so DEA would investigate, it, would negotiate it with the US attorney’s office and the system or the defendant here. And they would come up with an agreement that would include a legal agreement that’s called the settlement. And then an MoU. A lot of times it gets into some of the nitty gritty details about what they’re supposed to do. And it’s enforceable through the powers of each agency, another way to do it. If it’s really egregious, to file a complaint, civil complaint against them and have it entered into the court so that it’s a legally binding document that can be enforced with court penalties. 


Tim
Those are done in some of the more egregious and larger cases, some of them against, like pharmaceutical companies, for example, do that a lot. They do that a lot with them. You have an investigation that’s conducted by the DEA through the diversion division, and then that information is collected and then presented to the US attorney for consideration. They decide among themselves between the DEA and the US. Attorney’s office, what route will take, what provisions they’ll negotiate with the company about, get into the details back and forth about what the amount of money is going to be, the penalty, what the provisions are going to be, how long it’s going to last, those kind of things. And then once that’s all agreed to, then each party signs it and they announce it and it begins. So in the case of the UT settlement, there was an external auditor required, there was the ability for the DEA to enter the hospital anytime, for any reason, unannounced, without notice. 


Those kind of things are pretty stringent and they’re important for them to have with a company or system that’s, quote, “under probation” at that point. So it has several provisions in it that they negotiate and then enforce over a period of time. And a lot of times you can extend the terms of that if there have been violations, maybe violations that haven’t risen to the highest levels. And I’ve seen cases where they’ve extended it in order to make sure that it goes three years without anything happening. 


It’s really, it’s expensive. Not only the monetary amount that the company pays, but the cost of implementing it, hiring external auditors, being responsive, diverting resources away from healthcare to do the stuff that they should be doing. So I think that’s how they’re generally done. 


Terri
Yeah. The stuff they didn’t want to pay for before because they didn’t think it was yeah. Now they gotta you have no choice now. Yeah. Okay. 


Jeff
Great comment about the public trust before the agreement. Sort of the intro says, we agreed to these terms in an effort to work together. So it really is a cooperation between the regulator and its licensee to ensure high quality and safe patient care. So they put that first. This is about patient safety and to safeguard the UTSW staff because obviously it started with the death of unfortunate death of two nurses and the community. So it’s really that triangulated, keep our patients safe, keep our staff safe, and to regain that public trust. 


Terri
Right. Well, they certainly have done a lot since then. If you talk to them now about their program, in fact, people are jealous of all of their resources. And some people that maybe aren’t familiar with the case, they’re like, how did they get all those resources? There’s a story. But yeah, they’ve come out on the other side doing what sounds like a pretty thorough job when you talk to them and you hear about their program. Jeff, have you seen cases from a legal perspective that there has been harm of some sort to a patient? That maybe they didn’t have diversion on the table, they didn’t think about it as being the root cause of something, and perhaps that is why things went wrong and there was some patient harm because they had an. Impaired provider. I’m just kind of curious if maybe because in my experience, I’ve had to educate the risk department, the compliance department. 


It’s like, if there’s something that has happened, say, in the or wrong site surgery or what have you need to kind of consider that there may have been impairment going on. And they’re like, it’s not something that enters their mind. So I’m curious if you’ve seen cases like that where it was dismissed, but really it should have been looked at or maybe did come out in the trial. 


Jeff
Yes, I have. It’s interesting. It’s a great question. One of the things that for many years, I represented healthcare providers in medical malpractice cases. And in those instances, the allegations are you either failed to communicate something properly, or you failed to do something properly, you misdiagnosed, or, like you said, wrong site surgery, or performed a procedure improperly, or failed to give the right treatment. But as I moved on in my career a couple of decades later, and I started looking at bad things that happen in healthcare, it’s easy to direct them into that sort of category of just malfeasance, a healthcare provider not performing up to the standard of care, in that instance, causing harm to a patient. The case that I referred to started out as a nurse who did something improper. The thing that tipped me off to looking deeper and looking into the diversion issue was actually a record alteration. 


So, interestingly enough, I was looking at both the clinical medical records and the HR records of the nurse in question. So not only what he was doing for this particular patient, but what his HR records showed. And sort of the Eureka moment for me, Terri, was I got the HR file under NDA and looked at it and realized that there were two different versions of the chart. So after the event, the nurse in question made multiple key alterations to the record, which you do for two reasons. One is you’re impaired, or two is you’re trying to cover your tracks. What this nurse didn’t realize was when they investigated not the diversion, but the untoward event in the middle of the night with the misadministration of this innocuous medication into the patient’s spine, that the nurse manager photocopied the chart. So we had a copy of it prior to the alteration. 


