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14 Cards in this Set
- Front
- Back
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What new power was given to the FDA by the PREA (2003)?
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Testing of new drugs on children
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What role can the nurse fill to assist the FDA with the goals of FDA Amendment Act (2007)?
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Report usual effects of drugs.
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Describe the chemical name of a drug.
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This uses words describing the chemical composition. There is only one chemical name per drug; it does not change due to different manufactures.
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Describe the generic name of a drug.
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This name is assigned by the United States Adopted Names Council. There is only one generic name which may be referred to as the non-proprietary name.
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Describe the trade name of a drug.
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A manufacturing company assigns the trade name to a drug. Each manufacture can assign different names; therefore, you see many of one type of drug. This may be referred to as the proprietor name.
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Why is it important for the nurse to learn generic names of all drugs?
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1. The same generic name is never used for more than one medication.
2. The generic name of a drug will be the same no matter which company produces the drug. 3. Generic names of drugs in the same therapeutic class often have similar suffix making them easy to identify. |
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What are the two stages for new drug development?
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preclinical testing and clinical testing.
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What does preclinical testing encompass?
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The drug is evaluated for toxicities, pharmacokinetic properties, and potentially useful biologic effects.
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How many phases are in Clinical Testing?
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Five
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What are over the counter drugs (OTC)?
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Drugs that can be purchased without a prescription.
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Are generic name drugs and brand name drugs equivalent products?
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Yes, however their rate and extent of absorption may vary.
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Name 3 main sources whom have drug information.
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1. Clinicians & Pharmacists
2. Poison Control Centers 3. Pharmaceutical Sales Representatives |
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What was the first legislation to regulate drug safety?
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The Food, Drug, and Cosmetic Act of 1938.
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What set rules for the manufacture and distribution of drugs considered to have potential for abuse?
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The Controlled Substances Act. Passed in 1970.
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