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Law study
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Law study
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  1. What is required for labeling of excess or bulk compounded materials
    • 1. Reference to formula used
    • 2. Assigned control numbers
    • 3. Estimated BUD
  2. When is a certificate of analysis required and what's on it
    • Active ingredient is not USP of NF (compounding), and must be attained for each lot number from a firm in the US.
    • PLEA
    • 1.Product name
    • 2.Lot number
    • 3.Expiration date
    • 4.Assay
  3. rule on providing compounding samples
    • Not to practitioners or retail pharmacies
    • May sell to MD and institutional pharmacies
  4. DEA form 224
    New pharmacy registration
  5. DEA form 222
    • 1. Receiving registrant to transfer CII's
    • 2. Issued by the DEA containing
    •     a. Name of registrant
    •     b. Address of registrant
    •     c. Registration number
    •     d. Serially numbered
    •     e. Authorized activity and schedules
    • 3. Copy 3 (blue), keep at pharmacy
    • 4. Copies 1 & 2 to supplier
    •     a. DEA number
    •     b. Number of packages shipped
    •     c. Date shipped
    • 5. Supplier keeps copy 1 (green) and sends copy 2 to DEA registrant or BOP
    • 5. DEA keeps copy 2 (brown)
    • 6. One line per drug, strength, dosage form
    • 7. When purchaser receives order they enter the number of containers received and date
  6. DEA form 41
    • Disposal or destruction of controlled substances
    •   Also disposal from breakage or spillage
    •   DEA does not constitute this as a "loss"
  7. DEA form 106
    Report theft of loss of controlled substance
  8. Perpetual inventory of CII
    • 1. Maintained in retail and institution
    • 2. Reconciled at least once a quarter
    • 3. Any discrepancy (>5%) must be reported to BOP within 10 days
  9. Yearly controlled substance inventory
    • 1. Done during the first 7 days of May yearly
    • 2. Done at opening or closing of business
    • 2. Forward copy to the BOP
    •       a. Name of pharmacy
    •       b. Date & time
    •       c. Signature of responsible person
  10. Unprofessional conduct
    • 1. Filling an Rx that is more than 2 years old
    • 2. Misleading, false, or deceptive advertising
    • 3. Employing student, tech of RPh that is not licensed
    • 4. Willfully betraying pt confidences
    • 5. Obtaining any fee by fraud or misrepresentation
    • 6. Dispensing drug which differs from Rx without authority of issuer
    • 7. Filling an Rx if doubt pt-MD relationship
    • 8. Giving expired or mishandled drugs
  11. BOP members
    • 8 total
    • 7 voting
    •   4 RPh
    •   1 MD
    •   1 dentist or vet
    •   1 public member
    • 1 tech (no voting rights or parts in licensing or suspension)
  12. BOP member requirements and terms
    • 6 year terms, expire on March 1
    • Max of 2 consecutive terms
    • Cannot have any connection to school or college
    • Governor appointed (vacancy appointed w/I 6 months)
    • Meet at least 3 times per year (one must be held in June)
    • Professionals 
    •   a. active practice for at least 5 years
    •   b. US citizen
    •   c. WY resident
    • Public member
    •   a. US citizen
    •   b. WY resident for 5 years
  13. Advisory Board on Drugs and Substance Control
    • 1. Director of Dept of Health (or designee)
    • 2. BOP executive director
    • 3. BOP senior inspector
    • No compensation; travel and per diem
  14. Wyoming Narcotics and Drug Abuse Board
    • 1. Attorney General (or designee)
    • 2. Director of Dept of Health (or designee)
    • 3. Members of BOP
    • No compensation; travel and per diem
  15. Manufacturer Samples
    • CS samples must be kept on a record given to the BOP if shipped into Wy (IV & V exempt
    •   1. Name and DEA #
    •   2. Address of Manufacturer
    •   3. Name, address, DEA of registrant receiving
    •   4. Drug;name,strength, quantity/package, number of packages
    •   5. Date of shipment
  16. Collaborative Practice
    • 1. Cannot specify specific pharmacy for pt to fill meds at
    • 2. Allows RPh to conduct MTM
    • 3. MTM shall occur only for a particular patient pursuant to a specific written order from MD
    • 4. RPh must obtain written consent from the pt or their agent
    • 5. CPA agreement must be reviewed/renewed annually
    • 6. BOP must review all CPA prior to implementation
  17. Collaborative Practice Advisory Committee
    • 1. 5 members
    •   a. 2 RPH, at least 1 a member of BOP
    •   b. 2 MD, at least 1 a member of BOP
    •   c. BOP executive director
    • 2. Reports recommendations to BOP at next meeting
    • 3. BOP decisions delivered to MD and RPh within 10 days
    • 4. RPh must send 5 copies of CPA to BOP
  18. Collaborative Practice Agreement (CPA) criteria
    • 1. Names of physicians and RPh
    • 2. Types of MTM decisions RPh is allowed to make
    • 3. Physician to monitor compliance with CPA and clinical outcomes and intercede when necessary
    • 4. Prescribing MD ability to override the CPA when necessary or appropriate
    • 5. Physician, RPh, patient, parent, guardian to cancel CPA at any time
    • 6. MD & RPh signatures and dates
  19. Long term care pharmacy service - provider pharmacy
    • 1. must provide 24 hr emergency service (either directly or with another pharmacy)
    • 2. dispense drug pursuant to med order, proper packaging and drug recall procedures
    • 3. DUR for all new and refill meds
    • 4. communicate with consultant pharmacist
  20. Long term care pharmacy service - consultant pharmacist
    • 1. P&P: drug storage, admin, records
    • 2. inspect drug storage areas
    • 3. destroy unused meds
    • 4. CE for nursing personel regarding med admin
    • 5. review each patients chart monthly
  21. what is a therapeutic equivalent
    generic substitution
  22. what is a therapeutic substitution
    different classes of meds or within the same class
  23. Available quantity limits of an emergency drug supply
    • 1. # of drugs: 48
    • 2. # of doses of each drug: 30
    • 3. additional quantities require submission of an application listing the additional drugs requested with justification
  24. What facilities can have emergency drug supplies
    • 1. nursing homes
    • 2. hospices
    • 3. extended care facilities
    • 4. immediate care facilities
  25. Drugs administered from the emergency drug supply shall be limited to the following
    • 1. New legend drug order given by practitioner to a nurse for a pt of the facility.
