So, we will get started. Thank you for joining us today. It is so nice to see many familiar faces from the last session. I think maybe those of us who do medical center occupational health, maybe follow, we might need like our own room next year, like med center, med center, health care worker, health care worker, health care worker, all day long. We'll lobby for that. Woo, thank you. Yes. Okay. So, I'm honored to be with you today to speak about this Lessons Learned from Hazardous Medication Surveillance Program. I'm going to do the first few slides, but spoiler alert, star of the show here is my colleague Dr. Laura Brear, who was charged with implementing this program at the Mayo Clinic and took the lead in Let's Evaluate How This Actually Works. So, what we're talking about, and we have no disclosures, is doing surveillance for people who handle hazardous medication, right? So, first of all, just acmed basics, what are the potential health effects of exposure to hazardous medication? And we know that there are health effects, and that's the thing. You know, this is not a benign thing. This is not a hazard that you want people working with in an uncontrolled way. You do not want your workers being overexposed, acutely or cumulatively. There are, for chemotherapeutic agents and others on the hazardous medication list, adverse reproductive effects. There are carcinogenic effects, potentially organ toxicity, genotoxicity. And in fact, there is a list of potentially hazardous drugs in healthcare provided by NIOSH, which we just call the list, all right? So, the list is huge. Hundreds of medications are on this list, and everyone thinks it's a list of chemotherapeutic agents when they first hear about it, and that is a section. That is an entire section. But there are three sections of the list. There are those that are designated as a potential reproductive hazard, medications that you don't, that are not chemotherapeutic, and they're quite commonly used and handled in healthcare, colchicine, warfarin, fluconazole. These are on the list, okay? Then there are non-antineoplastic drugs that meet criteria for their list, which includes estrogens, progestins, many of the anticonvulsant agents, immunosuppressants, reverse transcriptase inhibitors, et cetera. So, these slides are in your swap card app. The link to the list is there. So, these are ubiquitous medications in our healthcare centers, particularly in our pharmacies, our compounding pharmacies, et cetera. This information is from NIOSH, and I don't have my reading glasses on. I'll read it from there, okay? I accidentally packed my sunglasses in my purse instead of my reading glasses today, just to tell you sort of a level set for where I am right now. So, NIOSH provides very helpful guidance for managing hazardous drug exposures in healthcare settings, and it is a comprehensive program that begins with hazard identification, customizing your occupational exposure risk assessment, doing the risk assessment, having a risk management plan, which involves lots of stuff, all the stuff that we know, right? Written plan, engineering controls, administrative controls, PPE, surface contamination testing, routine surface sampling, very important for this particular agent. And then, down near the bottom is medical surveillance, and here's what NIOSH now recommends as of 2023, okay, with a more refined approach to prior recommendations, is consideration of a baseline clinical evaluation, which involves a history exam and perhaps laboratory testing, a health questionnaire at hire and periodically, and a follow-up plan for health concerns that may arise, that the employees may voice, or for managing an acute exposure. So those are now the NIOSH recommendations. But that's not normally what's driving all of our angst, right? All the angst, all the emails, what does this mean, when does this go into effect, is really driven by the U.S. Pharmacopeia, the USP. So I didn't know a lot about the U.S. Pharmacopeia, what they were, I didn't understand why when they published their chapter numbers, they have to put the less than and equal sign on either side, USP 800, I don't know what that's about. I've learned what they are, I haven't learned about the less than equal signs yet. So they are an independent, non-profit organization that sets scientific standards to build trust in the supply worldwide of safe, quality medicines and other products. And they set lots of standards, how do you develop these, how do you compound them, how do you manufacture them? And it's not just these medications, supplements, herbs, food additives, et cetera. Now like many such organizations, including NIOSH, CDC, while they're not regulatory in and of themselves, these are standards that may be pointed to by an accrediting body. So for joint commission, for the folks that accredit your compounding pharmacy, et cetera, this may be the standard that they look to. So what is USP 800? Mostly not about medical surveillance. This is not for you to be intended to read in the back of the room, it's small print. The point here is that these are all the chapters, the USP 800, da, da, da, da, da, da, very last one, medical surveillance. Now, what happened this year in medical surveillance, in this chapter? This chapter underwent a legal change in terminology that confused me completely at the time and sort of sent ripples of panic throughout the medical center, our health section, what does it mean, what does it mean, what