Recently, livestock producers and veterinarians have been hearing about changes coming in the way antibiotics are used in food animals. In mid-December, the Food and Drug Administration (FDA) published a final “guidance for industry” that starts the clock running on some of these changes. Initially, it’s the animal health companies that will be adjusting their practices -- adjustments that will eventually make their way down to the people who prescribe and use the drugs: veterinarians and livestock producers.
The role of livestock antibiotics in contributing to resistant bacterial infections in humans is complex and has been long-debated. Producer associations have seen the writing on the wall for a couple of years now that these changes were coming. But what do they actually mean for producers?
What will change:
The labeled uses of “medically important” antibiotics for growth promotion and improvements in feed efficiency will go away. The FDA is asking drug manufacturers to voluntarily take these uses off their products’ labels. Because extra-label use of feed grade antibiotics is illegal, these uses will no longer be legal as well. The companies have until mid-March to tell the FDA what products they plan to do this with. After that, they have three years to make the label changes, so livestock producers currently using antibiotics for growth promotion will have time to adjust, depending on how quickly the companies switch over.
The list of what FDA considers “medically important” antibiotics is pretty long. It contains older drugs like tetracyclines and penicillin along with classes of drugs that are more critical to human medicine, such as cephalosporins and fluoroquinolones. When it comes to growth-promoting antibiotics that fall into this category, it’s drugs like tetracyclines, tylosin, and neomycin that will be affected.
These “medically important” products will shift from over-the-counter to “Veterinary Feed Directive” (VFD) classification – possibly with new label indications for treatment, control, or prevention. The VFD is not a new classification; it’s currently being used for newer feed-grade drugs like Pulmotil® in pigs and cattle and Nuflor® in pigs and fish.
This means that before a producer can obtain (for example) CTC (chlortetracycline) crumbles for his calves or pigs, he will have to obtain a VFD form filled out by his veterinarian. The form will specify the farm and animals to be treated, the duration of treatment, and which drug is to be used. The feed mill or distributor would need to have a properly completed VFD before they could supply the feed.
The VFD won’t be able to come from just any veterinarian. A veterinarian would only be able to issue a VFD for use in animals “under his or her supervision or oversight in the course of his or her professional practice, and in compliance with all applicable veterinary licensing and practice requirements.” Right now VFD’s have to be issued in the midst of a valid veterinary-client-patient relationship (VCPR) that’s spelled out by federal regulation. The new changes add some flexibility in that this relationship will be deemed appropriate by state and professional entities, such as the Board of Veterinary Examiners in South Dakota. This flexibility means that far-flung cattle enterprises may not need to be treated the same as an intensely managed hog operation, in regards to veterinary oversight. But it still means that a veterinarian needs to be involved – one that knows the operation and its needs well.
- The VFD forms will be easier to manage. Everyone’s recordkeeping requirement will be cut from 2 years to 1 year. The forms will be able to be transmitted and stored electronically. And thankfully for this veterinarian, they will no longer have to include an estimate of how much of the medication the animals will consume in the given time frame (this was hard to accurately guess a lot of times). The form will need to simply specify the inclusion rate of the drug, the number of animals to be fed, and the duration of the feeding.
What won’t change:
- The ability to use feed-grade antibiotics to treat, control, or prevent bacterial diseases. The term “prevention” is used in the situation where there is a very high risk of illness if you don’t administer the antibiotic. However, producers will need to obtain a VFD for these products as explained above.
- How one uses and obtains non-“medically important” feed grade products. Examples of these include ionophores like Rumensin®, Bovatec®, most coccidiosis medications, and certain growth-promoting medications like bacitracin (BMD®). Since they’re not used very often if at all in human medicine, there will be no changes in their use.
- Uses of water and injectable antibiotics – yet. There are proposals out there that would move water medications to “prescription” status like many injectable antibiotics.
- Extra label uses of feed-grade medications. Any use of feed grade medications not in accordance with their label is illegal now, and it will remain so.
- The ability of current distributors and feed mills to supply these products. Yes, there will be more paperwork related to more VFD forms, but these new proposals do not limit these businesses in what they can carry or manufacture.
- The need for veterinarians to be involved in decisions about feed-grade antibiotics. There is no better source of information about the proper uses of these products in livestock populations than the herd veterinarian. A close relationship with a veterinarian means that producers may avoid wasting time and money on ineffective uses of these products. Better yet, it may result in practical advice on how to prevent illnesses that would necessitate the uses of these products.
Antibiotic resistance is a complex and sometimes contentious topic among animal and human health professionals. The complexity of the issue means that a “silver bullet” solution is not going to present itself any time soon. All of us involved in using these products—in animals and people alike—play a role in ensuring that they continue to work for the sake of our animals and our family members. Understanding these proposed changes and proactively deciding how they will work into your operation is a great first step that we can all take.
NOTE: Product trade names are used for purposes of illustration only and do not constitute an endorsement of those products.
Source: Russ Daly, DVM, DACVPM