law final

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  1. active pharmacy practice
    pharmacist minimum of 400 hours per calendar year
  2. readily retrievable
    produced within 48 hours
  3. when is a COA not required for compounding
    if active ingredient is USP or NF
  4. what must be on the COA
    • Product name
    • Lot number
    • Expiration date
    • Assay
  5. what must be counseled on for compounded products
    • proper storage
    • use
    • shelf life
  6. rules regarding samples of compounded products
    • can't provide to practitioners
    • may sell to
    •   MD
    •   Instituitions
    • not to retail pharmacies
  7. DEA form 41
    destruction of CS
  8. DEA form 106
    lost or stolen CS
  9. DEA form 222
    CS II order form
  10. DEA form 224
    Pharmacy CS registration
  11. when must inventory of ALL controlled substances be done
    first 7 days of May each year
  12. CII inventory regulations
    • must be perpetual
    • reconciled at least once a quarter
    • discrepancies >5% reported to BOP w/I 10 days
  13. rules on inventories of ALL CS
    • opening or close of business in inventory date
    • forward a copy of the inventory to BOP
    •   name of pharmacy
    •   date and time
    •   signature of responsible persons
  14. who is a practitioner
    • physician
    • dentist
    • veterinarian
    • podiatrist
    • scientific investigator
    • pharmacy
    • hospital
    • instituition
  15. what shall be included in a patient profile record
    • full name
    • address and telephone #
    • DOB & gender
    • Rx drug orders at other pharmacies at least 2ys
    • pharmacist comments on therapy
    • medical history
    • allergies
    • drug reactions
    • other meds - OTC's
  16. rules on emergency when a MD can't be contacted
    • 72 hour supply of previously prescribed med
    • Cannot supply a controlled substance
  17. If a pt/practitioner relationship has ended (for reasons other than discharge) how long are refills honored for
    12 months
  18. who make up the board of pharmacy
    • 8 members
    • 7 voting members
    •   4 RPh
    •   1 MD
    •   1 dentist or vet
    •   1 public member
    • 1 pharm tech
  19. how long are the terms of BOP
    • 6 years, expires on march 1
    • max of 2 successive terms
  20. requirements for BOP members
    active practice for 5 years, US citizen, WY resident - for their prospective fields
  21. what happens if a vacancy occurs on the BOP
    • governor must appoint a replacement w/I 90 days
    • governor may remove any member
  22. how often does the BOP meet
    at least 3 times a year, one must be held in the month of June
  23. who make up the advisory board on drugs and substances control
    • director of Depy. of health or designee
    • BOP executive director
    • BOP senior inspector
  24. what must be recorded on CS samples received in WY
    • name and DEA number
    • address of manufacturer
    • name, address, DEA of registrant receiving
    • drug name, strength, quantity/package, # of packages (total quantity sent)
    • date of shipment
  25. requirements of the registrant upon receipt of CS samples
    • sign for
    • retain invoice
    • keep records of samples dispensed or administ.
    • sign or initial records of sample dispensed (bottom of each page)
    • make record available to BOP or DEA
    • class IV & V are exempted from these
  26. what is medication therapy management
    evaluating and rendering advice to the prescribing physician
  27. collaborative practice agreements - 5 points
    • cannot specify specific pharmacy
    • RPh must obtain written consent from Pt/agent
    • CPA must be reviewed/renewed annually
    • BOP must review prior to implementation
  28. who make up the CPA committee
    • 5 members
    •   2 RPh, at least 1 a member of BOP
    •   2 MD, at least 1 a member of BOM
    •   BOP executive director
  29. how many copies of a CPA must be sent to the BOP
  30. when is the decision of a CPA from the BOP sent to the MD & RPh
    within 10 days
  31. collaborative practice agreement shall include
    • names of physician and RPh
    • types of MTM decisions RPH can make
    • physician who monitors and intercedes
    • MD's ability to override when necessary
    • MD, RPh, pt (guardian) can cancel any time
    •   RPh retains cancellation for 2 yrs
    • MD & RPh signatures and dates
  32. CPA - MTM written order requirements (11)
    • pt name, gender, DOB, ht & wt
    • allergies
    • medical diagnosis
    • all current meds (OTC's & Rx)
    • pertinent lab values
    • MTM authorized including lab tests
    • method of communication between MD & RPh
    • frequency of MD follow up
    • date order will be renewed (annually)
    • signatures - MD, RPh, pt/agent
    • date
  33. who reviews pt's charts and how often in a long term care pharmacy service
    • consultant pharmacist
    • monthly
  34. what is a therapeutic substitution
    different class or within the same class
  35. what is a therapeutic equivalent
    generic equivalent
  36. who can be issued a permit for an emergency drug supply
    • nursing homes
    • hospices
    • extended care facilities
    • immediate care facilities
  37. what are the limits of drugs for an emergency drug supple
    • number of drugs = 48
    • number of doses of each drug = 30
  38. policy of an emergency drug supply is kept where and reviewed by whom
    • facility and pharmacy keep on file
    • reviewed by PIC of pharmacy and director of nursing
  39. how long do you have to report a discrepancy of an emergency drug supply to the BOP
    w/I 7 days of discovery
  40. who can a RPh administer immunizations to
