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psyc 179 notes on ch.12, 14 & 16

psyc 179 notes on ch.12, 14 & 16 - Chapter 12...

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Chapter 12- Dietary Supplements and Over-the-Counter Drugs -Dietary Supplements Where to draw the line between drugs and food (dietary supplements)? St. John’s wort (Hypericum): “natural remedy for depression” or “nature’s Prozac”; improve mood, reduce anxiety, and aid sleep Food, Drug and Cosmetic Act: “intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man” is a drug. Drugs become dietary supplements by the purity of the products and the accuracy in labeling with “nutrition information” and “serving size.” Won’t say it’s good for treating depression or insomnia. Dietary Supplement Health and Education Act (DSHEA): Redefined dietary supplements, definition of safety was altered so that a product is “adulterated” only if it presents “a significant of unreasonable risk of illness or injury,” statements can be made indicating the beneficial effects on some structure or function of the body or on “well being,” and has to say “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” -Some Psychoactive Dietary Supplements St.-John’s-wort “the devil’s scourge”- prevent possession by demons treatment of both anxiety and depression FDA raised concerns interacting with various prescription drugs. SAMe (S-adenosyl-L-methionie) active form of amino acid methionine-“methyl donor” more effective than a placebo and no less effective than tricyclic antidepressants Antidepressant? Ginkgo Biloba reduce blood clotting- blood thinner, improves circulation gingko+aspirin=dangerous Improve memory in Alzheimer’s patients- increase blood circulation in brain. -Over-the-Counter Drugs self-prescribed and self-administered for relief of symptoms of self-diagnosed illnesses 2 biggest markets are for aspirinlike analgesics and for cough, cold, and flu products. -FDA Regulation of OTC Products Kefauver-Harris amendment (1962): FDA set up criteria for new drugs and establishes procedure for reviewing all OTC drugs already on market. FDA didn’t study individual products, but active ingredients GRAS (“generally recognized as safe”): given currently available information, people who are informed and qualified would agree that the ingredient should be considered safe. “Safe”: “a low incidence of adverse reactions or significant side effects under adequate directions for use and warnings against unsafe use as well as low potential for harm which may result from abuse.”
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GRAE (“generally recognized as effective”) or GRAHL (“generally recognized as honestly labeled”): reasonable expectation for majority of population for the pharmacological effect of drug when used under adequate directions and warnings against unsafe use will provide significant relief.
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