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220 Cards in this Set

  • Front
  • Back
What is a causal sale?
transfer, delivery or distribution of RXs to NON-consumers
What is the MAXIMUM number of casual sales of total number of drugs you can DISPENSE and DISTRIBUTE on an ANNUAL bases
10 %


5% is for CS
Compounding is the prepartion, mixing, or labeling of drug, what MUST be what
pt specfic, result from practitioner RX
Can certain compounds be prepared in advanced when
in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns
For a RX order, the purose for the drug MUST appear on the labels when
if provided by doctor AND patients requets
Do pharmacist have prescriptivie authority
NO
What is a pharmacy manager
direct control of 1 prescription drug outlet
What is a pharmacy technician
unlicensed person who performs duties under the supervision of a pharmacist
The practice of pharmacy (for pharamcist) is what
interpretation, evaluation, implemetation, and dispensing of roder, pt cousenling drug serach and pharmaceutical care
What is the practice of pharamcy for technicians
drug/device prepartion, mixing, assembling, labelings, delivery, storage and receord keeping
Must pharmacist be on location to superivse technicians
YES
What are the powers/duties of the State Board of Pharmacy
invistating violations, inspecting and fining RX drug outlets, granting and renewing licenses, denying licenses, compounding rules
Does the State Borad all keep records, supoena witness, and embargo misbraded/adultered drugs
YES
Insurance companies for pharmacist and self-insured pharmacist must SEND malpractice claims to
STATE BOARD
After a liscense is revoked, you CANNOT reapply for
2 years
Must the pharmacy manager be a pharmacist
YES
If a pharmacy manager terminates employment, what MUST happen
owner must transfer state board registration to NEW manager within 14 days

AND pharmacy manager must notify BOARD immediately
RX drug outlet MSUT display what
BOARDS registration with owner's and manager name
What also must be displayed besides OWNERS and manager's BOARD registration
all pharmacist, and interns
What must you do to transfer ownership or change name or LOCATION of rx drug outlet
must apply to board

ALSO MUST LET DEA know if have CS
A pharamcy can reigister as a compounding PDO with SBOP if
Accreditted or PDO is owned solely by a pharmacist
If a pharmacy is compounding accredited, how much can they compound and DISPENSE/DISTRIBUTE
compound more than 10% of total sales
What is considered a causal SALE for a RX drug outlet or hospital
selling to another Rx drug outlet, wholesale or prescriber

must be less or equal to 10%
If a PDO is a registered compounding PDO may dispense compounding without 10% limitation to WHO
Practitioners or PDOs with the SAME OWNERS
You can NOT compound commerically available drugs EXCEPT
if signifcantly different or best medical interest of pt (dye allergy AND

MUST NOTIFY PT
A 24 hours drug supply can be given to a registered ER patient by hosiptal employee if
ORDERED by Dr
employee can give meds
INTERNS may practice pharmacy is UNDER
pharamcist direct and immediate supervision
A intern CANNOT do what
SUPERVISE, perform inital interpretation or FINAL RX evaulation
A pharmacist can SUPERVISE what
up to 3 tech if ONE of the 3 techs has
certification by nation board, or degree, 500 hrs experience at pharmacy
How many interns can a pharmacist supervise
2 INTERNS

