Chapter 4 fl pt 2 Flashcards
(133 cards)
1
Q
What functions may only a pharmacist OR registered intern (under the direct and immediate personal supervision of a pharmacist) may perform?
A
1) supervising and being responsible for CS inventory
2) receiving verbal rx
3) interpreting and identifying rx contents
4) engaging in consultation w/ a practitioner regarding interpretation of an rx and data in a pt profile
5) engaging in professional communication w practitioners, nurses or other healthcare professionals
6) advising or consulting w a pt, both as to rx and pt profile record
7) final check of a completed rx (NOT AN INTERN**)
8) being personally available to the pt or pt’s agent for consultation
9) preparing parenteral and bulk solutions
2
Q
Non-delegable duties of an rph to pharm techs
A
1) receiving new, verbal rx or receiving any change in the med, strength, or directions of an existing rx
2) interpreting an rx or med order for therapeutic acceptability and appropriateness
3) conducting the final verification of dosage and directions
4) engaging in prospective drug review
5) monitoring prescription usage
6) overriding clinical alerts
7) transferring an rx
8) preparing a copy of an rx or reading an rx to any person for purposes of providing reference concerning tx of the person or animal
9) patient counseling
10) receiving therapy or blood product procedures in a permitted nuclear pharmacy
11) pharmacist professional judgement
3
Q
How many pharmacy technicians shall not supervise more than ____ registered pharmacy technician
A
one
(still in the law this way but not technically correct as it is not up to date, see the 6:1, 3:1 and 8:1 ratio rule)
4
Q
Any pharmacy or pharmacist may allow a supervision ratio of up to ___ registered pharmacy technicians to one pharmacist as long as the pharmacist or registered pharmacy technicians are not engaged in sterile compounding
A
6:1 ratio
*NO STERILE COMPOUNDING
5
Q
Any pharmacy or pharmacist engaged in sterile compounding shall not exceed a ratio of ___ registered pharmacy technicians to one pharmacist
A
3:1 ratio – STERILE COMPOUNDING
this ratio only applies to pharmacists and technicians engaged in sterile compounding and does not affect the tech ratios for other activities not involving sterile compounding in areas of pharmacy separated from the sterile compounding area.
AKA a pharmacy could have 3 techs involved in sterile compounding supervised by a single pharmacist and 6 additional techs in a separate area involved in other dispensing being supervised by another pharmacist
6
Q
A pharmacy may allow a supervision ratio of __ registered pharmacy techs to 1 pharmacist if the pharmacy is a NON DISPENSING pharmacy or it is a dispensing pharmacy
EX: CALL CENTER or remote order processing pharmacy that does not dispense meds
A
8:1
NOTE: it may utilize an 8:1 ratio in any area physically separate (by a permanent wall or barrier) from the area where drugs are dispensed and there is no sterile compounding taking place.
EX: CALL CENTER
7
Q
Who determines the appropriate pharmacist-technician supervision ratio?
A
Prescription Department Manager or Consultant Pharmacist of Record
NO OTHER PERSON, PERMITTEE, OR LICENSEE
8
Q
Registered pharmacy interns can perform the same acts as a pharmacist when under the direct and immediate supervision of a FL licensed Rph. This includes those duties that a pharm tech can not perform such as counseling pts, receiving verbal rx, etc, EXCEPT:
A
-final check of an rx
-administering flu vaccines to pts 7 years of age of younger
9
Q
There is no maximum ratio of interns to pharmacists except when an intern is performing _______________ and for ____________
A
immunizations and for foreign pharmacy graduate interns
1:1
10
Q
A certified pharmacist (or certified registered intern) may administer vaccines to adults under ..
A
a written protocol with a supervising physician
(pharmacist & physician, not a pharmacy)
11
Q
To obtain certification for vaccinations, a pharmacist (or registered intern) must complete at least __ hours of CE concerning the safe and effective administration of vaccines, INCLUDING: CPR training
A
20 hours
12
Q
To maintain immunization certification, an rph must complete __ hours of CE during each two-year renwal
A
3 hours
13
Q
What immunizations are pharmacists allowed to administer?
