Dr. Lisa Faast and Jeff Hedges discuss hazardous drugs, including the emphasis that compliance goes beyond paperwork and is crucial in avoiding fines and bad inspections. The discussion then shifts to hazardous drugs, their misconceptions, and the regulations in both compounding and retail settings. They discuss the differences in policies and procedures and stress the need for an assessment of risks for every hazardous drug in the pharmacy.
Lisa Faast:
Well, hello, everyone, Dr. Lisa Faast here and I have an impactful session for you today, it's actually going to be the first of a series. There are so many compliance issue just in general in pharmacy, like, I think we're the most regulated industry. I know banking likes to claim that but they don't know pharmacy. And so there's so many changes coming to independent pharmacy for requirements and updates, and all the things you need to be compliant with, I personally can't keep up with them all. And so my go to is over at RJ Hedges, Jeff Hedges, and so he's going to be my guest. And this is probably going to be a several part series, if we were to try to talk about all the compliance issues in one big show, you would probably be listening for hours and probably fall asleep, even though it's highly important, it's very important to pay attention, these are going to impact your pharmacy, and all the legality things that happen with that you don't want fines, you don't want bad inspections, you want to make sure your employees are up to speed. So I'm very excited to bring Jeff Hedges on. The first session we're going to be talking about is hazardous drugs. Now you might be thinking those are just drugs. That's old news, kind of been there done that. But when I talked to pharmacy owners most kind of gloss over it. Most really, you know, they did a few things at the beginning, but that they really haven't stuck with it. I visit a lot of pharmacies whenever I travel, and I can tell you that 99% that I walk into, do not comply with all of the hazardous drugs regulations. And so I think it's going to be great to review kind of what the requirements are and what the expectations are. So I have Jeff hedges, as I said, a probably if you're in the independent pharmacy industry, you know him he has been around he is the titan of compliance for decades. Now, I don't know I don't want to date you too much, just but literally longtime as long as I've been around. He's been around helping independent pharmacies with compliance. But for any of you that might be listening, maybe you're new pharmacy owner, just getting in independent pharmacy. Welcome, Jeff. And can you give your you know, a brief introduction for someone who maybe doesn't know who you are, and all the awesome things that RJ hedges does?
Jeff Hedges:
Okay, thank you, Lisa. Titan, that's the first time that used was used on me. Normally, it's the old fart.
Lisa Faast:
No, you're a Titan.
Jeff Hedges:
So thank you. I own and operate RJ Hedges and Associates, which is a full scale compliance company. We have a interactive, user friendly software that you can find any answer within seconds. And we have clients all over the country, we have about 500. And they are well prepared. So but there's still a whole bunch of people out there that don't understand a lot of these subjects don't have a time. And it's actually impossible for a pharmacy to stay compliant now without help. So that's where we come in.
Lisa Faast:
That statement is so true, it is it is impossible to stay compliant. Without health, there are just too many things from so many different angles. And frankly, if you call compliance, just a bunch of paperwork in a binder, that's not compliance. You recently gave me a tour of like that interactive software that you talked about. And boy, like you guys have made it. Just amazing. I mean, my mind was blown, in the sense of like you said, the interactiveness, but the quickness, and then like the checklist, making sure that you've done everything like I was just floored by it. So I it's very user friendly, as you say, because compliance is more than just having the policies and procedures, it's actually following the policies and procedures and changing the behavior in your pharmacy. And it's also making sure that your employees know how to answer the questions. If you're the owner, or you're the pharmacist or maybe the pharmacy manager, and you all know the answers to the questions when you get an audit or an inspection or something like that. You may not be Isn't it always happened, Jeff, that they always come in when you're not there. The one time the pharmacists leaves the pharmacy to go to Las Vegas to a show or to Orlando or something. It's like that's when the people come in.
Jeff Hedges:
Yeah, so I think, yeah, they look at your calendar before they come in and make sure you're not there.
Lisa Faast:
They do they do it. It's it's really uncanny. And so your employees need to be trained. So the first topic that I want to tackle with you, in kind of this series that we're going to be doing is hazardous drugs. So let's just start it off. I think there's a big misconception between compounding and retail and like, Oh, this is only a compounding regulation. I don't have to do this for retail. And then I think the other big misconception is, yeah, I know I'm supposed to do this but who's really coming around and checking like I think those are the two things that I kind of hear. So let's just start off and start off with telling you It's just like, what are the requirements? And what it is, you know that that how can we fix those misconceptions?
