The DEA and Patient Own Meds

The DEA and Patient Own Meds with Susannah Herkert, Senior Managing Director at Guidepost Former DEA Supervisory Diversion Investigator

Patient Own Controlled Substance Meds is a no-win issue in every facility I have ever worked in or with. Well, guess what? There is a new twist that puts facilities at greater risk than you might realize. Susannah unpacks this and clearly states what the DEA regs are on this topic. You definitely do not want to miss this.

Transcript:

Terri
Hey, everybody, welcome back. This is part two with Susannah Herkert, the senior managing director at guidepost. After our first interview together, we kept talking when went cut the recording, and Susannah mentioned a topic that is a tough one, and there’s a lot here. So we decided we would just record again and keep on going. And the topic is patient owned meds, controlled substances. And I was telling her that, I don’t know, maybe every six months or so, I see something come up on the forums that are asking about patient owned meds and the DEA regs and how do you handle it? And it is definitely one of those things that is just a catch 22. So she and I started talking about it, and we’re going to include all of you in our conversation because there’s some really good information here. So, Susannah, go ahead and share with the listeners what you were talking about in terms of what you’re seeing with patient owned meds. 

Susannah
So, to Terri’s point, everyone’s talking in the healthcare facilities about patient owned meds, and how do you handle it? As you know, the DEA pharmacy manual outlines what the requirements are, and that DEA does not allow for patient owned medications, controlled substances to be given from the end user to another person. And so that’s where the potential violation comes in place. DEA sees it as an unlawful distribution when that patient turns over that controlled substance to another individual, even if that’s another DEA registrant or a healthcare facility. And so therein lies the problem, because a lot of individuals come to a hospital, whether it’s via ambulance or for intake, and they have controlled substances that they’ve been prescribed with them. So DEA does not allow those to be stored on site. And the only exception that DEA has allowed is if it’s deemed medically necessary for that individual to continue to take those, then they can be stored in a secure lockbox in the patient’s room. And so that’s the only exception to the rule that DEA has allowed. However, obviously, for patient care yeah. 

Terri
Does it say and stored in the lockbox in their room, like it has to be with them? 

Susannah
Yes. And so in a secure lockbox in their room. And so that can mean we’ve worked with facilities that includes a dual key lockbox to where a nurse has a key, and then the other key is stored with the patient’s belongings. But that obviously for patient safety reasons, that sometimes they should not have access to that. And so we’ve worked with facilities in outlining their policies on how to deal with that highly complicated and challenging DEA compliance issue. And so there’s the DEA compliance issue, where if DEA comes on site and you have those patient owned controlled substances stored in the pharmacy or stored in your automated dispensing cabinet, DEA is going to see that as you have taken possession of those controlled substances from the end user, which would be in violation of Title 21 for unlawful distribution. And so there’s no circumstance where you’re allowed to take possession of them. 

And the only exception if the ordering physician deems it’s medically appropriate for them to have them. And that’s where DEA has carved out the secured lockbox or areas with the patient’s belongings in their room. But that’s one side of it. So that’s the DEA compliance side of it. But the other side, which we are seeing a lot with facilities, is the risk that comes in when patients contact regulators or law enforcement regarding those meds. And so when those controlled substances are taken from a patient, often the family or that patient will call law enforcement or DEA and say that they took 30 of my oxycodone, I had a prescription for 80, and 30 are missing when they gave it back to me. And so a lot of times this is an individual that’s trying to just acquire more controlled substances and so they are taking their chances with calling law enforcement on it. 

But law enforcement will sometimes respond or DEA will come on site and then you’re exposing yourself to an additional review because once DEA is on site, they will probably review your policies and procedures related to patient owned Meds, maybe even do an audit at the pharmacy or evaluate. And so you have the compliance risk from how do you store and handle those controlled substances. But the other compliance risk are the patients that will contact law enforcement and regulators about those personally owned Meds. 

Terri
Oh my goodness. Okay, so a lot to unpack. First of all, I think we would all acknowledge that every facility wants those patients to take those meds away. We don’t want them take them, but that’s not always possible. So if it’s not possible and the meds are going to stay on site, then the DEA says that they need to be in the patient’s room. Right. That doesn’t qualify to put them on the nursing unit in a locked cabinet because I’ve seen that right in some of the forums. It’s like, no, you can’t take it from the patient, it needs to stay up. And they are a resident of the nursing unit, so keep them in the medication rooms up on the nurses unit. Do you think that would fly? 

Susannah
So I think what you described is about them being residents of that unit. I think that’s going to get into more of legalese on what determines residence in that residency, 30 days or more, right. Constructive possession residency. And I have seen that argued before. I know from DEA standpoint, the example that DEA gives in the pharmacy manual is that it’s to be stored. It could be stored in a secure lockbox with the patients belonging in their room. So DEA doesn’t say at the nursing unit, it doesn’t say down the hall. And so I think that’s a little bit open for interpretation on how to handle it. We’ve worked with facilities where we have a patient owned Meds committee that will make a determination of what’s in the best interest of that patient and the employees and that facility, given the circumstances that are presented. As Terri said, first and foremost, try not to accept them or try to have a family member come and retrieve them so that you are not stored on site. 

