The Drug Approval Process Ch 6
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Created by:
nmtbyjessika on September 28, 2011
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15 terms
Terms | Definitions |
|---|---|
American Hospital Formulary service (AHFS) Drug Information | published yearly by the American Society of Health-systems Pharmacists in Bethesda, MD. |
brand (trade) name | is controlled by business firms as a registered trade mark, Tylenol is a brand name for acetaminophen. |
chemical name | the name by which a chemist knows the drug; describes the constituents of the drug precisely |
controlled substances | drugs that produce tolerance and dependence and have potential for abuse or addiction |
Drug Enforcement Administration (DEA) | Enforces U.S. controlled substances laws and regulations. Also brings to the U.S. criminal system organizations involved in the growing, manufacture, and/or distribution of controlled substances to be trafficked in the United States. |
Drug Facts and Comparisons (F&C) | contains information on almost all drugs marketed in the US; drugs actions, indications, warnings and precautions, dosage and route for administration, adverse reactions, client information, overdosage, drug interactions, contraindications and comparisons charts and tables. |
generic name | The name given to a drug by the United States Adopted Names Council. Also called the nonproprietary name. The generic name is much shorter and simpler than the chemical name and is not protected by trademark. |
malfeasance | Giving the correct drug but by the wrong route that results in the clts death |
misfeasance | Negligence; giving the wrong drug or drug dose that results in the clts death |
nonfeasance | Omission; omitting a drug dose that results in the clts death. |
Physicians Desk Reference (PDR) | lists several thousand drugs with complete drug information given by pharmaceutic companies. |
pharmacology | is the study of the effects of chemical substances on living tissues. |
United States Pharmacopeia - Drug Information (USP-DI) | a three-volume set that is available in most hospitals and pharmacies. |
United States Pharmacopeia National Formulary (USP-NF) | the current three-volume authoritative source for drug standards is an annual publication with two supplements |
U.S. Food and Drug Administration (FDA) | Establishes standards that require drug companies to provide consumers with specific drug information |
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