Law Reverse

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kyleannkelsey
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295706
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Law Reverse
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2015-02-13 13:25:15
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Law Reverse
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  1. -legislative: develops and passes laws
    -executive: executes, develops and implements and signs all laws(except in the case of overriden veto)-judicial: interprets laws
    3 types of law and their functions
  2. -statutory: enacted by legislative branch in agreement w/executive, broad framework
    e.g. FDA-administrative: administrative agencies oversee implementation of laws passed by legislature, detail-orientede.g. boards of pharmacy
    statutory vs administrative law
  3. -intentional
    -negligent
    -without fault
    3 components of tort law
  4. -r'ship btwn individual and society
    -punishment: fines and/or imprisonment
    -e.g. FDA
    criminal law
  5. -r'ships btwn individuals
    -punishment: fines
    civil law
  6. intent to harm
    what is a major requirement of criminal law (i.e. in order to charge someone with murder you need to establish this)?
  7. -ordered states to establish minimum standards for pharmacists to offer counseling to Medicaid pts
    -not complying with this --> loss of federal funding
    OBRA 90
  8. -failing to do or doing something that a reasonable/prudent person would or wouldn't do (TARP)
    negligence theory
  9. a wrongful act for which a civil action will lie, except one involving a breach of contract
    tort
  10. -contract law: agreement btwn >=2 people with regard to future performance and payment
    -tort law: wrongful act for which a civil action can be brought
    2 types of civil law
  11. -intentional: harming someone else on purpose
    -negligent: harming someone by behaving recklessly
    -strict liability: has "without fault" element
    3 types of tort law
  12. -duty
    -duty breached
    -damages
    -direct causation
    4 elements of negligence (must be met for lawsuit to be successful)
  13. -statutory/administrative laws: e.g. offer to counsel pts on rx's
    -professional standards: e.g. if pt is harmed by MTM, the pharmacist will be held to APhA's MTM standards
    duty
  14. -duties not carried out or carried out inappropriately
    -pharmacists have a duty to know/act on medication information even if it goes against the prescriber's wishes
    duty breached
  15. -whether breach of duty caused substantial harm (physical, emotional/psychological or "pain and suffering")
    -awarded damages: compensatory or punitive (compensation + fine)
    damages
  16. -whether pharmacist directly caused damage
    -pharmacists have a duty to know/act on medication information even if it goes against the prescriber's wishes
    duty breached
  17. -per se: by or of itself, instrinsically
    -intentional violation of law that results in pt injury-automatically proves duty and duty breached
    -no professional liability insurance coverage negligence per se (statutory negligence)
    Negligence per se
  18. -assigns some blame to plaintiff b/c they contributed to negligence
    contributory negligence
  19. -jury awards a percentage of blame to plaintiff and defendent
    comparative negligence (fault)
  20. -superior is responsible for actions of employees under their supervision
    -essential to have policies/training in place to prevent law violations
    respondeat superior
  21. -traditional: right dose, drug and patient according to Rx order
    -expanded: judgmental responsibilities added (not dispensing inappropriate meds) and counseling
    traditional vs expanded pharmacist responsibilities
  22. T (mechanical errors)
    T/F: Most negligence claims due to wrong strength of drug dispensed
  23. -speculative: loss or gain is a choice, not insurable (e.g. gambling)
    -pure: can only experience loss, is out of one's control, is insurable
    speculative vs pure risk
  24. -risk management: avoiding lawsuits (includes risk avoidance, absorption, transfer and prevention)
    -assessment: benefits vs risks of prescribing upon reviewing Rx's
    risk management vs risk assessment
  25. -avoiding activity that exposes you to liability
    -e.g. not compounding opthalmic products in non-sterile environment
    risk avoidance
  26. -risk is recognized but nothing is done to reduce potential losses
    -done when potential loss is small or if insurance cost is too high
    risk absorption
  27. -shifting risk to 3rd party (e.g. insurance)
    risk transfer
  28. -includes: directions for use, side effects, DDIs, excessive dosages and contraindications
    -limitations: unforseeability
    duty to warn
  29. -addiction
    -excessive refills-common/dangerous side effects
    -therapeutic duplications
    -drug
    -disease contraindications-allergies
    duty to detect potential problems
  30. -assessment: information on whether or not pt should use a drug (major risks, what medication is used for)
    -management: information on correct use of drugs in order to minimize side effects and maximize efficacy
    risk assessment counseling vs risk management counseling
  31. -occurrence: best type of insurance, covers any incident that happens while policy is effective regardless of when lawsuit is filed (insurer assumes perpetual liability)
    -claims-made: doesn't have to be in effect when incident occurs but does when claim is filed (no current policy=no protection)
    occurrence vs claims-made policy
  32. -insurance can settle without admitting fault rather than go to trial
    "right to settle" clause
  33. -response to "The Jungle"
    -purpose: preventing manufacture, sale or transportation of adulterated/misbranded food and drugs
    -requirements: food and drugs can't be contaminated or misbranded
    1906 Pure Food and Drug Act
  34. -controlled sale of opium, morphine and codeine
    -created narcotics black market and required people/facilities distributing them to register and follow recordkeeping standards
  35. 914 Harrison Narcotic Act
  36. -diethylene glycol caused deaths but couldn't legally remove it from market for being unsafe
    -was removed because of misbranding (called "elixir" but contained no alcohol)
    1937 Sulfanilamide elixir tragedy
  37. -response to sulfanilamide incident
