Stay ahead of the antibiotic Rx curve
By MWI Animal Health
“All we can be certain of is increased scrutiny of antibiotic uses in food animal agriculture.”
So said Mike Apley, DVM, PhD, Professor of Clinical Sciences at the Kansas State University College of Veterinary Medicine, in an article published by the Colorado Livestock Association.1
That prophecy has come to pass.
The FDA published Guidance 263 on June 11, 2021. It requires the removal of antibiotics used in animal agriculture (and that are medically important in human health) from over the counter (OTC) products effective June 11, 2023. Starting then, those products will come under a veterinarian’s oversight and prescription.2
The directive includes more than just injectable antibiotics. In an UNL BeefWatch podcast, Becky Funk, DVM, Animal Health Teaching and Northeast Extension Specialist with the University of Nebraska-Lincoln, explained that numerous calf or cow bolus preparations are now going to be prescription only, as well as intramammaries.3
“The expectation is that producers will see familiar products start to disappear from store shelves as OTC products . . . as manufacturers finalize label changes and refine their marketing and distribution channels to assure compliance with prescription requirements,” wrote Funk and Jesse Fulton, Extension Educator and Director of Nebraska Beef Quality Assurance, in an article titled “New Antibiotic Restrictions Soon to Become Reality”.4
Effects of increased scrutiny
It’s important to understand that these products aren’t going away. Producers will just need a veterinary prescription to purchase and use them.
As for MWI Animal Health, its US distribution network includes seven pharmacies and 19 distribution centers across the nation. Paul Mercier, Vice President, MWI Production Animal Sales, says, “MWI has always championed and encouraged MWI producer-clients to have working relationships with their veterinary practitioners. The transition of these OTC products to prescription status will be business as usual for MWI and its customers who already have a valid veterinary-client-patient-relationship (VCPR).”
For producers, a VCPR means that your veterinarian knows who you are, knows the kind of livestock you are raising and what is being done with them, understands your management, and that you agree if they come out to diagnose an illness and use an antimicrobial to treat a disease or illness, you will follow their directions including dosage, duration, and withdrawal, explains Joe Paschal, PhD, Texas A&M AgriLife Extension Livestock Specialist, Corpus Christi.5
A VCPR adds your veterinarian to your management team as an animal health consultant. Under the VCPR, your veterinarian will work with you in writing standard operating procedures (SOP) for diagnosing and treating disease.
What if the treatment protocol isn’t working? You have the responsibility to contact your veterinarian so he or she can follow up with a different approach, Funk said.
Record keeping won’t be any different than what many producers are already doing and what’s required under the Beef Quality Assurance (BQA) program. In fact, because antibiotics will soon be prescription only, a record keeping trail will be very robust since both the veterinarian and pharmacy are legally required to keep records.
Protecting antibiotic use
If a producer doesn’t have a relationship with a veterinarian, now’s the time to get that done. The change doesn’t require producers to purchase antibiotics from a veterinarian, just that they have a valid VCPR, Funk and Fulton wrote. Mercier adds, “Producer-clients who order these medications from mwiah.com may do so as long as our pharmacy has proof that a VCPR exists.”
Fulton encourages producers who may not have a VCPR to plan ahead, especially if they are worried about the timeframe this new restriction could place on getting a scripted product for a sick animal.
“If they get that VCPR taken care of and the veterinarian already has an idea of what is taking place on their operation, it speeds the whole process up.” She encourages producers to not get left behind. “Get with your veterinarian, get your VCPR taken care of so that you don’t have any issues with this when this guidance takes effect.”
Judicious antibiotic use
Beyond establishing or maintaining a valid VCPR, there are things producers can do to limit their use of antibiotics. The first is to work with a veterinarian to establish a solid animal health program, including vaccinations.
To that end, becoming certified through the BQA program can arm beef producers and their employees with the knowledge they need to practice judicious antibiotic use. BQA offers many other management principles, as well, to help a cattle operation run more efficiently.
Paschal notes, “In the long run, practicing good biosecurity, correctly diagnosing illnesses, and the proper prescription of the right antibiotic may help shorten the incident of the disease, improve productivity or return of the health of the animal, and reduce overall antibiotic use in livestock, pets, and in humans.”
