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Exploring Pharmacy Compounding Regulations: Insights with Abby Roth and Sharone Wang · Taking The Supply Chain Pulse

• 0:10
  Speaker 1: Hello again everybody.
• 0:11
  Speaker 1: This is Fred Krantz from St Hodge, coming to you with another episode of Taking the Supply Chain Pulse, where we talk to healthcare supply chain, pharmacy industry leaders and influencers.
• 0:22
  Speaker 1: And today we have with us two people.
• 0:26
  Speaker 1: We have Abby Roth, the founder of Pure Microbiology, and my colleague, Sharon Wang, who is our pharmacy expert and who is going to ask the questions in this interview that I don't know enough to ask about.
• 0:41
  Speaker 1: So thank you both for being here.
• 0:43
  Speaker 1: Happy to have you here.
• 0:44
  Speaker 1: Abby, why don't you describe your background and how it relates to pharmacy?
• 0:49
  Speaker 1: Sterile compounding?
• 0:51
  Speaker 2: I'm a microbiologist by background and I worked in a contract lab for about 14 years where we would do environmental monitoring or EM.
• 1:03
  Speaker 2: We would go out in the field, collect samples of air surface, bring things back to the lab and process them.
• 1:11
  Speaker 2: We also ended up doing some product testing like sterility, endotoxin and things like that, and I really didn't start getting involved with pharmacy sterile compounding until about 2008.
• 1:26
  Speaker 2: And around that time was when we saw some change in some standards where now these sterile compounding pharmacies were required to collect samples, and I was getting inundated with questions about you know where do we collect samples, with questions about you know where do we collect samples, what do the results mean, and really had to get involved with the pharmacies, and at that point then I didn't know a whole lot about the standards that governed things, so I had to take a lot of time to learn about you know what actually goes on in a pharmacy and what the regulations are, so that I was able to help them.
• 2:08
  Speaker 1: Very good.
• 2:08
  Speaker 1: So what is sterile compounding and who regulates this activity?
• 2:40
  Speaker 2: So like the formal definition of sterile preparation to give to a patient.
• 2:44
  Speaker 2: So it's really taking, you know, again a commercially available drug or a bulk drug, doing some things to it, making some manipulations and getting something that is specifically made for that patient.
• 3:01
  Speaker 2: Things get tricky with regulations, though, with compounding, and who regulates that, and that kind of breaks down into like which group of compounders we're talking about.
• 3:12
  Speaker 2: So, when it comes to serial compounding, we have like the traditional compounder that gets a prescription from a prescriber and make something for a patient, and that's kind of what we think of as like traditional compounding that happens in the hospital, that happens in a community setting, and under that sort of compounding scenario it's actually state boards of pharmacy, departments of health that are the ones that are sort of regulating the laws and the standards that are put out there to be followed.
• 3:48
  Speaker 2: I mean, on the other side of that we have what's called an outsourcing facility and they also do sterile compounding, but they're doing it in more of a manufacturing sense, where they don't have a prescription for a patient and they are essentially manufacturing preparations that then you know, will maybe be purchased by a hospital to be able to be provided to patients Interesting.
• 4:17
  Speaker 1: Sharon, I've gone as far as I can go.
• 4:19
  Speaker 1: Can you pick it up from here?
• 4:21
  Speaker 3: Sure, of course.
• 4:22
  Speaker 3: So I mean, Abby, what you're describing, I think, just for general understanding, is you have sterile compounding, maybe at a very localized level, let's say within a pharmacy, within a hospital, and they're doing some type of manipulation.
• 4:36
  Speaker 3: Then you describe this outsourcing facility where they are sterile compounding, similar manipulations, but then their customers are, let's say, hospitals, doctor's offices, clinics, and then finally, I would say, then you have the drug manufacturer who they're also somehow manipulating and making some sort of product.
• 4:57
  Speaker 3: So I guess one question for understanding is what is different about sterile compounding from manufacturing?
