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TEST 1 MATERIAL I) Intro to Pharm 1. Acts A. PFDA 1906 – protect public from mislabeled drugs and false claims B. FDCA 1938 – drug manufacture must test for harmful effects & label drugs correctly C. D-H Amen 1952 – decided who & how drugs are ordered/dispensed D. K-H Amen 1962 – rqd proof of safety and efficacy prior to approval “grandfathered” a lot of drugs; permitted generics for old drugs E. Controlled Substances Act 1970 – 2. Definition of controlled substances (schedule) A. I – high abuse potential, no accepted medical use ex: heroin, LSD B. II – high abuse, accepted mdcl w/ Rx, no refills ex: opium, morphine, cocain C. III – less abuse, acptd mdcl use – oral/written Rx ex: paregoric D. IV – lower abuse, limited dependence ex: Phenobarbital E. V – may/may not require Rx ex: terpin hydrate w/ codeine 3. FDA Approval Process (phases) A. I – initial eval on small amount of normal people B. II – inc doses on larger amount of pts w/ disease; test effectiveness and side effects C. III – determine clinical effectiveness, drug safety, and establish safe doses take data to FDA and have them approve it 4. Names A. chemical – all the same B. generic – most common, lower case i.e. ibuprofen C. trade name – Tylenol, Datril 5. PDR – find out bad things about drugs (ADRs) Facts & Comparisons – easiest to keep up with/updateable LexiComp – very comprehensive/downloadable/book 6. Drug Sources – give examples A. plants – digoxin, vincristine B. animals – insulin C. minerals – Epsom salts, iron D. synthetic – antibiotics, steroids II) Basic Pharmacology 1. Level effects of drugs 2. agonist – fully activates receptor (intrinsic act =1) partial agon – not completely activated (b/w 0-1) competitive antag – agonist & antagonist both try to bind to the same receptor 3. Antagonism A. reversible – extra agonists push antagonist out of the way B. irreversible – antagonist can’t be moved 4. Pharmacologic antagonism – everything we’ve talked about – receptors compete Effect antagonism – effects are competing, not antagonists for same receptor ex: raising/lower blood pressure 5. 6. Phases
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A. pharmaceutical – formulation, stability, dissolution, controlled release B. pharmacokinetic – absorb, distribution, metabolism, elimination (moves thru body) C. pharmacodynamic – conc-effect rltnshp, drug-receptor intrctns (take @ time 0, etc) 7. Variables that affect drug absorption A. nature of absorbing surface – larger surface area, more absorption B. blood – higher blood flow, more absorption C. drug solubility – drugs need to be water soluble D. dosage forms – liquid, syrup fastest 8. Speed of absorption liquid, elixir, syrups suspensions powders capsules tablets coated tablets enteric-coated tablets sustained-release 9. The gut is the site of most drug absorption when taken by mouth 10. Routes of administration A. enteral – oral, gastric, small intestine, rectal B. parenteral – subcutaneous, IM, IV, intrathecal (spinal cord), epidural C. topical – skin, eyes, ears, nasal 11. Excretion/Elimination of Drugs
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