Drug Compounding: Is price more important than safety?

When talking with many of my friends who are horse owners it became clear to me that most people do not understand the difference between licenced drugs, generic drugs and compounded drugs. Since compounding tragedies have been in the news lately with the most recent being the 21 polo ponies dying in Florida I thought I would put this together to help horse owners make informed decisions.

Licensed Pharmaceutical Products (Brand Name Products)

Drugs that have a Drug Identification Number (DIN) are products that have undergone controlled studies to show that they are effective and safe to use at label concentrations and dosages. The testing is done under controlled federally mandated conditions called Good Laboratory Practices (GLP) and Good Clinical Practices (GCP). The active ingredient and all other components of the product were manufactured under federally mandated Good Manufacturing Practices (GMP) in federally inspected plants. Product quality, consistency, safety and stability are all federally mandated on these products. As a horse owner, you can feel comfortable knowing that when you give a pharmaceutical with a DIN number to your horse you are giving a product that has been tested and has been demonstrated to be safe and effective. These products include some of the drugs you are familiar with, some common names include; Banamine, Ventipulmin, Gastrogard and Strongid.

Generic Drugs

Generic drugs do not have to repeat the same rigorous safety and efficacy tests as the original, brand name product as it is assumed if they demonstrate equivalent blood-levels that they act the same as the approved licenced drug. This is called bioequivalence. In Canada, generic drugs also have a DIN and their active ingredients must be manufactured under GMP in federally inspected plants. Owners will not find very many generic dugs that are intended to be used in horses. An example of a generic drug is, Flunixin (generic Banamine).

Compounded Drugs

A compounded drug is produced by combining or altering ingredients to meet the special needs of a specific horse. For example; mixing two injectable drugs to create one injectable drug is considered compounding as is crushing a pill and mixing it with syrup to make an oral medication. Because there are many drugs that are not available with a DIN number for horses, compounding becomes necessary to treat certain conditions or illnesses. An example of a compounded drug that has been formulated to meet the needs of a specific horse would be having a pill put into a liquid formulation.



Where do the problems arise with compounded drugs?

Compounded drugs are not approved by Health Canada and do not have a DIN number. Because there is no externally regulated manufacturing process, finished product testing or stability testing, they can vary in potency, stability, purity and efficacy. Compounded drugs are not the same as generic drugs and should not be seen as a ‘cheap’ alternative to a licensed product. People may believe that a compounded product uses the same active ingredient that is used in a ‘Brand Name’ product, but there is no way to know if that is the case. Compounded products can include active ingredients that are sourced outside Canada or in situations where there may be minimal quality control. This is one of the reasons that compounded products may appear less expensive than a ‘Brand Name’ product.
There are many groups such as the American Association of Equine Practitioners (AAEP), the Canadian Veterinary Medical Association (CVMA), Canadian Animal Health Institute (CAHI) and the Ontario Veterinary Medical Association (OVMA) that have all produced guidelines for using compounded of drugs. These organizations recommend using a licensed drug whenever it is available and do not support the use of compounded products as a cheap alternative to federally approved products.

I know from my many years as a horse owner that my primary concern is for the health and safety of my horses. If using a compounded product that has no regulatory requirements for potency, safety, stability or production puts my horse at risk I am not interested just to save a few pennies. Another point to consider is the assurance and insurance received by using a ‘Brand Name’ product. In the rare event that a horse developed a problem related to the medication, the manufacturer would provide both technical and, depending on the case-specific circumstances, financial assistance. This will not occur with a compounded product. In fact, there isn’t even any government agency where you can report problems with compounded drugs.

If you look on the internet you can find that compounded drugs have been linked to the deaths of 21 polo ponies in Florida as well as the deaths of several horses in Louisiana. It is not known how many more unreported incidents may be occurring since compounded products are not federally regulated.

The next time you ask for a drug for your horse make sure it has a DIN. Your horse is worth more than the money you will save on compounded product!

Written by:
Jennifer Verhulst-Loch
Equine Product Manager Boehringer Ingelheim and long time horse owner/breeder

http://www.bloodhorse.com/horse-racing/articles/36479/horse-deaths-...

http://www.aaep.org/pdfs/drug_compounding_guidelineshttp://news.vin...

http://www.foxnews.com/story/0,2933,517619,00.html

http://news.vin.com/vinnews.aspx?articleId=15565