NR 293 EXAM 1 STUDY GUIDE |LATEST UPDATE & ALREADY GRADED

NR 293 EXAM 1 STUDY GUIDE |LATEST UPDATE & ALREADY GRADED 1. Which is correct concerning the safety of using warfarin (with a small therapeutic index) versus penicillin (with a large therapeutic index) a. Warfarin is a safer drug because it has a low therapeutic index. b. Warfarin treatment has a high chance of resulting in dangerous adverse effects if bioavailability is altered. c. The high therapeutic index makes penicillin a safe drug for all patients. d. Penicillin treatment has a high chance of causing dangerous adverse effects if bioavailability is altered. Rationale: Agents with a low TI (that is drugs for which dose is critically important) are those for which bioavailability critically alters the therapeutic and adverse effects. Clinical Trials - Phase 1 • Clinical evaluation is the first testing of a new compound in subjects for the purpose of establishing the tolerance of healthy human subjects at different doses; defining its pharmacological effects at anticipated therapeutic levels; studying its absorption, distribution, metabolism, and excretion patterns in humans. - Phase 2: • Performance of controlled studies on patients with the target disease or disorder to determine a compound’s potential usefulness and short-term risks. A relatively small number of patients, usually no more than several hundred subjects are enrolled. - Phase 3: • Trials are controlled and uncontrolled clinical trials of a drug’s safety and efficacy in hospital and out-patient settings. Gathers precise information on the drug’s efficacy for specific indications, determine whether the drug produces a broader range of adverse effects than those exhibited in the small study populations of the other two phases and identifies the best way of administering and using the drug for the purpose intended. • If approved, this information forms the basis for deciding the content of the product label. • Verify that the acceptable risk/benefit ratio seen in phase II persists under conditions of anticipated usage and in groups of patients large enough to identify statistically and clinically significant responses. Five Spheres of Influence and Multiple Factors That Impact Adherence & Self Management