Pharmaceutical Drugs and Regulations

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Questions and Answers

What may cause a drug to not advance to further clinical evaluation?

Having an effective pharmacological profile

Lower toxicity levels

Producing unacceptable side effects (correct)

Demonstrating high benefit-to-risk ratio

What types of drugs are classified as orphan drugs?

Drugs discovered but not adopted due to financial viability (correct)

Drugs that treat common conditions

Drugs with significant side effects

Drugs that have high market demand

Which of the following is NOT included in a drug label?

Brand and generic names

Chemical study information (correct)

Dosage and expiration date

Special drug warnings

What is the primary focus of pharmacology?

The study of drugs and their effects on living organisms Signup and view all the answers

Which of the following describes drug toxicity?

The harmful effects of a drug due to overdose or accumulation Signup and view all the answers

What characteristic do drug names often reflect?

The conditions they are used for Signup and view all the answers

What defines an adverse effect in pharmacology?

A secondary severe reaction that may justify discontinuation of a drug Signup and view all the answers

Which of the following drug preparations is thicker than an ointment?

Paste Signup and view all the answers

Fredrich Serturner is known for isolating which drug?

Morphine Signup and view all the answers

What does the Nursing Drug Guide (NDG) provide?

Organized drug monographs and nursing implications Signup and view all the answers

What is the purpose of the Physician's Drug Reference (PDR)?

To compile package insert information and advertising Signup and view all the answers

What does pharmacotherapeutics primarily focus on?

The use of drugs to treat, prevent, and diagnose disease Signup and view all the answers

What is anaphylactic reaction associated with?

A serious, immediate allergic reaction to a drug Signup and view all the answers

What is the correct method for instilling tablets or capsules in the eyelid?

Squeeze 2 cm on the lower conjunctival sac Signup and view all the answers

Which drug grouping describes medications that affect the central nervous system?

Benzodiazepines Signup and view all the answers

Which of the following is NOT a concern of clinical pharmacology?

Illegal drug manufacturing processes Signup and view all the answers

Which of the following is a key nursing responsibility regarding drug therapy?

Keep drugs in their original containers until at the patient's bedside Signup and view all the answers

What type of reaction does drug allergy refer to?

An immunological reaction to a drug Signup and view all the answers

What is advised against when crushing medications?

Crushing enteric coated tablets Signup and view all the answers

How should the auditory canal be straightened for an adult during otic medication administration?

Pull the pinna upward and backward Signup and view all the answers

What preparation step should be taken before pouring otic medications?

Clean the pinna and meatus of the ear canal Signup and view all the answers

What does pharmacognosy primarily study?

Medicinal drugs obtained from plants or natural resources Signup and view all the answers

What is the definition of pharmacovigilance?

The practice of monitoring adverse effects of medical drugs after their approval Signup and view all the answers

What is meant by the 'synergistic effect' of drugs?

When two drugs increase each other's effects Signup and view all the answers

In which phase do preclinical trials primarily take place?

Testing on laboratory animals Signup and view all the answers

What characterizes an orphan drug?

A drug that is not financially viable and lacks commercial interest Signup and view all the answers

What is the primary goal of the drug evaluation (clinical trials) process?

To test drug efficacy and toxicity at various doses Signup and view all the answers

What does the term 'potentiating effect' refer to?

When one drug increases the effect of another drug Signup and view all the answers

What do prototype drugs represent?

Individual drugs that exemplify groups of drugs Signup and view all the answers

What is a key requirement for drugs to be abandoned during Phase I studies?

Inadequate safety data from human subjects. Signup and view all the answers

Which pregnancy category indicates positive evidence of human fetal risk?

Category D Signup and view all the answers

What defines a Generic Drug?

Drugs no longer protected by patent. Signup and view all the answers

Which category of drug is considered safe without a prescription when used as directed?

Over-the-counter (OTC) Drugs Signup and view all the answers

What is the main criterion for a drug to be considered teratogenic?

The drug causes malformations or abnormalities in a developing fetus. Signup and view all the answers

What is a primary reason why drugs may be classified as too toxic during development?

Severe adverse effects on animal subjects. Signup and view all the answers

What distinguishes Category X drugs?

Evidence of total abnormalities or toxicity in studies. Signup and view all the answers

Study Notes

PHASE IV

First drugs of this group might treat rare diseases.
May exhibit dangerous adverse effects.
Often abandoned after preclinical trials or phase I studies.

FDA Drug Approval

FDA regulates drug development and marketing.
Phase I: Tests drugs on healthy subjects.
Phase II: Evaluates drugs in patients with the target disease.
Phase III: Conducted in clinical settings, assessing unforeseen effects.

Drug Categories in Pregnancy

Cat A: No risk to the fetus based on studies in pregnant women.
Cat B: No risk demonstrated in animal studies, no adequate studies in women.
Cat C: Adverse effects shown in animals; human studies not available.
Cat D: Positive evidence of human fetal risk.
Cat X: Known fetal abnormalities based on animal or human studies.

Drug Types

Over-the-counter (OTC) drugs are safe and available without prescription.
Prescription drugs require written directives for administration.

Pharmacology Basics

Pharmacology studies drugs' origins, structures, actions, and metabolism.
Drug toxicity refers to harmful effects from overdose or impaired elimination.
Drug allergy is an immunologic response, often presenting as anaphylaxis.

Evaluation of Drugs

Preclinical trials involve testing on animals for efficacy and toxicity.
Clinical pharmacology focuses on drug effects on the body and responsiveness.

Drug Effects

Inhibiting effect: Decreases drug effect.
Potentiating effect: Increases drug effect.
Additive effect: Two similar drugs enhance each other's action.
Synergistic effect: Different drugs enhance effects when combined.
Adverse effects/reactions may require drug discontinuation.

Prototype Drugs

Prototypes represent key drug groups and their clinical usage.

Drug Information Sources

Drug Labels: Contains brand/generic names, dosage, expiration, and warnings.
Package Inserts: Provides chemical details and studies enabling approval.
Nursing Drug Guide (NDG): Alphabetical drug monographs include nursing implications.
Physician's Drug Reference (PDR): Compilation of package insert information and advertising.

Topical Medications

Types include aerosols, powders, gels, lotions, and ointments for application.
Transdermal patches deliver medication through the skin.

Otic Medications

Clean ear canal before application; warm medication prior to use.
Ensure correct positioning during administration for effective delivery.

Nursing Responsibilities

Nurses manage drug therapy safely, maintaining proper drug handling and storage.
Avoid contamination of medications and ensure proper administration techniques.

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Description

This quiz covers the phases of drug development, from early research to FDA approval. It also explores the regulation of drugs and their potential effects, especially in specific populations like pregnant women. Test your knowledge on critical concepts in pharmacology and drug safety.