The Compliance Divas Podcast
Our podcast covers current topics such as infection prevention and control, OSHA and HIPAA compliance for dentistry. We discuss the latest regulatory information, answer frequently asked questions and give suggestions for dental practices to make compliance easy and sustainable. The Compliance Divas are a trusted source for consistent, accurate information based upon current guidelines, standards, science, and recommendations.
The Compliance Divas Podcast
#110 Managing Controlled Substances in Dental Settings
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Do you use DEA controlled substances or pharmaceutical medications in your practice? Not sure? Our guest speakers from Health First will review the difference in the various pharmaceutical medications in dental settings along with the proper tracking and disposal of these items. Listen in and take away best practices for managing narcotics and pharmaceutical waste in your practice or organization.
- Health First Pharmaceutical Services: https://www.healthfirst.com/waste-management/pharmaceutical-waste-disposal/
- DEA Drug Disposal: https://www.deadiversion.usdoj.gov/drug_disposal/
- Blog: How Dental Office Can Dispose of Unused and Expired Medication https://www.healthfirst.com/blog/how-healthcare-practices-can-dispose-of-unused-and-expired-medications/
- Waste Segregation Guide: https://info.healthfirst.com/healthcare-waste-segregation-guide
- Pharmaceutical Waste Recovery: https://www.healthfirst.com/store/medical-waste-management/waste-disposal-pharmaceutical-recovery-services/
- Mail Back Envelope for Unused Medications (non-narcotic): https://estore.healthfirst.com/product/envelope-recovery-unused-medications
Welcome.
SPEAKER_04I'm Leslie Cannon. I'm Mary Gavoni.
SPEAKER_03I'm Linda Harvey. I'm Olivia Long, and together we are the Compliance Divas.
SPEAKER_02Welcome to the Compliance Divas podcast. This is Linda Harvey, and I have the pleasure of being your moderator for this episode. Today the Divas have the pleasure of bringing you a topic we have not yet discussed. However, this topic has significant patient safety and provider safety implications, as well as regulated waste concerns. Before I reveal today's topic, I want to invite you all to subscribe to the Compliance Divas podcast through your favorite podcast channel or on our website, thecompliancedevas.com. And all the resources that we mentioned today will be in the show notes as well as on our website. And we invite you to submit any questions that you have to support at the compliancedevas.com. We bring clarity and simplicity to compliance by navigating the regulatory world to keep you on course. Now to reveal today's mystery topic, it is controlled substances and dental settings. As a risk manager, this is an important topic to me because it's a patient safety issue for safe administration of narcotics. And it's also a healthcare provider concern because we're working on preventing diversion and making sure that we're tracking and logging all this medication carefully. And I don't know about the rest of the divas, I think we would all agree, but more offices now are offering sedation dentistry. So this topic has to come front and center. We are extremely pleased today to have Health First as a returning sponsor for this episode. And today our special guest will be, I'll introduce them in just a moment to go through this topic. But Health First helps providers be prepared to save lives. They are most known for their emergency medical drugs and their on-track portal and tracking system to help offices stay compliant and up to date, as well as many other services that they offer that we'll be focusing on. We have Brian Foss with us, who is the product manager. He just is over the environmental products as they relate to the regulated waste stream. So welcome, Brian.
SPEAKER_00Well, thank you very much. Glad to be here.
SPEAKER_02We're super excited to get rolling in this topic. So I'll kick it off with Mary. And Mary, um, I know you have some questions you want to ask Brian about the different classification of pharmaceutical materials, just so we can help our listeners understand what exactly are we talking about when we say controlled substances.
SPEAKER_04Absolutely, Brian. Thank you again for um for being here. I find with my clients as well as the other divas that there is a lot of confusion and they don't really think about what is the appropriate um way to dispose of their controlled substances, which we're going to get to. But first of all, let's take a look at what are can you explain to us what are the different classifications of pharmaceuticals that we may have in a dental office and what do we need to know about each of these?
