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184 Cards in this Set

  • Front
  • Back
What is casual sale
transfer, delivery or distribution of RX drugs to non-consumers
What percentage can casual sale NOT EXCEED
10% of total # of drugs dispensed and distributed on an ANNUAL basis
What is compounding
prepartion, mixing, asembling, packaging or labeling of a drug
What is required for compounding
must be patient specific
from RX order
cannot distribute to Dr for treating patients
Can compounds be prepared in advance under certain condition
When must purose for drug appear on label
pt requests or provided by doctor
Do pharmacist have precirptive authority
How many drug outlets can a pharmacy manger direct control of?
ONLY 1 pharmacy
What is a pharmacy technician
unlicensed person who performs duties under supervision of pharmacist
What are duties of pharmacy technician
labeling, delivery, storage adn record keeping, adn compound
Must a pharmacist always be on location?
What are powers dutes of state board
grant and renew licenses, or deny, suspend or revoke, and keep records and collect fees, and investiage violations
Can state board subpoena witness and embargo misbranded/adulterated drugs
Must you tell state board when you settle of malpractice claim or judgements
Must you send into to state board reguarding insurance
After your license is revokes, you cannot reappy for licensure for at least
2 years
Must the pharmacy manager be a pharmacist
IF a pharamcy mangers terminates empolyements that must
OWNER must transfer state borad registration to new manager within 14 days, adn
When does new pharmacy manager need to notify board
What must RX outlets display in regards to registrations
owner and magager's name, pharmacist, and intern licences
Do you need to apply to board to transfer ownership or change name or location of RX outelt
Who can manufactors or wholesalers sell drugs to
wholesalers, hospitals, RX drug outlets, and practioners's
Who can make casual sales
Rx drug outlet, or hospital
Who can Rx drug outlet or hospital makes sales to
Wholesaler,praticioner, or other rx drug outlets
Is it in progress for authorizing pharmcist to compound drugs for "office use"
Pharmacy give 24 hr drug supply to reistered ER patient by employee if
ordered by pracitioners, or if employee can administer or dispense meds
What can interns do
all parts of pharmacy as long as under direct and immediate supervision
What is max amount of tech a pharmacist can supervise
If pharamcist supervises 3 tech, what is required
1 tech, has certification by board, training degree or 500 hrs expericence certified by pharmacy manager
What is max amount of interns a pharamcist can supervise
2 interns-but also 1 tech
When may a pharmacist refill w/o prescriber authorization if
resonablly tried to contact Dr
med is necessary for pts health
and old rx does not state "no emergency filling"
What is max amount of days for an emergency refill, any liability if doc refuses after filling
72 hours supply, NO
Is there any liability to pharmacist or drug outlet to refuse emergency refill
For labeling what needs to be on bottle
1. Pharmacies name and full addresss
2. patietn name 3. Doc's Name
4. Rx #, 5. Date
6. Directions
7. Drug
8. Cautionary Statements
Can RX labels use the title Dr. for nurse practitioners or PA
What needs to be on label for anabolic steriods
purpose must be on label
4 Ways a pharmacist MAY substitue generic drug
-communicated to patient
-if its on RX/file
-cost to patient is less than prescribed
Does patient have to consent if lower cost drug is not in stock, and only higher price drug is
When MAY NOT a pharmacist substitute a generic
hand-written, intialed by prescriber or orally
Do you have to follow DAW for facsimle?