A
flu
Tdap/td
HPV
Zoster recombivant/RZV
MMR
PCV13
PPSv23
Meningococcal ACWY
MenB
HepA
HepB
Hib
Varicella
immunizations recommended for travel (yellow fever requires further qualifications)
emergency use vaccines
14
Q
A pharmacist may not enter into a protocol unless he or she maintains at least ______ of professional liability insurance
A
$200,000
15
Q
Immunization records must be maintained for ___ years
A
5 years
16
Q
Florida allows certified pharmacists and interns to administer CDC recommended vaccines but only to patients __ years or older
A
18+
17
Q
FL is one of the few states that restrict pharmacists from administering vaccines to children; the only exception:
A
- Pharmacists (not interns) may administer to individuals 7 years of age or older for influenza vaccines
18
Q
_______________ means a system of standards and procedures to identify and evaluate quality-related events and improve patient care
A
Continuous Quality Improvement Program
19
Q
________________ means the inappropriate dispensing or administration of a prescribed medication
A
Quality Related Event
20
Q
What constitutes as a Quality Related Event?
A
1) a variation from the prescriber’s prescription order
2) failure to identify and manage:
-overutilization or underutilization
-therapeutic duplication
-drug-disease c/I
-drug-drug interactions
-incorecct drug dosage or duration of tx
-drug allergy interactions
-clinical abuse/misuse
21
Q
A CQI committee that reviews quality related events at least every _____ months
A
three months
22
Q
A pharmacy shall be inspected ____ during the first year of operation
A
twice
23
Q
A pharmacy which has had passing inspections for the most current three years and no discipline during that time shall be inspected every ___ years
A
two years
24
Q
A pharmacy which fails to pass an inspection or which is disciplined during the two year inspection cycle, will be inspected
A
annually until it achieves passing inspections and no discipline for the most current three year period
25
The prescription department of each pharmacy must have the following items:
- current pharmacy reference compendium (USP/NF, USP DI, Remington's science and practice of pharmacy, facts and comparisons, or EQUIVALENT, etc)
- current copy of laws and rules governing the practice of pharmacy
- phone # to nearest poison control center
- library requirements may be maintained in a readily available electronic format
26
List the label requirements for Drugs Dispensed to a patient
(8)
1) name and address of the pharmacy
2) date of dispensing
3) serial number (prescription #)
4) name of the patient, or if the patient is an animal, the name of the owner and species of animal
5) name of presriber
6) name of drug dispensed
7) directions for use
8) expiration date or BUD (cannot be greater than one year from the date dispensed)
9) if rx is CS, the federal transfer warning is required
27
List the label requirements for Customized Medication Packages
(9)
1) Name, address, telephone number of pharmacy
2) Date of preparation of the CPMP
3) Serial number (prescription number) for the CPMP AND a separate serial number for each drug dispensed
4) Patients name
5) Name of each prescriber
6) Directions for use and any cautionary statements required for each drug
7) Storage instructions
8) Name, strength, quantity, and physical description of each drug product
9) A BUD no more than 120 days from date of preparation
28
For all pharmacy permits, all original prescriptions shall be retained for a period of not less than __ years from the date of last filling
4 years
Note: this is longer than the 2-year requirement for controlled substance rx required by the DEA
29
Details regarding records maintained in a data processing (computer) system include:
- information stored in a computer system must be backed up at least ___________
- computer systems must be able to produce an audit trail of drug usage for the preceding ____ years
weekly
4 years
30
Records of dispensing - computer system must have the capability of producing a daily hard copy printout of all rx filled or refilled containing:
(8)
- rx #
- date of dispensing
- patient name
- prescribing practitioner's name
- name and strength of product dispensed (manufacturer if generic)
- quantity dispensed
- initials or identification of dispensing pharmacist
- if not immediately retrievable via CRT display, must also include patient's address, prescriber's address, prescriber's DEA # if CS, quantity prescribed if different from quantity dispensed, date of issuance of rx if different from date of dispensing, and total # of refills dispensed to date
31
If a pharmacy chooses to print the daily hard copy of records, it must be produced (printed) within ___ hours of date drugs were dispensed.
72 hours
32
If a pharmacy chooses to print the daily hard copy of records, each individual rph who dispenses or refills an rx shall verify that the data is correct by dating and signing (no initials) the daily hard copy within ____ days
7 days
33
Instead of printing the daily hard copy of records, a pharmacy may maintain a ________
log book in which each individual pharmacist signs a statement each day attesting that the info entered into the computer is correct
34
The computer system must be able to print a hard copy on demand by an authorized agent of the DOH. If no printer is on site, the hard copy printout must be provide within ___ hours or it is considered a failure to keep and maintain records
48 hours
*NOTE this is different than the summary record of CS dispensed in the last 60 days, which must be produced within 72 hrs
35
A pharmacy may perform centralized rx filling for another pharmacy if they....
