Drug Tracking's Impact on Pharmacy | Stephanie Varner, Capital Drug

This transcript was generated automatically. Its accuracy may vary.

[00:00:12] Mike Koelzer, Host: Stephanie for those that haven't come across you online introduce yourself and tell our listeners what we're talking about today

[00:00:20] Stephanie Varner: my name is Stephanie Varner. I'm the director of marketing for Capital Wholesale Drug Company. We're a wholesaler based out of [00:00:27] Columbus, Ohio, but we sell in the whole country. We're gonna talk about DSCSA from a wholesaler perspective.

 And what we're doing to prepare and how we can best support independent pharmacies.[00:00:42] 

[00:00:42] Mike Koelzer, Host: All right now stephanie When I hear that you're the marketing director

But you're doing the DSCSA, it makes me think that your title is marketing director and other crap that people [00:00:57] don't want to do 

[00:00:58] Stephanie Varner: You're correct. 

[00:01:00] Mike Koelzer, Host: I've been there. I've been there so many times because when I think of this DSCSA, it's going to take a lot of marketing to get it.

Across to people and,[00:01:12] all that kind of stuff. So it's going to take a lot of communication. And I imagine that's a skill that you're well schooled and qualified in.

[00:01:20] Stephanie Varner: The DSCSA has been around a long time. This started in 2013, [00:01:27] but people still don't understand what's required to be compliant. We're running into it every day. And then those that do understand what's required to be compliant they're not quite sure how to get there.

ANd there's been a lot of [00:01:42] changes. 

So that's been our mission for the last 12 months just getting out any kind of information that will help support the pharmacy, [00:01:57] Stephanie, here's my problem, the damn abbreviation is too long. I need something that turns it into a word like scuba or something like that. There's no word for [00:02:12] this. I mean, I'm looking, it's not like discs or something like that.

[00:02:16] Mike Koelzer, Host: There's no word. And then when it goes over four or five letters, that's too long for me. So I know it has the D, but then I get kind of mixed up in there. It's a long abbreviation .

[00:02:25] Stephanie Varner: It gets really [00:02:27] messy, in my opinion I just try To keep it as simple as possible when we're communicating. When we don't know the answer we go to the experts. We have experts with the HDA, um, the [00:02:42] Healthcare Distribution Association. They're wonderful. Super supportive for helping us understand what we need to do to comply 

[00:02:52] Mike Koelzer, Host: well one thing I do in pharmacy is I've learned over the years that when [00:02:57] these rules come out, you see different rules all the time, in Michigan we had one recently where they said that In general, doctors could no longer use paper prescriptions over the phone or fax.

They all had to be electronic and so on. And [00:03:12] I've learned that I sort of hang back a little bit just because it seems that there's enough pharmacists and businesses that need to know the black and [00:03:27] white part of it, it's done me okay over the years, just to kind of. Sit back a little bit. I remember years ago I slowly did triathlons and we'd be at one of the pre race meetings [00:03:42] and somebody would raise their hand and they'd say when we're doing this course, when we get to such and such, do we go left there or right or through the path?

And I was always thinking to myself, it's like [00:03:57] looking at that person, not to be judgmental. They don't look like they're going to be in first place, so they don't look like there's going to be a problem. And I thought if they're that far behind where they [00:04:12] can't see the person in front of them to follow, they probably shouldn't be in the race anyways.

So some people worry about those and it's good, but like in this one, I realized that because a lot of the stuff coming [00:04:27] down, it seemed like there were so many questions, sure enough, it was then delayed a year.

[00:04:33] Stephanie Varner: I think the DSCSA was put into law to 2013, and the whole intention [00:04:42] was to have the, all of the different steps, you can define it into 10 steps, 5 steps, but everybody would be at the same place by November 27, 2023. And one of the things that we started to [00:04:57] recognize in the beginning of this year was that the manufacturers weren't ready.

A lot of them hadn't even started the electronic process of connecting with the wholesalers, let alone having product identifiers on every [00:05:12] single product. item they sold. And you have to have all of that information shared before you can even start this process. So one of the things that we were very vocal about with the HDA and [00:05:27] whoever would listen to us was our concerns about whether or not the manufacturers were ready and what the disruption to the supply chain would look like.

