Kentucky to Tackle Drug Compounder Concerns

Kentucky to Tackle Drug Compounder Concerns
Photo: Anne M. Eberhardt

In a 12-month period that has seen drug compounders linked to horse deaths at a training center and integrity issues at the track, the Kentucky Horse Racing Commission is researching ways it could add regulatory oversight of drug compounders. 

Reform-minded KHRC rules committee chairman Ned Bonnie Aug. 27 called on fellow members of the committee to research the problems horse racing has encountered with drug compounders and come up with ideas to tackle the issue. The rules committee can make recommendations to the full commission.

"It's a serious matter in Kentucky and elsewhere," said Bonnie, who presented each of the committee members with research on compounders and other issues he hopes the committee will soon address.

Mary Scollay, Kentucky Equine medical director, said compounders operate under little federal oversight when compared to pharmaceutical companies that manufacture drugs. She said in recent months compounded medications have been linked to horse deaths and failed drug tests.

"There is risk. People should basically assume they are administering an unknown when they use a compounded substance," Scollay said. "They should be used with extreme caution. We have concerns with the health and safety of the horse and integrity of the sport. It is potentially a very dangerous situation."

Thoroughbred racing and breeding has use for legitimate compounding that allows the manufacture of a drug to meet the needs of a specific horse, for instance a form of a drug that is injected rather than taken orally for a horse that might have issues swallowing a medication. Also, compounders fill the void when a pharmaceutical company chooses to discontinue manufacture of a drug. 

But FDA-regulated pharmaceutical companies have clashed with some compounders, which they accuse of cheaply mass producing versions of FDA-approved medications. Those pharmaceutical companies say some of the cost savings comes from compounders' reduced regulatory oversight.

Horse racing has encountered numerous problems and concerns with compounders in recent months.

• Late last year the Racing Medication and Testing Consortium confiscated 19 compounded substances from the backstretch at Ruidoso Downs, most of which were manufactured by Texas-based Weatherford Compounding Pharmacy. Tests conducted on the products, which carried names like "Race Ready" and "Game Changer," have not revealed any elicit substances to this point. But industry regulators are concerned about the lack of label information detailing what is in the products and the fact that some were being marketed as performance-enhancing.

This year Quarter Horse trainer John Stinebaugh received a 16-year suspension and $40,000 fine when he had horses test positive for Sildenafil, the active ingredient in Viagra. Stinebaugh's attorney told the Albuquerque Journal that the positives traced to a Weatherford Compounding Pharmacy product. The attorney said Weatherford had agreed to pay owners for lost purses and Stinebaugh's legal fees as he attempts to overturn the suspension. The attorney told the paper that the Sildenafil traced to China through Attix Pharmaceuticals in Canada, then to Weatherford.

• In June lawsuits were filed against Wickliffe Veterinary Pharmacy in Lexington following the deaths and illnesses of eight horses that allegedly received an improperly mixed compound of toltrazurila and pyrimethamine. It was found that the compound had more than 13 times the amount of pyrimethamine that was supposed to be in the product. In follow-up tests, the U.S. Food and Drug Administration reported a similar finding in the Wickliffe product in question, and the company has said it has taken steps to improve its quality-control standards.

• Earlier this year California regulators revoked the license of one of the country's largest equine drug compounding companies, Precision Pharmacy. The California Board of Pharmacy ultimately issued a stay in that license revocation but required the Bakersfield, Calif. companywhich faced 21 allegations linked to quality controlto operate under probation for three years.

Bonnie had printed a page from the Precision website listing more than 100 compounds that it offers for use in horses. That same site, which features a photo of race horses turning for home, assures customers of the company's "uncompromising...quest for knowledge, quality, and our service to patients."

But the California Board of Pharmacy alleged the company allowed workers to manufacture drugs without gloves or masks and allowed them to manufacture compounds in a "back room" without the proper pharmacist-to-technician ratio.

The investigation began when Superior Equine Pharmaceuticals submitted a 2009 complaint that Precision was manufacturing an apple-flavored Phenylbutazone powder for which Superior carried a patent. The FDA would follow with a "cease and desist" letter to Precision and the California Board of Pharmacy launched an inspection of the compounder in September 2009.

That inspection would lead to the 21 allegations that included acting as a manufacturer without a license, failure to maintain proper labeling and records and placing false or misleading labels on prescriptions, failure to conduct end-product testing, the sale of misbranded drugs, and failure to maintain proper pharmacist to technician ratio during its manufacture process.

Scollay said quality control issues at compounders have led to versions of Clenbuterol with 10 times the proper concentration. She said such mistakes have led to drug positives and sanctions for horsemen and health issues and deaths for horses.

"The risk of compounded medicine is that they are not subjected to quality control to the level of your standard prescription medications that you get at the pharmacy and are produced by a pharmaceutical company," Scollay said. "So there is always a question about what is actually in the compounded medication."

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