Michael D Apley, DVM, PhD Kansas State University
To find the latest on this subject, or to find a vet near you (that’s registered so far) check out this url – http://www.honeybeeveterinaryconsortium.org/
Concerns about the use of antibiotics in the feed of food animals was first expressed back in the 1960s. Since then there have been multiple reports and evaluations by different groups around the world. Our use of antibiotics to prevent, control, and treat bacterial disease in food animals is currently under great scrutiny, with pressure to describe and reduce our use. In 2003, the FDA Center for Veterinary Medicine began to require the evaluation of the microbial safety of antibiotics that were being approved for food animals through their release of Guidance for Industry (GFI) #152. This was followed by a second document related to microbial safety, GFI # 159.
These two documents set new standards for evaluating how antibiotic use in food animals might have an effect on the ability to treat infectious disease in people, and on the ability for a resistant bacteria to proliferate and cause disease in our own intestinal tract.
In 2012, the FDA Center for veterinary medicine released another final document, GFI #209. In this document the FDA asked for voluntary compliance with two major changes in the way we use antibiotics in food animals. The first change was that pharmaceutical companies would voluntarily remove growth promotion claims for any medically important antibiotics used in the feed of food animals. Secondly, they asked that all remaining uses of medically important antibiotics in the feed or water of food animals be only under the supervision of a licensed veterinarian. The veterinarian has been put in charge of antibiotic stewardship for medically important antibiotics in food animals. In feed, this takes the form of a veterinary feed directive. In water, this takes the form of a prescription just as you would need to purchase a prescription injectable product.
A second document related to the requested label changes, GFI #13, was released in 2013. This document is the roadmap for pharmaceutical companies to get to where GFI #209 asked them to go. The pharmaceutical industry is complying with these requests, with anticipated completion of all of the label changes by December 2016.
There is a page on the FDA CVM website where it is possible to see the progress of all the listed labels which are affected by this change. Of the 283 affected labels, some have been withdrawn by the sponsor and others are in the process of being changed. The mechanism for rolling out the new labels later this year has not been finalized as of this writing, but we may expect that we will have sufficient time to understand the new labels and get a VFD in place for use in food animals prior to January 1, 2017.
There was some confusion when the final veterinary feed directive rule went into effect October 1, 2015. The confusion came about when producers and distributors heard that the final VFD rule had been passed and assumed that this was now required for all medically important antibiotics. The requirement for veterinary feed directive authorization for the remainder of the medically important antibiotics used in food animals will begin when their final labels take effect January 1, 2017. All of these drugs are also medically important antibiotics.
The veterinary feed directive rule puts forth the regulations under which a veterinarian may authorize, a distributor may distribute, and a producer may use a feed requiring veterinary feed directive authorization. Currently there are only three drugs which require a veterinary feed directive for their use. These are all medically important antibiotics. They include the feed version of tilmicosin (Micotil®) in both swine and cattle as well as the feed version of florfenicol (Nuflor®) in fish.
Medically important means that this antibiotic, or another member of this drug’s class, is important for therapy of bacterial diseases in humans. This list includes the following (with examples of antibiotics in this group with uses in food or water in cattle).
* Tetracyclines (chlortetracycline, oxytetracycline, tetracycline)
* Sulfas (sulfamethazine, sulfadimethoxine)
* Macrolides (tylosin, tilmicosin)
* Aminoglycosides (neomycin)
There are many other medically important groups used in food animals, such as the cephalosporins (ceftiofur), the fluoroquinolones (enrofloxacin, danofloxacin), and the phenicols (florfenicol), but they do not have feed or water labels for use in cattle.
Medically important antibiotics will require a veterinary feed directive for any label use in feed, and will require a prescription for any use in water. A very important point to understand is that any extra label use of a drug in the feed for food animals is illegal. There is no gray area to this part of the regulations. If it is not on the label, it cannot be used in that manner. This includes duration of administration, dose, and indication for use. In contrast, a veterinarian may prescribe extra label use of a medically important antibiotic in the water if they have met the requirements of the Animal Medicinal Drug Use Clarification Act (AMDUCA) regulations.
There is also a group of antibiotics used in food animals which are classified as not being medically important. These antibiotics will not require a veterinary feed directive to be used in the feed of food animals. Examples of non-medically important antibiotics, or other drugs not classified as antibiotics, used in the feed of cattle are as follows.
* Ionophores (monensin, lasalocid, laidlomycin)
* Decoquinate (not an antibiotic)
* Amprolium (not an antibiotic)
There is one exception: if non-medically important antibiotics are fed concurrently with a medically important antibiotic, their concurrent feeding will have to be authorized in the veterinary feed directive for the medically important antibiotic. For example, monensin may be legally fed concurrently with the medically important antibiotic tylosin. When fed by itself, monensin would not require a VFD. When fed with tylosin, the VFD authorizing the use of tylosin must authorize the concurrent feeding of monensin with tylosin.
You can confirm that an antibiotic to be used in the feed of your animals requires a VFD by looking for the following wording on the label. “Caution: Federal law restricts medicated feed containing this veterinary feed directive drug to use by or on the order of a licensed veterinarian.”
When you and your veterinarian agree that a medically important antibiotic is appropriate to use in the feed of animals under your care, then your veterinarian will provide you with a veterinary feed directive.
A veterinary feed directive is a written (nonverbal) statement issued by a licensed veterinarian in the course of the veterinarian’s professional practice that orders the use of a VFD drug or combination VFD drug in or on an animal feed. The VFD rule is clear that this authorization must take place within a valid veterinary-client-patient relationship, and that the veterinarian must be licensed in the state where the animals receiving the VFD feed are located.
A VFD may be either hard copy or electronic, but the regulations are clear that the authorization cannot be only in verbal form. Your veterinarian will keep the original copy and provide a copy to both you and the distributor of the VFD drug. The veterinarian may choose to provide the VFD in either electronic or hard copy form.
There are some general requirements that are clearly defined in the VFD final rule. The first is that animal feed bearing or containing a VFD drug or a combination VFD drug (a VFD feed or combination VFD feed) may be fed to the animals only by or upon a lawful VFD issued by a licensed veterinarian. Secondly, a VFD feed or combination VFD feed must not be fed to animals after the expiration date on the VFD. Third, use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extra label use) is not permitted.
The VFD final rule includes 15 specific informational inclusions in a VFD. The expiration date is how long the authorization to feed the VFD feed is in effect. This period may be stated on the label, or if the label is silent as to the duration of the authorization, the veterinarian may authorize this use for up to six months.
Your veterinarian will also specify the approximate number of animals to be fed the VFD feed by the expiration date of the VFD, the duration over which the VFD drug is to be fed, and the level of VFD drug in the VFD feed. Your veterinarian has no other option than to adhere to the label in authorizing these uses.
There are still some uncertainties as to specific details of the process, but producers should not interpret this as meaning we will fail in our efforts to institute this new system. The biggest thing producers can do today is to start the conversation with their veterinarians about what medically important antibiotics they are using in the feed or water. If a veterinarian doesn’t immediately come to mind, your first order of business is to establish a relationship. Be prepared that this will be a discussion and not an automatic authorization of your current practices.