Penzak 2 Flashcards
(115 cards)
1
Q
If a CVS has multiple locations, do they each need their own license?
A
Yes
2
Q
How early must you provide notice for the board when getting a pharmacy permit?
A
at least 30 days before opening
3
Q
4 Rs and a C: must comply with prescription department technical equipment
A
- References (Facts and Comparisons, equiv)
- Running water (hot and cold)
- Register for exempt narcotics (doesn’t really apply, but memorize)
- Rx balance with appropriate weights
- Compounding equipment (for the level of compounding required)
4
Q
To manufactuer, bottle, package, repackage, what must you do?
A
have an ANNUAL registration with ALBOP (different from pharmacist license)
5
Q
What is a 3PL?
A
3rd Party Logistics (UPS is an example)
6
Q
How large should a prescription room be?
A
240 ft
7
Q
How large should a working space be for 1 pharmacist?
A
16 sq ft
8
Q
How large should a working space be for 2 or more pharmacists?
A
24
9
Q
How much space must be unobstructed?
A
36 in
10
Q
Where should pharmacy licenses be displayed?
A
prominently and conspicuously
11
Q
Does the name of the pharmacist on duty need to be displaced?
A
yes
12
Q
what 3 things need to be displayed at all times in a pharmacy?
A
- pharmacy license
- name of pharmacist on duty
- name of supervising pharmacist
13
Q
IND definition
A
drugs that have not been through the full FDA drug approval process
14
Q
To use an IND, it must be for a
A
serious, immediately life-threatening diseases
15
Q
To use an IND, no other
A
comparable or satisfactory alternative therapy must be available
16
Q
To use an IND, it must be under investigation for
A
the disease or condition in question
17
Q
To use an IND, sponsor must be actively
A
pursuing approval
18
Q
To use an IND, for serious diseases, there must be
A
sufficient evidence of safety AND efficacy
19
Q
Mdication samples may only be distributed to
A
practitioners licensed to prescribe OR pharmacies of health systems
20
Q
starter packs are/are not samples
A
are NOT
21
Q
The prescriber must make what for samples?
A
written request
22
Q
drug sample receipts must contain which 5 things?
A
- name and address of prescriber
- name and address of hospital/health facility
- name, address, and TITLE of the person acknowledging delivery of samples
- brand name, strength, quantity, and lot number
- date of delivery
23
Q
is it legal to mail controlled substances?
A
yes, but must have an inner container marked and sealed pursuant to CSA regulations
24
Q
What must an inner container in a mailed controlled substance have on its label?
A
- name and address of pharmacy
- practitioner/person dispensing
25
Regulations for mailed prescriptions: exterior labeling
must have NO indication that it contains medication contents
26
Which case recall is the following: Reasonable probability that the product will result in serious adverse health consequences or death
I
27
Which case recall is the following: Not likely to cause adverse health consequences
III
28
Which case recall is the following: Product may temporarily cause medically reversible health consequences
II
29
Class recalls and medical devices are similar; the most severe of each is
most severe recall is I; most risk for medical devices is III
30
Are pick up stations allowed?
no pharmacy shall authorize any person, firm, or business establishment to serve as a pick-up station
(except for federally qualified health centers (FQHC))
31
What is the ONE exception to pick-up stations being prohibited?
federally qualified health centers
32
Are kiosks available to pick up meds?
not currently available
33
are drive-thrus prohibited in AL?
no
34
Are vacuum tubes prohibited in AL?
no
35
What is a residential care facility?
1. convaslescent home
2. nursing home
3. extended care facility
4. mental health facility
5. rehabilitation facility
6. developmental/disability center
7. assisted living facility
8. a specialty care assisted living facility
36
Wich drugs can be repackaged, relabeled, and stored (as a UNIT DOSE) for a residential care facility that doesn't have a pharmacy located on its premises
any legend (can NOT repackage controls)
37
Can certified nurse practitioners (CRNP), PAs, and certified nurse midwives (CNMs), write for CII?
Yes, if certain conditions are met
38
Which conditions must be met for CRNPs, PAs, and CNMs to write for CIIs?