Can you lose your license if you commint of felony or do not notify board within 30 days of any criminal convictions
Can you lose you licence if your deemed unfit or incompetent
Can you lose your licence is you fail to notify pharmacy of disapline in another state
What are types of disciplines
refusal to renew, suspension, revocation
conditions on license
fines on pharmacies
What is letter of admonitions
confidential letter of concern
What is condition on license
make you retake exam, training, supervision or restrictions
How much pharamcies may be fined for violations
What is only thing in law that allows you not to dispense something
to coerce a pharmacist to dispense against his/her better judgement, or coerce a non-pharamcist to practice pharmacy
Can pt of licensed facility or pt's family donate unused meds
Only what type of medications can be resipensed for LTC, adn to who
NON-controlled meds from nursing homes, in-pt hospice, assisted can donate to another pt of same facility or medcial ssistance program
Examples of licensed facility
hospital, hospice LTC, and assisted living
Requirement of meds in order to be redispensed
unopened and sealed or individually packaged-unit dose, and customized patitient medication packages
When do meds expire after donation date
< 6 months
What is Colorado Cancer Drug repository program
PHARMACIES may accept prescription drugs to be re-dispensed from cancer pts or families
Requirements of meds in order to be redispensed
unopened, sealed containers FROM MANUFACTURER, unit-dose, does not require refirgeration or patient registration
What patietns can recieve the cancer meds and cost
uninsured/underinsured, can only charge a HANDLING fee
On Controlled substances records they MUST show
DATE, pt's name, address, CS kind and #
How many days to you have to report CS theft to law enforecement and board
30 days
Is there is an AD for a brand name drug is must include
Must CS records be kept confidential
Must the borad develop adn maintain a CS prescription tracking program
What must board develop in CS RX tracking program
Pharmacy Name and Addres, Pt name, Docs Name, Date, Drug, QUANTITY, method of payment
What other data is needed for CS RX tracking program
other data to determine if a pit is using multiple precribers or pahramcies for same or similar med
For electronic moitinoring of CS RX drugs who should that data be available to
DR's prescribing or moinitoring abuse, pharamcies dispencing to patient, law enforcement with court order, adn patient
Can a pharmacist be EMPLOYED and dispense for a prescriber
Can a Rx drug outlet have referall fees to other health profession persons
WHen do you have to timely report to board pattern of misconduct if
dangeer to health, safety or patietn or public welfare
Who are the only people that can take an oral order
intern/pharmacist--electronic ok
If there is an order clafification or change what needs to be on hard copy
initals, date and person conveying change
What needs to be on RX process ordered for substituted drugs
Dates, BOTH drug names, and NDC# OR distributors
Can a computer alter prior transcations?
How long should we keep refill info
2 years
What type refill info is needed
rx order, or daily computer prinout, person who authorized refill, pharmaicist name or license #, date adn quantity if changed
Can tech entry?
Yes, as long as no intrepration
If patient wants a copy of orginal script what must we do
have COPY FOR REFERENCE ONLY, and initals and date
What does an Rx transfer require
ONE pharmacist--can't have 2 interns
Can electronic tranfers be done by techs
yes if no changes are made
How many times can a CIII-CV be transferred
ONCE--unless RX does not change (kaiser)
Can Non-CS drugs be transfered as long as refill remain
Must pharmacist name inital or license # be on final evaulation of dispensing record
Can drugs be dispensed if no recognized medical utility or application
Must pharamcist ensure drugs are issued for a "legitimate medical purpose
Can an internet pharmacy dispense if no valid preexisting patient-practitoiner relationship
Pharmacies cannot dispense on basis of what 3 thigns
Internet based questions
Internet based consultation
or Telephonic consulation
What is expection to rule that drug name on container must drug IN container
research with placebo
What are only drugs that can be returned
Unit dose
Customized patient medications
RTS (patient never picked up_
If a pharamcy accets unused meds for resdispensing what must this have
RETURN protocols approved by SBOP
What are automated cassettes
containers that counts, packages for dispensing and labels RX drugs
Can automated cassettes be used for CS
When can you compound for <90 supply
based on prior 6 month history, for RX, adn formulations and compounding records are kept
Can you do causal sales to practitioners if <10%
yes--still fine pointing
What must be on labeling of compounded product
quantity, Quantity of active ingredient, beyond-use-date, and this product was compounded by pharamcy, and lot number, and storage
How many hours are require for internship, max hours with drug manufactor or reserach
1500, max 450
How long does a preceptor need to be licensed and in practice, and w/o disciple
2 years--5 w/o disipline (LOA dont count)
When must interns notify SBOP of address change or another empolyer
30 days
Are pharamcist and interns required to wear ID badge with license #
When must a CS take place with a manager change, and by who
72 hours, new manager/ or owner
How many pharmacies in same physical place
only 1
Minimum pharamcy hours, when must submit hours to board
2 days per week, and 4 hours, must submit if less than 32 hours
Does State board require professional reference library, is electronic ok
What needs to be in professional reference library?