But based off the type of patient care, whether you’re a behavioral health rehab or acute facility, sometimes the patient owned Med committee is going to need to determine what’s the best course of action. But we never recommend putting anything in policy that would directly violate DEA’s guidance. 

Terri
Yeah, for sure. Good point. And if it’s in a secure area in their own room, is there anything that stipulates that patient needs to have access? No. Okay, so we can be totally locked up in their room because you think about it, with the rest of their belongings. Well, what if they want their shirt? They can get their shirt out. We don’t care. Right? Theoretically. But we certainly don’t want them getting the meds. 

Susannah
Right. And that’s exactly what we try to balance based off the type of facility in their policies and procedures. Because it’s not appropriate sometimes for patients to have access even if it’s not a controlled substance, because for patient safety reasons. Right. And so that’s why sometimes we recommend the dual key access where a nurse has one key, the other key is stored with the nurse, but there’s no access unless both keys are placed in. But all of that’s going to be based off the cognitive function of the patient as well. There’s all these different kind of scenarios that we work through facilities with because you want to make sure that your facility has all of that information, has the appropriate procedures in place, but also has the appropriate committee for what we call kind of the 80 20. So 80% of your patient owned meds are going to fit into your policies and procedures as written. And then 20%, you’re probably going to have a patient owned Meds committee review and determine the best course of action. 

Terri
Wow. And I mean, that’s a huge investment, too, to make sure that every room has the appropriate double lock security. When what percentage of the time are you going to have a patient? Maybe you need your isolation rooms and then you need your controlled substance, patient owned med rooms that they go in there. All right, so let’s say that right now, facility just doesn’t have it. They’re working on it. You get a patient that comes in, they’re not going to take their own meds while they’re there because it’s on formulary. There’s really no reason for those meds to be there. Really should send them home, but can’t send it home for whatever reason. But you certainly want to mitigate that patient that may turn around and say they took 30 of my oxies. Do you find and maybe you don’t know because you don’t really keep track of everybody versus the patients that create a problem. 

But if it’s like, okay, well, here’s your meds, let’s count it together. Let’s deal it together. You sign, I sign. Even if they had thought they were going to try to take advantage of the facility, would that mitigate it? Because now they know, okay, I can’t get away with it at this facility. Or have you seen them still try? 

Susannah
I’ve seen them actually still try. So they’ll find tamper envelopes, but once that tamper envelope walks out of view of the patient, they’ve stolen my medications. And so we have seen that’s where the risk comes in with that as well, because the patients even with the tamper envelope, some sites have even gone so far as to become DEA collectors. And so now that DEA has modified their collection status, you can modify your DEA registration to be a collector and place that collection receptacle at the facility. And so if the patient doesn’t have a representative or does not have a way to get it home, they can drop that in the collection receptacle as well, or use the mailback envelopes that will send the controlled substances back to a reverse distributor to be destroyed. And so part of the policy or the things that we review are all of these different kind of cascading things. 

These are all of the different options. And that’s really to your point, Terri, of if you have a robust diversion program or anti diversion program, this is another one of those. If you have a robust program in place that goes through all of these options to try not to have controlled substances on site, if you have a triggering event with a patient or something else, then that’s going to put you in a much better position with regulators when they come on site, rather than what a lot of the facilities that have dealt with this in not a good light with regulators is that well, we just put everything in the pharmacy and we put it in tamper bags, and it’s stored in the closet back there. And then when regulators go open that closet, they find oxycodone from a patient that hasn’t been there in nine months still sitting in the closet. Because that’s part of it. Things get left behind as patients are discharged a lot. And so then you have controlled substances on site in your pharmacy that aren’t on your inventory. And so you can get hit on your inventory for having controlled substances in your pharmacy that aren’t on your inventory, plus having patient owned meds on site. 

Terri
Right. If a facility is a collector, then that means it’s coming in as waste, right. It’s never going to make it back to the patient. Is that correct? 

Susannah
Right. So if they modify their registration to be a collector, once it goes into those, they look like mailboxes, it drops into that mailbox, and those liners are sent to the reverse distributor and they’re destroyed. 

Terri
Okay. Yeah. So definitely not going to be the patient’s preference. 

Susannah
So a lot of times it’s not. But some facilities, this has worked well because the rules are posted right. That say, do not bring controlled substances on site. If you do, you will be asked to return them to a family member or we have a collection receptacle where you can place those controlled substances. 

Terri
Yeah. And I wonder how many patients all of a sudden can make it work that somebody can come pick it up. 

Susannah
Exactly. For the facilities that have gone this way the first month or two, there’s a bit of challenge with all of this change to it, but then you start to see less and less patient owned Meds are coming on site. 

