Upcoming Changes Regarding Antibiotic Use; Increasing Veterinary Oversight
INCREASING VETERINARY OVERSIGHT
Sam Holst, DVM , Laura Bruner, DVM
We are now less than a year away from the implementation of new Food and Drug Administration (FDA) regulations that will eliminate sub-therapeutic (growth promotion) use of antibiotics deemed medically important for human medicine, as well as increase veterinary oversight of antibiotics used for therapeutic purposes.
WHY ARE NEW REGULATIONS BEING IMPLEMENTED?
These regulations are part of FDA’s strategy to ensure the judicious use of medically important antibiotics in foodproducing animals.
WHAT ANTIBIOTICS ARE DEEMED MEDICALLY IMPORTANT FOR HUMAN MEDICINE?
The majority of antibiotics utilized in the swine industry to prevent, control, and treat disease are deemed medically important to human medicine, with the following exceptions: bacitracin (BMD), carbadox (Mecadox), narasin (Skycis), bambermycin (Flavomycin), and tiamulin (Denagard). These antibiotics are considered non-medically important.
WHAT EFFECTS WILL THE NEW REGULATIONS HAVE?
FDA’s new regulations regarding antibiotic use will have two primary effects:
- Growth promotion label claims for medically important antibiotics will be phased out
- Increased veterinary oversight for therapeutic (prevention, control, treatment) use of antibiotics
- Medically important feed grade antibiotics will require a veterinary feed directive (VFD)
- All antibiotics delivered via the drinking water will require a veterinary prescription
Antibiotics deemed medically important for human medicine will no longer be able to be fed for growth promotion purposes. Pharmaceutical companies that manufacture feed grade antibiotics have until December 2016 to remove growth promotion label claims from these antibiotics; however, it is likely that some companies may phase out growth promotion claims ahead of the December 2016 deadline. Examples of medically important antibiotics with current growth promotion claims include: chlortetracycline (CTC), oxytetracycline (OTC), OTC + neomycin (Neo-Terramycin), tylosin (Tylan), and virginiamycin (Stafac). These antibiotics will remain available for in-feed use for prevention, control, and treatment purposes.
Additionally, medically important feed grade antibiotics will require a VFD issued by a licensed veterinarian. A VFD is a written statement from a licensed veterinarian that authorizes a client to obtain and use a VFD antibiotic in or on animal feed in accordance with label directions. The table below outlines which antibiotics currently require a VFD, which antibiotics will require a VFD beginning January 1, 2017, and which antibiotics will not require a VFD.
VETERINARY FEED DIRECTIVE (VFD) STATUS OF FEED GRADE ANTIBIOTICS AND ADDITIVES
In addition to increasing veterinary oversight for feed grade antibiotics, additional veterinary involvement will be required for all antibiotics (medically important and non-medically important) that are delivered through the drinking water. These antibiotics will require a veterinary prescription.
WHEN DO THESE REGULATIONS GO IN TO EFFECT?
The portion of the new regulation that dictates the removal of growth promotion claims from medically important antibiotics is currently in effect; however, pharmaceutical companies have until December 2016 to finalize label adjustments.
VFD and prescription requirements will go into effect on January 1, 2017. As of this date, all medically important feed grade antibiotics will require a VFD and all antibiotics administered in the water will require a veterinary prescription.
WHAT DOES THIS MEAN FOR PRODUCERS?
The days of purchasing antibiotics over-the-counter are essentially coming to an end. As of January 1, 2017, producers wishing to utilize VFD or prescription antibiotics will need to work with a licensed veterinarian. In order to issue a VFD or prescription, a licensed veterinarian must have a veterinary-client-patient relationship (VCPR) established with the producer. Only after a VCPR has been established can a veterinarian legally issue a VFD or prescribe an antibiotic.
Maintaining complete and accurate records will be vital to verify compliance with the new regulations. Producers, veterinarians, and feed distributors are all required to keep a copy of VFDs for 2 years. Additionally, producers need to keep record of antibiotics administered via the drinking water or injection for 1 year. The FDA requires that the following information be recorded for water and injectable medications:
- Date of administration
- Animal ID or group designation (i.e., barn 2, room 1)
- Product administered
- Route of administration
- Initials of person administering
- Withdrawal time
It is also advised that producers have a good working relationship in place with the feed mill(s) they work with. Ensure mill personnel understand and are prepared for the new VFD regulations. Create a list of diets fed and designate the diets that contain antibiotics to help facilitate preparedness and communication between all parties involved.
WHAT DOES THIS MEAN FOR VETERINARIANS?
As previously mentioned, veterinarians must establish a VCPR with the producer prior to issuing a VFD or prescribing a water soluble antibiotic. VCPRs provide the basic framework for interactions between clients, veterinarians, and animals. The following criteria make up the Federal definition for VCPRs:
- The veterinarian assumes responsibility for making clinical judgments regarding the health of the patients.
- The veterinarian has sufficient knowledge of the patients by virtue of examination and/or visits to the facility where the patients are managed.
- The veterinarian provides any necessary follow-up evaluation or care.
Some individual States’ also have VCPR definitions written in their veterinary practice acts which take precedence over the Federal definition. Specific requirements can vary from state to state; therefore, it is prudent for veterinarians to know and understand the requirements in the state(s) in which they practice.
The requirements for establishing a VCPR are rather straightforward with the exception of what defines “sufficient knowledge” of the patients.
It is generally accepted that an initial visit to the site where pigs are kept is required to establish a VCPR when interacting with a producer for the first time; however, the question of whether routine visits are required to maintain a VCPR after one has been established is less clear. Some State VCPRs explicitly give the frequency in which veterinarians must conduct site visits while others have no specific visitation requirements.
Ideally, veterinarians would be able to conduct routine visits to all sites where they offer veterinary services to monitor herd health. Unfortunately, routine visits to all sites in large systems or companies can become impractical due to the sheer number of sites alone. Factor in sites in multiple states, multiple health statuses and biosecurity requirements, and veterinarians that work with multiple clients and the impracticality of routinely visiting every site is evident.
However, these logistical restrictions should not inhibit veterinarians from having adequate knowledge of the health of the pigs in their care. Diagnostic testing, access to production records, and communication with caretakers or field staff along with medically appropriate site visits can provide veterinarians with the information they need to make informed decisions regarding pig health. While there are no legal requirements for diagnostic testing or documented communication with caretakers, these procedures can be used to help veterinarians maintain sufficient knowledge and veterinary oversight when routine visits are not practical.
The amount of time required for veterinarians to issue the amplified number of VFDs will increase significantly. It is very likely that some veterinarians could go from issuing less than 10 VFDs per year to issuing several hundred per year. With each VFD taking approximately 10 minutes to complete, the added time required will be substantial. Additional time will also be needed to track and update information on sites, feed mills, and clients.
Changes to VFD requirements will allow for multiple sites to be included on a single VFD, as long as all sites listed are supplied by the same feed mill. This may potentially reduce the time needed, but veterinarians will need to be able to justify and ensure that veterinary oversight is maintained.
January 1, 2017, is quickly approaching and preparing for the changes ahead of time will prevent a potential delay or gap in antibiotic treatment. Communication between producers, veterinarians, and feed distributors will be vital to implementing required changes as seamlessly as possible to ensure appropriate care for pigs is maintained. Additional challenges are likely to present themselves and how those involved in the swine industry handle these challenges will likely shape antibiotic use in the future.
- Sam Holst, DVM , Laura Bruner, DVM
Dr. Sam Holst and Dr. Laura Bruner are veterinarians and consultants at Swine Vet Center, P.A., located in Saint Peter, Minnesota.