SPEAKER_00Sure, no problem. Um so there's three different classifications of pharmaceutical waste that's really important to understand the differentiation. First, we have non-controls. Uh, non-controls is going to be your routine pharmaceutical uh that you have in your offices. Then we have controlled pharmaceutical. Uh, and controlled substances uh is really it's really important to understand when you have controlled substances, when you actually order the controlled substances, and also how do you use it or how do you dispose of those. The third classification is um is hazardous pharmaceutical. It's uh it's it's really important to understand uh the when you have hazardous waste. These are pharmaceuticals uh that have uh toxicity and also uh is really harmful for the environment. And also could also be uh, if it's put into the wrong hands, could also be very detrimental. So uh that's a different classification. Uh, but we will concentrate mostly on the non-controls and the control substances uh in this conversation. Uh again, on the controls, and we'll talk mostly on controlled substances. Why is it most important? Is because those are the ones that are tracked by the DEA when you are purchasing those um medications, and they also want to track how you use those. Are they used on a patient or are they disposed because they were expired and unused? And how did you dispose of those? And is there tracking behind that disposal?
SPEAKER_02Great information, Brian. Mary, we would like to ask.
SPEAKER_04Yeah, I just wanted to ask for a little clarification from Brian. When you talk about the non-controlled um items that would be in offices, can you give us a couple of examples?
SPEAKER_00Ooh, um, you know, we do have antibiotics. It's the antibiotics, it's uh, you know, uh the uh the dental anesthetics, uh the carpuls. Uh that's a really important one. It is non-controlled. Um, and and there's a lot of conversations around dental carpuls because um what do you do with them? Uh if if they're unused, yes, it's a pharmaceutical waste. If they are actually partially used, what do you do with the rest of that? And this is where we talk about the state of the dental carpole. Uh there's a couple uh issues here. OSHA is concerned about that dental carpole if it produces, if there's actually uh bloodborne pathogens in that dental carpole. So if you actually see any type of bloodborne pathogens that's in the carpal because of the of the use and that you aspirate after you use uh, you know, when you uh you know administer that medication, that should be put into the sharps container because it is a blood-borne pathogen risk. We have, even though there might be a little bit of dental uh anesthetic left, we should put that in the sharps container because it has that blood-borne pathogen. But let's just talk about the the state of the carpole that does not have blood-borne pathogen and it still has anesthetic waste. That actually should go into a pharmaceutical recovery uh program so it can be recovered and disposed of correctly. Why are we concerned about this? Mainly it's because of the EPA concerns. You know, traditionally, uh many, many years ago, it was actually uh considered okay for us to flush down our medications down the toilet as proper disposal. We don't like that anymore. That's really an environmental concern that gets into our wastewaters. Uh the waste water treatment plants cannot control or filter that pharmaceutical out of our waters and it gets into our into our systems. Now, when you put um carpules into a sharps container, what's the most common way of disposal of sharps? Well, they go into a very large autoclave to steam autoclave those that medical waste. That autoclave creates wastewater. Well, if that dental carpole is in the sharps container and it gets mixed in with the sharps in this wastewater, it goes straight down the drain. It's no different than if you actually just dispose of it down the drain or down the toilet. So we so EPA is very uh uh adamant about the ability to take a dental carpole that is still has some anesthetic left and put it into a pharma recovery so it's properly processed and disposed of. Let's talk about how pharmaceutical waste is disposed of. So both DEA and also the EPA are the two main regulatory agencies that are really interested in what you're doing with your pharmaceutical waste. Both of them recommend incineration as the proper disposal and destruction of pharmaceutical waste. This is why we need to have all non-controlled and controlled pharmaceuticals properly processed and disposed via incineration.
SPEAKER_02Thank you, Brian. That's a great distinction between the types of uh controlled and non-controlled substances, and we'll delve into more of that as we go through. But um, I'd like Olivia to get with you and just kind of re-clarify about some of the materials and containers and different things that you all, your options that you have for helping offices, not to put them down the drain.
SPEAKER_03Brian, I think you touched on a lot of good points that I wanted to ask you some questions about. And I loved how you clarified about the carpules, because we see this being mishandled frequently, and we love having Health First as a resource. You indicated earlier, you know, who has a stake in this? You mentioned OSHA as well as EPA, they're both regulatory. Uh, but if you would highlight again about your pharmaceutical recovery services and how dental practices cannot just dispose of these substances down the toilet or in the trash. Can you mention that again so our listeners can have a good idea what they can utilize from Health First?