If they weren't ready for us to receive the product in, [00:05:42] we have to have complete tracing documents. All of the information required by DSCSA has to be completed on those documents. Or we have to quarantine that product until we can get it straightened out. Well, every [00:05:57] single.

Product identification has to be complete in these documents and You may get to a production status and the connection with the manufacturer for a month Everything's smooth going along just [00:06:12] fine. Then they make a change to one of their labels Maybe change the size of a container.

If they don't communicate that information back to us, now the connections fail. The files come in and they fail. [00:06:27] And now it stops the process. 

[00:06:30] Mike Koelzer, Host: So let's say a big pallet of drugs comes in. Where before you could basically say, all right, there's the palette.[00:06:42] 

Do wholesalers then have to scan every bottle or what you were alluding to so that you can take the word from the manufacturer that these thousand bottles on here [00:06:57] are X one to X one thousand and. That's good enough, but I imagine then if that is good enough, you'd probably have to scan them individually as they go to the Pharmacy [00:07:12] though because somehow you have to find out because they're not getting a thousand at a time.

[00:07:15] Stephanie Varner: Correct. So, when we get a pallet we scan the label on the outside of the plate, license plate, whatever you want to call it on the outside of the pallet, and then we can receive the product as [00:07:27] as long as the data is matching up. to the ASN, which is an advanced shipping notice that we get from the manufacturer.

We scan it, we look at it, everything's got to match up. Then we can accept it and receive it and [00:07:42] put it on the shelves. When we pack an order, capital, we scan every item that's going into the tote. So, it's checked in two places before it even ships. So, we have the pickers who scan it. [00:07:57] And then we have the packing team that scans, and then we box it and ship it.

[00:08:03] Mike Koelzer, Host: Is this going to be a barcode or more like a QR code? Because every bottle has to be different. It has to have their own license

[00:08:11] Stephanie Varner: [00:08:12] Yeah, right now it's a 2D barcode that's on the bottle, on a, on each container. Anything with a package, it's labeled. And right now it's the T3 information. So you're tracking the [00:08:27] information on the content in that package. You're tracking where that product came from. That's currently what we're working with. That changes once the law goes into effect. And it becomes more [00:08:42] complex. There's different data that's going to be required. It's much more extensive, it has a serial number for every single bottle of product identifier.

And then in that information that's passing back and [00:08:57] forth, it's location.

Everybody has to have a global location number that will have to be part of this whole process once it changes over. 

Right now there are parts of this law that are in effect. They can be [00:09:12] enforced. When the stabilization period was announced it's the enforceability of the law that's changed. It's not the fact that it isn't going into effect because it is very much going into effect. And what we [00:09:27] found, in fact, at the end of August when this stabilization period was announced, we had a huge uptick in manufacturers.

Getting into gear with us, getting the information to us, starting the connection. They started testing [00:09:42] files. WE anticipated when this announcement was going to come out that everybody would just slow down and go Oh, we got a break. We can just relax a little bit. We noticed exactly the opposite with our manufacturers that we aligned [00:09:57] with when we have over 250 and they really Many of them really started kicking into gear and this is after four or five emails trying to call them. When are you gonna start up your connection with us?

But really, they [00:10:12] really started moving along after the announcement, which is not what we anticipated.

[00:10:18] Mike Koelzer, Host: wAsn't it like October 1st or something when it was supposed to go in or was it the first of the year?

[00:10:23] Stephanie Varner: It goes into effect November 27th, [00:10:27] 2023.

[00:10:27] Mike Koelzer, Host: But that's off now till 2024. Oh, the 

[00:10:30] Stephanie Varner: the 

enforcement, the enforcement of those electronic interoperable documents

go into effect. 

[00:10:40] Mike Koelzer, Host: It's supposed to be going, but they're not gonna [00:10:42] come down on you until

a 

[00:10:44] Stephanie Varner: Correct. So, we're putting everyone in place to make sure those processes are complete before we send the product out. If there is an issue with the tracing document, [00:10:57] with an EPSIS file eventually, then... You have to correct it before you can receive it. 

And a pharmacy, when a dispenser pharmacy receives a product, right now they're supposed to look at their [00:11:12] ASN, their advanced shipping notice, and make sure what they ordered is in line with what's on their advanced shipping notice.