In the meantime, however, Funk and Fulton emphasize that producers shouldn’t stock up on antibiotics before the change goes into effect. Why? Medications could reach their expiration date and lose effectiveness before they’re even used.
“There’s a shelf life on products for a reason,” Fulton explained on the UNL BeefWatch podcast. “And it might be that the product either degrades or changes over time. If that product is degrading in the bottle and we go to treat that animal, we may see a treatment failure.” What’s more, under dosing animals with a degraded antibiotic can lead to antibiotic resistance.
Curbing antibiotic resistance
That resistance is what the increased scrutiny and restrictions on antibiotics are designed to address. Since some antibiotics are used in both livestock and humans, the FDA’s concern is that antibiotic-resistant bacteria could develop more quickly from the widespread use of certain antibiotics that are medically important to humans — negatively affecting both humans and animals.
Tylosin, penicillin, and tetracyclines are among some of the more popular antibiotics available over the counter as injectables — that is, for now [See Figure 1].
Products unaffected by the change include ionophores, antiparasiticides, injectable and oral nutritional supplements, oral pro/prebiotics, and topical non-antibiotic treatments. These products will continue to remain available through standard OTC channels.
“Although the percentage of antibiotics used in agriculture is declining, we want to continue to use them judiciously and intelligently,” says Thomas Hairgrove, DVM, Texas A&M AgriLife Extension Specialist, College Station. “Data shows agriculture is responding in a positive way.”
H. Morgan Scott, DVM, agrees. “Science comes down to this: Less is better, but zero is not an option,” the veterinary epidemiologist and professor in the Texas A&M College of Veterinary Medicine & Biomedical Sciences (CVMBS) said in “Progressive Cattle”.6
“We know that the less of an antibiotic we use, the slower resistance will rise. But you can’t not treat animals. We have a moral obligation to treat sick animals we’re in care of. So the judicious use (of antibiotics) comes into using this limited resource as best as possible in the future.”
For more information, visit fda.gov/animal-veterinary for the following:
- FDA finalizes guidance to bring remaining approved over-the-counter medically important antimicrobial drugs used for animals under veterinary oversight
- List of Approved New Animal Drug Applications affected by GFI #263
- GFI #263: Frequently asked questions for farmers and ranchers
References
1Apley, Michael, DVM, PhD. Antibiotics: What lies ahead? Colorado Livestock Association. Available online at: https://coloradolivestock. org/antibiotics-what-lies-ahead/
2Guidance for Industry #263: Recommendations for sponsors of medically important antimicrobial drugs approved for use in animals to voluntarily bring under veterinary oversight all products that continue to be available as over the counter. June 11, 2021. Available online at: https://www.fda.gov/regulatory-information/search-fdaguidance-documents/cvm-gfi-263-recommendations-sponsorsmedically-important-antimicrobial-drugs-approved-use-animals
3UNL BeefWatch podcast. Antibiotic restrictions soon to become reality. March 28, 2022. Available at: https://www.feedlotmagazine. com/new-antibiotic-restrictions-soon-to-become-reality/ audio_c6eb88ea-aea6-11ec-86a0-3ba7e0640643.html?utm_ medium=social&utm_source=email&utm_campaign=user-share
4Funk, Becky, DVM, and Fulton, Jesse. New antibiotic restrictions soon to become reality. Drovers. March 4, 2022. Available online at: https:// www.drovers.com/news/industry/new-antibiotic-restrictions-soonbecome-reality
5Himes, Susan. All antibiotics for livestock will soon require a vet’s prescription. Agriculture & Life Sciences, Texas A&M University Department of Animal Science. November 12, 2019. Available online at: https://animalscience.tamu.edu/2019/11/12/all-antibiotics-forlivestock-will-soon-require-a-vets-prescription/
6Cooper, David. The future of antibiotic use in cattle. Progressive Cattleman. April 24, 2015. Available online at: https://www. progressivecattle.com/topics/herd-health/the-future-of-antibioticuse-in-cattle
Fig. 1. Some of the products that will see label changes to prescription-only status
