Transcript Chapter 1 - Delmar

Chapter 1
A Brief History of Veterinary Pharmacology
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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
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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
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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
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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
– 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
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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
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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
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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
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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
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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
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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)
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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
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