Pharmacology Exam 1 ch. 1-9 Moraine Valley Community College
Laws - ANSWER-Govern all aspects of the drug process legislation protects/ informs the public consumers expect the RX to be safe
United States Pharmacopeia (USP) - ANSWER-verify purity and exact amounts of ingredients drugs marketed in the US must conform to USP Standards
Centers that monitor drugs - ANSWER-FDA office of commissioner center for biologic evaluation and research center for devices and radiologic health center for drug evaluation and research center for food, safety, and applied nutrition center for veterinary medicine National center for toxicological research
biologic drugs - ANSWER-drug made by living cells
biosimilar drugs - ANSWER-comparable effectiveness to biologic drugs but not exact, they are a copy of original RX and should not be called generic
Nurses need to know 6 characteristics of a drug - ANSWER-Name of the RX intended use effects on the body contraindications adverse effects special considerations
Drug Approval - ANSWER-Process set by the FDA consists of preclinical research, 4 phases, and new drug application (NDA)
Phase 1 of drug approval process - ANSWER-Clinical Investigation with 20-80 volunteers 1 / 2
Checking for serious side effects occurs after pre-clinical research (lab testing)
Phase 2 of drug approval process - ANSWER-several hundred people consists of RX and Placebo Checking to see if the drug does what it is intended to do
Phase 3 of drug approval process - ANSWER-patient variability take the RX to clinics and hospitals
New Drug Application (NDA) - ANSWER-submitted after phase 3 of the drug approval process is the RX is still preforming well The FDA either approves the NDA or it doesnt - if it is not approved it can not move into phase 4
Phase 4 of drug approval process - ANSWER-After NDA approval by FDA then post market surveillance is maintained
New Molecular entites - ANSWER-and RX that is truly unique and structurally different from existing drugs about 20-30 per year
Post-marketing surveillance - ANSWER-Adverse Event Reporting System (AERS) FDA public meetings it takes 4-5 reports of the same adverse event for the FDA to review and decide to pull the medication or issue a black box warning
Cost of a drug prior to approval - ANSWER-12 years of research 350 Million $ before it is submitted to FDA
Reclassification - ANSWER-prescriptions can be changed to OTC but a high safety margin must exist
Schedule 1 drug - ANSWER-highest abuse potential no medical accepted use no refill
Schedule 2 drug - ANSWER-high abuse potential accepted medical use no refills (there are exceptions)
Schedule 3 drug - ANSWER-moderate abuse potential accepted medical use
- refills in 6 months
Schedule 4 drug - ANSWER-low abuse potential
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