CO Pharmacy Practice ACT
CO. Controlled Substance ACT
Board Rules and Regulations
DEA CS Rules
Can only pharamcist unlock pharmacy
If there are any security breaches, when must they be written to SBOP
within 10 days, even if no one entered--security breech anytime someone unlicensed enters pharmacy
Are prescription drugs outlest requied to adequate inventory, pharmacetuial servieces, adn have no contidtions likely to lead to error
What is CDTM
Collaborative Drug Therapy Managment
What do pharamcist do in CDTM
provide, monith and implement and modify drug therpay
How can pharmacist perform of roles of CDTM
after physican diagnosis, order and written agreement adn follow protocol, and inform patient
What must pharamists following when monitoring and implementing drug theraphy
protocol with clear criteria, and specific directions for pharamcist to follow
Do protocls have to be consistant with evidence-base medicine
Must protocols be signed and dated by authorizing physician
How often is CDTM reviewed
What must a CDTM pharamcist submit
notification form, and written agreeemtn w/ physican or gernal authorization plan
How long must CDTM records be maintained
7 years
How much libability insurance must CDTM pharmacist have
1 millon dollars
For each tech, the manager must post
1. Certification
2. Training program degree
3. 500 hrs expereince
4. Documentation that tech has no of the above
For CDTM access to protocols at pratice location are required what else
scietific literature which protocols are derived
What are one of 5 qualifications you must meet to be CDTM pharmacost
1. Accredited pharmacy practice residency
2.BS Degree
3. Pharm D.
4.BCPS or National INstutie for standards in Pharmacist
5. In-pt and HMO
For CDTM if you have a BS what else do you need
ACPE certificate program and 40 hrs superivsed
What else is needed for Pharm D. and CDTM
40 of CE clinical practice, and 40 of supervised clinical training
What is gradnfather clause for CDTM 8/1/05
needs attest adn certify clinical traning, doc needs to attrest and, yo need to attest and show documentation
Do you have to have procedures for RX delivery/stroage outside pharmacy at request
IF you Pharamcy drug outlet goes out of buiness do you have to removed RX to another outlet
Where does ID of final evaulation pharmcists need to be
on daily printout, or other maintain and easily accessed record
Can pharmacy give RX order form with pharmcy or pharmcist name on
If in legal proceedings allegin a drug or device law when must you notify board
in writing within 72 hrs of knowledgle
When must you notify board of disposition
within 30 days
Who determines contents of emergency kits of approved facilites (nursing, intermeidate and extended)
Medical director and pharmacist
What are approved facilites emergency kits limited to
60 drugs/12 CS
<30 doses of one drug dosage or strength
orals allows
Who approves home health and hospice kit contents
Pharmacist and nursing director
What are emergency kits contents of home health and hospice
60 drugs
<30 dosages of any doage or strenth
ONLY injectables
Expections not to have drug records not immediately retriveable
off-site storage approved
board approval to not keep orgainal ns records--can instead be online
What are 5 things that need to be immeditely available to SBOP
1. DEA 222 forms
2. CS inventories
3. RX and CS-distribution, losss and surender or disposal
4. Pharmcist/intern list x2years
5.Manufactor or distributor
For CS inventories do you need to include drugs dispensed, but not yet given?
