Pharmacy Times spoke to Seth DePasquale, RPh, BCSCP, senior director of hospital and health systems at Visante, about his session at the APhA 2022 Annual Meeting & Exposition, titled "Keeping Up with USP 800."
Seth DePasquale: Yeah, so what's really interesting about USP 800, and in bringing in the idea of a designated person, which I kind of I'm more or less equate that to, you know, the first steps that USP is officially taking, to put a quality person, a quality role in standards. So, you know, I mean, I can quote directly from USP 800, however, I have it in front of me, you know, it's “qualified and trained to be responsible for developing and implementing procedures, overseas Entity Compliance with USP 800 and other applicable laws, regulations and standards, and ensures competency of personnel, and ensures environmental control over the storage and competent areas for hazardous drugs.” So, the designated person has a very central role in making sure that you are as a facility compliant with all aspects of USP 800. And again, you know, that, like I have already said it, you know, it really comes down to it's a rebranded way of saying, “a quality person,” but, they have a lot of responsibilities that make them put them in the position where, you know, they're responsible for documenting different things, making sure they have the proper SOPs that are required, which we'll talk about, too. And, you know, it's the first defined role, I feel like that USP has kind of put in standard that, uh, you know, really, is basically telling people that you must have a person that is overseeing the operations specifically for hazardous drug handling. And I think it's actually a very, very good thing, very important role. And, you know, just one other thing that I just want to mention, because a lot of pharmacies may think that, that role has to be filled by a pharmacist, and it doesn't. Again, just to reiterate what it says, it says “you need to have a qualified and trained person for developing…,” that doesn't necessarily mean it has to be a pharmacist, you can have a technician doing that as well, or somebody else and that's, you know, that maybe is has been in quality in the past in another capacity. In fact, I think that might actually even be a little bit more qualified person is that if we had more quality people from the you know, the big pharma industry maybe involving compounding, I think that would actually get us to where we were, where the trajectory I think that USP has in mind.
DePasquale: What's really interesting, and I'm gonna say it again, you know, that they really, this is like a quality control personnel or quality assurance personnel. And if we talk about that in terms of Big Pharma, the quality department can even outrank the CEO of a very large pharmaceutical company. So the quality department, if they say that this is not going out, or this is not happening, it's not happening. And the CEO, even the top guy can't say anything about it. So, you know, it's that important of a function that the designated person has, in terms of, specifically, you know, data collection, and documentation. Anytime that, you know, there's some exposure or a spill or, you know, there's something, you know, that has gone awry within the compounding area, all that should be documented, and have corrective and preventative actions documented and, and it's really an opportunity for process improvement. And that's sort of the, where I see that the key function of the designated person is, you know, documentation, data collection, corrective actions, and keeping everybody in line.
DePasquale: But, you know, first things first, safety is paramount in this whole discussion, especially if we're talking about spills and exposure to some of these hazardous chemicals. And, honestly, some are more hazardous than others. But, you know, I think pharmacists have a good idea of which ones those are. But nonetheless, first things first, safety. And USP 800 says anywhere that there's hazardous drugs being handled, you need a spill kit available. And the spill kit should be big enough or small enough to handle the size of the spill that you may or may not be dealing with, which may include the use of even having on site a powered air purifying respirator, or PAPR, which is essentially a like an apparatus that goes over your head to kind of (it's blowing out air), and to keep anything from coming into the breathing space of the person wearing it. So it's really a very good layer of protection for, especially if it's a big spill, and involving powder or liquid that's been sprayed, and there's a whole bunch of droplets everywhere. But then on top of all that stuff, having a spill kit with all the proper materials for cleaning up the type of spill, the size of the spill, the garb that needs to be worn gloves, and then you have to also know how to clean the spill, so you first contain it. And then you go through the process of deactivating, decontaminating, cleaning and disinfecting, which is all very nicely laid out and USP 800. On top of that, though, there's this other layer of having SOPs that dictate all that stuff. So it's very important. And one thing that I like people to be aware