Confused About Compounding?--in the Vet World

May 10, 2012

Tips on avoiding illegal imposters of brand-name drugs.

From AQHA Corporate Partner Merial

Dr. April Knudson is an equine specialist with Merial Veterinary Services. She has a special interest in sport horse lameness and internal medicine. She holds a doctor of veterinary medicine from the University of California-Davis. Below, she answers a question about compounded equine drugs.

Q. Some of my friends at the barn were talking about compounded drugs and whether or not they are safe to use. What are they? Should I ever use them?

A. I’m glad you asked that question because the equine drug marketplace can be overwhelming. There are websites offering drugs for sale, products being sold at equine events around the country and opinions available from everyone who has ever owned a horse. It’s really important to sort through all of the information and consult with your veterinarian, if needed, before giving anything to your horse.

First, let’s clear up any confusion about what is meant by a “compounded drug.”

The American Association of Equine Practitioners defines a compounded drug as one that is created by manipulating an existing U.S. Food and Drug Administration-approved drug.¹ Examples include crushing a tablet to make a paste or gel or adding a flavor to a drug to make it more palatable.²

For a drug to be legally compounded:

• It must be compounded by a licensed veterinarian or pharmacist for a single horse to meet a specific need,²
• The horse owner must have a valid client-patient relationship with the prescribing veterinarian,²
• There must be no FDA-approved, commercially available drug that will appropriately treat the patient,¹ and
• The product must be made from an FDA-approved commercially available drug.¹

While the use of legally compounded drugs is recognized as an occasional necessity in equine health care, AAEP cautions veterinarians to “limit the use of compounded drugs to unique needs in specific patients.” Because of the time and financial investment required to bring a new equine drug to the marketplace, there are times when a legally compounded medication could be a veterinarian’s only option.

Unfortunately, some FDA-approved equine drugs are illegally manufactured, then advertised and/or sold to horse owners who are led to believe that they are the same as those legitimately on the market. These drugs have not been through the stringent FDA approval process, so they have not been demonstrated to be safe or effective for their intended use.³ Illegal manufacturers often make claims about how well the drugs work, but are not required to prove them. Consider these claims carefully and, if in doubt, ask the manufacturer for proof that the product works and that the manufacturer can back up its claims.

Currently, there are a number of illegally manufactured drugs being marketed to horse owners as the equivalent of brand name drugs such as Ulcergard (omeprazole), Gastrogard (omeprazole), Adequan (polysulfated glycosaminoglycan), Banamine (flunixin meglumine), Phenylbutazone, Protazil (diclazuril)and Regu-Mate (altrenogest). Horse owners should be especially wary of any product claiming to be the same as or the “generic” version of Ulcergard or Gastrogard. These two brand-name drugs are the only FDA-approved products for the prevention⁴ and treatment⁵ of equine stomach ulcers. There is no generic version of either product.

While compounded drugs have not received FDA approval, rest assured that brand name and even generic drugs have, which helps ensure that the product label claims are truthful and accurate.¹ Before considering any drug for your horse, checking to see whether that drug is FDA-approved should be an important consideration. This can be done by looking for a New Animal Drug Application number, or, for generic animal drugs, an Abbreviated New Animal Drug Application number. The six-digit numbers and the statement “Approved by the FDA” are usually found on the drug’s label. A list of approved drugs can also be found in a database that can be accessed by searching the Internet for “AnimalDrugs@FDA.”

Remember, if you have any doubts, consult your veterinarian.

For more information about Ulcergard and Gastrogard, visit www.ulcergard.com andwww.gastrogard.com.

Important Safety Information: Caution: Safety of Gastrogard in pregnant or lactating mares has not been determined. Ulcergard can be used in horses that weigh at least 600 pounds. Safety in pregnant mares has not been determined.

¹ American Association of Equine Practitioners. Equine Veterinary Compounding Guidelines. Available at: http://aaep.org/pdfs/drug_compounding_guidelines.pdf. Accessed February 27, 2012.

² Animal Health Institute and American Veterinary Medical Association and American Veterinary Distributors Association. Veterinary Compounding. Available at:http://www.aaep.org/siteadmin/modules/page_editor/images/files/AHI%20Compounding.pdf. Accessed March 21, 2012.
³ Lau, E. Confounding compounding part II. Veterinary Information News Service. Available at:http://news.vin.com?VINNEWs.aspx?articled=14399. Accessed February 28, 2012.
⁴ Ulcergard product label.
⁵ Gastrogard product label.

Source found herehttp://americashorsedaily.com/confused-about-compounding/