• 5:05
  Speaker 3: Are those two similar or are they actually completely different in the eyes of the law and also in the eyes of the activity that you're actually doing?
• 5:15
  Speaker 2: Yeah, and they are like really two different things.
• 5:17
  Speaker 2: When we're talking about compounding, we're taking that product that was prepared by the manufacturer, which is an FDA approved drug product, or we're taking a again a bulk drug, bulk drug substance that's being purchased and doing what we would consider non sterile to sterile compounding.
• 5:40
  Speaker 2: So the two are very different.
• 5:43
  Speaker 2: And you know, again, we have, like these different levels where the 503A pharmacy, as we'll put it, which is, you know, the term that comes out of the Food, drug and Cosmetic USP 797, the United States Pharmacopeia chapter on sterile compounding and maybe some other like state laws, and then you have the outsourcing facility where they're following you know the current good manufacturing practices or the CGMPs, and they're the ones that are going to be regulated then by the FDA, where, at the same point, sharon, like when you're talking about the manufacturers, they're also regulated by the FDA.
• 6:33
  Speaker 2: And I think what's wild about that sort of setting is that the sterile compounders that are in these outsourcing facilities that are again basically manufacturing compounds, they have to follow the CGMPs but they get a couple exemptions and they have a couple different you know guidances from the FDA that they end up following and it's not strict to you know the manufacturing expectations that we see with a true drug manufacturer you know the manufacturing expectations that we see with a true drug manufacturer, I see.
• 7:11
  Speaker 3: So I mean, it just sounds like there's just first of all, like multiple regulating bodies for any of these processes.
• 7:14
  Speaker 3: And then it's also that you know you really have to define what processes that you're actually doing, and I think that you know in this case it just it's.
• 7:23
  Speaker 3: I think it perhaps in description it sounds a bit confusing, but I think that you know in this case it just it's.
• 7:26
  Speaker 3: I think it.
• 7:26
  Speaker 3: Perhaps in description it sounds a bit confusing, but I think in practice you know what the confines of what you're doing in your facility, whether it's a pharmacy or, let's say you're, you're a drug manufacturing plant.
• 7:37
  Speaker 3: Obviously they're very different on a day to day.
• 7:39
  Speaker 3: So, yeah, it's very interesting to see you know who is regulating what, just to make, and you know, at the very end of the day, it's really about consumer protections and making sure that products are safe to the public.
• 7:53
  Speaker 2: Yeah, I would actually add to that, sharon, with kind of the note on, like the regulatory oversight, the 503B, like outsourcing facilities.
• 8:03
  Speaker 2: A lot of them still have to get licensed by their states, so their state boards of pharmacy are still coming in there and some of them kind of struggle a little bit in knowing and understanding what should be done in these facilities, because they're not really familiar with the CGMPs.
• 8:21
  Speaker 2: So it is a it's a very interesting landscape um from a regulatory standpoint yes, um, it's.
• 8:29
  Speaker 3: It's kind of, you know, with on the on the manufacturer regulatory side.
• 8:33
  Speaker 3: As a pharmacist, that's really something that we don't really come into contact at all in terms of regulations and, as in pharmacy, we're very much governed by, let's say, overarching nationwide, you know, let's say, fda regulations, but in addition, um, the state plays a really large role and it's like when you we're very much governed by, let's say, overarching nationwide, you know, let's say, fda regulations, but in addition the state plays a really large role, and it's like when you kind of get up into the drug manufacturing level, it's like the state starts exiting and it becomes more of a US.
• 8:58
  Speaker 3: You know they're encompassed by those regulations, so that's always really good to get an idea of.
• 9:04
  Speaker 3: So I mean, we've been talking about those USP standards and I think one thing that's really happened in the pharmacy world is that they were actually recently updated, and they were updated late last year, and that's something that commonly happens.
