When compounding pharmacists say that they provide targeted solutions, it seems that they really mean it. After all, if your 5,000-pound rhinoceros balks at taking his antibiotics, who else are you going to call?
The Rio Grande Zoo in Albuquerque, N.M., called Michael Blaire, R.Ph., co-owner of Diamondback Drugs, a Scottsdale, Ariz.-based national veterinary pharmacy with an emphasis in compounding. One of the zoo’s rhinos had an infection, and 150 ground-up antibiotic tablets were making his food extremely bitter.
“We needed something sweet and chewable,” Blaire said.
The answer? A Rice Krispies treat the size of a car hood. It took two technicians 21/2 hours and two dozen boxes of cereal to prepare the prescription and cut it up into 21 doses.
“But 21 days later, we had a cured rhino,” Blaire said.
Not all compounding solutions have quite so much snap, crackle or pop. But the case of the sweet-toothed rhino does illustrate both the depth of the problems compounders sometimes face and the creativity they can bring to their work.
On the horns of a dilemma, a specialized response can mean the difference between wasted effort and welcome relief.
The compounding professionals at Stokes Pharmacy in Mount Laurel, N.J., don’t get many calls from zoos, but they do keep close tabs on drug shortages that can cause rhino-size problems for veterinary practitioners. Moving quickly to produce an otherwise unavailable drug is a key facet of the compounding equation these days.
In recent years, pharmaceutical companies have discontinued a number of drugs that have underperformed in the marketplace or have faced FDA scrutiny, increasing demand for the remaining drugs in a category.
“When these products become unavailable, it can put veterinarians in a difficult position,” said Mike Tursi, owner of Stokes, which has been compounding since 1975. “When they and their patients have a need, we want to be there for them.”
Representatives at Stokes and other leading compounding pharmacies say they monitor FDA websites, read veterinary publications and clinical briefs as well as talk regularly with veterinarians and wholesalers so they can respond quickly when shortages loom.
“We have to keep our eyes open and ears to the ground to get a jump on things,” Blaire said. “We want to be positioned so that when people say, ‘Have you heard?’ we can say, ‘Not only have we heard, but we’re ready with solutions.’”
More than anything else, compounding pharmacists provide veterinarians with options, which makes things easier on practitioners and their clients. The most nimble pharmacies can compound in a wide range of forms, including capsules, flavored suspensions, eye drops, mini medications, injectables and transdermals.
“There’s so much diversity, even within a species,” that compounding can give practitioners the specificity they crave, Blaire said.
Preparing a medication that best suits the size and breed of a dog makes treatment more efficient and effective, industry professionals say.
“And from a communication standpoint, you can talk to a dog for five hours, but if he doesn’t want to swallow a capsule, he’s just not going to do it,” Blaire noted. “So to be able to flavor an oral medication or turn it into a transdermal gel can make the difference between being able to treat or not.”
With compliance being a significant issue in veterinary medicine, the skills of a compounder become even more valuable, practitioners say. Stokes goes so far as to perform taste tests on some products.
“Any pharmacy can crush a tablet, mix in a suspending agent and send it out,” said Arthur Dustman, director of operations for Stokes.
An extra emphasis on quality and building a high level of trust with practitioners also helps distinguish a veterinary compounding pharmacy, industry professionals say.
At Stokes, facilities are typically dedicated for specific uses. And when a portion of the operation is used in multiple ways, it undergoes a 15-step process of cleansing and decontamination between uses, Dustman said.
Quality has always been a concern, and safety has become a critical issue, especially since the tragic 2009 case in which a misfilled compounding prescription led to the deaths of 21 polo ponies in Florida.
The Florida Board of Pharmacy issued a letter of reprimand and administrative fine to Franck’s, the compounding pharmacy in the case, and Franck’s was able to regain its good standing with the board. Still, the FDA pursued litigation, and the case is still in the courts. The federal agency contends that compounding from bulk ingredients makes the product a new, unapproved drug.
Among those with an acute interest in the litigation is the International Academy of Compounding Pharmacists. The organization’s CEO, David G. Miller, R.Ph., spoke on issues related to the case at the annual convention of the American Veterinary Medical Association in August.
Miller voices concerns that by pressing its case, the FDA is turning compliance guidelines about compounding from raw ingredients into an enforcement tool—one on which he says the agency failed to take public comment. He’s also worried about confusion as to whether state or federal regulators have jurisdiction.
“It’s really about this disconnect between law and bureaucracy and what is in the best interest of the patient, which is how we are trained to think,” Miller said.
“In veterinary and pharmacy practice, it’s not always the best clinical approach (to compound from commercially available drug products),” Miller continued. “Sometimes it makes more sense to use the pure drug.”
Calls to the FDA seeking comment were not returned.
In a 2010 news release on the case, Bernadette Dunham, DVM, Ph.D., director of the agency’s Center for Veterinary Medicine, said the FDA is concerned about compounders circumventing the drug-approval process “by manufacturing drugs under the guise of pharmacy compounding.”
Blaire called the case “a cloud hanging over our shoulder.” But he added that if the FDA does gain jurisdictional power, he expects that it would exercise it with discretion.
“The key is to not give them the reason (to exercise power),” he said.
In the meantime, there are more immediate—and, in Blaire’s case, more physically imposing—challenges for compounders to confront. Like the time Blaire got a call from a New Jersey aquarium seeking help treating a hippopotamus that had swallowed an umbrella.
The answer? Fifty-five gallons of flavored mineral oil compounded to speed the umbrella through the hippo’s system.
“It took a couple of days, and it went fine,” Blaire told the Arizona Republic newspaper. “Well, I don’t know how it actually went. … I don’t want to know,” he added, laughing. “But he’s around to tell the tale.”
And isn’t that the first measure of success for a compounding pharmacist who isn’t afraid to offer up big and creative solutions?