And I know a lot of people don't do it right now. It's not being enforced right now. But it could be enforced. If somebody wanted [00:11:27] to enforce it, they could enforce it. The tracing document should align with whatever you've ordered. All of it should have complete information on it. And if you're missing information, you have to make those corrections.

[00:11:40] Mike Koelzer, Host: And then Stephanie the [00:11:42] pharmacist, then the pharmacy, they've got to get this and then they've got to then in turn, know exactly what bottle was used for what patient, right? It goes all the way down through that.

[00:11:55] Stephanie Varner: The product [00:11:57] that they dispense has to match up with what's on their shelf. Whether or not it's specific to the tracing of the dot of the item is stopped Once it received into the pharmacy,

[00:12:10] Mike Koelzer, Host: Oh, it stops there. 

[00:12:11] Stephanie Varner: It's not [00:12:12] from the pharmacy out to the patient 

So when you dispense it, you're not tracking it any longer. It's just what you receive in and put on your shelf that has to align with the documents.

So I'll give you an example You [00:12:27] order product from capital

You get that product in, six months later you're audited. PBM comes in to audit you. They're going to say, I want to see everything that you brought from, February [00:12:42] 1 to February 15,

2022. So if you, whatever you bought from Capital will be in our portal.

You can go in and you can get your documents out of our portal. If you receive ASNs [00:12:57] electronically right now, you can go in and look at your electronic Shipping notices and make sure they're aligned with what you received in. If you're missing any parts of what's required by the law, and that's, you've got to [00:13:12] the container size, the name of the drug, the strength of the drug.

You have to have certain things in that document. If you're missing any of it, you can be fined by a PBM right now. This is going to happen. It's

coming. 

[00:13:26] Mike Koelzer, Host: so the [00:13:27] pharmacy doesn't have to, there's no requirement for us as pharmacists to follow that medicine. It kind of seems [00:13:42] odd to me that it stopped at the pharmacy because. I know part of this came from some of the compounding errors years back when they had all the deaths and things and it [00:13:57] seems like they'd want this program to be able to make it all the way to the patient to find out who got this bad bottle of such and such, but it's stopping before it gets to that.

[00:14:10] Stephanie Varner: Yeah, it stops. If [00:14:12] there's a patient issue, they should be able to track it back to the pharmacy based on, who dispensed the drug, 

[00:14:19] Mike Koelzer, Host: And maybe when they got it, but maybe not necessarily what exact bottle it

[00:14:24] Stephanie Varner: Well, I think, DSC, DSCSA was [00:14:27] put in place to track drugs to keep illegitimate suspected drugs out of the supply chain. And so. You still, as a pharmacy, have to, you have to do a visual [00:14:42] inspection. You still have to make sure that there isn't something strange with the label, with the content within the container.

I mean, it's still your responsibility, just like you do right now. When you receive a product, you do a visual inspection. [00:14:57] It's just the next step. You have to make sure the tracing documents follow that drug from point of creation to the point of dispensing and you have to be able to do this electronically and track who's touched it,[00:15:12] who's had custody of the product, who's owned it, to the point of where it's dispensed.

The whole purpose of this was to have, this is my understanding, was to have a kind of a streamlined process. [00:15:27] So we're all doing the same thing. So we're keeping illegitimate Product out of our supply chain by all following the same methods 

[00:15:36] Mike Koelzer, Host: if you're in the FDA or whatever, and you're trying to find a [00:15:42] problem medicine, 

let's say, that makes sense that they want everything the same because if you've got a, Every different wholesaler tracking things differently. You could spend a whole year just going through someone's [00:15:57] records to find out how they're recording certain things.

So I can see the value of having everything the same way. That makes a lot of sense.

[00:16:05] Stephanie Varner: To my knowledge, this isn't about a drug that goes bad and gets dispensed. But it will help with [00:16:12] the recall, the process of recalling products. You're going to know exactly where that product was shipped. It's not going to be as complex as sending letters out and trying to track the product by lot number.