What needs to be on pharmacist intern employee list
name, license #, sample of initials, signature and starting date
What is method A
produces daily prinout
For daily documentation of CIII-CV what do you need 1 of
either final evaultion of hard-copy
or sign a separate bood attesting computer info is correct and reviewd
When must manual data be restored in event of computer failure
7 days
What is Method B
online-RX info retrival
At inspectors requests when must you print RX orders with, adn sorted by
within 2 hrs, adn sorted by variable in 72 hrs
If you do not print RX orders for inspect in method B, then what must you do
provide an assiatnt to help inspect review RX orders by computer
IF non-CS are off premises, when must they be availabe to inspector
2 business days
In the Voluntary peer health assiatnace organization, who are the 5 memebers
3 RPHS (1 recovered)
1 Bd staff member (non-voting)
1 Pyschiatrist or MH provider (non-voting)
What do rehabilitation evaulation committe members do
reccomed to board if they can pracitce again, and magaing contract with program
What are examples of PHI
name, address, name or relativies, DOB, email, picture
What is only way you can disclose an invidiauls PHI
if for treatment, paymentment or operations of your job
Can you disclose an individuals PHI to the invidual
How many years must we have of information of the disclosures we make
6 years
Must a business have written policies and prodcedure for follwoing hippa, adn must we train ALL employees
How long is a Colorado pharmcist licenesed issued for and when expire
2 years, expires on ODD years
How long are Colorado outlet registered for
1 years, expire also 10/31, must be renewed annually
How many CE are required every 2 years by who
24hrs CE by ACPE
When do not need CE
if you renew licence within 1 year of completing pharamcy school
How many hours does SBOP accepts of CME for doctors
6 hrs
What is APN,RN, CPN, and requirements
listed on board of Nursing APN registry
written collabtive agreement with DOC, adn RXN # from board or nursin
What are limits of ANP prescriptive authority
within practice, w/o docs supervision, and has own DEA #
What is DDS or DMD, and requirements
Denstist, and colorado license
Limits of DDS prescriptive authority
any drug within practice, can do CII--not self unless emergencies
What is OD, and requirements
Colorado License, adn certified as Therapeutic Optometirst TPA
What are OD limits on prescriptive aurhtority
antibiotics, antihistamines, anit-inflamm, and analgesics, and anti-glucoma
Can an OD prescribe CII
Limits on Exams of OD
mydratitics, mitotics, cycloplegics, and anesthetics
What are requirement for MD DO
colorado license
What are requirements for PA
CO certification by board of medical examiners
Limits on PA
within doc's practicing area
written RX on supervising RX form-own DEA #
What is required for presciption with PA
must be on supervising docs rx form, with docs preprinted name, address and telephone #
Any limits on DPM or DVM
any drug within practice
Must state license wholesales or distributors if in complinace with federal guidelines
Can community pharmacist receive any drug samples
NO prescriptions---only OTCs
Are trafficking in drug coupans for a free drug ok
Who can receive drug samples
prescribers or hospitals/health care providers at written request
Can drugs samples be sold,purchased or traded
Must medical decvies be safe and effective, and can require pre-market approved
3 Classes of medical devices
1. Minor potential
2. Moderate
3 Major potential impact
Can pharamcist stock hazardous substances
Are child resistant containers required for all ORAL RX drugs
What OTCs requries requires child resistant containers
ASA, motrin, APAP, Fe+, lidocaine, naproxen, benadryl, adn loperamide
What is exception to child resistant containers
if labeled not children resistant, or upon patients request or docs request
Does child resitant apply to tocial or non-orals
NO--injectable ok
Is federal antitampering act enforecd by FDA, FBI,a dn Dept of Agriculture
Does 190 proof ethyl alcohol require a deal stamp or taxes
Do hopitals require a special AFT permit for tax-free etoh, should it be labeled to prevent unauthorized access
Can abortive drugs or devices be mailed
How must CII be mailed
2 wrappers, one plain outer, adn 1 inner with pharmacy
What is national practitioner data bank?
inhibts interstate movement of incompetent practicioners