• 9:18
  Speaker 3: Obviously, regulations and standards, they really should be updated on a pretty continuous basis, just so that way we're all keeping up to date with all the new technologies and you know any new findings that are discovered.
• 9:32
  Speaker 3: And so can you give me some examples of maybe some major changes.
• 9:36
  Speaker 3: And then how did those changes impact pharmacies?
• 9:41
  Speaker 2: Sure.
• 9:41
  Speaker 2: So we probably can put all of that into like three big buckets, four big buckets, I'd kind of say.
• 9:48
  Speaker 2: One of the biggest changes was related to beyond use dates become more strict and not just kind of allowing these much longer dates based off of just drug stability alone, but really trying to tighten things up with the sterility concerns that we might have right.
• 10:22
  Speaker 2: So there were major changes to BUDs, where we had operated previously under what we would consider like low risk, medium risk and high risk compounding, and that was all based on how many manipulations did we do and how many containers were we using.
• 10:41
  Speaker 2: And that has completely gone away, which has thrown people for a major loop.
• 10:47
  Speaker 2: Some of them because there's we now have what are called categories and we have category one, two and three.
• 10:53
  Speaker 2: And you know, some folks are just trying to say, oh well, low risk is category one and it's like not so fast, that's not quite how it works.
• 11:03
  Speaker 2: And a lot of that then ties into the next bucket, which is facility design, where we have the opportunity for like a segregated compounding area, which is where we would perform category one compounding where we have short beyond use dates, compounding where we have short beyond use dates.
• 11:25
  Speaker 2: Then we have the clean room suite and that really got, I think, more defined in the new version of the chapter and in there we can do category two and three compounding so we can get some longer beyond use dates.
• 11:37
  Speaker 2: So you know there was a lot of changes with facility.
• 11:54
  Speaker 2: There's a lot of things in that section that sort of just cleaned up with better defining things like air changes per hour and pressure differentials and some of the sort of just engineering control pieces that maybe weren't quite as clear in the previous chapter.
• 12:03
  Speaker 2: We did have also a lot of changes to the viable sample collection.
• 12:08
  Speaker 2: So collecting air and surface samples, again, what sort of threw people a little bit was the increased frequency on surface sampling.
• 12:17
  Speaker 2: We went from surface sampling being done periodically and, sharon, if you can define periodically, for me that would be amazing because I I didn't know what it meant Um, so a lot of times people were just defaulting to like, oh well, we'll do it every six months, like we do air, um, and now for the bulk of people it's going to, um, you know, being being done monthly and uh, that has really being done monthly and that has really, really thrown, you know, people for training needs and some things like that.
• 12:55
  Speaker 2: And you know, the last bucket I will mention here would be training and competency.
• 12:57
  Speaker 2: We really got some great information in 797 now much better defining competency assessments, training expectations and maybe one of the coolest things in the chapter was A lot of the training.
• 13:12
  Speaker 2: Now the pharmacies could define themselves and it wasn't so much kind of hitting the easy button and following what's in the chapter, but based on your work practices and your workflow and your facility design you could design training to meet needs and it was actually a really great ad.
• 13:32
  Speaker 2: Kind of scares some people because it puts all the power in their hands.
• 13:35
  Speaker 2: But you know, for other locations it'll take some pressure off where you don't have to train everybody on everything.
• 13:44
  Speaker 3: Right.
• 13:44
  Speaker 3: I mean, I think that you know, with the changing of those standards, it wasn't just one thing that I think pharmacies, let's say, had to react to the four bucket, the four large buckets that you really described.
• 13:57
  Speaker 3: It's like a combination of all of that which really started dictating how pharmacies could respond to that.
• 14:04
  Speaker 3: So, for example, let's say you're in a pharmacy and let's say you're not meeting those facility requirements.
• 14:10
  Speaker 3: Well, now you're going to need to do capital costs to update those facility requirements.
• 14:16
  Speaker 3: So, for example, you had mentioned air changes per hour.