This is, it'll be a [00:16:27] much more precise process, 

[00:16:29] Mike Koelzer, Host: Okay, I got to complain a little bit here, Stephanie. I 

got to go back. So. Years ago, this is when you were a little child, they had all the HIPAA laws come out. So if you're 29 now, that was back when you were [00:16:42] about eight or nine years old. But I always said as a pharmacy, it's like pharmacists know HIPAA. Working in a community pharmacy we've been HIPAA compliant for hundreds of years, since independent [00:16:57] or community pharmacies were in place, we didn't really need a law to tell us to respect people's privacy.

And so when it was usually for the big boys, it seems in this case. Now, what I like about it, it [00:17:12] doesn't seem very onerous for the pharmacy itself. It seems like we just have to have something set up. To know what's coming in from the wholesaler, but it's not, like we've talked, it's not the pharmacy to the patient.

[00:17:27] It Seems like it's not a big load on us.

[00:17:29] Stephanie Varner: it's really not that much different than what you're doing already. You all have SOPs in place to deal with products that come in that might be illegitimate. You're looking at the [00:17:42] product and doing, you're validating it when you get it. Hopefully you're buying from an authorized trading partner, someone who's licensed to sell the product to you.

But, the bottom line is that it's a lot of it, you're already [00:17:57] doing it. One of the most important parts of this, I believe, for the pharmacy is just making sure you're tracing documents aligned with the product you're bringing into your pharmacy. Because that's where you could get into a [00:18:12] situation where you can be fined.

You don't want to have a document from six months ago that was missing the container size. But you are, you're all doing what's required of you right now to have a pharmacy and to

[00:18:27] dispense. So one of the things that I think everybody gets kind of hung up is What's this data going back and forth

and It has to be electronic, you know It has to be they want to be able to [00:18:42] electronically follow product from the inception and then back up so it's got to come downstream and then if you're returning product to come back upstream.

Those documents have to follow that product through the whole supply chain. [00:18:57] 

But you know, I mean how many times have you gotten illegitimate products in your pharmacy Mike? 

[00:19:05] Mike Koelzer, Host: I know of one time. 

We got a handful of counterfeit drugs. [00:19:12] And I don't know how that plays out with other pharmacies, 

but Stephanie, it's kind of like a man with a toupee. I mean, I think I can pick out all the bad toupees, but the good ones, I don't pick out. So I suppose I've found [00:19:27] some counterfeit, but probably a lot has gone through. If it's good, how the hell would I know what made it through the pharmacy?

[00:19:33] Stephanie Varner: Of everyone I've ever spoke with, and I've been in, the pharmaceutical distribution business for 16, 17 years now it's only [00:19:42] happened a couple times that I'm aware of, and it was product that, They probably bought from another source, like thinking they could buy it from, somewhere online that it was legitimate.

But I have not ever seen it. I [00:19:57] know in the, for the wholesalers I've worked for, we've never received a legitimate

product. It doesn't mean that we haven't had some quality issues with the product. 

[00:20:07] Mike Koelzer, Host: Stephanie, my dad and I, God rest his soul, we used to go out to [00:20:12] lunch with the wholesalers and halfway through the lunch, my dad would always reach over for the napkin holder and pull out a napkin and pull his glasses off and pretend to wipe his tears, as the wholesalers were [00:20:27] saying how, they weren't making any money and things like that. Here's my contention. The wholesalers. This is their problem. It's not much on 

us, and the wholesalers are just complaining out [00:20:42] loud to everybody about how much they have to do.

[00:20:45] Stephanie Varner: I agree

[00:20:47] Mike Koelzer, Host: You agree? 

[00:20:49] Stephanie Varner: I feel like the brunt of this Law is on the wholesaler to be honest. I mean, I just because You know when you're working [00:20:57] with manufacturers that have Hundreds of SKUs every one of them have to give us the right information to be able to make this even work. So it's very complex in that sense.

And some of them are Very [00:21:12] far away from us and there's language barriers. I mean, there's a lot of different things

[00:21:16] Mike Koelzer, Host: Oh, that's interesting. The different manufacturers, there's language barriers with them because you've got people all over, right? 

[00:21:23] Stephanie Varner: Correct. 

[00:21:24] Mike Koelzer, Host: Germany and all that stuff.[00:21:27] 

[00:21:27] Stephanie Varner: Most of this communication is by email. And so when you're doing something very highly technical and you're kind of going back and forth in email, you can lose, it's not that you're not all speaking the same. [00:21:42] language, but it's how it's presented, it just could be 

difficult. 

