Speaker 1:
You're listening to the Pharmacy Podcast Network.
Speaker 2:
Compliance is hard, but finding the answers doesn't need to be. Join Jeff Hedges and his staff on the Pharmacy Compliance Guide, as they help you and your pharmacy staff navigate through some of the complexities to help you stay stress-free and in compliance. The Pharmacy Compliance Guide is a proud member of the Pharmacy Podcast Network.
Speaker 3:
Welcome, welcome to another episode here on the Pharmacy Compliance Guide. We're so glad that you've tuned in. Today, we're going to be chatting about USP 800. Now you may be wondering if anything has actually happened since the December 1st implementation date, because it's been just a little bit quiet.
Speaker 3:
There was a lot of movement going into the implementation date and folks are trying to figure out exactly how 800 would impact their specific facility. There was some confusion around who had to implement. Was it just compounding operations or all pharmacy operations? There were state boards of pharmacy touting no action on their end. Some folks were saying, "Oh, no, it's going to get delayed." Other said, "I'm not doing anything until my state board says I have to." Some folks took the stance, "I'll start when someone else gets fined."
Speaker 3:
So a lot of folks were trying to prepare for the inevitable, but what actually has happened? The implementation date was about four months ago and where exactly do we stand now? Today I'm joined by Jeff Hedges, our own in-house compliance expert. He's a walking compendium of so much knowledge. We joke eventually we're going to have to clone him and issue a clone to each and every one of our clients. So Jeff, thanks for imparting some of your thoughts and pearls of wisdom on us today.
Jeff Hedges:
Yes, it's good to be back and I hope today's podcast will give everyone a respite from the COVID-19 emergency.
Speaker 3:
So can you tell us what enforcement actions you've seen so far?
Jeff Hedges:
Up until the COVID-19 outbreak, there were states enforcing USP 800 at retail and longterm care pharmacies. But then on March 12th, USP concluded their appeal process on USP 795 and 797, which changed everything concerning hazardous drugs. Then two days later, President Trump declared a national emergency to combat COVID-19 epidemic. The COVID-19 epidemic is going to go away, but USP 800 is not. What we're going to cover today is what will occur when the national emergency is over.
Speaker 3:
I'm hoping we can spend a little bit of time chatting about how USP 800 got mixed up with all the appeals process with USP 795 and 797, maybe about the players in the regulatory arena for USP 800, and understand exactly what they were looking for. And also, to get your thoughts on not only what pharmacies should be doing, but what they may expect if an inspector would visit their facility.
Jeff Hedges:
Sure thing. That sounds like a lot to cover, but really it should be fairly easy. Where do you want to start?
Speaker 3:
Can you tell us why there's so much confusion around hazardous drugs and how exactly USP 795 and 797 got thrown into the mix in the first place?
Jeff Hedges:
First, 795 and 797 are chapters specifically for compounders, while USP 800 does have a lot of compounding implication. All pharmacies have items on their shelves that NIOSH deems hazardous. So USP 800 does have implications for each and every pharmacy here in the United States and beyond.
Speaker 3:
Well, what was the beef with 795 and 797?
Jeff Hedges:
USP had appeals pending for 795 and 797 back in November and December of 2019, causing the delay for those chapters to have their new versions implemented. When you dig into it, the issue was all around the beyond use dating requirement. We won't dive down that rabbit hole as to the particulars. I'll just say, USP has their theoretical aspect of what should happen. And it did not jive with the compounders who are actually doing the work.
Jeff Hedges:
Then on March 12th, USP announced something I never dreamed that would happen. USP actually remanded those two chapters and have sent them back to their compounding expert committees with recommendations for future engagement on the issues raised in those appeals.
Speaker 3:
Okay. So what exactly does that mean?
Jeff Hedges:
Basically, all the work that everybody's done trying to follow and prepare to implement the proposed guidelines for 795 and 797 has gone out the window. And USP is now using the previous and very outdated versions of 795, which was last revised way back in 2014, and worse yet, 797, which was last revised back in 2008, as their current official version.
