AAEP’s board of directors in cooperation with the association’s Drug Compounding task force made the decision, citing their non-regulatory status as a blockade in enforcing lawful product sales. Association representatives say the ban is the only way to ensure AAEP isn’t an instrument in the sale of illegal and potentially harmful drugs.
“We support legal compounding methods,” says Sally Baker, AAEP’s director of public relations.
“In the past, we asked compounding pharmacies to sign an agreement stating they would not sell or exhibit products not in compliance with Food and Drug Administration rules, but we found that companies were not abiding by the agreement and this action is a direct effect of some compounders’ non-compliance.”
The International Academy of Compounding Pharmacists (IACP), which represents compounding pharmacists, responded to AAEP’s decision with a letter, followed by numerous unreturned phone calls, according to L.D. King, the group’s executive director.
“The IACP wants to work with AAEP to conceive a plan that doesn’t essentially exclude compounders from their convention,” King says. “I acknowledge that some compounding companies engage in poor practices, but eliminating all compounders is an injustice to the profession and the companies.”
An ongoing point of concern with IACP and compounding pharmacies is that FDA regulations are “impossible to be in 100 percent compliance with,” King says.
“AAEP adopted FDA’s policy, which rules out the use of pure (bulk) ingredients to be used in compounding,” King says. “This is an impossible request to make and there’s no patient safety reason for it.”
AAEP says compounded drugs were displayed at its 2007 convention were available through FDA-approved venues, and that was against the signed policy and the driving force behind its current decision.
“I agree that FDA compliance is difficult to adhere to 100 percent in regard to practice reality,” says Charlotte Lacroix, DVM, JD, of Veterinary Business Advisors Inc., Whitehouse Station, N.J. “However, the profession’s concern is stopping the pirating of brand-name drugs that could cause an adverse reaction to the pet.”
While no agency has denied the benefits legitimate compounding pharmacies bring to the industry, IACP is taking AAEP’s decision personally, making accusations that big pharmaceutical companies have bought the association’s decision.
“We’d like AAEP to disclose its financial ties to drug makers,” King says. “It’s not a coincidence that AAEP’s corporate partners are largely composed of drug companies, which account for the majority of the complaints against compounding pharmacies.”
Because AAEP is a non-profit organization, some authorities in the industry find IACP’s comments to be off focus and counterproductive.
“Compounders need to stop their whining accusations against AAEP and look to their own profession to find a way to eliminate the problems,” Lacroix says. “More stringent monitoring is necessary to give compounding pharmacies more legitimacy.”
Lacroix cautions veterinarians and organizations hosting conventions to be wary of putting faith in compounding companies without investigating their practices.
“It would be difficult to pin AAEP or another association as liable for a mishap when a compounded drug sold at a convention harms an animal,” Lacroix says.
“However, there is a false sense of legitimacy to companies introduced in convention exhibit halls. AAEP is very brave for taking the first step in an attempt to eliminate rogue practices. If anything, they are losing money with this decision by making the purchase of booth space less attractive to compounding pharmacies.”
Lacroix says AAEP’s stance isn’t an overreaction, noting that the backlash against a harmful compounded drug is directed at the prescribing veterinarian.
“Practitioners are the first in line to be sued if an animal they’ve treated is harmed by a compounded drug,” Lacroix says. “Veterinarians can be sure the compounding company they’ve purchased from will not be ready to indemnify the veterinarian if they lose their license over prescribing a compounded drug having an adverse affect.”
Due to AAEP’s decision, last year’s tally of 17 compounding pharmacies has fallen to single digits for 2008.
Meds for Vets in Sandy, Utah, is among the compounding companies that will not be attending the conference.
“AAEP is one of many shows we exhibit at,” says Jan Erickson, president, Meds for Vets.
“Conventions are an effective and efficient way to communicate with the consumer. We have been attending the AAEP convention for eight years. We’ll lose out on sales at the conference and the contacts we’d make that spur year-round business.”
Erickson says the AAEP decision was unexpected.
“We fill a gap within the industry that is needed,” Erickson says. “I feel like AAEP has turned its back on the compounding industry. I don’t feel like there is a purpose for us to attend the conference. We’ll advertise elsewhere.”
Cornerstone Pharmacy and Compounding in Versailles, Ky., plans to attend the AAEP convention, but is uncertain about long-term financial implications that its inability to discuss compounded drugs there will have.
“Last year AAEP representatives examined our literature and pharmaceuticals like police,” says Robin Reed, owner of Cornerstone Pharmacy and Compounding. “We are unhappy that we can’t display our new products. AAEP is an important show for us. I’m hopeful the decision will be reversed next year.”
Pharmacy Resources Inc. in Denver, Colo., says 80 percent of its business is equine related and common ground must be found with AAEP.
“I’ll be going to the conference primarily to touch base with my existing clients,” says Gregg Pederson, owner of Pharmacy Resources. “AAEP has historically been the only convention I attend, but if I’m not permitted to discuss my business next year, I’ll have to go elsewhere.”
Despite not being allowed to exhibit compounded drugs at this year’s convention, not all compounding companies share heightened concern regarding AAEP’s decision.
“We will still have a booth at this year’s AAEP conference,” says Andy Clark, DVM, chief executive officer of Hagyard Equine Medical Institute/Hagyard Pharmacy in Lexington, Ky.
“I don’t agree with IACP’s conclusions about AAEP. I think AAEP made the decision to eliminate compounding pharmacy displays for educational purposes. They want to make a stance against copy-cat drug makers. They have the right to control their trade show as they deem necessary.”
AAEP says it will reconsider allowing companies to exhibit compounded drugs for future conventions, but says there will be no change in the current year’s decision.
“I hope other organizations consider following suit,” Lacroix says. “AAEP will be the test case.”
The American Animal Hospital Assn. and the American Veterinary Medical Assn. representatives said their associations currently do not plan to similarly restrict compounding pharmacies.
Article found in Veterniary Phamacy News here.