So when you then go back and put all the pieces together and then, I mean, this is the depth of the investigation when it comes to diversion. If you looked at the paper chart and then the electronic record, the Epic record, there were some things that didn’t make sense. But when you started to correlate that with the audit trail for epic. So sort of popping the hood and going in to find out what you don’t see when you log in, but what it actually showed sort of in the back office of who’s been in, where the alterations were being made and when they were being made. And they were all being done by this one person. So then it sort of morphed from is this just a bad nurse? 

So why is it that some of the alterations related to medications that weren’t being given the right way or weren’t potentially being given at all? The other advantage was the patient hadn’t died soon afterwards. He actually lived through what was the diversion and the consequences of the diversion and could speak to the fact that he was intractable pain following the surgery when there were specific orders to handle postoperative and perioperative pain. So then we started to think, why is this patient in so much pain when he’s supposedly getting all of this intravenous fentanyl? Well, he wasn’t getting the intravenous fentanyl, so you can sort of go down parallel paths, but now sort of with the wisdom of retro spectroscopy, looking at it backwards. 


Terri
Is that a word? 


Jeff
Yeah, I just made it up. 


Terri
I like it. 


Jeff
You start to look at things, well, maybe it just isn’t an incompetent or a nurse who’s doing something or other healthcare provider is doing something improper. Why are they doing it improperly? Maybe they’re doing it because they’re impaired and they’ve diverted. So my eyes are much wider open to those issues. And I think that’s a word to the wise for anybody who’s looking at untoward consequences of health care in any sort of healthcare institution. 


Terri
Yeah, and it really kind of comes down to that for just about every person that I dig into with an audit. Not to that extent that egregious. But is this a practice issue because they’re just a little careless or they don’t know they’re new, or is this a diversion issue? I mean, really, we need to ask that question every single time, right? And most of the time, their managers are very quick to say, oh, it’s a practice issue, but it’s like, not so fast. There’s a lot that we don’t really know until we have a conversation. 


Jeff
They overlap, whether it’s a systemic problem or a people problem. I’ll give you one example. I teach in the anesthesia department at a major American healthcare system and teach risk management. And one day I was in the operating rooms observing practices, not looking for people, but looking to see if I could help them improve their practices. And they still to this day, document controlled substance waste in their operating rooms. On paper, they have a sheet with the patient’s names and columns for the drugs. And there’s a little spot for the waster and a little spot for the witness. And they’re supposed to put their not even signatures, their initials. So one day I went and I took a copy of that form to the pharmacist who lives in the operating room core at this particular hospital, giving out the medications they need for that unit. 


And I said, what would cause you to escalate the return of one of these forms with all the controlled substance waste for the day to a diversion investigation? And he said, It’s pretty simple. I said okay. He said, the lack of a set of initials, that’s it not an audit, not a real analysis of it. And I thought that was pretty weak. And then I said, how do you know that the person who signs off as the waster of the morphine or the ketamine or whatever it isn’t the same person who signs off as the witness using a different pen and writing different initials and maybe writing with their nondominant hand? And he said, I have no idea that it is or isn’t the same person. So there’s a perfect example of an A list hospital continuing to promulgate or continuing to not fix this vulnerability, which is so obvious. 


I mean, I saw it in five minutes. I’m sure you see it with some of your clients and the health systems. You nobly advise, but it’s remarkable how Complacency lives on. Even with the knowledge that diversion is. 


Terri
Rampant, the DEA is not going to like that. If they come in. 


Tim
There’S going to. 


Terri
Be a problem that might fall under the systemic problem. Yeah. All right, well, this has been fantastic. Any last comments that you want to give to the listeners of maybe one thing they should be doing? Make sure they’re doing that they can decrease their risk of trouble? 


Tim
Well, I would just say, in general, diversion control is important. It’s important to the DEA and federal regulators. We have an overdose crisis and a drug abuse crisis in this country, and this contributes to it. So we need to be as vigilant and as efficient as possible to address the problem, and that includes healthcare professionals. 


Terri
Yeah. 


Jeff
I think the teaching point from all this is if you don’t think your facility has a diversion issue, you’re being a bit naive, and you should look harder so that the Joint Commission or the DEA doesn’t come calling and get you above the fold in your hometown newspaper with a big settlement. 


Terri
That’s true. We don’t want to be in the news for that reason. All right, thank you. Some good words of wisdom. I want to thank everybody, buddy, for listening. Hit the subscribe button. And I want to thank our sponsor, whose product line is an active deterrent to diversion. Check out their website, imiweb.com to get that free trial box of tamper evident caps for IV syringes. Thank you, gentlemen. 

Picture of Terri Vidals
Terri Vidals

Terri has been a pharmacist for over 30 years and is a drug diversion mitigation and monitoring subject matter expert. Her years of experience in various roles within hospital pharmacy have given her real-world insight into risk, compliance, and regulatory requirements, as well as best practices for medication and patient safety.

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