Prescription and Extralabel Use Flashcards
what are the three parts of the veterinary-client-patient relationship?
veterinarian has assumed responsibility for making medical judgements for animal and client has agreed to follow instructions of veterinarian
sufficient knowledge of animal by veterinarian
practicing veterinarian readily available for follow-up in case of adverse reactions or failure of therapy
who is in charge of drug approvals and regulations?
federal: food and drug administration
a product number is assigned to each drug product associated with a ____________________________
NADA: new animal drug application
under what conditions are drug approved?
specific purposes
specific dosages or dosage ranges
specific population within specific species
what is the label claim or use usually labeled as?
indications
what must drugs demonstrate for label claims?
efficacy and safety
what is extra-label drug use?
any use of drug that is not described on the label and approved by the FDA
what does it mean that a drug is listed on the index?
unapproved but has legal marketing status
what does a prescription drug product require?
doctor or veterinarian authorization to purchase and use
what can you compound from?
approved animal or human drugs
who must veterinarians register with the purchase, administer, or dispense controlled substances?
DEA
who can veterinarians prescribe medications for?
animals where they have a proper veterinary client patient relationship and have established a diagnosis
what must veterinarians have in massachusetts to dispense, administer, or purchase any scheduled drugs?
MA controlled substance registration
what must prescriptions for controlled substances contain?
same basic format
also DEA registration number
must be written prescription
what statement must be included on a veterinary feed directive?
“use of feed containing this veterinary feed directive drug in a manner other than as directed on the labeling is not permitted”