Consent Forms

Extra Label Consent Forms

Many of the drugs we commonly use in the practice of veterinary medicine are drugs that are not labeled or approved for use in veterinary patients. Basically except for labeled dosages of veterinary approved drugs used for the labeled indication, dose, route and species, all other use of these or any other drug products is considered extra-label. An act passed by the FDA in 1994 called AMDUCA allows veterinarians to prescribe human drugs and veterinary drugs in different ways under certain conditions. One of the key conditions is that the use must be on the order of a veterinarian with a valid client-patient relationship and not result in violative residues in food animals. It is important for your clients to understand that the use of certain drugs is limited in veterinary patients and not endorsed by the manufacturer or the FDA. Much of the information about dosing and efficacy has been derived from anecdotal use before there are controlled studies to support safety and efficacy. In these cases, it is important to have evidence that you have informed your client of that fact. Informed consent means that you have discussed the extra label use of the drug and educate your client to be more vigilant about reporting any side effects so that the risk to your patient is minimized. VPR can help by providing the form for your client to sign that states they understand the conditions under which this drug is being prescribed. Veterinarians want what is best for our patients. Having an owner who understands the risks and benefits and that we have taken those factors into consideration in the use of a product will help keep everyone working together for the health of our patient.

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