Antibiotic sales for food animals dropped 33% overall from 2016 to 2017 with tetracycline sales decreasing 45% over the same period, much to the surprise of industry supporters and those critical of antibiotic use in production animals alike. The Food and Drug Administration’s (FDA) recently released 2017 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals was long awaited, providing the first full year of data since the full implementation of the Veterinary Feed Directive (VFD).
More specifically, Guidance for Industry (GFI) #213 and the revised federal regulation provided the oversight over water and feeds containing medically important antibiotics, bringing them under veterinary oversight. Unsurprisingly, as pressure upon the FDA to combat antibiotic resistance mounts, the FDA has plans to move all remaining OTC products containing medically important antibiotics under the purview of veterinary oversight in the coming years.
The FDA Center for Veterinary Medicine will “Issue and implement a final strategy (e.g. GFI) to bring all dosage forms (including, injectable, intramammary, etc.) of medically important antimicrobial drugs approved for use in food-producing animals under the oversight of a licensed veterinarian.” This goal is one of many outlined in the FDA’s Supporting Antimicrobial Stewardship in Veterinary Settings: Goals for Fiscal Years 2019-2023 action plan. These steps would ultimately finish what the VFD started, indeed bringing all medically important antimicrobials under veterinary oversight.
FDA’s plans set 2019-2021 as the target dates to release the draft and final strategies for bringing all antimicrobials under veterinary oversight with the final strategy proposal detailing the actual dates for implementation. Dr. John Hallberg, Director of Regulatory Affairs for Zoetis, says he believes FDA is working to meet these goals, planning to release a draft strategy in September of this year with the intent of a final plan via GFI in October of 2021.
In contrast to the institution of the VFD, which removed growth promotion claims and implemented record keeping requirements, Dr. Hallberg indicated that the upcoming label changes for the remaining OTC products will more simply add the required prescription/veterinary oversight labeling. Despite these label changes, some veterinarians may see significant changes to their client base, especially those who service smaller or more rural producers more likely to utilize OTC antibiotics due to financial considerations or availability of veterinary care.
Not to be underestimated, this market represented 5% of all antibiotic sales in 2017, largely made up of oxytetracyclines and penicillins. To put this in perspective, OTC antibiotics represented over 270,000 kilograms of active ingredients sold in 2017. While this portion is far less than the 3 million kilograms of antibiotics used under purview of a VFD, the change could notably impact certain veterinarians depending on your specific clientele.
As producers who historically have only relied upon veterinarians for more emergent care begin to seek out a new source of antimicrobials, veterinarians are offered an opportunity to expand their client base, increase animal welfare, and detail the value-added services they can provide. To prepare for the onset of this change, there are several steps to consider taking to ensure the transition benefits you, your clients, and their livestock.
Establishing clear and specific guidelines for what your clinic considers a valid Veterinary Client Patient Relationship (VCPR) can be a simple first step if you have not already done so. Not only is a VCPR a legal requirement for writing prescriptions but it can save you a great deal of hassle when it comes to meeting client expectations. Dr. Hallberg emphasizes this as a key component to adapting to the new rules, commenting that “this change to Rx labeling could be an impediment at times, but producers will simply need to establish a proper rapport with a veterinarian.”
Regulatory requirements for a valid VCPR vary by state, but typically follow similar standards. The American Association of Bovine Practitioners has guidelines for establishing a VCPR which are freely available and focus on six points:
- A written agreement between the veterinarian/practice and client,
- Continued veterinary oversight of the client’s animals, drug use, and treatment protocols,
- Clarified relationships with consultants or other veterinarians,
- Written treatment protocols for common conditions which are periodically reviewed,
- Written or electronic records of treatments which are periodically reviewed,
- Provide prescription drugs for specific time frames and specific protocols.
You or your practice may decide to take additional steps for clients to establish or maintain a valid VCPR with you depending on how you operate and the clients you typically serve.
These guidelines will be a necessity when new clients begin seeking a veterinarian with which they have not had a previous relationship or for those who hope to obtain antimicrobials without maintaining a proper relationship. AABP’s Drug Use Guidelines for Bovine Practice state that “veterinarians are reminded of their ethical responsibilities to not dispense, recommend or prescribe drugs solely for purposes of income generation,” making it important for clients to understand that a VCPR must extend beyond your clinic being a source for antibiotics.
Clear client expectations can also help to prevent awkward situations or those which may paint your service in a poor light. By laying out ground rules from day one, the chance of miscommunication that could tarnish your reputation is diminished.
When speaking with Carla McLachlan, Program and Events Manager for Michigan State University’s College of Agriculture and Natural Resources, hobby farmer, and lifelong supporter of 4H, about the impact this GFI may have on smaller farms, she raised a concern that should not be overlooked. “I am confident that the welfare of livestock will suffer as hobby farmers will delay treatment if quick access to antibiotics is limited to a vet farm call.”
While this certainly may be true in certain instances, the change also represents an opportunity for veterinarians to improve welfare conditions if these clients can be convinced of the advantages a veterinary relationship brings. McLachlan agrees, continuing, “If hobby farms are able to set up […] working relationships with the [veterinarian] in their area, with regular annual/biannual visits […] and then be able to obtain the antibiotics as needed – I think overall that would be good.”
The key point is the limit farm calls may place on antimicrobial availability. Some producers who have become accustomed to providing their own animal care may choose to delay or forgo veterinary treatment due to financial concerns as OTC antibiotics are no longer easily available.
Fortunately, reducing the barrier of a farm call is no insurmountable feat and many veterinarians are likely to have had programs in place for many years that circumvent this issue. McLachlan emphasized that the cost of antibiotics themselves is generally not the issue- she typically finds antibiotics through her veterinarian similarly price to those currently at commercial farm stores. The solution then, for many smaller farmers and ranchers, is minimizing the number of farm calls and on-farm time to obtain necessary antimicrobials.
Reducing the cost barrier can certainly be difficult for smaller clients with whom you have had little or no relationship previously. It will be imperative to sell yourself and your ability to provide value-added services to these producers. Clients may need to be convinced that the occasional farm call and maintaining a relationship will result in long-term benefits. For instance, many clients may benefit substantially from insights on nutrition, facility management, or simple instructions, like giving proper subcutaneous or intramuscular injections.
How you present yourself and your clinic will likely be specific to each client. Producers may respond best to knowing that their animals will be better cared for with regular visits from your clinic while some may be swayed by understanding the potential profit gain by raising healthier animals. For example, when diseased animals are properly diagnosed and treated with the appropriate antibiotic, rather than an OTC penicillin, animal health will invariably improve. Others may be more interested in your abilities to help them grow or diversify their operation or be attracted to other unique services your clinic offers.
Beyond this, offering a clinic farm store or working with a catalog service can substantially reduce costs to clients. With an established VCPR, protocols, as simple or extensive as they may be, can be instituted with producers of all sizes, specific to their farm. With protocols for common diseases in place, the need for a trip to the farm can be eliminated for most issues that may arise. Instead, clients may pick up needed antibiotics from your store or have them shipped through your catalog, saving them the farm call expense while saving you time traveling to and from calls and regularly restocking your truck.
Where to Begin
An effective day one step is to simply communicate the proposed changes with your current clients. Even if you know specific producers do not ascribe to using OTC antibiotics, the conversation may be beneficial. The more word spreads, the more likely it is to reach producers who you currently do not work with but may be in need of a veterinary relationship in the coming future. The sooner these relationships can be established, the easier the transition can be for everyone involved.