SPEAKER_00Sure. So uh we have a fantastic program that we call Pharmaceutical Recovery Services. Uh, and this is a mailback program. We offer three different boxes: a one-gallon, a five-gallon, and a ten-gallon box. The important thing about this uh mailback program is that this is you're actually working with a reverse distributor. We have a partner, reverse distributor called RP Returns, reliable pharmaceutical returns. They are a DEA registered reverse distributor. This is not only important for non-controls, but even non-controls. It's really important to use a reverse distributor because if you don't have a full understanding of the classifications of you have non-controls or controls, the reverse distributor will actually help out and they will guide you through the uh the recovery program. Um, so and and what's really important here is that when you're working with pharmaceutical waste, and specifically non-controlled pharmaceuticals, you have to use specific DEA forms. There's a form called Form 41 uh that you use for any type of controlled substances. If you actually have a what we call a schedule two controlled substances, you also use a what they call a schedule, uh a Form 222 form. And that's specific for Schedule 2 control substances. That's really your your opiates, uh, the strong medication. They really truly want to know what's what's going on with those medications. The reverse restributor uh at RP returns, we actually have access to their portal. They're gonna help you digitally produce those forms. And so they're gonna help by you take your medications and through the NDC codes, you actually type in the NDC codes into the online uh portal through RP returns, and they actually help you manifest all those wastes. What's nice about that is once you have the manifest, you print the manifest, you add it to the box, it's sent over to RP returns. They actually open up that box, they categorize what they receive from you, and they report off of it. If it's DEA controlled substances, they will they will process that paperwork for you. This is really, really important because, as I said, you have to you have to register yourself with a DEA, you have to have a DEA license when you purchase controlled substances. You also have to use your DEA license when you dispose of those controls because the DEA wants to know what you did with them. It's a full cradle-to-grave program. They want to make sure that if it's not used on a patient that we're properly recovering those medications and destroying them for not only environmental but also diversion control.
SPEAKER_02Brian, those are some good classifications. And I think it's really important that our listeners understand that everything is tracked with this process when you when you start getting into and administering and storing controlled substances on site in your dental practice. And so there's a lot more that can be said about that. But what I want to do is get to kind of get have Leslie talk about some pharmaceutical waste and who's gonna come knocking on our door asking about that and our waste and our documentation, right?
SPEAKER_01Well, that's true, Linda. I think that our listeners want to know who might knock on their door, what agencies could they be in trouble with? And today we're seeing more emphasis, particularly in California, there's a requirement for a two-hour uh course on prescribing opiates. So I know that in June there's another course that is going to be a DEA compliant eight-hour substance abuse course that prescribers will have to take. And I believe that making sure that the disposal or the return uh reverse distribution is an important thing for uh them to look to know about. And so uh how how would a dental practice or dental team members know that they're compliant with uh these regulations? Who where would they look up the regulations and what agencies or entities should they be looking for?
SPEAKER_00Um so I I mentioned uh the two main agencies that are really interested in what you're doing with your pharmaceuticals is the DEA and also the EPA. Uh who's gonna come knocking your door and wants to see uh what you are doing? And and most times it is a local state regulatory agency that represents uh the national regulatory agencies. So it's not necessarily gonna be the DEA knocking on your door or the EPA, it's really that local regulatory uh agency who's interested in what you're doing overall in your office, not only just the environmental, but also many other factors. Uh, those are the ones that are gonna look at do you have pharmaceuticals? What are you doing with those? Specifically, do you have control? Are you handling those correctly? Do you are you tied to a proper uh disposal program? Do you have a proper reverse distributor in hand? Um it comes to regulatory compliance with the DEA, they have uh when it and specifically control substances, they have three different ways that you can destroy and track controls. The first one is uh you can destroy it in an on-site method, but you do need the presence of a DEA agent or an eight or an authorized person as a secondary um confirmation how are you destroying those waste. It's a very complex way of destroying your waste locally. The second is uh use a DEA agent uh locally to dispose of your waste. That's also a very kind of a cumbersome, difficult way of doing it. You're gonna find a police station or a DA agent and actually take your waste streams uh to that location. The third one is really the most appropriate, and that is deliver it to a reverse distributor uh by common carrier. Uh, what is a common carrier? UPS, FedEx, USPS, and deliver it to a reverse distributor. As I mentioned, we have that in our recovery mailback program. It's tied directly with RP returns as a registered reverse distributor. So we see that as the most uh common is the easiest one for a dental office to use. Let's go back to the regulatory agency who's gonna knock on your door. Um they want to see do you have that process in place? We have had customers come to us frantic because they did not have a process in place. They had controlled substances in hand, they could not confirm with a agent, a local state agency, how are they doing it? How are they disposing of it? They called us up, we got them involved. The the a the state agency says if you don't confirm with us and prove to us that you have a process in place, then fines will occur. And we have heard uh the probably the last one I had um was going to be fine about $40,000 for each occasion. So it's not uh trivial. It is they it's this is really important. Now, of course, every state is different. You mentioned California. California is definitely up there in terms of regulatory compliance, and they're very interested in what you're doing with it. Not only DEA, but California also gets really involved with the EPA uh and what you're doing with your waste streams. Let's talk about the EPA. What what are they concerned about? I talked about um, you know, EPA is always gonna be say, what are you gonna do with the environment? How do you protect the environment? Not only do they say that we also like incineration because it gets it out of the environment. It doesn't get into the waste streams or the the water streams, it properly destroys it. And also, I I do want to make a specific. There's a lot of times that there's take back programs out there uh from the uh from you know police agencies. Um EPA and DEA say that um any type of healthcare facility or healthcare-related business that generate pharmaceutical waste should not use takeback programs. Why is that? It's because it's not tracked. We don't know that you're properly disposing of your waste correctly. So they want you to use a program that's tracking how you're disposing of your waste. You you mentioned also California. California um they just define um any type of pharmaceutical waste no different than medical waste. So they want trackability and they want make they want to make sure that you have proper disposal. So it's really, really important, even though we have this overall regulatory compliance, it you always have to check with your local and state regulatory agency to make sure that you are doing it correctly for your area.
