Compound drug mixing for pet prescriptions

Krista Ostrum loads a cat medication into individual dose applicators at Juro's Home Medical Pharmacy at 2043 Grand Ave. on Friday. This compounding of pet medications may become illegal under U.S. Food and Drug Administration policy now being reviewed.

When Fluffy, your feline who just shredded a new curtain gets her next dose of Fluoxetine or kitty Prozac, you may have to give her a pill, rather than rubbing a gel in her ear.

That will be the outcome if the U.S. Food and Drug Administration formalizes a policy prohibiting pharmacists from mixing or compounding pet medications from pure chemicals. Instead, they would have to buy commercially available drugs and grind up the pills.

"In the eyes of the FDA, the only thing you can use on Fluffy is the capsule manufactured and sold at a drug store. The FDA said it is an unapproved drug if you're turning that capsule into a gel to rub inside Fluffy's ear," said David Miller, a pharmacist and chief executive of the International Academy of Compounding Pharmacists. He's also a pet owner who works in Washington, D.C.

This issue is a top concern for Miller and IACP's 2,000 members. And time is short.

The FDA is soliciting suggestions about the standards, but comments must be received by next Friday. That's a 45-day comment period, instead of the normal 90 days, and the issue is just gaining attention.

When Linda Roers at Juro's Home Medical Pharmacy first learned about the standards, she started sounding the alarm and contacted about 90 veterinarians.

"It was odd for me to call all these local vets, and they didn't know about this," Roers said.

The FDA already regulates the safety of the wholesale pharmaceuticals used by humans and animals. And livestock, used for human food, have a different set of regulations.

This policy reaches down to local veterinarians and pharmacists, telling them what ingredients to use, in which dose and whether the drug should be a pill, liquid or gel.

Strangely, the FDA allows pharmacists to use pure chemicals to mix human medicine.

"It's OK for Pete, the kid, but not Petey, the parakeet," Miller said. "I honestly believe the FDA has backed itself into a corner."

A call Friday to the FDA for comment reached a recorded message that said responses take two business days.

Mark Jurovich, a pharmacist and treasurer for Juro's in Billings, has been compounding meds for humans and animals for 13 years. Mixing vet prescriptions is 5 percent to 15 percent of his business.

For the past two years, he's also traveled to Washington, D.C., to lobby Montana's congressional delegation about this issue.

Veterinarians treat so many species and sizes of animals that compounding from pure chemicals is the only way to get the doses and delivery methods right, he said.

Take, for example, an 8-ounce kitten, a 6-pound cat and a Siberian tiger at ZooMontana.

"They're all felines. They need the same medicine. But the kitten needs a tiny dose and the tiger a much larger dose, and you don't want to use pills on her," Jurovich said. "But when the doses or delivery methods change, it's all considered unapproved or off-label by the FDA."

Treating birds makes up about 15 percent of Diana Kuehn's practice at Caring Hands Veterinary Hospital in Billings.

"Most of what we use is off-label because birds need such tiny doses and so many meds are not approved because the companies won't spend the money to get them approved," she said.

Pills are mostly fillers, dyes and inactive ingredients, Kuehn said, so getting the active drug dose right for a cat or a small dog would be tricky and would mean crushing many pills. And sometimes Kuehn prescribes a generic to save the pet owner some money, including a dry eye ointment that costs $50 for a small tube of the brand name.

Shepherd veterinarian Vicki Bokum said there are drugs she studied in her vet school textbooks that still work well, but are no longer approved by the FDA. So she sometimes resorts to compounding, including a drug to treat incontinence.

"If a dog is urinating all over your house and the drug to treat him is off-label now, the owners might euthanize the pet," Bokum said. "My job is to save the animals."

The deaths in 2009 of 21 Venezuelan polo ponies after they were flown to Florida and were given a vitamin compound commonly used to relieve travel stress plays a role in this FDA debate.

The FDA had banned Biodyl, a legal drug in South America. So, the polo team's vet called in a prescription to Franck's Pharmacy to compound the drug, but it was mixed incorrectly. Venezuela dispenses the drug in a much stronger dose than the U.S. used to, which contributed to the deaths.

The FDA brought action against Franck's, based on an opinion first issued in 2003 that prohibits the use of pure chemicals to mix vet medicines. But that opinion doesn't carry the legal clout of a congressional law or agency ruling, Miller said, and shouldn't be extended to all other U.S. pharmacies.

"The FDA has taken a position, which it admitted all the way back was not the right position, but they are defending it and now by developing these comments, they are looking for a solution." Miller said.

The larger concern, Miller said, is that the FDA appears to be taking on the role of veterinarian instead of focusing on making sure the U.S. drug supply is pure and safe.

"Do you really want someone in Washington, D.C., making decisions about how horses in Billings, Mont., are treated? That's the job of vets in Montana."

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Contact Jan Falstad at jfalstad@billingsgazette.com or 657-1306.