Speaker 3:
So for those states and organizations that thought USP 800 would be postponed or couldn't be enforced because of the appeal on the other two chapters, what do you have to say to them?
Jeff Hedges:
It means, without a doubt, that USP 800 is now in effect for all pharmacies. States that said that they would not enforce USP 800 because of the appeal will now need to follow the USP 800 guidelines to the full extent of the rule.
Speaker 3:
Full extent of the rule. Whew! Can you walk us through it, but more like the nickel version of USP 800?
Jeff Hedges:
Essentially, the chapter known as USP 800 deals with hazardous drugs or HDs, specifically how they are handled, stored, dispensed and disposed of. If the drug is on the NIOSH list, regardless of the table, it's a hazardous drug. There are two pathways for the hazardous drugs, one for the compounders and then another one for the retail and longterm care operations.
Jeff Hedges:
If you compound hazardous drugs, you will have to store all your hazardous drugs and components in your C-SAT or your negative pressure lab. The staff needs to don personal protective equipment per the SDS from the manufacturer. Baseline medical testing also needs to occur and a lot of other additional items.
Jeff Hedges:
But today, I'd like to hone in on the retail pharmacies, as the majority of the pharmacies listening today will fall into this category. These retail and longterm care facilities that do not compound at all, or possibly only compound items with components not on the NIOSH list. These pharmacies are to have some key policies and procedures in place, need to have their hazardous drug inventories segregated, and use separate counting tools for the dispensing practices. They are not to have hazardous drugs in the automated equipment, and they must have a signed assessment of risk for each hazardous drug in their facility. And I'll touch on that shortly.
Speaker 3:
Okay. So thanks for the short recap. Now earlier, you touched a little on the confusion element with 795 and 797, but I know there's been some discussion about the verbiage used in different publications. Can you shed some light on where that's actually coming from?
Jeff Hedges:
Let's look at the statement around automation and packaging machines used in section one of the NIOSH list versus section 12 on USP 800. The NIOSH list as written by the CDC is a federal regulation. It is recorded in the federal register by HHS and has several pages of guidance, and then lists hazardous drugs broken into three tables.
Jeff Hedges:
In section one on page two, it states, "Tablets and capsule forms of hazardous drugs should not be placed in automated counting machines, which subject them to stress and may produced powder contaminants into the work area." There is no specific hazardous drug table listed. It just states, "hazardous drugs." But when you read section 12 of USP 800, it adds one word. "Tablets and capsule forms of antineoplastics hazardous drugs must not be placed in an automated counting or packaging machine, which subjects them to stress and may create powder contaminants."
Jeff Hedges:
That one word, antineoplastics, has everyone thinking, okay, don't put table one drugs in my automation, but I can put table two or table three hazardous drugs in my automation. But you can't, and here's why. The NIOSH list itself is a more restrictive requirement. So when conflicts like this appear, you have to look at precedence and which rule or regulation has the greatest authority. And in this case, it is the NIOSH list. It has the greatest authority coming from the CDC and HHS. So the statement of automation trumps USP. Now, some like to point out USP's FAQ site. And yes, I know what items 68 says, but again, it's who has the greatest authority. And it is NIOSH.
Speaker 3:
So Jeff, we've been checking the NIOSH list regularly waiting to see when the next round of changes would happen, the ones they promised would hit back in December of 2019. And there's actually an interesting thing happening right now to the NIOSH list in the form of a draft proposal that appeared on Friday, May 1st. Can you fill us in on what it is, how it's going to impact these hazardous drug regulations, and what the impact is going to be to pharmacies?
Jeff Hedges:
In past writings and podcasts, we've discussed the confusion between NIOSH and USP when it comes to the use of hazardous drugs in automated counting and packaging machines. On May 1st, NIOSH posted on the federal register their draft NIOSH list of hazardous drugs in healthcare settings 2020, procedures and risk management information.
