DEA Controlled Drugs | Pharmacy Compliance[Podcast]

Lisa Faast:
Hello everyone, Dr. Lisa Faast here and I've got another compliance episode for you with our industry friends, RJ Hedges, Jeff hedges from RJ Hedges, the compliance guru for all things independent pharmacy, if you're worried about any compliance following the law, worried about an inspection, RJ hedges is really your one stop shop for everything that you ever might need to be legal or compliance for. And so today's session is on the DEA, DEA, we all know obviously controlled drugs, very regulated. But there's some things that are happening in independent pharmacy that I think we all need to be aware of. And so Jeff and I are going to have a discussion about these changes and how you can make sure that you and your staff are prepared for any questions you receive, either from the DEA or your board of pharmacy along these lines. So let me bring on my guest, Jeff hedges. Jeff, thank you so much for joining me again today and helping independent pharmacy owners and pharmacists and our listeners to be compliant. For anybody who doesn't know who you are, could you give us give a brief introduction about RJ hedges and what it is that you guys do for independent pharmacies?

Jeff Hedges:
RJ hedges associates, we started the company back in 2006, in compliance and started with HIPAA. And we've grown with all the different compliances that have come through over the last 1516 years, which has been a lot. We have a platform, we trademark that compliance portal. We have our software for every individual component with compliance. It's point and click, everything's customized to the individual pharmacist. Everybody has a dedicated project manager. So if you call in, we all get upset you call in and they don't know you. And they don't. They have no idea who you are, but on offer ours, the customer service is the most important. So you got the same dedicated project manager who acts as your assistant clients officer all the time. So it's worked really well.

Lisa Faast:
Yeah, so we're gonna be talking about the DEA now. And, you know, I remember way back when I was around whenever Sudafed first became a thing, and that was really like, the first thing that I ever remembering that like I had to go and answer some questions and take a class and I got a little certificate, and you had to do that for all your employees. And that that was kind of I think, the first domino and all these dominoes that have kind of fallen since then. I mean, I think it's important, you know, the opioid epidemic epidemic is a real thing. I don't think it's necessarily all pharmacies fault, even though we get a lot of the burden. But what are the changes? Or what are what do independent retail pharmacies need to be aware of when it comes to DEA compliance?

Jeff Hedges:
Well, the first thing is it's, it's a, it's an old requirement, but now they're unfortunate. It's called corresponding responsibility. So what that means is, is that if you are if the doctor orders a prescription to be filled from you, if it's under 50 mm ease, which is morphine measurement equivalent. I had, it's just one of those crazy names the government came up with. So anyways, if it's under 50, mme stubby tail. But if it's over 50, between 50 and 89, then you have to have a conversation with the doc, you got to look at their prescriptions, you got to check the PMP you got to do all these little things here. But you got to go back and talk to doc to make sure he or she understands that we're now into the regulated area.
There is no quote documentation requirement. However, I highly recommend you document it into into the patient profile for that script. Because if you had the conversation, but you didn't write it down, technically never happened. So write it down. And it's just the doctor says, well, it's just short term, patients just had as bout to have surgery just had surgery. were anticipating less than 30 days. Perfect. But that denotes those scraped off you got. Now when the patient hits 90 or more mm ease, that's where the starch Okay, now, the DEA I've had several conversations with them, and their field offices are all independent and managing this in different ways.
So and that makes it very bad because the CDC has their role before about opioids getting out into patients. And then they came out here a couple months ago was a new one. Well, a lot of the field offices are still using the old one, and they're not going to move up to the to do item because opiates are so dang dangerous. And, of course, you're the ones the cost, all you did was fill a script, they don't understand if you don't fill the script, you can lose your PBM contract. It's a double edged sword. So But anyways, when you have a 90 mme, and that's total, you got to talk contact a doctor, you work with a doctor, they're gonna be upset. They they're getting bombarded as much as you are.

