September 07, 2015

(Dan) Welcome to Doc Talk. We’re excited that you joined us today. We’re going to have a great show. Dr. Mike Apley from the College of Veterinary Medicine who is a Clinical Pharmacologist is going to join us and talk to us about the changes that are occurring in antibiotics, whether it’s in the feed or in the water. Bound to be a great show. Stay tuned. Thanks.

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(Dan) Hey Mike welcome to the show. (Mike) Thanks. (Dan) Folks, it’s my pleasure to introduce you to Dr. Mike Apley who is a Boarded Clinical Pharmacologist and a professor here at the Veterinary School at Kansas State University and there’s a lot of changes going on. (Mike) Hmm, huh. (Dan) And specifically you know the changes that the veterinary feed directives, changes in antibiotics in the feed, and it’s kind of hard to keep up on all of it. But that’s something that you do for us in the industry and beyond. And so, tell us what got this dang thing started. (Mike) Oh man, we’ve only got a half hour don’t we? (Dan) Yeah, no. (Mike) It all started back in the ’60s with concerns about the use of antibiotics in feed for livestock. There have been numerous reports and studies up through that time waxing and waning of interest and things continue to build, to reaching a head now. A few years ago, Guidance 209 came out. So, the way the FDA talks to us is through guidance documents. And this is a guidance for industry, us being the industry in the pharmaceutical industry. And they said two things in that document, they said, “We don’t think that use of antibiotics for growth promotion is a judicious use.” And they use the term judicious because they get to define that, rather than using the term hazard which has got a whole regulatory cascade that happens when you start that. Second, thing that they said is, “All antibiotics that are used in the feed and water for livestock are going to be veterinary controlled, oversight.” Whereas now, as our listeners would know, they can go buy a bag of medicated feed, milk replacer, medicated feed, or medications to put in the feed or water medication without a prescription. (Dan) You just go the farm store. (Mike) Farm store or wherever you want to go. That’s being viewed as not being well enough controlled with the concerns about antibiotic resistance today. So in 2012, the final version of 209 came out after much discussion. Then they needed to give us a road map on how to accomplish Guidance 209 and that’s Guidance 213. (Dan) OK. (Mike) That’s directions for the companies to open up the labels that are affected, remove any growth promotion claims. Which are claims strictly for increasing feed efficiency or rate of gain without any disease prevention or control or treatment. And there are 26 companies that are affected and 283 products. (Dan) Wow. (Mike) And so, a lot of those products are generic copies of one another, or something like that, or combinations. But still a large number of labels are going to need to be developed. The clock started ticking this year and these companies are expected to have complied by December of 2016. So, that’s when all these changes will come about, required veterinary oversight, meaning you can’t just purchase them over the counter. And also that no growth promotion claims for those antibiotics through the feed anymore. (Dan) So anything that has the growth promotion claim, that’s coming off? (Mike) Well, there’s a couple of very important exceptions for cattlemen and number one would be the ionophores, so monensin, which we know as Rumensin, one example and then the bambermycins, which we know as GainPro, those would be exempt from this because we just don’t have any indication they’re related to anything used in human medicine. And then bacatracin, which we don’t use. But GrowSwine, for producer listeners, tiamulin is a pleuromutilin, is not included. So, those are the four main groups that wouldn’t be included that are exempt from this. Tetracycline is included. Any growth promotion claim, stuff like that. (Dan) Cool. We’re going to take a break folks. When we come back we’re going to continue with Dr. Apley. We’re going to talk about what kinds of antibiotics this ruling will affect. Thanks for watching Doc Talk.

