Pharmacology Introduction

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Questions and Answers

What is the primary purpose of the Durham-Humphrey Law of 1952?

To establish clearer distinctions between OTC and Rx drugs (correct)

To ban the advertising of prescription drugs on television

To prohibit the development of new prescription drugs

To require pharmaceutical companies to disclose the ingredients of their products

What is the main goal of the Kefauver-Harris Bill of 1962?

To prohibit the use of certain active ingredients in over-the-counter medications

To reduce the cost of prescription drugs for seniors

To demonstrate the effectiveness of drugs through stricter testing rules (correct)

To increase the availability of antibiotics for oral infections

What is the purpose of package inserts?

To display the ingredients and dosage forms of a medication

To list the potential side effects of a medication

To provide instructions for dispensing medication to patients

To provide information negotiated between the manufacturer and FDA (correct)

What is the primary function of the Controlled Substances Act of 1970?

To establish a system for classifying drugs based on their abuse potential and medical use Signup and view all the answers

What is the primary difference between a prescription drug and an over-the-counter (OTC) drug?

The availability of the medication without a prescription Signup and view all the answers

What is the main purpose of the Food, Drug and Cosmetic Act of 1938?

To establish labeling requirements for drugs, including ingredients and directions for use Signup and view all the answers

What is the primary purpose of the Harrison Narcotic Act of 1914?

To establish federal control over the distribution and use of narcotics Signup and view all the answers

What is the primary difference between a generic drug and a brand-name drug?

The patent status of the medication Signup and view all the answers

What is the primary purpose of the Food and Drug Act of 1904?

To regulate interstate commerce related to drugs Signup and view all the answers

What is an example of a drug that was reclassified from a prescription drug to an over-the-counter (OTC) drug?

Ibuprofen Signup and view all the answers

What is the primary focus of pharmacology?

The study of drugs Signup and view all the answers

What is the term for the process by which the body absorbs, distributes, metabolizes, and eliminates drugs?

Pharmacokinetics Signup and view all the answers

What is the name of the agency responsible for regulating the manufacture and distribution of controlled substances?

Drug Enforcement Administration (DEA) Signup and view all the answers

What is the term for the biochemical, physiological, and behavioral effects of drugs on the body?

Pharmacodynamics Signup and view all the answers

What is the term for the official name of a drug selected by the U.S. Adopted Name Council?

Generic name Signup and view all the answers

What is the primary responsibility of the Food and Drug Administration (FDA)?

All of the above Signup and view all the answers

What is the term for the process of developing a new drug?

Drug development Signup and view all the answers

What is the term for the chemical compound administered to diagnose, treat, or prevent conditions and diseases?

Drug Signup and view all the answers

What is the term for the patent-protected name of a drug?

Brand name Signup and view all the answers

Study Notes

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

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Description

This course introduces students to the basics of pharmacology, covering drug terminology, development, and regulation. Course overview and objectives are also discussed.