- have the same owner
OR
-have a contact with the other pharmacy
36
centralized prescription filling -
on the rx label, which pharmacy is labeled?
both the central fill pharmacy and the originating pharmacy shall be identified on the label
37
centralized prescription filling -
the originating pharmacy must be identified on the label by _____ and ________
name and address
38
centralized prescription filling -
the central fill pharmacy may be identified on the label by ____
code
39
centralized prescription filling -
delivering prescription from a central fill pharmacy directly to a patient is allowed for what kinds of rx?
non-controlled ONLY
*DEA only allows central fill pharmacies to send filled prescriptions to the originating pharmacy
40
centralized prescription filling -
when a central fill pharmacy delivers a filled prescription to a patient, is it considered dispensing?
No, this is because it is treated more like the central fill pharmacy is delivering the rx on behalf of the originating pharmacy
41
A class II institutional central fill pharmacy may only deliver meds to ____________
the originating pharmacy
42
T or F
A community pharmacy which acts only as a central fill pharmacy and notifies the Board is exempt from requirements for a patient counseling area
True
43
When there is a change of ownership, what must be completed? (3)
- must provide transfer info to the BOP
- must complete and inventory of all CS
- transfers of CII drugs must be down with a DEA 222 form.
44
T or F
All outdated damaged, deteriorated, misbranded, or adulterated rx drugs shall be removed or quarantined from active stock
True
45
T or F
A human trafficking sign at least 11 in by 15 in size printed in 32 font must be posted in the pharmacy
true
46
Per the Florida Pharmacy Act, what drugs can a pharmacist order/prescribe and dispense?
1) any medicinal drug of single or multiple ingredients in any strength whose AI have been approved for OTC sale
2) any medicinal drug recommended by an FDA advisory panel for transfer to OTC status pending approval by FDA
3) any medicinal drug containing an antihistamine or decogestant as a single active ingredient or in combo
4) any medicinal drug containing fluoride in any strength
5) any medicinal drug containing lindane in any strength
6) any OTC proprietary drug approved for reimbursement by the Florida Medicaid program
7) any topical anti-invectives excluding eye and ear anti-infectives
47
Drugs that are prescribed and dispensed by a pharmacist per the Florida PHarmacy Act must have what included on the label?
1) name of the RPh ordering med
2) Name and address of pharmacy dispensing the drug
3) Date of Dispensing
4) Rx #
5) Name of patient
6) Directions for Use
7) Clear statement that the order cannot be refilled
8) Trade name or generic name
9) quantity dispensed
48
Any drug that an RPh orders, prescribes and dispenses cannot exceed a ____ day supply and cannot be refilled
34 day supply (or standard course of treatment)
Patient profile must be maintained for 4 years
49
A pharmacist can work with whom for Drug Therapy Management?
physician, PA, dentist, or podiatrist
APRNs are not included
"Prescriber Care Plan"
50
A CPA permits a certified pharmacist to enter into a CPA with whom?
physician (MD or DO)
for certain chronic conditions
51
What are the chronic health conditions in a CPA that a pharmacist can manage?
1) arthritis
2) asthma
3) COPD
4) T2DM
5) HIV/AIDs
6) obesity
7) HLD
8) HTN
9) anti coag
10) nicotine dependence
11) OUD
any others that are adopted by the board of medicine
52
to be a certified CPA pharmacist, one must complete an initial ____ hour course approved by the board
20 hrs
*no less than 8 hours of the course shall be offered through a live webinar or video conference
53
to be a CPA pharmacist, one must maintain at least$_________ of professional liability insurance coverage
$250k
54
CPA Pharmacist -
maintain records of all patients receiving services under a CPA for a period of _____ years from each patients most recent provision of service
5 years
55
a CPA shall automatically terminate __ years after execution if not renewed
2 years
56
T or F
In the event. of an addendum to the material terms of an existing CPA, the pharmacist shall send a copy of the addendum and the initial agreement to the BOP
FALSE; pharmacist maintains a copy of the addendum and initial agreement.
