NURS-UL 3365 Chapter Notes - Chapter 4: Boxed Warning, Ace Inhibitor, Orphan Drug
30 Jan 2020
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Drug polymorphism: vary in drug responses because of age, gender, size, and body composition. Hipaa: protects health insurance coverage for workers and their families when they change jobs; protects patient information. Better to diuretics than beta-blockers or ace inhibitors. Asians and hispanics needs lower dosages for antidepressants. Phase i: small number of healthy subjects to determine dosage range and pharmacokinetics. Phase ii: small number of diseased volunteers; dosage range refined. Phase iii: larger number of patients followed provides info on rare/infrequent adverse events; identify risk. 3 objectives: establishing effectiveness, safety, and dosage range. Phase iv: post-marketing studies; voluntarily done by pharmaceutical companies; black box warning: strictest warning by the fda indicating severe adverse effects. Written prescription expires in 6 months, <5 refills in 6-month period, warning labels. Cough and diarrhea medications with limited opioid quantity. Ethical principles: autonomy, beneficence, confidentiality, justice, nonmaleficence, veracity.
