200 QUESTIONS AND CORRECT DETAILED ANSWERS |
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Pure Food and Drug Act (1906) - ANSWER: Forbade the manufacture, sale, and
transportation of adulterated or mislabeled foods and drugs.
Shirley Amendment of 1912 - ANSWER: Prevented fraudulent therapeutic claims by
drug manufacturers
Harrison Act of 1914 - ANSWER: Established the word narcotic and required the use
of a stamp on narcotic drug containers. Also regulated the importation,
manufacture, sale, and use of opium, codeine, and their derivatives
Food, Drug, and Cosmetic Act of 1938 - ANSWER: A New drug could not be marketed
until proven safe, tested for toxicity, and required adverse drug effects to be
reported.
Durham-Humphrey Amendment (1951) - ANSWER: Replaced Laws of 1938. Required
designation of whether or not the drug was prescription or OTC
Schedule I - ANSWER: This type of drug has no accepted medical use in the United
States and has a high potential for abuse
Schedule II drugs - ANSWER: Accepted for medical use but with severe restrictions
(high potential for abuse)
Schedule III drugs - ANSWER: Have low potential for abuse with an accepted medical
use. Perscription only
Schedule IV - ANSWER: Abuse potential exists, but less than Sch III. Examples are:
Ambien, Darvocet and Lorazepam.
Schedule V drugs - ANSWER: Lowest potential for abuse. May be sold OTC to people
that show ID
Kefauver-Harris Amendment (1962) - ANSWER: Requires proof of safety and efficacy
of a drug for approval before marketing
Controlled Substances Act (1970) - ANSWER: Replaced all laws passed prior to it
concerning drug control. 5 drug schedules put in place based on potential for abuse.
Poison Prevention Packaging Act (1970) - ANSWER: Implemented child resistant
packaging
Drug Listing Act of 1972 - ANSWER: drugs must have a National Drug Code number.
, Drug Regulation and Reform Act of 1978 - ANSWER: Quicker development and
distribution of new drugs
Orphan Drug Act of 1983 - ANSWER: Established funding for research of rare chronic
illnesses for new and old drugs.
Drug Price Competition and Patent Term Restoration Act of 1984 - ANSWER: Eased
requirements for marketing generic drugs
Omnibus Budget Reconciliation Act (OBRA 1990) - ANSWER: Mandated that OTC
drugs be documented
Anabolic Steroid Control Act of 1990 - ANSWER: placed all into category III drugs
(CSA)
Prescription Drug Amendments of 1992 - ANSWER: Allowed rapid approval of drugs
for life-threatening diseases
Food and Drug Administration Modernization Act of 1997 - ANSWER: Allowed rapid
approval of drugs by the FDA
Pharmacokinesis - ANSWER: the movement of drugs through the body via
absorbtion, distribution, metabolism, and excretion
drug blood level - ANSWER: amount of a drug present in the blood
plasma binding - ANSWER: when proteins bind to drugs and decrease the amount of
free-flowing drug in the bloodstream allowing the drug to stay in the body for
longer.
Examples of Sulfonamides - ANSWER: Sulfamethoxazole, sulfisoxazole, sulfadiazine
Uses for Sulfonamides - ANSWER: Treating UTIs, Ulcerative colitis, 2nd and 3rd
degree burns
Drugs that interact with Sulfonamides - ANSWER: Oral anticoagulants, methotrexate,
and hydantoins
What are the 4 groups of penicillin? - ANSWER: Natural penicillins, penicillinase-
resistant penicillins, aminopenicillins, extended-spectrum penicillins
Uses for Penicillins - ANSWER: UTIs, Septicemia, Meningitis, Intra-Abdominal
infections, Sexually Transmitted Infections (syphilis), Pneumonia and other
respiratory infections