57
T or F
A physician may not delegate the authority to initiate or prescribe a CS as described to a pharmacist
true
58
A pharmacist who practice under a CPA must complete an __ hour CE course
8 hrs
59
Certification for testing or screening for and treatment of minor, non chronic health conditions include what?
flu
strep
lice
skin condition (ringworm, athlete's foot)
minor uncomplicated infections
60
Certification for testing or screening for and treatment of minor, non chronic health conditions;
the pharmacist must complete a onetime basis ___ hour education course
20 hr (8 hr live)
maintain $250k liability coverage
61
Certification for testing or screening for and treatment of minor, non chronic health conditions --
within __ days of entering into a written protocol with a supervising physician, a pharmacist shall submit a copy of written agreement to the BOP through the pharmacist's online licensure account
5 days
62
Certification for testing or screening for and treatment of minor, non chronic health conditions --
upon request from a pt, a pharmacist shall furnish records to a healthcare practitioner designated by the pt within a reasonable timeframe, not to exceed __ days
5 days
63
A pharmacist must provide written information to a pt advising the patient to seek f/u care with his or her primary care physician PRIOR or AFTER performing testing, screening, or treatment services for the first time?
prior
64
All community pharmacies must have a licensed pharmacist who is designated as the _________
PDM
65
in a community pharmacy, who is responsible for:
- maintaining all drug records
- providing for the security of the prescription department
-ensuring the pharmacy's compliance with all statutes and rules
PDM
66
When there is a change in PDM, no later than ___ days after the change, both the pharmacy permittee and the newly designated PDM shall notify the board of the change AND THE IDENTITY of the new PDM
10 days
67
A community pharmacy that commences to operate must have the prescription department open for a minimum of __ hours per week
20 hours
68
A community pharmacy may delay the commencement of operations after receiving a permit by notifying the BOP in writing within ___ days of the election to delay commencement of operations and the reason for doing so.
14 days
AND the pharmacy must display a 1in sign at the main entrance stating the pharmacy has not yet commenced operations and drugs may not be sold nor prescriptions filled or dispensed
69
Within ___ days of commencement of operations, the pharmacy shall notify the board in writing that the pharmacy has commenced operations and the date of commencement
2 days
70
Any pharmacy that fails to commence operations within ___ months of the date of receipt of the FL pharmacy permit shall provide a written state to the board office, which shall include the reasons the pharmacy has not yet commenced operations, the efforts the pharmacy has made to commence operations, and the date the pharmacy expects to commence
6 months
71
Any pharmacy not open ___ hours per week must post the days and hours the pharmacy is open and info for after-hours access and shall also have a written policy and procedure for transferring an rx or receiving an emergency dose
40 hrs
72
a pharmacist may take a meal break not to exceed ___ mins, during which time the prescription department is NOT considered closed
30 mins
a pharmacist is considered present and on duty during a meal break if the pharmacy posts a sign that indicates the specific hours of the day during which meal breaks may be taken by the rph and assuring pts that a pharmacist is available and on premises for consultation upon request during meal break -- a pharmacist may NOT leave the premises for a meal break
registered pharmacy technicians may remain in the pharmacy!!***
73
T or F
Pharmacists MUST substitute a generic equivalent, unless requested otherwise by the purchaser, if the drug is on the pharmacy's positive formulary
true
substitution is mandatory if the product is on a pharmacy's positive formulary. all community pharmacies are required to have a positive formulary in florida
74
a pharmacist may take a meal break not to exceed ___ mins, during which time the prescription department is NOT considered closed
30 mins
a pharmacist is considered present and on duty during a meal break if the pharmacy posts a sign that indicates the specific hours of the day during which meal breaks may be taken by the rph and assuring pts that a pharmacist is available and on premises for consultation upon request during meal break -- a pharmacist may NOT leave the premises for a meal break
registered pharmacy technicians may remain in the pharmacy!!***
75
When is it prohibited to substitute a generic equivalent?
-written prescriptions, a prescriber may prohibit substitution by writing the words "MEDICALLY NECESSARY" in his or her own handwriting on the rx
-verbal prescriptions, a prescriber may prohibit substitution by expressly indicating to the rph that the brand name drug prescribed is medically necessary
-electronic prescriptions. a prescriber may prohibit substitution by making an overt act to indicate that the brand name drug prescribed is medically necessary
76
What is a positive formulary?
Each community pharmacy shall develop a formulary of generic and brand name drugs which if substituted would not pose a threat to the health and safety of patients
it is available to the public, BOP, or any physician requesting it
77
What is a negative formulary?
the BOP and BOM shall develop a formulary of drugs that demonstrate clinically significant biological or therapeutic in equivalence which may not be substituted
78
The BOP and BOM must removed a drug from the Negative Formulary if every commercially marketed equivalent of the drug has a/an "__" rating in the FDA Orange Book.