• 14:20
  Speaker 3: If you're both beneath the minimum, then you're going to need to get basically get back up to standard.
• 14:25
  Speaker 3: But some of those fixes, they're not.
• 14:26
  Speaker 3: They're not.
• 14:27
  Speaker 3: You know, a switch of a button and you do it.
• 14:29
  Speaker 3: They're very large, let's say renovation projects, large, let's say renovation projects.
• 14:37
  Speaker 3: And so you know, when you're on the pharmacy side and you're thinking, ok, I have to completely, let's say, restructure my clean room because it now needs to be up to standards, then comes the question, you know, do you even have the staff or do you even have the volume to make, let's say, the monthly air sampling worthwhile or the monthly service sampling worthwhile?
• 14:57
  Speaker 3: And so it's, you know.
• 14:59
  Speaker 3: I want to try to explain that it wasn't.
• 15:01
  Speaker 3: It's not really just one thing.
• 15:02
  Speaker 3: I think pharmacies, when they look at the new, updated standards, we're always we're really seeing how it all ties it together, Because essentially it's like one portion really affects another person, which really affects another portion.
• 15:14
  Speaker 3: So it's like now you're in that same pharmacy and you're realizing, ok, my air changes are not meeting the standard and I have to, you know, renovate the whole entire pharmacy.
• 15:24
  Speaker 3: But then you look at your staffing and then you realize like, well, you know, I really probably don't even make that many IVs, you know, per day, per day, and then it just turns into a okay, well, you know, do we really, are we really going to continue trying to make, let's say, category two products?
• 15:40
  Speaker 3: Should we go back down to category one products?
• 15:43
  Speaker 3: Does that fit our needs better?
• 15:44
  Speaker 3: So it's almost like these new standards they, yeah, they're really just shifted just a lot of thinking, I think, in our operations and we're just, you know, constantly considering, you know, how do these standards make sense for each facility?
• 15:59
  Speaker 3: And I think that was interesting too, where it's almost like when you read through the standards, it's like the standards they give you an ability to basically use it for your facility in a way that makes sense for your facility.
• 16:13
  Speaker 3: So the standards don't push you to say, oh, you must continue to make Category 2 products.
• 16:21
  Speaker 3: It's basically telling you does Category 2 products even make sense to you?
• 16:25
  Speaker 3: And it's not like the USPs are taking away from your complete ability to make sterile compounds.
• 16:31
  Speaker 3: It's just that it just defined it a bit more.
• 16:35
  Speaker 2: I think that's a great point that you make with that, where again the chapter opened up so much flexibility for you right and gave you the ability to look at your operations and workflow and, like you said, make those decisions.
• 16:48
  Speaker 2: Do I want a clean room?
• 16:50
  Speaker 2: Maybe not, you know and looking at, especially some places in like infusion clinics or oncology centers, where they don't need a full clean room suite.
• 17:00
  Speaker 2: They can operate quite well on a segregated compounding area because pretty much the patient comes in, says you know, maybe run a couple of blood tests or whatever, check a couple of things for that patient and say, oh yeah, we're good, we'll go make you your drug and we'll get it to you in like half an hour.
• 17:18
  Speaker 2: It's not like the drugs need to sit around for a long period of time and need a longer, longer date.
• 17:24
  Speaker 2: So you know your point on that is is 100 percent like spot on.
• 17:29
  Speaker 2: Usp really did try to make this a lot more flexible to meet a lot of different workflows and work environments and leave some decision making up to the pharmacy for what's actually best for them.
• 17:42
  Speaker 3: Sure, I think that, and I think you know, coming from USPs, I'm sure their perspective it's like they would have rather had, let's say, a clean room that was truly functioning, more of a clean room with appropriate BUDs, than, let's say, a facility that you know your air changes aren't really up to par, your surface sampling isn't really up to par, but you're still churning out products that you're putting a beyond use date of an extended period of time, and I think that that's the they're trying to kind of hedge some of that risk in doing that.
