🌍 Core Ethical Principles
- Respect for persons – honor autonomy, informed consent.
- Beneficence – do good, protect from harm.
- Justice – fairness in treatment and research.
⚗️ Phases of Drug Research
- Preclinical trials – animals/labs.
- Phase I – small group, safety and dosage.
- Phase II – larger group, effectiveness + side effects.
- Phase III – even larger, confirm effectiveness, monitor adverse reactions.
- Phase IV – post-marketing, long-term effects.
Clinical research design:
- Independent variable = what is changed/tested.
- Dependent variable = what is measured (outcome).
🧑⚕️ ANA Code of Ethics
- Guide for safe, ethical nursing care.
- First adopted in 1950, revised in 2015.
- Nurse’s role in research:
- Ensure patient safety.
- Protect research integrity.
📜 Drug Standards & Legislation
- USP & NF – set official drug standards.
- Federal laws regulate drug approval & safety.
- Nurse Practice Acts – define scope of nursing practice.
- Canada – Health Canada regulates drugs.
🧠 Clinical Judgment in Research
- Concept: Safety first.
- Recognize cues: Spot eligible patients.
- Analyze cues: Teach as needed.
- Generate solutions: Ensure protocol integrity.
- Take action: Support informed consent, document accurately, act as advocate/educator.
- Evaluate outcomes: Were patients safe? Was protocol followed?
🚫 Drug Counterfeiting
- Counterfeit drugs may:
- Have wrong/no ingredients.
- Have too little active ingredient.
- Contain contaminants.
- Come in fake packaging.
- Nurse role: Educate patients on safe drug sources.
💊 Drug Names
- Chemical – scientific formula.
- Generic – official, nonproprietary name (e.g., acetaminophen). Starts with lower case
- Brand/Trade – marketed name (e.g., Tylenol).
🛒 Over-the-Counter (OTC) Drugs
- Safe for use without provider supervision.
- FDA standardized labeling (2002).
- Nurse role: teach about risks, interactions, and correct use.
📚 Credible Drug Resources
- AHFS Drug Information
- U.S. Pharmacopeia–Drug Info
- Medical Letter / Prescriber’s Letter
- MedlinePlus (NLM.gov)
- Handbook of Nonprescription Drugs
✅ In short:
- Ethics = Respect, Beneficence, Justice.
- Research = 4 phases + nurse ensures safety/protocol.
- Nurses must know drug laws, names, counterfeiting risks, OTC safety, and reliable resources.