of that anyone that's listening, and I try to spread this, as far and wide as I can, whenever I talk is that the FDA is coming to your facility sometime soon. And that includes hospitals. And so the importance of SOPs in the eyes of the FDA is extremely important. You have to have processes and procedures written down, and then all of your personnel need to be aware of those processes and procedures and following them. And in fact, if they spot somebody, say for instance, they've already looked over an SOP, and then they're going on the floor and looking at your operators and seeing what they're doing. And they see deviations from the SOP, in terms of how somebody is carrying out a process, that's a problem, and you're essentially not following your own policy. So you know, it's a really key thing that we in pharmacy have to take a lot more seriously these days with the FDA getting more and more involved in compounding. But yeah, those are the basic steps. And the last and final thing I'll say is and bring up again, is having a corrective and preventative action program in place where you're documenting all the pieces of information regarding the spill, how the spill occurred, under what circumstances, the time of day, who it was, how big the spill was, how you cleaned it up all this stuff and, and formulate, you know, the root cause of that problem, and then that may involve changing the SOP to reflect a better process and procedure. So, you know, again, CAPA comes into play. Once more in, you know, whenever a spill occurs to hopefully make an, a better process or procedure and, and the “P” part of that, prevent, is key you were hoping to prevent any kind of spills from happening.
DePasquale: Hazard Communication program is really a program so that everyone in your facility is more or less on the same page, and the SOPs know how they're supposed to be handling drugs and maybe even specific to particular job types. For somebody that's compounding they may have a little bit more stuff to kind of be trained on. But what it boils down to is his hazard communication plan, the main purpose is to communicate to all personnel what to do if an exposure occurs, if spills occur, how to handle hazardous drugs properly. And then another key thing is safety data sheets. And you're required to have any kind of hazardous drug on site, you should have an SDS, or safety data sheet, for that. And all the personnel should know how to get to that forum because there's a lot of key pieces of information on the SDS, you know, emergency protocols for decontaminating yourself or what to do first aid wise and what kind of PPE should be required for that particular substance? So, yeah, the hazardous communication plan is really another one of those key fundamental pieces of USP 800 that it's actually a really short paragraph and USP 800. But it's quite important there's a laundry list of SOPs, and I unfortunately don't have them memorized, but fortunately, I do have right in front of me.
DePasquale: Um, so you know, minimally USP 800 says that you should, and I emphasize the word should, have the following SOPs: Hazard Communication program, Occupational Safety Program, designation of HD areas, receipt, storage, compounding of HDs, use and maintenance of proper engineering controls, hand hygiene, and use of PPE based on activity, whether it be the receipt, the transport, compounding, administration, spill or disposal, or storage. And then I talked about deactivation, decontamination, cleaning and disinfection, that's another SOP, dispensing, transport, administering environmental monitoring, which is wipe sampling, which is also a “should” in USP 800. It's not a requirement. Disposal, spill control, which of course we talked about, and then there's medical surveillance. Medical surveillance is also a “should” I should mention, it's not a requirement necessarily of USP 800. And then there's several others that I could mention that, you know, may just be a good idea in terms of defining roles within the organization, having an SOP that dictates that you have a designated person, what exactly their role is and function. In SOP for documentation, what documentation needs to be retained and kept on file, a CAPA, which hopefully most pharmacies would already have a CAPA SOP, but if they don't, I think a CAPA SOP would be good as well. So, those last few are just some that I've thrown in that are not in USP 800 that I think are also good ideas. But yeah, SOPs are very important that everyone knows everyone's on the same page and following the SOP and not deviating from it. And if somebody is actually doing something that may be better than what the SOP says, change the SOP. So, there's quite a bit of flexibility in there in terms of being able to change your own SOPs and, and, having the culture of continuous quality improvement. And it's an ever-changing line and, you're never going to get to it, like a parable that you're just never going to get to, but there's always going to be room for improvement. And I think that's another key lesson to kind of take from all this is that we really need to take on a culture of continuous quality improvement within compounding and pharmacy at large.