[00:21:48] Mike Koelzer, Host: I hope this doesn't go down to the customer. It sounds like something that would be the next step.

 Like this [00:21:57] drug is being recalled, this lot number, these 10 bottles, what customers got these 10 bottles, which of our customers got these 10 bottles? I hope it doesn't go down to that, 

but it probably [00:22:12] will. 

[00:22:12] Stephanie Varner: I mean, how are you doing a recall right now? 

[00:22:15] Mike Koelzer, Host: I don't know different ways. I mean, right now we don't track by lot number. So the lot number comes in, but we don't record what lot number goes to individual [00:22:27] patients. As far as I know, that's not a law but with this, that's not going to improve at all what you're saying, but I hope they don't, I hope they don't throw that in there.

[00:22:40] Stephanie Varner: I'm not sure [00:22:42] exactly if this impacts that part of your business. You will have access to documents that have the lot number. And when you I know from previous experience when we had to track products because of a recall. [00:22:57] We would look, when that product was received with that lot number, and then who we sold it to, and then we would send them a letter.

If it was so broad the scope of the recall, we would send it out to everyone who ever bought it from us. And it would have the lot numbers [00:23:12] listed.

I don't see that changing now. 

[00:23:14] Mike Koelzer, Host: Everybody says like computers come around and things are better and it's true but back in the day if you had a sales tax audit at your pharmacy 

 This is, let's say, back in [00:23:27] the 60s, show us how much you paid to such and such wholesalers.

How much tax did you charge? All right. That's either good or bad. Nowadays. It's like, show us the [00:23:42] tax that the customer paid on this tube of toothpaste in the spearmint flavor, between 5 PM and 8 PM I mean, that's going overboard, but it's like with the more information you have [00:23:57] available, everybody wants to feel needed in their job and they come in and they want that more information. 

[00:24:02] Stephanie Varner: But don't you think if you know now what to expect, so if the State Board of Pharmacy is going to come in and do an audit 

to see if you're compliant, [00:24:12] one of the things with this law is just knowing what to expect.

[00:24:15] Mike Koelzer, Host: that's a good, that's a good 

[00:24:16] Stephanie Varner: you 

So I don't think it's all bad. I, it's a pain, we're all just I never thought that I would be doing this full time.

And, It's [00:24:27] eased up a little bit, but jeez, everything that goes into getting this whole supply chain set up to comply with these, it's crazy. 

[00:24:39] Mike Koelzer, Host: How has this been for you? Because every [00:24:42] wholesaler has one of you. So how has this been for you personally? Is it uh, stressful? Is it... Anxious? anger? Is it frustration? Does this do for you compared to where you were, [00:24:57] three years ago with your outlook on pharmacy and your job and so on?

[00:25:02] Stephanie Varner: It seems to me that this industry changes, pretty much completely flips over every five years.[00:25:12] 

Maybe like three to five years. So it just kind of goes hand in hand where we were ready for something, right?

[00:25:18] Mike Koelzer, Host: You're kind of gearing up for it 

[00:25:19] Stephanie Varner: It does not ever stay the same. I was in another line of distribution that wasn't [00:25:27] pharmaceutical.

But, that was such a much more consistent

industry.

And this is, it's just crazy to me how things change 

with this industry. And you can look at the [00:25:42] generic market and branded generics. And then now we're getting into biosimilars and all these different types of drugs.

And then you get into the formulas, like... The reimbursements and formularies and all this stuff it's just crazy how complicated it's [00:25:57] all, 

[00:25:57] Mike Koelzer, Host: I'm not a huge left or right guy, but I think a lot of it goes to big government slash staff assistance, all this. It's 

like once they get over a hump, And now they have to find something else to do to keep [00:26:12] them busy.

Some of it's busy work.

[00:26:14] Stephanie Varner: I... I find it hard not to get a little paranoid about what the whole intention of this law is. I'm not really quite sure yet. Again, I've talked to a lot of smaller [00:26:27] distributors who play a very important role in getting medications. to physicians who dispense or, very, like, highly unique medications that aren't in the mainstream, but for a very rare [00:26:42] disease.

