Pharmacology chapter 1
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Questions and Answers

Which of the following is NOT a source of drug information in Canada?

  • Patient Self-Care: Helping Patients Make Therapeutic Choices
  • Canadian Drug Legislation (correct)
  • Compendium of Self-Care Products (CSCP)
  • Compendium of Pharmaceuticals and Specialties (CPS)

    • What is the 'proper name' of a drug in Canada?

  • The nonproprietary or generic name (correct)
  • The chemical name
  • The brand name
  • The official drug name

    • Which legislation establishes requirements for the control and sale of narcotics and substances of abuse in Canada?

  • Food and Drugs Act
  • Food and Drug Regulations
  • Controlled Drugs and Substances Act (correct)
  • National Association of Pharmacy Regulatory Authorities

    • Which of the following is a possible difference in drug names between Canada and the U.S.?

    <p>The brand name (A)</p> Signup and view all the answers

    Which Act/Regulations primarily focus on protecting the public in Canada through the Therapeutic Products Directorate?

    <p>Food and Drugs Act (B)</p> Signup and view all the answers

    What are the three categories used to name drugs?

    <p>Chemical, generic, and brand names (C)</p> Signup and view all the answers

    Which of the following is a characteristic of prescription drugs?

    <p>Typically have a higher potential for misuse (C)</p> Signup and view all the answers

    What is the main focus of drug classification methods?

    <p>Grouping drugs based on their effects and uses (A)</p> Signup and view all the answers

    Which process is essential for bringing new drugs to market?

    <p>Clinical trial and regulatory approval (A)</p> Signup and view all the answers

    What distinguishes Canadian chemical names from proper drug names?

    <p>Their naming conventions and structures (D)</p> Signup and view all the answers

    What is pharmacology primarily concerned with?

    <p>The effects and actions of drugs (B)</p> Signup and view all the answers

    Which of the following best describes biologic therapy?

    <p>A new class of drugs made from large, complex proteins (C)</p> Signup and view all the answers

    Which name of a drug is emphasized for use in formularies?

    <p>Generic name (A)</p> Signup and view all the answers

    What characterizes therapeutic methods?

    <p>They are approaches to treating illnesses. (D)</p> Signup and view all the answers

    What is the significance of the chemical name of a drug?

    <p>It provides the exact chemical constitution of the drug. (D)</p> Signup and view all the answers

    Which classification specifically involves drugs that do not require a prescription?

    <p>Nonprescription drugs (D)</p> Signup and view all the answers

    What is the primary focus of the United States Pharmacopeia (USP)?

    <p>Setting drug standards (D)</p> Signup and view all the answers

    Which of the following sources would provide the most comprehensive drug information for health professionals?

    <p>The United States Pharmacopeia (USP) (B)</p> Signup and view all the answers

    Which controlled substance schedule is characterized by having a high potential for abuse and no accepted medical use?

    <p>Schedule I (B)</p> Signup and view all the answers

    What type of drug classification is based on the physiological or chemical action of a drug?

    <p>Chemical or physiological classification (D)</p> Signup and view all the answers

    Which entity is tasked with monitoring drug safety in the United States?

    <p>Food and Drug Administration (FDA) (D)</p> Signup and view all the answers

    Which of the following classifications refers to drugs that are used illegally or for recreational purposes?

    <p>Illegal or recreational drugs (C)</p> Signup and view all the answers

    Which source is typically best for obtaining information on nonprescription medications?

    <p>Package inserts (B)</p> Signup and view all the answers

    What is the primary agency responsible for regulating controlled substances in the U.S.?

    <p>Drug Enforcement Agency (DEA) (A)</p> Signup and view all the answers

    Which drug schedule indicates drugs with the highest risk for abuse?

    <p>Schedule I (C)</p> Signup and view all the answers

    What is the average duration of the Clinical Research and Development phase in drug development?

    <p>5 years (C)</p> Signup and view all the answers

    What does a black box warning indicate?

    <p>There is a very serious life-threatening problem associated with the drug (B)</p> Signup and view all the answers

    How many rare health conditions are estimated to exist as per the National Organization for Rare Disorders?

    <p>6000 (A)</p> Signup and view all the answers

    What is the purpose of fast tracking in drug development?

    <p>To expedite approval for life-threatening illnesses (B)</p> Signup and view all the answers

    What is the average time taken for a New Drug Application (NDA) review?

    <p>17 months (B)</p> Signup and view all the answers

    Which of the following organizations promotes the development of orphan drugs for rare diseases?

    <p>National Organization for Rare Disorders (B)</p> Signup and view all the answers

    Which of the following is a requirement for individuals dispensing controlled substances?