And what happens is, you guys say, Hey, we're in this area, DEA is going to look at the whole sellers, we're going to look at it. Do you have a treatment plan? Well, turn down the mic, because you're blind, we'll get some four letter words there. So, but you got to explain the, this whole process starts with the pharmacy. And if they find something wrong, they're going to nail the pharmacy, then they're going over to the doctor. And they're going to nail him or her. Normally guys get in trouble boys or girls. So But anyways, it's a very tough day. So it's we've been tested as trying to figure out a way to we can make it easier for the doctor. So and also you so you don't get beat up. So what we've done, we develop a treatment plan, we can fill out a lot of it, you send it over to Doc, they can put in their what their plan is the scale the patient off opioids, if it's chronic or long term, or they are in hospice, then you just have to put down what the diagnosis is. And that's fine. Whatever you do, you never hold back medications for hospice patient, or chronic, a chronic severe patient, you got to take care of them first. But everybody else, you got to get this document. So in our policies, what we're looking at, okay, we've we want you to have the conversation with what's the physicians, tell them what's going on, give them the document, when exceeds I explained to him beforehand what it is. So they send it over to him, I asked us put down the treatment plan, which is fairly simple. And then fill it out, I'll sign it and send it back to you. That's the requirement you need. Problem is you got to get one every six months. So that's the challenge.

Lisa Faast:
You know, you're talking about the morphine equivalents, which that is, you know, that's a standardized thing. And I know many pharmacy management systems have now started to put flags in the prescriptions that convert to the morphine equivalents to help make it easier for the pharmacies. How was the DEA looking at? I know, a few years ago, the Holy Trinity, you know, the muscle relaxers, the pains, the benzodiazepines. That was their hot button issue. Do we still see that being a hot button issue with the DEA? And is there any corresponding responsibility with those types of prescriptions? You know, about refusing to fill or justifications for those combinations?

Jeff Hedges:
Okay, yes. Okay, well, on the 50 mm ease, if there's a benzoate into it, it's associated with it, then that becomes regular, and I forgot to mention that earlier. But other than that, it's just, it is what it is. And you just deal with it. Now, as far as if you pay at the sender, you get to skip you send a treatment plan over the doc to get them to sign it. And they refuse to you just have, I'm only gonna do this three times. So and then that's time it's filled, you send it back over, they refuse it again. So the third time you tell them, I will not read, I will not fill this scrip without this document completed. And then you tell the patient that if your physician is refusing to complete the documentation required by DEA, and we're not going to be able to fill your script, the patient will get more locked in what you will. So it is, I mean, why is it the pharmacist to has to be the bearer of this bad news and be the cop?

Lisa Faast:
That was just frustrating about all of this is, you know, they don't go after the doctors that are the ones prescribing. You know, many times and I've I've been there where doctors don't even want to give the pharmacist the diagnosis code, like I've had doctors, you know, say Oh, it's a violation of HIPAA. You know, it's like somehow we're not even a part of the the care team and it's, it's really just ridiculous on how you know many I think it's changed somewhat recently, but there are still many old school doctors out there that make this a true and real burden. And I think that's really important for pharmacies. I remember when the short into the opioids was out a couple of years ago, when the DEA, you know, racked back how many opioids could be manufactured, and there was going to be a shortage. And we printed up a nice letter, and we went around to all of our doctors, I flew up to one of my pharmacies, and we met with all the doctors and passed it out. And we wanted to let them know that it wasn't us. Like, here's what's happening in the industry, here's what's being put on us. I mean, that kind of helped set the stage that kind of helped them to understand where we were coming from. So I think this is another one of those opportunities that you can develop a better relationship with your prescribers. You know, write up a little one sheet, little bullet points of what's happening, you know, the local DEA office, putting some resources in there, hey, here's our local DEA office, here's their phone number, if you want to call and cooperate with this, but let them know what your procedures are going to be beforehand, and how you're going to handle it. And ask the doctor, how do you want this handle? Hey, if we have a patient, and they get flagged, and they're at 90. Mme are there at 55?
Are all the different things, how do you want us to handle it and work with them beforehand, and I think that helps make them a little less defensive, if they feel like they had some say in the in the process. And I also think that creates a stronger relationship with you and that doctor, you know, you might even turn and turn it into a little bit of a marketing, you know, thing, like, here's all the things that we're doing, you know, we're trying to help let's, I we're here to make this easy on you, you know, we'll we'll do it your way. And all those kinds of things. It just makes you appear flexible, and you know, really a part of that care team. But it is a burden on the pharmacist, it's unfortunate. And I will also say this doesn't have to be the work of the pharmacist, you can have a technician go through do these, do the outreach, all the different things, you know, obviously pharmacists are involved in the process.
But it doesn't have to be the pharmacist that does all the the dirty work or all the paperwork, so to speak. So involve the rest of your team, make sure they're all educated and make sure you just create a seamless workflow of communication between you and the doctor on how you want to do that some doctors might want a phone call, some might want an E scribe note or something like that. But I think it's really good if you can be flexible with those offices to accommodate them. Corresponding responsibility is a huge, huge thing. But there's also other things that are happening with the DEA that they're starting to look for a lot of these things very similar to the hazardous drugs is that the laws have been on the books or the rules have been on the books, but the enforcement has been a little all over the place. So kind of the next thing that's kind of happening with enforcement is background checks. So can you tell us a little bit about the background check requirements for your pharmacy staff when it comes to control drugs?