    •   a. Can take dosing for 96 hours or less
    •   b. Until the next scheduled delivery
    •   c. RPh notified w/I 48 hrs of removal for
    •       review of pt profile
    • 2. Drugs ordered by MD PRN and reviewed by RPh
    • 3. Removal of any controlled substance can only be done after the RPh has received and order and grants access to supply
  26. Rules of facilities that have emergency drug supplies (not limits)
    • a. Must be licensed by the WY dept of health
    • b. Drugs remain property of pharmacy who has the permit
    • c. Permit renewed annually
    • d. facility and pharmacy shall establish written P&P and kept on file at both places 
    •   1. reviewed annually   
    •   2. signed by PIC and director of nursing
    • Must notify board if service is D/C'd
    • If pharmacy is located at same site as facility, they are exempt from these requirements
  27. what immunizations can a pharmacist administer to "healthy adults"
    • 1. Hep A & B
    • 2. HPV
    • 3. MMR
    • 4. Meningococcal
    • 5. Pneumococcal (polysaccharide)
    • 6. Td,tdap
    • 7. Influenza
    • 8. Zoster
    • 9. Varicella
  28. what immunizations can a RPh administer to a minor
    • 1. Influenza
    •    a. Shall have parent or legal guardian consent
    •    b. Shall be present during administration
  29. who can RPh administer vaccines to
    • Healthy adults (18 yo and up with not CI)
    • High risk adults (18 yo and up with CI) with Rx
    • Minors (7-17 yo) = influenza
  30. training programs for RPh to administer vaccines
    • 1. APHA immunization training program (Pharmacy-based immunization delivery)
    • 2 WA state's program (Vaccinating adults and adolescents: An immunization program practicum session)
  31. Additional certifications for RPh to give vaccinations
    • 1. CPR by AHA or red cross
    • 2. 1 contact hour (0.1 CEU) of immunization annually. Must be approved by  ACPE
  32. Forms for patient's prior to vaccination
    • 1. Vaccine information statement (VIS) given to each person for each vaccine.
    • 2. Immunization Questionaire and Consent Form
    •   a. 2 copies provided to pt
    •   b. keep on file for 6 years
  33. requirement space for immunizations
    • 1. minimum 48 ft2
    • 2. at least 6 feet tall partition
    • 3. pt must be seated with back support
  34. Items needed to be a valid prescription
    • 1. Name of pt
    • 2. Drug name and strength
    • 3. Qty to be dispensed
    • 4. Directions for using the drug
    • 5. Date of issuance
    • 6. Recognizable signature
    •       a. can be digital or electronic
    • 7. If oral order; name of authorized agent
  35. What can a RPh change on a controlled Rx after consultation/ approval of the prescribing practitioner
    • 1. Drug strength
    • 2. Drug quantity
    • 3. Directions
    • 4. Dose form
  36. What can a RPh add or change on a controlled substance Rx without consulting the prescriber
    • 1. Pt address - with proper verification
    • 2. Prescriber DEA - verification from a reliable source
  37. When a change is made to a Rx, what must be documented
    • 1. Person consulted
    • 2. Date
    • 3. Initials of RPh
  38. What is a RPh not allowed to change on a controlled substance Rx
    • 1. Pt name
    • 2. Drug (unless generic substitution)
    • 3. Prescribers signature
  39. Who can issue Rx's for controlled substances
    • 1. physician
    • 2. dentist
    • 3. podiatrist
    • 4. veterinarian
    • 5. mid-level practitioner
  40. What are the criteria for authorizing an "emergency situation"  oral control Rx
    • 1. Immediate administration of drug is necessary for proper treatment of the user
    • 2. No appropriate alternative Tx is available, including administration of med that is not controlled
    • 3. It's not reasonably possible for prescriber to provide written or electronic Rx to pt
  41. Process of issuing an emergency oral CII without a Rx
    • 1. Limited to the amount to adequately treat pt during emergency period
    • 2. Immediately reduced to writing by RPh and contain all info except MD signature
    • 3. RPh must make reasonable effort to determine MD is registered
    •   a. Call back to personal number
    •   b. Other good faith efforts to ensure ID
    • 4. W/I 7 days written Rx must be provided
    •   a. postmarked within 7 day period
    •   b."authorization for emergency dispensing"
    •   c. Date of oral order (not written date)
    •   d. be attached to oral Rx
    •   e. RPH notifies board if not done
