-
must report to SBOP pattern of misconduct in pharmacy practice if...
danger to health, safety, or welfare of a pt or the public
-
-
must be included during order clarification/change
- intials
- date
- person conveying change
-
how long refill info must be kept for
2 years
-
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
-
Rx transfer is NOT allowed between...
- 2 interns
- (needs at least 1 pharmacist)
-
ETO
- electronic transfer orders
- by techs between 2 compatible systems if no changes made
-
according to CO SBOP, how many times can CS II be transferred?
NONE
-
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)
-
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
-
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
-
required for initial interpretation and final evaluation (3)
- 1) pharmacist's name
- 2) initials
- 3) license #/secure electronic ID
-
review of order, order entry, & drug regimen
initial interpretation
-
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
-
final evaluation
- medication properly prepared, in suitable container, w/ proper label
- drug regimen review if refill
-
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
-
when CAN drugs be returned for redispensing? (3)
- 1) unit dose packaging
- 2) Med Packs
- 3) return to stock (original container & label)
-
ONLY exceptions for when pharmacies can accept returned CS from patients (2)
- 1) recall
- 2) dispensing error
-
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
-
Why would a non-resident PDO be required to register with SBOP?
if shipping, mailing, or delivering Rx drugs/devices into CO
-
how many pharmacies are allowed in the same physical space
ONE (1)
-
identified as "transfer of ownership of PDO" (2)
- 1) sale of
 20% of shares/ownership interest - 2) incorporation of an existed PDO
-
requirement if PDO is relocating
apply to SBOP at least 30 days prior to relocation
-
when CS inventory must be done upon pharmacy manager change
72 hours
-
who must perform CS inventory
pharmacy manager/designee
-
requird pharmacy business hours
2 days per week, 4 continuous hours per day
-
must submit hours to SBOP in writing if open less than __ hours per week.
32 hours
-
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
-
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
-
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
-
2 characteristics of dispensing area
- 1) only pharmacist can lock/unlock
- 2) floor to ceiling physical barrier
-
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
-
time in which a written report of a security breach must be submitted
10 days
-
CDTM
- Collaborative Drug Therapy Management
- pharmacist review & evaluation of drug therapy to provide, monitor, & modify drug therapy
- also known as MTM
-
MTM
- Medication Therapy Management
- also known as CDTM
-
CDTM is pursuant to...
physician diagnosis, order, & written agreement
-
specific written plan for course of medical treatment
protocol
-
when are protocols insufficient?
- when they are:
- vague
- nonspecific
- rely on pharmacist discretion without definition
-
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
-
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
-
responsible for Rx delivery/storage outside pharmacy at pt's request
pharmacy manager
-
time in which pharmacist must notify SBOP in writing when any legal proceeding begins AND ends
30 days
-
3 facilities PDOs or hospital other outlets may provide emergency kits of drugs to
- 1) LTCF
- 2) hospices
- 3) home health agencies (HHA)
-
who is responsible for accuracy of contents of kit
pharmacy manager
-
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
-
LTCF/in-patient hospice emergency kit drug limits
- up to 60 drugs
- 12 may be CS
-
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)
-
HHA/outpatient hospice emergency kit drug limits
-
how long Rx drug records must be kept for (& readily available to SBOP)
2 years
-
how Rx orders are organized
numerical sequence
-
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
-
CS inventory must record (4)
- 1) name
- 2) strength/dosage form
- 3) # units/volume
- 4) outdated CS
-
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
-
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
-
Rx information METHOD B
- online Rx info retrievel (2 years)
- daily (q24h) backup
- printable at request
-
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
-
requirements for pharmacist or intern to administer vaccines (2)
- 1) ACPE course - 12hrs didactic, 8 hrs live training
- 2) CPR course
-
how long immunization records must be kept for/provided at SBOP request
THREE (3) years
-
amount allowed to be compounded at in advance
- 90 day supply
- (based on 6 months history)
-
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"
-
when formulation/compounding records DON'T have to be kept
when compounded per the manufacturer's labeling instructions
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