are we doing, what do we have to do, is the medical surveillance now mandatory, what's happening? So what happened was that this chapter now became what is called compendiably applicable. I read that. I still had no idea what happened. So what that means is that if this chapter is referenced in another chapter that is mandatory, thou shalt must do these things, and that chapter says, and thou shalt do, oh, the part of chapter 800, then that part of chapter 800 is now mandatory, okay? Let me do that one more time. So previous, so this chapter has lots of stuff, you saw all the things, right, all that stuff is in there, and some of those things are referenced in mandatory chapter, what they call things that you should, you must do, you shall do in order to meet our standards, right? So if any of these things are referenced in a mandatory chapter, that part, that thing that's referenced is now also required, okay? So only to the extent to which these other chapters apply. So what this says, and it's the legalese, and it's in your slides, and I can't read it to you because I have my glasses, is it is applicable and compendially required only to the extent to which USP general chapters 795 and 797 apply, and for hazardous drugs this means only when there is, the practitioner is compounding, okay? So this is about compounding. So what do they say in chapter 800 anyway? The program recommends, they recommend but do not require a medical surveillance program, and they define what they say that is, which is a pre-placement assessment in which they recommend you get a record of the hazardous drugs handled, the quantities and dosage forms that are handled, the estimated number of drugs handled per week, the estimates of hours spent handling hazardous medications per week or per month, and performance of physical assessment and labs linked to target organs of commonly used hazardous drugs, such as a baseline complete blood count at pre-placement, recommended, not required pre-placement CPC. So that's why we are here today, is that last little part. Laboratory testing. Now, so there are potential challenges. We do not have biomarkers that will tell us exposure for all the different things people may be exposed to. Were you exposed to estrogen? We don't have tests for that. CPC abnormalities are very common. I won't go into that more, but nonspecific findings on routine testing can't be attributed to occupational exposure, and there are potential harms of over-testing. Unnecessary tests that do not improve clinical decision-making are over-tests, and the harms are enumerated here, cost, worry, misdiagnosis, over-diagnosis, false positives, false negatives, and an entire cascade of unnecessary follow-up testing. Long list of references on the harms of over-testing is available to you in your slides. And with that, I'd like to ask Dr. Brewer to take the podium. So back in kind of 2018 through 2019, when USP-800 was announced that it was coming out, Mayo Clinic leadership asked for a multidisciplinary group to look at USP-800 and determine what we would need to do to align with these practice standards. That multidisciplinary group was led by pharmacy and nursing, because that long list of the different sections within USP-800, most of them do not apply to occupational health or medical surveillance. They're things like use of PPE, labeling, transport of medications, safety with compounding, and those sorts of things. I was asked to be part of that enterprise group, and then we also had within our employee occupational health, we developed an enterprise group with representation from nursing providers and other stakeholders from our three Mayo Clinic sites, Rochester, Arizona, and Florida, and our four Mayo Clinic health system regions, so representing our 78,000 employees. We started by doing some benchmarking to see what each of our sites were doing currently at that time, pre-USP-800, and we found that we were very much not standardized across the Mayo enterprise. So I think every program was opt-in. None of them were mandatory. We had low participation. One of our regions that I think had 6,000 total employees had one person enrolled in their hazardous medication surveillance program, so you can imagine if that one person developed breast cancer or had a miscarriage, there's no way to know if it's related to their workplace exposure or not when you have an NF1. There was variation in timing, how frequently they were doing surveillance, no testing or questionnaires at baseline, variation in the labs even. Some sites, I think all of the sites were doing a CBC, some with a differential, some without, some urine testing, some a complete metabolic panel, variation in physical exam. Most sites were not doing a physical exam, but some were, and the ones that were, the physical exam differed for what they were looking for, and there was no aggregate analysis of any of the results. We couldn't do aggregate analysis because the data differed across all of the sites. So that was our first step to sit down and say, you know, should we standardize across all of the sites? Do we want to have a medical surveillance program? Because it was recommended but not required in USP 800. We decided at Mayo Clinic that we did want to develop a program because we wanted to do that aggregate analysis and see, you know, were our staff having health effects from hazardous medications? We determined that we would have automatic enrollment of staff identified by