- Published: Friday, 12 August 2016 22:34
Recently, there have been several headlines regarding compounded medications and the associated risks to horse health and welfare. In some cases, using an improperly compounded medication can lead to death. Any death of a horse is difficult. Those that are preventable – as in the case of an improperly prepared compounded medication – are unacceptable. Writing off the use of all compounded medications, however, would be a rash decision. Compounded medications, when used responsibly, may have a place in horse racing.
The question is how do we know when compounded medications should be used and what medications are appropriately compounded? As horsemen/women, we may lack a degree in chemistry or be unfamiliar with the nearly unpronounceable names of drugs prescribed veterinarians prescribe. But that should not relieve us of having a basic understanding of certain terms and practices, like compounding. A basic grasp of pharmaceutical processes, together with open communication with experts (e.g., veterinarians) regarding this issue helps facilitate a safe and responsible environment for acquiring and using compounded drugs.
What is a compounding? Compounding basically occurs when a pharmacist or a veterinarian combines one or more FDA approved medications, adds flavorings to medications, or creates an alternative formulation (e.g., paste form versus powdered form) from an existing FDA approved medication. Compounding, in the strictest sense, occurs when a veterinarian mixes hyaluronic acid and a corticosteroid prior to a joint injection. It can also include adding flavoring to powdered bute and combining it with inactive ingredients into paste form. The key words here are FDA approved medications which provide some reassurance that the drugs used in compounding are safe and meet strict guidelines for production and labelling.
Compounding differs from FDA approved manufacturing as there is no specific government requirement to prove that a substance is stable, pure, effective, present in the correct concentration, prepared in a sterile environment (if appropriate), or safe to use prior to sale. FDA approved manufacturers, on the other hand, are required to prove that each lot of a medication is made to certain specifications – including that it is present in the appropriate concentration and does not have any other active or unidentified inactive ingredients contained therein. Generic drugs, meaning those drugs that identical in composition to a brand name drug, are FDA approved and required to meet these same specifications.
So, given the safeguards for traditional pharmaceuticals, why is compounding so popular? According to the American Association of Equine Practitioners, compounding pharmacies “are a necessary and beneficial component of veterinary practice.” In some cases, a veterinarian may need a medication made in a different formulation than available from a manufacturer – for example an oral form not injectable. This allows the medication to be tailored to a specific horse based upon a specific diagnosis from the veterinarian. Also, in some instances, medications that have an FDA approved version are temporarily or permanently unavailable. If there is no other equivalent medication available (human or veterinary) then the FDA will generally allow the compounding of that medication.
While compounding pharmacies are an appropriate way to obtain some medications, it is important that either you or your veterinarian thoroughly research a company before ordering medications. While technically under the regulations of both state and federal authorities, there is little funding for FDA oversight and enforcement. Generally, the regulatory model is reactive – only requiring an inspection if an issue has arisen. Thus, it is “consumer beware” and largely up to you to ensure you are dealing with a reputable compounding pharmacy.
Reputable compounding pharmacies will follow the FDA rules regarding what they can and cannot do for a veterinarian or a consumer. For example, if you ask a reputable compounding pharmacy to compound an available FDA approved medication, they will decline as that would be illegal. Similarly, if you ask a reputable pharmacy to create a large quantity of a medication for a single patient – they should decline as they can legally compound limited quantities. In addition, compounding pharmacies are not allowed to make new drugs and circumvent the FDA approval process (a timely and costly endeavor). Finally, the FDA specifically prohibits the compounding of medication to provide a more affordable alternative to an FDA approved medication.
So, given these issues, what can you do as a trainer to ensure that the medications that you or your veterinarian administers to your horses are safe, effective, and reliable? First and foremost, it is important to have open communication with your veterinarian. You should request that your veterinarian use only FDA approved medication (including generic medication) for your horses. If, however, an FDA approved medication is not available, it is important to have a frank discussion with your veterinarian about the pharmacies they use to compound medications. Some compounding pharmacies have accreditation from the Pharmacy Compounding Accreditation Board (PCAB) – an industry standard that, among other things, requires that the pharmacy test samples of the medication before they are sold. These products may cost slightly more than you find from other compounding pharmacies, but the risk of your horses’ health and welfare and the risk of an unintentional positive test is decreased.
Most horsemen/women purchase their compounded drugs through their veterinarian. When you receive a compounded medication from your vet – you should research whether the pharmacy has any negative records (such as warning letters, notices of adulteration/misbranding, and recalls). These notices are available at www.fda.gov. If they do, you may be dealing with a less than reputable compounding pharmacy. The FDA website will also tell you whether there are human or veterinary medications on the market that can be used in lieu of compounded medications. If, instead, you elect to find a compounding pharmacy on your own – after receiving a written prescription from your vet – you must be comfortable that you can judge the pharmacy. If you are unable to or uncomfortable with judging the reliability of a compounding pharmacy do not use a compounding pharmacy. By doing so, you put your horses at greater risk for health issues and you at greater risk for a positive test.
Importantly, you should be suspicious of compounded drugs offered “over the counter” (without a prescription) or at a price that seems too good to be true. Often times not only can the quality of ingredients be compromised, but the potency /quantity of active ingredients can be different than advertised or labeled. This could lead to serious and damaging effects on a horse’s health.
There are both risks and rewards in deciding to use compounded drugs and horsemen/women need to understand that there are ways to reduce these risks and determine which are acceptable to you. Knowledge, in this instance, is power. Horsemen/women should not be hesitant to ask their veterinarians or the compounding pharmacy about the use compounded medications in their horses. At the end of the day, the horses’ health and welfare are the trainer’s ultimate responsibility.