Compounding the issue

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May 01, 2001

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.

This is a perfect reason to become familiar with the federal regulations. Those documents explain that it is illegal to increase a practitioner's profit margin by reducing the cost of the product.

"Practitioners can charge an appropriate handling fee," says Bertone, "but it is against the law to mark-up a compounded drug."

Many practitioners also use compounding pharmacies when they desire an existing product in a non-available form. This is one of the best uses for compounding.

Many horses do not tolerate the oral administration of certain drugs. An injectable form of that drug would make treatment easier and reduce stress on both the horse and the veterinarian. This type of compounding follows the official rules which state that compounding may be done only when there is no approved drug that, when used as labeled, will, in the available dosage form and concentration, appropriately treat the condition.

Ask questions

There are some ways to determine if you are dealing with a good compounding pharmacy or not, and Bertone advises practitioners to ask these questions and to verify the answers.

Is there a licensed pharmacist on staff? According to Bertone, "compounding may be legally performed only by a licensed pharmacist or veterinarian. These individuals have the training, and legal and ethical responsibility to follow good compounding practices. Verify the state license number and look for more than a loose association between the pharmacy and the pharmacist."

Does the company compound medications for the laymen without a prescription?

"A 'yes' answer to this one," says Bertone, "casts that pharmacy in a suspect light."

That activity has been deemed unethical by most state pharmacy boards.

If bulk product is used to produce compounded formulations, are the raw materials of high quality?

Quality compounding pharmacies can usually produce certificates of analysis (CoA) for the materials used in the formulation. These bulk products should be United States Pharmacopeia/National Formulary listed approved products.

Does the compounding company ship products interstate? Many states contend that pharmacies may ship drugs interstate if the drug was prescribed by a veterinarian. Some pharmacies may be required to be registered in both states in order to ship drugs between them.

Does the pharmacy use an advertisement that goes beyond services offered? It is generally not allowed for pharmacies to advertise specific prices, though this issue is currently being debated. A good compounding pharmacy, however, should not need to engage in sensational advertisement to draw attention to it.

Benefits

Overall, compounding is a wonderful benefit to animal patients and providing drugs in a more absorbable, palpable or acceptable form is truly a service.

This benefit is offset by the possibility that the compounded drug you may use may not be as strong or as pure or as concentrated as you expected. If one is aware of these problems then compounding may be used when appropriate.

"Cheaper is not always better," says Bertone, "so a complete comparison of compounded drugs and standard formulations may be necessary before a choice can be made. If you are going to use compounded ivermectin then you should do fecal examinations to ensure that you are providing your clients with effective therapy. Compounded omiprizole use should be followed with gastroscopic examination to evaluate results. When these additional examinations are factored in there may not be much cost-saving with compounded products," says Bertone.

The testing and treatment follow-up is done for the practitioner by the drug company in its therapeutic trials and during manufacturing when quality and purity are monitored.

Long-range problems

While compounding companies may initially improve some of the options, both medically and economically, available to the patient and the practitioner, the existence of these companies is causing some longer range problems.

Many drug companies are unwilling to develop new products if these products are easy to compound. The expense of research and development can never be returned if the product will be compounded just as soon as it hits the market. This lack of interest in developing newer drugs may ultimately slow medical developments and make it actually harder for veterinarians to treat their patients.

The ultimate decision rests with the client, however, and Bertone suggests that compounding be an option that is well explained to the horse owner. There may be pluses and minuses that fit each individual case. As long as the client is informed, they can participate in an intelligent decision and use compounding to its utmost advantage for situations that demand it.