supervisors, so we got rid of the opt-out or opt-in option. We determined an exposure threshold, so we went back and forth about this. This was basically a consensus standard within our organization where we said staff who handle hazardous drugs at least two times a week, at least 26 weeks per year, would be automatically enrolled but then we would give them information and if they wanted to opt out, they could. And that took away this, you know, interpretation of what is kind of regular exposure to hazardous meds. We started including a baseline surveillance in the year 2022 or for staff that were hired after that that had this level of exposure. We decided across the enterprise that we would do surveillance every two years in the same quarter across the enterprise and that would include a screening questionnaire. We started with the questionnaire used by the Oncology Nursing Society and then we added a few questions to that, some of the questions that are on the OSHA respirator medical questionnaire. And then we, after a lot of discussion, we got consensus that we would standardize to do only a CBC with differential across all of our sites. So some sites initially felt very strongly about doing urine testing but then when we asked how they're using that testing, we eventually got consensus on this. The questionnaire and CBC results would come in through our nurses and we had criteria where based on responses to the questions or abnormalities in the CBC, they would be escalated to a provider. And we really did kind of quality improvement cycles, PDSA cycles on that because initially we were getting flooded with, you know, this person has a lab test that's, you know, 0.1 out of the reference range and so we developed some language that could be automatically sent to employees that mild abnormalities are normal but which ones we wanted to see. So we ran this cycle in 2020. We did it again in 2022 and that's the data that we'll present today. With that CBC with differential at baseline and after two years and then the CBC was only completed for employees that first did the questionnaire. So they didn't get their lab requisition until they did the questionnaire. All testing was free of charge to the employees and they got all of the results. These are the results for that first cycle of the CBC data back in 2020. So we call this the baseline for the program but it actually included nurses that had been working, nurses and other staff that had been working with hazardous meds for potentially many years and staff that were new that hadn't been working with hazardous meds. So it's, it was kind of nice because it includes a natural control group. There were over 600 employees that had not handled hazardous medications so far. And what we found from that, we stratified it based on amount of time that they were working per week on average with hazardous meds. You can see across the top it goes from less than two hours a week up to 21 or more hours per week working with hazardous meds. We found no correlation of lab abnormalities with increasing exposure with hazardous meds. In fact, we found that that internal control group, the group that hadn't worked with hazardous medications at all, 57% had one or more abnormalities within their CBC, which is interesting because the total group of over 2,600 employees on average had 57% had one or more abnormalities in their CBC. We also, we didn't include all of the data here, but we also analyzed each individual component of the CBC separately, and no individual component had a statistically significant correlation with exposure to hazardous meds. We also analyzed it correlated with exposure to spills because sometimes, you know, a single exposure to a spill might increase your risk of health effects or lab abnormalities. There was no correlation with exposure, so we will be, we're in the process of writing this up and submitting it, and we're hopeful to get that published pretty soon. The other thing to note on this is of those that completed the questionnaire in this first cycle, the 2,600, only 109 people did not go on to complete their CBC, so pretty much everyone completed their CBC with this cycle. For cycle two, we grouped it, we grouped it a little bit differently. Anyone who did not yet have exposure to hazardous meds or those that had very infrequent exposure, less than two hours per week, we grouped those together, and then we had three groups, less than two hours, 2 to 20, or greater than 20. We also found no statistically significant correlation with frequency of exposure, and the results were very similar to that cycle one, you know, about 55 to 57 percent had one or more abnormalities. Again, we assessed every single CBC component, and there were none that were statistically significant. We did find, actually, I should have kept the total for this group. We did find with cycle two that the proportion of employees that completed their questionnaire and decided not to do their CBC was much, much higher. I have that percentage on a later slide, but basically employees were telling us that they weren't finding value in doing this CBC. They just kind of opted out of that part of it. We then analyzed, we then looked at the employees from cycle one and the employees from cycle two and pulled out all of the cases where we had matched data, where we had an employee that did surveillance both in cycle one and in cycle two to see if we were seeing changes over that time. We had a total of 845 