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Compounders In Spotlight After Deaths

Compounding pharmacies have received scrutiny since the deaths of 21 polo horses shortly before the U.S. Open Polo Championship.

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Compounding pharmacies have come under increased scrutiny since the deaths of 21 polo horses shortly before the U.S. Open Polo Championship in Palm Beach County, Fla., in April.

Franck’s Pharmacy of Ocala, Fla., admitted April 23, just days after the deaths, that it incorrectly prepared medication used to treat the horses.

An internal investigation led by an outside lawyer “concluded that the strength of an ingredient in the medication was incorrect,” said Jennifer Beckett, Franck’s chief operations officer.

The statement did not specify the ingredient, but Florida State Veterinarian Thomas Holt, DVM, said the deaths most likely were caused by a selenium overdose.

At press time, it was unclear whether the team’s veterinarian specified an incorrect selenium dosage in the prescription or if the pharmacy caused the error. Beckett told Veterinary Practice News that she cannot comment because of the ongoing investigation.

“We are waiting for the investigation to take its course,” she said.

The larger question may not be who is at fault, but what effect this will have on the compounding industry. Will this tragedy lead to tighter regulations and increased scrutiny of compounding pharmacies? It may be too soon to tell.

Laura Alvey, a spokeswoman for the U.S. Food and Drug Administration, said the FDA could not comment on possible effects because of the open and active investigation.

Understanding Regulations

The FDA generally defers to state authorities on the day-to-day regulation of veterinary compounding.  However, the agency will consider enforcement action when the activities of veterinarians and pharmacists raise concerns about adulteration or misbranding.

FDA-initiated regulatory action may include issuing a warning letter, product seizure, injunctions or prosecution.

It’s yet to be determined whether Franck’s Pharmacy will face legal or regulatory action. Franck’s has been in business for 25 years and has been highly regarded in the industry.

“Veterinary Compounding,” a brochure created by the Animal Health Institute, the American Veterinary Distributors Assn. and the American Veterinary Medical Assn., defines compounding as the manipulation of a drug to make a different drug to meet the needs of a particular patient. Examples of compounding include adding flavoring to a commercially available drug and creating an oral suspension from crushed tablets.

Federal regulations must be followed to compound a drug legally. Among those, as outlined in the brochure:

• A valid veterinarian-client-patient relationship must exist.
• The health of an animal must be threatened or suffering, or death may result from failure to treat.
• There must be no FDA-approved, commercially available animal or human drug that, when used as labeled or in an extralabel fashion in its available dosage form and concentration, will appropriately treat the patient.
• The product must be made from an FDA-approved commercially available animal or human drug.
• The amount of product compounded must be commensurate with the need of the animal identified in the prescription.
• All relevant state laws must be followed.

Exceptions Exist

“Compounding an animal drug is illegal unless done by a veterinarian, or a pharmacist on the order of a veterinarian, within the practice of veterinary medicine and in compliance with our regulations,” said Alvey, the FDA spokeswoman.

The compounding of animal drugs from bulk drugs or unapproved drugs results in an unapproved new animal drug that is deemed “unsafe,” Alvey said.

Are there exceptions to the regulations? Yes.

For example, if a veterinarian diagnoses a condition for which no FDA-approved drug is available, he may find it necessary to compound, or prescribe a compound, from non-FDA-approved substances to satisfy the requirements of good veterinary medical practice.

According to the compounding brochure, “The veterinarian is then responsible for the safety and efficacy of the compounded drug. In cases where no approved drug or combination of approved drugs can adequately address a specific patient’s need, veterinarians and pharmacists must carefully assess whether the use of an unapproved substance in a compounded veterinary drug is consistent with state law and FDA policy.”

Biodyl Widely Used Abroad

The prescription for the 21 polo horses, according to Venezuela’s Lechuza polo team, had been for a compounded vitamin supplement containing vitamin B, potassium, magnesium and selenium.

Media reports first indicated that the product was Biodyl, which is made in France by Merial Ltd. of Duluth, Ga. The injectable product, used worldwide in horses competing in strenuous competitions, helps them recover faster.

Biodyl is not approved for use in the U.S. but is approved for sale in many other countries, where it has been used safely for decades, according to the company.

The polo team issued a statement saying that Biodyl “is not the issue in this instance.”

Merial confirmed that its product had not been given to the Palm Beach horses.

Is it legal to compound Biodyl in the first place? According to federal regulations, the answer is no.

Steve Dickinson, a Merial spokesman, warned of the dangers associated with using compounded drugs because they haven’t had the rigorous studies that an FDA-approved product has had.

“Still, compounding pharmacies do have a role in veterinary medicine,” he said. “But only if a particular case meets the criteria.”

Eleanor Green, DVM, Dipl. ACVIM, Dipl. ABVP, past president of the American Assn. of Equine Practitioners, agreed that compounding has a place.

“The AAEP recognizes the importance of drug compounding for equine patients because there aren’t enough FDA-approved drugs to meet all the important health needs of horses,” said Dr. Green, dean of Texas A&M University’s College of Veterinary Medicine and Biomedical Sciences.

Veterinarians also need to be aware that compounding, including a formulation in a novel drug-delivery system such as transdermals, may affect the absorption and depletion of a drug, according to the AVMA’s policy on compounding.

The AVMA says one element in evaluating a compounder is whether the pharmacy is accredited by an independent board such as the Pharmacy Compounding Accreditation Board.

To receive PCAB accreditation, compounding pharmacies must meet criteria such as completion of an extensive application, documentation of written policies and an on-site inspection of quality-control procedures.

“Being accredited by PCAB is not required, but it is a way to validate that (a pharmacy) meets high quality standards,” said Tom Murry, PharmD, JD, the group’s executive director.

More than 50 compounding pharmacies, including some that compound animal drugs, have earned accreditation and 128 are going through the process.

Franck’s Pharmacy is not accredited by the PCAB. Murry could not comment on whether Franck’s is going through the accreditation process.

Tips for Veterinarians

Tom Murry, PharmD, JD, executive director of the Pharmacy Compounding Accreditation Board, offers this advice for veterinarians:

• Work closely with compounding pharmacies that have additional training in veterinary medicine.
• Write clearer prescriptions, such as avoiding naked decimal points (write 0.5 g and not .5 g) and avoiding trailing 0’s (write 5 g and not 5.0 g). These steps could  help avoid a tenfold overdose, he noted.
• “The first question (to a compounding pharmacy) should not be, ‘How much does this cost?’ but ‘How do you verify quality?’”

Education is Key
The AAEP has set its own guidelines about equine compounding drugs.

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