April 17, 2009
Competitive pricing, counterfeit drugs, unreliable sources for drugs and the honesty that our profession must maintain present an everyday dilemma. How can veterinarians avoid being tarnished by scandals of adulterated and contaminated food and drugs and still maintain the public’s trust?
Dawn Merton Boothe, DVM, Ph.D., Dipl. ACVIM and ACVCP, director of pharmacology at Auburn University, asked veterinarians to combat the adulteration of products in her letter to the editor in the Dec. 1 Journal of the American Veterinary Medical Assn.
Compounded drugs are not approved by the Food and Drug Administration. When approved drugs are not available or not suitable as packaged by the manufacturer for a doctor’s intended use in a particular patient, compounding of that drug is allowed. The compounding industry is growing fast and is not yet well regulated.
Veterinary compounding is regulated by 50 state boards of pharmacy that use vague federal laws that are interpreted inconsistently. Most compounding pharmacies are run by pharmacists of variable expertise who oversee the preparation of the ingredients.
Veterinarians must realize that compounded drugs offer no guarantee of potency, stability, bioavailability, safety or efficacy. We have become comfortable using FDA-approved products, with guaranteed analysis, efficacy and warnings regarding adverse events while using that particular drug as a single agent or in combinations with other drugs. FDA-approved drugs also list contraindications in the package insert.
The hundreds of compounding pharmacies nationwide do not use standardized methods or bases for their compounded products. Only a few pharmacies run tests on the stability of their purchased and outsourced compounds.
Some are illegally manufacturing medications under the guise of pharmacy compounding. The field has sprawled into a confusing crossover situation for veterinarians. We have human pharmacists preparing products for animals. If they do not respect and understand the human-animal bond, they might purchase “bargain” bulk or raw chemical preparations made in China and other unreliable sources to save money. Without testing these bargain agents for reliability, stability and contaminants, our patients are at risk.
For instance, potassium bromide, cisapride and diethylstilbestrol and other discontinued or no-longer-approved human drugs can be prepared only from bulk chemicals for veterinary medicine, and they are loosely supervised. We need to protect our veterinary patients from being victimized by this potential hazard.
For example, Pergolide for horses is available only through compounding pharmacies. Compounded Pergolide is stable for 30 days and must be kept in a temperature-sensitive environment. Many pharmacies sell Pergolide with a six-month dating, and the product is not stored adequately to ensure its stability.
Since this is a common problem, we need to be concerned about the thousands of horses that are not receiving the proper formulation. We need to be concerned about how the public views the DVM-equine bond.
Our trusted DVM image is under scrutiny by the public, particularly horse lovers who protest the catastrophic fractures such as those endured by Barbaro and Eight Belles. Much of the public feels that these breakdowns are the result of racing too-young horses.
These immature racehorses are pushed to perform, even with injuries. They are given drugs for pain, inflammation and pulmonary hemorrhage to allow them to continue to perform, which most private equestrians would not allow for their companion horses.
Our trusted veterinarian image is also under scrutiny in the arena of farm animal treatment. The battle over Proposition 2 in California had veterinary opponents who favored keeping laying hens in battery cages and confining veal calves and breeding sows in crates that are barely wider than their bodies. Thank goodness the members of the California Veterinary Medical Assn. stood fast with their ethics and commitment to enforce our ancient contract with animals to provide stewardship and the eight freedoms that all living beings deserve.
Gigi Davidson, RPh, Dipl. ICVP, director of clinical pharmacy services at North Carolina State University, says, “Ultimately, the veterinarian is accountable for what happens to the patient.”
“Veterinarians must realize that even if evidence abounds regarding the safety and efficacy of a compound, they are responsible for determining whether the compound is achieving the desired therapeutic effect,” Dr. Davidson wrote in a recent article for AAHA News.
“Veterinarians should keep track of the results for their patients who have been prescribed compounds and make sure they know what exactly is going into each prescription.”
Davidson cited the case of a canine patient treated with pyridostigmine (Mestinon) solution for myasthenia gravis at the N.C. State College of Veterinary Medicine's teaching hospital. The dog was doing well on the treatment but returned several months later weak and unable to stand.
"Apparently the owner had taken her prescription for pyridostigmine solution to a compounding pharmacy and the well-intentioned pharmacist had offered to compound a more dog-friendly flavor of the pyridostigmine," Davidson said. "Unfortunately, the pharmacist included methylcellulose in the vehicle which completely bound the pyridostigmine, making it unavailable for absorption. Luckily, we realized the mistake before the dog was euthanized."
How can we rest assured about compounding drug quality? Drs. Booth and Davidson both feel that the best way to combat the problem is to prescribe only through trustworthy and credentialed pharmacies that are accredited or in the process of being accredited by the Pharmacy Compounding Accreditation Board (PCAB).
The board was established in 2004 as a voluntary accreditation program to ensure quality and sound ethical standards for compounding pharmacies. Davidson said: “All 50 states regulate compounding pharmacies differently and hold them all to different standards. If a pharmacy meets the incredibly rigorous accreditation standards of PCAB, then a veterinarian can be assured that the pharmacy is legally and ethically impeccable and that its compounds are of the highest possible quality."
The board has accredited nearly 50 pharmacies in 40 states, and as many pharmacies are awaiting accreditation. The PCAB website keeps a roster of accredited pharmacies that have the board’s Seal of Accreditation. Veterinarians also may call 919-824-5753 and speak to Tom Murry, the organization's executive director, and he will direct you to an accredited pharmacy in your state.
Go one step further to combat compounding concerns. Ask your favorite compounding pharmacy to seek board accreditation ASAP. Your patients and your clients deserve the effort!
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