Jeff Hedges:
Okay, there are two, there are two parts. Part one is on the retail side and long term care, they're lumped together. And then the other side is a compounding on sterile preparations. The first part for us in the retail industry, there are 12 distinct policies and procedures you have to follow. On a compounding side, there are 38. So there's quite a difference between them. The big thing, what hazardous drugs are coming in, and you have you've had hazardous drugs before, but the difference is, it's now being regulated. Now 800 came into effect, two days before the pandemic was ordered in March of 2020. A long time ago. Initially, no one looked at it. And then here about a year ago, state board started to implement it, and it started coming in the pharmacies. And now, everyone, on November 1 will be looking at hazardous drugs. EPA is involved, the EAS involved, HHS is involved. So they're all pushing this and then so what do you need in a in a retail pharmacy? That's quite a big question. Well, the first thing is, you have to have a document called an assessment of risks, that document needs to be prepared for every hazardous drug that you have in your pharmacy. Now, if there are groups of items like like birth control tablets, their manufacturer package, they're in the container, you never touch them. Okay, so that's, that's a great item. But there's a lot of different ones, you only need one assessment or risk. However, when we go in entity other items, if you got one that's a capsule, a tablet, a liquid, a crane, each one of them needs their own individual assessment arrest, there are 144 that a pharmacy needs to have. And they need to be very prepared properly. There are templates all over the place. Ours is one page, I don't understand why some of these are seven pages long, because it's don't need all that data. It's retail under the retail rules. So and all you have to do it's fairly simple. Product Name, you listed whether it's table one, two, or three. One of the big items is a manufacturer manufacturer's packaging, first control tab, that's manufacturers that packaging, then the form, okay, again, tablet, capsule, liquid cream, whatever it may be, they all need that. Does it require what they call manipulation? Okay, that means you have to get your hands into it and start working. If you say yes, on that answer, it has to go over to a non sterile compounding lab. There's no ifs, ands or buts about it emulsification. Now, it's just with amoxicillin. That's not considered compounding unless sharing color, California. So they consider that compounding out there under their state rules. And then you have to have containment strategies. What are you going to do? If there's a spill? Again, if it's not a liquid, it's fairly easy. But this is a liquid drain, it's considered a natural spill, and then you need a spill kit. And then you have to review it. Normally, it's the pharmacist in charge or a staff pharmacist who's been assigned to this. And it's signed off initially. And then it's reviewed every year, and there has to be a signature on it. And when we developed this, I knew the TVM we're gonna get into this. And so we have five years sign off on the form, and then we retain it for five years. And sure enough, the PB ends are starting to add this. So they want to get they want to get in everybody's business for no reason whatsoever, whether they have the authority or not. But anyways, it's that simple. I mean, we got a document, it's actually looks that easy. So it's not supposed to be difficult. And if it is difficult, then you're probably doing something wrong. And, and just because another person said I heard that this is going to be the way it is nine times out of 10 is incorrect. So if the person doesn't understand fully what the rule is, then they're gonna give you bad information. So but also, and this is the main document, especially they look at, that's the first document they look at. Because if you don't have it, you're you're, you're out of compliance period. The other item is is dispensing tools, you need to have your dispensing tools separated, they have to be marked with hazardous drugs. And I always like keeping them in a separate place. And we'll get to that moment. Also, it counts for the automated counting machines. There are two main ones out there, the icon, and the one started at all with a lot of Kirby luster. They're both great systems, they both have their advantages and disadvantages. But up until about a year ago, if you if you had to run a hazardous drug through those machines, you would have to take it apart and clean it. So USP came out with clarification that said, a table two, two and three, if they go through it, you don't have to do it don't have to claim it's wise to claim at the end of the day, because you're using them all the time. But the problem is, is they always said there's residue left there. That also included robots. So they came out and said no to robots period, which on the long term care site that's devastating. So what happened is, is that point, again, USP came back and said twos and threes are okay to run through your robot. They're not concerned about the dust on those items, and you can dispense through those machines. That's that was a big relief for everybody. The next item is a spill kit. Because if you have a liquid and it spills and it's hazardous drug, you have to have the proper means of cleaning up those spills. What we did, we put together spilt it because they were all over the place and value what they had and everything. And everybody has Bill kits for bodily fluids. But also, you need another one for hazardous drugs. So we just combined it into one kit, the five gallon bucket, everything you need is in there. And, and it's one of those things, it's going to sit in the corner. Hopefully you never use it. Unless I'm there, it's always seems like when I'm in a pharmacy, the best story was over the for pharmacy, Georgia, and they had a full day and Eli and his little boy came in with his mom and he had to go to the bathroom. And he saw all those toilets. And he sat down did his business. We laughed at it. It was hilarious. Mom was embarrassed. But but when we got done laughing I said, Okay, how you gonna handle it? I said, this is technically a biological it is a spill. So how are you going to clean it? So then took the fun out of it. But anyways,
Lisa Faast:
Somehow I don't think there was much fun in there and to begin with, but
Jeff Hedges:
Oh it's cute.