    • healthy adults only (19 years of older)
    • high risk adults by Rx from a licensed MD
  41. what 10 immunizations can a RPh administer
    • Td
    • MMR
    • varicella
    • influenza
    • Pneumococcal (polysaccharide)
    • hep A
    • hep B
    • meningococcal
    • HPV
    • zoster
  42. what is required of a RPh to administer immunizations
    • APHA or WA training
    • CPR by APHA or Red Cross
    • 1 contact hour (0.1 CEU) annually
  43. what are the requirements for the immunization questionnaire and consent form
    • 2 copies provided to pt
    • keep on file for at least 6 years
  44. what must be recorded on the Rx of any generic drug dispensed
    NDC # or manufacturer number
  45. changes to a CII Rx a RPh is allowed to make after contacting the MD
    • drug strength
    • drug quantity
    • directions for use
    • dosage form
  46. changes to a CII Rx a RPH is allowed to make without contacting MD
    pt address with proper verification
  47. Changes to a CII Rx a RPh is not allowed to make
    • pt name
    • CS prescribed (except generic substitution)
    • date issued
    • MD signature
  48. 7 electronic Rx requirements
    • pharmacy must be licensed
    • transmitters phone number
    • date of transmission
    • ID of intended pharmacy
    • use of MD, digital or electronic signature
    • deem original RX and maintain for 2 yrs from date of last dispensing
    • equipment maintained to prevent unauthorized access
  49. 5 steps in transferring a Rx (non-controlled)
    • write void on face of original, or electronic Rx
    • name of transferring RPh or Intern
    • name of receiving RPh
    • telephone # of receiving pharmacy
    • date of transfer
  50. 7 requirements of transferring an electronic CS Rx. Transfer RPh must provide the following to receiving RPh
    • date of original dispensing
    • number of refill remaining
    • dates and locations previous fills
    • transferring pharmacy's name, address, DEA#
    • transferring pharmacy Rx # (each dispensing)
    • name of RPh transferring the Rx
    • name, address, DEA# & Rx# of pharmacy that originally filled the Rx if different
  51. readily retrievable info required for Rx refills
    • date filled
    • quantity
    • RPH initials
  52. readily retrievable info required for refilling CIII & CIV
    • date
    • quantity
    • name of RPh
    • dated by RPh
    • amount dispensed
  53. what must be recorded on the back of a partial fill Rx
    • date of partial fill
    • quantity dispensed
    • remaining quantity to be dispensed
    • ID of RPh
  54. for what reasons is a faxed CII accepted
    • compounded for direct administration by parenteral, IV, IM, SQ or intraspinal
    • resident of LTC facility
    • terminally ill pt (federal law: hospice PT) RPh must write "terminally ill"
  55. what must be on the Rx label of a CS
    caution: federal law prohibits the transfer of this drug to any person other than pt
  56. what is NOT required on a CS Rx label
    • drug name, strength, quantity
    • pharmacy telephone
    • RPh initials
  57. what is required on a unit dose or unit of issue product that is in addition to the normal Rx label requirements
    • manufacturer's lot number
    • manufacturer's expiration date or 12 months; whichever is sooner
  58. what 4 exceptions must be met in order for a dispensed Rx drug to be returned to a pharmacy. ALL 4 must be met
    • Rx drugs were maintained under control of persons licensed to administer drugs
    • can only be returned to pharmacy from which originally dispensed
    • PIC shall ensure conditions of transportation, storage are such as to prevent deterioration and/or contamination that would affect the efficacy and/or toxicity
    • must be initially dispensed as a unit dose or unit of issue
  59. what 3 shall not under any circumstances be returned to the pharmacy
    • controlled substances
    • Rx no in unit dose or unit of issue
    • not labeled in accordance with laws
  60. when is a non-resident pharmacy license renewal date
    annually by july 1
  61. what is the date to reinstate an expired pharmacist's license
    by march 31 each year
  62. what 11 structural and equipment requirements for a retail pharmacy
    • sink w/hot & cold water (not restroom)
    • proper lighting, ventilation, temperature
    • adequate shelving, counter (uncluttered)
    • fax machine
    • separate refrigerator (36-46, 2-8C)
    •   may have freezer (-13 to -14, -20 to -10C)
    • class A Rx balance or electronic scale (10mg)
    • adequate security (locked when not open)
    • automated counting devices (calibrated 1/4ly)
    • numbering all Rx's, printing equip for labels
    • licenses & certs issued by BOP displayed
    • professional reference library
  63. what is considered a professional reference library
    • WY pharmacy laws
    • facts and comparisons or comparable
    • drug interaction text with 1/4ly updates
    • WY state BOP News maintained in binder
    • FDA Orange Book
  64. requirements of a non-resident retail pharmacy
    • provide 6 days a week & 40 hr/week
    • toll free #; must be affixed to label
    • must be licensed in WY
  65. who has access to an institutional pharmacy after hours and some stipulations
    • supervisory or charge nurse (designated in writing) to meet the immediate needs of a pt. quantity removed shall not exceed amount needed until pharmacy reopens (ex MDI's etc)
    • procedures established to allow RPh to verify drug removal (leave package or unit-dose sample with records)
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law final
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