In a recent Penn State webinar on Dec. 6, 2022, Hayley Springer, DVM, discussed how over-the-counter “medically important” drugs will shift from an over-the-counter status to a prescription status effective on June 11, 2023. She explains how antibiotic resistance happens, why these changes are going into effect, products affected by the change and how producers can prepare.
How does antibiotic resistance happen?
The reason for the change is due to antimicrobial resistance. The CDC defines antibiotic resistance as the ability of a bacteria to resist the effects of an antibiotic that would otherwise kill it or stop its growth. This means that as we use antibiotics, no matter why we use antibiotics, gradually bacteria become resistant to them.
“So, drugs that we are using might not work. The animals that we are treating might not get better. It's all because of changes within those bacteria,” Springer said. “By responsibly using antibiotics, we can help reduce the development of antibiotic resistance. And it's important to remember that antibiotic resistance is not just an issue within our farm and that it can spread beyond the farm.”
Within every bacteria population, there are a few resistant organisms. When we treat with antibiotics, we kill off all the susceptible organisms and it leaves those resistant organisms that are no longer impacted by that antibiotic. When the bacterial population grows back, a greater proportion of the population is resistant. When this is a pathogen that's causing disease in a human or an animal, it becomes a very concerning situation.
“One of the other interesting things that bacteria do is pass drug resistance between each other. And it's not even just between individuals of the same species,” Springer said. “We can see antibiotic resistance being passed between different species. So, for example, a salmonella can pass resistance genes to an E. coli making that E. coli resistant to the same things that the salmonella was resistant to.”
What does that mean for your farm?
One of the main goals of our farms is to produce safe, wholesome food. Antibiotic resistance, especially when we are talking about fecal origin bacteria, which is what most of our foodborne bacteria are, can end up as resistant foodborne disease.
“Where I think we have the most risk in terms of human health is our employees on the farm. If our animals have an antibiotic-resistant infection, they could or even are harboring antibiotic-resistant pathogens like salmonella or E. coli. They could pass that on to the people working in close contact with them,” Springer said. “So I think this is a great reminder that antibiotic stewardship can impact human health, and it can impact the human health of people who are right on our farm.”
Antibiotic resistance can also cause it to be more difficult to treat sick animals.
Why are these changes coming into effect?
The changes going into effect are about veterinary oversight. The antibiotic label changes we are seeing are intended to improve judicious use of antibiotics through improved veterinary oversight.
“It's important to notice that animal agriculture is part of the story. Because we are part of the story, we are also part of the solution. Antibiotic stewardship includes the judicious use of antibiotics and minimizing the need for antibiotics,” Springer said. “So, what does judicious use of antibiotics look like? We generally consider that as having good veterinary oversight, making sure that we are using the right antibiotic that makes the most sense in terms of fixing the disease without using a really high-powered antibiotic we might need for important human diseases.”
Good veterinary oversight includes a veterinarian client patient relationship (VCPR), which is the basis for interactions among veterinarians, their clients and their patients and is critical to the health of animals. Within the relationship, the veterinarian plays a big role and is responsible for clinical judgments and ensures sufficient knowledge of the owner, animals and facility itself. By entering into a VCPR, the owner is agreeing to follow the veterinarian’s advice. VCPRs are needed to access prescription and veterinary feed directive medications. The veterinarian can help guide medication selection such that we make sure we are using the right medication for the disease being managed. They can also identify when there’s a need for extra-label use when no labeled products are available or working on-farm.
Products impacted by the upcoming changes
There are three different groups of veterinary products classified by access: 1) prescription products; 2) veterinary feed directive products; and 3) over-the-counter products (Figure 1). The prescription and veterinary feed directive products already require a valid VCPR. Over-the-counter products do not need a VCPR and can be acquired from retail locations. However, they do require a VCPR if they are used any way other than what’s listed on the label directions.
Over-the-counter products are separated into antibiotic and non-antibiotic products. Over-the-counter antibiotic products are then further split into medically important and non-medically important. When looking at the upcoming changes in June of 2023, the only group of products that are going to be impacted are the medically important antibiotics that are currently over-the-counter.
“There are 93 total products that are impacted by these changes. 70 of those products are pioneer products, meaning they are name brand products. This impacted 22 ingredients and eight different antibiotic classes,” Stringer said. “When we look at those 70 pioneer products, we can see that a lot of these products are labeled for cattle" (Figure 2).
Products impacted include intramammary antibiotics for lactating or dry cow treatments, injectable antibiotics, oral antibiotics (both boluses or liquid) and ophthalmic eye ointment. Of the 70 pioneer products, 36 of them are injectable products, 21 are oral products, 10 are intramammary products and three are other routes that include eye ointments.
How should farms prepare?
Changes in June of 2023 will differ depending on where producers get their antibiotics.
“If you currently get your antibiotics from a veterinarian, you are probably not going to see a whole lot of change,” Springer said. “However, if you currently get your antibiotics from the farm store, they won't be there come June 2023. So you need to make sure you have a plan. You won’t be able to go to the farm store and get tetracycline or mastitis tubes.”
Step one of that plan should be assuring you have a valid VCPR. Talk with your veterinarian about what antibiotics you are going to use and how you are going to get them. You might get them directly from your veterinarian, use a mail order pharmacy service or they might have a dropshipping program where you can order and have them shipped to you.
A great way to establish a valid VCPR is bringing a veterinarian onto your farm. Ask a vet to come help you with biosecurity to identify disease risks within your herd and risks for spread of disease. Work with your veterinarian to develop a plan to mitigate all these risks. Another way is to ask your vet to help you identify opportunities to prevent disease by developing a vaccination protocol that is convenient and tailored to your operation's risks. Similarly, your vet could help you establish a medication protocol for identifying disease, moving sick animals and which products to administer, including information such as how much, how long and what route. It is also important for a medication protocol to describe when and how to follow up if that animal is not responding.
Disease prevention is a huge part of antibiotic stewardship and is one way we can take an extra step to being a part of the solution for antibiotic resistance.
“Advocating for prevention is huge to me,” Springer said. “I think this is one of the most valuable ways we contribute to antibiotic stewardship through preventing disease. I also think that it's one of the best ways for us to improve our operations from an animal well-being standpoint, from a production standpoint and from a profitability standpoint."