How Technology Is Affecting The Future Of Compounding Pharmacies? Pharmacy Technology

How Technology Is Affecting The Future Of  Compounding Pharmacies? Pharmacy Technology

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thank you everybody for joining us today we are back with lou diorio and we are going to be touching on a couple of different topics but we're starting out with technology and how technology is going to affect the future of pharmacies and i'm excited about this topic because not only is it important and lou has mentioned he's been seeing a lot of changes lately but we are going to be talking about this at the conference as well so this will be set us up so if you have any questions you can bring them to the event anyway lou why don't you introduce us to the topic hi good afternoon everybody as as the boss said we're going to talk about automation technology and software which i see as three different things immediately when we talk software everybody has some software available or in use technologies are sort of to me the tabletop low lower cost entry into the world of automation and robotics and then i'd like to talk a little bit about true automatic robotic practice and the reason that i i sort of pestered vivian uh to to to put this together today is that we're seeing a direct trend from the post sort of coveted fallout of shortages right everybody's talking about shortages supply chain is a problem supply chains disruptions supply chain shortages i want to focus on two two shortages in particular human resource shortages the every one of our clients has reached out to us to talk about or whine about or complain about the inability to find competent and qualified technicians to help in the compounding process as well as the inability to find competent and qualified pharmacists to help in the compounding process so that's one that's one facet of the shortage i want to talk about the other piece is no great surprise to anybody that continuing and fluctuating drug shortages so the shortage of raw materials finished goods uh all of that sort of plays into the conversation that i'd like to have this afternoon i thought it was interesting and with vivian and i talked about this i thought it was interesting that folks that six months or a year ago didn't have the money to invest in their compounding infrastructure to the tune of ten thousand dollars are now reaching out to ldt and to me to to help them vet devices that are in the neighborhood of 350 450 a million dollars and that shift in the conversation you know struck me as obviously very odd and when you drill into why that's happening a couple things and the biggest one is that the shortage of labor and the fluctuation in labor is driving this because you can be more efficient with the core staff that you have and a call out or a you know a cluster of covid cases that puts a small amount of your staff on the shelf for that that sequester time that everybody has in their protocols or should have in their protocols per the cdc that helps you sort of level out that labor model so when we're talking about investing you know three hundred and fifty thousand dollars in a syringe filler or six hundred and fifty thousand dollars in a in a oncology robot those costs are more easily reachable if you put them in the context of you know how does that help me flatten out my and become more efficient with the labor i do have and then all of the other safety and efficiency sort of tenants come with that vivian right barcoding and particle counters and cameras and label capture and the and all the other elements inside their safety software that makes your production more traceable more trackable and in the event of a problem much more easily recallable so that's that's sort of that piece and then if you make the assumption that the folks that are investing these significant dollars in this type of robotics they do a full implementation how does that play in the conversation about drug shortages the shortages of api the shorter shortages of finished uh fda approved goods that go into compounds i i would you know i take the stance that if you can use the things that are already built into the basic robotic uh software things like grouping like products together things like you know using overfill and using uh using multiple vials more efficiently um in in these robots that doesn't eliminate a drug shortage because if you can't get it you can't get it but if you do have a limited supply of whatever drug we're talking about it is probably a better bet that automation can help you maximize what you do have on hand as opposed to leaving it up to individual humans who may or may not have the same sort of skills the same sort of fastidious sort of thought process to make sure that you do maximize whatever raw materials you have on hand so right so the idea being that once it's automated and you've got the robots you eliminate any risk of excessive waste right and if you go to my website we talked extensively about control process controlling the process so if you can standardize and control that process as it rolls along and that's exactly what the robot and its software is designed to do that that forces the efficiency that we're talking about so at the end of the day you do get something for these really big outlays of money right now and i i think i mentioned i talked to one company and they had something for ivs uh automating the iv process and they said and i don't remember exactly what how it worked but it was something about how it not only automated the process or created more efficiencies but it also i guess helped on time from running back and forth between the