Jeff Hedges:
In one of the sections, NIOSH ceded its regulatory content to USP. This means when the 2020 draft version is adopted, USP 800, section 12 will take precedence. Tablets and capsule forms of antineoplastic HDs must not be placed in automated counting and packaging machines, which subject them to stress and may create powder contaminants. Meaning, only table one hazardous drugs will be forbidden from automated counting or package your machines.
Jeff Hedges:
Don't get too excited. This is only the draft version of the NIOSH list. But the importance of this one statement should not be taken lightly. In my professional opinion, I would say that very soon, every pharmacy will be able to place table two and table three hazardous drugs into their automated medication packaging and counting systems. This is a major clarification with huge change to the industry, especially with the longterm care pharmacies.
Speaker 3:
Wow, that is a lot to take in, but thank you so much for forecasting what could happen in the future. Now, if we are looking ahead, who is actually enforcing this? What type of enforcements could we see in the future and have there been any enforcement measures to date?
Jeff Hedges:
Most folks have been stuck on their state board of pharmacy, thinking they are the sole enforcer, but really, there are a few other agencies, including state-level environmental protection departments. Then we have EPA, FDA and OSHA.
Jeff Hedges:
Let's start with the State Department of Environmental Protection. That's what we call it here in Pennsylvania. This department goes by other names, depending on your state. Either way, those state level environmental departments have been trained by the EPA and they can come into your pharmacy to enforce environmental protection requirements found in USP 800 in your pharmacy. And that mainly deals with disposal of hazardous drugs.
Speaker 3:
What else are they looking for at the state level?
Jeff Hedges:
They may ask, what are you doing with your expired hazardous drugs? Do you have a plan? Do you have a process for dealing with those expired drugs? If not, those are enforceable infractions that could result in a pharmacy being not fined, but closed. On a more important note, you may have heard that hazardous drugs that are expired are hazardous waste. Well, that is no longer true. EPA changed the rules on August 23rd, 2019. This change permits your returns company to have the pharmacy quarantine the expired hazardous drugs. The returns company will come and pick up your expired hazardous drugs from your quarantine area, which is usually a small box, and take it to their facility to review and dispose of, if deemed necessary.
Speaker 3:
Very interesting. See, there's one of those pearls of wisdom we were talking about. Now, what can you tell us about these federal entities?
Jeff Hedges:
FDA is primarily looking at the compounding side and they're inspecting compounders routinely. OSHA will get involved if there's an injury, and EPA will come in if there's a spill. For our retail pharmacies, you're mostly going to see the state level enforcement. So make sure you know what your state is doing and know that it may change since you've last checked. In states like California, Delaware, and even here in Pennsylvania, state board inspectors are actively working, visiting pharmacies, and USP 800 is being incorporated into the items they are inspecting to see if you're following them.
Speaker 3:
Can you give us some more particulars on what they may be looking for?
Jeff Hedges:
How well do you remember our nickel tour from earlier? They are looking for policies and procedures, a spill kit, to see whether you're segregating your drugs, separate counting tools marked with hazardous drugs on them, and the assessment of risks. The policies and procedures don't need to be complicated. They're meant to show you understand the regulation and have a written documented system in place to follow. These don't need to be really big and elaborate, but you do need to know how you're going to store your hazardous drugs, how you're going to dispose of them, how to assess the risk for spill control, and any other special training your staff may need.
Jeff Hedges:
Some examples would be responsibilities for personnel handling hazardous drugs, dispensing, disposal, safe club procedures, just to name a few. But one area you should have regardless, and it should be updated because of USP 800, is your hazardous communications plan. It needs updated to include hazardous drugs and hazardous waste, and it needs to include the mandatory training under OSHA and now EPA. Even if you weren't implementing USP 800, all employers in the United States are and have been required to have the hazardous communications plan.