Terri
Interesting. Okay. Yeah. But definitely don’t want them in your pharmacy. 

Susannah
Yeah. 

Terri
Because in the previous podcast that we did together, we talked about that biennial inventory and that has come up, too. Which do you count the stuff that is patient owned Med in your thing? Which I guess you better not count it because you don’t want them to know it was there. 

Susannah
Right. That’s one of those. Either way, you’re going to be in a bad space because if you don’t count it and they find it, why is it not on your inventory? But then if it’s on your inventory, well, why did you take possession of it in the first place? So that’s never going to be a good situation to be in. 

Terri
Yeah. Wow. Yeah, I know. Patient owned Meds is just one of those things. I mean, there’s a few topics that come up over and over that really we all just want to ignore because it’s like there is it’s a no win. Marijuana and patient owned meds. Those are two of the big things that come up. 

Susannah
Unfortunately. It just brings that compliance risk because there have been diversion events involving nurses and patient owned Meds, because obviously it’s not going to create a discrepancy report when you’re taking controlled substances out of a bag. Right. These are not electronically monitored, typically per pill. And so there have been situations where nurses have diverted the patient owned Meds. 

Terri
Absolutely. So this is an important piece to kind of talk about the DEA. Have they had any discussions that you’re aware of over the practicality of this and the fact that you are potentially increasing diversion risk by pharmacy not being the holder of these Meds? Because I’ve seen places where they tamper proof it and then put it in the Pixis or the Omnicell or whatever machine they have. But then if the patient is on these Meds, then it’s sent up a dose at a time with a sign off and a full inventory. And the pharmacy, they have checks and balances, right? Not as much as the nurses would up on the floor until it’s time for the patient to go home and then maybe you realize something has been missing. So it really is, I think, a better diversion mitigation piece if you’re keeping it in the pharmacy, any discussions at all surrounding the balance of it’s, this patient, but yet they’re now in our facility and so we need to do what is the safest and mitigate diversion the best that we can. 

Susannah
I think from DEA standpoint, it’s that if at all possible, they need to be using something that’s on formulary at the hospital, that they should not be taking any of their personally owned controlled substances, but around discussion of storing in the pharmacy. I mean, from everything that I have seen, it can only be in the patient’s secure lockbox or with their personal belongings. But that comes in where patient safety has to be balanced. And some of the forms and documents we’ve developed for clients creates that dosing form that nursing has to follow and has to be audited if it’s going to be stored in, say, a portable lockbox that’s taken into that patient’s room during their stay. And we’re seeing an increase and that’s why hopefully maybe there will be changes to this in the DEA space because with the elimination of the X number and the increase of suboxone, a lot of these patients are coming on site with their personally owned suboxone or methadone. 

Susannah
And those are ones that, depending on the treatment program they’re part of, they have to show that they have used those medications in order to return to those treatment programs. And so that’s creating an additional compliance risk because you would not want the patient to have access to those while they are on site and to make sure that they’re dosed properly. But this might be the time where there might be more discussions with DEA on how to handle that, not just and that would be an acute or behavioral health as well in handling those controlled substances. 

Terri
Interesting because they have to show that they’ve taken it every day. And can you get a doctor’s note? I was inpatient for five days, so I got it from the inpatient pharmacy. Yes. 

Susannah
It’s a very complicated issue, to say the least, which is why having policies and procedures first and foremost that your facility can truly follow because the last thing you want is to have policies and procedures around patient owned meds that they just simply can’t follow based off the type of facility. And then allowing a patient owned meds committee or additional individuals to be involved in some of these discretionary areas where it’s not a one size fits all. 

Terri
Yeah. And then I guess as long as you can explain what you’ve done and why you’ve chosen to take a particular approach on a patient by patient basis, then it would probably go better for you than if you just say we just store it all in the pharmacy, show you put some thought into it. Even if you technically broke the rules for a particular patient, if you can explain that. 

Susannah
Right. It’s all about the documentation, the chain of custody forms that are used, and the audit process of it. So are you monthly ensuring that you’re following the process? Are you auditing the paperwork? Has your patient owned Meds committee documented the appropriate decisions? Because, as we tell everyone from DEA comes in, if it’s not documented, it didn’t happen. And so we see so many of these facilities saying, well, I stopped, and I talked to so and so in the hall about it, and that was our decision. Okay, well, can you show me that documentation around it? Right? It doesn’t exist. And so that’s why creating those forms, having that documentation closed loop process in case something does happen with patient owned Meds will put you in a much better light when regulators come on site. 

Terri
Interesting. Okay, listeners, one more committee for you. The Patient Owned Meds Committee. Nobody will volunteer for that one, right? 

Susannah
No hands going up for that one. 

Terri
Definitely not. All right, well, more fantastic information. Susannah, thank you very much for sharing that with us. This is a sticky one. Thank you.