A rating
79
A pharmacist may not substitute a generic drug for a prescribed brand name drug it is listed on the ____________ Formulary
Negative
80
If a drug is prescribed that is on the Negative Formulary, but no brand name is specified, a pharmacist must:
dispense a product that has an approved New Drug Application or Abbreviated New Drug Application to market the drug
Note: in this case, whichever brand is dispensed should also be used for any refills
81
What are the current drug on the negative drug formulary?
1) Digitoxin
2) Conjugated Estrogens
3) Dicumarol
4) Chlorpromazine (solid oral dosage forms)
5) Theophylline (controlled release)
6) Pancrelipsase (oral dosage forms)
82
T orF
Every Community Pharmacy shall publicly display in a prominent place with a clear and unobstructed view, at or near the place where prescriptions are dispensed, a sign in block letters not less than 1 in in height which reads:
"CONSULT YOUR PHARMACIST CONCERNING THE AVAILABILITY OF A LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG AND THE REQUIREMENTS OF THE FLORIDA LAW"
True
83
Prior to delivery of a prescription that has been a generic substitution, a pharmacist must:
notify a patient of any generic substitution,
the amount of the price difference,
and the patient's right to refuse the substitution
*method of communication is determined by rph
**rph must also inform a pt if their cost sharing obligation (copay) exceeds the retail price of the rx if they paid cash
84
True or False -
A pharmacist may only dispense a substitute biological product if the FDA has determined that the product is bio similar and interchangeable for the prescribed biological product
true
85
To date, FDA has only designated one biological product as interchangeable. What drug?
Semglee (insulin glargine-yfgn) was approved by FDA as interchangeable with its reference product Lantus (insulin glargine)
86
What is required to be recorded in writing or electronically for a transfer?
- prescription information
- name of the pharmacy transferred from
- rx #
- name of drug
- original amount dispensed
-date of original dispensing
-# of remaining authorized refills
87
What is required to be recorded in writing or electronically for a transfer that is RECEIVED?
- prescription information
- name of the pharmacy transferred from
- rx #
- name of drug
- original amount dispensed
-date of original dispensing
-# of remaining authorized refills
- name of requesting pharmacy, name of rph, date of request, cancel rx
88
T or F
Electronic transfers can only happen during pharmacy business hours
FALSE
electronic transfers of rx are permitted regardless of whether the transferor or transferee pharmacy is open for business
89
DEA only allows transfer of refills and not of original prescriptions for CS; although by policy, they allow original rx to be transferred if they are ___________ prescriptions for CS.
electronic
90
Pharmacies that are under common ownership or utilize a common database may dispense an rx in the common database and such a dispensing is NOT considered a transfer
T or F?
True
study tip on this **** to know!
91
In the event an rph receives a request for an rx refill and the rph is unable to readily obtain refill authorization from the prescriber, the pharmacist may dispense:
- a one time emergency refill of up to a ___ hour supply of prescribed medication
- a onetime emergency refill of __ vial(s) of insulin
72 hour
one vial
pharmacist must create a written order and sign rx, and notify prescriber
92
If the Governor issues an emergency order or proclamation of a state of emergency, the rph may dispense up to a ___ day supply in the area or counties affected by the order of proclamation provided that the rx is NOT a CII, the med is essential to the maintain of life or to the continuation of therapy in a chronic condition
30 day supply
93
Florida allows emergency refills for both non-controlled drugs and schedule _________ substances.
CIII-V
*this is FL law, no guidance from DEA
remember, no refills with CIIs!
94
What requirements are needed for a patient record? (6)
1) name of pt
2) address and telephone of patient
3) age or DOB of pt
4) patient's gender
5) a list of new and refills rx obtained by pt at the pharmacy during previous 4 years
6) pharmacist's comments relevant to pt's drug therapy
95
patient records shall be maintained for a period not less than ___ years from the date of the last entry in the profile record
4 years
96
A pharmacist shall review the patient record and each new and refill rx present for dispensing in order to promote therapeutic appropriateness by identifying:
1) over utilization or underutilization
2) therapeutic duplication
3) drug-disease C/I
4) drug-drug interactions
5) incorrect drug dosage or duration of tx
6) drug-allergy interactions
7) clinical abuse/misuse
97
T or F?