    <p>They must be registered with the DEA (D)</p> Signup and view all the answers

    What is the approximate probability of a drug acquiring a new black box warning or being withdrawn from the market within 25 years?

    <p>20% (B)</p> Signup and view all the answers

    Study Notes

    Drug Definitions, Standards, and Information Sources

    • Pharmacology studies drugs and their effects, derived from Greek words pharmakon and logos.
    • Physiotherapy uses water, light, and heat; psychotherapy identifies stressors and methods to reduce them.
    • Different therapeutic methods include diet, drug, physiotherapy, and psychotherapy, often used together.
    • Biologic therapy uses a new class of drugs to treat disorders affecting the body's organs, tissues, and cells. Biologic agents are complex proteins in living systems.
    • Chemical names are most meaningful to chemists, as they describe the exact chemical constitution and atom placement of the drug.
    • Generic names are used by formularies, and are not capitalized.
    • Official names are listed by the FDA.
    • Brand or trade names are capitalized, registered by manufacturers.
    • Nurses should use generic and trade names when teaching patients about new prescriptions.
    • Drug classifications include body system (e.g., cardiovascular, gastrointestinal), therapeutic use (e.g., antacids, antibiotics), and physiologic/chemical action (e.g., anticholinergics, calcium channel blockers).
    • Prescription drugs require a physician's order.
    • Nonprescription (OTC) drugs are sold without a prescription.
    • Illegal or recreational drugs are used for non-therapeutic purposes and obtained illegally.
    • Biosimilars are biologic products similar in structure/function to existing approved biologics.
    • Official drug standards in the US are controlled by the United States Pharmacopeia (USP)/National Formulary (NF) and the USP Dictionary of USAN and International Drug Names.
    • Sources of drug information include package inserts, nursing journals, and electronic databases (e.g., CINAHL, Lexicomp, ePocrates, DailyMed).

    Drug Legislation

    • US Drug Legislation is governed by the Federal Food, Drug, and Cosmetic Act (1938, 1951, 1962). The Controlled Substances Act (1970) defines five classifications of controlled substances (Schedules I-V).
    • The FDA monitors US drug safety.

    New Drug Development

    • New drug development has four stages: preclinical research and development (18 months); clinical research and development (2-10 years average); NDA review (17 months); and postmarketing surveillance.
    • Fast tracking expedites drug development for life-threatening illnesses
    • Parallel tracking allows for patient inclusion in trials without participation in controlled trials when no other alternatives exist.

    Postmarketing Surveillance Stages

    • Postmarketing drug surveillance is an ongoing review of the adverse effects of new drugs.
    • A black box warning indicates a very serious, potentially life-threatening problem.
    • There is a 20% probability of a drug acquiring a black box warning/being withdrawn from the market within 25 years of release.

    Rare Diseases and Orphan Drugs

    • The National Organization for Rare Disorders estimates 6,000 rare health conditions affect 20 million Americans.
    • Orphan drugs are developed for rare disorders.
    • The Orphan Drug Act (1983) promotes development of products for rare disease diagnosis/treatment.

    Audience Response Questions

      1. Nurses should use generic and trade names when teaching patients.
      1. The best source of information is electronic databases.
      1. The US entity responsible for monitoring drug safety is the FDA.
      1. Schedule I drugs have the highest abuse risk.
      1. It takes 8-15 years on average to bring a drug to market.

    Canadian Drug Names and Legislation

    • Official drug names are described in the Food and Drug Regulations.
    • Chemical names are most meaningful to chemists.
    • Proper names are non-proprietary/generic names for official Canadian drugs.
    • Brand names are also used.
    • Canadian Drug legislation includes the Food and Drugs Act (1927), and the Food and Drug Regulations (1953, 1954, 1979)
    • The Therapeutic Products Directorate aims to protect the Canadian public.
    • National Association of Pharmacy Regulatory Authorities (NAPRA) assigns drugs to categories (Schedule I, II, III, Unscheduled).
    • Controlled Drugs and Substances Act (1997) regulates narcotics and controlled substances.

    Sources of Drug Information in Canada

    • Compendium of Pharmaceuticals and Specialties (CPS)
    • Patient Self-Care: Helping Patients Make Therapeutic Choices
    • Compendium of Self-Care Products (CSCP)

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    Related Documents

    Chapter 1 Drug Definitions, Standards, and Information Sources PDF

    Description

    Explore key concepts in pharmacology, including drug definitions, classifications, and therapeutic methods. Understand the differences between chemical, generic, official, and brand names, as well as their significance in patient education and care. This quiz covers important standards and information sources related to pharmacological practices.

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