(Dan) Hey there folks, welcome back to Doc Talk. Dr. Dan Thomson here with Dr. Mike Apley and we’re with the College of Veterinary Medicine at Kansas State University where Dr. Apley is a Boarded Clinical Pharmacologist and is a national and international leader on many of the topics having to do with antibiotics in food animals. And when we left we were talking about the guidance documents and kind of what got us here Now let’s start to break it down and talk about which antibiotics this is going to effect. (Mike) So, it’s as we talked before the break, basically everything except the ionophores. (Dan) Yep. (Mike) And the bambermycins, which again we know as like GainPro. Bacitracin and the pleuromutilins, which is Tiamulin when it’s used in swine and not in cattle. So, those are the four that are exempt. And then the next question is, “Well if it’s everything else, which specific uses?” So the uses that are disappearing is any labeled inclusion, so say in milk replacer or in feed that has a growth promotion claim. So, only for increased feed efficiency or improved rate of gain. (Dan) Those are gone. (Mike) Those are gone. Unless they are able to show that say for example, ten milligrams per head per day, which is the growth promotion claim has a claim for, or an effect in preventing a disease or controlling a disease. But they are going to have to bring the data to the CVM to show that. You know we probably require some more extensive, additional work with that. The thing about Guidance 213 is it holds a carrot out there that says, “If you just want to come in, pull the growth promotion claims and add the part about we are going to require veterinary oversight,” then, we’ll just let you do that without opening up the rest of what we call the package where they might be required, well you need to update this, that, that which can run into millions of dollars. So, examples that our listeners might use, where they will now need a veterinary authorization to do that, would be for example using oxytetracycline or chlortetracycline in the feed of newly arrived calves at one gram per hundred pounds per day. That’s a therapeutic claim, not prevention, not control, not growth promotion. You can still use it, but you’ll have to have a veterinarian provide what’s called a veterinary feed directive. (Dan) Got it. (Mike) And the VFD will require veterinary supervision or oversight and the FDA Center for Veterinary Medicine is leaving the veterinary oversight up to the states. So each state will be deciding exactly how they will define that. And it could go as deep as how often a veterinarian would need to examine the animals or talk to the owner. It could be more superficial than that. So, that’s the big change. (Dan) And I think the big thing is, is that one of the big changes that is going to have to happen is the veterinarians have to be on the farm. I mean, yes the veterinarians on the farm today, but it’s going to put the veterinarian in a position to really serve rural America by being on the farm proactively rather than reactively. (Mike) And everyone needs to understand that this is a way to put the veterinarian in the position of being responsible for maintaining the tools we have today. Judicious use. Do we really need to use these; are we using them in the best manner? That’s going to be up to your veterinarian to help a producer define and understand and the eyes are upon us. (Dan) Yep, well we’re going to take a break. When we come back, we’re going to talk about the oversight. Just like what we’re talking about here. And things that will be required for producers to utilize these products with the new guidance documents. You’re watching Doc Talk and we’ll be back in a minute.

(Dan) Folks, welcome back to Doc Talk. I’m Dr. Dan Thomson, here with Dr. Mike Apley who is a Boarded Clinical Pharmacologist and a national and international leader on pharmacology, specifically when we started to talk about antibiotics and food animals. There isn’t anybody that is more of a go-to type person for information in the world than Dr. Apley and it’s an honor and a pleasure to have him here on the show. Mike, when we talk about the new regulations coming, there’s going to be some oversight. Now how are we going to get this done and still be able to, you know, do our business? (Mike) Well, we’re working on that. (Dan) OK. (Mike) And that’s why each state is going to be responsible for defining their oversight. And I think the state boards of veterinary medicine, boards of veterinary examiners; they’re called different things in different states. The agriculture entities in the individual states, state associations of veterinary medicine, state cattlemen, swine producers, whatever types of groups you have, are pretty well aware of this now. And they are working together to say, ” “How do we make this happen?” There are concerns, for example, what if I need to have Drug X for the feed? I’m having an outbreak, I want to add it in the next mix and I don’t know where my veterinarian is, or I’ve got to get a hold of him. We’ve got to start laying those plans now on how to do this. And you need to have a working relationship with your veterinarian. They need to know your operation, and you need to know them. They can write and authorize these. The duration of the veterinary feed directive, which will be required for all feed antibiotics is still up in the air. It’s going to be dependent on the label for each drug. So for example, there are two versions of a drug called tilmicosin right now, one for swine, and one for cattle. One the authorization is good for 45 days and the other is good for 90, so we’re hoping that we have some consistency in the duration. (Dan) So, that is how often they have to get the vet feed directive? (Mike) To authorize. (Dan) Every 45 days or every 90 days. (Mike) Yeah. (Dan) And we really don’t have that on our parenteral drugs. (Mike) No. (Dan) As far as the definition. You know, when I would write scripts as a consulting veterinarian I did it every quarter, but uh… (Mike) So, we might have as long as up to six months now, is what they’re saying, but it will depend on individual drug label. And that’s all up in the air, and we’ll know more as we move forward. (Dan) But the thing is, there’s going to have to be that BCPR, define clinical cases, and have those documents in order. It’s not different than animal welfare or anything of that nature. It’s really going to be in the best interest of the producer to have these kinds of definitions laid out when they’re asked. (Mike) It’s a planning process and it’s nothing different than what you have to have in place now to purchase a prescription injectable drug. So, we’re just adding those in. (Dan) So, anything else on the oversight that people need to be aware of? When will this you know, kick in? (Mike) December of ’16. It depends on the individual labels. If there’s an individual label that’s approved before that, it might go into effect sooner. So, our listeners need to sit down with their veterinarian and discuss every drug they’re currently using or may use in their feed or water. Every antibiotic. So, that they can start laying plans for this on how that will be taken care of. (Dan) Well, it’s great. When we come back, we’re going to discuss with Dr. Apley what’s next. And talk about the veterinary feed directives and other drugs that may be effected. You’re watching Doc Talk. We’re glad that you joined us.