  42. Controlled substance (II-V) shall be printed on security paper. Features indicating security
    • 1. If scanned or copied "void" appears on front
    • 2. Erasure protection on green or blue background on front side
    • 3. Clear instructions printed on the paper indicating the front and back sides
    • 4. Security warning list on the front or back
    • 5. Qty check-off boxes plus numeric forms of quantity values or alpha and numeric values of quantity value
    • 6. refill indicator (circle or check number of refills or "NR") plus numeric form of refill values or alpha and numeric form of refill values
  43. What parts of a controlled substance Rx can't be prepared by authorized agent
    • 1. Dating
    • 2. Signature
  44. What doctor information needs to be on a controlled prescription
    • 1. Full name
    • 2. Address
    • 3. Telephone number
    • 4. DEA number
  45. How can controlled substance Rx's be prepared
    • 1. Written in ink
    • 2. Typed
    • 3. Electronically generated
  46. Identification of a pt with a controlled substance Rx
    • 1. Visual recognition at drop off
    • 2. Photo ID, record on back of Rx
    •      a. Name
    •      b. Type of ID
    •      c. ID number
    • 3. Pick up; if not the pt, then their name needs to be recorded on Rx, patient profile, or signature log.  
  47. When do controlled substance Rx's not need to be on security paper
    • 1. Faxed Rx for CIII-V
    • 2. Faxed refill request (CIII-V)
    • 3. Electronic refill request (CIII-V)
    • 4. Electronic Rx
  48. officials exempt from registering for controlled substances DEA requirements
    • 1. Branch of service (US army, public health service, etc)
    • 2. service ID number (public health service employee uses their SSN)
    • 3. Rx shall have the name of the officer stamped or printed as well as signature
  49. electronic Rx requirements
    • 1. pharmacy must be licensed to receive
    • 2. transmitters phone number for verbal verification of date and time
    • 3. ID of intended pharmacy
    • 4. Use MD digital or e-signature unique to them
    • 5. Deem original Rx and maintain for 2 yrs
    • 6. Equipment must be maintained to prevent unauthorized access
  50. digital signature
    • 1. intended for same force and effect as manual
    • 2. unique to authorized signer
    • 3. capable of verification
    • 4. sole control of the authorized signer
    • 5. linked to Rx; if info changes then signature is invalid
    • 6. conforms to laws and rules and regs
  51. transfers of controlled substances
    • 1.NO C2 allowed
    • 2. C3-5 one time
    •   a. real time online database sharing = transfer up to the maximum refills permitted
    • 3. must be between 2 licensed pharmacists
  52. documentation on script requirements of transferring RPh or intern non-controlled
    • 1. write void on face of original
    • Record on the back of Rx
    • 2. Name of transferring RPh or intern
    • 3. Name of receiving RPh
    • 4. name of receiving pharmacy
    • 5. Telephone number of receiving pharmacy
    • 6. Date of transfer
  53. additional requirements for transferring a controlled substance
    1. Address, & DEA of receiving pharmacy
  54. receiving RPh or intern requirements of a transfer
    • 1. Write transfer on face
    • 2. Name of pt
    • 3. DOB if available
    • 4. Name of MD
    • 5. Date of issue
    • 6. Date of first fill
    • 7. Date of last fill
    • 8. Number of refills authorized
    • 9. Number of refills remaining
    • 10. Original Rx #
    • 11. Name of transferring RPh
    • 12. Name and tele of transferring pharmacy
  55. additional requirements needed when receiving a transfer of a controlled substance
    • 1. DEA # of MD
    • 2. Pharmacy name, address, DEA # of transferring pharmacy
  56. partial filling of CII requirements
    • 1. permissible if pharmacy can't supply the full quantity, not if pt wants partial
    • 2. Must make a notation of quantity supplied on the prescription
    • 3. Remaining portion of the prescription may be filled within 72 hours
    •   a. if not; RPH must contact MD, no more dispensed
    • 4. RPH must record on the back of Rx
    •   a. date of partial
    •   b. Qty dispensed
    •   c. Remaining quantity to be dispensed
    •   d. ID of RPh
  57. What needs to be on a refill authorization that is faxed to the pharmacy
    Initials of the authorizing agent
  58. When can a CII be faxed
    • 1. If compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, sub Q, or intraspinal infusion.
