Pharmacology Introduction

Course Overview

• Course DDS 6215: Pharmacology, covers drug terminology, development, and regulation
• Agenda: Course overview, drug terminology, drug development, and evolution of drug regulation

Drug Terminology

• Pharmacology: Study of drugs, from "pharmaco" (drug or medicine) and "ology" (study)
• Drug: Chemical compound administered to diagnose, treat, or prevent conditions and diseases, alleviate pain, and control or improve physiologic or pathologic conditions
• Pharmacokinetics: Body actions on drug, including absorption, distribution, metabolism, and elimination (ADME), influencing dosages and dosing intervals
• Pharmacodynamics: Drug actions on body, including biochemical, physiological, and behavioral effects, and mechanism of action (MOA)

Drug Nomenclature

• Chemical name: Precise chemical structure, e.g., 2-diethylamino-2,6-acetoxylidide
• Generic name: Official name selected by U.S. Adopted Name Council, e.g., lidocaine
• Brand or trade name: Patent-protected, e.g., Xylocaine

Drug Development

• Process involves multiple stages, from discovery to marketing

Drug Regulatory Agencies

• Food and Drug Administration (FDA): Oversees prescription drug approval, manufacturing standards, labeling, and sale as prescription or over-the-counter (OTC) drugs
• Drug Enforcement Administration (DEA): Regulates manufacture and distribution of controlled substances, such as opioids
• Federal Trade Commission (FTC): Oversees OTC drug advertising

Federal Drug Regulation

• Food and Drug Act (1904): Regulates interstate commerce, prohibiting harmful substances
• Harrison Narcotic Act (1914): Establishes federal control over distribution and use of narcotics, requires prescribers' registration
• Food, Drug and Cosmetic Act (1938): Prohibits interstate commerce unless drug is safe and effective, requires labeling with ingredients and prohibits false/misleading claims
• Durham-Humphrey Law (1952): Clarifies distinction between OTC and Rx drugs, prohibits routine prescription refilling
• Kefauver-Harris Bill (1962): Requires demonstration of effectiveness, stricter testing rules, and labeling of adverse experiences, contraindications, and efficacy
• Controlled Substances Act (1970): Creates drug schedules based on abuse potential and medical use, establishes current Rx writing requirements

Misc. Topics

• Package inserts: Information negotiated between manufacturer and FDA, including description, dosage forms, pharmacology, indications, and dosing, adverse experiences, black box warnings, pregnancy, and lactation information
• Label and off-label use: Allowed if justified by good medical practices, e.g., antibiotics used for oral infections
• Prescription drug reclassifications: Rx to OTC, e.g., ibuprofen and naproxen, and schedule changes, e.g., oxycodone
• Generic drugs: Patent expiration leads to market availability with another trade name, demonstrating similar pharmacokinetic and pharmacodynamic profiles, and "equivalent" to branded drugs