• 18:14
  Speaker 3: And so they're basically saying for those facilities that where their clean rooms are not really, let's say, the best of standards, they're basically saying you may need to just go ahead and demote to a segregated compounding area, because we'd rather you do that and put shorter beyond use states on, so that way we can, you know, protect our patients and protect the public.
• 18:35
  Speaker 3: It's kind of what it seems like the logic came to, absolutely so, speaking of some of this, I am always curious to see, you know, how other countries around the world are doing the same, are doing, and I'm wondering do they follow similar things?
• 18:52
  Speaker 3: Do they follow similar things?
• 18:52
  Speaker 3: Do they have their own similar guidelines or regulations, or how much.
• 18:58
  Speaker 3: How influential is USP?
• 19:07
  Speaker 2: I would say worldwide.
• 19:08
  Speaker 2: I mean generally speaking.
• 19:08
  Speaker 2: Usp as a whole is followed throughout the entire world.
• 19:10
  Speaker 2: Right, even though it's marked as the United States pharmacopeia, we see its use internationally.
• 19:13
  Speaker 2: And then there are other pharmacopeias out there, you know, like Japan has one and so on.
• 19:20
  Speaker 2: But as far as USP 797 goes, or the other compounding chapters, we do see some of those being adopted, like Australia, the United Arab Emirates, like they've definitely adopted USP 795, which was for non-sterile compounding, 797 for sterile and USP 800 for hazardous drug handling.
• 19:47
  Speaker 2: I think what's interesting too is, like our neighbors up north in Canada, they have their own standards which come from the National Association of Pharmacy Regulatory Authorities, which is NAPRA, and what they have done is put together similar standards where it's the same kind of concept of doing like non-hazardous sterile preparations, hazardous sterile preparations, and then they have one on non-sterile.
• 20:17
  Speaker 2: So it's very similar to what we have, and those were drafted based off of maybe unfortunately the last version of 797 in 2008.
• 20:28
  Speaker 2: So some of the things kind of aren't quite up to the same level as what we do in the United States, but they also put their own twist on some of those as well.
• 20:39
  Speaker 2: As far as Europe goes, it's sort of like the United States there, where different countries have some different regulations and some of them are a little bit more of a GMP feel than what we see here in the United States.
• 20:55
  Speaker 2: I think a good example of that is in the United Kingdom.
• 21:00
  Speaker 2: They have a couple of agencies and regulatory bodies there.
• 21:05
  Speaker 2: Where you know one of them, which is Medicines and Healthcare Products Regulatory Agency, they kind of put out the overall, like you know regulations and some guidance that are out there and really they are expecting adherence to good manufacturing practices.
• 21:22
  Speaker 2: So that's totally different than what we do in the United States where it's like, well, pharmacy, like no GMP.
• 21:30
  Speaker 2: We want to have nothing to do with with that, especially, like I said, in that traditional compounding setting.
• 21:37
  Speaker 2: And then they have also the General Pharmaceutical Council where you know they will do some more of the regulatory or overseeing of some of the standards but they'll also put out some information as well.
• 21:51
  Speaker 2: So you know it's it's different as well.
• 22:01
  Speaker 2: So you know it's different and I just think it's fascinating how the United States has not kind of quite adopted some of the same GMP mindset, even though some of those concepts are excellent and really should apply to what we do.
• 22:10
  Speaker 3: Yeah, I mean, you know, with US, I think you know US health care is always, you know, we're always at the forefront of technology and we're always also on the forefront of spending as well, and so it's always very interesting to see, like you know, especially if a lot of other countries they're looking at our health care models, if they're looking at even our facility design, and so I always wonder about that.
• 22:33
  Speaker 3: And so I always wonder about that, and I know that you know a lot of, obviously, other countries and just you know, if you see something really good, you want to, let's say, make sure that we were in compliance with everything.
• 22:56
  Speaker 3: But from what you say, it sounds like other countries.
