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Chapter 1 A Brief History of Veterinary Pharmacology Copyright © 2011 Delmar, Cengage Learning A History of Veterinary Pharmacology • Origins of veterinary pharmacology date back to the early 1700s in Europe • Study of the physical and chemical characteristics of materials used as medicine is known as materia medica • Scientists extracted and synthesized drugs from plant components, bacteria, and animal sources • Today most drugs are made synthetically in laboratories Copyright © 2011 Delmar, Cengage Learning Pharmaceutical Terminology • Pharmaco- means drug – Pharmacology is the study of drugs • Therapy means treatment of disease – Pharmacotherapy is the treatment of disease with medicines • Kinetics is the scientific study of motion – Pharmacokinetics is the study of drug motion, which includes absorption, blood levels, distribution, metabolism, and excretion of drugs Copyright © 2011 Delmar, Cengage Learning Pharmaceutical Terminology • Therapeutics is the study of drug use in the treatment of disease – Veterinary Pharmacotherapeutics involves investigating how a sick animal responds to drugs • Dynamics is the study of forces and their relation to motion – Pharmacodynamics involves understanding the interactions between the chemical components of living systems and the drugs that enter those systems Copyright © 2011 Delmar, Cengage Learning 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 – The Pure Food and Drug Act established standards for drug strength, purity, and guidelines for drug labeling • Until the late 1930s, the FDA had little power to determine and enforce correct drug dosage information • In 1938, Congress passed the federal Food, Drug, and Cosmetic Act (FDCA), which required that a drug be adequately tested to demonstrate its safety when used as its label directs • In 1972, the FDCA was amended to include many more protections Copyright © 2011 Delmar, Cengage Learning Regulation of Drug Products • The FDA is headed by a commissioner and organized into a number of different centers • The FDA’s Center for Veterinary Medicine (CVM) ensures that approved veterinary medicines will not harm animals • The FDA-CVM prohibits the sale and use of a drug that would cause animals to suffer serious health problems • The 1968 amendments to the FDCA made drug manufacturers specify drug withdrawal periods and detection methods for determining drug residues in animal foodstuffs Copyright © 2011 Delmar, Cengage Learning Categories of Drug Products • Over the counter drugs – May be purchased without prescription – No significant potential for toxicity when taken as directed – Use of OTC drugs may mask underlying medical conditions Copyright © 2011 Delmar, Cengage Learning Categories of Drug Products • Prescription drugs are regulated by the FDA and are limited to use under the supervision of a veterinarian or physician, because of their potential danger, toxicity concerns, administration difficulty, or other considerations • Prescription drugs are prescribed to animals once a veterinarian/client/patient relationship has been established – 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 Copyright © 2011 Delmar, Cengage Learning Categories of Drug Products • Extra-label drugs are drugs used in a manner that is not specifically described on the FDA-approved label – May include use of a drug for an animal when the drug is only approved for use in humans – May include use of a drug for a treatment that is not listed on the FDA-approved drug label • Extra-label drug use is allowed under the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) – The key constraints of AMDUCA are that any extra-label use must be by or on the order of a veterinarian within the context of a veterinarian/client/patient relationship and that the use cannot result in drug residues in food-producing animals Copyright © 2011 Delmar, Cengage Learning Categories of Drug Products • Food Animal Residue Avoidance Bank (FARAD) • FARAD is a computer-based system designed to provide information on how to avoid drug, pesticide, and environmental contaminant residue problems • FARAD contains current label information including withdrawal times of drugs, official tolerances, scientific articles, pharmacokinetics, and the fate of chemicals in food animals • FARAD also provides a list of drugs prohibited for use in livestock Copyright © 2011 Delmar, Cengage Learning Categories of Drug Products • Controlled substances are drugs considered dangerous because of their potential for human abuse or misuse • Controlled substances are regulated by the Drug Enforcement Agency (DEA) through the Comprehensive Drug Abuse Prevention and Control Act of 1970 • Controlled substances are labeled at multiple schedule levels (refer to Table 1-2 in your textbook) Copyright © 2011 Delmar, Cengage Learning Categories of Drug Products • 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 orders • Controlled substances must be stored in a locked cabinet or safe • Authorized handlers of controlled substances must keep records of orders, receipts, uses, discards, and thefts of controlled substances for two years following each transaction – Controlled substance use is usually recorded in a controlled substance log Copyright © 2011 Delmar, Cengage Learning