can still do 3 (2 interns and 1 tech or 1 intern and 2 tech
A pharmacist may REFILL a Rx w/o prescriber if
resonably try to contact prescriber, med is necessary for pts health, up to 72 hrs and does NOT state NO emergency refills
Can you do CII for emergency fills
NO
What MUST CHARTS ORDERS contain for LABELING
Hospital Name
Pt name and Location
Drug and precautionary statements
experiation date
What is required for an RX LABEL according to CO (8)
Pharmacy name/address
Pt Name
Dr Name
DRUG NAME
Date
Serial Number
Directions
Cautionary States
Can Dr be used for NP or PA
NO
For anabolic steriods what MUST be on the label
PURPOSE MUST BE ON LABEL
When can the pharmacist substitute generic drugs
if equivalent
COMMUICATED TO pt ORALLY and in writing
RX label file stated drug prescribed and drug name
COST to pt is LESLSL
ONLY TIME you can give a higher price med instead of generic is if waht
pt consents
When can a pharmacist NOT substitute generic drug
if stated dispensed as written, hand-writted or orally communicatted by prescriber
Can DAW be preprinted on faxes or rxs
NO
When can you liscence be revoked
Misrepresentation, fraud, decide, guilty or deferred judgement for FELONY
YOU must notify the board within how many days of ANY criminal conviction or DEFERRED judement
within 30 days
Can you have you liscence revoke if you are unfit or imcompetent
YES
Types of Discipline include refusal to renew, letter of admonitition, condition on license, training
YES
It is UNLAWFUL to coerce a pharmacist to dispense against her better judement
YES
Pt's of licensed facility the pts family can donate to UNUSED NON-CS to PDO or pharmacist of facility for redispensing to another pt or non-profit if what
orginial container that is UNOPENED and SEALED OR INDVIDUALLY package
How many times can a medication be donated
ONCE
Pharmacies may ACEEPT RX drug from CANCERS pt or familes if what
returned meds are unopended seals, containers, pharmacies DO NOT charge pts for medciations, and pts receiving the meds have certain eligilbility requirements
Controlled substance records must be kept for what
2 years
What must CS records contain
Date
Pt's name/address
CS drug and number
CS theft
When are CS theft must be reported and WHO for COLORADO LAW
30 days to STATE BOARD and LAW ENFORCE
Ad for brand name drug must also include generic
YES
Must CS records be kept confidentidal
YES
Colorado Precription Drug monitoring program MUST matain CS tracking, and gives specfic INDIVIDUAL info to who
Practitoners
Pharmacists
Law Enforcement
Pt
Can a PDMP be used by a pharmacist in a clinical setting
NO
Pharmacist cannot exhibit, discuss or reveal any Rx or therapeutic effect or degree of pts ilness or any medicial information with anyone EXPECT
Pt or Authoriez rep
Dr, Pharmacist, or Tern caring for pt, tech insurance
Recordkeeping pharmacist, law enforcement or require be law
Can a pharamcist be EMPLOYED and DISPENSE FOR A DR
NO
Can you interefere with the pharmacist/patient counseling
NO
ALL PRECRIPTION drugs MUST be procured from what
SBOP registered entity and PERSONS
IS A TIMELY report of misconduct in pharmacy required when
danger to health, safety or welfafe of pt
Who are the ONLY people that can TAKE ORAL orders
pharmacist/intern
What is required for documentation of ORDER clafifcations
THREE THINGS

your initals, date and person conveing change
ON an RX order for a substituted drug what must you include
DRUG names and NDU or distributor
Are there Rx drug outlet referral fees to health professionals
NO
When MUST you write on a Rx that is given to pt, who has already fill RX
COPY FOR REFERANCE ONLLY
When you WRITE COPY FOR REFERANCE ONLY, what must you write on orginial
initals, date and copy indication
Are RX tranfers allowed between 2 interns
NO
Electronic transfers ORDERS, can be made by and between technicans, WHEN
between 2 compatible systems if NO changes are made
Can a CII be transfer
NO

NEVER TRANSFER A CII
How many TIMES can CIII-CV be transfered
ONCE

expected if shared real-time and is same RX #
How many times can a NON-CONTROLLED substance be transfer
as many as refills remain

and within ONE year of issue date
When a pharmacist makes a transfer, what do you do to transferred RX
VOID
Write your name, the name of pharmacist receing the RX, and the name, address, phone# of PDO, and DATE
What additional info must you have for controlled substance for the TRANSFERING pharamcist
VOID, Your name, pharmacist name receiving, the address, phone number and DEA and date
Pharmacist RECEVING tranfer what must you do for a transfered RX
TRANSFER on RX, issue and date of original Rx, number of original refill and remaining, date of last refill, Rx of original rx and tranfers pharmacist name address phone number and DEA# is CS
Only refill/dispense RX for up to 1 year from ISSUE DATE by
practicioner
For inital and FINAL evaluations what is needed
pharmacist name or inital or license or electonic ID
What is consider an inital interpretation?
reivew of the drug reigmen