And these distributors this is the financial hardship on them that they might not be able to overcome. So now you're blocking. access to a medication that's very much needed. That's the problem I [00:26:57] don't really quite understand the necessity for all of it. Parts of it I do understand.

I think, one of the things that we were very concerned about, and again, the FDA just put out, kind of a [00:27:12] transition of your inventory announcement, but we didn't know up until recently. If we were going to be able to sell anything that's on our shelf prior to November 27th, 

because it didn't have the data.

It needed [00:27:27] the data, the tracing documents and the data to match up. And that was going to affect every pharmacy out there that had product on their shelves prior to November 27th,

2023. But now they've actually put language [00:27:42] out that states that, you don't have to have that data. 

to comply with the law.

You can sell it, and until that product's gone, you won't be out of compliance by selling a product that's already on the shelf. So that affects the [00:27:57] pharmacy greatly. There were a lot of people that were concerned about whether they had products on their shelves. Should I just take it down to nothing?

Should I be bringing in a product? Should I wait until after? November [00:28:12] 27th, but now they've done this transition thing, so we don't have to worry about that.

[00:28:16] Mike Koelzer, Host: I worry about other stuff, but one thing I've gotten better at is these laws. I alluded to that earlier they usually work something out. If you're willing to hang [00:28:27] back just a little bit and not try to be the leader 

[00:28:30] Stephanie Varner: Um, 

[00:28:30] Mike Koelzer, Host: knowing all the information.

[00:28:32] Stephanie Varner: I totally understand what you're saying regarding, hanging back and kind of letting this play out because there will be more stuff that FDA is going to put out in the context [00:28:42] of this law that, there'll be tweaks to it. But it's really important.

I think it's important to be prepared because I think that there still will be certain levels of enforcement. [00:28:57] of this law right after November 27th of 2023, because there's parts of this law that haven't gone into effect yet. And those are the ones that are not going to enforce. But prior to November 27th, [00:29:12] there are several requirements that the pharmacies will have to comply with.

[00:29:18] Mike Koelzer, Host: Oh, that's interesting. What are those?

[00:29:20] Stephanie Varner: So you have to make sure you're working with an authorized trading partner. you have to have all the licensing. Has to be [00:29:27] accurate, up to date,

You have to be able to receive, validate and store electronic shipping notifications. So, the ASN, and again, if a wholesaler, to be compliant, we have to have a portal for you.

[00:29:42] So, when you log into our website your portal is there. You can get all of your information. Everyone you're dealing with should give you access.

You have to have access to that information. You've got to have in process, you [00:29:57] have to have standard operating procedures for quarantining suspected product, illegitimate product. You have to have a process in place to notify, your trading partners if something isn't 

legitimate.[00:30:12] You have to report it.

It's required that you report it back to the FDA. of time. Those things are still enforceable.

[00:30:21] Mike Koelzer, Host: Those are all dated. Is it the 27th of November?

[00:30:25] Stephanie Varner: Yes,

[00:30:26] Mike Koelzer, Host: [00:30:27] Those are all there. So pharmacists can't just drop their guard and say, none of this is happening. That none of that only refers to maybe the actual product tracing, but all the other stuff is still 

in force. 

[00:30:40] Stephanie Varner: what goes into [00:30:42] effect, but won't be enforced for a year, but what goes into effect on the 27th of November is the electronic interoperability, so you have to be able to receive documents

By, you know, electronically, you can't just print it [00:30:57] and have it on a file at your pharmacy. That won't comply if they come in to audit you.

And you have to have certain information on that tracing document. It's the T3, which most people know about. 

It's been in 

effect [00:31:12] for a long time. Well, It's the tracing information. It's the T3 statement. Tracing information, a tracing the statement, and the

history. 

[00:31:22] Mike Koelzer, Host: while. 

[00:31:23] Stephanie Varner: So you, that information still has to comply.[00:31:27] 

You have to have the name of the drug, the strength of the drug, those things. That's 

part of the compliance, but it has to be on the document.

[00:31:34] Mike Koelzer, Host: and all that is due this November.

[00:31:36] Stephanie Varner: It goes into effect.

