drug lit approval process & misadventures

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drug lit approval process & misadventures
2012-12-10 15:11:01
drug lit approval process

drug lit approval process
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  1. 1906 pure food and drug act
    food processing, mislabeling
  2. 1912 sherley amendment
    strength and purity
  3. 1914 harison narcotic act
    recreational drug use
  4. 1931 FDA
  5. 1938 food drug and cosmetics act
  6. 1952 durham-humpphrey amendment
    divided prescription and nonprescription. refills, legend drugs
  7. 1962 kefauven-harris amendment
    efficacy, needs NDA approval (safe & effective)
  8. 5 functions of the FDA
    • 1. approval of drugs
    • 2. bioequivalence standards
    • 3. prescription drug labeling and advertising
    • 4. CGMP
    • 5. drug health¬† fraud
  9. body of rights, obligations, and remedies to provide relief from suffered harm
    tort law
  10. inflicter
  11. sufferer in a case
  12. 3 aspects of tort law
    • defendant had legal duty
    • defendant breached the duty
    • damages were caused by breach
  13. liability based on relative negligence
  14. liability base on wrongful acts by more than one person acting independently that caused the same injury
  15. liability of imputation upon one person for the acts of another
    deep pockets
  16. liability where the employer is responsible for the negligent acts of its employees
    respondeat superior
  17. sharing of liability among a group of people
    joint and severally liable
  18. 4 D's of negligence
    • duty breached
    • damages/injury
    • direct causation
    • defenses absent
  19. liability based on the character of the product
    prove injury from a defective and unreasonalby dangerous product
    strict liability
  20. what type of law is breach of warranty
  21. risk unique to the drug
  22. risk created by the drug in comvination with some extrinsic factor (interactions)
  23. judgement that occurs before prescribing
    risk assesment
  24. judgement that occurs after prescribing
    risk management
  25. who is becoming the "learned intermediary" and what does it mean
    • pharmacist
    • duty to communicate manufacturers' warnings
  26. 2 medication guides
    • FDA approved patient labeling
    • primarily for outpatient Rx products with serious and significant public health concerns
  27. "duty to warn"
    warn of all relevant side effects
  28. 5 things for OBRA counseling
    • name and decription of medication
    • dosage from and route of administration
    • dosage
    • duration of drug therapy
    • special directions for use
  29. injury that occurs with normal doses
  30. a big problem in misadventures
    lack of reporting
  31. 3 types of misadventure identifications
    • chart review
    • indicator drugs
    • technology
  32. what are most medication errors caused by
    the system not the individual
  33. 5 "rights"
    • drug
    • dose
    • patient
    • route
    • time