PHRD5045 Pharmacy Law - CO State Board of Pharmacy Rules (Exam #2)

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daynuhmay
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241327
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PHRD5045 Pharmacy Law - CO State Board of Pharmacy Rules (Exam #2)
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2013-10-18 01:53:38
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CO State Board Pharmacy Rules
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CO State Board of Pharmacy Rules
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  1. must report to SBOP pattern of misconduct in pharmacy practice if...
    danger to health, safety, or welfare of a pt or the public
  2. who can take oral orders
    • pharmacist
    • intern
  3. must be included during order clarification/change
    • intials
    • date
    • person conveying change
  4. how long refill info must be kept for
    2 years
  5. characteristics of refill info kept in pharmacy
    • 1) on back of Rx order or daily computer printout
    • 2) entry by tech if no interpretation
    • 3) date & qty (if changed)
    • 4) person authorizing refill
    • 5) pharmacist's name/initials/license # or secure electronic ID
  6. Rx transfer is NOT allowed between...
    • 2 interns
    • (needs at least 1 pharmacist)
  7. ETO
    • electronic transfer orders
    • by techs between 2 compatible systems if no changes made
  8. according to CO SBOP, how many times can CS II be transferred?
    NONE
  9. according to CO SBOP, how many times can CS III-V be transferred?
    • 1 time 
    • (unless shared, real-time online database -> transfer to max refills permitted)
  10. what a pharmacist must do when transferring an Rx
    • write "void" on original Rx
    • on back of voided Rx: name, name of receiving pharmacist/intern, name, address, phone# (DEA# if CS) of receiving PDO
  11. what a pharmacist must do when receiving a transferred Rx
    • on transferred Rx, write "transfer"
    • issue/dispensing date of original Rx
    • # refills authorized/remaining
    • date of last refill, Rx# of original Rx
    • name of transferring pharmacist/intern, address, phone #, (DEA#) of transferring PDO
  12. required for initial interpretation and final evaluation (3)
    • 1) pharmacist's name
    • 2) initials
    • 3) license #/secure electronic ID
  13. review of order, order entry, & drug regimen
    initial interpretation
  14. included in drug regimen review (8)
    • 1) known allergies
    • 2) rational tx & contraindications
    • 3) reasonable dose, duration
    • 4) reasonable use directions
    • 5) ADEs, interactions
    • 6) therapeutic duplication
    • 7) proper utilization & optimum outcomes
    • 8) abuse/misuse
  15. final evaluation
    • medication properly prepared, in suitable container, w/ proper label
    • drug regimen review if refill
  16. def'n of a legitimate doctor-patient relationship
    • pt has a medical complaint
    • med hx taken
    • physical exam performed
    • logical connection between complaint, hx, exam, & prescribed drug
  17. when CAN drugs be returned for redispensing? (3)
    • 1) unit dose packaging
    • 2) Med Packs
    • 3) return to stock (original container & label)
  18. ONLY exceptions for when pharmacies can accept returned CS from patients (2)
    • 1) recall
    • 2) dispensing error
  19. info req'd in written/printed record of return to stock meds (5)
    • 1) Rx number
    • 2) drug name/strength
    • 3) qty returned to stock
    • 4) date of return
    • 5) location filled
  20. Why would a non-resident PDO be required to register with SBOP?
    if shipping, mailing, or delivering Rx drugs/devices into CO
  21. how many pharmacies are allowed in the same physical space
    ONE (1)
  22. identified as "transfer of ownership of PDO" (2)
    • 1) sale of 20% of shares/ownership interest
    • 2) incorporation of an existed PDO
  23. requirement if PDO is relocating
    apply to SBOP at least 30 days prior to relocation
  24. when CS inventory must be done upon pharmacy manager change
    72 hours
  25. who must perform CS inventory
    pharmacy manager/designee
  26. requird pharmacy business hours
    2 days per week, 4 continuous hours per day
  27. must submit hours to SBOP in writing if open less than __ hours per week.