Speaker 3:
You mentioned segregating HDs and separating counting tools. What exactly do you mean?
Jeff Hedges:
It is how you set up your hazardous drugs in your pharmacy. As you conduct your hazardous drug inventory, it is our recommendation that you take a bin and place all hazardous drugs in that bin.
Speaker 3:
Is this required?
Jeff Hedges:
No. Separating your hazardous drugs is not a regulatory requirement. However, it is a common sense approach to store and handle your hazardous drugs.
Speaker 3:
Now why is that?
Jeff Hedges:
USP 800 requires the pharmacy to identify and mark separate counting tools for hazardous drugs. When the pharmacy segregates their hazardous drugs into one bin, you can then store your counting tools with your hazardous drugs. We recommend having a sign in place saying, "hazardous drug storage area." This is how you can maintain compliance with this role.
Jeff Hedges:
When the hazardous drug is to be dispensed, the technician must go to the hazardous drug bin, retrieve the hazardous drug, and then the counting tool. They pour the medication onto the tray, use the spatula to count, place the excess back into the stock bottle, and the required medication then goes into the dispensing vial. While the pharmacist is checking the prescription, the technician cleans the counting tools and then returns a hazardous drug stock bottle and the counting tools back to the hazardous drug bin. This is a very simple, common sense approach. Plus the cleaning wipes that you just used must be a product that kills TB, HIV and Hep B, and they can go in the regular trash. And we'll talk about that in a moment.
Speaker 3:
Does the pharmacist or technician need any PPE?
Jeff Hedges:
Not unless there's a spill. They never really touch or handle the drugs with their hands. When looking at the SDS, it will provide guidance at the compounding level, not at the retail level. However, it is the pharmacist's in charge final decision as to which way they go.
Speaker 3:
Speaking of spills, you also mentioned needing a spill kit. What should it have in it, and should I buy one or can I just make one on my own?
Jeff Hedges:
Pharmacies should already have some type of spill kit in place to deal with biohazards. That would include a solidifier, a scoop, bags, gloves, disinfectants, and other items like that. And it should be sent off to be disposed of as a bio waste, if and when that ever occurs. After all, we're a pharmacy. Sick people come into the pharmacy, and occasionally, bodily fluids come out of that person. And that is considered to be a bloodborne pathogen. You need to have the means to clean up that and dispose of it.
Jeff Hedges:
Having one for a hazardous drug spill is a bit more involved and because your hazardous drugs could be a solid or a liquid. You need the supplies to clean up both, including absorbent pads, towels, and following the OSHA guidelines, it also needs to have a respirator, booties, gowns and protective gear. There should also be enough supplies for two people, because it should be designed for a two-person team.
Jeff Hedges:
You may be wondering, why in the world do you need a two-person team for it if you drop a few pills on the floor? Well, realistically, that is an overkill. But if you're dealing with a serious hazardous item, you need two people to clean it up in case they have a reaction to that spill. The chances of this happening in our retail setting are extraordinarily rare, but we still need to follow the regulation, and that is the recommendation. Some pharmacies are buying chemo kits and that's okay. Just to make sure it has everything you need. And those kits may have more than you need.
Speaker 3:
Well, the only thing from your nickel tour we haven't talked about is that assessment of risk. Do I need one for my entire facility? Can I do it based on table? Or is it by dosage or something else?
Jeff Hedges:
Sorry to burst your bubble, but none of those. You actually need to complete an assessment of risk for each hazardous drug based on the form type, like a tablet versus a capsule. And based on the packaging, as if it's in a stock bottle or manufacturer's packaging. Let's look at Estradiol. It comes in a capsule, a cream, a gel, a patch, a ring and also in a tablet. That's five different assessment of risk because it comes in five different forms.
