Compounded drugs and clinical practice (Proceedings)


Compounded drugs and clinical practice (Proceedings)

Aug 01, 2009

Compounded drug formulation for use in equine clinical practice has at least two clearly ethical appeals, one contentious issue, and one non ethical practice.

1. Drugs that are not available in commercial formulations useful in horses can be compounded for better ease of administration and clinically effective applications. Also, drugs without Food and Drug Administration (FDA) approval, human or otherwise, can be formulated. This is the essential function that pharmacy compounding fulfills, because there is a large need for medications in equine practice relative to the small number of drugs FDA approved for horses.

2. Compounding of drugs that have been approved for horses, but have been withdrawn by the sponsor is fair game for compounding pharmacies (e.g., oral flunixin meglumine powders, or dipyrone injectable). Again this is an essential function fulfilled by compounding pharmacies.

3. Compounded drugs are often far less expensive than FDA approved formulations for other species, especially those approved for human beings. Compounding of these formulations is a contentious issue. By the letter of the guide this is inappropriate compounding. However, expense of products approved for human beings can preclude treatment. It is the author's opinion that if the veterinarian and the owner are aware of issues in using compounded drugs, this is a rational use for them.

4. Compounded drugs that mimic FDA approved drugs are often far less expensive than FDA approved formulations for horses. This is the disturbing form of compounding that has a severe negative impact on drug development and equine practice. In addition, this is an unethical practice as defined by most pharmacy boards and good compounding practice. As an example, using compounded omeprazole, clenbuterol (both for oral use), or flunixin meglumine, (for iv use) in horses is not advisable or appropriate on several levels. Quality of clinical medicine, negative impact on equine drug development, and client expectations are just a few issues. The quality of the compounded medication cannot be guaranteed. Hence, it is reasonable to assume that this increases your liability, and reduces the quality of care delivered. Compounding of these drugs is considered unethical by the AVMA.

Veterinary compounded drug quality is greatly unregulated in most states. Essentially quality is dictated by the ethical and knowledge bounds of your pharmacist. Clearly an essential part of rational therapeutic drug use is the knowledge of the quality, strength (concentration), purity and availability of the molecule in the formulation you intend to administer. In this respect, when a compounded drug is prescribed, veterinarians should have complete knowledge of the compounding pharmacy selected for this process, since the veterinarian bears a portion of the responsibility for the use of these formulations. In addition, veterinarians must decide when quality is outweighed by cost. In other words, when is a clinical decision to use a compounded medication worth the risk of ineffectiveness or adverse responses in the patient and to the client.

It is judicious for veterinary practitioners to assume that they are ultimately responsible for the use of a compounded product. This more clearly defines the seriousness of using compounded formulations. Clearly, it behooves the veterinary practitioner to be sure that the compounding pharmacy is following appropriate compounding pharmacy laws and guides.