(Dan) Folks, welcome back to Doc Talk. Dr. Dan Thomson here with Dr. Mike Apley. We’re from the College of Veterinary Medicine at Kansas State University where Dr. Apley is a Clinical Pharmacologist and a national and international expert on food animal and antibiotic usage. And we’ve talked about everything that’s happening. But what are we going to be facing next? What are we looking at next with antibiotics? (Mike) When you split uses of antibiotics and food animals into different categories, you have therapy, prevention, control and growth promotion. So growth promotion is leaving for antibiotics. Our current administration, the FDA Center for Veterinary Medicine considered the use for antibiotics for prevention and control of disease in food animals to be a judicious use, an appropriate use and they lump it in with therapeutic. There are multiple advocacy groups, which would not lump that in. So, prevention and control is the next thing to look at. I think everyone is well aware that those are going to be the next uses. (Dan) And those would be stuff like metaphylaxis, or mass treatment on arrival for new cattle. (Mike) Yep. (Dan) And would that be just in the feed or would that be feed and parenteral, or you don’t know yet. (Mike) Don’t know, it seems like feed and water because it medicates the whole herd or flock at the same time, seems to be having a higher focus on it. Injectables if applied to the whole group surely aren’t out of the question to be discussed. So for beef cattle it would be anything administered to the group on arrival at the feedlot for example. Or if you put something in the feed to prevent or treat respiratory disease to the entire group at the time of weaning, and in pigs, when they’re weaned and put into the nursery. You know, those types of things where we know that this disease is going to occur probably at this time, because of historical evidence and we’re going to try and get in ahead of it. Those are going to be the things that are going to be discussed. And the reasoning is, or the assertions on the part of the advocacy groups is the only reason you have to use those is because the nature of the facility. And therein is the real crux of the discussion and what it always comes down to is that it’s the nature of the production facilities that require those uses, which is… (Dan) You said something to me the other day that has stuck with me on this topic. And it gets back to there aren’t new classes of compounds coming up. And the thing about whether we get wrapped around the axle with activists groups and things of that nature. Put that all aside. As a responsible industry and as a responsible profession, it comes down to do we want to have products that work in the future? (Mike) Sure. The last time we got a new product class that we are using today in food animals, is 1978. We’ve had new modifications, chemical alterations and overcoming some resistance, etc. since then and a lot of new really good antibiotics. But the last time we got a new class was ’78. (Dan) Well, thanks for being on the show today. It’s a great show. Great to have Dr. Apley spend some time with us and we’re going to have to get him back on and have a further discussion on this topic for sure. Thanks for watching Doc Talk. Remember always work with your local veterinarian and if you want to know more about what we do on Doc Talk you can find us on the web at Thanks for watching the show. I’m Dr. Dan Thomson and I’ll see you down the road.

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