Pharmaceutical Drugs and Regulations

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.