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Do your animal health protocols meet new FDA guidelines?

Gary Neubauer Published on 19 March 2012

This year, the U.S. Food and Drug Administration (FDA) announced that it would soon be modifying 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 new order does not affect FDA’s approved indications for ceftiofur.

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When was the last time you reviewed your dairy’s protocols for pharmaceutical use? If it’s been a while, now is the time to make sure your product use is in line with these new guidelines and is helping you avoid any residue violations.

The first step to making sure your dairy is prepared for the new regulations is to consult with your management team, which should include your veterinarian. Regularly consulting with your veterinarian as part of a valid veterinarian-client-patient relationship will not only help you avoid residues and improve cow health, but also improve the overall performance of your herd.

Veterinarians are invaluable resources of information on animal health and 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 develop written protocols for disease detection and treatment.

These protocols ensure your dairy is compliant with FDA guidelines while utilizing the newest product solutions available. 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.

Putting protocols into action
Once you and your veterinarian agree on protocols, employee training is the best way to put them into action. Thorough employee training and retraining should encompass a variety of topics, especially for those responsible for detecting sick cattle and determining proper treatment.

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Here are some key aspects of training and retraining that can ensure accurate animal health treatments.

• Proper disease identification: Providing the right medication and treatment depends on the type of illness being treated. Employees need to be trained on what to look for when determining proper treatment. Be sure they know what resources are available to them if they aren’t sure, and make sure they never guess when it comes to pharmaceutical use.

• Provide correct dosage: Following the label directions on medications means knowing how much of it to give. One of the new FDA guidelines prohibits a change in medication dosage. Giving too much or too little is considered extra-label drug use. If the label says to give 1.5 mL per 100 pounds of bodyweight, make sure you are accurately estimating weight and providing an appropriate dosage.

Every animal health product has a minimal inhibitory concentration (MIC) level for the diseases for which it is indicated. The MIC level is the lowest concentration of that drug that inhibits more than 99 percent of the bacterial population.

If you are dosing under the MIC, a complete cure will not be achieved and the bacteria can begin to build a resistance to that treatment. Weight tapes can be a great tool for determining the weight of the animal and ensuring an appropriate dose is administered.

• Complete the protocol: Giving the full treatment regimen is just as important as giving the proper dosage. 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 relates back to the regimen’s MIC level. Bacteria remaining after the first few days could begin to build resistance if the treatment is not completed.

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• Keep complete and accurate records: A 2007 Penn State study found that only 51 percent of dairies surveyed maintained antibiotic treatment records. Accurate records are critically important to avoiding drug residues in meat and milk. Your records should note the animal treated, date and time of treatment, drug and dosage administered and the length of any milk and meat withdrawal.

The keys to maintaining accurate records include timing and understanding. 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. It is crucial to make sure anyone who is entering or reviewing the information in the records understands the system.

• Follow withdrawal times: Medications are labeled with the appropriate withdrawal period for milk and meat, and following that time is key to avoiding drug residues. The condition of the cow may slightly affect the drug metabolism, but following the listed withdrawal period will protect your operation.

Keeping accurate records is a good way to make sure withdrawal times are followed. If clear and correct records are not kept, you won’t know how long a cow has been withheld for either milk or meat, and it will become very difficult to ensure the withdrawal period has been followed.

Take advantage of herd management software that makes it easy to double-check if the cow has been withheld the appropriate length of time.

• Monitor protocol compliance: Once a system is in place, follow up regularly to ensure that what was agreed to during training is still in action out in the barn. Compliance with drug protocols and rules is vital to avoiding drug residues in meat and milk.

Being involved during employee training and retraining, during protocol writing and reviewing and during treatment will help keep all your employees focused on following proper drug treatments. Routinely involving your veterinarian or other consultant can reinforce the importance of protocol compliance with employees.

You’re a beef producer, too
Avoiding drug residues takes a commitment from the whole team on the dairy. Through proper training and commitment to following protocols and label directives, your operation can protect itself from the risk of a residue.

As dairy producers and beef producers, it’s important that we consider the product we are sending into the food supply. Only healthy, mobile cattle fit for human consumption should be sent to slaughter. This will not only protect your dairy from the consequences of a drug residue, but it might offer opportunities to generate more income from cull cow sales.

Ask yourself: Would I want to drink this milk or eat this beef? If not, it’s best to finish the treatment before returning that animal to the milking herd or shipping it for meat production.

The FDA ruling on extra-label drug use of cephalosporins is just another reminder of the importance of following label directives through developed and implemented written treatment protocols. With the new regulations going into effect soon, use the time now to talk with your veterinarian about the best treatment regimen for your dairy operation. PD

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Gary Neubauer
Senior Manager of
Veterinary Operations
Pfizer Animal Health

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