SPEAKER_01Well, that's a lot of information, Brian. Thank you so much for recapping that. And uh, from what I understand, using a reverse uh distributor with a common carrier, such as Health First, is really the only way to go because if you take on site, you don't have tracking. If you bring a DEA agent into your office, that might not be very cost effective. So thank you so much for all that information.
SPEAKER_00No problem.
SPEAKER_02And I agree, Leslie. I think uh thank you. Sorry, Brian. I think that that's important to have that provider behind you that's going to help you with the tracking and the disposal. So that's why Health First makes so much sense because earlier, Brian, you mentioned from cradle to grave. And so it begins with cradle when a provider who has a DEA license orders these narcotics and these controlled substances. And then it's being able to, okay, what are we doing? How are we tracking it through the orders? We've got those paperwork. How are we tracking it during the administration in our office? We have our narcotic logs. How are we tracking the disposal and where it goes back from there? And that's where it goes from DEA and state laws to the EPA, as well as some state disposal laws. So the cradle to grave is so important.
SPEAKER_00It is very, very important.
SPEAKER_02Thanks. So one thing I mentioned in my introduction, Brian, that I'd like you to uh to address it was just controlling diversion. What does that mean when I because I was talking about from the provider safety, but what happens when things aren't tracked and uh these narcotics are diverted? Can you talk to our listeners about that?
SPEAKER_00Sure. Yeah, I talk a lot about diversion control. And what does that mean? That means that we are properly making, we are making sure that our medical, our our pharmaceuticals, while we while we're using it, are safely stored so someone can't walk away from and with them. And also when we dispose of them, you know, what are we doing with them? Diversion means keeping it out of the hands of people who should not be using or having them. And so it's really important. We talk about best practices being any type of pharmaceutical waste you have in your office. We recommend that you dispose of those. You get them out of your office on a quarterly basis. It's no good to have pharmaceuticals that aren't. Being used sitting around in your office where they could uh get in the hands of the wrong people. And that's what we talk about cut diversion control, making sure that it does not get in the hands of the wrong people.
SPEAKER_02And Brian, that's so true because we've all read and know of the stories that have happened in the medical world where the diversion has happened, either with an anesthesiologist or a nurse or another provider who is diverting us because they're abusing the drugs and it's very sad circumstances, but it does happen. And so that brings us to the point where if in the office the tracking logs aren't accurate, you know, when you're dispensing, when the when the orders you receive come in, that goes on to your narcotics logs. And then when you dispense on a daily basis to the patients, those numbers are subtracted and you get your new totals of what you have on hand at the end of the day. And those if that information has to be consistent. And I'd like to add another piece to that, Brian. And when you're talking about uh controlled substances, it's I think it's very important that our listeners first identify what substances they're using in their practice that are controlled and non-controlled, especially if there's sedation happening in that practice and your doctor or doctors have a sedation permit. What are the logs? What are the forms that you need to have? And then when you identify this those substances and what schedule they are, the schedule is the category that the EPA has put them into, as far as, like you said, when you mentioned opioids. So fentanyl is one of those that's in a class two narcotic. And as such, it has to be on a separate log from everything else that's dispensed in the practice. So there's little nuances that are very important. And I just want to chime in one more thing here, Brian. And that is when it comes to these documenting and tracking these drugs, propofol is also a sedative that's used frequently. We know many GI providers do that before the GI procedures and it's common in dental settings. Well, that's not a controlled substance, but I recommend as a risk manager that you track it as if it's a controlled substance, because it's one of those drugs that's highly diverted and highly abused. And we just want to keep the temptation out of everybody's hands because ultimately ultimately it can ruin lives, um, shut down practices, and harm patients. So that's my dissertation, Brian.
