The American Veterinary Medical Association announced in June that it had modified its policies on compounded pharmaceuticals for use in veterinary medicine, partially in response to a recent Senate bill sponsored by the Health, Education, Labor and Pensions Committee that would impose tighter federal restrictions on compounding pharmacies.
"The bill would definitely make it more difficult for pets to receive the medication that their disease requires," said Jennifer Gimon, R.Ph., owner of BCP Veterinary Pharmacy in Houston, Texas.
That's not good news for clinicians who believe compounded drugs play a vital role in their patient care.
Ben Brown, DVM, owns The Travel Vet mobile veterinary practice in Davis County, Utah. He says that about 5 percent of the prescriptions he writes are for compounded drugs, and he uses a combination of veterinary-specific pharmacies and general pharmacies with veterinary-specific divisions.
"Many of our patients are much more amenable to taking a compounded formulation of a medication, especially when a medication course is chronic," Dr. Brown said. "Some of our feline patients would be very difficult to medicate without a specific formulation."
Cats are notoriously difficult to orally medicate, but they aren't the only creatures benefiting from the craft of compounding.
"We have been called upon to make some novel chewable treats for elephants and rhinoceroses using a Rice Krispy-treat base," said Michael Blaire, R.Ph., chief executive officer of Diamondback Drugs in Scottsdale, Ariz.
"We [also] once created a concentrated anti-fungal liquid to be injected into mealworms that were later fed to non-compliant monkeys."
Pharmacists say that the role compounding pharmacies play in today's veterinary practice has evolved quickly over the last 10 years.
"Access to more sophisticated dosage forms and active ingredients, coupled with the very dramatic increase in shorted or back-ordered items, has dramatically increased the utilization of compounds in a typical veterinary practice," said Rebecca Sheehan, Pharm.D., the general manager of Phoenix-based Roadrunner Pharmacy.
Sheehan also noted that compounding's role in veterinary medicine is much more significant than its role in human medicine, for example.
"[Veterinary] clinics often have a need for office-stocked items, a topic poorly addressed by state boards and one of increasing importance, given the growing back-order problems that every clinic faces," Sheehan said.
In addition, Blaire said that because of the variety of species that veterinarians work with, and the variety within each species, the need for custom compounding increases exponentially.
"Most veterinarians maintain that they could not provide effective medical care for many of their patients without access to compounded medications," Blaire said.
In 1995, when she launched BCP Veterinary Pharmacy, Gimon said business was tough.
"Veterinarians had to be educated on what I could do for the patients," she said. "My goal was not to take business away from the veterinarians, but to ensure the animals would receive the correct dose of medication and [it would] be palatable. Today, many more veterinarians are open to the help a pharmacist can provide."
While the growth of compounding pharmacies can be attributed in part to an increase in general practices using their services, Blaire said that the rise of veterinary specialists is another significant factor.
"The emergence of veterinary specialties like cardiology, oncology and neurology, as well as the growth of veterinary specialty and referral centers, has driven an increase in the need for compounded medications," Blaire said.
"Many of the medications used by specialists are not available in approved veterinary products, and off-label use of approved human products would expose veterinary patients to unnecessarily high, potentially toxic doses."
"Compounding for veterinary patients has become more sophisticated and exacting. But, the therapeutic successes have grown as well."
"Compounding pharmacies give practitioners access to medications that have become otherwise unavailable," he said. "These pharmacies also provide valuable alternative formulations of medications, and this variety of medications and formulations allows a practitioner a wider range of treatment options for certain patients."
Those are the patients Gimon said are living longer, happier and healthier lives.
"Several times I have seen pets outlive their owners and the new owners continue using the compounded prescription," Gimon said. "I see several animals that have been on our products for over 10 years. And I believe it would have been much harder for both the owners and pets to remain compliant for that length of time with the difficulty involved in splitting pills and the horror of the pilling method."
In Brown's mobile practice, transdermal gels and flavored suspensions are the most common compounded medications he prescribes. "As with any process, mistakes and inconsistencies can occur during the production of compounded medications," Brown said, which is why he appreciates a close-knit veterinarian-pharmacist relationship.
"I communicate directly with the pharmacist each time a prescription is filled for a patient," Brown said. "The relationship between the pharmacist and the veterinarian is critical in successful patient care, and helpful in discussing medication and formulation options."
Serving all 50 states, Diamondback, BCP and Roadrunner place quality and safety at the forefront of their businesses and strive to meet and exceed the standards outlined in the United States Pharmacopea Chapter 797, for sterile compounding, and 795, for non-sterile compounding.
"Although each state has its own regulations, the definitive standards for quality compounding are already laid out," said Sheehan. "These two chapters and others within the reference are considered the hallmarks for high-quality compounding to which all pharmacies should aspire."
However, because compliance with these standards is not mandated, Sheehan recommends that practitioners screen pharmacies on whether they adhere to these standards and how they do so.
Brown has watched the trend of regulating compounding pharmacies evolve over the past several years, and said that tighter regulation is designed to improve and ensure quality and consistency of compounded medications.
"Many of the changes have evolved as a result of some negative incidents involving compounding pharmacies," he said. "The human fungal meningitis outbreak in October 2012, and the death of multiple polo horses in Florida in 2009, were both determined to be related to problematic compounded medications."
That's why Sheehan urges veterinarians to do their homework when choosing a compounding pharmacy.
"Animal health providers should scrutinize their pharmacies. Ask the hard questions, and ask for proof. Vets screen referral vets all the time before they send cases to them; pharmacies should be no different."
Veterinary compounders oppose proposed Senate bill
In early June, TheHill.com, which covers news on Capitol Hill, reported that a group called My Meds Matter, comprising various compounding pharmacies, launched opposition to a bill approved in May by the Senate Health, Education, Labor and Pension Committee that "would give the FDA increased regulatory power over compounding manufacturers who tailor drugs’ dosages or other properties to fit specific patient needs.”
The drug compounding process has come under fire again after dozens of people died from a meningitis outbreak linked to the Massachusetts-based New England Compounding Center.
Chief executive officer Michael Blaire, R.Ph., of Diamondback Pharmacy, a member of the group, said that while for now there is no language in the bill directly involving veterinary compounding, the bill is nevertheless distressing.
"Unfortunately, there is nothing currently in the Senate bill that will increase patient safety or do anything to prevent an occurrence like the New England Compounding Center from happening again,” Blaire said.
"The current Senate bill will only serve to restrict patient access to compounded medications. The unintended consequences of this bill are frightening. At any moment, an amendment may be added that would at best restrict, and at worst, completely destroy, compounding for animal patients.”
Rebecca Sheehan, Pharm.D., of Roadrunner Pharmacy in Phoenix, agrees that the Senate bill would have a dramatic effect on veterinary compounding on several levels, including imposing strict guidelines on pharmacies that ship across state lines.
"It is entirely possible that the technology and expertise resides in another state, a decision best left to the prescriber,” she said. "Of equal importance is that dosage forms with any level of complexity may very well be banished, and the use of properly tested bulk powders may be severely restricted, profoundly limiting therapeutic considerations.”
Sheehan said she firmly believes that treatment options are between the veterinarian and the pet owner, and that this legislation will limit those options.
"The Senate bill fails to bring clarity to this subject; it seems like a knee-jerk response to a crisis,” she said.
"I encourage every practitioner who utilizes compounding to review these topics and get involved in their state’s regulatory issues. Most of the rules and laws are guided towards human medicine and often fail to address the critical needs of veterinarians who do need office stock, who do need to dispense small amounts of acute medications, who do need fundamental drugs when commercial sources are unavailable.”