employees that met that criteria, and we looked at, you know, the percentage that were normal CBCs in cycle one, normal in cycle two, abnormal to abnormal, and abnormal to normal. And you can see, you know, there's not a lot of change here. So, you know, you have some employees flipping from normal to abnormal. You have a very similar number of employees flipping from abnormal to normal, and there's not statistically significant difference across exposure levels. Some other outcomes of interest. So the questionnaire that we did, we asked about incident cases of leukemia or other cancer, liver disease, or neurologic disorders, and we analyzed that in association with spills, also in association with time handling hazardous medications. There was no statistically significant correlation. We also analyzed birth outcomes. So in our cycle one, we said, you know, we asked about for healthcare workers that identify as female, we asked did they have any adverse birth outcomes, including miscarriage, stillbirth, or birth defects. And when they answered yes, we didn't know which one of those it was. So we learned a lesson for cycle two that we needed to split those out. And for males, we asked if their spouse had had any adverse birth outcomes. We didn't find any statistically significant correlation. In cycle one, we asked about symptoms, and we had the whole grid of symptoms at the top. We asked them to put any symptoms that they had any concern could be associated with their work with hazardous medications. And I think, you know, it was at the end of the questionnaire. People just didn't read that, and they saw symptoms, and they just started marking all of the symptoms they have, like thinning hair, and, you know, weight loss, and those things. And so we had a lot of follow-up work for that from our nurses calling them, and they'd say, oh, that's not associated with work. I've had that for 10 years before I started working. For cycle two, we got smart, and we didn't include the grid. We had just the question that said, do you have any medical symptoms that you have any concerns that are related to hazardous medication exposure? If they marked yes, then it populated the grid, and then they marked that. And we had only nine of over 2,000 employees that responded to the questionnaire that reported that, so then we could follow up with them. This, I think, was the most kind of the most useful piece of our hazardous medication surveillance program and something that we added. So on the questionnaire, we added questions for the employee to tell us if they had any safety concerns. If they did have safety concerns, had they talked about those with their supervisor? Would they like to talk to one of our nurses or someone in occupational health? And every single one of these employees, whether they said they had safety concerns that they'd already discussed, even if they said they didn't want to talk to us, we called them, we talked to them, and we basically collected information about these safety concerns. And then, unless it was something where we felt that it was an urgent issue that we had to deal with right away, we actually held those for the six weeks until we got done with the surveillance cycle, and we provided the supervisor with a de-identified report. So we didn't tell them which employee reported this. We just said, you know, as one of the outcomes of our surveillance program, one or more of your employees have said that they have concerns with, you know, placement of hazardous medications or PPE and some specifics, so that they could try to mitigate that concern. So, in summary, from our study, we found that there's a very high prevalence of abnormal CBC labs in the general population and in healthcare workers. More than 50 percent had at least had one or more abnormality on their CBC. We did not find that those abnormalities were correlated with occupational exposure to hazardous medications, which doesn't mean that those hazardous medications don't pose a health risk. We absolutely know that they do. From prior research, this shows that, in my mind, this shows that our protections that we have in place are working, and we also found that a large percentage of employees opted out of cycle two, so 38 percent of the employees that completed the questionnaire in cycle two didn't complete the CBC. They told us they didn't find it useful. And in this cohort, there weren't any trends in adverse health effects or reproductive effects from handling hazardous meds with appropriate precautions. So, we got together with our enterprise, Employee Occupational Health Specialty Council, which includes all of the physicians overseeing employee health across the Mayo Enterprise. We discussed this data, and, you know, we felt, we really felt that there wasn't a reason to continue it based on this evidence-based review of our data. You know, the reason we test, if it doesn't change what we're doing, there's really no point in doing it. You know, we don't want to, like, cause unnecessary concerns or unnecessary testing for our employees. We felt that that, however, we felt that those questions about safety for our employees and the screening for health effects based on the questionnaire were still very useful, so we're still, we're going to keep the questionnaire as part of our surveillance, which is less of a burden for our employees, and we'll continue to analyze that in aggregate. We also felt the questionnaires were useful in terms of