Brian Nowosielski  0:21  
Hello. My name is Brian Nowosielski, and welcome to the Over the Counter Podcast. Today, we're joined by Mitch Lamb, Senior Director of Regulatory Operations and Services at D2 solutions and pharmacy industry expert with over 15 years of professional experience. D2 Solutions is a healthcare consulting and technology company focused on market access, reimbursement and patient support. Welcome and thank you so much for joining me today. 

Mitch Lamb, PharmD  0:46  
Hey, Brian, thanks for having me. 

Brian Nowosielski  0:47  
Awesome today. Mitch and I are going to be discussing pharmacy accreditation. More specifically. We'll be talking about the operational challenges behind it and why today's pharmacy landscape calls for it now more than ever. Mitch to start us off today, what are the primary or most common reasons for why a pharmacy business would seek some sort of accreditation?

Mitch Lamb, PharmD  1:07  
Yeah, that's a good question. I think it's something that a lot of people aren't even aware of when they get into pharmacy. When I was fresh out of school, working out of retail like you would expect the corner drug store, something that that never comes across your plate. But the world of specialty pharmacy is more unknown than some of the other facets, I would say. And we're talking high-dollar, rare medications, the more dangerous drugs, the serious side effects, like chemotherapy and that kind of stuff. And to be able to sell these drugs, it's not like your standard blood pressure medications, where it's available to everyone who is a licensed pharmacy, who can get into that network. These are limited distribution drugs. And if you're a manufacturer and you have a specialty drug, you most likely have a limited distribution network. So they specifically want one or a handful of pharmacies to handle their medication, and they're only going to pick the best of the best. They're not going to tolerate anyone who's not up to snuff, right? So one of the ways they do this, and this is truly, like, the first barrier of entry to get into these network, is, do you have an accreditation? Do you have two accreditations? What do you do? What kind of accreditations are they? And that's truly the first step into network access as a pharmacy, to even begin the business.

Brian Nowosielski  2:33  
Awesome, cool. Yeah, I appreciate you laying the groundwork for what it is, what, why it's needed. We can definitely, we can try to keep this conversation in pharmacy, in general, specialty pharmacy is more the fits the mole within this conversation. So good, that's totally fine. So kind of discussing the time frames, I guess you could say, but why is treating accreditation as a constant operational pulse more effective than treating it as a kind of one time milestone?

Mitch Lamb, PharmD  2:59  
I would go a step further than that, actually, Brian, and say, it's not an option. You have to, and the reason I say that is experience. So folks will come to us and say, "Hey, we want to get in this network, help us get accredited." And reaccreditation isn't for three more years. And then they would do nothing for three years, and then come back and say, "All right, time to get reaccredited, by the way, we've done nothing," and by then it it's so much harder to get re accredited than the initial accreditation, and I think that's something a lot of folks don't expect. And if, if you're relatively inexperienced as a Director of Pharmacy making these decisions, this can sneak up on you. When you have these tasks and it's very laid out. You have to do this task at this interval. You have to do this task, and you have to say in your PNP what the interval is, and then you have to document that you're doing it. Documentation is nine tenths of the battle here. And some of those steps, some of those requirements, not only do you have to attest that you're doing them - I'll give you an example, the PSVs, the license verifications, when you get those are date and time stamped from the Boards of Pharmacy, so you can't cheat that, even if you wanted to. You can't lie about it. If you didn't do it, you didn't do it. So if you're not keeping up with it, you're going to come back with either, either just a flat out refusal or a conditional accreditation where they say, Okay, you're basically on probation until you can prove to us, and then we'll give you a full accreditation down the road. And you really don't want to be in that position, and it's preventable. It's just when you go into it, you don't know what you don't know. 

Brian Nowosielski  2:59  
Awesome. Perfectly said, yeah, obviously, I think that's like the perfect answer as to why it needs to be that pulse, like I had asked, obviously, those intervals, those deadlines, can cloud anyone's like judgment or how they work, but being proactive seems like the best kind of first float forward, as far as keeping up.

Mitch Lamb, PharmD  2:59  
Yes, sir. It's the only way to do it. We had to adapt our business to help people. Not only do the accreditation, the reaccreditation, but we had to build a whole new division just to help with the monthly process, where we're basically holding people's hands to get it done, because it's that important, and it's it can be that difficult.

Brian Nowosielski  2:59  
Awesome. And like you said, it's not optional. So conversations like these are super important no matter when they happen. 

Mitch Lamb, PharmD  2:59  
Yeah, imagine getting kicked out of network with the manufacturer they don't want to do business with you because you didn't keep up with you didn't keep up with your accreditation. That could be as catastrophic to your bottom line. So it's a big deal. 

Brian Nowosielski  3:45  
Awesome. Yeah, very well. Said, cool. So just wanted to touch on some risks and some challenges, and then wrap this conversation up with assessing what's going on right now, as far as like everything in the industry related to accreditation. What are the risks associated with last minute preparation for pharmacy accreditation, as opposed to putting a significant and well established focus on it, as we briefly touched on previously.

Mitch Lamb, PharmD  4:08  
Yeah. So again, the primary focus, the key is you want to keep in network, and that's your risk factor. That's number one above everything else. You know, if you're not doing specialty, if you don't need it for network access, then accreditation becomes a different a different tool together, where it's saying that you're a leg up on all the other competitors, all the other pharmacies, and you can use that for negotiating purposes. But when it comes to network access, that's truly the crux of it, I would say.