pharmacy i guess you could have all the stuff right up there and then it would it just automatically mix everything does that sound about right yeah since i talked to them yeah i mean you know you if you dedicated five minutes to a uh compounding robotics and you know you you put that into google you'll come up with you know thousands and thousands of of hits and i think you know from a compounding perspective you know you have companies like uh like equishield like uh riva that are out there that are the new generation of automation there are other companies that have been around a while older technology but now we've gotten to the point where companies like um uh like grifles are are you know are developing they're not purchasing automation they are using their own engineers to develop true automation geared to pharmacy because the first generation of robots you know 10 15 years ago they were all repurposed from you know robotic arms and things like that were repurposed from detroit so they were using a slightly modified assembly arm robot that would have been you know putting rivets into a car and adapted it to the pharmacy practice but now because we are two and three generations removed from that companies that have an engineering perspective or an engineering resource are doing things specifically for pharmacy so for those folks out there that are looking at large production for the for you know whether you're an a or a b if they're looking for repetitive formulations and high volume you know right off the rack you can get stuff for vial filling syringe filling uh flexi bag filling um if you have something that's a hybrid of that or something that's more specialized uh because of the competition the uh the they're more apt to actually be able to create for you a custom solution so that's kind of exciting so there are things out there that can help you and you just have to do your due diligence get out there and and talk to folks um and there and as i said it you know robotics full-blown automated robotics can start at a couple hundred thousand and go to you know over seven figures so it's a big big play it's a big market let's talk then a little bit about the market that we're talking about because it i know that you put when we talk about this a lot of times it's mostly about hospitals but how about how does this tie into 503bs and 503as yeah no i think it's not exclusively hospitals i mean hospitals embrace syringe technology and repetitive fill technology because of the nature of their practice and because hospitals could control a formulary and they could sort of funnel doctors prescription habits into a limited sort of song sheet but 503as because they are in a more competitive marketplace had less ability to do that but because of fda activity and the requirements for end product testing and sterility testing and the the expenditures that are required to put together a valid beyond use date to put on your prep the marketplace has you know as far as the breadth of skus the number of of items that are being produced that's actually coming down so it's actually 503a practice community practice independent compounding has actually come to sort of meet that so if you do have a practice where you have several um you know repetitive fixed formulations that you are spending an incredible amount of labor to produce well then why not automate that process for 503ps uh and this goes back to this goes back to the early 90s when robotics started to rise and really get up to sort of a commercial um a commercial viable commercial point um companies like caps companies like farmedium investigated investigated robotics and and farmedium in particular was looking at automation back then because they're um you know both of those providers their their compounding model is and was very well for mediums gone but the the model was very hands-on literally and labor intensive and the reason that they didn't jump in the boat for automation was the lack of throughput so relative numbers i mean we have production pharmacies that are manually creating with a single technician you know for round numbers 50 to 60 iv bags an hour with a relative you know with relative uh ease and with a high level because of barcoding and because of some other in-process checks with a high level of confidence you look at a you know you look at some of these automated you know robots and after you plop down a million dollars their top throughput is somewhere between 15 15 and 20 bags an hour so you know it's economies of scale now that seems to be shifting there are robots out there that if you do a single fixed formulation over and over and over again they can get you to uh on the syringe side 150 units an hour and on the on the iv bag side um 100 you know 100 plus depending on exactly what the preparation is so it's more reachable so 503bs are you know depending on what their business is there are obviously um i've been to 503bs that are already using robotics because the great um the great bulk of their menu if you will are syringes and syringe fillers have been around for a long time and and so have uh you know vile filling equipment it's just a matter of you know in the past you would go and you would buy what was traditionally considered a um a full-blown cgmp vial filling line so that would come with a huge price tag that would come with a lot of burden of upkeep and set up and uh and a certain amount a certain expectation of engineering expertise that you had to have on site to tweak these lines i mean we had a client uh several years ago that was moving towards 503b they were using a cazzoli vial filling machine that at full production could fill