Dr. Mike Apley
Dr. Mike Apley

The federal Veterinary Feed Directive means “the days of no records and verbal treatment protocol are gone.”

Dr. Mike Apley, professor of veterinary clinical sciences at Kansas State University, delivered that message to producers and other members of the swine industry Thursday during KSU Swine Day in Manhattan.

“We have never had the legal ability to use feed drugs other than as labeled. We’ve never had that legal opportunity,” Apley said. “So if you’re using a feed antibiotic in a way that’s not specifically allowed on the label, you are breaking the law. That has not been enforced, because how do you know?

“Now as we move into the Veterinary Feed Directive, a veterinarian is going to have to make an FDA accessible record of what that drug is authorized to be used for, and in follow-up the FDA may go to any site that a VFD copy is at and investigate how it was used. So the transparency is going to be greatly increased.”

During his presentation – titled, “Countdown to the New Feed Directive – What Do We Need to Know?” – Apley told the audience 1978 was the last time the agriculture industry got a new class of antibiotics that is still in use today in food animals.

“When do you think we’ll get a new and novel class of antibiotics again for food animals?” Apley asked. The large meeting hall in the K-State Alumni Center went silent. “Yeah, don’t hold your breath. Because if we get them, they are going to the human side.”

The industry needs to keep that fact in mind as it contemplates moving forward once VFD is fully implemented Jan. 1, 2017, Apley said.

“We get all wrapped around the axle about being blamed for human things and what’s going on in human medicine … But the thing we better get over is thinking that’s the only issue and it’s not about protecting the use of these drugs for ourselves in food animals and in veterinary medicine,” Apley said. “Because if you are thinking that isn’t an issue, you’re dead wrong.”

The Federal Drug Administration Center for Veterinary Medicine released the final VFD rule in late May which details how a veterinarian can authorize use of medically important antibiotics in feed and water for food animals. The VFD is a mechanism for carrying out the FDA’s Guidance for Industry documents 209 and 213.

A voting member of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, Apley said the two documents are a way of saying: “Here’s what you should be doing, and the other is compliance policy guidelines – which is really public communication to their personnel on how they should interpret regulations and enforce regulations.”

Apley said Guidance for Industry 209 contained two important points:

1.     The use of medically important antimicrobial drugs in food production animals should be limited to those uses that are considered necessary for the health of the animals. “That means not for growth promotion.”

2.     Use of medically important antibiotics in food animals will be under the guidance of a veterinarian. The veterinarian will be authorizing those uses, in feed and water.

Document 213 defined how the goals of 209 could be met through compliance policy guidelines.

“As of December 2016, a veterinarian will have to authorize any antibiotic use in the feed except for the ionophores (Rumensin, Bovatec, Catalyst), the bambermycins (Gainpro), bacitracin (BMD, Baciferm), and tiamulin (Denegard, used in swine),” Apley said in an article he wrote earlier this year for K-State’s Beef Cattle Institute. “All other antibiotics used in the feed are classified as “medically important” (based off of importance in human medicine) and will require a veterinary feed directive (VFD), which requires knowledge of the client’s operation.”

A VFD will be required for any type of medicated feed containing a medically important antibiotic, including medicated milk replacer, Apley told the audience Thursday.

All water antibiotics will require a prescription, even for label uses. Apley predicted water soluble antibiotics likely will disappear from the shelves of local farm supply stores rather than merchants becoming authorized to dispense drugs on the basis of a prescription. Medicated milk replacer and medicated feeds if they contain a medically important antibiotic also likely will be in scarce supply at the farm store, he said.

“You need to understand that a VFD is not appropriately referred to as a prescription,” Apley said. “We use the term prescription and say it’s like a prescription because a veterinarian is giving you a document that authorizes the use. The difference is if I write you a prescription it’s going to have to be filled by someone who is authorized in the state of Kansas, in our case, to dispense that drug on behalf of an order from a licensed veterinarian.”

In some states, a pharmacy board licenses the distributor to fill the order of a licensed veterinarian.

“A licensed veterinarian cannot distribute on the order of another licensed veterinarian because we’re not pharmacists,” Apley said.

Now the VFD is different in that when it was brought forward by Congress, Congress was very clear it is not a prescription, Apley said.

“[Congress] wanted to make it so there was an increased ability to distribute those drugs, so that someone just has to send a letter to the FDA to say we’re going to sell VFD drugs … so then the FDA knows there’s someone [the agency] can go check and see their VFD records,” Apley said.

Since the Guidance 213 was put into effect in December 2013, all 26 companies representing the 283 affected labels came forward voluntarily to cooperate, Apley said.  

“[Guidance] 213 gets referenced a lot but that’s a roadmap for getting 209 and the carrot for the companies was if you remove growth promotion uses from the label, add the requirement for veterinarian oversight for the ones affected by 209, then that’s what will change,” Apley said. “We’re not going to go back in and look at the environmental safety technical section, we’re not going to look at the microbial safety technical section within human food safety. We’re just going to change those.”

VFDs have to be written by a licensed veterinarian in the place the animals reside, Apley said.

“Just because I am licensed in Kansas does not mean I can write a VFD for pigs in Oklahoma or Missouri,” he said.  

Apley also discussed the duration and expiration dates outlined in a VFD.

“If the label says 10 days, you don’t feed it for nine, you don’t feed it for 11. You feed it for 10,” he said. “That’s what they will be looking for.

“The expiration is how long your VFD authorizes the use of that feed. The expiration will be specified on the label of the drug,” Apley said. “I cannot write it for anything different. If it is not authorized on there, there’s going to be a default time where a veterinarian can write the VFD to be in effect. … We’re hoping [FDA] gives us a lot of standardized days, so veterinarians and producers can work out a standard reauthorization cycle to reevaluate and reauthorize it.”

With new regulations on the horizon, the challenge is to figure out how they are going to be implemented at the level of the animal, he said.

“The good thing is we’re starting to work on these over a year in advance,” Apley said. “I have heard some people say the FDA is waiting out there to make big examples [out of violators], and I just don’t think that is true at all. I think they realize we’re all going to have to work at this together to figure some things out.”

The veterinary profession is not only going to be responsible for almost all antibiotic use in food animals, now it’s also going to be accountable, Apley said.

The biggest takeaway for producers in this discussion, Apley said, is to have a veterinarian that knows their operation. And a focus needs to be placed on antibiotic stewardship.

The first step in practicing stewardship is to decide if there is a non-antibiotic alternative which will appropriately prevent, control and treat the disease, Apley said. If not, then select an antibiotic that has been demonstrated to be safe and effective for this purpose, he said.

Dispensing antibiotics in feed (74 percent) and water (21 percent) account for about 95 percent of medically important antibiotics sold by kilograms with a food animal label in the U.S., Apley said. And about 98 percent of medically important drugs are sold over the counter, requiring no veterinary authorization.

“That does not pass the front page of the newspaper test, and that’s one of the big drivers of the VFD,” Apley said.

The industry has to develop alternatives to the use of antibiotics for some agricultural purposes, he said.

“Something I hear from people is, ‘Well, agriculture is getting all the blame,’ and that couldn’t be further from the truth. They are taking a really hard look at themselves in human medicine, too.”

Three factors will drive the use of antibiotics in the future. Regulation, legislation and retailers.

When it comes to use of antibiotics in food animals, some retailers believe there are only two options: Stick with the status quo or never use them, Apley said.

“Our job is to give them a very responsible place in the middle.”