Bart Barber, DVM, of Rood and Riddle Equine Hospital in Lexington, Kentucky, helps us understand what compounding pharmacies are, and what legal and illegal compounded drugs are and how to tell the difference.
Veterinary oath: “Being admitted to the profession of veterinary medicine, I solemnly swear to use my scientific knowledge and skills for the benefit of society through the protection of animal health [and] the relief of animal suffering . . . ”
The ability of the veterinarian to relieve animal suffering has made enormous advances in the past 50 years. Our understanding of disease processes, the development and refinement of surgical technique and our diagnostic abilities have been vastly improved over recent decades. Imagine what James Herrriot would think of digital radiography or MRI. It’s a great day to be a veterinarian!
The advancement that has probably had the broadest affect is the improvement in our drug arsenal. Diseases that were death sentences for animals a few years ago are now cured by a few simple injections or a course of tablets. What can currently be done with pharmaceuticals is nothing short of a miracle. It seems certain that the greatest improvements that lie ahead of us will also come from this avenue.
One of the resources that we have for obtaining medications is through compounding. Compounding is defined as the manipulation of one or more drugs to form a new one. Many times an animal may require a medication that is not commercially available in the appropriate strength, in a flavor for maximum palatability or a suitable method of administration. Compounding encompasses everything from something as simple as mixing two injections to far more complex formulas. It is an essential part of our own human health care system as well as veterinary medicine. Without this resource many of the tools we have to combat disease and suffering would be unavailable to us and we would, in fact, be no better off than we were 50 years ago.
One truth in compounding is that not all compounding pharmacies are equal. Compounding pharmacies are not subject to the same oversight and regulations that drug manufacturers are. There have been some compounding pharmacies that–because of this lack of oversight–have produced compounded medications of poor standards, or have produced compounds to make a profit rather than to fill a legitimate need. These bad practices have given compounding in general a black eye.
It has also left many wondering who they can trust and what is legal and ethical in compounding.
The issues are broad and there are many interpretations. Those who are very familiar with compounding talk about the black and white issues as well as the gray ones. For the casual observer it can be very confusing and time consuming to sort out the issues.
One of the easiest rules to understand is that for a drug to be legally compounded there can be no commercial drug available.
Omeprazole is a common example of a drug that is compounded by bad actors. Omeprazole is a commercially available medication found in the form of Gastroguard and Ulcerguard. Because it is commercially available there is no reason or justification for compounding omeprazole.
Some compounding pharmacies continue to disregard this rule and compound it anyway and sell it to consumers who buy it willingly because it is less expensive than the manufactured drug. This practice is clearly illegal, and both the buyer and the seller are in violation of the rules.
For compounds to be dispensed to patients a veterinarian must issue a prescription to the pharmacy. A valid Veterinarian-Client-Patient relationship must exist for the veterinarian to legally prescribe a compounded product. This means that the veterinarian must actually have knowledge of the animal and be familiar with its health problems. The veterinarian must also be readily available to oversee treatment, or must have arranged for follow-up evaluation in the event of adverse reactions or the failure of the treatment regiment.
These are just a few of the rules governing compounding. The AVMA website offers more detailed insight and can be viewed at http://www.avma.org/issues/drugs/compounding/veterinary_compounding_brochure.asp.
The gray issues regarding the use of compounds have a tendency to become better defined to black and white as solid principles are observed. If relieving animal suffering and doing what is best for the animal is the primary goal the issues become much clearer. In fact, there are few decisions to be made, only principles to be acted upon.
In 2007, the partners of Rood and Riddle Equine Hospital opened Rood and Riddle Veterinary Pharmacy. While we recognized that there were several reputable compounding pharmacies already doing business, we felt we could add our own vision and expertise to the market. Veterinary compounding is unique. With this in mind we hired pharmacists and staff with extensive knowledge of the horse and the horse industry. It is the goal of our pharmacy staff to be not just a retailer, but a resource for veterinarians and horse owners.
It is not realistic to expect horse owners or even veterinarians to know all of the rules that apply to compounding. When someone uses our pharmacy they can be comfortable that all rules are strictly adhered to, relieving them of the responsibility of understanding pharmacy law themselves. The veterinarians of Rood and Riddle are also customers of the pharmacy. We use compounds from the pharmacy on a daily basis and are confident that our products are safe and efficacious.
We continually receive feedback from those administering the medications and have made them as convenient and palatable as possible. Our customers may use our products with the assurance that Rood and Riddle’s veterinarians use them in our hospital and in the field, and they are readily available for consultations with our clients and our veterinary colleagues.