Merely hearing the word "compounding" may bring up memories of a news story that greatly affected horsemen everywhere. A simple mistake in placement of a decimal point when formulating a compounded supplement led to the deaths of 21 polo ponies in Florida.
What exactly is compounding? Compounding is changing a drug in any way. This could range from adding flavoring so your horse will eat his medications, all the way to combining medications into one delivery system, or as in the Florida case, creating a whole new medication or supplement from separate raw ingredients.
There are times when compounding can be extremely helpful. Flavoring a medication for a finicky horse or taking a pill medication and turning it into a paste for delivery can mean the difference between your horse getting the medication he needs or not. Every adjustment has the potential to change how the drug works, however.
The Food and Drug Administration, or FDA, regulates drug compounding for veterinary medicine, as do state governments. In addition, state boards of pharmacy and state veterinary medical boards have rules and regulations that must be followed.
What are compounded drugs?
First, what aren't they? Compounded drugs are not "generic" drugs. Generic drugs have the same primary ingredients as name brand drugs but without the name brand behind them. Just like name brand drugs, a generic has to be tested, shown to be safe and effective, and the FDA oversees the entire manufacturing process.
Generally, compounded drugs are also not "extra label usage drugs." Extra label drug usage occurs when there is no FDA-approved drug or version of a drug that is appropriate for the condition being treated in an animal or approved for a certain species. In the case of horses, for example, your veterinarian may need to prescribe a drug that is not approved for use in equines to treat a specific problem in your horse. Careful records are kept and the medication is labeled just for your horse and his condition.
Many extra label use drugs have a fair amount of anecdotal experience behind them, including reports in various veterinary journals. Extra label drug usage is a fact of life for many animals, including equines, exotics, and small ruminants. It is not financially worthwhile for a drug company to go through all of the testing on multiple species for many of these medications.
Compounded drugs have less oversight and research behind them than FDA-approved drugs; if any at all. By manipulating a drug, the compounding may change how it acts in your horse's body, how your horse eliminates it, and/or how your horse metabolizes it. In addition, drug interactions are also unknown. This can be very dangerous for a horse that is on multiple medications.
There are times when a compounded drug may be necessary. As the AVMA (American Veterinary Medical Association) points out, there are two situations when an animal may need a compounded medication. The first is if there is no approved drug commercially available for a health problem. A veterinarian and a pharmacy may be forced to create the medication for your horse. The second situation is when the preparation your animal needs can't be created from an already approved version of a drug. Obviously, those conditions aren't all that common - though more so for horses and livestock than for house pets.
Compounding a medication can also be illegal - and is in most cases, although the FDA chooses to overlook some veterinary exceptions. Purchasing a compounded medication is illegal if you do not have a patient/client relationship with the prescribing veterinarian. Making a medication that "mimics" an FDA-approved drug is also illegal. Drugs manufactured this way avoid FDA oversight and regulation. They may be less expensive, but the risks for potential problems are very high.
Compounded medications should also be made up on a case-by-case basis. An individual patient may need the medication, but that is not a justification for making up enough to dose many horses (unless all are in a similar situation and under the care of the same veterinarian). Making up large quantities of a compounded medication with plans to sell it to owners or veterinarians without a specific patient in mind is illegal.
A compounded medication should only be used if an animal's health is in danger or the animal is facing suffering or a potential loss of life. So, a compounded medication to improve your horse's jumping skills would not be legal. Your horse's ability to jump does not affect his overall ability to continue living a reasonable life.
It is important to remember that most pharmacists have no training in veterinary medicine. Most of their compounding training for animals consists of flavoring medications for small animals. To compound a veterinary medication, the pharmacist must work with your veterinarian to ensure that the resulting medication is safe for your horse. There are some continuing education courses for pharmacists who deal in veterinary medications. If you need a compounded drug, it is worthwhile checking to see if your pharmacist has had any special training.
Some state pharmacy boards will not allow medication into their state that an out-of-state pharmacy produced unless that pharmacy has also met their state's requirements. In addition, you want a pharmacy that is accredited. Ideally, an independent group such as the National Association of Boards of Pharmacy's Vet-VIPPS and/or the Pharmacy Compounding Accreditation Board will have certified a pharmacy you are using.
It is important to realize that compounded drugs have no official shelf life or expiration date. These medications have not gone through FDA approval processes, so that date has not been determined. Basic standards for manufacture may not have been met and safety and efficacy data are generally lacking. If your horse has a reaction to a compounded drug, liability is often limited since the drug is not an approved medication. The risk may be entirely your own. Adverse reactions should still be reported for future knowledge, however.
The bottom line for you as a horse owner
- Use FDA-approved drugs if at all possible.
- If your horse needs a compounded drug for a serious condition, monitor him closely for response to the treatment and for any adverse effects.
- Only use a compounded medication under the guidance of a veterinarian who knows your horse.
- Verify that any compounding pharmacy you use is accredited by an independent organization.
- Be prepared to accept the risks involved.