PHRD5045 Pharm Law - Ch. 8 (Final Exam)

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daynuhmay
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252784
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PHRD5045 Pharm Law - Ch. 8 (Final Exam)
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2013-12-12 07:02:59
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pharmacy law
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pharmacy law
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  1. purposes of malpractice law (2)
    • 1) compensate the victim
    • 2) deter careless/irresponsible acts
  2. an unintentional act through inattentiveness or carelessness that causes harm
    negligence or malpractice
  3. 4 elements of negligence
    • 1) duty
    • 2) breach of duty
    • 3) causation
    • 4) damages
  4. types of negligence (3)
    • 1) ordinary negligence
    • 2) gross negligence
    • 3) criminal negligence
  5. plaintiff's challenge in malpractice case
    • prove all 4 elements of negligence
    • disprove affirmative defenses
  6. defendant's challenge in malpractice case
    • disprove any one if not all the 4 elements of negligence
    • prove the affirmative defenses
  7. an objective reasonable standard for requiring that degree of care that a reasonable prudent pharmacist would use under similar circumstances
    duty for pharmacists
  8. standard pharmacists held to for mechanical type acts
    error-free standard
  9. important determinant of duty
    relationship of defendant and plaintiff
  10. for the pharmacist to be liable (with respect to duty), what must be the case?
    the harm must be foreseeable
  11. degree of prudence and caution required of an individual who is under a duty of care
    standard of care
  12. what determines the level of negligence required to state a valid cause of action?
    standard of care
  13. a non-judgemental error in filling (misfilling) a prescription
    breach of duty
  14. virtually sufficient for presumption of negligence
    evidence of a misfilling
  15. doctrine of negligence per se
    if a pharmacist violates a statute or regulation, the violation in itself could establish negligence bc the statute is standard of care
  16. most common reason for wrong drug error by pharmacists
    misunderstanding between the prescriber and pharmacist
  17. plaintiff must prove defendant's negligent conduct was a substantial factor in the harm caused
    actual cause
  18. liability with the party whose misconduct most directly caused the damages; usually based upon a determination of foreseeability
    proximate cause
  19. requirement for the defendant to be liable for harm to the plaintiff
    each of the links in the chain of causation must be foreseeable to the defendant
  20. compensatory/expectation damages
    actual damages
  21. Eggshell rule
    must accept patient as he/she is (not treat like a "normal" patient)
  22. punitive damages
    exemplary/non-compensatory
  23. common law rule completely barred plaintiff's recovery if the plaintiff could have avoided the consequences of the defendant's negligence by ordinary care
    contributory negligence
  24. statutory, requiring court to base judgement award on relative negligence of each party; compensation based on % culpable
    "pure" comparative negligence
  25. plaintiff is permitted to recover whatever percentage of the damages corresponds with the defendant's percentage of fault, provided that the plaintiff is less than 50% at fault
    "modified" comparative negligence
  26. defers the statute of limitations until the plaintiff actually discovers what caused the injury
    discovery rule
  27. employer is responsible for the negligent act of employees even if the employer is not negligent himself or even present
    *subdoctrine of Respondeat Superior
    Vicarious Liability
  28. when pharmacist duties are expanded to include the duty to monitor and intervene (3)
    • 1) relationship between pharmacist and pt should expand duty
    • 2) harm to pt is reasonably foreseeable¬†
    • 3) public policy concerns (eg: inc. health care costs)
  29. 2 other theories of pharmacist liability
    • 1) implied warranty
    • 2) warranty of fitness (relying on seller's expertise)
  30. the risk of ________ requires companies to develop continuous quality improvement programs and use them correctly.
    corporate negligence
  31. type of liability that focuses on the conduct of the pharmacist as the factor in why a drug product was not safe
    professional liability
  32. type of liability that focuses on the product itself
    • drug product liability
    • *drug not liable if not defective
  33. grounds for product liability actions (3)
    • 1) negligence
    • 2) breach of implied warranty/warranty of merchantability
    • 3) strict liability
  34. liability without fault
    • strict liability
    • *action of choice by plaintiffs
  35. what comes under scrutiny in relation to strict product liability
    adequacy of marketing, directions, and warnings for a drug
  36. adequacy is determined by (2)
    • 1) reasonably balanced perspective of hazards, safety, effectiveness are provided
    • 2) warning is timely
  37. if a risk is known, who does the manufacturer owe the duty to directly warn?
    • the prescriber
    • NOT the patient
  38. Learned Intermediary Doctrine
    plaintiff has no action against manufacturer if physician received an adequate warning (even if they didn't provide it to the pt)
  39. may erode learned intermediary doctrine
    DTC (direct to consumer) advertising - manufacturers marketing directly to consumers can allow physicians to drop out of the loop
  40. what does SL (Strict Liability) apply to?
    products, NOT services
  41. conclusion of pharmacist if a product is "not defective" from the manufacturer
    pharmacist could not make the drug defective by dispensing it in the usual manner

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