assessing spill frequency and monitoring. So, in the first two cycles, we looked to make sure that everyone that reported that they'd had a spill had filed an employee incident report, and we found that we had really good compliance with that, which was good, but that's another way that we can kind of make sure that things aren't slipping, that employees aren't getting exposed without PPE and things like that. And so, we're launching our next cycle this coming June, and I can tell you our employee health nurses are very happy that we're making this pivot. I anticipate our healthcare workers will also be very happy that we're making this pivot. If there is a spill or if there's some concern, the medical directors or nurse practitioners overseeing these programs still have the autonomy to do individualized testing if they feel like that's needed, but it just won't be standard as part of the two-year cycle anymore. So, I think with that, we will open it up for any questions. I just want to thank you both for this presentation and trying to tackle this monster. So, I work in Ohio. We have 19 hospitals, and trying to come up with a standard for this has been just brutal. So, we did similar things, the questionnaire and the CBCS baseline, but the bigger issue in talking with colleagues is, what are you really surveilling based on this list of 1,000 different medications? Yeah. Also, misunderstanding by associates. We had a question on there, have you ever had radiation? Well, everyone thought that meant a chest x-ray, so we were calling everybody about x-rays. And so, in some further discussions, it was the spills that became important. What type of spill was it, and then what kind of surveillance and testing would you have after that? So, I love your conclusion, because it's what our experience has been, too, and the thought process is the same. There was no standard, and everybody saw, you know, major pharmacological treatments and the PEP and the containment. It's a basic pharmacy program, but if there's anything falls offline, you know, then it comes to you. Examine them and test them for everything. Well, when you look at the scope of that, how to do that effectively and not worry people and spend money needlessly was a big issue. So, thank you so much, and I really appreciate this. Your findings are going to be really helpful for me to take back. Thank you so much. Yeah, and, I mean, one thing we found is that our staff, they're really well trained for cleaning up spills. They have spill kits. They're not just rushing in and cleaning up spills without gloves on or things like that. They want to protect themselves as well. Thank you for an excellent presentation. Based on your presentation today, it seems like there is no need to have the baseline when these employees are coming in. You're not doing any urinalysis or the CBC for these folks, correct? Correct, and we discussed that extensively. You know, I think that this data, we said, okay, we don't need to do every two-year surveillance, but should we keep the baseline so that we at least have a comparison? The challenge with that is that, you know, these are like humans that are changing over time. So, you know, you could have a baseline CBC and not have another CBC for 10 years until, you know, something happens at work that's prompting you to do that, and really comparison back with that CBC when someone was 22 isn't giving you a lot of data. So we decided that, you know, rather than doing the baseline at hire, if there is a big spill that we have concern may have, you know, gotten on someone's unprotected skin or been especially hazardous, we would basically do a baseline right then, right after the spill, and then potentially do one six weeks later. But most of the time, you don't even need that if they're using the right precautions and cleaning it up appropriately. So that was another question. It takes to, according to U.S.B. 800, when pharmacy staff is using or mixing those formulations, so they are supposed to be using their full PPE. So we should not be expecting any exposure from those. So you are not doing any baseline no matter what then. That's a good. Thank you. I mean, so we have absolutely left it up to the discretion of the provider, you know, for them to assess on an individualized basis if they have concern. And, you know, certainly one of the reasons they might do baseline testing, like say they had a pharmacy staff that was compounding and they were using the right PPE and they had a spill and, you know, we didn't feel that there was increased risk medically because they were using the right PPE, but they had a lot of anxiety about it. We might offer baseline testing and follow-up testing, you know, six weeks later because of that concern. So I don't want to say we would never do it with PPE. It's really left up to the discretion of the provider, but we would not be routinely doing it. Thank you. Yeah. Hi. I just had a couple of quick questions because this was hot on the plate on Friday as I was answering. One question is, up until now at my organization, how USP 800 medical surveillance was handled was no questionnaire even, but AHRQ Health will avail itself for consultation to employees if they had any concerns, those who have been identified to be exposed, and obviously management if they had an actual exposure. Does the November 2023 change any of the language? And the reason that decision was made that there was no reviewing guidance and there was