Antibiotic Stewardship is Not New to Cattle Ranchers: Update on New Regulations and What It Means for the Beef Industry
by Josh White, Executive Director, Producer Education and Mandy Carr Johnson, Ph.D., Sr. Executive Director, Science & Product Solutions, National Cattlemen’s Beef Association, a contractor to the Beef Checkoff
Antibiotic use in food-producing animals has become a topic of interest across food-producing animal industries as well as in consumer and regulatory arenas. Over time, the guidance to industry has evolved and this article captures the current guidance from the Food and Drug Administration (FDA) and the beef industry’s producer programs.
There has been a great deal of discussion lately about how antibiotics are used in raising livestock. The reality is that farmers and ranchers take antibiotic use in livestock very seriously and continuously evaluate the way they use antibiotics based on the best possible science.
In fact, for nearly 30 years, there have been quality assurance programs in place to help make sure farmers and ranchers are continuously improving the way they raise beef, including the way they use antibiotics, in order to protect human health, as well as animal health. This is often referred to as “antibiotic stewardship.” Today, cattlemen and the entire livestock community are working together to continuously improve the way antibiotics are used in animals, because they care about how their practices impact antibiotic safety and efficacy. As new FDA Guidance goes into effect, it’s important to understand what this new guidance means for the beef industry.
What is Guidance #209?
The FDA Guidance for Industry (GFI) #209, “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals,” was issued in April of 2012. This document outlines the agency’s direction for use in food animals of “medically important antimicrobial drugs” or those deemed “important for therapeutic use in humans.” The document outlines the framework for the voluntary adoption of principles to 1) limit medically important antimicrobial drugs to use in food-producing animals that are considered necessary for assuring animal health; 2) limiting such drugs to uses in food-producing animals that include veterinary oversight or consultation. These efforts are outlined to foster collaboration between the public, public health, animal health, and agriculture communities to develop and implement strategies needed to assure that the public health is protected while also assuring such strategies are feasible and that the health needs of animals are addressed. The continued availability of effective antimicrobial drugs is noted to be critically important in this guidance to help combat infectious disease in both humans and animals.
What is Guidance #213?
In December 2013, FDA issued the Guidance for Industry #213 “New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209”. This document was intended for sponsors of approved applications for new animal drugs and new animal drug combination products containing medically important antimicrobial new animal drugs for use in or on medicated feed or water of food-producing animals. The guidance describes the voluntary changes to the conditions of use for these types of compounds consistent with GFI #209. These voluntary changes include the phasing out of production uses (growth promotion or feed efficiency) of medically important new and combination products and the need for veterinary oversight of medically important antimicrobial drugs used in feed or water of food-producing animals. Prior to 1993, most antimicrobial drugs were approved for over-the-counter (OTC) use in food-producing animals and many were administered through medicated feed or drinking water. Since 1993, new antimicrobial animal drugs for use in food-producing animals have been labeled with Rx or Veterinary Feed Directive (VFD) marketing status, with exceptions of generic copies of existing OTC and approvals of combination medicated feeds using existing OTC antimicrobial Type A medicated articles. FDA anticipated the complete implementation within 3 years of the final guidance publication, but the implementation happened in less than half that time.
What is a Veterinary Feed Directive?
A Veterinary Feed Directive (VFD) is a written (nonverbal) statement issued by a licensed veterinarian in the course of the veterinarian’s professional practice that authorizes the use of a VFD drug or combination VFD drug in or on an animal feed. This written statement authorizes the client (the owner of the animal or animals or other caretaker) to obtain and use animal feed bearing or containing a VFD drug or combination VFD drugs to treat the client’s animals only in accordance with the conditions for use approved, conditionally approved, or indexed by the FDA. All product labeling and advertising for VFD drugs, combination VFD drugs, and feeds containing VFD drugs or combination VFD drugs must prominently and conspicuously display the following cautionary statement: "Caution: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian." The use of a VFD feed requires the professional supervision of a licensed veterinarian. Producers must obtain a VFD order from their veterinarian, then send, or take, the VFD order to a feed manufacturer or supplier to get the VFD feed. Producers, who manufacture their own feed, must have a VFD order to get the VFD product for use in manufacturing the medicated VFD feed. Producers who also manufacture feed for others should be aware that they are acting as a distributor and additional requirements apply.
What is “extra-label use”?