• 23:00
  Speaker 3: It probably affected them as well when they were also having to conform to the new standards.
• 23:07
  Speaker 3: So that's, and then, and then, of course, europe, the fact that they're more, let's say, gmp leaning.
• 23:15
  Speaker 3: That's very interesting to me because you know that seems very and for you know, for the record, I think for our audience, gmp tends to be a bit more strict than USP standards, and so you would think that perhaps, you know, the more strict you go in terms of, especially in terms if you're talking about sterile products, that should probably, I think, logically, that seems to make more sense to be going in that direction.
• 23:38
  Speaker 3: So it's kind of interesting where we sit in terms of around the world.
• 23:43
  Speaker 3: I guess one question I also have for you is you know, based on your experience and I think I know that you have had a lot of experience looking at different guidelines and kind of trying to figure out you know which ones would work really well for these environments For you in an ideal clean room setting.
• 24:02
  Speaker 3: What procedures would you like to see performed in the sterile compounding process?
• 24:09
  Speaker 2: I don't know if there's anything like specific that I would say that's like missing from what needs to happen in the day to day that I see.
• 24:14
  Speaker 2: I would say that's like missing from what needs to happen in the day-to-day that I see.
• 24:16
  Speaker 2: But where we tend to be lacking a lot of times is with a focus on contamination control.
• 24:21
  Speaker 2: Right, because we're working in these environments where we're producing sterile medications but we know that that environment is not truly going to be a sterile environment.
• 24:34
  Speaker 2: We have to really work on preventing microbes from getting in.
• 24:39
  Speaker 2: So, ideally, like I really would love to see facilities spending a lot more time focusing on, like, their material transfer process, because we're bringing things from outside of the clean room inside and I don't know where those things were before they got here.
• 24:57
  Speaker 2: Right, a lot of our products may come from overseas.
• 25:00
  Speaker 2: You know they're sitting on a dock for a while and then they're making their way to a warehouse and you know, really thinking about the logistics of how those materials are getting to us, how they're being stored and all of the microbes that might be coming along with them, and trying to be sure that we're doing a great job, wiping those materials with appropriate agents to kind of limit some of that.
• 25:25
  Speaker 2: You know, along with that too, it's like garbing we actually didn't mention this yet but like 797 is a minimum standard, like if you follow exactly what's in that standard, you're a C student and for, I think, many of us, we're looking to do more than that and the chapter allows you to to go above and beyond and to do more.
• 25:46
  Speaker 2: And a great example of that is with garbing.
• 25:48
  Speaker 2: Like we're only required to wear like a clean room gown, so it doesn't fully enclose our body, so we're still shedding particles and like making a mess.
• 25:58
  Speaker 2: So it really would be great to be able to have a lot more places.
• 26:04
  Speaker 2: Be like you know what we're going to put on a coverall, or, as some of us call them, bunny suits, right and enclose everything that we have.
• 26:12
  Speaker 2: So we're trying to limit our impact on the space and really drive that contamination control point home.
• 26:18
  Speaker 2: So you know, that's really something that I would love to see the sterile compounding pharmacies take a lot more time to work towards implementing.
• 26:27
  Speaker 3: Yeah, and I think you know in that same vein for the next go around, as far as revisions to the USP standards, what trends do you predict will be included in that next set?
• 26:39
  Speaker 3: I think it's coming the next 10, 8 years, 10 years, 5 years.
• 26:47
  Speaker 2: Well, yes, we waited a very long time for changes this go round.
• 26:51
  Speaker 2: We had one come out for sterile compounding in 2008, and now it was 2023 until we finally got the next chapter being official.
• 27:01
  Speaker 2: It's a process.
• 27:04
  Speaker 2: I mean, I had the honor of serving on the USP committee the last cycle, so there's so much that goes into revising these chapters, to revising these chapters, one of the things that I would expect to see maybe not in the next cycle of the USP committee well, they're not touching 797 and 795.