know allergies
rational theapy/contraindications
dose, duration of use
directions
abuse/missue
What is considered the FINAL evaluations
medication if properly prepared in a suitable container with proper label
RECORDS of INITAL interpreations and FINAL evaluations MUST be kept for
2 yeasrs
What is INFORMATION needed on ALL initial and FINAL evaluations
DATE and pharmacists name OR INITIALS OR LICENSE #
DRUGS cannot be dispensed if there is NO recognized medical utility or application
TRUE
A WRITTEN Inital Evaulation and FINAL evaulation must be SIGNSED and DATED by the pharmacy manager documenting what
MANNER OF which all inital and final are handel
Where SHOULD the policy for how the pharmacy handles inital and final evaultions be POSTED
posted NEXT to board registration
How long should the written policy of how the pharmacy handels inital and final evaluations be KEPT
3 yrs from date of issue
What MUST The new manager due with the Inital and FINAL evaluation notice within
MUST sign and date within 72 hours
For internet pharmacies a pharmacist CANNOT dispense an RX based on what
internet based questionari
internet based consultatn
telephone consultation
For internet RX to vaild what must
face to face occurf
What is considered a legitmate doctor-patient relationship
pt has medical complaints
medical history taken
physican exam
logical connetion between complaint, history exam and prescribed drug
For an RX to be valid, it MUST be issued for a legitiimate medical pruspse by practiconer with >1 in person medical evaluation
YES
Is an RX for a NON-CS and CS for "office use" for a prescriber valid?
NO

only exception to OFFICE USE for compounds!!!
What is the ONLY an RX for office use is valid
giving compounds to physicans
In general drug can NOT be returned or exchanged for resdipensing, what are the expections
UNIT DOSE packaging
Customized pt medication
RTS
RTS can be returned to stock, what is experiration date
1 yr or maufacturer's date
For HIPPA must be block out the pt's name and other PHI
YES
DEA issued cation for pharmacies to take back CS, except
recall or dispensing error
If an RX is return to stock, what must happen
Written record, with the RX number, drug name/strength, QTY returned, date of returnCa
Can auotmated cassette be used for CII's
NO
Does the SBOP insepct the manufacturer's maintenace adn cleaning records for automated cassettes?
YES
What is packaging
preparing a drug in a container other than the orginial manufacturie's container
Pharmacies may accept UNUSED NON-CS CANCER drug from a pt or family if
unopeneded unit dose packing
drug NOT expired
does not require refiergation and dispense to uninsured
Interns require 1500 hours which all can be through the school of pharamcy
YES
What is the maximum hours an interns can have with a drug manufacture or research
450
A preceptor is what
oversee the pharmacy intern
2 years licensed and in practice, no discipline for last 5 years, ad
Preceptor can be approved by who
SBOP or school of pharmacy
A pharmacist can only supervise a MAX of how many interns
2 interns
A pharmacist must notify SBOP in 30 days of what
employment change or address change
Pharmacy manager must notfiy the board of quiting
immediately
MUST a pharmacist or pharmacist intern wear an ID badge
YES
For the Naplex and MPJE, must pass both within what time frame
24 months
If license is inactive or expired 24 months or less, what is need to reinstate
24 hours of CE
If license is inactive for >24 months what is needed to reactive
1 ce for every month inactive and PASS MPJE
A PDO must register with the SBOP
YES
MUST a NON-RESIDENT PDO who ships, main or delivers RXs to Colorado also be reigistered with the SBOP
YES
When should you apply to SBOP before relocation of PDO
30 days
Must you apply to SBOP upon tranfer or ownership interest 20% or greater
YES
If a PDO closes within 72 hours what must happen
RX must be relocated to another PDO where pts can doctor can access
Both instate and non-resident PDO must be under the direct charge of pharmacy manager
YES
PDO SBOP resigistration is VOID if mangaer cease to be manager, and the owner must apply to transfer new manger within
14 days or PDO will close
NON-resident PDO has writtent notice to board all all the pharmacist dispensing how often must they inform
ANNUALLY and within 30 days of office/officer/pharmacist cahnge
CS inventory must be completed within what timeframe of a manger/owner leaving
72 hours
A pharmacy must be open at least 2 days per week and at least 4 hours at a time
YES
When do you need to submit hours to board when what
open less than 32 hours a week
Compounding/Dispesing area must be at least 225 sq feet and how big for satellite
100
Must the compounding dispensing area have a sink with hot/cold water, refrigerator/freezer
YES
Must there be 24 inches of free floor spae between shelf and shelf sections
YES
A Professional referance library must be easily accesible-- and what must it contain
CO pharmacy practice act
colorado CSA
SBOP rules/regulations
DEA
Sterile/Cytotoxic compounding referance
Can the professional referance library be ONLINE if readily available
YES
For Security of pharmacy a pharmacist must always be within the building
YES
WHo can unlock a dispensing pharmacy
only pharmacist
IF SOLE pharamcist leave one PDO to enter another in SAME building what must happen
close 1st one
A security breach should be written to the SBOP within how many days
10 days
Colorado CDTM has been effective since 2005
YES
MUST a CDTM have BOTH a protocol and written agreement
YES
A pharmacist cannot review and evaluate drug thearpy until what
until 3 THINGS
physican diagnosis, order, and written agreement
What is a protocol
specific written plan for course of medical treamtnet
Are protocol that are vague, nonspecific or rely on pharmacist discretion insufficient
YES
MUST a protcol have instructions for responding to acute allergic reactions and ADR
YES
MUST a protcol be consistent with Evidenced based medicine
YES
MUST a protocol be SIGNED and dated by a physican
YES
A CDTM procotol is a written agreement between a licensed pharmacist and physcian, may either party withdrawl at anytime
YES
How often must the CDTM be reviewed
annually
CDTM requires an inital diagnosis by physican, and phsycian ORDER for referalal for an INDIVIDUAL pt
YES
Are blanket authorization permitted
NO
The pt must be informed of CDTM
YES
MUST The CDTM be on-file at practice location and available upon SBOP request
YES
What are the requirements for CDTM for pharmacist
1. Residency
2. ACPE certificate program and 40 hrs of supervised clinical training
3. BCPS
4. Grandfather cluse
What is the grandfather clause
practicing pharmacist prior to 8/1/05 and attest and certify they were provided clinical training
How long must CDTM records be mainted
7 YEARS LONGEST KNOW
MUST the manager reports