Jeff Hedges:
We have identified about 100 common hazardous drugs found in a normal retail and longterm care pharmacy, and it results in about 140 assessment of risks. Like our policies and procedures, these don't need to be hard or complicated. I've seen many versions, some with three pages long, that are way, way more complicated than they need to be. They are regulatory correct, but you don't need to impress anyone with a complicated assessment. In the end, you need to have one completed listing the drug name, the form, the packaging, the handling and care instructions, the containment strategies and the risk. The SDS should accompany these assessments. The assessment of risks need to be reviewed and signed annually. If you want more information, check out one of our previous podcasts specifically on assessment of risks.
Speaker 3:
So for those listening that may not have started, or maybe didn't get too far into their implementation, are there any words of advice that you have for them?
Jeff Hedges:
Start now, the regulations are in effect. Regulators are not going to inspect during the COVID-19 emergency, but when this is over, you can expect these inspections to start at all levels nationwide. We haven't seen too many, but we have had so many reports that the FDA has been in the pharmacies for two weeks, asking the same information day in and day out.
Jeff Hedges:
States like here in Pennsylvania, the state board pharmacies are asking for proof of policies and procedures for 800. California, Delaware, Iowa, Illinois, and others have been enforcing USP 800 since December 1st. Environmental department agents are asking for one drug specifically, Warfarin. They want to know what you do with it when it expires, and they want to make sure you don't have it in your automation systems.
Jeff Hedges:
Did you know that the RxSafe 1800, where the medication never leaves a stock bottle, is okay to be used for hazardous drugs? I know this is tough for facilities who use automation, especially those on the LTC side, filling as much as a million scripts a week. But I think most manufacturers of automation equipment are searching for ways to amend their systems or are helping to create new technology that will comply with this standard. I've seen some really interesting things coming down the pipeline. Technology's evolving fast. We just need to be patient.
Speaker 3:
We still haven't heard anything about a specific dollar amount for fines or penalties. What do you think the enforcement is going to look like moving forward?
Jeff Hedges:
I've actually talked to a few state inspectors across the country who have asked my opinion and advice on what to do. For most infractions, they typically will allow 30 days to correct the discrepancy. If you would have an inspection and be given 30 days to fix it, comply with it. Be polite. The inspector has a job to do, just like yours. You can fix virtually anything in 30 days. If you feel overwhelmed and you don't understand what they're asking for, reach out. We can help.
Jeff Hedges:
USP 800 isn't going to go away. It's only going to get bigger and there's going to be more enforcement. Your state is going to have to start enforcing this. So take the time and get your resources in line and get your regulations implemented. It's not a hard process. Think back a few years ago. You probably thought the regs around pseudoephedrine were hard and overbearing, and look at it now. It's just a normal part of everyday practice. It wasn't hard to implement at all. Hazardous drugs will be the same. It's just going to take some time to get used to a new process.
Speaker 3:
Jeff, thanks so much for sharing all that info with us today. We at the Pharmacy Compliance Guide and RJ Hedges and Associates want to thank you so much for listening and let you know that we're here to help. I always say, do what you do best and contract the rest.
Speaker 3:
While you're out there helping your patients, if you want to have some experts help with this regulation, we'd be more than happy to repair your hazardous drugs policies and procedures, complete all the support documents and training you need, send you our handy hazardous drugs labels to help identify the HDs on your shelf, or you can even use them on your counting equipment. Maybe customize our 140 assessment of risks for you, or possibly even ship you a spill kit. We've got easy options and can even bundle it together for one complete package.
Speaker 3:
And, of course, if you're doing non-sterile compounding, we've got you folks covered too with our compounding compliance program. Best wishes, please stay safe, and thank you so much for supporting our communities. Toodles.
Speaker 2:
Thanks for listening to another episode of the Pharmacy Compliance Guide, sponsored by RJ Hedges and Associates. Be sure to search the entire library of podcasts, helping you stay informed on the latest pharmacy compliancy issues, by visiting pharmacy compliance guide.com.