• 27:26
  Speaker 2: For a while.
• 27:26
  Speaker 2: I don't think those are not going to be touched.
• 27:30
  Speaker 2: But the interesting thing that we have kind of going right now is that USP 800, which was on the handling of hazardous drugs, like in the healthcare settings, that came out in 2016.
• 27:42
  Speaker 2: So some of the language that you know was in the 2008 version of 797 didn't jive with the 2016 800.
• 27:53
  Speaker 2: And now we have the same problem where what's in 800 doesn't quite match up with what's in the new versions of 795 and 797.
• 28:03
  Speaker 2: So, to answer your question, I think we're probably hopefully going to see some changes to USP 800 in the next coming couple of years and, again, I don't know that it's going to be anything that's going to be making it more stringent or more difficult.
• 28:23
  Speaker 2: 800 just needs a lot of clarification, information, and actually there are some things that could get dialed back and actually make the chapter a little bit more user friendly.
• 28:33
  Speaker 2: Hopefully, seeing is there's an.
• 28:39
  Speaker 2: We actually have a quality assurance in pharmaceutical compounding chapter, which is 1163.
• 28:48
  Speaker 2: And I'm not sure that a whole lot of folks know that that exists, but it's an informational chapter that's definitely due for an overhaul.
• 29:02
  Speaker 2: So I'm hoping, as far as like USP compounding revisions, that one gets touched very soon and we'll kind of then be able to take the what's in 797 and explain the how's, because 797 tells us what to do but it usually doesn't tell us how to do anything, so getting some support in another chapter would be amazing.
• 29:25
  Speaker 3: Right, right, right.
• 29:26
  Speaker 3: And I think sometimes on the pharmacy side, the way that we interpret it, we kind of do it and we're like does this meet?
• 29:32
  Speaker 3: Does this meet what 797 is trying to say?
• 29:36
  Speaker 3: Yes, there's.
• 29:38
  Speaker 3: I think sometimes that there's a bit of a interpretation that is also confusing for pharmacists and sometimes related to regulations.
• 29:46
  Speaker 3: It would be nice if it was just very straightforward and very, like you know, obvious about how to do it.
• 29:51
  Speaker 3: So, yeah, that's very, that's very interesting that you know with with the new guidelines.
• 29:57
  Speaker 3: So I mean, this last, this last go around, was pretty earth shattering, I know, for in the pharmacy world and you know, just to give our audience a background, I mean, it's like it came out.
• 30:08
  Speaker 3: I think they first did kind of like a soft preview where they announced it to the world like, hey, we're going to change it.
• 30:13
  Speaker 3: And then I know that there was there was the response was there was such a strong response from the pharmacy community that they had to put it on hold for a little bit and then, and then they resumed it in 2023.
• 30:25
  Speaker 3: So, and unveiled the final product, I should say, and we're all still adjusting to it.
• 30:32
  Speaker 3: I think the I know the initial like first six months or first year.
• 30:36
  Speaker 3: Oh man, it was.
• 30:37
  Speaker 3: It was a rough time for us all because, you know, we were really just I mean trying to digest just the new information and obviously everyone in pharmacy want to be compliant.
• 30:47
  Speaker 3: We want to do what's best for the patients, but we also wanted to interpret the new, the new standards correctly.
• 30:55
  Speaker 2: Yeah, and that takes time and money.
• 30:58
  Speaker 3: And money Exactly.
• 31:00
  Speaker 2: Because a lot, of, a lot of the changes did result in either needing additional staff or, like we were talking before, funding for renovations or, just now, being able to like the competency tests, for most people went from annually to every six months, doubling a huge workload for whoever's administering those.
• 31:21
  Speaker 2: So, yeah, definitely was a big change.
• 31:26
  Speaker 3: You had talked about competency and I know that we had recently attended the an American Pharmacy Association American Association for Healthcare Pharmacists a presentation and I remember in one of those they were talking about the competency even shifting versus like pass fail.
