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Unformatted text preview: PHR 338 : Fall 2010 Exam #1 Study Guide Dr. Karboski QUESTION: Does anyone know if those drugs listed under number 7 of Drug Interactions are the only ones we need to know? Because he gave us many many more in the notes. Introduction to Pharmacology 1. Purpose of the Pure Food and Drug Act of 1906, Food Drug and Cosmetic Act of 1938, the Durham-Humphrey Amendment of 1952, the Kefauver- Harris Amendment of 1962 and the Controlled Substances Act of 1970. Pure Food and Drug Act of 1906: • passed to protect the public from mislabeled or adulterated drugs • drug company required to list if one of 11 dangerous or perhaps addicting drugs • false and misleading claims about the curative properties of the drug not allowed on the package • only drugs sold in interstate commerce were covered (downside) • Designated the United States Pharmacopoeia and National Formulary as official standards • Set standards for strength and purity • Sherley Admendment (1912) : prohibited fraudulent therapeutic claims Food Drug and Cosmetic Act of 1938: o Drug manufacturers must: - Test for harmful effects- Drug labels must be accurate and complete Durham-Humphrey Amendment of 1952-specified how prescription drugs can be ordered and dispensed -set up system for prescription and OTC drugs Kefauver-Harris amendment 1962-required proof of safety & efficacy prior to approval -permitted generic versions (‘38-’62) Controlled Substances Act of 1970-classifies on abuse potentials 2. Definition of Schedule I, Schedule II, Schedule III, Schedule IV, Schedule V controlled substances Schedule I : High abuse potential; no accepted medical use*, research protocol only , may lead to severe dependence (LSD, heroin, marjiuana, mescaline, peyote, psilocybin) Schedule II: HAP, accepted medical use*, tight control (written prescription/no refills), MLtSD (morphine, opium, meperidine, cocaine, secobarbital, dextrophetamine) Schedule III: low/moderate physical dependence, high psych depen., written/oral prescip. 6 mon refill (acetaminophen with codeine, anabolic steroids, paregoric - diarrhea) Schedule IV: limited dependence written or oral prescrip. 6mtRefill (phenobabital, diazepam, cholral hydrate - sleeping pills) primarily anti-anxiety/sleeping pills Schedule V: limited dependence, may/may not require presc. (cough syrups/ terpin hydrate with codeine, codeine in limited form) 3. The differences between Phase I, Phase II and Phase III studies of the FDA approval process. Phase 1: use on small # of normal people, initial evaluation Phase 2: use on people who have disease, limited controlled evaluation Phase 3: Extend critical evaluation, fine-tune drug knowledge to put into market; establishing safe/effective dose 4. Differentiate between the chemical, generic and trade name....
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This note was uploaded on 02/14/2012 for the course PHR 338 taught by Professor Karboski during the Fall '09 term at University of Texas at Austin.
- Fall '09