an ACOM WOMA statement from 2019 that review did also a big review on the evidence. There was no mandate, I guess, that language. So the first quick question is that, does that change now the mandate to do more? And the second one is just the opt-out questionnaire as opposed to an opt-in. Because there was a concern about when you follow an opt-out approach, was that not prying on also having these employees answer questions pertaining to reproductive health and things that may be sensitive and they may not want to share or disclose? So maybe I'll answer the second question first and leave the first question to you, the question about whether it changes if a medical surveillance system is required with the 2023 change. So we manage the opt-out process very similar to how we manage hepatitis B vaccine declination. So we give employees information about the program. They're able to see the questionnaire if they want to. We tell them they're going to be automatically enrolled, but they have the option to opt-out of the questionnaire or the whole program if they want to. But at any time in the future, if they change their mind and they want to opt-back in, they can. And we actually have employees check a box that they've attested that they've read that to opt-out. We send three reminders for the questionnaire. And with the third reminder, we have that option to actually I think we changed it with the last year where we have that option to decline anytime they get that questionnaire so our legal council reviewed that as well and made sure that you know that information that we're giving them that they know that it's voluntary that it's not going to you know impact their employment that the information will be kept confidential and occupational health and only aggregate de-identified information will be shared with others so hopefully that answers your question about that about that opt-out process but an opt-in program makes it really hard to analyze data because the employees that opt in are typically the ones that only have a concern that they have a health effect so it's really hard to do a broad analysis of it I'll pass it to dr. Swift for the first question yes so as I understand it your question is did something happen in November of 2023 that changed the mandatory nature of medical surveillance for people who do compounding correct so no what it made what it made USP chapter 800 now applicable to people who do compounding including all of the sections of USP 800 which include mostly not medical surveillance but for the medical surveillance statement in chapter 800 it was completely unchanged it says recommends but does not require medical surveillance thank you so much for sharing this information I think fear is really based in the unknown and having this objective data really helps us to address those fears both fears of patients our employees as well as fears of providers like what am I missing if I'm not doing lab XYZ so I did find it interesting the number of people that that did not do that second CBC was there any education based on on just the fact that there is a standard variation of abnormalities and CBCs across populations period either to your eoh staff or to your employees in general what type of information was given regarding medical surveillance specifically but like before that cycle to you're wondering if they knew that there were abnormalities in cycle one so they didn't do cycle two I don't think that that was the case because just because of kind of the sheer volume of employees that we were screening it took us quite a while to get the results of the data pulled out of our system that baseline data we we implemented the program in 2020 in a point in time for existing employees but then we waited to pull the data actually until after 2022 because any employees that were hired during that first two years we wanted to include their baseline data in that analysis so we didn't actually share any of the aggregate results with employees prior to cycle two but you know we did we did have a number of employees that we called initially in that first month when pretty when like over half of the employees were coming back with a CBC abnormality and then we developed a statement that we would send to employees that said you know minor abnormalities in lab results are very common OHS will review this and if we have concerns we'll reach out to you and then we implemented some internal criteria of kind of what would flag it to talk to one of our providers we encouraged employees that if they had any concerns they should talk to their PCP but one of you know one of the biggest abnormalities that we saw was anemia in women of childbearing age and we added we added a question in cycle 2 where it actually asked has anyone ever told you that you have anemia because in cycle 1 we would call people and they'd say oh yeah I've had anemia for five years I know about that I get followed for that so thank you both I still look forward to this publication hopefully soon I echo that Amy Behrman University of Pennsylvania I really just have three short statements one is thank you wonderful work it will help all of us thank you so much for both doing it and presenting it and can't wait to have it to site number two I find it oddly reassuring that our lawyers are all saying the same things or at least ours and yours are saying the same things and the third is we have a somewhat similar actually fairly similar process where we