veterinary compounding fulfills a need

VETERINARY C O M P O U N D I N G FULFILLS A NEED

William E. Jones, DVM, PhD

Given the current veterinary drug availability scenario, there is a growing trend for veterinarians to utilize the services of a compounding pharmacy. It may have started among those in small animal practice, but now has been found useful by many veterinarians in various species-specific practices, in- cluding equine practice. Extra-label use of FDA-approved drugs is an important aspect of practice these days, because the formulation of many drugs for human use is seldom ideally suited for animal administration. In general, compounding is done to obtain a drug product which can be administered in a more satisfactory manner such as: an injectable when only a pill source is available; a larger bolus when only small pills are available; or in a pow- dered form to put on a grain supplement when only pills are available.

Acting in accordance with the Extra-label Drug Use in Animals Act, which became effective in 1996, the FDA has established regulations that define "extra-label use" as essentially any deviation from the label of an approved drug. 1 In this definition, compounding of approved human and animal drugs is permitted as long as it is done by a veterinarian or a pharmacist on the order of a veterinarian within the practice of veterinary medicine. The FDA does not, however, permit veterinary compounding from bulk drugs, although there are situations in which this is done without FDA interference.

While the field of veterinary compounding is quite different from human compounding, many pharmacists are learning to cope with the unique problems involved. LloydV. Allen, Jr., PhD,

RPh, editor-in-chief of the new Inter- national Journal of Pharmaceutical Compounding wrote in an editorial, 2 "Deciding to compound patient-specific medications for animals requires an entirely new way of thinking about dosing and administering drugs. How does one calculate the dose for an animal with weights ranging from a few ounces to over a thousand pounds? What dosage form is most appropriate? What flavors do they like? How can one ensure compliance? Are there any unique metabolic functions that must be considered? Is the animal a food- producing animal, a companion animal, a recreation animal or a competi- tive animal? Some pet owners seem to be willing to spend more for their companion animal's health than they do for their own; they may complain about a $25 prescription for themselves but gladly pay $75 for a prescription for their pet.

"One of the most interesting and rewarding aspects of veterinary compounding is the excitement and will- ingness among pharmacists to share information concerning how specific problems are being handled. This networking is invaluable and also enables pharmacists and veterinarians to really work together in solving patient problems. After all, whoever heard of using a mouse or an egg as a dosage-form/ drug-delivery system? What about put- ting the gel or syrup on the paw of a cat to get it to lick it off to take its medicine?

"Working with very small birds to large herds of cattle, veterinary com- pounders are rapidly growing in num- bers and appear to have a great future. In fact, there are already a number of 'veterinary-compounding-only' pharmacies in operation."

Compounding is an especially at- tractive modality for specialty prac-

rices. Dr. Gary Riggs described how he got started using compounded drug products, long before the Extra-label Act came into being, a About 13 years ago he was asked to do some work with the local zoo. There just were not suit- able drug formulations for use on many of these various species. He says the zoo community has been one of the first to realize the need and effectiveness of the compounding pharmacist. As so- phistication of veterinary medicine has improved, compounding has become more important. Dr. Riggs says, "We absolutely cannot practice without compounded medications." Not sur- prising, many equine practitioners have come to the same conclusion.

A recent issue of the International Journal of Pharmaceutical Com- pounding carried an article describing various compounded medications that are common for various species of animals. 4 One product mentioned by a Kentucky pharmacist was an anti-in- flammatory gel for that hydrocorti- sone, in a concentration not available in other products. Pharmacists in Virginia compound a variety of medications for equine practitioners. Michelle Thomp- son, RPh, describes several com- pounds she commonly prepares. A special topical ointment containing an appropriate equine concentrat ion of itraconazole is very good for horses suffering a fungus infection. Eye medications are often compounded; for example, 1 - 2% cyclosporin in an oil base for conjunctivitis.

Other examples of commonly compounded medications for horses have been cited, s Aside from medications for equine protozoal myeloencephalitis, dipyrone, combiotic, and some steroid injections are common. Estrone and testosterone are frequently prescribed. Another popular drug is the generic version of ivermectin, often put into a special formulation to make up a more palatable paste for horses- - such as an apple flavor. Combinations of

610 JOURNAL OF EQUINE VETERINARY SCIENCE

gli;

NSAIDs in various formulations for specific cases are popular. Hormones for injection include estrone, testosterone and progesterone. Prednisone injection (crystalline prednisone suspen- sion) is often prescribed.

Veterinary compounding has become so popular that some pharmacies are specializing in compounding nationwide, or at least are developing a sideline in veterinary compounding. E.W. Bradley, RPh, FACA, explains to other pharmacists how to improve profitability with veterinary compounding. 6 He says, "We have discov- ered that it is important to understand several basic differences in the ap- proach veterinarians use as they treat their patients and serve their clients.

Veterinarians' pharmaceutical needs are significantly different from the needs of physicians who treat human patients. The medical terminology is different in some areas, medications used for specific disease states in humans are used for other disease states in animals, and there are also signifi- cant differences in many laws and regulations for this area of practice. It is important to understand these differences, along with the impact they have on pharmaceutical products main- tained in the pharmacy, equipment needed to prepare these unique medications, and other specialized facility needs and ways to market specialty pharmacy services to these individuals."