    • 2. Resident of long-term care facility
    • 3. "Terminally ill" (duly noted) patient
  59. requirements of a Rx that is faxed
    • 1. notation that this is a fax
    • 2. MD 
    •     a. Fax#
    •     b. tele #
    • 3. pharmacy
    •    a. name
    •    b.address
    •    c. tele
    •    d. fax
    • 4. date of fax
    • 5. time of fax
    • 6. transmitting agent if not MD
  60. Rx label requirements
    • 1. pt name
    • 2. brand or generic name (unless MD requests not to state
    • 3. drug strength
    • 4. drug quantity
    • 5. pharmacy name, address, tele
    • 6. MD name
    • 7. Rx number
    • 8. date of fill/refill
    • 9. directions
    • 10 RPh initials
    • 11. accessory labels
    • 12. products physical description
    •   a. new drug on market (120 days)
    •   b. national reference file no description
  61. additional requirements on a controlled Rx label
    caution: federal law prohibits the transfer of this drug to any person other than pt
  62. Unit dose or unit of issue requirements for packaging
    • 1. brand name and/or generic
    • 2. strength

    • 3. manufacturers lot number
    • 4. manufacturers expiration date or if prepackaged or repackaged by pharmacy then 12 months or manufacturers expiration date (whichever is sooner)
  63. Exceptions to when a pharmacy can accept medications from patients for re-dispensing. All must be met
    • 1. Rx drugs were maintained under control of persons licensed to administer drugs
    • 2. Can only be returned to pharmacy from which originally dispensed
    • 3. PIC shal ensure conditions of transportation, storage are such as to prevent deterioration and/or contamination that would affect the efficacy and/or toxicity
    • 4. Must be initially dispensed as a unit dose o unit of issue
  64. What shall not be returned to the pharmacy under any circumstances
    • 1. controlled substance
    • 2. Rx not in unit dose or unit of issue
    • 3. not labeled in accordance with laws
  65. If a product can be returned (according to the guidelines) then what shall apply
    • 1. Products in manufaturer's unit dose or unit of issue may be re-dispensed as often as necessary
    • 2. Prepackaged or repackaged into unit dose and unit of issue in the pharmacy may be redispensed one time only
    •   a. may be removed and dispensed in a traditional dispensing system
    • 3. partially used unit of issue may not be emptied or repackaged
    • 4. additional units o medication can't be added to partially used unit of issue packages
  66. date of renewal for restoration of expired RPh or tech license
    March 31
  67. date of renewal for emergency drug supply permit
    june 30
  68. date of renewal for resident pharmacy/telepharmacies
    june 30
  69. date of renewal for non-resident pharmacies
    june 30
  70. date of renewal for drug distributor
    july 1
  71. date of renewal for CS license registration
    july 1 every 2 years
  72. date of renewal for intern license
    September 30
  73. date of renewal for pharmacist license
    December 31
  74. date of renewal for preceptor license
    December 31
  75. date of renewal for technician license
     December 31
  76. reporting deadline to BOP for telepharmacy license and opening
    60 days prior
  77. reporting deadline to BOP for new/remodeled pharmacy blueprints
    30 days prior
  78. reporting deadline to BOP for pharmacy closure
    21 days prior
  79. reporting deadline to BOP for retail pharmacy change of ownership
     21 days
  80. reporting deadline to BOP for emergency drug supply CS discrepancy
    7 days
  81. reporting deadline to BOP for retail pharmacy closure/change of ownership notification to the public
    14 days prior
  82. reporting deadline to BOP for CS inventory from change in PIC
    15 days from completion of the inventory. A copy of the inventory along with Certification of Responsibilities as Pharmacist-in Charge shall be forwarded to the board
  83. reporting deadline to BOP for change of PIC
    • 7 days if PIC changes
    • If PIC is going to be absent for > 30 days a new PIC must be assigned, responsibility is on the owner of pharmacy.
  84. reporting deadline to BOP for technician change of employment of mailing address
    30 days
  85. reporting deadline to BOP for manufacturer/wholesaler changes
    30 days
  86. continuing education requirements
    • pharmacist - 1.2 CE (12 contact hours, 1 contact hour = 50 minutes)
    • technician - 0.6 CE (6 contact hours)
  87. Structural requirements of a retail pharmacy
    • 1. sink with hot and cold water exclusive of restroom facilities
    • 2. proper lighting, ventilation & temperature
    • 3. adequate shelving, counter, working surface clean and uncluttered
    • 4. Fax machine
    • 5. Separate frig with thermometer (36-46F or 2-8C) limited to storage of drugs.
    •   a. may have a freezer -13-14F or -20 to -10C
    • 6. class A Rx balance or electronic scale wit 10 mg sensitivity
    • 7. adequate security
    •      a. locked when pharmacy not open
    • 8. automated counting devices calibrated quarterly
    • 9. numbering of all Rx's, printing equipment to produce Rx labels
    • 10. licenses and certificates issued by BOP displayed in view to the public
    • 11. Professional reference library (text or electronic format)
    •       a. current Wyoming pharmacy laws
    •       b. current edition of facts and comparisons    or a comparable reference accepted by BOP
    •       c. current drug interaction text that provides, at a minimum, quarterly updates
    •       d. Wyoming state board of pharmacy quarterly newsletter by access to website
    •       e. current edition, with supplements, of the US food and drug administration (FDA) "orange book" or an alternative reference that provides the same information. Proven
  88. non-resident retail pharmacy service requirements
    • 1. must provide at least 6 days/week and 40 hrs/week a toll free telephone service that can connect pts to a pharmacist
    • 2. toll free number must be affixed to the label of each medication dispensed
    • 3. must be licensed by WY to advertise any services in WY
  89. who has to sign CS control sheets (meds used in surgeries) when there is a disposal
    • MD
    • nurse
    • witness
  90. what do you do with meds that are brought into a hospital by a pt
    • 1. ID and administer pursuant to MD order
    • 2. If not given,
    •    a. package, seal, and return to an adult member of pt family.