    -required: proof of safety for drugs and directions for use on label
    -not required: proof of efficacy-exception: pre
    -1938 drugs didn't have to prove safety (e.g. phenazopyridine)
    1938 Food, Drug and Cosmetic Act
  38. -established non-legend (OTC) and legend (Rx) drugs
    -prohibited refills w/out prescriber consent and authorized pharmacists to refill with consent
    -established minimum information required on prescription label
    -allowed pharmacists to accept oral orders from prescriber
    1951 Durham-Humphrey Amendment
  39. -caused phocomelia
    1961 Thalidomide disaster
  40. -amendment to FDA
    -required drugs to be safe and effective
    -established good manufacturing practices
    -human testing (not pre-1938 drugs)
    1962 Kefauver-Harris Amendment
  41. -classifications for drugs of abuse (e.g. narcotics, non-narcotics)
    -beginning of scheduled drugs
    1965 Drug Abuse Control Amendments
  42. -created DEA
    -created closed system to control manufacture, distribution, prescribing and dispensing of controlled drugs
    1970 Comprehensive Drug Abuse Prevention and Control Act
  43. -created ANDA for multisource/generic drugs
    -allowed marketing of generics w/out conducting safety/efficacy studies but required GMP and proof of bioequivalence
    984 Drug Price Competition and Patent-term Restoration Act
  44. -amendment to FDA
    -addressed diversion of samples, drug coupons, exported drugs, wholesale distribution and drugs purchased by hospitals
    1987 Prescription Drug Marketing Act
  45. -applies to anyone who tests materials derived from human body
    -established quality-control standards-e.g. need CLIA waiver to stick pt's finger for glucose test but not if pt sticks own finger
    1988 Clinical Laboratory Improvement Amendment
  46. -required pt profiles for Medicaid recipients, DUR and offer to counsel for Medicaid pts
    1990 Omnibus Budget Reconciliation Act
  47. -dietary supps regulated but not evaluated by FDA
    -dietary supps not considered drugs-allows structure/function claims but not health claims
    1994 Dietary Supplement, Health and Education Act
  48. -regulates how protected health information must be stored and when/ to whom it can be released
    -regulates transmission of health information by workers
    1996 Health Insurance Portability and Accountability Act
  49. -amendment to FDA
    -replaced "Caution: federal law prohibits dispensing without prescription" with "Rx only"
    -clarified compounding guidelines
    -eliminated "this drug may be habit forming" from Rx narcotics/hypnotics
    1997 Food and Drug Modernization Act
  50. -distinguishes btwn traditional pharmacy compounding and large
    -scale operations (can register w/FDA as outsourcing facilities
    - similar to manufacturers)
    -created track-and-trace pathway
    2013 Drug Quality and Security Act
  51. -INDA: approval to start Phase I, II, III studies
    -NDA: drug is available for general use
    -ANDA: needed to market generics if patent runs out on brand
    -SNDA: switches drug from Rx to OTC
    INDA/NDA/ANDA/SNDA
  52. F (NDA, ANDA or SNDA)
    T/F: A drug with an INDA can be distributed, promoted, prescribed or dispensed
  53. 1. label on drug container
    2. package insert
    3. PPI or MedGuide**only required for some drugs (OCPs, etc) required legend drug labeling for
    manufacturers, packagers and distributors
  54. F (NDC used for identification)
    T/F: An NDC # on the label means a drug has an approved NDA
  55. Gotcha! Neither
    selling an OTC product without a lot # or expiration date is: adulteration or misbranding?
  56. anyone working on behalf of the registrant
    which pharmacy workers can order schedule III, IV or V drugs?
  57. -initially: whoever signed the initial/renewel application
    -via power of attorney: people designated by initial person
    which pharmacy workers can order schedule II drugs?
  58. II
    form 222 is used to order schedule: II, III, IV or V drugs?
  59. -form 222
    -form 222a
    f someone is granted power of attorney on behalf of a pharmacy's DEA registrant, which forms can they sign?
  60. -original: tan, sent to and kept by supplier
    -duplicate: green, sent to supplier and then DEA by end of the month
    -3rd copy: blue, retained to record # and date of packages received for each item
    3 components of triplicate form
  61. F (neither)
    T/F: Nebraska law requires a signature or initials on the blue copy of the triplicate form
  62. 60
    the triplicate form is valid for ___ days after it was signed
  63. -products manufactured domestically and exported can only be reimported by original manufacturer
    • -prohibits buying Rx drugs from other countries
    • -exceptions for 90 DS of drug for personal use
    • 1. drug not approved in US and treats serious condition
    • 2. drug won't be commercially distributed by importer
    • 3. drug isn't considered risky
    • 4. proof that drug is for tx of condition
    • Drug Diversion Act
  64. -stops counterfeit, diverted or stolen Rx drugs from entering supply chain
    -requires verification of suspicious products -tracing information for 6 years-ok to transfer drugs btwn hospitals/pharmacies when wholesaler is out of stock (need invoices)-<=5% of revenue ($) can be transfers
    Drug Supply Chain Security Act
  65. hospitals can fill patients' drugs for lower prices than community pharmacies b/c of lower contract prices
    "own use" doctrine
  66. -starter pack: 3-4 DS that pts can use while pharmacy is ordering new drug
    -drug sample: states "sample, not for sale", requested by prescriber and sent to prescriber or hospital pharmacy only
    starter pack vs drug sample
  67. F (prescriber or hospital pharmacy only)
    T/F: Drug samples can be sent directly to community pharmacies with prescriber authorization
  68. -manufacturing: not part of traditional pharmacy practice b/c is not done under a specific Rx for a specific patient
    -compounding: for a specific Rx or for teaching (i.e. not dispensing) purposes
    manufacturing vs compounding
  69. -defines 503(b) pharmacies as outsourcing facilities where products are compounded in large quantities w/out individual Rx's
    -503(b) pharmacies must register w/FDA-distinct from traditional 503(a) pharmacies
    Drug Quality and Security Act (Compounding Quality Act)

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