SPEAKER_00You know, I totally agree. And and I also wanted to mention, because we all talk about controls, um, I do believe that a practice uh should really uh perform safe uh uh disposal programs, not only for controls, but also non-controls. Uh, even though they aren't tracked as much as controls, I do believe that there's gonna be a time that they are. Um so if you can practice using that reverse distributor program for all your pharmaceutical waste, you're really gonna be covered for everything that comes down uh down the future. Because I really do think that this is gonna continue on as I I I it pharmaceutical waste is probably my favorite subject these days because it's changing so dramatically, so quickly. It's and it's just really uh to me, it's it's very exciting uh because it's an important subject to talk about.
SPEAKER_02It is, and when you consider the fact it's changing, and our uh doctors who have a DEA license now have to follow the mate law, the medication access and training expansion. So we know that went into effect earlier this year. So as we wrap, as we begin to close our podcast, let's do a quick round, Robin, if there's any stories or quick last-minute questions that we have for Brian.
SPEAKER_01Well, yeah, you know, Linda, I've had dental practices actually have EPA, a local EPA, come to their office and cite them for not disposing of their sharps in a timely manner. And during COVID, we were so many times not seeing patients and on a regular basis, and so the sharps containers didn't get filled up as much, and a dental practice got dinged for uh not disposing in a timely basis. I like that Brian said uh disposing quarterly at least would be good. I also know of another practice where they were actually pouring out some of the control substances that they used for IV sedation meds uh just in their in the back of their office and not reverse distributing it, the uh leftovers. And uh and that uh frightened me that that could be something that they could get in big trouble for as well.
SPEAKER_00Yeah, you know, uh the the whole disposal on site or destruction on site process, even though there is ways on doing it, and if you have multiple people there that we consider authorized as as uh uh watching the process, it's still not a fantastic process because you can't prove any type of on-site destruction process for any type of waste treatment, you cannot prove how you did it and that you did it correctly. So we always we always practice and we always recommend using a third-party program with reporting.
SPEAKER_02And Brian's gonna have a great chart for us that we're gonna put into the show notes as well and on our website. Uh Mary, what would what are your last thoughts for Brian as we wrap up?
SPEAKER_04Um, well, not exactly a thought for Brian, but just uh a statement that um we didn't touch on drug inventory um that of course practices must keep if they have schedule two drugs. And just a reminder to our listeners that not only can the DEA um audit you, but your state dental board could audit you as well to make sure that you have an inventory of those medications on site.
SPEAKER_02Yes, and they're required to do an initial inventory, which we didn't speak about. And I know your statement, Mary, has special requirements for another inventory at periodic times too. So it's very important to be in tune to that because that is different than the dental board regulations because it comes under the pharmaceutical laws in each state. Thank you. Thank you, Olivia?
SPEAKER_03I just want to thank you, Brian, for helping us to understand this information and putting it in such a concise manner. And we really look forward to incorporating this to our client practices and having you as a resource.
SPEAKER_00Well, my pleasure. This was uh very enjoyable. I'm glad that we were able to talk about this subject.
SPEAKER_02Well, thank you very much again for being with us, Brian. And I would like to leave our listeners with a thought that when it comes to disposal, whether it's narcotic, non-narcotic, it's pharmaceutical waste, it cannot go down the drain. You cannot express it in the drain, you cannot express it into uh the trash on a piece of gauze, it cannot go into your sharps container, unless perhaps it's a totally empty vial. So pay attention to how everything is going back into the environment because I think many of us are environmentally conscious, and this is one way we can help out with the environment, in addition to being compliant and safe in your practice. So thank you for joining the compliance divas episode this week. We bring clarity and simplicity to compliance by navigating the regulatory world to keep you on course. We invite you to subscribe to the Compliance Divas podcast through your favorite podcast channel or on our website, thecompliancedeivas.com. All the resources that we mentioned today will be in the show notes as well as on our website, thecompliancedeivas.com. And we always invite you to submit any questions that you have to support at thecompliancedevas.com. And we look forward to seeing you in the next next episode.