Lec1 Flashcards
Pharmaco-
= drug, medicine
Pharmacotherapy
treatment of disease with medicine
Pharmacotherapeutics
field that examines the treatment of disease with medicine (the response of living organisms to drugs in the presence of disease)
Pharmacokinetics
the study of the absorption, distribution, biotransformation (metabolism), and excretion of drugs
Pharmacodynamics
the study of the mechanisms of action of a drug and its biological and physiological effects
FDA Origin
Came into being as a government agency to the federal Pure Food and Drug Act of 1906
Established standards for drug strength/purity and guidelines for drug labeling
Had little power to determine and enforce correct dosage information
FDA Ammendments and other changes
Food, Drug and Cosmetic Act of 1938
Required that a drug be adequately tested for safety when used as labeled, and was further amended in 1972 to include more protections
FDA’s Center for Veterinary Medicine (CVM) makes certain that approved drugs will not harm animals or at least that benefits outweigh adverse effects
The 1972 “New Animal Drugs” amendment requires manufacturers to demonstrate safety and efficacy
Must provide reliable method to detect drug residues and acceptable drug withdrawal periods for food animals
What is the importance of drug regulation to the FDA?
Prescription drugs are regulated by the FDA; Limited to use under the supervision of a veterinarian, physician, or dentist due to potential danger, toxicity, difficulty with administration or other concerns
VCPR Importance
Must exist before a prescription drug can be prescribed or dispensed
Animals must be examined
The Vet assumes responsibility for clinical assessments based on sufficient knowledge about the animal’s health, need for treatment and follow-up care
What label must be on all prescription drugs?
Prescription Drug Legend: “Caution: Federal law restricts the use of this drug to use by or on the order of a licensed veterinarian.”
Extra-label Drug Use
the use of a drug in a manner not specifically described on the FDA-approved label; Allowed under the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA)
Must not result in drug residues in food animals
Over-The-Counter Drugs (OTC)
may be purchased without a prescription
No significant potential for toxicity when taken as directed
No special administration requirements
Who regulates controlled substances/drugs
Regulated by the Drug Enforcement Administration (DEA)
What act established the DEA?
The Comprehensive Drug Abuse Prevention and Control Act of 1970 (a.k.a. Controlled Substances Act)
How are controlled drugs classified?
Controlled drugs are classified into one of five schedules based upon the drug’s potential human abuse vs. medical benefit and addictive liability
The higher number in the schedule, the lower the risk of abuse potential
Controlled drug labels indicate the level of control in Roman numerals inside an upper case letter C
Veterinarians have direct access to controlled substances and usually keep them stored at their own facility where the possibility of theft may occur