    •   b. store in pharmacy and return only upon discharge after advice given regarding continuing meds
  91. in an institutional pharmacy when does the PIC or designee do inspections of drug storage areas
    quarterly
  92. what records are maintained with floor stock
    • 1. date and time of removal
    • 2. pts name and location
    • 3. name, strength, dosage form, and qty removed
    • 4. printed name and signature of nurse removing
  93. Access to institutional pharmacy after hours
    • 1. allowed if required to treat immediate need of patient
    • 2. only supervisor or charge nurse have access
    •   a. must be designated in writing
    • 3. records of drug removal must be kept
    •   a. date and time of removal
    •   b. pts name and location
    •   c. name, strength, dosage form, qty removed
    •   d. printed name andsignature of nurse removing drug
    • 4. Qty removed shall not exceed amount needed until pharmacy reopens
    •   a. exceptions: drugs commercially packaged (MDIs, otics, topical, insulin & ophthalmics)
    • 5. Procedures established to allow RPh to verify drug removed (leave package or unit-dose sample with records)
  94. When providing off site pharmaceutical care what must be communicated to the BOP in writing
    • 1. name, address, license # of each RPh providing service
    • 2. name, address, license # of each pharmacy exchanging info with facility
    • 3. description of audio, video, data link that will be utilized to exchange info between pharmacy and off site pharmacist
    • 4. description of scope of work & pt info that is to be shared, minimum pts medical records
    • 5. May perform remote order processing if RPh has access to pt info including labs
  95. Off site RPh shall at a minimum do what
    • 1. review new med orders
    • 2. review al sterile compounding performed by nursing staff
    •   a. exception; meds during CPR or emergency
    • 3. shall communicate with institutional pharmacy staff on a daily basis or whenever pharmacy is open for business
  96. hour requirements for a institutional pharmacy to be open
    • 50+ beds = 40 hr/week
    • 26-49 beds = 20 hr/week
    • 1-25 beds = 5 hr/week
  97. Institutional pharmacy structural/equipment/security requirements
    • 1. enclosed and lockable
    • 2. adequate space for storage, compounding, labeling, dispensing, and sterile preparation of drugs
    • 3. sink w/ hot/cold water exclusive of bathroom
    • 4. pharmacy arranged in an orderly fashion and kept in clean and good operating condition
    • 5. properly lighted and ventilated
    • 6. temps
    •   a. pharmacy: 59-86F (15-30C)
    •   b. fridge: 36-46F (2-8C)
    •   c. freezer: -13 to 14F (-25 to -10C)
    • 7. store all antiseptics, disinfectants, and other drugs for external use separately from internal and injectable medications
    • 8. frig including device to monitor the temp daily
    • 9. computer and software
    • 10. fax capability within pharmacy
    • 11. if use of a balance is required; class A with 10mg sensitivity
    •   a. inspected every 3 years by BOP
    • 12. all pharmacy staff must wear ID badges including name and position
    • 13. director shall designate, in writing, by title and specific area those persons that shall have access to pharmacy areas
    • 14. each RPh responsible for security while on duty
    • 15. reference stuff??
  98. requirements for a new or remodeled pharmacy
    • 1. blueprints to BOP no later than 30 days prior to construction
    • 2. no less than 500 square feet
    • 3. identified counseling area
    •   a.sufficient privacy
    •   b. 3 ft minimum
    •   c. restroom facilities, not in footage, limited to pharmacy staff
    •   d. secure access
    •      1. in business; solid core or metal doors with deadbolt and locking knob
    •      2. glassed areas need intrusion detectors
    •      3. wall extend to roof or security accepted by board
    •   e. separate frig, sufficient in capacity to serve the needs of the pharmacy staff for food and beverage "employee use only"
    •   f. all Rx shall be processed w/ electronic equipment, sequentially numbered. Adequate computer terminals and printers to process anticipated Rx's
  99. emergency drug cart set up and maintenance
    • 1. up-to-date under supervision of RPh
    • 2. secured with a breakable seal
    • 3. listing of all drugs on cart
    •   a. strength, quantity, location
    • 4. drugs are labeled
    • 5. RPh notified of entry
    • 6. P&P
  100. requirements of an emergency outpatient label
    • 1. name, address, and tele of institution     
    • 2. name of pt    
    • 3. drug; name, strength, qty    
    • 4. directions for use    
    • 5. date    
    • 6. accessory cautionary info    
    • 7. MD name     
    • 8. initials of nurse    
    • 9. NO RPh initials required
  101. What records need to be kept when an emergency outpatient medication is given
    • 1. pt name    
    • 2. date of issuance    
    • 3. name of drug    
    • 4. pts facility record number    
    • 5. Initials of nurse of administered and distributed the drug 
    • f. log for meds administered shall be reviewed by RPh at least weekly?   
