PHR 915 Block 2| 137 Questions| With Complete Solutions

Pure Food and Drug Act: Year correct answer: 1906 Pure Food and Drug Act came from what? correct answer: "The Jungle" by Upton Sinclair that discussed filthy conditions of meat processing Quinine Regulation: Year correct answer: 1848 Quinine Regulation: Activities? correct answer: Mexican-American war resulted in malaria, farmers sold bark by weight, started added debris to gain profit, regulation enacted by Dept. of Agri. Food Drug and Cosmetic Act: year and formation activities? correct answer: 1938; diethylene glycol found to be toxic when used in abx. led to clinical trial law. Durham-Humphrey Amendment; year/activities correct answer: 1951; difference btw. rx and otc law Durham-Humphrey Rx definition correct answer: 1. habit forming 2. toxic or unsafe method of use 3. Needed New Drug Application(NDA) Thalidomide 1962 correct answer: gave to pregnant women in germany for nausea; caused inadequate growth of limbs DESI Review correct answer: resulted form thalidomide; Drugs are labeled 1. effective 2. probably effective 3. possible effective 4. not effective.; Poison Prevention packaging act of 1970 correct answer: must have child safe caps except on ER meds; children must not be able to open 85% and after shown 80%; 90% of adults must be able to open 1972; OTC Drug Review correct answer: drugs between 38-62 were reviewed by ingredients and by a pharmacist federal anti-tampering act 1983 correct answer: Chicago tylenol incident; congress indicated barrier to determine tampering 1994; dietary supplement health and education act correct answer: DSHE;; nutritional supplement labeling can include standard of nutritional support; drugs may be DSHE approved but not FDA approved OTC label elements must be for layman education level correct answer: problems include illiterate, non-english, rx-otc switch trend, advertisement of drugs correct answer: only us and new zealand; rx controlled by fda, otc controlled by ftc law correct answer: body of principles that govern conduct and enforced by government or must be obeyed or face consequences as result of actions ethics correct answer: principles of government that are conducted but not enforced