Chapter_7_OTC - Chapter 7 OTC Drugs and Herbal Products NUR 3145 Major Legal Events Affecting U.S Drug Use 1938 Food Drug and Cosmetic Act Required that

Chapter_7_OTC - Chapter 7 OTC Drugs and Herbal Products NUR...

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Unformatted text preview: Chapter 7 OTC Drugs and Herbal Products NUR 3145 Major Legal Events Affecting U.S. Drug Use 1938 – Food, Drug, and Cosmetic Act Required that drugs be cleared by the U.S. FDA before being marketed for human use 1951 – Durham-Humphrey Amendments Established the distinction between prescription and OTC Drugs 1962 – Kefeauver-Harris Amendments Established that drug manufacturers must prove safety and effectiveness of their products 1972 – OTC Drug Review FDA- initiated scientific review of OTC product ingredients in use at that time (>500) OTC Drug Review Purpose to ensure appropriate safety, effectiveness, & labeling standards for the OTC products at that time Products unsafe were removed from the market Reclassification from prescription to OTC of more than 40 primary drug products The FDA’s Nonprescription Drugs Advisory Committee is responsible Advantages of OTC Status Convenience, pts allowed to self-medicate minor ailments Financial consideration Manufacturers make more money Overall health care decrease due to direct reduction in drug cost, elimination of physician visits, and elimination of dispensing fees Disadvantages of OTC status May cause delay in seeking appropriate treatment May increase out of pocket cost Increase risk of adverse effects or drug interactions Herbal Products About 30% of all modern drugs are derived from plants Also known as alternative medicines The National Center for Complementary and Alternative Medicine (NCCAM) classifications: 1. 2. 3. 4. 5. Alternative medical systems Mind-body interventions Biologically based therapies Manipulative and body-based methods Energy therapies Herbal Products Herbal medicine Commission E Monographs (Germany) Alternative medicine Herbal Products (cont'd) Dietary Supplement and Health Education Act (DSHEA) of 1994 Herbal products are considered “dietary supplements” No proof of efficacy or safety required No standards for quality control May claim effect but do not have to promise a specific cure Consumer Use of Herbs Therapeutic agents for treatment & cure of diseases Prophylactic agents for long-term prevention of disease Proactive agents to maintain health & wellness & “boost” one’s immune system Table 7-4 Conventional medicines derived from plants Conditions Treated by Herbal Products Anxiety Colds Arthritis Constipation Cough Headache Fever Infection Insomnia Ulcers Stress Weakness Premenstrual syndrome (PMS) Commonly Use Herb or Dietary Supplements Name Use Possible Interactions Aloe Skin irritations, laxative If taken po, lowers blood glucose and K Echinacea Stimulate Liver irritation, immune system interact with immunosuppres ents Garlic Lowers lipid levels, etc. Lowers blood glucose, bleeding Commons Herbs cont. Ginkgo Memory enhancement Bleeding Ginseng Memory enhancement, treat fatigue Decreased effect of anticoagulants St. John’s wort Depression Interfere with cytochrome P450 system Saw palmetto BPH Bleeding Valerian Sedative, antianxiety Drowsiness Herbal Products A major difference between legend drugs & herbal medicines (supplement) is that the DSHEA requires no proof of efficacy or safety & sets no standards for quality control for products labeled as supplements Manufactures of supplements must claim effect but do not have to promise a specific cure on the label The FDA has the burden of proving that the product is safe Other countries put this burden on the manufacturer Misc. http:// MedWatch Program – call 800-332-1088 to report adverse effects of prescription drugs, OTC drugs, herbals, & dietary supplements ...
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  • Winter '16
  • Pharmacology, Food and Drug Administration, Over-the-counter drug, OTC Drug Review, herbal products

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