Jeff Hedges: Okay. DEA has in the pharmacist manual, and a couple other references that if anybody who touches or has contact or has access to a controlled substance must have a criminal background check, completed and on file. And what it is, is anybody who has a felony conviction, revolving around a controlled substance, they're forbidden to work in, in the pharmacy, they can't be the driver, they can't be the custodian, they cannot walk behind the counter period. They'll pull your license in a heartbeat if they find that out. Now, the requirement is once but it's one of those things as you generally know everything that's happened in your, in your staffs life, probably a good idea every seven to 10 years just to run it again. It's one of those safety things Yeah, might cost 30 bucks may cost 40 bucks, it's but it's so much less of a burden. Because everything starts with a fine with DEA, and every fine is a minimum of 14 grand. So yeah, up there real quick. So with that, so make sure you have a month file, best place to put them as your personnel folder that way they're not going to get lost. That's where we recommend them and and just having right there, it's easy to go with.

Lisa Faast:
What about when getting the DEA license and I know I've gone through this and actually the last pharmacy I bought it was really hard to like change all our DEA stuff we even had our DEA, like inspector help us fill out the paperwork and it's like was still filled out wrong and like it's it's gotten a little confusing where even the DEA people can't like direct you correctly. But there's all these different labels for people. There's the registering to the coordinator, and apparently we were putting wrong people's names and wrong lines. And we eventually got it figured out but it was a little it was almost became a little humorous if it wasn't so frustrating. But what's what's the status of all of that and what are all these designations and titles and what do they mean?

Jeff Hedges:
Okay, so we've we actually do this for our clients. So we got it down pretty that, actually, once you get your pharmacy license, then you apply for your DEA license, which is really nice now before it was six to eight weeks, and now we're turning them in 48 hours, if everything's if there's nothing there, which is amazing that you can get something processed that fast from the government. So, but once you go through, get that done, it's the first thing you do, you got to do your registered application. The registrar is the person who is solely responsible for the control drugs, and C Sox. So it's primarily a C sock requirement. Okay, so you're the one that's ordering, you're the one that's receiving, and everything from their that point of view. And a lot of pharmacies, that's all they have. So I inspections, I would say the coordinator is the is that number two, they can do all the things that the registering can, can, so you go through that process, and, and you're in good shape, they're handling any that all the information anyway. And you can have more than one. So here's what happens with the inspections. When they come on. They're gonna check your, your dea 220 twos, which are now electronic, they're gonna check your criminal background checks, and they're going to talk to the staff without you. And then say, especially, they're going to already know if there's only one registrar out there. So they'll come in and they'll say, Does your boss ever take a day off? Or go to a conference and all that? And that's gonna answer though, yeah, they take they just came back from Cardinal or Mercersburg, or wherever. And, and they say, Well, who did the controls? Well, we put it in the system. They reviewed it from remotely, and they submitted the order perfectly legal. Now the drug comes in, they said, Do you ever go into that tote and pull those controlled substances out? All now I'll get in trouble for that. Then they say, Well, you got a patient who needs that medicine really bad right now. Have you ever gone inside that tote and pulled it out? They kill you without even knowing.