Florida does not have mandatory patient counseling, but requires an OFFER TO COUNSEL (both written and printed) for BOTH new and refill rx.
True
*counseling is up to the professional judgement of the rph.
98
When is counseling not required?
- inpatients of a hospital or institution where licensed healthcare practitioners are authorized to administer drugs (ie nursing home)
- pt refusal
99
What requirements must be met in order to have an Outpatient Dispensing Using an Automated Pharmacy System?
- under supervision and control of the community pharmacy
- the APS is housed in an indoor environment area and in a lcoation to increase pt's access to their rx
- notification to the board of location and any changes in location
- mechanism that provides LIVE realtime pt counseling by an rph in this state before dispensing of any medicinal drug
- confidential PHI
- NO CONTROLLED SUBSTANCES!!!!!!!!!
- maintains record of drugs dispense and identity of rph
100
For an automated pharmacy system, the community pharmacy shall review the policies and procedures how often and how long should they maintain record of the policies and procedures?
annually; 4 years
(policies and procedures requirements on page 200)
101
Prior to closing a pharmacy notification must be made in WRITING to the BOP indicating the date of closure and advising the board which permittee is to receive the rx files
T or F
true
The pharmacy permit must be returned to the board
102
On the day of closing the pharmacy must:
- physically deliver the rx files to a pharmacy within a reasonable proximity of the pharmacy closing
- affix a sign on the front entrance of the pharmacy advising the public the new location of the rx files
103
No later than ____ days after the pharmacy has been closed, the pharmacy permit must be returned to the board office, and the permittee shal file a written report with the board office containing the information required.
10 days
104
A written report to the board office for closing a pharmacy requires what information? (4)
1) confirmation that a sign has been posted, indicating the name and address of the pharmacy where the rx files have been transferred
2) confirmation that all legend drugs have been transferred to an authorized person or destroyed; if transferred, provide names of all persons
3) if CS drugs were transferred, the report must indicate the names and addresses of the persons to whom they were transferred
4) confirmation that DEA registration and all blank DEA 222 order forms were returned to the DEA Miami Regional office
105
Only _______ pharmacies can dispense CII or CIII rx.
community pharmacies (including limited community pharmacy permits)
106
Pharmacists may fill rx from fax orders sent by the pt, but may not dispense the rx until......
They have the original written rx
107
Per the BOP, drugs that were shipped to a patient but not delivered may or may not be returned to stock?
they may be returned to stock as they have not been dispensed.
the rph making the decision to return the drugs to stock of the pharmacy must exercise his or her professional judgement
108
Unclaimed rx may be retained by a pharmacy and be reused for a period of _________ from the date of filling unless it has an earlier expiration date
1 year
109
A pharmacy selling any quantity of dextromethorphan must require an obtain proof of age from the purchaser before completing the sale, unless the purchaser's outward appearance the person making the sale would reasonable presume the pruchaser to be ___ years of age or older.
25+ (for ID)
person needs to be 18 or older to purchase
110
The BOP must be notified of a change in the consultant pharmacist of record within __ days of the change
10
111
What are the labeling requirements of drugs for inpatient of a nursing home? (ie blister package)
1) name and address of pharmacy
2) name of prescriber
3) name of pt
4) date of original filling or refill date
5) rx #
6) directions for use
7) name of drug
8) quantity
9) transferring warning it is a CS
112
What are the requirements of repackaged or Unit-dose drugs?
1) brand or generic name
2) strength
3) dosage form
4) manufacturer name
5) expiration date
6) Lot # (manufacturer's lot number or lot number assigned by pharmacy)
113
A close drug delivery system is a system in which the actual control of unit dose or customized patient medication packages are maintained by the facility and not by the individual pt -- what pharmacies are this?
Class I, Class II, Modified Class II, or special ALF facilities
*note, unused unit-dose or customized medication packages may be returned to the pharmacy for re-dispensing if each package is sealed and is clearly labeled with name of drug, dosage strength, manufacturer's control # and expiration date
114
Vendor Pharmacy is a community pharmacy or Special Closed Door Pharmacy which has a contract to dispense drugs to a patient in a facility holding a ___________________ or _____________________ permit
Class I institutional Pharmacy
Modified Class II B Permit
115
A vendor pharmacy may transmit a starter dose rx, excluding a _______________________ rx
controlled substance rx
116
Labeling of patient-specific meds dispensed from an institutional class II, modified class II Type B, or class III permit
1) name of active ingredients
2) amounts of concentrations of active ingredients
3) BUD and time
4) storage requirements - if applicable
5) ID of responsible compounding personnel and/or dispensing rph
6) labels for batch-prepared compounded sterile products must also include (control or lot #, auxiliary labeling, device-specific instructions, labels for specific pt meds must also include: pt name, location of med to be delivered, directions for use and cautionary instructions)
APPLIES TO ALL MEDS NOT JUST IV
117
Institutional pharmacies may not dispense drugs to outpatients unless they obtain a community pharmacy permit.
