10/16/2014 3:18PM

Group urges stronger restrictions on compounded medications

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LEXINGTON, Ky.  – A racing advisory group is recommending that state regulators adopt rules that would require additional labeling of compounded medications and bar the use of any compounded medication that has an FDA-approved alternative, the group said Thursday.

With the approval of the new model rules at a board meeting on Monday, the advisory group, the Racing Medication and Testing Consortium, is signaling a crackdown on a class of substances that has increasingly drawn the scrutiny of regulators over the past several years. The rules are being forwarded to the Association of Racing Commissioners International, an umbrella group of racing commissions, which is expected to recommend that its members adopt the rules.

Compounded medications are the main class of products available at lightly regulated Internet pharmacies, and they have been targeted over the past two years by some regulators worried about the integrity of the formulations of the products and, oftentimes, the alleged illegal race day use of the substances. Although some compounded substances are marketed as powerful performance enhancers under snazzy trade names, the vast majority of those, according to tests performed by racing regulatory laboratories, contain no efficacious ingredients. As a result, they don’t work, but they also don’t turn up in post-race tests, causing some trainers to continue to use the substances on a “just-in-case” basis.

At the same time, many compounded medications are also commonly and legally administered to horses  for therapeutic purposes, often because a specific substance or formulation is no longer manufactured or sold under FDA approval. That is requiring the racing industry to carefully consider rules on the use of the substances so as not to completely ban them.

Dr. Dionne Benson, the head of the Racing Medication and Testing Consortium, stressed that the new rules are not intended to target legitimate uses of compounded medications, but she also said that tighter regulations wouldn’t do any harm and, ideally, lead to less abuse.

“It is crucial that commissions have the ability to protect the health and welfare of the horse,”  Benson said. “Controlling – not eliminating – the use of compounded medication is an important step to assist the commissions in that role.” Benson added that the American Association of Equine Practitioners, which represents racetrack vets, worked in consultation with the RMTC to develop the rules. 

As a class, compounded medications include generic formulations of drugs that are currently on the market, formulations of existing drugs that are no longer commercially available, and novel formulations of two or more substances.

Under the new rules, generic formulations would be banned as long as an FDA-approved alternative is commercially available. In addition, compounded formulations of two or more drugs would “constitute the development of a new drug” and would be required to be formulated with FDA-approved substances, as long as FDA-approved versions were available.

The new rules would restrict the use of any compounded drug to the horse who was prescribed  the substance . The rules would also require that all compounded medications be labeled accurately, with any mislabeling constituting a violation. The labels would have to include information on the compounder, a date of expiration for the drug, an accurate listing of the active ingredients, and other information. If the drug has expired according to the label, possession of the substance would be a violation.

Veterinarians and trainers often turn to generic formulations of drugs to save money, especially for costly drugs that have to be administered regularly, such as Gastrogard, the anti-ulcer medication. The new rules may have the effect, then, of increasing the costs of medicating some horses.

The new rules are also an acknowledgment that compounded substances can be dangerous for both the integrity of the sport and the health of some horses.

While some compounded medications that are marketed as performance-enhancing are little more than snake oil, other compounded substances have been blamed for post-race drug positives. Most recently, the attorney for Bruce Levine, a leading trainer in New York, blamed two recent positives for vardenafil, the active ingredient in an erectile-dysfunction drug, on contamination of a compounded substance Levine was administering to horses to treat bleeding in the lungs. Levine was suspended 21 days and fined $5,000 in New York for one of the positives.

More ominously, some formulations from compounding pharmacies have been blamed for sicknesses and even deaths. Earlier this year, the FDA issued a warning about a compounded formulation from a pharmacy in Lexington that was designed to treat EPM. The drug was blamed for causing the deaths of four horses and sickening a handful of others at a farm in Florida. Eight years ago, a formulation of clenbuterol was blamed for killing at least six horses in Louisiana.

 

 

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