Questions and Answers
Define the term Clinical Pharmacology.
Study of drugs in humans, including healthy volunteers.
What is the definition of Pharmacology?
The study of drugs and their interactions with living systems.
What are the four basic terms essential to pharmacology?
Clinical Pharmacology, Drug, Pharmacology, Therapeutics.
List the properties of an ideal drug.
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What does pharmacokinetics study?
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What is the first stage of drug development?
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Which phase of clinical testing involves healthy volunteers?
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The Food, Drug, and Cosmetic Act of 1938 mandates drug safety testing.
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What does the term 'extrinsic drugs' refer to?
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What is the purpose of drug therapy?
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The FDA stands for ______.
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Match the following types of drugs with their definitions:
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Study Notes
Learning Objectives
- Key concepts in pharmacology include defining terms, properties of ideal drugs, drug development processes, pharmacokinetics and pharmacodynamics, and nursing practice's connection with pharmacology.
Basic Terms in Pharmacology
- Clinical Pharmacology: Examines drugs in humans and includes studies with patients and healthy volunteers.
- Drug: Any chemical that alters physiological processes in living organisms.
- Pharmacology: The scientific study of drugs and their interactions with biological systems.
- Therapeutics: Utilization of drugs for disease diagnosis, treatment, and prevention.
Properties of an Ideal Drug
- Ideal drugs should be Effective, Safe, Selective, and considered the Best Drug available.
- Additional desirable traits include: Reversible, Predictable, Easy to administer, Inexpensive, Stable, and Simple naming.
- Mnemonic for properties: ESSB (Effective, Safe, Selective, Best) and RPEF-ISES (Reversible, Predictable, Easy to administer, Free from interactions, Inexpensive, Simple name, Stable).
Drug Development Process
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Stage 1: Preclinical Testing involves animal studies assessing Toxicity, Pharmacokinetics, and Biological effects, lasting 1-5 years to establish investigational new drug status.
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Stage 2: Clinical Testing consists of four phases:
- Phase I: Tests on healthy volunteers to understand metabolism and effects.
- Phase II & III: Involves patient trials to evaluate therapeutic effects, dosage, and safety.
- Phase IV: Post-marketing surveillance to monitor effects in the general population, identify adverse events.
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Legislation:
- FDA established regulations but initial acts focused on quality and purity rather than safety or effectiveness.
- The FDCA of 1938 introduced mandatory safety testing and FDA approval.
Pharmacokinetics and Pharmacodynamics
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Pharmacokinetics: Focuses on what the body does to the drug including:
- Minimum effective concentration: Lowest drug concentration needed for an effect.
- Steady state: Drug entry and elimination are balanced.
- Duration of action: Time drug maintains minimum effective concentration.
- Potency: Measure of drug strength.
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Pharmacodynamics: Examines effects of drugs on body systems, emphasizing how medications facilitate bodily functions.
Nursing Practice and Pharmacology
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Medication can prevent, correct, or alleviate health issues, assist in treatment, and aid in diagnosis.
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Drug therapy involves:
- Identifying health issues.
- Selecting appropriate drugs or combinations.
- Determining the best administration routes and schedules.
- Ensuring accurate dosing.
- Activating patient participation in their treatment plan.
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Types of Drugs:
- Intrinsic drugs: Endogenous chemicals produced by the body.
- Extrinsic drugs: Must be externally consumed to influence bodily functions.
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Therapeutic Objective: Aim for maximum benefit with minimal harm during drug therapy, focusing on response intensity.
Drug Regulation
- DEA: Requires all prescribers to register and obtain a DEA number for controlled substances.
- FDA: Enforces standards established by the United States Pharmacopeia (USP), which creates guidelines for drug purity, strength, and labeling.
New Drug Development Facts
- Development typically spans 10-15 years and costs approximately $2.558 billion for each approved medication.
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Description
Test your knowledge on the foundational concepts of pharmacology in this NURS 3020 module. The quiz covers essential terminology, drug properties, drug development, pharmacokinetics, and pharmacodynamics. It also explores the crucial link between pharmacology and nursing practice.
