Penzak 1 Flashcards
1
Q
Who has legal authority to be in a pharmacy?
A
- Pharmacist
- Tech
- Intern/extern
- Pharmacist assistant
2
Q
Intern definition
A
graduated with professional degree
3
Q
Extern definition
A
Still in school, no professional degree
4
Q
Pharmacist assistants ratio
A
none
5
Q
Pharmacist assistants definition
A
someone who has practiced pharmacy under an RPh’s direct supervision for ≥15 years
6
Q
Who is in charge of making sure no one is in the pharmacy that shouldn’t be, and that laws are being followed?
A
supervising pharmacist
7
Q
Supervising pharmacist definition
A
PIC
8
Q
Only people ______ may practice pharmacy
A
Licensed by ALBOP
9
Q
What constitutes “practice” of pharmacy
A
- interpretation and evaulation of prescription orders
- compounding, dispensing, administering, and labeling of drugs and devices
- Drug selection, therapy management
- Drug utilization reviews
- Proper and safe storage of drugs and devices
- Maintenance of proper records
- Advising of therapeutic values, content, hazards, and use of drugs and devices
10
Q
What is an intern/extern able to do?
A
anything a pharmacist can do while under the immediate supervision of a licensed pharmacist
11
Q
ratio of interns/externs to pharmacists
A
3:1
12
Q
What is the application fee for techs?
A
$60
13
Q
What is the background check fee for techs?
A
$40
14
Q
What is the transaction fee for techs?
A
$4
15
Q
What is th total registration fee for techs?
A
$104
16
Q
Are techs licensed or registered?
A
registered
17
Q
Age requirement for techs
A
17
18
Q
Techs registration requirements
A
- 17 or older
- good moral character
19
Q
A pharmacist whose license has been denied or revoked can/can NOT become a tech?
A
can NOT
20
Q
All techs receiving their initial registration on or after Jan 1st, 2020 shall complete a
A
board-approved training program
21
Q
When should techs submit evidence of completion to the board of their board-approved training program?
A
within 10 days of completion
22
Q
How long do techs have to complete their board-approved training program?
A
6 months after registration
23
Q
All techs MUST wear a
A
name tag while on duty
24
Q
Al techs MUST notify ALBOP if they ________; they must do so within _____ days
A
change employment status; must notify within 10 days
25
When do techs renew their license
biennially on ODD years (pharmacists are EVEN years)
26
how much CE do techs need?
6 hours/renewal period (2 years)
27
how much CE needs to be live for techs?
2 hours/renewal period (2 years)
28
If no techs are certified, what is the ratio of techs to pharmacists?
2:1
29
if 1 tech is certified, what is the ratio of techs to pharmacists?
3:1
30
If 2 techs are certified, what is the ratio of techs to pharmacists?
4:1
31
A pharmacy tech shall/shall not counsel
Shall NOT communicate orally or in writing, medical, therapeutic, clinical, or drug information, or communicate any information recorded on a patient profile that requires professional judgment
32
A tech can/can NOT document receipt of controlled substances (CII-CV)
can NOT
33
Pharmacy techs can/can NOT accept a new prescription
can NOT
34
Who can call in drug orders to a pharmacy
basically anyone (including receptionists), but only pharmacists/interns/externs can accept
35
A tech can/can NOT prepare a copy of a prescription or read a prescription to another person
this is considered transferring; can NOT perform this
36
A tech can/can NOT provide a prescription or medication to a patient without a pharmacist's verification
obviously, can NOT
37
Can techs perform a drug utilization review?
NO! can collect data for DUR under the direction of the RPh, but cannot use professional judgment regarding what the data means
*be careful about questions like this on MPJE
38
What should be available regarding techs for review by ALBOP
written control procedures and guidelines for supervision of techs by an RPh and for performance of tasks by techs
39
Controlled substance records must be kept for at least
2 years
40
Which law requires that controlled substance records be kept for at least 2 years?
The Controlled Substance Act
41
Controlled substance paper Rxs must be kept at
the pharmacy itself
42
Schedule(s) ____ records must be maintained separately from all other pharmacy records
I and II must be separate from CIII-CV and legends
43
Can you have a central location that is off-site from the pharmacy to store financial and shipping records?
yes, but must be able to deliver them to the registered location within 2 business days
44
If you have an off-site central location, what info can be stored there?
shipping and financial records only
45
If you have an off-site central location, how quickly must you be able to retrieve these records?
2 days
46
Is an intern/extern allowed to counsel a patient on a new medication?
yes, but only under the direct supervision of a pharmacist
47
T/F: Pharmacy techs must be licensed in the state of AL?