Brian Nowosielski  6:22  
Awesome, yeah. And then a lot of talks outside topics like these, is like interoperability and pharmacy and making partnerships connections, and this is like the and when you bring a pharmacy business, is bottom line in there. Like, network access, obviously seems like one of the one of the most important, if not a very important, kind of aspect of as to growing your bottom line, growing your revenue, having access to those drugs and dispensing, as far as see fit, definitely makes sense like this. Personally, this isn't a topic that it's, it can be very confusing, I'm sure, like those bottom line type of things like that's it's very understandable and important. I can see the importance in that. 

Mitch Lamb, PharmD  7:04  
That's the only angle we've talked about so far, or I've talked about so far. But moving aside, from just business wise in dollars and cents, all of the standards, if you go through and look at them one by one, at the heart of them, what the accreditation organizations are trying to do, whether it's your URAC, ACHC, whomever, they're best practices, they really are. So at the end of the day that what's the name of the game is to help the patient. That's why any of us have jobs - full stop. And while you're in the midst of it, and you're like, you're looking at some of the metrics you have to gather, and you're wondering, why are we doing this? We're just checking off boxes. At the end of the day. That's why these are best practices, and we are trying to always improve the quality of service for the patient, that sometimes it's easy to get your eye off of the goal, but at the end of the day, that's why we're all here. 

Brian Nowosielski  7:54  
Awesome. Yeah, that was perfectly said. Cool. So talking about the challenges, I have a feeling this will go into the documentation of it all. Like you said, that's a big portion of all this. But what are the most persistent challenges within this space, and what prominent tools or technology has risen to alleviate pharmacies and pharmacists burden?

Mitch Lamb, PharmD  8:14  
Yeah, good questions. All right, so some of the most persistent challenges, so the documentation is number one, and that's truly why we created AccredComply, which is one of our tools to help with this. So having the organization with that much data, with just the recurring task, and the tasks are coming from different silos within the company, there's a lot of moving pieces to it, so organization documentation and then further in depth to getting some of that documentation can be challenging. One that jumps out just off the top my head: shipping. Shipping is always a bit of a nightmare. It's a little bit easier with the current standards than it's been in the past, but sending out shipment tests. So, you go to an area, we ship to the Pacific Northwest, we're going to set out. It just an empty tote, basically, have some temperature monitors on it, and then we're going to see if it holds water. We're going to test our pack out. So doing that and keeping track of that has been notoriously difficult for folks in the past, so things like that are truly hurdles as for what's in the marketplace now, traditionally, there's been consultants, such as ourselves that can help folks get across it, and there's not a whole lot in terms of technology out there, other than AccredComply through us. And that's why we built it. We needed it. We needed a tool to help facilitate our own clients through it. And then by the end of building it, we said, oh, we have a product here, so we basically turned it loose for other folks to use too, but it there's still so much uncharted territory out there to be had. It's truly an amazing space to work in.

Brian Nowosielski  9:52  
Awesome, great, no, yeah, I appreciate you touching on various aspects cool. So I'm going to touch on one more thing, and then I'm going to add on kind of a last follow up question and give you the floor to discuss things that we may not have talked about, but in the meantime, with pharmacy based services ramping up now, more than ever, obviously, sure you're no stranger to understand that that's where the crux of what pharmacies want to be doing to keep themselves sustainable with that kind of going on right now. Why might this be a unique moment for pharmacy accreditation?

Mitch Lamb, PharmD  10:23  
With doing the other pharmacy operations, such as, I assume you're getting towards more things like pharmacists giving vaccines, pharmacists prescribing, that kind of thing. So the accreditations generally aren't talking to those items specifically, you'll see that come up more in like CE regulations. So if you're a pharmacist, are you giving shots? And if so, you have to do an hour of vaccine, CES and state X. So a lot of things will be covered there. The accreditations, at the end of day for that kind of business model, are truly honing in best practices, like we talked about earlier. But in terms of market access, that kind of thing, you're not going to see a whole lot of impact there for it. It's truly getting into network to begin with, where it's really the most bang for your buck, where it's the most powerful. And it's one of those things where, if you're a corner retail store and you're an independent and you're really just battling the $4 list, that kind of thing, you may not have $40,000 to go out and get an accreditation to say I'm better than the guy down the street. So it's one of those things where you need to evaluate your position and market, where you are, where you want to be, and what's appropriate. And that's conversations that we have with folks all the time.

Brian Nowosielski  11:33  
Awesome, cool. That's all I have for you. But just wanted to give you the floor to see like, whether it be like develop, developments ongoing right now, or just like general main takeaways from the pharmacy accreditation space right now. But is there anything that we didn't touch on that you think is, like, super important, that you think our audience would take away from this?

Mitch Lamb, PharmD  11:51  
I guess one thing that I think is pretty beneficial to the pharmacy industry is how the standards change from version version, and I'll use URAC as an example, because they've recently, recently turned over from 5.0 to 6.0 and, and you see those standards change, and you see them evolve with the times. And I know I talked about shipping earlier, they've really changed shipping in the standards and what's required, I think, in a positive direction, not just for pharmacies and workload management, but I think it also benefited them and their surveyors and their workload as well and how difficult it is to manage. So I think they do a pretty good job of evolving with the times and staying current. So it's always interesting to see what they change when the new standards come out, but that's something you really want to keep your ear to the ground with, if you are one of these people, where your company has tasked you with keeping up with accreditation, you want to know when their standards are coming and then what's changing within them.

Brian Nowosielski  12:49  
Awesome, yeah, and definitely goes back to that, that proactive and just the best businesses, the most successful ones are the ones that are staying up with stuff like this and checking all the boxes. And even going beyond that, I appreciate providing some nuance to a complex thing within pharmacy that's always been there and will always be there, but, yeah, I really appreciate you taking the time today. 

Mitch Lamb, PharmD  13:34  
Oh, happy to be here, bud. Anytime. 

Brian Nowosielski  13:44  
Awesome. Thanks, everyone.