Responsible Drug Use in Cattle
Clell V. Bagley, D.V.M.,
USU Extension Veterinarian
Doug S. Hammon, D.V.M., Ph.D.,
USU Veterinary Clinician
The access to drugs by cattle producers and laws governing the use of drugs in livestock have been gradually changing, but many producers are just beginning to notice the change. The Food and Drug Administration�s (FDA) Center for Veterinary Medicine (CVM) is responsible for assuring that animal drugs and medicated feeds are safe and effective and that food from treated animals is safe to eat. Laws for drug use in food producing animals have been enacted to protect consumers from the potential effects of drug residues in milk and meat products. A growing concern is the emergence of multi-drug resistant strains of bacteria that affect both animals and humans and in which inappropriate drug use may be a contributing factor (see http://www.fda.gov/cvm/default.html). In addition to providing optimum health for production animals, our highest priority, as producers and animal health professionals, must be to assure the safety of the food supply: that is our responsibility.
What can you legally use and how can your veterinarian help you to maintain access to those products you may want to use?
The FDA-CVM has the responsibility for determining the market status of animal drugs. This agency has allowed producers access to drugs for their livestock via two routes, with another route as a subcategory. The two basic classes of drugs available to livestock producers are �over-the-counter� (OTC) and �prescription� (Rx) drugs. The subcategory is that of �Extra-Label Use Drugs� (ELUD).
Prescription drugs are classed as such by FDA because of their potential for toxicity or other harmful effects, unique method of use, or the special considerations required for use. This class of drugs must always bear on the package and label, the legend: �Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.�
This provides a regulatory and legal tool that the FDA can use against livestock producers, if they do not abide by the law. Current drug-use laws can be used as an even greater leverage over veterinarians with the threat of loss of their license to practice, along with the legal costs. The FDA recognizes this vulnerability of veterinarians and seems to �like� to use it against them, if they misuse drugs in production animals. However, drug supply outlets and producers are often not very concerned about prudent drug use issues, especially when it relates to drugs that they sell or use every day. So, they often expect the veterinarian to be rather casual about drug prescriptions and to �make it� so they can buy (or sell) the desired product. If the practitioner is hesitant to oblige them some producers get very angry and some drug suppliers �bad mouth� the practitioner for just �wanting money.� Another part of the problem is that a few veterinarians do get away with quite casual regard for the regulations, even for long periods of time, so it makes those veterinarians who are trying to abide by the legal guides appear to be self-serving.
The simple fact with regard to prescription drugs is that the regulations are tight and will continue to get tighter. If producers want to be able to use Rx drugs, they need to develop and build a relationship with their veterinarian so the practitioner can abide by the legal requirements and still provide the Rx drugs (or prescriptions for them) when they are needed and appropriate. Also, drug suppliers need to recognize this requirement for veterinary involvement and not �short-circuit� the process just to �make a buck� themselves.
The OTC drugs can be purchased from multiple sources, but must be used exactly as labeled. That is the complete fact for OTC drug use for producers. Anything more or less than that is illegal.
The third route for drug use is a subcategory for the other two and is titled �Extra-Label Use Drugs� or ELUD. Extra-label use is the actual or intended use of a drug in any manner that is not in accordance with the label. Under provisions of the AMDUCA Act passed in 1994, the FDA recognizes the professional judgment of veterinarians and allows the extra-label use of drugs (either OTC or Rx) by veterinarians or at their direction, under certain conditions.
This extra-label use is limited to situations where the health of an animal is threatened or suffering and death may result from failure to treat, but only by or under the supervision of a veterinarian. In addition, veterinarians may only consider using drugs in an extra-label manner when there are no available drugs that are labeled to treat the disease the veterinarian has diagnosed or those drugs have been ineffective.
One very important aspect required for ELUD is that there must be a �valid veterinarian-client-patient� relationship. The conditions for such a relationship include that the veterinarian has the responsibility regarding the health of the animal(s) and the client has agreed to follow his/her instructions; the veterinarian has sufficient knowledge of the specific animal or situation; also that the veterinarian has examined the animal(s) and/or made a recent and timely visit to the premises of the specific animal(s); and the veterinarian is readily available for follow-up in the event of adverse reaction or a failure of the treatment program. Extra-label use of drugs requires the veterinarian to make an accurate diagnosis of disease and the veterinarian assumes responsibility for determining proper withdrawal times to ensure avoidance of drug residues in milk and meat products.
So, if it has been a couple of months since your veterinarian has seen your animals, you have a pneumonia outbreak and decide that you would like to use some �special� drug rather than an OTC product � you should not expect your veterinarian to automatically provide the drug or the directions for you to use a product in an �extra-label� manner without ever seeing those specific animals. That is asking the practitioner to go against the requirements imposed by the law, as well as against his ethical principles.
At stake is the future availability of useful and effective drugs for treatment of production animal diseases!! All parties involved in the production animal industry must be proactive on prudent use of drugs. Remember, consumer perception is reality. The consumer expects animal products that are wholesome, safe, and free of drug residues. If we can�t assure the consumer our products meet their expectations, they will spend their money on other food products.