    32 hours
  28. must be included in PDO professional reference library (5)
    • 1) CO PPA
    • 2) CO CSA
    • 3) SBOP Rules
    • 4) DEA CS rules (21 CFR)
    • 5) sterile/cytotoxic compounding references
  29. characteristics of PDO compounding/dispensing area (3)
    • 1) same location as satellite
    • 2) sink has hot/cold water, drain, vent
    • 3) all necessary equipment for compounding/dispensing
  30. 4 characteristics of room within compounding room (if there is one)
    • 1) documentation submitted to SBOP before using for dispensing/compounding/Rx storage
    • 2) sign on door of SBOP approval
    • 3) unlockable door (unless CS storage)
    • 4) SBOP access during business hours
  31. 2 characteristics of dispensing area
    • 1) only pharmacist can lock/unlock
    • 2) floor to ceiling physical barrier
  32. what must occur if the sole pharmacist leaves one PDO to enter another PDO in the same building
    • 1st PDO must be locked/enclosed by barrier 
    • no non-pharmacist may remain inside
  33. time in which a written report of a security breach must be submitted
    10 days
  34. CDTM
    • Collaborative Drug Therapy Management
    • pharmacist review & evaluation of drug therapy to provide, monitor, & modify drug therapy
    • also known as MTM
  35. MTM
    • Medication Therapy Management
    • also known as CDTM
  36. CDTM is pursuant to...
    physician diagnosis, order, & written agreement
  37. specific written plan for course of medical treatment
    protocol
  38. when are protocols insufficient?
    • when they are:
    • vague
    • nonspecific
    • rely on pharmacist discretion without definition
  39. required for a CDTM protocol (3)
    • 1) instructions for responding to acute allergic rxns & ADRs
    • 2) consistent w/ evidence-based medicine
    • 3) signed & dated by authorizing physician
  40. sets forth information required to assure competent practice of pharmacy in an integrated health care fashion
    • written agreement between a licensed CO pharmacist and licensed CO physician
    • signed & dated
    • reviewed annually
  41. responsible for Rx delivery/storage outside pharmacy at pt's request
    pharmacy manager
  42. time in which pharmacist must notify SBOP in writing when any legal proceeding begins AND ends
    30 days
  43. 3 facilities PDOs or hospital other outlets may provide emergency kits of drugs to
    • 1) LTCF
    • 2) hospices
    • 3) home health agencies (HHA)
  44. who is responsible for accuracy of contents of kit
    pharmacy manager
  45. characteristics of emergency kits in LTCF & in-patient hospices (4)
    • 1) contents determined by medical director & consulting pharmacist
    • 2) drugs in kits limited
    • 3) 30 doses of any drug dosage form/strength
    • 4) oral dosage forms permitted
  46. LTCF/in-patient hospice emergency kit drug limits
    • up to 60 drugs
    • 12 may be CS
  47. characteristics of HHA/outpatient hospices (4)
    • 1) contents determined by director of nursing & pharmacist
    • 2) drugs in kits limited
    • 3) 30 doses of any drug dosage form or strength
    • 4) NO oral dosage forms (only injectables)
  48. HHA/outpatient hospice emergency kit drug limits
    • up to 60 drugs
    • NO CS
  49. how long Rx drug records must be kept for (& readily available to SBOP)
    2 years
  50. how Rx orders are organized
    numerical sequence
  51. must be immediately available to SBOP (6)
    • 1) excuted DEA-222 forms
    • 2) CS inventories, dispensing, receipt records
    • 3) Rx drug orders
    • 4) Rx & CS drug distribution, loss, surrender, disposal records
    • 5) pharmacist/intern employee list
    • 6) manufacturer, distributor, repackager - list of symbols & codes
  52. CS inventory must record (4)
    • 1) name
    • 2) strength/dosage form
    • 3) # units/volume
    • 4) outdated CS
  53. Rx information METHOD A
    • computer system must produce daily printout q24h
    • new Rx's differentiated from refills
    • CS diff from non-CS
    • identity of final pharmacist
  54. in event of computer malfunction/failure...
    • must be manual procedure for CS documentation
    • manual data must be restored into computer sytem w/in 7 days
  55. Rx information METHOD B
    • online Rx info retrievel (2 years)
    • daily (q24h) backup
    • printable at request
  56. if using documentation Method B, at inspectors request, PDO must...
    • print Rx orders w/in 2 hrs, sorted by variables (w/in 72hr)
    • OR
    • provide computer for review of Rx orders
  57. requirements for pharmacist or intern to administer vaccines (2)
    • 1) ACPE course - 12hrs didactic, 8 hrs live training
    • 2) CPR course
  58. how long immunization records must be kept for/provided at SBOP request
    THREE (3) years
  59. amount allowed to be compounded at in advance
    • 90 day supply
    • (based on 6 months history)
  60. compounded drug labeling within hospitals as floor stock includes (3):
    • 1) beyond-use date
    • 2) batch (lot) number
    • 3) "this product was compounded by the pharmacy"
  61. when formulation/compounding records DON'T have to be kept
    when compounded per the manufacturer's labeling instructions

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