“Extra-label use” is de?ned in FDA’s regulations as actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling. For example, feeding the animals VFD feed for a duration of time that is different from the duration speci?ed on the label, feeding VFD feed formulated with a drug level that is di?erent from what is speci?ed on the label, or feeding VFD feed to an animal species di?erent than what is speci?ed on the label would all be considered extra-label uses. Extra-label use of many injectable animal health products is permitted under the prescriptive guidance of a veterinarian. Extra-label use of medicated feed, including medicated feed containing a VFD drug or a combination VFD drug, is not permitted.
Producer or client responsibilities under a VFD order include:
- Only feed animals a VFD feed or combination VFD feed based on a VFD order issued by a licensed veterinarian;
- Do not feed a VFD feed or combination VFD feed to animals after the expiration date on the VFD order;
- Provide a copy of the VFD order to the feed distributor if the issuing veterinarian sends the distributor’s copy of the VFD through you, the client;
- Maintain a copy of the VFD order for a minimum of 2 years; and provide VFD orders for inspection and copying by FDA, upon request.
What producer programs exist addressing antimicrobial use?
The Beef Quality Assurance (BQA) program is a voluntary, nationally-coordinated, state-implemented program to provide guidelines for raising cattle under optimum management and environmental conditions. Started by the beef industry in the 1980’s, the program is guided by an Advisory Board composed of veterinarians, animal scientists, meat scientists, cattlemen, dairymen and a state BQA coordinator. Beef Quality Assurance is committed to continually improving training materials and educational resources to extend relevant tools for anyone who works with cattle.
A significant part of the BQA program involves antimicrobial stewardship training about the appropriate use and administration of pharmaceutical products, the honoring of withdrawal times, the prevention of environmental contamination, the need for good record keeping, and the importance of a valid veterinarian-client-patient relationship. A Beef Producer’s Guide for the Judicious Use of Antimicrobials in Cattle highlights fourteen major considerations for using antimicrobial drugs as necessary for the health of cattle.
The BQA program will update training materials to support changing regulations such as the revised Veterinary Feed Directive, effective October of 2015, as well as FDA Guidance 209/213 which will go into effect by December 2016.
A Producer’s Guide for Judicious Use of Antimicrobials in Cattle (BQA)
- Prevent Problems: Emphasize appropriate husbandry and hygiene, routine health examinations, and vaccinations.
- Select and Use Antibiotics Carefully: Consult with your veterinarian on the selection and use of antibiotics. Have a valid reason to use an antibiotic. Therapeutic alternatives should be considered prior to using antimicrobial therapy.
- Avoid Using Antibiotics Important in Human Medicine as First Line Therapy: Avoid using as the first antibiotic those medications that are important to treating strategic human or animal infections.
- Use the Laboratory to Help You Select Antibiotics: Culture and sensitivity test results should be used to aid in the selection of antimicrobials, whenever possible.
- Combination Antibiotic Therapy is Discouraged Unless There Is Clear Evidence that the Specific Practice Is Beneficial: Select and utilize an antibiotic to affect a cure.
- Avoid Inappropriate Antibiotic Use: Confine therapeutic antimicrobial use to appropriate clinical indications, avoiding inappropriate uses such as for the treatment of viral infections without bacterial complication.
- Treatment Programs Should Reflect Best Use Principles: Regimens for therapeutic antimicrobial use should be optimized using current pharmacological information and principles.
- Treat the Fewest Number of Animals Possible: Limit antibiotic use to sick or “at risk” animals.
- Treat for the Recommended Time Period: This will minimize the potential for bacteria to become resistant to antimicrobials.
- Avoid Environmental Contamination with Antibiotics: Steps should be taken to minimize antimicrobial drugs from reaching the environment through spillage, contaminated ground run off or aerosolization.
- Keep Records of Antibiotic Use: Accurate records of treatment and associated outcomes should be used to evaluate therapeutic regimens and always follow proper withdrawal times.
- Follow Label Directions: Follow label instructions and never use antibiotics other than as labeled without a valid veterinary prescription.
- Extra-label Antibiotic Use Must Follow USDA Regulations: Prescriptions, including extra label use of medications, must meet the Animal Medicinal Drug Use Clarification Act (AMDUCA) amendments to the Food, Drug, and Cosmetic Act and its regulations. This includes having a valid Veterinary/Client/Patient Relationship (VCPR).
- Subtherapeutic Antibiotic Use is Discouraged: Antibiotic use should be limited to the treatment, prevention or control of disease.
Tags: Beef Issues Quarterly, Issues Updates, Winter 2015
December 21, 2015