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Food and Drug Administration and Compliance Issues
Sunday, May 19, 2013
Your Horse’s Life is Not Worth the Risk: What Every Horse Owner Should Know About Drug Compounding
Every horse owner has the right to know the safety and efficacy of medications a veterinarian prescribes for their horse. But even the most experienced horse owners may not be aware of the health risks involved with using compounded drugs. Compounded drugs are unregulated drugs produced by altering or combining other drugs to serve a patient’s particular need.
Recently, compounded drugs have been linked to tragic incidents in the horse industry, including the sudden death of 21 polo ponies in April and the deaths of several horses in Louisiana in 2006. Because compounded drugs are not regulated, other incidents remain unreported.
The American Association of Equine Practitioners acknowledges that reputablepharmacies produce legitimate compounded drugs to improve the health of horses when an FDA-approved option doesn’t exist. However, when inappropriately compounded and used, these drugs may pose a serious threat to the health of your horse. Knowing the facts about legitimate and illegitimate compounded drugs will help you and your veterinarian decide on the best treatment option for your horse.
What is a compounded medication?
Compounding is a process to produce a medication by combining or altering ingredients for the special needs of an equine patient. Only a licensed veterinarian may write a prescription for the compounded medication. Because there is a scarcity of approved medications for use in horses, there is a legitimate need for compounding in equine veterinary medicine. Some examples of legitimate compounding would include crushing a tablet and creating a paste or gel to aid in the administration to the patient or mixing two anesthetics in the same syringe for use in your horse.
Weigh the risks of unregulated medication.
Compounded drugs are not approved by the Food and Drug Administration and can vary in potency, stability, purity and effectiveness. And because these products are unregulated by the government, compounded drugs have the potential to pose serious safety risks to horses.
Compounded drugs are not generic drugs.
Because compounded drugs are generally cheaper than FDA-approved medications, horse owners often confuse compounded drugs with generic drugs. Generic drugs are biologically equivalent to a brand-name drug. Unlike compounded drugs, generic drugs go through an FDA approval process and are manufactured in an FDA-approved facility.
Don’t skimp on quality medication.
A compounded drug should never be requested, used or prescribed as a cost-saving measure. Putting your horse’s health at risk with a “knock off” drug could end up costing your horse’s life. Stay on the safe side and request FDA-approved medications
In the interest of the welfare of your horse, the American Association of Equine Practitioners advises the use of legal, FDA-approved medications when such a drug exists. FDA-approved medications undergo years of testing and are closely monitored by the government to ensure a consistent, safe performance.
“As a horse owner, your primary concern is the health and welfare of your horse. Because compounded products have no regulatory requirements for potency, safety, stability or production testing, they are to be used only as a last resort when there are no approved products available,” says Dr. Kenton Morgan, chairman of the AAEP Biological and Therapeutic Agents Committee.
“It is appropriate to request that your veterinarian inform you any time he or she will be using a compounded product to treat your horse.” It’s important for horse owners to communicate openly with their veterinarians about the use of compounded drugs. Though your vet should always notify you when a compounded drug is being prescribed, be sure to request FDA-approvedtreatment options for your horse. If your veterinarian recommends a compounded drug, ask why the compounded drug recommended is the best treatment option for your horse. Understanding the potential risks and benefits of your horse’s medication is part of your role as a responsible horse owner.
To view the AAEP’s position statement on drug compounding, visit www.aaep.org.
The American Association of Equine Practitioners, headquartered in Lexington, Ky., was founded in 1954 as a non-profit organization dedicated to the health and welfare of the horse. Currently, the AAEP reaches more than 5 million horse owners through its nearly 10,000 members worldwide and is actively involved in ethics issues, practice management, research and continuing education in the equine veterinary profession and horse industry.
Tips for Horse Owners:
* Communicate openly with your veterinarian about his or her practice’s use of compounded drugs.
* Request FDA-approved medication.
* When a compounded drug is recommended, ask your veterinarian to explain why it’s the best treatment option.
* Don’t skimp on cost: Compounded drugs should never be selected to save money.
* Make sure your prescription is clearly marked and labeled.
* Don’t confuse generic drugs with compounded drugs.