Bradley developed a survey docu- ment that was forwarded to many veterinarians to determine their pharma-

ceutical needs. He attended a number of veterinary meetings at the local, state, regional and national levels to gain a thorough understanding of potential needs of veterinarians and their clients and patients.

Too many pharmacists, however, are unaware that compounding for animals is subject to very different and more restrictive federal requirements than is compounding for humans, ac- cording to W. Wes Siegner, Jr. 1 "The much more restrictive legal requirements that pertain to animal compounding will strike most professionals as irrational," he says. "What is the public health basis for permitting the use of bulk drugs when compounding medications for humans, while prohibiting the same practice for animals and subjecting violations of this prohi-

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bition to criminal and civil penalties? The FDA's answer, that Congress was concerned about residues in food, makes little sense when one considers the public health implications of human versus animal compounding. The answer to this question is complex and mostly political, rather than scientific. Professional groups have vigorously defended their rights to compound human drugs from bulk drug substances but have not adequately defended those same rights for compounding animal drugs. The FDA has, therefore, been able to gain more regulatory authority over animal compounding than over human compounding."

The Federal Food, Drug and Cos- metic Act (FFDC Act) contains a sec- tion (127) specifically dealing with compounding. Two years ago this sec- tion was amended to provide for broader provisions in tile practice of compounding. 7 It comes as a surprise

to many pharmacists and veterinarians that this compounding amendment does not apply to veterinary compounding. This leaves a crying need for veterinary practitioners and pharmacists to band together to lobby for more sensible FDA control of animal drug compounding.

It seems that the major concern of the FDA, and the lobbyists who influ- ence their decisions, is in protecting the patents held by pharmaceutical compa- nies that have gained FDA approval for a particular product. The FDA is very sensitive to complaints from manufac- turers who hold patents, who claim they have been violated by bulk compounding. This seems fair enough when the manufacturer makes available to the market a product that an- swers the need of veterinarians. But it seems to fall out of the bounds of fair- ness when a manufacturer is allowed to prohibit sale of a compounded medica-

tion containing its FDA-approved product, when it does not offer a similar product for sale. An example of this occurrence recently was when the drug company holding the patent on diclazuril began prohibiting pharmacists from using bulk diclazuril in formulations designed for treatment of equine protozoal myeloencephalitis. Although this attitude is understand- able from the patent holder's point of view, the only product containing diclazuril on the market was a mixture in chicken feed--- and that was not even for sale in the United States.

Of course there is a case to be made that the cost of research to "prove" a drug and gain FDA approval is a price horses and their owners have to pay to improve veterinary medicine in the long run. Usually an exclusive patent

Continued on page 655

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on a drug combinat ion results in less availabil i ty of that compound and a higher price to the veterinary client. For example, IDEXX Laboratories ob- tained a patent and an exclusive license last year on a compound medicat ion used to treat equine protozoal my- eloencephalit is. 8 Their patent covers methods and compos i t ions for the treatment of EPM and related protozoal infections using pyr imethamine and a sulfonamide in the absence of trimethoprim. The company holding the patent is now vigorously protecting against infringement of this patent by pharmacies that attempt to compound this combinat ion of drugs for treating EPM. As a result, many veterinarians have turned to less promising therapies for treating the disease.

In view of the many hurdles and pitfalls associated with legal drug compounding for animals, it is important for the veterinarian to make a careful

decision regarding the pharmacy he/she will use. The local pharmacy is not al- ways the best choice, if that pharmacy is not accustomed to doing compounding, particularly animal drug compounding. With today's inexpensive, rapid, express services nation-wide, the veterinarian has a wide choice of pharmacists from which to choose. All of those specializing in animal drug compounding are anxious to offer their advice on any compounding request. They are waiting on a call and eager to help.

Note: The Professional Compounding Centers of America, Inc. (PCCA) is an indepen- dent organization of 2,400 pharmacists with a special interest in drug compounding. PCCA is the compounding pharmacist's premier re- source for bulk pharmaceuticals, equipment, devices, flavors, ACPE-approved seminars and training classes, and consulting assistance. (www.thecompounders.com) Pharmacists inter- ested in veterinary compounding are invited to the October Veterinary Seminar and Symposium on the subject, in Houston, Texas, conducted by the PCCA (Oct. 14-16). Veterinary professionals will discuss new dosage forms, special formulations, and the latest advances in veterinary compound-

ing. The seminar also features an extensive work- shop line-up, providing tremendous networking opportunities. Earn 20 hours of ACPE-approved contact hours and learn new ways to meet your animal patients' needs. For more information call 800-331-2498.

REFERENCES

1. SiegnerAW:When is compounding for animals legal? IntJ Pharm Comp 1999; 3(3):188.

2. Allen LA: (Editorial) Int J Pharm Comp 1999;3(3): 171.

3. Compounding and the specialty veterinary practice. (An interview) Int J Pharm Comp 1999;3(3):172.

4. Davis J: Compounding for creatures: What works? Int J Pharm Comp 1999;3(3):182.

5. Jones WE: Compounded drugs in equine practice. JEVS 1999; 19(3): 154.

6. Bradley EW: Improving profitability with veterinary compounding. Int J Pharm Comp 1999;3(3): 180.

7. Jones WE: Veterinary Compound- ing. JEVS 1998;18(8):488.

8. Internal Medicine: JEVS 1999; 19(7):446.

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Volume 19, Number 10, 1999 655

veterinary compounding fulfills a need

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