pharm ch. 2 drug leg

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darbydo88
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90692
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pharm ch. 2 drug leg
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2011-06-15 17:30:45
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exam I
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  1. Gives the drug its chemical and biologic properties
    chemical structure
  2. Drug nomenclature
    • chemical name
    • generic name
    • trade/brand name
  3. INDA
    Investigational New Drug Application
  4. What does the FDA do?
    Watches over the drug making process
  5. 4 phases of human studies
    • -informed concent
    • phase I
    • Phase II
    • phase III
    • phase IV
  6. Involves explanation of purpose of study
    explains procedures
    explains risks
    Informed concent (signed before study starts)
  7. Small number of healthy volunteers
    determines opitmal dosage, pharmocokinetics, several tests-blood samples
    lasts 5-7 years
    Phase I
  8. Small # of volunteers with disease or condition Determines the drugs effectiveness and side effects
    lasts 5-7 years
    phase II
  9. large number of patients with disease or condition at a medical research center
    Determine infrequent rare side effects
    look for risks of drug
    dosage, range, saftey, effectiveness
    phase III
  10. Used to compare new drug with already existing medication in that class
    post marketing study to evaluate the saftey effects of currently used drugs
    Phase IV (optional)
  11. NDA
    New drug application
  12. NDC
    New drug code (trade/brand name)
  13. how long does a new drug have a patent?
    17 years
  14. What two criteria in order to be generically equivalent?
    • Theraputically equivalent
    • pharmacudecally equivalent
  15. Drug that has identical amounts of the same active chemical ingredients in the same dosage form that has the same STRENGTH, QUALITY, and PURITY
    Pharmacudecally equivalent
  16. When a drug administered in the same amount provides the same theraputic effect-inluding duration and intensity
    Theraputically equivalent
  17. Drug organization into two groups
    • Theraputic classification
    • pharmacological classification
  18. Cateogorized by theraputic usefulness
    Theraputic classificaiton: Anti-hypertensive, Anti-hyperlipidemic
  19. characterized by how the drug works
    • pharmacological classification:
    • diuretics and vasodialators
  20. Used to compare and evaluate drug response among diff drugs that are similar
    dose-response curve
  21. used to determine frequency of administration of medication in order to maintain an effective drug response
    time-response curve
  22. *The first US law passed to protect the public from adulterated or mislabeled drugs
    required that drugs meet standards of strength and purity
    required that the type and amount of narcotic be listed on the label
    Pure Food and drug Act (1906)
  23. Prohibited the use fo fraudulent therapeutic clamims by drug companies
    Sherley Amendment (1912)
  24. Aimed at curing drug addiction or dependence
    established the word "narcotic"
    proved that narcotic drugs produced physical or psychological dependence
    Harrison Narcotic Act (1914)
  25. *designated the United states pharmacopeia (USP) and the National formulary as official standards and empowered the federal governament to enforce them
    Pure Food and Drug Act (1906)
  26. stated that drug products that entered the market needed to be properly tested for safety
    required that drug lables and literature by complete and accurate, stating the dose, manufacturer's name and address, lists and amounts of potentialy harmful ingredients, a warning if the drug might be habit-forming, directions for use, and contraindications
    Food, Drug, and cosmetic Act (1938)
  27. designed the "birth of the legend"
    stated that prescriptions for narcotics, hypnotics, habit-forming drugs, and harmful drugs could be refilled only iwht a new prescription, and required tah tthe label state this fact. Specified how prescription drugs and refills could be ordered and dispensed.
    Durham-Humphrey Amendment
  28. required that drug products must be effective before entering the market.
    Kefauver-Harris Amendment (1962)
  29. designed to improve the administration adn regulation of the manufacturing, distribution,a dn dispensing of controlled substances by legitimate handlers of these drugs to help reduce their widespread dispersioninto illicit markets.
    this act grouped controlled substances into five categories based on a drug's potential for abuse and medical effectiveness
    It limited the number of perscription refills for controlled substances (5)
    Controlled Substance Act (1970)
  30. This administration was created to watch over the controlled Substance Act of 1970
    DEA Drug enforcement Administration (1973)
  31. Provided grants to research compainies to develop new drugs for diseases or conditions that were rare
    Orphan Drug Act (1983)
  32. Controlled Substances are divided into what categories
    Schedule I-Schedule V
  33. Drugs in Schedule I
    • Heroin
    • LSD
    • Marijuana
  34. Drugs in schedule II
    • amphetamines
    • meperidine
    • Pentobarbital
    • Percodan
    • Ritalin
    • Mepergan Fortis
    • Morphine
    • Codeine
  35. Schedule III drugs
    • Fiorinal
    • Tylenol with Codeine
    • Empirin with Codeine
    • Vicodin
    • Marinol
  36. Schedule IV drugs
    • Dalmane
    • Librium
    • Valium
    • Xanax
  37. Schedule V drugs
    • Lomotil
    • Robitussin AC
  38. a number given to a physican or place that has narcotics
    DEA number
  39. Drugs are divided into 2 categories
    • Non-prescription Medications (OTC's)
    • Prescription Meds
  40. Legend Drugs
    perscription drugs that are not addictive
  41. What catedgory are legend drugs and Controlled substances (schedule I-V)
    Prescription Meds
  42. how can you get a prescription
    • doctor call
    • doctor note
    • doctor fax
  43. What is a precription
    a legal document that provides the med the strength, quantity, directions, doc info, and refill info.

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