The T3 statements have been in effect, and have been provided [00:31:42] to you since 2015.

[00:31:44] Mike Koelzer, Host: I remember that I was gonna say it's 

10-15 years ago. It was something like that. I remember those now

[00:31:49] Stephanie Varner: So, anything that's... Prior to it, they call it enhanced drug distribution security. So E D [00:31:57] S was part of what was going into effect after the 27th. And that's with this more complex data that will be electronically interoperable. Those are the things that won't be enforced until 2024.

But anything prior [00:32:12] to it, it's fair game because the law goes into effect. Even though it's been going along in steps, it's still going into effect on the 27th of this November. So you have to comply with what's required prior [00:32:27] to the enhanced part of this, where you have. More complete documentation.

You've got your global location number. You've got to have that for each pharmacy, for, wherever you're shipping, because that's part of all that data. [00:32:42] That will not be enforceable until after the 27th of November 2024. But prior to, you have to have this information that's been in place for a while now.

That will be enforceable after the 27th [00:32:57] 

of November this 

year. 

[00:32:58] Mike Koelzer, Host: It's good that you're on the show. I didn't know all that.

[00:33:02] Stephanie Varner: Whether the State Board of Pharmacy, I've talked to several State Boards of Pharmacy. They're not going to be Enforcing even the beginning part of [00:33:12] this act

But it doesn't mean that PBMs won't 

You know, so you have to be prepared and have access to your documents, so you don't have situations where you have a clawback because you didn't have the right [00:33:27] information.

So, keeping all of that information accessible and knowing where to go to get it is what's going to probably be the most difficult part of this for a pharmacy. 

[00:33:39] Mike Koelzer, Host: What in your position [00:33:42] is a nightmare scenario of this happening and. Maybe there's no such thing because maybe it doesn't happen in three hours.

Maybe everything that's happened is going to be drawn out over months, [00:33:57] but what would be the worst case scenario for you? Not in reality, but just in a nightmare kind of way.

[00:34:04] Stephanie Varner: What is concerning is we can have everything going very smoothly and in production For a couple [00:34:12] months and then all of a sudden the files start failing

And so we're receiving products.

We've been getting it for months. The files have been great. Everything is smooth. And then all of a sudden 

You're having failure. So [00:34:27] that, it's a concern because right now Especially with drugs that are in demand and having issues with supply, you gotta get them in as fast as you can. You'll get them in the morning, receive them, put them on the shelf, and [00:34:42] they're out before the end of day.

And that's because pharmacies haven't been able to get them, and they've got patients 

who need them. 

So, that's, what if it's a drug that everybody needs and [00:34:57] Something happens with those product identifiers, so , the system fails, and then we've got to spend this time to correct it, and then you've got to wait for them.

I mean, what if they're in India,

And, it's 12 hours difference or 13 or [00:35:12] whatever the time is. But you've still got to be able to get this to happen quickly. And I feel like we're all working on this with a sense of urgency like never before.

tHe supply chain issues, they're more prevalent this [00:35:27] year than I think they've ever been.

We feel confident that we're, we have everything in place at our company to be able to handle it. Now we've got to get the correct information. And I believe that's, that's a [00:35:42] Kind of a scary thing to think about where we are in production for a while everything's smooth and we're on to the next one And then you have these failures 

Because you know something is missing on that License plate on that [00:35:57] palette, so you then you've got to figure out what you know, you take it apart Which part can you put away which do you have to wait?

It's very complicated the receiving process 

[00:36:07] Mike Koelzer, Host: With your marketing background is [00:36:12] this new law and maybe other similar laws like this for pharmacies and wholesalers and the whole industry? Do you think the presentation from the government Is done [00:36:27] in a decent way or if you were in charge, would you market something differently or is there no marketing to it? It's just black and white.

Get the damn thing done.

[00:36:40] Stephanie Varner: I think that, [00:36:42] and again, I, I'm not that versed on the law. This is just from the perspective of a marketing person. But, I, we have this conversation I talk to other wholesalers when I go

to different meetings and people [00:36:57] within our company, we just have a kind of conversation like, couldn't they have done it another way?

And part of that, we think, why didn't they just say, if your pharmacy is going to dispense a drug, you have to buy from an authorized trading [00:37:12] partner. And then, enforce that part of this. So, for us, Authorized Trading Partner, we already have to do all this stuff.

