Animal Health Products in Today's Pork Production

Today's successful pork producer must also be a successful businessman. A growing industry attracts people willing and eager to supply the goods and services that that industry needs. In our industry, there are new management ideas, new feed formulations and new products available, each with a cost and a return.

Unfortunately, the supply of pharmaceutical products available to pork producers has not been able to keep pace with the industry's needs. During the past ten years, producers have experienced market loss of five effective products or product classes. Penicillin-streptomycin, nitroimidazole-dimetridazole and ipronidazole, oral nitrofurozone and furazolidone and chloromphenical have all been withdrawn from the market for various regulatory reasons. As well, within the last five years there have been no new pharmaceuticals with uses approved for swine entering the market.

The Coalition for Animal Health, a group of food animal producer and veterinary organizations, companies that manufacture animal health products, and other stakeholders in the health of animals, have supported a bill introduced in the U.S. Senate that promises to help streamline the drug approval process for new animal health products. This gives our industry continued hope for new products being available, but we have to realize this will take some time.

No one wants to have to use drugs or antibiotics in pork production. This is an expense that adds to the cost of production, decreasing the potential for profit. However, there are times when our animals need medical attention to maintain production. Given the losses in product availability and the present process needed for new product approval, our industry needs to do everything possible to continue to develop the confidence government agencies and the consuming public have in our ability to responsibly use drugs and antibiotics.

The Federal Food, Drug and Cosmetic Act

Strict interpretation of the Federal Food, Drug and Cosmetic Act, the law dealing with drug use in animals, could keep animals from receiving proper veterinary care. This could result in the inability of the producer or veterinarian to alleviate animal suffering and death and prevent economic losses. For example, the approved label for the common antibiotic procaine penicillin is very specific regarding uses in swine. The label states: For the treatment of . . . swine for erysipelas . . ." and at a dosage of 3,000 units per pound of body weight or 1 ml for each 100 lbs. of body weight once a day." This is the only approved use of penicillin in swine. Strict interpretation of the Federal Food, Drug, and Cosmetic Act would make it illegal to use it in any other manner.

The Compliance Policy Guide

Fortunately, the Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) has recognized that there are instances in which there are simply no approved drugs for some conditions in animals needing treatment. In these situations, strict enforcement of the law is not always reasonable. Thus, the CVM has developed documents called Compliance Policy Guides (CPGs).

CPGs are designed to be guidance for the FDA's field and headquarter offices by which the use of drugs in animals can be reasonably regulated. For example, Proper Drug Use and Residue Avoidance by Non-Veterinarians," CPG 7125.37, states that . . . use of an unapproved new animal drug or an approved new animal drug contrary to label directions constitutes a violation of the [Federal Food, Drug and Cosmetic] Act." However, it goes on to say that the FDA will allow veterinarians, acting in a valid veterinarian-client- patient relationship and following other specific guidelines, to consider using a drug contrary to label directions when the health of the animal is immediately threatened and suffering or death would result from failure to treat the affected animal(s).

The CPG detailing the accepted manner in which drugs can be used contrary to approved label directions is called the Extra-Label Use of New Animal Drugs in Food-Producing Animals," CPG 7125.06. While officially recognizing that use of any drug outside label constraints makes the drug unsafe and is illegal, this CPG helps determine if the FDA has a regulatory interest in such use.

Extra-label Drug Use

Extra-label use means using the drug in a manner other than that on the label but under the guidance of a veterinarian with which there is a valid veterinarian-client-patient relationship (VCPR). Examples of extra label drug use include:

• Using a different dose;
• Using a different frequency or route of administration;
• Using a drug for longer than is directed on the label;
• Treating different diseases than those indicated on the label; and
• Treating a different species of animal than those approved on the label.

Whenever extra-label drug use is needed, you and your veterinarian take on additional responsibilities to ensure the meat coming from these animals doesn't contain violative drug tissue levels. You need to make sure your veterinarian has made a medical diagnosis of the condition being treated and gives you complete written directions about how to use the drug. Also, you need to make sure all treated animals are identified and you keep written records of the drug use. This is important because you may need to follow, as directed by your veterinarian, extended drug withdrawal times before marketing.

The Veterinarian-Client-Patient Relationship

One condition allowing extra-label drug use says there must be a valid veterinarian-client-patient relationship (VCPR). What is a VCPR and how do you know if there is one?

The American Veterinary Medical Association (AVMA) has defined when a VCPR exists. This definition is included in the CPG 7125.06 and thus could be used in determining if extra-label drug use is appropriate.

According to the AVMA, a VCPR exists when:

• The veterinarian has assumed the responsibility for making medical judgments regarding the health of the animal(s) and the need for medical treatment, and the client has agreed to follow the instructions of the veterinarian.
• There is sufficient knowledge of the animal(s) by the veterinarian to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s). This means the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of an examination of the animal(s) and/or by medically appropriate and timely visits to the premises where the animal(s) are kept.
• The practicing veterinarian is readily available for follow-up in case of adverse reactions or failure of the regimen of therapy.

The VCPR is the cornerstone of allowing prescription and extra-label drug use in animals. It ensures a way to involve a scientific process and professional judgment in deciding if and how to use these drugs. By understanding the importance of the VCPR, of responsible drug use and of the CPG guidelines, all pork producers can do their part in maintaining government confidence in our industry's ability to access new and existing drugs. In addition, our domestic and foreign consumers will know they can buy a safe, quality pork product.

The Pork Quality Assurance Program

The National Pork Producers Council's PORK QUALITY ASSURANCE (PQA) Program gives the pork producer the tools needed to answer questions from the government, consumers, and others about the responsible use of all animal health products during pork production. It is a Hazard Analysis and Critical Control Point (HACCP) system that gives the producer the opportunity to examine their pork production system to find ways to increase efficiency and ensure a quality product.

One of the ten identified Critical Control Points for quality assured pork production is having in place a valid veterinary-client-patient relationship. The program recognizes the importance of this association between the producer and the veterinarian.

In addition, the PQA Program gives the producer the type of record keeping system needed to show responsible drug use. Sample animal treatment, feed mixing and drug inventory control records are supplied with each PQA LEVEL IIIsm booklet.

Take-Home Message