Make Sure You’re Compliant with New FDA Guidelines
Feb 15, 2012
When was the last time you reviewed your dairy’s protocols for pharmaceutical use?
By Gary Neubauer, DVM, senior manager, Pfizer Animal Health Technical Services
Last month, the U.S. Food and Drug Administration (FDA) announced that it would soon modify extra-label use of cephalosporin drugs in cattle. Effective April 5, 2012, veterinarians can continue to prescribe extra-label use of any cephalosporin as long as it is the same dosage, used through the same route of administration and in the same species as its FDA-approved label. The order prohibits the use of human cephalosporin drugs in food animals and prohibits the use of cephalosporin drugs for disease prevention.
The new order does not affect the FDA’s approved indications for ceftiofur. When used according to approved label indications, ceftiofur products are safe and effective in treating indicated diseases while helping to protect the food supply.
This ruling presents an opportune time to review your disease identification and treatment protocols with your veterinarian. When was the last time you reviewed your dairy’s protocols for pharmaceutical use? If it’s been a while, you’re not alone, according to research from Penn State.
· Nearly 80 percent of producers do not have written treatment protocols.
· Half of dairies do not always keep written treatment records.
· More than 20 percent of producers administer extra-label medication without always having written orders or guidelines from their veterinarian.
Start with your veterinarian.
Every dairy producer should work with a herd veterinarian who makes timely visits to the dairy and is responsible for making animal health judgments. Veterinarians are continually studying the science behind products and their treatment protocols. They know the management style at your operation and can best help you and your management team determine appropriate protocols for disease detection and treatment.
Develop written protocols for disease.
Work with your veterinarian to draft protocols that cover major herd health events and provide a clear course of action once a disease is diagnosed. These protocols should tell farm workers what drug they should use, how and for what it should be used, as well as milk and meat withholding times. All protocols should be written in a notebook or included in a herd software program like PCDart or DairyComp 305. Having these procedures in writing is not only one of the most important steps you can take to reduce your risk of a drug residue violation, it is your legal obligation as a producer of food.
Administer treatments properly.
Everyone on the dairy who administers drugs should go through a training program, conducted with the help of your veterinarian. This training should cover the established farm protocols for disease detection and treatment, as well as how products are to be administered. Medications are labeled to be given in an intramuscular, subcutaneous or intravenous manner, and there are scientific reasons as to why each is labeled as such. Varying from the labeled route of administration can greatly affect the length of the meat or milk withdrawal time and lead to violative residues.
Ensure accurate dosage is administered.
Following the label directions on medications means knowing not only how to administer product but also how much of it to give. Proper product dosage is an often overlooked aspect of protocol compliance and is dependent on accurately estimating cattle weights. Most product dosage labeling is based on the animal’s weight such as 1.5 ml per 100 pounds of body weight. An important part of employee training is to make sure your team is able to estimate weights correctly and administer an appropriate dosage. Weight tapes can be a great tool for determining the weight of the animal as well.
Complete the protocol.
Giving the full treatment regimen is just as important as giving the proper dosage through the proper route of administration. If an animal starts to look better after three days, but the medicine is prescribed for five days, you need to give all five days of treatment. This will ensure a clinical cure is achieved and reduce the chances of a relapse.
Document all treatments.
Systems should be put in place to ensure all treated animals are properly recorded and never leave the operation before an appropriate withholding time has been reached. After you administer a treatment, mark the animal in a visual way (chalk, paint, leg band, etc.) and record it in your records system immediately. The longer you wait, the greater the risk of the treatment not getting recorded properly or even at all. All farm workers must be able to understand the record-keeping and identification program as well as its importance.
The FDA ruling on extra-label drug use of cephalosporins is a good reminder of the importance of following label directives through developed and implemented written treatment protocols. Use the time now to work with your veterinarian to make sure your dairy is compliant and all employees who administer treatments have been thoroughly trained on how diseases are to be identified and treated.