Substance diversion/LOSS (30 days)
Imparied pharmacists
Signifigant practice errors (resulting in death)
YES
Must a manager maintain recors?
YES

daily printout
II/FEE records
Sterile/Nonsterile compounding manual
What must the manager REPORT for each TECH
certification from national board
degree from program
500 hrs certifited by pharmacy manager
or documents that tech has NONE
Can a pharamcy give a provider an RX order form with pharmacy or pharmacist name
NO
Can a PDO only have one name
YES
PDO or hospital OTHER outlets may provide emergency kits of drugs to who
LTCF/ inpatient hospice

outpatients and HHA
Who is responsible for accuracy of contents of EMERGENCY KITS
manager
Who determines the content of LTCF or INPATIENT HOSPICE
consulting pharmacist and medical director
What is are the limits for LTCF and inpatient hospice
60 drugs/ 12 are CS

30 or less of ANY dosage form or strength
What is the ONLY kit that can have ORAL dosage forms
LTCF and inpatient hospice!!!
Who determines contents of HHA and outpatient hospices
director of nursing and pharmacist
What are the limits of HHA and OUTPATIENT hospical
60 drugs and NO controlled substances

30 or less of any dosage form or strenth

ONLY injections
What emergency kit does NOT allow ORALs
HHA/outpatients

only can have injectables!!!
All emergency kits must have tamper evident seal, and when do they expire
in 1 year or exp of earliest drug
When must a pharmacist or desingee inspect contents of KIT
within 72 hrs of being opened and ANNUALLY
WHO can receive emergency kit?
ONLY for FACILITY pts after a physican ORDER!!!
What NEEDS to be immediately available to board for inspection
1. EXCEUTED 222 forms
2. CS recors
3. RX drug orders
4. RX and CS distribution, loss or surrder or disposal

ALL In last 2 years

also need

5. pharmacist/intern in last 2 ears
6. manguactor distributor or repackager
What things can be available to BOARD in 48 hours or (2 business days)
1. UNexexcuted DEA 222 forms
2. receipt records for NON CS
3. anything else
What MUST the CS inventory records
1. Name, strength and dosage form
number of units, and outdated CS
exact or estimated count
RX drug outlet can use computers for RX using method A or B, what is method A
computers system must produce DAILY printout q 24 hours
Method A produces a daily print out every 24 hours, what what
NEW rx differentitai from refills
CS from non-CS
indenity of pharmacist
For method A, for daily documentation of CIII-IV, you need wither
final evaluation that pharamcist verifies
OR
pharmacist signs a separate log book
Must there be an manual produced in event of computer failure for method A
YES and must be restored into computer within 7 days
What is METHOD B
on-line RX info retriveal
Method B is an online info retrival, that is back up every 24 HOURS, must be printable at inspector's request OR have LOCK OUT feature
YES
METHOD B (on-line) rx orders must prinited within
2 hours

OR PROVIDE COMPUTER and ASSISTANT for REVIEW
METHOD B if you want RX orders sorted by variables how much time do you need to prodcue for inspectors
72 hours
What is needed on RX recepit of DRUGS (from Mckesson)
Date,
Name of drug, strength, dosage form and qty
geernic name and or NDC #
distributor and recieve outlets name and address

IF CS also both parties DEA number
A CII RX receipt what is main thing you need
222 FORM attached to invoive


REMEBER RECEIPT RECORDS ARE ALL MAINTAINED SEPARATELY!!!