assess for we start but with a opt opt out and we're we're not going to make it very easy to opt out assessment of people's confidence in their safety protocols and processes if there is a flagged response to those questions do you know do you understand how to use your spill kit whatever it might be that will actually flag to safe to our environmental health and safety staff rather than occupational health because they will be doing the retraining then we have a separate section on symptomatology and spills which will be confidentially transmitted of course to our nurses for screening so my only comment there is that we're trying to streamline and unburden our nursing staff a bit by sending the people who need safety training directly to safety yeah and we actually do something pretty similar like if someone says that they have they have concerns with the PPE that they're wearing that they're worried maybe it's not the right PPE we would engage our occupational safety colleagues and ask that they talk to the supervisor about that concern hello I'm Lynn flowers I work currently for the Department of Defense in one of their public health centers but formerly worked for the Navy in a clinic attached to Naval Hospital and we had an experience with their hazardous drugs program where we felt people were over enrolled basically in the Navy industrial hygiene and even the supervisors were allowed to identify these people for the surveillance program and some of these people were in the program we felt as if they worked next to this hazardous drug they looked at it they may use it they may be giving an injection of methotrexate maybe once a year maybe never so we went out and did our own risk assessment and really narrowed down what we felt that people truly should be in that program so I'm curious to for you to talk about your process of risk assessment and exposure you had mentioned that people who worked with it two or more or two hours or more per week for 26 weeks were part of this program can you talk about what what what was considered an exposure for you yeah assessment process yep so I I went back to this slide about our criteria and it's actually a little bit more detailed from this what we give to the supervisors to help identify the staff so it's staff who handle administer or dispose of hazardous medications at least two times per week at least 26 weeks per year so we actually our nursing leadership brought this forward to to like nurse administrator and nurse manager meetings we presented this program broadly we had a list of departments that we thought would likely have staff that need to be enrolled so that those were like you know transfusion clinics that are administering hazardous meds like the oncology department where they may be handling bodily fluids of patients on anti-neoplastic medications and then we actually had a form that supervisors could fill out to tell us a little bit more so that we could decide do they need to be enrolled or do they not and we assess that every other year basically like the six months leading up to this program we look at okay who's enrolled are those the right people are we missing anyone with cycle two we looked at the people from cycle one who weren't new to Mayo Clinic but said we don't actually have exposure and we were able to pull some of those people out of surveillance but it was it was kind of nice to have that control group too so yeah so I don't think that we we would go so far as trying to kind of pull everyone out I think that people kind of self exclude with the opt-out questionnaire we're more concerned with making sure that we're including those that that do meet this criteria but it's not working next to someone else who is handling hazardous meds they actually have to be handling them touching them themselves yeah thank you I appreciate it great lecture hi I'm Melissa McDermott University of Maryland Baltimore I just have a couple of comments number one for people that might have been nervous with one of the last slides dr. switch showed nobody has to do biomonitoring for a specific toxicant right there that's sort of left over from previous years when people wondered about it out loud or in publications but it's not required and regarding the CBC's I'd just like to mention that the reason that was included was as a baseline that's why the world word baseline was there for example you probably don't want somebody who has a pre-existing condition where their white counts three to be handling alkylating agents as you know for a work setting and I've actually had that happen to me so I was you know I would say situations like that where it's cleaner when you've started this and get new hires it's more like it's a it's more of a mix because you all had to kind of enter it where you've got had people who you know legacy employees and you're then trying to balance all this stuff and it was not included the CBC was not included to use that as an indicator across your whole program that you do or don't have a problem it was supposed to be a baseline sort of individual result I completely understand the sort of messiness of that I've had to deal with that in the past on the other hand when you find something that tells you to this person shouldn't be doing this job they can still be a pharmacist they just need to be met you know mixing TPN or something like that I had a worker who was treated as a teenager for Hodgkin's lymphoma and so these are people that probably you