Now is the time for veterinarians to begin working with clients in preparation for changes mandated by the FDA’s new veterinary feed directive (VFD) rule. The new rule takes effect on Oct. 1, 2015, and will immediately apply to those drugs which already require a VFD. It will apply to the new VFD drugs when their new labels are phased in during December 2016.
The rule will require, in many cases, more veterinarian involvement in their clients’ herd-health programs, which should provide revenue opportunities for practitioners and better health and productivity in client herds.
On the other hand, the rule makes veterinarians more accountable for antibiotic stewardship on the farm. When veterinarians write VFD orders, they will specify the purpose for using the drug; the animals in which it will be used; and the dosage, duration and withdrawal periods, all in accordance with the product label. The rule increases the need for veterinarians and clients to understand and follow the label specifications for medicated feeds, including the distinctions between use for prevention, control or treatment of disease.
Kansas State University veterinarians Mike Apley, DVM, PhD, DACVCP, and Brian Lubbers, DVM, PhD, DACVCP, stress that extra-label use of medicated feeds is not allowed under current regulations, and the new VFD rule will place veterinarians in a position of greater accountability for compliance with the law. According to FDA, the VFD order must include the statement “Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extra-label use) is not permitted.”
General examples of extra-label use of a VFD feed could include feeding animals a VFD feed for a duration of time that is different from that specified on the label, feeding VFD feed formulated with a drug level that is different from what is specified on the label or feeding VFD feed to an animal species different than what is specified on the label.
More specific examples of extra-label uses of medicated feeds include using chlortetracycline for treatment of footrot or pinkeye, “pulse” treating an entire feedyard at regular intervals for the purpose of increasing feed intake or using an off-label dosage of chlortetracycline in the feed for prevention of anaplasmosis.
Today, with most feed-grade antibiotics available over the counter, some producers have become accustomed to using them for purposes not specified on the product labels.
Unfortunately, Apley says, there are no feed-grade products currently labeled for some of these applications, and in today’s climate, new approvals, particularly for preventative uses, are increasingly difficult to secure.
Lubbers says veterinarians today sometimes have little involvement in their clients’ use of medicated feeds, unless they are called in to fix a problem. The VFD rule will provide an opportunity for them to become more closely involved and gain a better understanding of health-management practices within a client’s operation. Many veterinarians are embracing this opportunity, he says, but they also face challenges in lining up the necessary cooperation with clients, nutritionists and feed suppliers in order to issue and execute a valid VFD.
As pressure builds to reduce antibiotic use, veterinarians will increasingly face legislation, regulation and what Apley terms “retailation,” in reference to policies set by retailers in response to consumer concerns. Retailation, he says, can force changes in the industry faster and more aggressively than government regulations and, unfortunately, may place different weights on scientific input and marketing opportunities.
Guidance 213 removes production or performance claims from medically important antibiotics, and Apley says pressure is mounting among some groups to discontinue or severely limit disease-prevention uses of antibiotics in livestock production. Currently, FDA’s Guidance for Industry 209, which outlines the agency’s strategy for judicious antibiotic use, states “Veterinary involvement in the decision-making process associated with the use of medically important antimicrobial drugs is an important aspect of assuring appropriate use, including judicious prevention use. When determining the appropriateness of a prevention use, veterinarians consider several important factors such as determining the medical rationale for such use, and that such use is appropriately targeted at a specific etiologic agent and appropriately timed relative to the disease.”
Lubbers stresses that FDA has given the industry time to prepare, with the VFD rule and Guidance 213 scheduled for full implementation in December 2016. Now is the time for veterinarians to sit down with clients, look at the antimicrobial products they are using, determine which of them fall under the VFD rule and begin planning a process for writing VFD orders and managing medicated feeds accordingly.
Apley also recommends that veterinarians work closely with clients and recommends several steps to optimize antibiotic stewardship:
1. Seek alternatives to antibiotics for preventing, controlling and treating disease.
2. If no effective alternatives are available, verify that the chosen antibiotic is safe, effective and approved for the use in question.
3. Ensure the producer is able to use the product in a manner that is safe, effective and in accordance with the label.
4. Review and evaluate outcomes of antibiotic use and apply the information to future decisions.
The veterinarian’s role in VFD compliance
Following announcement of the new veterinary feed directive (VFD) rule, the FDA released a series of VFD brochures, which list the specific responsibilities of veterinarians, clients and distributors such as feed mills for compliance under the rule. The brochures also include a list of commonly asked questions and answers and the specific information to include on a lawful VFD.
According to the brochure intended for veterinarians, the veterinarian writing a VFD order:
· Must be licensed to practice veterinary medicine.
· Must be operating in the course of the veterinarian’s professional practice and in compliance with all applicable veterinary licensing and practice requirements.
· Must write VFD orders in the context of a valid veterinarian-client-patient relationship.
· Must issue a VFD that is in compliance with the conditions for use approved, conditionally approved, or indexed for the VFD drug or combination VFD drug.
· Must prepare and sign a written VFD providing all required information.
· May enter additional discretionary information to more specifically identify the animals to be treated/fed the VFD feed.
· Must include required information when a VFD drug is authorized for use in a drug combination that includes more than one VFD drug.
· Must restrict or allow the use of the VFD drug in combination with one or more over-the-counter drug(s).
· Must provide the feed distributor with a copy of the VFD.
· Must provide the client with a copy of the VFD order.
· Must retain the original VFD for two years.
· Must provide VFD orders for inspection and copying by FDA upon request.
The FDA documents also note that veterinarians can file VFD forms either in paper or electronic formats. In many cases, drug companies will make VFD forms specific to their products available, but veterinarians can prepare their own VFD forms, and the brochures list the information that must be included.
Find the VFD brochures and other information in the Judicious Use of Antimicrobials section on the FDA Center for Veterinary Medicine website at fda.gov/AnimalVeterinary.