II
III, IV, V
NON-CS
When must NON-CS receipt MUST be available for state board
within 48 hours
MUST CII recepits be separate from other controls
YES
What is NEEDED on record of distribution (casual sale)?
Drug name, strength, from #, manufactors NDC, date, name and address and DEA number of distrubting out and receiver
Can records of distribution be manual or electronic
YES
Is the peer health assistance program volunatary or mandatory
BOTH
Peer Health Assistance Program program provide a formal program to treat participatiant imparients
YES
How long are records in the PHAO after succesfful completion
3 YEARS
PEER HEALTH Assistance program reports to SBOP
quaterly
PHAO also reports if participant test + for drugs or is unable to practice with reasonable skill and safety
YES
How many people make up the Rehabilitation Evaulation Comittee
5 members

3 RPH (with 1 addict recovered)
1 Board staff memeber (non voting)
Phsyciarst or MH provfer (non-voting)
Trained pharmacist or trained interns may administer vaccine if completed
ACPE course 12 hrs didactic and 8 hours LIVE, CPR
When the SBOP inspects vaccines what is needed
Certifate of CDC approved course, CPR card
COPY of MD authorization and proctol for allergic reactions
and written policy for contaminated supplies
How long must immuinzation records be maintained
3 yrs
How are vaccines administered according to SBOP
CDC recommended
MUST all pts receive the VIS
YES
MUST pts give written, and sign informed consent
YES
Who should receive Adverse events
VAERS and pts PCP
When is needed on the immunization records which are maintained for 3 years
Pt name address and physican date and address, DOB, response to indication/contraindiction
date/site of injection
name dose, manufacturer lot # and exp date
Must the VIS verison and date also be on immunization records
YES
What is most day supply you can provide for compounding
90 day supply or less
ALL compounded drugs are pursuant to a practitioner's order
YES
Detailed labeling rules are required for sterile/non-sterile Rx, what must be added to ALL labels
Beyound use date
Lot number and this product was compounded by the pharmacy
Must a PDO keep records on practitioners and OTHER PDOs it DISTRIBUTION to
YES
What information should you receive from another PDO prior to giving a CS
vefifciation or DEA registration of licence
Can CS be distributed outside the US
NO

only expection is PDO is registered with DEA as an exporter!!
What policy and procedure manual is required of all PDO
NON-sterile
How often should the Policy and Procedure manual for NON-Sterile be review by manager
annual and also signed annual
When must the new manager sign the NON-sterile policy and procedure manual
30 days
When a Policy and Procedure mangual required fro STERILE products
if sterile compounding is preformed
What policies should Policy and Procedure manual follow for compounded products
USP 797
IF a STERILE drug is categorized as immediate use, when exp time for room temp vs refrig
1 hour for room temp

1 for frig
IF a STERILE drug is categorized as LOW RISK > 12 h, what is room temp, refrig, and freeze exp date
Room temp is 48 hrs
Refrig is 14 days
Freeze 45 days
If a is LOW risk <12 hours BUD, what is room temp, refrig
< 12 hours


NO freezer
What defines a LOW risk sterile product
<3 sterile products
What defines a medium risk sterile product
multiple pts or given on multiple occasions

THINK M
What is consider a HIGH risk CSP
drug componded with NON-sterile compoents
What is expiration date for NON-sterile products for SOLIDS (non-aqeous liquids)
6 months or

25% of time remaining whichever is eariler
What is the expiration date of water non-sterile fomulations
14 days at cold temp
If a formulation is intented for 10 supply when does it expire
10 days
All personal who prepare CSP shall be provided training beforehand, and (diactic review, pass written and media fill testin and aspectic skill initital) adn how often reivew
ANNUALY for low and medium

every 6 months for HIGH risk
How often should clean rooms and primary enginereering control be certified
every 6 months
SHALL all records of CSP be maintained for 2 years
YES
When does sterility testing must occur for CSP
Batches >25
multiple dose vials for multiple pts