• 31:46
  Speaker 3: I think some of our traditional ways of doing competencies to maybe do it more on a graded scale of some of our procedures and you know, I think even that was just very just different thinking because we are trying to adjust and adapt to the newest new USP standards.
• 32:02
  Speaker 1: You guys have stimulated some thoughts in my head, which is not necessarily a good thing.
• 32:07
  Speaker 1: But I got one comment for you, abby, and a question that you're not going to be expecting.
• 32:15
  Speaker 1: So the first comment I have is for both of you folks.
• 32:19
  Speaker 1: You know I'm a supply chain generalist, so suppose I was at the Cedar Crest Campus over there Lehigh Valley Health Network, where I used to be at one time anyway and I decided well, I think I want to build a consolidated service center in Lower Macungie and I think I want to throw the pharmacy in there too.
• 32:38
  Speaker 1: I would realize from listening to this presentation that I needed to know a lot of stuff before I made any decisions, and we have two different types of expertise present in today's session.
• 32:50
  Speaker 1: We have Sharon, who is a pharmacy operations specialist, and we have you, that's a microbiology specialist.
• 32:57
  Speaker 1: You know to take care of avoiding all the really you know the really hazardous mistakes and processes in design.
• 33:04
  Speaker 1: I think we have another session that we've identified here that would be just a good session about hey, I'm thinking about putting my pharmacy operation in a consolidated service center.
• 33:18
  Speaker 1: What do I need to do?
• 33:19
  Speaker 1: I think you guys could do a great job and I'd love to have another session with you about that.
• 33:23
  Speaker 1: Does that sound fair?
• 33:25
  Speaker 2: Yeah, sure Sounds great.
• 33:27
  Speaker 1: And now for the big question that you're not expecting, Abby how has your experience as a microbiologist helped you as a youth soccer coach?
• 33:41
  Speaker 2: Oh well, so that's a good question and I actually have an answer for you on that one Having coached like five year olds.
• 33:52
  Speaker 2: They're unpredictable Microbes are unpredictable.
• 33:57
  Speaker 2: So definitely, having that that microbiology background where you don't know what to expect from those microorganisms Maybe they're going to grow today, maybe they're not going to grow today it was the same as coaching five-year-olds where you know what, is Amelia going to decide that she wants to play soccer today or is she going to sit down in the middle of the field and we're going to try to figure out how to still have a good time.
• 34:28
  Speaker 2: And that's really my takeaway from micro and how I've kind of applied that to coaching kids too.
• 34:35
  Speaker 2: You just have to go with it.
• 34:38
  Speaker 1: A follow up question, then, is do microbes always run toward the ball, no matter what they're supposed?
• 34:50
  Speaker 2: to do?
• 34:50
  Speaker 2: Oh no, they stay in their position, fred there you go.
• 34:56
  Speaker 1: So if you've ever seen, if you ever seen five-year-olds playing soccer, it, it doesn't matter what's going on.
• 35:02
  Speaker 1: Wherever the ball is, that's where they are.
• 35:05
  Speaker 2: That's right.
• 35:07
  Speaker 1: Well, abby, it's been great having you on the episode and, like I say, I think there's a lot of subject matter here that we could get into another discussion about, because it just jumps out to me, being a generalistist, that if I want to try to do something, I need to know, I need to have a lot of good information before I can commit.
• 35:29
  Speaker 1: And pharmacy it's even more so than just figuring out how big of a warehouse you need to design to accommodate med-surg distribution.
• 35:38
  Speaker 1: It's a lot, lot different.
• 35:39
  Speaker 1: So thanks so much for joining us.
• 35:41
  Speaker 1: I hope you have a great weekend, sharon, thanks for your expertise, as always, and we'll see everybody again in another episode of Taking the Supply Chain Pulse.
• 35:53
  Speaker 1: Thank you.