Over-the-Counter Antibiotics Changing to Prescription Only By Dr. Lee Jones, M.S., D.V.M., Associate Professor, Dept. of Population Health, UGA

Over-the-Counter Antibiotics Changing to Prescription Only

By Dr. Lee Jones, M.S., D.V.M, Associate Professor, Department of Population Health, University of Georgia

Beginning in June 2023, you won’t be able to purchase over-the-counter (OTC) antibiotics at the local farm supply store. On June 10, 2021, the U.S. Food and Drug Administration (FDA) finalized Guidance for Industry #263 (GFI 263), which outlines the process for animal drug sponsors to voluntarily change the approved marketing status of certain medically important antimicrobial drugs from overthe-counter (OTC) to prescription (Rx). GFI 263 provides for a two-year implementation period. While some products may change from OTC to Rx status beforehand, by June 2023 all OTC antibiotics will become Rx only. Some products were voluntarily pulled by companies; other products, such as injectable penicillin and oxytetracycline (both 200 mg/ml and 300 mg/ml), will be available by Rx only.

FDA took this action to attempt to address the concern of antibiotic resistance in human and animal health. Antimicrobial use in humans, animals and even plants may contribute to the development of antimicrobial resistance in microorganisms.

Any antibiotic use can contribute to antibiotic resistance, so it’s important to avoid unnecessary or inappropriate uses of antibiotics. GFI 263 puts responsibility for the use of medically important antimicrobials into the hands of veterinarians, who are trained to understand not only when these medications are needed, but also what is the appropriate drug, dose, duration and administration method to resolve infection and protect animal health and our food supply. The veterinarian’s expertise is critical to ensuring the responsible use of antibiotics in animals. https://www.avma.org/resources-tools/onehealth/antimicrobial-use-and-antimicrobial-resistance/ over-counter-antimicrobials-changing-prescription-only.

In years past, farmers could go to a farm supply store and purchase antibiotics or order some of the products through online companies without involving a veterinarian. Soon, though, farmers will need to plan ahead and discuss buying their antibiotics with a veterinarian. The veterinarian can either sell the antibiotic products directly to farmers or provide a prescription so the farmer can purchase antibiotics through another supplier.

All prescriptions or Rx will require a veterinaryclient-patient-relationship (VCPR). For Georgia, this

means that the veterinarian is familiar with your farm and animals and the herd health program on the farm and has visited the farm in the last year. The Food and Drug Administration has placed antibiotic decision responsibilities on veterinarians. Veterinarians can advise farmers when and how to effectively use antibiotics in their animals. Not all antibiotics work the same or on every infection. In fact, some overthe-counter medications are nearly useless for some infections. This means that farmers are wasting time and money treating some diseases and have to eventually find a prescription antibiotic to help heal their animals anyway. The veterinarian isn’t required to give the antibiotic, and farmers can keep a supply of antibiotics available to use as needed.

For farmers who already work with a veterinarian, nothing will change. However, for farmers who have been used to the convenience of buying what they want from their local store, it will change how they legally acquire antibiotics.

When the Veterinary Feed Directive went into effect in January 2017, many farmers quit feeding antibiotics in feed and mineral. Most saw absolutely no effect of not feeding. That’s because the levels were too low and intake so inconsistent that they weren’t effective to prevent or combat infections. Following the implementation of the VFD, sales of antibiotics in feed dropped significantly and animal health wasn’t significantly changed.

FDA intends to move antibiotics from convenient use to judicious use. Judicious use means that antibiotics are used in animals only after a diagnosis has been made that indicates antibiotics should be used. In the past, antibiotics were sometimes used with the saying, “I don’t know if she needs, it but it can’t hurt anything.” We know now that indiscriminate use actually does reduce effectiveness. We see drugresistant bacteria, parasites, fungi and even weeds. Nature has a way of fighting back. Judicious use also includes keeping proper records of when and how antibiotics were used. For instance, sometimes a lameness can be caused by an infection in the hoof, hoof rot, or an injury. Treating an injury with antibiotics will not improve the condition and will delay selling the animal for 4-5 weeks until the withdrawal period has passed.

Records can help improve our antibiotic decisions. For instance, if an animal is treated but didn’t respond, we can review whether the diagnosis was correct, whether the correct dose was given, whether the best antibiotic was selected, or whether the treatment was too late in the course of disease. Using records, we can help save time and money by making more effective antibiotic decisions afterward.

AVMA Position Statement on Judicious Use of Antimicrobials

Judicious therapeutic use of antimicrobials is a core principle of the broader goal of antimicrobial stewardship. Antimicrobial Stewardship involves maintaining animal health and welfare by implementing a variety of preventive and management strategies to prevent common diseases; using an evidence-based approach in making decisions to use antimicrobial drugs; and then using antimicrobials judiciously, sparingly, and with continual evaluation of the outcomes of therapy, respecting the client’s available resources. In addition, other management and intervention strategies may be considered prior to antimicrobial therapy for infectious diseases.

When the decision is made to administer an antimicrobial for prevention, control and treatment of diseases caused by bacteria, veterinarians should preserve the effectiveness and availability of existing antimicrobial agents, while striving to optimize therapeutic efficacy and minimize antimicrobial resistance. In accordance with the FDA, therapeutic uses are associated with the prevention, control and treatment of specific diseases that are necessary for assuring the health of animals. https://www.avma.org/ resources-tools/avma-policies/judicious-therapeuticuse-antimicrobials.

Which Products are Included?

All OTC antibiotics are included. A full list of antibiotic drugs can be viewed on: https://www.fda. gov/animal-veterinary/judicious-use-antimicrobials/ list-approved-new-animal-drug-applications-affectedgfi-263. It includes all injectables, pills, water additives, mastitis treatment – everything. It doesn’t include products to treat internal or external parasites or products that don’t contain antibiotics.

Some farmers won’t be happy with FDA’s action; however, for most farmers who already use a veterinarian for herd health and production services, nothing will change. To be honest, I haven’t used an OTC product for many years because most aren’t as effective as they used to be. Perhaps if we discontinue using them for convenience, they might be effective again in the future.