Veterinarians are more than just antibiotics dispensers. That was the underlying message of a webinar put on by Dec. 6 by Penn State University Extension about the changes coming to the sale of veterinary antibiotics.
Beginning in June 2023, animal antibiotics will no longer be labeled for sale over the counter. That means farmers will be required to go through a veterinarian to get antibiotics they used to be able to buy freely at their local farm supplies store.
It’s part of an effort by the U.S. Food and Drug Administration to combat antibiotic resistance, but many small farmers are upset by the change. Farmers say it will make it more costly to operate, on top of how difficult it can be to find large animal veterinarians.
There is a lack of veterinarians who will see and are knowledgeable about livestock in some rural areas, but using vets for more than just emergencies could create an environment that will support more veterinarians working in rural areas.
“One of the things I often talk about is making sure that we’re utilizing veterinarians such that we can encourage and support more veterinarians in our communities,” said Hayley Springer, during the webinar. Springer is an extension veterinarian and assistant clinical professor at Penn State. “Through building these preventative things into how we interact with our veterinarians, we can help build the business.”
What it means
The FDA’s Guidance for Industry No. 263 recommends manufacturers of “medically important antimicrobials” that are currently available over-the-counter label their drugs available by prescription only. The guidance was finalized in June 2021 and will take effect on June 11, 2023, nationwide.
This means farmers will need to have a veterinary-client-patient relationship, or VCPR, in order to get antibiotics. This includes injectable, oral, intramammary and ophthalmic antibiotics. There are 93 individual products impacted. A full list can be found at: www.fda.gov/animal-veterinary/unpublished-judicious-use-antimicrobials/list-approved-new-animal-drug-applications-affected-gfi-263.
This change will not affect the availability of over-the-counter dewormers and vaccines.
If a farmer does not already have a VCPR, now is the time to get one. The definition varies slightly state-to-state but basically a VCPR means the veterinarian knows an animal and/or the operation well enough to diagnose and treat a medical condition.
“You’re going to need to bring a veterinarian onto your farm,” Springer said.
The FDA does not allow VCPRs to be established through electronic means, according to the American Veterinary Medicine Association, but they could be maintained through telemedicine.
The why
Some attendees to the webinar asked about ways to get around the need for a VCPR. Springer instead came back to the reason why the change is happening.
Antibiotic resistance not only makes it more difficult to treat sick animals, but it can impact human health.
“We have to remember that one of the main goals of our farms is to produce safe wholesome food and antibiotics and resistance, especially when we’re talking about fecal origin bacteria, which is what most of our foodborne bacteria are, can end up as resistant foodborne disease,” Springer said.
She brought up a salmonella outbreak in 2017 that originated from a group of dairy calves. It was a multidrug resistant strain that infected 56 people, resulting in 17 hospitalizations in 15 states. There were three people infected in Ohio. About 60% of the cases had direct contact with the livestock.
Of the 56 people, 31 were under the age of 11. The reason so many young people were impacted was because the calves were 4-H projects, Springer said.
Bringing antibiotics under veterinary oversight is a key part of judicious use, which is part of antibiotic stewardship, Springer said.
An earlier FDA guidance for industry recommended antibiotics administered in feed or drinking water be made prescription only. That type of antibiotic represented about 95% of the market. Sales of the feed administered antibiotics dropped significantly after being made prescription-only, suggesting to the FDA that moving the products under veterinary oversight influenced judicious use.
The other part of antibiotic stewardship is minimizing the use of antibiotics, a key to which is disease prevention, Springer said. Farmers can work with their veterinarians on biosecurity, vaccination and medication protocols.
Disease prevention is also one of the best ways for farmers to “improve operations from an animal wellbeing standpoint, from a production standpoint and from a profitability standpoint,” Springer said.
(Reporter Rachel Wagoner can be reached at 724-201-1544 or rachel@farmanddairy.com.)
More resources:
Full list of antibiotics affected by GFI 263
FDA’s GFI 263: Frequently Asked Questions for Farmers and Ranchers
Past Farm and Dairy coverage:
FDA proposes animal antibiotics go behind counter
What farmers need to know about FDA guidance ending OTC antibiotics
