1. Drug Development and Ethics Flashcards
3 core ethical principles
- respect for persons
- beneficence
- justice
the right to be informed and the right to voluntary participation
informed consent
Who is responsible for obtaining informed consent, providing education, expectations, and answering the pts questions
the health care provider
What is the nurse’s role in informed consent?
- serve as advocate
- be knowledgeable about the drug or health care procedure
testing drug compounds in animals and tissues (about 3.5 years)
drug discovery
test drug for safety in 20-80 healthy people (about 1 year)
phase 1 trial
test effectiveness in 100-300 real patients (about 2 years)
phase 2 trial
confirm safety and effectiveness of drug in 1,000+ patients (about 3 years)
phase 3 trial
submitting data to FDA for review (about 2.5 years)
FDA applications
test for long-term effects, optimal and additional uses
phase 4 trial
published annually with high standard for therapeutic use, pt safety, quality, purity, strength, packaging, and dosage form
US Pharmacopeia
What does USP mean behind a drug name?
means the drug has met the standards of the US Pharmacopeia
Food and Drug Act of 1906
first law to regulate drugs, prohibit sale of misbranded and adulterated drugs; does not address effectiveness and safety
1912 Sherley Amendement
prohibits false therapeutic claims on drug labels
1938 Federal Food, Drug, and Cosmetic Act
FDA ensure drugs are safe prior to marketing and require labeling with adverse side effects (ASE)