1. must have QASC certificate
2. must have a CII PERMIT (LPSP)
3. Must have a DEA#
4. must have a collaborative practice agreement
5. CII must fall within scope and be listed as formulary set forth by physician that CPA is in
39
best option for destruction of unwanted meds
take-back programs; pharmacies can NEVER dispense again, though
40
second best option for destruction of unwanted meds
"flush list" - check to see if can be flushed safely down toilet)
41
third best option for destruction of unwanted meds
mix meds with undesirable substances - do NOT crush them. mix with cat litter, used coffee grounds and throw away
42
Can an RPh give emergency refills?
yes, but under certain conditions
43
conditions in which pharmacists may fill emergency refills
1. cannot get ahold of HCP and required for life/progression of disease
2. not CII or CIII
3. must be 72h supply
4. must notify HCP within 72 hours after dispensing
44
CII expiration
non
45
legend expiration
none
46
CIII expiration
6 months or 5 refills; whichever comes first
47
CIV expiration
6 months or 5 refills, whichever comes first
48
CV expiration
no expiration UNLESS partially filled, in which case 6 months or 5 refills
49
Conditions in which CIIs can be faxed
1. can fax and fill before arrives, given that there's a hard copy provided before dispensing
2. if under hospice care or LTCF, can fill as if hard copy
3. if needed to be compounded and administered through a needle
50
must a prescription label show the BRAND name/
no, unless otherwise indicated by the provider, it should show the ACTUAL DRUG PRODUCT dispensed
51
What info is required on an Rx label?
1. name and address of pharmacy
2. prescription number
3. date of prescription
4. name of prescriber
5. name of patient
6. name and strength of drug
7. directions
8. auxilliary labels
52
how soon must one notify ALBOP if they change work?
10 days
53
How often must one renew their license?
every 2 years on EVEN numbered years
54
how many CE hours must one obtain?
30/2 years, renew on even years
6 must be live
55
if you get your alabama license on an odd year, do you need to obtain any CE hours before renewing?
no, you will then need 30 hours (6 live) the following cycle
56
definition of sharps
medical term for devbices with sharp points/edges
57
where can sharps be used
at work, home, while traveling
58
examples of sharps
needles, syringes, lancets, autoinjectors, infusion sets
59
how to dispose of sharps
used sharps should be immediately placed in a container
60
if sharps containers are not readily available,
use a heavy-duty plastic household container such as laundry detergent, cat litter container
61
what should you NEVER do with sharps
flush them or place them in trash bins or recycling bins
62
what should you do if you are accidentally struck by another's used sharp
wash the area with soap and water or disinfectant (alcohol), seek immediate attention
63
Suboxone
buprenorphine + naloxone
64
Subutex
buprenorphine
65
What are Suboxone and Subutex used for
pain OR addiction management
66
Who is qualified to prescribe suboxone and subutex
physicians that are DATA-waived
67
How does a physician get authority to prescribe suboxone and subutex?
1. notify DHHS
2. obtain unique identification number
3. CSAT will send letter to the physician of the new DEA number and get a revised DEA registration certificate
4. DATA numbers start with X
68
if suboxone is administered for pain without an X
no problem
69
if Rx is for suboxone for addiction, but no X
call doc an dsee if they have contacted DHHS
70
Can a doctor prescribe suboxone after submitting for a DATA number despite not having an X
yes, as long as the doc has notified DHHS they may begin treating patients right away
71
If suboxone is being used for addiction management, can it be called/faxed?
no, unless the prescribing HCP has obtained a signed HIPAA form or if the patient brings to pharmacy
72
nonsterile compounding
795
73
sterile compounding
797
74
hazardous drugs
800
75
can a pharmacist compound preparations of OTC?
yes, but can't exceed the OTC dose of the medication (can't make famotidine 40 mg if OTC is 20 mg)
76
What restrictions exist for pharmacists compounding non-sterile products?
1. can only make reasonable amounts of the product ahead of time
2. product must be sold directly to consumer
3. product may not be made in bulk and sold to other vendors
4. product must be stored within the prescription department
77
What is the min amount of hours a pharmacy can be open?
