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84 Cards in this Set
- Front
- Back
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Origins of veterinary pharmacology |
date back to the early 1700s in Europe |
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Scientists extract and synthesize drugs from |
plant components, bacteria, and animal sources |
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Today, most drugs are made |
synthetically in laboratories |
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Materia Medica |
study of the physical and chemical characteristics of materials used as medicine |
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Pharmaco- |
drug |
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Pharmacology |
the study of drugs |
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Therapy |
the treatment of disease |
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Pharmacotherapy |
the treatment of disease with medication |
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Kinetics |
the scientific study of motion |
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Pharmacokinetics |
the study of drug motion |
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Pharmacokinetics includes |
absorption, blood levels, distribution, metabolism, and excretion |
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Therapeutics |
the study of drug use in the treatment of disease |
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Veterinary Pharmacotherapeutics |
involves investigating how a sick animal responds to drugs |
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Dynamics |
the study of forces and their relation to motion |
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Pharmacodynamics |
involved understanding the interactions between the chemical components of living systems and the drugs that enter those systems |
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Regulation of drug products |
The food and Drug Administration (FDA) became a government agency to enforce the federal Pure Food and Drug Act of 1906 |
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The FDA established |
standards for drug strength, purity, and guidelines for drug labeling |
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Until the 1930s |
the FDA had little power to determine and enforce correct drug dosage information |
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In 1938 |
congress passed the federal Food, Drug, and Cosmetic Act (FDCA) |
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FDCA |
The federal Food, Drug, and Cosmetic Act |
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The FDCA required |
that a drug be adequately tested to demonstrate its safety when used as its label directs |
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In 1972 |
the FDCA was amended to include many more protections |
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The FDA is headed by |
a commissioner and organized into several different centers |
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FDA-CVM |
Food and Drug Administration-Center for Veterinary Medicine |
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The FDA-CVM ensures |
that approved veterinary medicines will not harm animals |
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The FDA-CVM prohibits |
the sale and use of a drug that would cause animals to suffer serious health problems |
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The 1968 amendments to the FDCA |
made drug manufacturers specify drug withdrawal periods |
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Categories of drug products |
over the counter drugs, prescription drugs, extra-label drugs, controlled substances |
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OTC |
over the counter |
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OTC drugs may be |
purchased without prescription |
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OTC drugs toxicity |
no significant potential for toxicity when taken as directed |
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Use of over the counter drugs may |
mask underlying conditions |
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Prescription Drugs are regulated by |
the FDA |
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Prescription drugs are limited to use under |
the supervision of a veterinarian or physician, because of their potential danger, toxicity concerns, administration difficulty, or other considerations |
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Prescription drugs are prescribed to animals once |
veterinarian/client/patient relationship has been established |
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Veterinarian/client/patient relationships |
arise when an animal is seen and examined by a veterinarian who assumes responsibility for making clinical assessments based on sufficient knowledge about the animal’s health |
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Extra-label drugs |
are drugs used in a manner that is not specifically described on the FDA-approved label |
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Extra-label drugs may include |
use of a drug for an animal when drug is only approved for use in humans or for a treatment that is not listed on the FDA-approved drug label |
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AMDUCA |
the Animal Medicinal Drug Use Clarification Act of 1994 |
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Extra-label drug use is allowed |
under the AMDUCA |
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Any extra-label use must be |
by or on the order of a veterinarian |
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Controlled substances |
drugs considered dangerous because of their potential for human abuse or misuse |
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Controlled substances are regulated |
by the Drug Enforcement Agency (DEA) through the Comprehensive Drug Abuse Prevention and Control Act of 1970 |
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Controlled substances are labeled |
at multiple schedule levels |
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Veterinarians who use or prescribe controlled substances must |
register annually with the DEA, keep the DEA informed of all address changes, and receive a registration number to be used on all prescriptions and supply ordered |
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Controlled substances must be stored |
in a locked cabinet or safe |
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Authorized handlers of controlled substances must |
keep records of orders, receipts, uses, discards, and thefts of controlled substances for two years following each transaction |
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FARAD |
Food Animal Residue Avoidance Bank |
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FARAD is |
computer-based system designed to provide information on how to avoid drug, pesticide, and environmental contaminant residue problems |
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FARAD contains |
current label information including withdrawal times of drugs, official tolerances, scientific articles, pharmacokinetics, and the fate of chemicals in food animals |
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FARAD provides |
a list of drugs prohibited for use in livestock |
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In the United states, new veterinary drugs must |
go through a series of tests mandated by the FDA |
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New medications can take |
years to get approved—what organs and functions does it affect? |
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Four major steps in drug development |
1) Synthesis/discovery of a new drug compound 2) Safety/effectiveness evaluation 3) Submission and review of the New Animal Drug Application (NADA) 4) Post-marketing surveillance stage |
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Synthesis/discovery of a new drug compound |
preliminary studies |
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Preliminary studies |
determine the intended effect and possible toxic side effects |
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Preliminary studies may include |
computer modeling, testing in lab media, or testing on bacteria or fungi |
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Safety/effectiveness evaluation |
pre-clinical studies |
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Pre-clinical studies determine |
a drug's safety and effectiveness through short-term and long-term tests |
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Pre-clinical studies check for |
immediate drug reactions, organ damage, reproductive effects, and carcinogenicity, and teratogenicity |
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During the pre-clinical stage |
Submit INAD application for the drug to the FDA |
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INAD |
Investigational New Animal Drug |
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Clinical trials begin once |
the INAD application is approved |
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Satisfactory clinical trial results allow |
scientists to file a NADA with the FDA, EPA, or USDA |
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NADA |
New Animal Drug Application |
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Successful drugs are granted |
approval and license |
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Post-marketing surveillance stage |
The drug company and the government monitor the product during the duration the drug is being manufactured |
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Monitoring of new drugs |
ensures product safety and efficacy |
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Short-term tests |
(hours following a test dose) check the animal for obvious adverse reactions |
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Long-term tests |
(typically run for 3 to 24 months of repeated dosing) check the animal’s various organ systems for toxicity damage |
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Special tests |
reproductive effects, carcinogenicity, teratogenicity |
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Reproductive effects |
conception, fertilization, pregnancy |
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Carcinogenicity |
cancer causing |
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Teratogenicity |
fetal defects in pregnant animals |
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Toxicity evaluation is conducted on |
mice |
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Toxicity evaluation highest dose |
that results in tissue and organ damage |
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Toxicity evaluation highest dose |
that results in permanent injury or death |
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Effective |
the amount of the test drug that causes a defined effect in 50% of the animals that receive itED50 |
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Lethal |
the amount of the test drug that kills 50% of the animals that receive itLD50 |
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Therapeutic index |
the drug dosage or dose that produces the desired effect with minimal or no signs of toxicity |
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Therapeutic index is also called |
the margin of safety |
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Therapeutic index is determined by |
comparing the lethal dose and effective dose of the drug LD50/ED50z |
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A wide therapeutic index means |
that the drug canproduce its desired effect without producing toxicity |
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Additional post-marketing surveillance stage testing |
Systems-oriented screening Evaluation of long-term effects Evaluation of reproductive effect,carcinogenicity, and teratogenicity |