Lisa Faast:
Yes, yeah, having a spill kid. It's like an insurance policy, you hope to never use it. But when you need to use it, you need to use it.
Jeff Hedges:
Right. The other thing is you have to have access to safety data sheets. And when it comes to hazardous drugs, they are extraordinarily important because they're gonna give you containment strategies. They're going to tell you what's PPE is dated, all that stuff that you need on that document. The other 90% is for transportation for manufacturers, you don't need it. So it's mainly first day PPP, our PPE and those items there. Now, one of the other things I like to do, and this is not a requirement, but I like to segregate the hazardous drugs, get obey, put your birth control tablets on the bottom shelf and bottom two shelves, they're the most bulky, and then set up your shelf with hazardous drugs, on whatever method you do for sorting your drugs on your shelves. And then it doesn't matter. It's just how you want to work it there. Then you keep your conical tools there. And the reason is, the tacks are busy. They're the ones grabbing everything. If they if you're hazardous drug cutting tape, try and spatula on the counter. They're gonna use it because they're gonna grab the first step. Yeah, when we go through the training, everybody's gonna be really diligent for the thought the first two weeks and then they're gonna go back. So but if You take that accounting tool and put it back on the bay where you have all your hazardous drugs, they have to get the drug and they have to get the county track. It's a simple way to do it. And it's, it's not going to be hard. And I know I have a couple pharmacy systems all day always know because we have a red flag that comes up on the on the software. And I said, Yeah, how many people are looking at it? And they're, they're proud of their system, which is good. But humans are humans, and we're going to take the easiest way out. Absolutely.
Lisa Faast:
So question about on the retail side of things, because I know when USP 801st came out, there was a lot of confusion. And I think that confusion still persists. Do technicians have to wear gloves? When counting the hazardous drugs? Do they have to wear masks? Do they have to have any other PPE if they're dealing with those, you know, finalized, manufactured? You know, it's a tablet in a bottle, they're just pouring in counting? What kind of PPE? Or is that part of the assessment that they do. And it's kind of up to them to decide what is what is needed or what is not?
Jeff Hedges:
Yeah, so it has to be added on to the assessment. But in reality, and hazardous drugs is not for the patient, it's not for anybody else, it's for the technician and the pharmacist, because they're handling it over and over. If the if the form is in a tablet or capsule, you're pouring it out on tray, you're counting it with a spatula, you're returning the access back to the stock bottle, and you're putting the correct amount into the vowel. You're not touching it. So tactically, you don't need a gloves. And you definitely don't need a mask. So the mask ends actually formally ends on May or May 11. But, but it doesn't, that's no requirement for if you have to wear a mask and a pharmacy for hazardous drugs, you're in a negative pressure room with a respirator. So looking at it from that point of view. And then if it's liquids, yeah, put gloves on. It's common sense, you, you should have been doing that from before. Because you don't want to cross contaminate, you don't want to spill, you want to keep everything nice and tight. So but other than that, the segregation of the tools, and the assessment of risk, those are the big items, which then leads us into the inspection. So who's inspecting this on the retail long term care site? It's the State Board of Pharmacy. And don't say they never looked. And they don't look at it, because they've all been trained by EPA, at HHS, on what has a STRUG is and how to look at. So say pour comes in a lot of times, you know, the state board inspector, and you have a good conversation, catch up on some things. And then they pull out their checklist. And on that checklist. So we've had a number of states that are already doing this. Now, item number one, I would like to see your assessment of rash. You can't say, Well, I got them in the back room and then call someone to get them because they're supposed to be for that pharmacy. You can't say I'm not sure let me see. And this also applies to attacks. Because that's the stop that's a pharmacist is busy and can't come to clinic right away. That's inspection starts with your pharmacy techs and face it, they're going to do 90% of the work. So they need to understand and you just whenever asked, assessment risk, oh, okay, right here, home up, and it's home. That first impression on any audit inspection is the key. So after that, they're gonna say, hey, I want to see your hazardous drug county tools. Oh, over here on the bay with our hazardous drugs you pull about and they see it right away. Again, another good item. So and then it goes to talk about your robots your pill Connors. And then they asked for, I need to see your policy and procedure mail. A lot of states now have stated that your policy and procedure manual actually has to have the pharmacies name on it. So you can't use a canned one that you borrowed from someone because it has to have your information on. So again, they're gonna look at that. And I've had states where they actually read the policy and then quiz the staff. So so that's one of the other things a lot of times you don't get in trouble because cause you violated law, you're in trouble because you violated your policies. So and if you have this, it's not hard. And think about fraud, waste abuse and pseudo federal when they came by it was like nightmare for everybody totally realized, Oh, this is pretty easy. So yeah, it's all about preparation.