20/week
78
what are the requirements for posting daily pharmacy hours
1. sign must not be less than 1 inch in height
2. sign must either be displayed at main entrance or at prescription department
3. sign must be in a prominent place with unobstructed view
79
Security of the pharmacy
must be physically enclosed, locked, and secured when not in use EXCEPT in temporary absence of a pharmacist
80
The enclosed and secure area of a pharmacy must encompass
all drug products and devices that otherwise would require dispensing by a pharmacist. This includes STORE ROOMS
81
may the owner of a pharmacy designate an unregistered person to have a key/access device?
yes, but supervising RPh must agree to this arrangement and have a signed agreement that is submitted to ALBOP prior to issuing them a key
82
Who must always have a key?
first responders need to have a key available to them; this is usually done by supplying a Knox Box and also must be submitted to ALBOP prior to making the agreement
83
If changing hours of operation, how soon do you need to notify ALBOP before notifying public
no law
84
what does AL state law regarding to offer to counsel patients?
must have FACE-TO-FACE on all new prescriptions and where appropriate; unless deemed inappropriate or unnecessary
85
who can counsel patients?
only pharmacist/supervised intern
86
what must be included with every prescription
a printed statement including the pharmacy's teleophone number
87
how long can a pharmacist leave without closing the pharmacy?
1.5 hours at a time, no more than 3 hours/day, and no more than a week if sick
88
can a tech ring out a prescription if a pharmacist stepped out of the pharmacy to eat?
yes if it doesn't require counseling
89
if the pharmacist does NOT reasonably believe that the controlled drugs are secured if he/she leaves, then
everyone has to leave the pharmacy and lock it up until they return
90
how long is the pharmacist allowed to be temporarily absent?
30 minutes
91
where can the pharmacist go when he/she temporarily leaves?
must remain on site and available for emergencies
92
in the event of robbery/theft
1. call police
2. file form 106
3. notify ALBOP
93
if theft occurs, what must be sent to ALBOP?
1. copy of police report
2. copy of DEA form 106 (email or fax, NOT mail)
94
if theft is committed by ALBOP licensed pharmacy staff
report the name and license number to ALBOP state drug inspector in the area - NOT DEA!!!
95
If theft includes non-controlled drugs
notify ALBOP inspector assigned to your area
96
May syringes be sold without prescription?
yes, but cna refuse
97
what are the AL rules for selling pseudoephedrine?
1. must be sold by a pharmacy licensed by albop
2. no more than 3.6 g/day
3. no more than 7.5 g/30 days
98
Requirements for purchasing pseudoephedrine
1. 18 years old
2. VALID ID (unsuspended, in date): can be DL, state ID, uniformed services ID card, or US/foreign passport
(info must be kept ina log boog)
99
If a prescriber dies, are their old prescriptions valid?
yes, but only for a 30 day supply with no refills
100
can physicians treat themselves or family members
generally no, unless emergency and no other HCP is available. It should also be temporary if so.
101
Can a physician prescribe a controlled substance for themselves
no
102
Can a physician prescribe a controlled substance for their spouse
no
103
Can a physician prescribe a controlled substance for their brother/sister
yes
104
Can a physician prescribe a controlled substance for their child
no
105
Can a physician prescribe a controlled substance for niece
yes
106
Can a physician prescribe a controlled substance for cousin
yes
107
Can a physician prescribe a controlled substance for their parent
no
108
Can a physician prescribe a controlled substance for their grandchild
yes
109
if you suspect that a HCP is prescribing for family members/themselves
contact the ABME (alabama board of medical examiners)
110
can physicians prescribe non-controlled substances to themselves or family members?
no clarity
111
What are the requirements for CIIs?
written or electronic Rx that meets all DEA requirements; if written, must be manually signed by practitioner
112
Is there a time limit within which a schedule II Rx must be filled and signed by practitioner?
no, but RPh must determine if still needed
113
Is there any law that says that CII can only be dispensed as a 30 day supply?
no (insurances may impose this)
114
is an oral order for CII ever permitted?
Yes, if emergency situation for LTCF, hospice, home healthcare, then may supply
115
if a CII is filled as an oral order for either a LTCF, hospice, or home health, are there any additional requirements?
Yes; need not to exceed 72 hour supply, and must provide a hard copy of the prescription to the pharmacy within 7 days