don't want seeing alkylating agent exposure for the rest of their life and I'd make one more comment as somebody who's thought about this and studied this for a very long time I'm not convinced that spills are the only exposure opportunity air quotes completely agree with your protocol for spills and definitely we need to be doing something like that I agree with you that at time 30 minutes after a spill nobody's gonna have an abnormality but that's so that can be your baseline your baseline however what about the people you're inheriting or you're employing and already have something you wish you'd known about and it didn't come up in the questionnaire or whatever so that was the reason not that we're all okay now because the controls and the exposed have the same H&H that's not what the use is on the other hand if I had a big data set like yours I'd have done the same thing you did so thanks very much and thank you dr. McDermott and I just also want to just recognize that our awareness of this hazard is so important and thanks largely to the work that dr. McDermott has done and led in this field and kudos to you for looking out for health care workers for decades and being a fierce advocate for the safety of these workers and for that date we all owe you a debt of gratitude personally many of you in the room may not know the the leadership that this woman has shown over the years thank you so much yeah I fully agree with that I think you know that will be something that will absolutely emphasize when we publish this that we don't want these results to make people feel like they can let down their guards with working with hazardous medications that it there absolutely are known health risks with that right their recommendations we're all trying to do but there's no other group of workers in this country I am carcinogens and there isn't a red line about what we can and cannot do with them which is why we really do need a comprehensive and down menu of safe handling thank you I'm gonna follow up on what dr. McDermott said just about baseline testing to rethink it as a protection of medical legal protection from the employer the analogy would be having someone work with the liver toxicant and not doing baseline liver function tests and letting them use PPE and stuff and waiting to do the liver function tests once they've had a spill and it comes back to show elevated liver function tests you need to have a baseline to show that they had it before by the fact that you're even considering them in protective means they have some risk of an exposure from some type of chemical so from a medical legal standpoint what you don't want to find out if you do a baseline after an after exposure and then to find the problem because by the fact that you're there something hazardous is there they're gonna say well the PPE didn't work does that make sense to you the analogy would be is if if you're concerned that it may cause some CBC problems you should do that as a baseline when they start from a medical legal standpoint it's going to be a lot easier as expert witness to say that well they could have gotten that damage for the two years before they had this accident because they have been exposed just wearing their PPE that makes sense yeah it's I mean it's food for thought I think that we would we would we would need to yeah reduction for the employer you know versus that so you sort of want to think about and I went through the same thing I consult for the the DOD and they said oh we're going to require to ask for PFAS testing for our firefighters but they said we don't want to spend it it's just going to be the annual when they come in for the annual and I had to explain to them we need to do a baseline for the PFAS even though it doesn't mean much but we need to show that they may have had an elevated level before they even came in because they're now but if it shows elevated to your level a year later we don't know what caused that problem and the other thing that I think is worth mentioning here and we were recently we had a visitor to our program on and most you may know I'm Francesco Violante from Italy has been president both of their national organizations for occupational medicine and they're actually doing specific biomonitors for the actual drugs being handled they're readily available their hospital makes it free of charge to them and so the biomonitoring this is a very blunt instrument that we're talking about the United States just a CBC or an LFT but the future may indeed hold the ability for us to have more precise instruments that would be very useful in detecting overexposure prior to harm which is what we want to do is not let people get harmed first and then find out oops by the way you have a problem and so I think that many of our international colleagues are ahead of us on this curve and are employing on a national basis some techniques and tools that we are not we don't have available right now in any scalable sense or any practical sense but I would say we need to continue this conversation you know as our tools evolve and as we just keep getting better and better what we have right now is an admittedly very blunt tool no other questions thank you guys so much feel free to come up and chat with us or email us

Lessons Learned

Hazardous Medication Surveillance Program

Medical Surveillance

Health Effects

NIOSH Recommendations

US Pharmacopeia USP 800

Baseline Clinical Evaluation

Regular Monitoring

Challenges