    •   1. discrepancies reviewed w/ ER nursing supervisor
  102. criteria for issuing emergency outpatient medication
    • 1. when normal community and outpatient pharmacy services are not available
    • 2. designated nurse may administer and distribute meds as long as
    •   a. MD order is presented and a copy available for RPh review
    •   b. Med is prepackaged by RPh or tech and distributed using an automated dispensing device: kept in locked cabinet
    •   c. Qty limited to 72 hour supply
    •   
    •   
  103. what records need to be maintained for automated dispensing devices
    • Records maintained for 1 year
    • 1. date of removal (no time required)
    • 2. drug; name, strength, dosage form, qty
    • 3. pt name
    • 4. nurse name and ID
  104. requirements for parenteral labels
    • 1. name and amount of drugs added
    • 2. date and time added
    • 3. expiration date
    • 4. rate of administration
    • 5. name or ID cod of person adding the drug
  105. institutional medication orders must include
    • RPh must review MD orders before initial dispensing of medication or soon after if emergency
    • 1. pt name and location
    • 2. drug; name, strength, directions, date, MD signature or agent signature
  106. What is the purpose of issuing a controlled substance prescription
    Issued for a legitimate medial purpose by a practitioner acing in the usual course of his professional practice
  107. Identification of patient with controlled substance that is being mailed out
    • 1. noted on Rx or in pts file with the name and address of where the Rx was sent
    • 2. The date of mailing shall be entered too
  108. electronic Rx transmission requirements
    • 1. Verified by a third party auditor
    • 2. Individual practitioner has obtained a two-factor authentication credential for signing
    •   a. Something prescriber has
    •   b. Something prescriber is
    •   c. Something prescriber knos
  109. Criteria for issuing multiple control Rx's
    • 1. Each Rx is dated when it is prescribed
    • 2. Written instructions when to fill, not on the first Rx if intended to dispense immediately.
    • 3. Practitioner concludes that providing the pt with multiple Rx's doesn't create undue risk
  110. what are the exclusions to inspection unless written consent is given
    • 1. financial data
    • 2. sales data other than shipping data
    • 3. pricing data
  111. Unusual CII's
    • GD-TTAPPPS
    • glutehimide
    • diphenoxylate
    • Tapentadol (nucynta)
    • Thebaine
    • Amobarbital
    • Pentobarbital (nemobutal)
    • pethidine (meperidine)
    • PCP (phenylcyclidine)
    • secobarbital (seconal)
    •  
  112. Common CIII's
    • BACK CHILD 2M
    • buprenorphine (butrans)
    • Anabolic steroids
    • codeine (90mg/dose; <1.8%)
    • ketamine (ketalar)
    • Chlorphentermine
    • hydrocodone (15 mg/dose; <0.3%)
    • fiorinal (butalbital, aspirin, caffeine)
    • lysergic acid
    • dronabinol (synthetic and encapsulated)
    • mixtures of GHB
    • mixtures/suppositories of: secobarbital, amobarbital, pentobarbital
  113. CV's
    • pregabalin (lyrica)
    • lacosamide (vimpat)
    • codeine (0.2%)
    • diphenoxylate (2.5mg) Atropine (25mcg)
    • pyrovalerone
  114. pseudophederine purchasing limits
    • 1. 3.6 grams/day
    • 2. 9 grams/month
    • 3. 7.5 grams/month by mail order
    • 4. not more than 2 packages in a single transaction
  115. tech in training
    • 1. must apply for permit within 10 days of starting on the job training
    • 2. permit valid for 2 years and may not be renewed
    • 3. count towards RPh:tech ratio unless registered with CC program
  116. tech qualifications
    • 1. 18 years old
    • 2. no felony w/I 3 yrs
    • 3. no hx of drug abuse or satisfactory evidence of rehab
    • 4. high school diploma or equivalent
  117. what must the seller of pseudophederine provide
    • 1. verification of purchaser by photo ID
    • 2. products by name
    • 3. Qty sold
    • 4. Address of purchaser (federal requirement)
  118. which warrants are served during normal business hours
    administrative inspection warrant (AIW)
  119. Minimum requirement on a pedigree
    • 1. name of Rx drug
    • 2. Dose form and strength
    • 3. Size of container
    • 4. # of containers
    • 5. Lot # & NDC
    • 6. Name of manufacturer
  120. which chapters of the Wyoming pharmacy act have been repealed
    • 5 - poison regulations
    • 7- computer regulations
    • 11
  121. which chapters of the control substance act have been repealed
    5
  122. If a drug is compounded in bulk quantities or excess what must be documented in the log book
    • 1. name of product
    • 2. ingredients and qty's
    •     a. including manufacturer
    •     b. lot number
    •     c. expiration dates
    • 3. lot number (assigned by a pharmacist)
    • 4. BUD
    • 5. Date of preparation
    • 6. Initial of compounder
    • 7. Initials of pharmacist if prepared by tech
    • 8. Qty prepared
  123. How many times can a CV be refilled
    1. as many as authorized
  124. Separate registrations for independent activities (info only)
    A person registered to dispense, or to conduct research (other than research described in paragraph (a) (4) of this section) with controlled substances listed in Schedules II through V shall be authorized to dispense and to conduct such research and to conduct instructional research with those substances.
