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active pharmacy practice
pharmacist minimum of 400 hours per calendar year
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readily retrievable
produced within 48 hours
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when is a COA not required for compounding
if active ingredient is USP or NF
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what must be on the COA
- Product name
- Lot number
- Expiration date
- Assay
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what must be counseled on for compounded products
- proper storage
- use
- shelf life
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rules regarding samples of compounded products
- can't provide to practitioners
- may sell to
- MD
- Instituitions
- not to retail pharmacies
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DEA form 41
destruction of CS
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DEA form 106
lost or stolen CS
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DEA form 222
CS II order form
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DEA form 224
Pharmacy CS registration
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when must inventory of ALL controlled substances be done
first 7 days of May each year
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CII inventory regulations
- must be perpetual
- reconciled at least once a quarter
- discrepancies >5% reported to BOP w/I 10 days
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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
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who is a practitioner
- physician
- dentist
- veterinarian
- podiatrist
- scientific investigator
- pharmacy
- hospital
- instituition
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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
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rules on emergency when a MD can't be contacted
- 72 hour supply of previously prescribed med
- Cannot supply a controlled substance
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If a pt/practitioner relationship has ended (for reasons other than discharge) how long are refills honored for
12 months
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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
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how long are the terms of BOP
- 6 years, expires on march 1
- max of 2 successive terms
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requirements for BOP members
active practice for 5 years, US citizen, WY resident - for their prospective fields
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what happens if a vacancy occurs on the BOP
- governor must appoint a replacement w/I 90 days
- governor may remove any member
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how often does the BOP meet
at least 3 times a year, one must be held in the month of June
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who make up the advisory board on drugs and substances control
- director of Depy. of health or designee
- BOP executive director
- BOP senior inspector
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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
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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
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what is medication therapy management
evaluating and rendering advice to the prescribing physician
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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
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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
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how many copies of a CPA must be sent to the BOP
5
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when is the decision of a CPA from the BOP sent to the MD & RPh
within 10 days
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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
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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
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who reviews pt's charts and how often in a long term care pharmacy service
- consultant pharmacist
- monthly
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what is a therapeutic substitution
different class or within the same class
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what is a therapeutic equivalent
generic equivalent
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who can be issued a permit for an emergency drug supply
- nursing homes
- hospices
- extended care facilities
- immediate care facilities
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what are the limits of drugs for an emergency drug supple
- number of drugs = 48
- number of doses of each drug = 30
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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
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how long do you have to report a discrepancy of an emergency drug supply to the BOP
w/I 7 days of discovery
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who can a RPh administer immunizations to
- healthy adults only (19 years of older)
- high risk adults by Rx from a licensed MD
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what 10 immunizations can a RPh administer
- Td
- MMR
- varicella
- influenza
- Pneumococcal (polysaccharide)
- hep A
- hep B
- meningococcal
- HPV
- zoster
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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
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what are the requirements for the immunization questionnaire and consent form
- 2 copies provided to pt
- keep on file for at least 6 years
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what must be recorded on the Rx of any generic drug dispensed
NDC # or manufacturer number
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changes to a CII Rx a RPh is allowed to make after contacting the MD
- drug strength
- drug quantity
- directions for use
- dosage form
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changes to a CII Rx a RPH is allowed to make without contacting MD
pt address with proper verification
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Changes to a CII Rx a RPh is not allowed to make
- pt name
- CS prescribed (except generic substitution)
- date issued
- MD signature
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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
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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
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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
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readily retrievable info required for Rx refills
- date filled
- quantity
- RPH initials
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readily retrievable info required for refilling CIII & CIV
- date
- quantity
- name of RPh
- dated by RPh
- amount dispensed
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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
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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"
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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
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what is NOT required on a CS Rx label
- drug name, strength, quantity
- pharmacy telephone
- RPh initials
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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
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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
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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
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when is a non-resident pharmacy license renewal date
annually by july 1
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what is the date to reinstate an expired pharmacist's license
by march 31 each year
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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
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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
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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
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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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