Lisa Faast:
Yep. Compliance is easy when you're prepared. Like that's, I mean, that's really what it's about. And it's about training. And it's about reminding, because like you said, everybody's good for the first two weeks, and then you kind of slack off. And that's where you need to have somebody to, you know, designated to be your compliance officer, somebody that loves details, love nitpicking. And somebody that just really, really likes that kind of stuff, make sure it's a good fit for that person. And so you've obviously covered a ton of stuff, I think you've covered like, basically, the lovely the A to Z, we're not even going to get into the compounding compliance, because like you said, there's about three times as many requirements, they're over compounding. And that's a whole other conversation. But I think you got, you know, if you're a retail pharmacist or retail independent pharmacy owner, you now have a good idea of kind of what needs to be done. Really, it's for things that you that you pretty much marked out, which they're simple, but they're not simplistic. And that's, that's, I think, an important distinction. And so, there's a lot of little tiny things under there that aren't hard, but you got to do it. So as we wrap this up, Jeff, if somebody's like, Yes, I need help with this. I can't keep compliant with everything. Because I that's not my full time job, I need to run my pharmacy and do all those things. How can they contact you? How can they get, you know, I got to see that awesome demo of your guys's site, how can they go and see if that maybe is a good fit for them.
Jeff Hedges:
You can two ways you can email us at sales@rjhedges.com, or you could call into the office at 724-357-8380. And we'll get you to the right person or persons. And they'll take care of you. We have all the policies and procedures. When we deliver them to you that's online. They are customized to your pharmacy. We also have all the hazardous drugs, assessment arrest, which is a huge item. And I have a young lady here that we taught how to do it. And we have a couple peer review pharmacist. And she knows that better NATO, she's catching their mistakes now. So we have them available. And we also have the spill kits. So it's all affordable, we can get them you get one or the other all three and a package. I'm not going to quote the price, but it's it's very reasonable. And yeah, just call in. You can actually order it online at rjhedges.com. And they got hazardous drugs, you can make the selection right there. That's probably the fastest and easiest.
Lisa Faast:
Be ready November 1. As you said, Jeff, like all of the state boards of pharmacies, many have already been doing this. Some are just kind of coming online, if you will. But this is definitely one of the additional changes that is happening for pharmacies in November 1. So now's the time to get prepared. You know, if you've kind of been slacking off, we got a little lazy on it. That's okay. Let's just get back up to speed make sure we got all our ducks in a row. Because with all the things happening, whether it's the DIR fee apocalypse, the DSC SCA, like all the different things that are happening in pharmacy in the next like, five to six months is a little crazy. This is one that's fairly easy that you can cross off the list in and get done. So I highly recommend you check out RJ hedges website, get a demo if you want. It's absolutely fabulous and make sure your pharmacy is compliant. So thank you, Jeff. I look forward to talking to you again, I think up next is DEA stuff. So if you are concerned about being compliant with all of your control requirements, or you're unaware of some of the changes coming up and DEA make sure you watch out for that episode. So thank you so much, Jeff, for joining me.
Jeff Hedges:
Okay, thank you for having me.
