Beginning in June, many antibiotics will be available only with veterinarian oversight.
Antibiotic resistance. It’s real. And it has been for a long time.
That is the reason behind the Food and Drug Administration’s recent action to make all medically important antibiotics in human medicine prescription only for use in veterinary medicine.
FDA’s action, known as Guidance for Industry 263, goes into effect June 11.
For beef producers who have an existing veterinary-client-patient relationship, or VCPR, little will change, according to Dr. Mike Apley, professor of clinical sciences with Kansas State University’s College of Veterinary Medicine.
He says they will have to work with their veterinarian to source antibiotics, or have a prescription to purchase from a distributor, rather than buying the antibiotic over the counter from a feed store or other distributor.
“The reasoning [behind the FDA’s actions] is that resistance is a real issue and we need to address it,” Apley says. “When you apply a very effective selective pressure on a highly mutable population with quick generation times, here we are.”
In other words, bacteria that survive the use of antibiotics due to being resistant may remain as a major part of the bacterial population — and make therapy more difficult in the future.
He understands the frustration and inconvenience it will place on some beef producers, but says in the larger scheme of things, his understanding of the FDA approach is that the overall interest of helping to preserve these valuable tools by putting them under a veterinarian’s oversight outweighs the extra expense and inconvenience it imposes.
“It’s long been the FDA’s intention to make all medically important antibiotics prescription,” Apley says.
The first part of that was in 2017 with Guidance 209, the veterinary feed directive, which put medically important antibiotics used in feed and water under a veterinarian’s oversight. For example, producers noticed things like the 10-gram chlortetracycline crumbles were no longer available at the feed store, he says.
The specifics
What will happen next with Guidance 263 is that it puts all medically important antibiotics under a veterinarian’s oversight (veterinary feed directive or prescription). Over-the-counter medically important antibiotics currently on the shelf such as penicillin, spectinomycin, tylosin and oxytetracycline will go away unless that store registers as a drug distributor and begins to accept prescriptions for these products.
Requiring a prescription for antibiotics used in food animals is not new; a long list of medically important antimicrobials have been prescription since they were approved, including tulathromycin, gamithromycin, tildipirosin, tilmicosin, enrofloxacin, danofloxacin, florfenicol and ceftiofur.
A total of 91 product applications fall under Guidance 263. Visit FDA’s website, under the animal-veterinary section, to reference a complete list of affected animal drug applications.
These are antibiotics FDA determines to be medically important in human medicine and where bacterial resistance to antimicrobials is a top concern.
Not all antimicrobials used in food animal production are affected, however.
“There are some in-feed antibiotics that remain non-medically important and are currently available,” Apley says. “The ionophores [e.g., monensin and lasalocid] remain where they were. But if they’re used at the same time as a medically important antimicrobial like tylosin, they have to be authorized to be used through a veterinary feed directive.”
Solid relationships
At the core of FDA’s new guidelines is an established VCPR. But what does that mean, exactly?
In cowboy lingo, if you and the veterinarian can’t howdy with each other after church, you may not have a VCPR.
If you and a vet do not know each other well enough to do that, now is the time to establish a relationship, says Dr. Michele Barrett, medical lead for U.S. technical services with Zoetis.
“The critical part is for producers to make sure they have a valid veterinary-client-patient relationship going into spring vaccination season,” Barrett says. “The ‘now’ is about preparing producers and veterinarians with the information they need about this change to come up with a plan for a smooth transition.”
It is especially important for beef producers who don’t have a VCPR or a veterinarian nearby, she says.
“It’s going to require producers to do some outreach, as well as veterinarians, to make sure they are appropriately servicing that population of producers, so that they have accessibility to the treatments that they need for their animals,” Barrett says.
Apley tells of a rancher who is 120 miles from the nearest veterinarian. The vet waited until he was in the area to stop by the ranch and become familiar with the operation.
“Then when she needed medication, she was able to talk to the veterinarian and meet him halfway to pick up the drugs,” Apley says. “It’s going to increase some of the efforts like that.”
If you are in an underserved area and have a VCPR, you will be able to order antibiotics online or over the phone and have them delivered. But without a valid VCPR, the veterinarian can not sign off on those type of orders.
“If you’re in an underserved area and if you are going to treat your cattle yourself, you’re going to have to have a conversation with your veterinarian and have those drugs on hand,” Apley says.
He uses foot rot as an example. Diseases like foot rot can happen despite best efforts at prevention.
“If it’s a wet year, I don’t know what you do to completely prevent it,” he says. So having the appropriate medicines on hand is helpful. But remember that drugs do go out of date. “If you buy a bottle and it outdates three years from now and there’s half left, you should discard it appropriately and get more.”
That’s where antibiotic stewardship enters the conversation.
“The concept of antibiotic stewardship is only treating animals that need to be treated and making sure they’re treated appropriately,” Barrett says. “I like to think of a continuum of care that starts with prevention and minimizing the number of animals that get sick and actually need treatment.
“The next step is having that conversation with your veterinarian on how to appropriately identify disease and what treatments would be best for the disease pressure and disease occurrence. Really, prevention is a key and important first step in the antibiotic conversation.”
She recommends focusing on spring vaccination.
“These conversations can occur during spring vaccination season to make sure those vaccine protocols are robust and tailored to the disease pressure of that operation,” Barrett says, “and to make sure we are producing the healthiest animals we can moving forward.”
However, even a robust vaccination program is not the only tool to ensure a healthy herd.
Another significant portion of an overall herd health plan is biosecurity, Barrett notes.
“Limiting exposure or entrance of disease onto an operation, minimizing the spread of disease,” is what a biosecurity plan is all about. It basically involves quarantining cattle brought onto the ranch from outside, bred heifers bought as replacements, for example, until their disease status can be determined.
“Sometimes it’s having biosecurity protocols regarding visitors who may be around the facilities, or even around nutritional management,” Barrett says. “All these factors play important parts into providing that prevention and boosting the immunity of our animals.”
As beef producers look to the new FDA guidelines coming this June, it could result in a significant change in how they manage animal health. The experts recommend to consider the potential impacts when going about spring herd health plans.
“Timing is critical,” Barrett says. “Have an early plan.”
Burt Rutherford, former senior editor of BEEF magazine, now owns Rangeview Strategies based in Wheat Ridge, Colorado.
FDA Defines: Veterinary-Client-Patient Relationship
- A veterinarian has assumed responsibility for making medical judgments regarding the health of (an) animal(s) and the need for medical treatment, and the client (the owner of the animal or animals or other caretaker) has agreed to follow the instructions of the veterinarian;
- There is sufficient knowledge of the animal(s) by the veterinarian to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s); and
- The practicing veterinarian is readily available for follow up in case of adverse reactions or failure of the regimen of therapy. Such a relationship can exist only when the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of examination of the animal(s), and/or by medically appropriate and timely visits to the premises where the animal(s) are kept.
And that’s OK, Dean says: “Level the playing field. And then let consumers decide for themselves.”
Burt Rutherford, former senior editor of BEEF magazine, now owns Rangeview Strategies based in Wheat Ridge, Colorado.