So, we're already doing it.

 if we're never buying from a source other than a [00:37:27] manufacturer, how are we going to get a legitimate product? And, with this law, We could still get an illegitimate product if it's shipped from the manufacturer. They just have to get the documents to line up. All the data has [00:37:42] to line up. But if you are buying from someone like Capital, we buy everything from them.

We've never bought from anyone other than a manufacturer.

Brand, generic, we don't buy anything if it doesn't come [00:37:57] direct. So, the chances of us passing along something to you... That's illegitimate. It's highly unlikely.

[00:38:05] Mike Koelzer, Host: That is a real interesting perception because I think like, [00:38:12] Let's say I get, my 13 year old or something at the pharmacy and you know Ringing up the register

And I don't even think they know what work is. I started when I was 13 Things are delayed though with [00:38:27] kids now and they need time to play their video games all day, and on their phone I don't have to tell my 13 year old all the ins and outs of the accounting and why this has to happen and why we keep track of this, I just [00:38:42] have to say, every time someone comes up to buy something, you hit this button That's kind of like with the pharmacies. You're right.

 This wholesaler has to be certified, etc. That's kind of enough for us. 

[00:38:53] Stephanie Varner: Right 

 Then you know, there's enough of us out there that [00:38:57] are legitimate that you shouldn't have a problem

Finding a source and as someone you can work with I just that's the part. I don't really understand. It just seems like the complexity of this data, I mean, this has [00:39:12] created, I've heard, a 4 billion industry that's benefiting, profiting off of this new law, and it's not us, and it's not you.

So, who's benefiting from this law?[00:39:27] 

It's securing our supply chain, which is very critical, that it's

smart. Again, I think the flow of information is very important. We're working at a faster pace. It's, everything's kind of this data driven, but, again, I, [00:39:42] is it, the complexity of this necessary? I didn't, I was involved with the law.

I try to read it and understand it, which is, you just get so twisted up if you're trying to read the FDA.

website, but,[00:39:57] I do think that there are benefits to it and of course if it keeps the supply chain safe so a patient doesn't get something, um, that's, could hurt them,

then it's, it's good, but [00:40:12] 

Getting there is very complicated if you're buying from multiple sources. You need to really consider having some support at your pharmacy level.

And they're out there. There's tons of them. I'm sure most people have already been [00:40:27] contacted by quite a few, but it really, that's important, so it makes it easier for you to comply. You have the access, so you're protected 

against someone coming in and doing an audit.

[00:40:40] Mike Koelzer, Host: And Capital has that 

[00:40:41] Stephanie Varner: We[00:40:42] 

And everybody likes to do it a little bit differently, so... So, we know of different other compliance solutions that we recommend to people. 

We just try to help people find a solution for them. If they want [00:40:57] to talk to us about what we are offering, that's great. But there are a lot of people out there that will help you. And a lot of times it's your pharmacy management software. That has aligned with someone who also can refer, so it's all tied [00:41:12] into their, to the software you already have in your pharmacy.

So, that will keep it easier for you to be able to go through this process. So,

you know, I 

i would highly recommend that, that's who you talk to if you're using Pioneer [00:41:27] Rx or Rx30 or whoever you're using. Ask them, and they may have someone that you can align with very easily, 

electronically. 

[00:41:36] Mike Koelzer, Host: Stephanie. Thanks for joining us today. I think with [00:41:42] a lot of this stuff, as it starts to pick up speed, you start seeing more articles and podcasts and things on TV and all that kind of stuff.

And people kind of hear it from a few different angles and it starts to add [00:41:57] up in their head. So I think we're doing our little part of giving some of that feeling of the situation and moving in the right direction. So I appreciate your time. And that nightmare I spoke about, don't think about it.

It's all under control.[00:42:12] 

[00:42:13] Stephanie Varner: I'm not worried about it Mike. We'll figure it out. 

We got a whole nother year. 

[00:42:17] Mike Koelzer, Host: Yeah, exactly. All right, Stephanie. Thanks again. I look forward to keeping in touch.

[00:42:21] Stephanie Varner: All right, thank you Mike, I appreciate your time.