So and now they got because they know you don't have a registrar or a coordinator. So that's where the pharmacist gets in trouble. Because you're handling drugs outside what the statutes were at, you have to have the coordinator who's there to take care of things when you're not. And it's fine. I mean, it's okay to have two or three, I know DEA will normally recommend only one. But reality, if you can get three, that's perfect. But that takes care of the staff. And now a lot of states are low, are making their inbound reception of drugs a lot easier, where now the tests can actually handle, count them. Put the number audit completed on the invoice that you have the what the quantity is, and then the coordinator or to register and punches it into the entity SOC system is registered. Remember those logins are specific for the individual. So if the tax has has a user username and login, and they're doing it, well, you're both in trouble if you get caught. So, but people are going to answer your questions, because they're nervous, and they're going to answer from what their memory is, they're not going to answer in the way you want them to. So it's always good to have everything done upfront. So and you don't want I mean, they come in as older, this inspector, the better. The oldest, we have the old folks, they're more reasonable. They've come up through the system, they understand it, but this whole new group of DEA inspectors, they only have one thing in mind, how can I make a name for myself so I can move up. So if I can get a $2 million fine, and put that pharmacists in jail because of this? That's a career boost for them. So it's, again, all you're trying to do is take care of your patients.

Lisa Faast:
Yep, absolutely. That was a really good scenario to go through because it's always that one time that happened, you know, it's like everything's good and then you go to a conference, you go to this you come up sick, you get COVID You know, whatever the case may be, and that's when it all just you know, kind of turns to chaos and you just try to take care of the patients you know, you're not, you're not selling the stuff out the back door. You're you know, following all the same procedure. Just now that one person that's supposed to be there isn't there. And that's where it can definitely get very confusing. And so if you just tell us that pharmacies need to be aware of that the DEA agents are looking for in pharmacies nowadays.

Jeff Hedges:
Mainly, they're just the biggest thing is that coming in, you will be inspected by DEA at some point. If you have a doctor or nurse practitioner that's feeding you scripts and they get in trouble. They're coming to see you. And it's probably happened, they'll walk in, they'll say, Well, we're investigating the doctor in the area, they want certain scratch. Okay, they have to have a subpoena to take those scripts out, which is fine. They always do. But the problem is why they have your documents. They're inspecting you when you're not even there. And I've seen this happen a number of times where they're investigating the doctor, and they pick up all the pharmacies at the same time.

Lisa Faast:
Yep. So how can a pharmacy get in touch with you? If they're worried about their controlled substance compliance, they're worried that you know, the employees can't answer those questions correctly, how can they get in touch with you to get get their pharmacies up to speed?

Jeff Hedges:
The easiest way is one, go to our website, rjhedges.com. And we have all our products and services there with videos and demos right there for you. So you can actually see what you have and some of the products you can actually order online. If you need to talk to someone to fill out the questionnaire. And it'll be routed to our sales team. Email us at sales@rjhedges.com. Or if you need to call 724-357-8380. My staff answered phone and get you to the right person right away.

Lisa Faast:
Awesome. We will post all of that content information there. If you're listening to this episode, this is one in kind of a series of compliance that we're doing with Jeff hedges because there are a ton of changes that are coming to pharmacies, not necessarily new laws. Sometimes it is new laws. And sometimes it's just enforcement of old law. So if you haven't already get caught up on all your hazardous drug requirements, listen to that episode. And we are going to have more compliance sessions coming up because we want to make sure that you are covered and you feel safe and you can sleep well at night, because pharmacy is tough enough. You don't need to have a bad inspection or get a terrible fine, which is happening. It definitely the pandemics officially overcome may 11. The audits have been increasing already. And it's only going to get worse and so we want to make sure that you are covered. So thank you so much, Jeff, for joining me for this. I can't wait to do our next sessions. I'm learning a ton. I know it's a big boost for our listeners and I appreciate your time.

Jeff Hedges:
Okay, thank you very much and have a great day everybody.