An exception is that drugs may be dispensed by a Class II or Class III institutional pharmacy to a pt of the hospital's ED or hospital inpatient upon d/c if the prescriber determines that the drug is warranted and that community pharmacy services are not readily accessible, geographically to the pt
the prescribing and dispensing must be fora supply of the drug that will last for the greater of up to ____ hours or through the next business day.
If there is a governor declared emergency, the quantity may be for a ___ hour apply.
48 hours
72 hours
118
When the pharmacy department is closed, a SINGLE DOSE may be obtained by whom?
under the supervision of a physician or charge nurse
119
Automated Distribution and packaging (Pyxis)-
A pharmacist must perform prospective drug use review and approve each med order prior to administration except for:
- an override med
- a low-risk override med
- physician-controlled med (ie ED, operating room, Cath labs, etc)
120
For override meds in a Pyxis, a pharmacist shall perform a:
retrospective drug use review
121
Who may a decentralized automated medication systems be restocked by?
pharmacist -- must perform a DAILY AUDIT or barcode verification
registered pharm intern
registered pharm tech
122
A quality assurance program is required for all automated medication systems. Records must be maintained for:
____ days for daily audits {noncontrolled rx}
____ years for any report or analysis that is part of the QAP {controlled rx}
60 days
4 years
123
Emergency Med Kits in Nursing Homes -
FL law does not specify the types or quantities of drugs that may be maintained. The contents of the kit must be determined by:
facility's medical director
director of nursing
and consultant pharmacy
124
Can Emergency Med Kits in nursing homes contain CS?
yes
An emergency kit in a nursing home is one of the RARE EXCEPTIONS where DEA allows non-dispensed (or bulk) CS to be stored at a location that does NOT HAVE a DEA registration
125
An inventory of the contents of the Emergency Med Kit must be attached to the outside of the kit, which must include the earliest expiration date of the kit drugs. If the seal is broken, the kit must be restocked and resealed by when?
the next business day after use
126
A provider pharmacy may provide pharmacy services to where using an automated pharmacy system?
LTCF
Hospice
Correctional facility
127
For an automated pharmacy system at a nursing home that has CS in the inventory, does this require a separate DEA registration?
YES
Although DEA does not require a separate DEA registration at a nursing home that is storing CS in an Emergency Med Kit, if the nursing home is using an APS to dispense routine med or as an emergency med kit, a separate DEA registration for the APS at the facility, in the name of the provider pharmacy, is required.
128
T or F
An automated medication system that contains controlled substances shall not allow simultaneous access to multiple drugs, drug strength, or dosage forms of CS
true
129
Is therapeutic substitution allowed in nursing home facilities
yes
130
T or F
Only a nuclear pharmacist may receive rx for therapeutic or blood product procedures in a permitted nuclear pharmacy
True
In a nuclear pharmacy, a registered pharm tech may take an order for a diagnostic radiopharmaceutical, but not for a therapeutic or blood product procedure
131
In nuclear pharmacy, the immediate outside container must be labeled with:
1- name and address of the pharmacy
2- name of prescriber
3- date of original filling
4- standard radiation symbol
5- the words "Caution: Radioactive material"
6- name of procedure
7- rx #
8- radionuclide and chemical form
9 - amount of radioactivity and the calibration date and time
10- expiration date and time
11 - volume if liquid
12- number of items or weight if a sold
13- number of ampules or vials if gas
14- if for a Tc 99m product, the molybdenum 99 content to USP limits
15- name of pt OR physicians Use Only
16- initial of dispensing rph
132
In nuclear pharmacy, the inner container must be labeled with:
1) standard radiation symbol
2) the words "caution: radioactive material"
3) radionuclide and chemical form
4) rx #
133
in nuclear pharmacy, the hot lab, storage area, and compounding and dispensing area must be a min of ___ ft2
150 ft2