  125. What shall be on a controlled substance label
    • 1. Date of filling
    • 2. Pharmacy
    •     a. name
    •     b. address
    • 3. serial number of Rx
    • 4. Pt name
    • 5. Prescribers name
    • 6. SIG
    • 7. Cautionary statements
  126. When is a partial fill of CIII-IV permissible
    • 1. Each partial is recorded in the same manner as a refill
    • 2. Total qty dispensed in all partial fills does not exceed total qty prescribed
    • 3. No dispensing after 6 months of issuance
  127. What medications are reported to the PDMP
    CII-IV
  128. Which patients won't show up on the PDMP
    • 1. Inpatient of a hospital
    • 2. Correctional institution
    • 3. Nursing facility
    • 4. Waiver requested by retail pharmacy that dispenses less than 25 controlled substance Rx's/month in state.
  129. When do resident/nonresident pharmacies report medications to the PDMP program
    1. No later than 7 days after the Rx was dispensed.
  130. Who initiates unsolicited reports from the PDMP program
    1. BOP and these are sent to the pharmacies and practitioners that are distributing the medications to the pt
  131. Who initiates solicited reports to the PDMP program
    • 1. Pharmacists and practitioners
    • 2. Personal request can be done in person at the BOP with proper ID
  132. What items are common for prospective and retrospective DUR's
    • DID TOC
    • 1. Drug-disease contraindications
    • 2. incorrect dose or duration of treatment
    • 3. Drug-drug contraindications (interactions)
    • 4. Therapeutic duplication
    • 5. Overutilization & underutilization
    • 6. Clinical abuse/misuse
  133. What item is in a prospective DUR but not retro
    drug-allergy interactions
  134. what item is in a retrospecive DUR and not prospective
    • therapeutic appropriateness
    • appropriate use of generic products
  135. Records of what documents must be maintained for 2 years by a custodian after an institutional pharmacy closure
    • 1. Completed DEA 222 forms or retrievable electronic equivalent
    • 2. Invoices for purchases of Schedule III, IV, V
    • 3. Patient specific records
  136. Records of what documents must be maintained for 2 years by a custodian after a retail pharmacy closure, or change in ownership
    • 1. Completed DEA 222 forms or retrievable electronic equivalent
    • 2. Invoices for purchases of Schedule III, IV, V
    • 3. Patient signature logs
  137. What is different about the labeling of Rx drug containers and unit of issue packages
    • Unit of issue has
    • 1. Manufacturer's lot#
    • 2. Manufacturer's expiration date
  138. What must a RPh do if their license has lapsed due to non-payment of renewal fees
    • 1. Letter requesting reinstatement
    • 2. Pay back fees (5 years)
    • 3. Copies of CE's (5 years)
    • 4. 2 recent letters (from pharmacist or owner) attesting to good character
    • 5. If licensed outside WY, letter from that board stating current license status
    • 6. 2 fingerprint cards
    • 7. Notarized employer affidavit attesting to the active practice (400 hours minimum) in the year preceding application date

    • Minimum competency shall be established and may include:
    • 1. MPJE
    • 2. Internship (period may vary)
    • 3. Board review
  139. Specific requirements for licensure of non-resident pharmacies to ship Rx drugs into the state
    • 1. Copy of pharmacy license from resident state
    • 2. Copy of latest inspection
    • 3. Copy of current DEA registration
    • 4. List of partners, members, or principal officers and registered agent (if any)
