Lecture 1: Introduction and Prescriptions Flashcards
What is pharmacology
Study of agents used to treat, diagnose and prevent disease
What are the two major subdivisions or pharmacology
Pharmacodynamics and pharmacokinetics
What is pharmacodynamics
Biochemical and physiological mechanism- what the drug does to the body
What is pharmacokinetics
Absorption, distribution, metabolism and elimination, what the body does to the drug
Are over the counter drugs labeled or off labeled use
Labeled use
if off labeled use should prescribe the OTC drug
What are the 4 classes or prescription drugs
- Labeled use
- Extra-label use
- Compounded
4, controlled
What are the 3 groups of drugs
- Over the counter
- Prescription/legend drugs
- Vaccines and biologics
What are the 2 central philosophies for drug regulation use for animals regarding OTC drugs
- To protect the public from inadvertent consumption of harmful amounts of drugs given to livestock
- To allow livestock producers to protect the health of their animals with minimal oversight
What must be defined for an OTC labeled use drug
Dose, frequency, duration, route of administration, in a given species, and to treat a specified disease
In order for a drug to be considered over the counter all of the information for labeled use must be…..
Written down in a manner easily understood by a lay person
When is a prescription required
- The labeled use can’t be easily understood by a lay person
- Professional (veterinarian) is needed to diagnose the disease and monitor the patient for a response to the drug or adverse effects
T or F: labeled use only applies to prescription drugs
False, applies to prescription and OTC
Use of a drug in some manner other than the label or use of a drug for which there is no label is considered
Extra label drug use (ELDU)
What act/law defines labeled use
Federal food, drug and cosmetic act
In 1958 the FD&CA made ____ illegal and why
Extra labeled drug use because there were problems with drugs ending up in food chain
In 1994 what act/law was passed to overturn the decision of FD&CA in making ELDU illegal in 1958 and why
Animal Medicinal Drug use Clarification act
More people started having pets in their homes and therefore we needed to use certain ELD to treat diseases
What are the regulations for prescription ELDU
- Veterinarians must adhere to the labeled use, unless they judge it is ineffective
- ELDU is ONLY allowed for FDA approved animal or human drugs
- A human drug can’t be used if an animal drug can be used for the indication
- Requires veterinary supervision and an active VPCR
- Can’t be administered in food but can be in water
- Particular restrictions for food animals (see separate card)
- Use of an OTC in a way that isn’t labeled is ELDU- consider prescribing
What are the particulars/specifics for regulating prescription ELDU in food animals
- Only for therapeutic use, not for production
- Can’t result in any tissue residue that may be a risk to public health
- In the absence of scientific data on human food safety, the animal must be kept out of the food supply
Why can’t prescription ELDU be administered in food or liquids OTHER than water
Considered compounding
Who is responsible the vet or producer for monitoring food animals being kept out of food system if prescribed an ELDU that either has residue in tissues and/or was on a medication that has no scientific data on human food safety
VETERINARIAN
Who legalized compounding
AMDUCA
Is compounding ELDU
Yes
What is compounding
Alteration of the original dosage form for ease of administration or because the labeled form is inappropriate for the intended purpose or because an approved drug does not exist
Who determines what drugs can be compounded
FDA
