Monday, July 14, 2014

Even in 2001 Veterinary Compounding had Pros and Cons some of which remain today

Compounding the issue
 
DVM360 MAGAZINE 
The last five years have seen a tremendous increase in the amount of compounded drugs used in veterinary medicine.
Almost every veterinary hospital refrigerator door has a selection of advertising magnets from a variety of compounding pharmacies, and flyers arrive in the mail weekly from businesses offering generic versions of the major equine drug preparations.
These compounded products are often less expensive and are offered in more different forms (liquids, pastes, injections) than the currently available products. Want injectable clenbuterol? Want a generic ivermectin? Want a peppermint-flavored, once-daily oral antibiotic? Compounded drugs offer convenience and profit, so what's not to like?
Buyer beware
Dr. Joseph Bertone DVM, MS, diplomate ACVIM, and former Food and Drug Administration veterinarian, urges all practitioners to take a strong look at the use of compounded drugs in their practices and to educate themselves as to the legal issues involved.
He advises that many pharmacies are not what they seem and that there are potentially serious problems with the use of some of these formulations. "Essential to rational therapeutic drug use," writes Bertone, "is a knowledge of the quality, strength (concentration), purity and availability of the formulation we intend to administer."
When drugs and other products are purchased from major drug companies, it is the reputation of that company that the veterinarian relies on. Products used in such a situation are expected to have been tested at some level, and production is expected to be controlled for issues of purity, strength and quality.
Problems can and do still occur but the company accepts its share of liability and generally the practitioner can be relatively certain that Merial's Eqvalan for instance, will contain 1.87 percent ivermectin.
Drugs and other products compounded by a pharmacy do not come with the same type of guarantees. A generic injectable glucosamine preparation may contain 80 percent glucosamine or it may contain 90 percent. That glucosamine may be 75 percent pure or it may be less than 25 percent pure and its absorption may or may not be as listed. It becomes crucial, therefore, for the practitioner to trust the compounding lab that is being used and to understand the appropriate drug regulations governing specific states.
As Bertone advises, "It is judicious for veterinary practitioners to assume that they are ultimately responsible for the use of a compounded product."
Regulation
Compounding of animal drugs is regulated principally by the FDA at the federal level and by the pharmacy boards at the state level.
Some states require a pharmacy license before veterinarians can use compounded drugs.
The FDA regulates compounding through the Federal Food, Drug and Cosmetic Act. Section 21, Part 530 of these regulations deals with "Extra Label Drug Use in Animals". There is also another section of the regulations (Compliance Policy Guide 608.400) that specifically addresses "Compounding of Drugs for Use in Animals." It is important that practitioners review these sections and understand the legal responsibilities that arise from the use of a compounded product.
Patient's view
More important than the possible legal complications, at least from the patient's point of view, is the potential difference in a compounded product's strength, purity and quality.
When treating a specific condition, many decisions often are influenced by the horse's response to treatment. If the compounding drug that you are using is weaker or more poorly absorbed than other "drug-company" products, then you may not be able to accurately evaluate a specific horse's response to treatment. Did the infection not go away because that was not the best antibiotic for this condition or because the compounded drug was not concentrated enough? Is the horse still lame because the specific treatment drug was inappropriate for this condition or because the compounded drug lacked purity?
Questionable compounded drugs can completely destroy the practitioner's ability to treat many conditions.
Know the regs
If there are so many potential problems with compounded drugs, then why are there so many pharmacies advertising?
In many instances compounded products are slightly less expensive than standard drugs. This difference in price may mean the difference in a horse that would not be treated if the client had to pay the standard fee.
This decreased price is also seen as a profit source by some veterinarians in that they can pay less for compounded drugs. These drugs are then resold to clients at a higher price.
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