– Dr. Michelle Arnold, UK Veterinary Diagnostic Laboratory
Beginning soon, a valid veterinarian-client-patient relationship must exist to use many drugs that are currently purchased over the counter.
On June 11th, 2021, The Food and Drug Administration (FDA) finalized a Guidance for Industry (GFI) #263, which outlines the process for animal drug manufacturers to change all remaining antibiotic formulations used in animal health care from over-the-counter (OTC) to prescription status. Products commonly used by beef producers such as injectable penicillin and oxytetracycline (for example, LA300) will no longer be available without a prescription from a veterinarian as of June 2023. Specifically, all dosage forms of medically important antimicrobials approved for use in animals will only be available from, or under the supervision of, a licensed veterinarian, and only when necessary for the treatment, control, or prevention of specific diseases. Producers will need to consult a veterinarian to obtain all antibiotics in any form (injectable, bolus, topical, intramammary) or to request a prescription to purchase them from a distributor.
FDA’s goal through GFI #263 is to curb the development of antibiotic-resistant bacteria and, in turn, reduce the risk of human infections that are difficult to treat due to ineffective antibiotics. To accomplish the goal, FDA is promoting the implementation of “responsible antibiotic stewardship practices in veterinary medicine” which are defined as “actions that preserve the effectiveness of antibiotics while maintaining animal health”. Examples of responsible practices include 1) only using antibiotics when necessary to treat a sick animal; 2) establishing vaccination protocols and other disease prevention plans to reduce the need for antibiotics; and 3) livestock owners and veterinarians working together to make decisions to improve the overall animal health and welfare of the herd over the long term.
Given that this change is less than 6 months away, what can a livestock producer do now to prepare for it? For a veterinarian to legally sell or prescribe prescription products, FDA states, “A licensed veterinarian may legally use or dispense a prescription animal drug only within the course of her/his professional practice where a valid veterinarian-client-patient relationship exists. Veterinarians employed by drug manufacturers or distributors may not legally dispense prescription drugs to laypersons unless they meet the above criteria. Similarly, practicing veterinarians or their employees may not legally sell prescription animal drugs to walk-in customers unless the same criteria are met.” Therefore, the first step to do now is establish a valid veterinary-client-patient relationship (VCPR). Kentucky has its own definition of a VCPR (see Box 1 below). Although the rules are straightforward, how to build a VCPR first requires communication with a veterinarian and asking the question “What do I need to do to establish and maintain a VCPR with you?” The law requires the veterinarian to be familiar with the client, the livestock, and the management of the animals on the farm through “medically appropriate and timely visits” to the place the animals are kept. Scheduling routine veterinary visits to the farm at intervals established by the veterinarian is a perfect way to meet this requirement. At a minimum, the veterinarian needs to know the livestock business you are in (commercial cow/calf; stocker/backgrounder; seedstock operation), what vaccines are routinely given and when, what diseases are recurring problems at the farm and how you typically treat them (for example, pinkeye, foot rot, bronchopneumonia, calf scours, etc.) and any health concerns that may be on the horizon. Some veterinarians will execute a written VCPR agreement although it is not required.
Once the VCPR is established and recognized by both the client and the veterinarian, then the discussions can begin regarding how to obtain prescription antibiotics after June 2023. Working with the veterinarian to establish when antibiotics are necessary before illness occurs is crucial to having the drugs on hand when needed. Setting up treatment protocols in advance with the veterinarian for common problems on your farm, including a written plan of when to treat an animal (also known as a “case definition”), what drug to use (dose, route of administration, how often to give it), what treatment records should be kept, and how withdrawal times will be recorded and observed will reduce the need for emergency veterinary visits and expedite treatment. An important piece of the protocol is to establish when an antibiotic treatment should be considered a failure and what the next step should be when failure is recognized. The treatment protocol needs to be discussed with every person on the farm who may be involved in identifying, pulling and treating an animal in the herd.
Although producers express frustration if a veterinarian does not honor a request for a prescription medication or veterinary feed directive (VFD), it is important to understand that any violative antibiotic residue detected at slaughter will result in an investigation of the veterinarian who prescribed the drug, even if the drug was administered improperly by the producer and/or instructions were not followed. In addition, if a drug is used in any manner differently from what is written on the label (known as Extra label drug use or ELDU), the meat withdrawal time usually must be extended. For example, if a higher than label dose is used, it changes when the residue concentrations will fall below the drug testing tolerance. Bear in mind that any drug delivered with a dart is considered extra label use and may require an extended withdrawal period, even when all other label directions are met. The only way a drug can legally be used extra label is when it is prescribed by a veterinarian, who must also issue an extended withdrawal interval. Veterinarians can contact the Food Animal Residue Avoidance Databank (FARAD) for guidance in establishing the required withdrawal time.
Bottom Line: Talk to your veterinarian, sooner rather than later!
EDITOR’s NOTE: During the most recent OSU Beef Team Virtual Beef School, Dr. Justin Kieffer offered the brief explanation embedded below regarding the FDA’s GFI #263 and also the definition of VCPR.