    • 5. List of all registered RPh, specify PIC
  140. How do non-resident pharmacies counsel patients in wyoming
    Orally and/or by written information accompanying the dispensed prescription
  141. How long does a pharmacist or technician have to wait to request a hearing if their license has been revoked.
    36 months after final ruling
  142. How long does a pharmacist or technician have to wait to request a hearing if their license has been suspended.
    At least 1/2 of the suspension has elapsed
  143. A dispensing pharmacy may outsource prescription drug order provided they have these minimum requirements.
    • 1. Have the same owner
    • 2. Written agreement specifying services to be provided
    • 3. Real-time database
    • 4. Maintain original Rx at dispensing site for 2 years
  144. Where are the P&P kept for a centralized pharmacy set up
    At the locations that are specific to them, and they are review annualy
  145. What records are maintained at the dispensing pharmacy
    • 1. Date & time the request for processing was transmitted to the central fill pharmacy
    • 2. Date and time the dispensed prescription was received from the central pharmacy, including the method of delivery and name of person accepting delivery
  146. What records shall be maintained at the central fill pharmacy
    1. indication of the date the Rx was shipped to the dispensing pharmacy
  147. Automated Storage and Distribution Systems only allow patient access to prescriptions that are what
    • 1. Do not require an offer to counsel by a pharmacist
    • 2. Are properly labeled and verified, by RPh, before being put into system
    • 3. No a CII
  148. What are the criteria for using an automated storage and distribution system
    • 1. Allows a pt to choose to use or not
    • 2. Located in a building, in pharmacy wall
    • 3. Method to identify pt
    • 4. Secure from inappropriate removal
    • 5. Provides a method for consultation, if requested
    • 6. No dispensing if counseling is required
  149. What does the board adopt as the official listing of Dangerous Substances for the State of Wyoming
    "Prescription Drug Product List" of the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations
  150. Minimum Structural, Security and equipment requirements to operate a telepharmacy
    • 1. No less than 150 ft2, exclusive of restroom
    • 2. Pt consultation room
    •      a. 25 ft2
    •      b. adjacent to telepharmacy
    • Pretty much the same stuff as is required by a retail pharmacy
  151. Reference requirements of a Telepharmacy
    • 1. Wyoming pharmacy laws
    • 2. Wyoming BOP newsletter (3 ring binder)
  152. Record keeping for a telepharmacy
    • 1. Daily printout of Rx's dispensed at telepharmacy will be dated, signed by RPh at parent pharmacy and filed
    • 2. All written Rx's shall be delivered to parent pharmacy for filing w/i 72 hours
    • 3. Files are kept separate from parent pharmacy
  153. What programs will give 0.6 CEU's
    • ACLS
    • PALS
  154. What program will give 0.4 CEU's
    PSAM - Pharmacist self-assessment mechanism
  155. How many hours must a PIC be physically present
    32 hours/week or 80% of the time if open less than 40 hrs/week
  156. What situations increase the penalty of having methamphetamine
    • 1. Within 500 feet of a residence, business, church, or school
    • 2. Minor present
    • 3. Firearm used
    • 4. Booby trap was used
  157. No person shall possess more than 15 grams of methamphetamine except
    • 1. Retailer or wholesaler
    • 2. Drug manufacturer
    • 3. Pharmacist
    • 4. Health care professional in the course of his practicing profession
    • 5. Person has a variety of strengths, brands, types, purposed and expiration dates of products
  158. Display requirements of methamphetamine products
    • 1. Behind the counter
    • 2. Locked case
    • 3. W/I 30' of and direct line of sight of cash register with theft detection
    • 4. Displayed in a location under constant video surveillance
    •    a. People looking and removing packages are within camera view
    •    b. Camera records images at least once every 10 seconds
    •    c. Images are kept for at least 168 hours
    •    d. Retailer posts a sign stating surveillance
    •    e. Any theft or suspicion reported to cops
  159. Criteria for "immediate-use" compounding
    • 1. Simple transfer of not more than 3 commercially manufactured packages of sterile nonhazard products and not more than 2 entries into any one container
    • 2. Limit to 1 hour of compounding (unless more is required)
    • 3. Aseptic technique - under supervision if not immediately administered
    • 4. Admin begins no later that 1 hour following the START of preparation
    • 5. If the preparer doesn't immediately admin or witness then it needs labeled
    •    a. patient ID
    •    b. name & amt of ingredients
    •    c. name or initials of preparer
    •    d. BUD - exact 1 hour & date
    • 6. If admin has not begun in 1 hour - discard
  160. BUD of "multiple-dose container"
    28 days unless specified by manufacturer, usually these products contain an anti-micorbial agent
  161. What is the ISO classification of  "primary engineering control" PEC
    ISO class 5
  162. Storage of low-risk level compounds
    • In the absence of passing a sterility test
    • 1. room temp - 48 hours
    • 2. frig - 14 days
    • 3. freezer - 45 days (-25C or colder)
  163. Storage of "medium-risk" compounds
    • In the absence of sterility test
    • 1. room temp - 30 hours
    • 2. frig - 9 days
    • 3. freezer - 45 days (-25C or colder)
  164. What constitutes a "medium risk compound"
    • 1. multiple small doses of sterile products are combined for: multiple pts, or 1 pt multiple times
    • 2. Compounding procedure includes complex aseptic manipulations other than the single-volume transfer
    • 3. Procedure is unusually long 
  165. What constitutes a "high risk compound"
    • 1. nonsterile ingredients or device
    • 2. Air quality < ISO 5 for more than 1 hr 
    • 3. Improper garbing
    • 4. non-sterile water containing preps are stored form > 6 hrs before sterilization
  166. Storage of "high-risk" compounds
    • 1. room temp - 24 hours
    • 2. frig - 3 days
    • 3. freezer - 45 days (-25C or colder)
  167. Quality assurance testing for compounding of different "risk" level compounds
    All are at least annually except "high risk" is semi-anually
  168. If a person leaves a sterile compounding environment, what is the one article that can be used again
    Non-shedding gown
  169. What must happen if a new PIC is assigned and the facility does sterile compounding
    The new PIC must review, date, and initial the P&P manual within 30 days
  170. How many gloved fingertip tests must a compounder pass before allowed to compound
    3 and then annually
  171. How often is air sampling performed in a compounding facility
    every 6 years
  172. What shall be included in the description of wholesale distributor facility and warehouses
    • 1. Square footage
    • 2. general description of security
    • 3. term of lease or ownership
    • 4. address
    • 5. Temp & humidity control
  173. Some less obvious requirements for facilities that store or handle prescription drugs
    • 1. Quarantine are
    • 2. Commercial location
    • 3. Entry into areas with Rx drugs shall be limited to authorized personnel
  174. What needs to happen if a pedigree can't be authenticated
    • Wholesale distributor shall
    • 1. quarantine
    • 2. File report with the board w/i 3 business days
  175. Who is responsible for the administering returns of damaged or outdated goods
    Licensees and pharmacies
  176. What must be done if a wholesale distributor has a discrepancy, through counterfeit, contraband, etc
    Report to the board with in 10 days

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