Antibiotic Label Changes: Are veterinary clinics and clients prepared?

By Hayley Springer, MS, DVM, PhD

Judicious use of antibiotics is crucial to antibiotic stewardship. The Food and Drug Administration (FDA) recognizes that veterinarians are key to guiding responsible antibiotic use and has taken steps to increase veterinary oversight of medically important antibiotic use in animal health. The term medically important (MI) refers to antibiotics belonging to classes that are important in human medicine. This accounts for nearly all antibiotics used in veterinary medicine, except ionophores. In 2017, FDA implemented the first of these changes by bringing medically important antibiotics administered in animal feed under veterinary oversight through the implementation of veterinary feed directive (VFD) rules. The second change, which will come into effect later this year, will shift all remaining OTC MI antibiotics, regardless of route of administration, to prescription status. The affected products are labeled for many species, including beef and dairy cattle, swine, sheep, poultry, horses, dogs, and cats, so it could impact any veterinary practice, though farm animal practices will certainly see a bigger change.

Complicating this change is the fact that exact timing on when the change will hit store shelves is unclear. FDA has requested that manufacturers begin shipping the newly labeled product by June 11 of this year but has also agreed to honor labeling on any OTC products that enter distribution channels prior to the deadline, allowing them to be sold and used through the expiration date. Some manufacturers shipped the last of their OTC-labeled product early in the year, which may run out before June, while other products may remain on shelves beyond June. With the uncertainty on timing, it is important to assure veterinary clinics and clients are prepared for this change now.

As OTC antibiotics become unavailable at retail stores, clinics may see an uptick in calls about establishing a veterinarianclient-patient relationship (VCPR) or whether a current client’s VCPR is still valid. This is an excellent opportunity to review what the clinic or an individual veterinarian require to establish and maintain a valid VCPR. Assuring that all office staff understand these requirements and can clearly convey them to current or prospective clients will aid in a smooth transition. Educating office staff on what products will and will not be affected by the changes will also be helpful, as many clients are uncertain as to which products will remain OTC and which will require a prescription. The FDA website has a full list of products affected by the upcoming antibiotic label changes.

For both new and established clients, this is a good time to discuss antibiotic use and review or develop treatment protocols. This allows the VCPR veterinarian to understand current antibiotic use practices and to determine whether they are comfortable providing prescriptions for currently used OTC products or if a protocol change is warranted. The ultimate decision on which antibiotic products to prescribe will fall to the veterinarian, presenting an opportunity to improve antibiotic stewardship. In some cases, current prescription products may be the better choice because they may provide the advantage of a shorter treatment interval, improved compliance, or a lower re-treatment rate. However, it is important to recognize that the antibiotics that are currently OTC are largely earlier-generation antibiotics, that, given similar treatment outcomes, may be the preferred choice from a stewardship standpoint.

These antibiotic use conversations with clients are important, not only from medical and stewardship standpoints, but also for business reasons. As current OTC antibiotics shift to prescription status, they will need to be purchased from veterinary clinics or through pharmacies. Understanding what products clients are currently purchasing OTC and which of these will be prescribed by veterinarians will allow clinics to adjust medication purchasing to assure availability for clients.

The upcoming antibiotic label changes will hardly be noticed by some clients and will be a major change for others. Good preparation by veterinarians and veterinary clinics can help smooth the transition of OTC antibiotics to prescription status for both the clinic and clients. This is a good time to focus on the details of establishing and maintaining a VCPR, treatment protocols, and assuring all members of the clinic are comfortable talking with clients about the upcoming changes.

About the Author: Dr. Hayley Springer began her academic career after time in both mixed and dairy-only veterinary practice. Her ongoing clinical work primarily revolves around calf health and management of infectious diseases in cattle. She is also involved in both livestock-related and vector-borne-disease extension work, as well as teaching in livestock production, veterinary science, and One Health courses. Her research interests are in pre-harvest food safety with a focus on managing antimicrobial resistance on dairy and veal farms.