and cap thirty thousand vials an hour their batch size was two three four thousand so they would spend the entire morning setting this thing up run it for half an hour and then spend the rest of the day cleaning and breaking it down so you know that that kind of labor you know that kind of labor math really didn't make too much sense but now with the new technologies getting smaller getting more user-friendly um it's more reachable you know and and you know god well my question is uh okay so that's really good information but my my what i was wondering my next question is you said that all these clients now are calling you and asking you what is it what are the questions that they have what is it that they're asking you to look into is it just that to look into the specifics or how you can um the specifics of what will work for them or is it also things like how can they streamline better streamline their entire process and then you you kind of left up to figuring that out yeah the assumption yeah the assumption the assumption is that any automation and and it's probably not correct but i'm sorry to interrupt there's more questions there is another part of that question which is um good lord now i forgot what it is was sorry i didn't mean to interrupt started it no i just went out of my head the the jumping off point is that any automation is going to make you more efficient and and increase your throughput that's only true to a point if you have to totally scrap your labor model you have to totally scrap your your operational and production model you only do that if you really are getting a significant change a significant uptick in your process so some of the more small scale folks it's a matter of right old the old technology was you buy our robot you have to do it our way well with software being where it is now and the flexibility of some of these robots they can actually push it into your current process and make that process more efficient not it's not as it was in the old days where it was a a matter of throwing out the baby and the bath water and having to learn the robot right this is the old for those of you that were uh you know twilight zone fans right is machine serving man or is man serving machine and you know my my sort of experience is probably the best solution for you and there's no one solution but probably the best solution for you is somewhere in the middle right so so that's one consideration the other bit of vetting beyond price is the ability to finance right which is you know monetary space right do you want to or do you want to bring in a robot that's going to require huge renovation in your in your physical plant in the in the past i would almost bet 90 of the time that if you brought in automation you had to expand your footprint that's not true anymore those technologies that i mentioned at the top that are tabletop in addition to some of the newer robots they can basically fit into the same footprint that you have a six foot laminar flow workbench or a six foot biological safety cabinet so it's a matter of now you have the real estate it's a swap out the other bit of this is you know can you can you get the right disposables are the supplies available for for these robots that's why there's a lot of question you know this question comes up a lot more when you're talking about hazardous drug there's a hazardous drug robot out there that uses their own proprietary spikes and tubing and you know that to me is kind of a foolish uh you know you're putting yourself into a corner by design and if we're talking about single source and supply shortages why would you want to do that to yourself so that's a concern the other bit of this is you know the software how difficult is it to learn the software how much support am i going to get from the vendor you know how much customization of the software or integration of the software into my uh into my pharmacy or into my hospitals his system right even for those guys those guys and ladies out there that are doing long-term care uh compounding and you know can you you know is this have you just created an informational island and you're gonna have to do a whole bunch of data entry to get it into the into the medication record so so a lot of that gets gets flushed out before any contracts are signed what does it take to clean these things how much is it going to cost for me to validate uh the uh the the the products the preps that are made on these robots um you know it's not part of current 797 but is certainly in the proposed um the proposed 2021 out for draft chapter that the the validation of these robots is going to become is is going to be less sort of fluid and more rigid in its requirements so that comes with an associated cost so we are more than capable of doing a match between the pharmacy and the reference laboratory that's going to do that testing can that testing you know if that testing is not done correctly and questions get asked by an accrediting body like the joint commissioner achc the local board of pharmacy or the fda and you don't have robust enough data that whole program goes offline until you can provide those documents to whatever whatever regulator is asking so those are all the complex things that we go through when we talk about vetting and setting up an implementation plan for the particular pharmacy or compounding business that we're talking about okay big or small yeah all right good we have to end it there because we're past our 15 minutes but i guess the beauty of this conversation is if you want to know more you can come to the conference there you go

2022-08-04 20:01

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