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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
|
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What is the MAXIMUM number of casual sales of total number of drugs you can DISPENSE and DISTRIBUTE on an ANNUAL bases
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10 %
5% is for CS |
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Compounding is the prepartion, mixing, or labeling of drug, what MUST be what
|
pt specfic, result from practitioner RX
|
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Can certain compounds be prepared in advanced when
|
in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns
|
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For a RX order, the purose for the drug MUST appear on the labels when
|
if provided by doctor AND patients requets
|
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Do pharmacist have prescriptivie authority
|
NO
|
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What is a pharmacy manager
|
direct control of 1 prescription drug outlet
|
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What is a pharmacy technician
|
unlicensed person who performs duties under the supervision of a pharmacist
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The practice of pharmacy (for pharamcist) is what
|
interpretation, evaluation, implemetation, and dispensing of roder, pt cousenling drug serach and pharmaceutical care
|
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What is the practice of pharamcy for technicians
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drug/device prepartion, mixing, assembling, labelings, delivery, storage and receord keeping
|
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Must pharmacist be on location to superivse technicians
|
YES
|
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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
|
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Does the State Borad all keep records, supoena witness, and embargo misbraded/adultered drugs
|
YES
|
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Insurance companies for pharmacist and self-insured pharmacist must SEND malpractice claims to
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STATE BOARD
|
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After a liscense is revoked, you CANNOT reapply for
|
2 years
|
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Must the pharmacy manager be a pharmacist
|
YES
|
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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 |
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RX drug outlet MSUT display what
|
BOARDS registration with owner's and manager name
|
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What also must be displayed besides OWNERS and manager's BOARD registration
|
all pharmacist, and interns
|
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What must you do to transfer ownership or change name or LOCATION of rx drug outlet
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must apply to board
ALSO MUST LET DEA know if have CS |
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A pharamcy can reigister as a compounding PDO with SBOP if
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Accreditted or PDO is owned solely by a pharmacist
|
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If a pharmacy is compounding accredited, how much can they compound and DISPENSE/DISTRIBUTE
|
compound more than 10% of total sales
|
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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% |
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If a PDO is a registered compounding PDO may dispense compounding without 10% limitation to WHO
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Practitioners or PDOs with the SAME OWNERS
|
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You can NOT compound commerically available drugs EXCEPT
|
if signifcantly different or best medical interest of pt (dye allergy AND
MUST NOTIFY PT |
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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
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pharamcist direct and immediate supervision
|
|
A intern CANNOT do what
|
SUPERVISE, perform inital interpretation or FINAL RX evaulation
|
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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 |
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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
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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
|
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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
|
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For anabolic steriods what MUST be on the label
|
PURPOSE MUST BE ON LABEL
|
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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 |
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ONLY TIME you can give a higher price med instead of generic is if waht
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pt consents
|
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When can a pharmacist NOT substitute generic drug
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if stated dispensed as written, hand-writted or orally communicatted by prescriber
|
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Can DAW be preprinted on faxes or rxs
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NO
|
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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
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within 30 days
|
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Can you have you liscence revoke if you are unfit or imcompetent
|
YES
|
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Types of Discipline include refusal to renew, letter of admonitition, condition on license, training
|
YES
|
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It is UNLAWFUL to coerce a pharmacist to dispense against her better judement
|
YES
|
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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
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ONCE
|
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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
|
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Controlled substance records must be kept for what
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2 years
|
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What must CS records contain
|
Date
Pt's name/address CS drug and number CS theft |
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When are CS theft must be reported and WHO for COLORADO LAW
|
30 days to STATE BOARD and LAW ENFORCE
|
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Ad for brand name drug must also include generic
|
YES
|
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Must CS records be kept confidentidal
|
YES
|
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Colorado Precription Drug monitoring program MUST matain CS tracking, and gives specfic INDIVIDUAL info to who
|
Practitoners
Pharmacists Law Enforcement Pt |
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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 |
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Can a pharamcist be EMPLOYED and DISPENSE FOR A DR
|
NO
|
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Can you interefere with the pharmacist/patient counseling
|
NO
|
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ALL PRECRIPTION drugs MUST be procured from what
|
SBOP registered entity and PERSONS
|
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IS A TIMELY report of misconduct in pharmacy required when
|
danger to health, safety or welfafe of pt
|
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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
|
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Are there Rx drug outlet referral fees to health professionals
|
NO
|
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When MUST you write on a Rx that is given to pt, who has already fill RX
|
COPY FOR REFERANCE ONLLY
|
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When you WRITE COPY FOR REFERANCE ONLY, what must you write on orginial
|
initals, date and copy indication
|
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Are RX tranfers allowed between 2 interns
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NO
|
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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 |
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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
|
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Pharmacist RECEVING tranfer what must you do for a transfered RX
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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
|
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Only refill/dispense RX for up to 1 year from ISSUE DATE by
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practicioner
|
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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 |
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What is considered the FINAL evaluations
|
medication if properly prepared in a suitable container with proper label
|
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RECORDS of INITAL interpreations and FINAL evaluations MUST be kept for
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2 yeasrs
|
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What is INFORMATION needed on ALL initial and FINAL evaluations
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DATE and pharmacists name OR INITIALS OR LICENSE #
|
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DRUGS cannot be dispensed if there is NO recognized medical utility or application
|
TRUE
|
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A WRITTEN Inital Evaulation and FINAL evaulation must be SIGNSED and DATED by the pharmacy manager documenting what
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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
|
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How long should the written policy of how the pharmacy handels inital and final evaluations be KEPT
|
3 yrs from date of issue
|
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What MUST The new manager due with the Inital and FINAL evaluation notice within
|
MUST sign and date within 72 hours
|
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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 |