F
48
which ways may one dispose or destroy controlled substances?
1. Destroy with DEA agent onsite
2. Deliver product to REVERSE DISTRIBUTOR
3. Return to wholesaler/manufacturer
4. Request special assistance of the special agent in charge of the nearest DEA office
5. Facilities (hospitals) can destroy medications without prior approval
49
If using the assistance of a special agent in charge of the nearest DEA office to destroy a controlled substance, what is needed?
DEA form 41 (surrender of controlled substances)
50
What does a DEA form 41 do?
acknowledges surrender of controlled substances (usually for destruction)
51
Can hospitals destroy their own controlled product?
yes, they are given special guidelines
52
CSOS
Controlled substance ordering system
53
What does DEA form 222 do?
paper form allowing for ordering CI and CII
54
What does CSOS do?
allows ordering of CI, CII, CIII, CIV, and CV meds
55
to use a CSOS, what must you have?
power of attorney (need to apply for a digital certificate)
56
What does the digital certificate associated with the power of attorney needed to use CSOS do?
allows you to digitally sign for the order
57
How many copies of DEA form 222 are there?
3
58
Copy 1 of the DEA form 222 is
brown, and is kept by the wholesaler/supplier
59
Copy 2 of the DEA form 222 is
green, and is sent to the DEA by the wholesaler
60
Copy 3 of the DEA form 222 is
blue, and it is kept by the pharmacy
61
Which DEA form 222 is kept by the DEA
green (copy 2)
62
Which DEA form 222 is kept by the pharmacy
blue (copy 3)
63
Which DEA form 222 is kept by the wholesaler?
brown (copy 1)
64
Ordering CIII, CIV, and CV substances
Ordered directly from individual business (wholesaler/supplier) that is REGISTERED WITH DEA
65
Do individual pharmacists have a DEA number?
no, the facility/pharmacy will have a DEA number, but pharmacists do not individually
66
Who has a DEA number?
1. wholesaler/supplier
2. Pharmacy
Pharmacists do NOT, they have a controlled substance license from ALBOP (not registered with DEA)
67
Who can legally possess prescription drugs?
1. Facility (pharmacy, hospital, LTCF, physician's office, etc)
2. End-user
68
Each pharmacy is required to have a PERMIT from
ALBOP
69
Before opening, each pharmacy must be
inspected
70
Each pharmacy must be staffed with
a licensed pharmacist and registered personnel
71
Pharmaceutical products may only be dispensed bia
1. Prescription
2. Drug order
72
Definition of prescription
any order for drug or medical supplies, written or signed or transmitted by word of mouth, telephone, telegraph, closed circuit television, or other means of communication by a legally competent practitioner, licensed by law to prescribe and administer such drugs and medical supplies, intended to be filled, compounded, or dispensed by a pharmacist
73
A prescription is an order for medication that is
dispensed to or for an ultimate user; therefore, it is NOT INTENDED FOR IMMEDIATE ADMINISTRATION
74
Definition of medication order
An order for medication which is dispensed for IMMEDIATE ADMINISTRATION to the ultimate user (inpatient orders are not prescriptions; they are meant for immediate administration and are therefore orders)
75
If the DEA asks for the schedule II records from your pharmacy, how long do you have to comply with their request?
2 business days
76
Medication SAMPLES may only be distributed to
licensed practitioners (or pharmacies of hospitals/health care entities)
77
Samples may/may not be sold
may NOT be sold
78
Starter packs left at pharmacies are/are not considered samples
are NOT considered samples
79
To obtain samples, prescribers must make a
written request
80
Drug sample receipts must contain 5 things:
1. name and address of REQUESTOR
2. name and address of HOSPITAL/INSTITUTION
3. Name and address and title* of PERSON ACKNOWLEDGING DELIVERY of samples
4. Brand name of drug, strength, quantity, and lot
5. Date of delivery
81
Drug samples are highly regulated by
Prescription Drug Marketing Act
82
Controlled substances must be accounted for by a ____ process
closed loop ("cradle to grave")
83
You must maintain records of CS in which 3 ways
1. inventory
2. receipt
3. distribution
84
inventory
drugs had on hand at any time
85
receipt
drugs coming into the pharmacy (name, strength, quantity, date)
86
Distribution
where the drugs go when they leave the pharmacy
87
What is a drug pedigree
verification process (where pharmacies get their drugs)
88
Wholesaler distributors are required to be
licensed
89
Drug Supply Chain Security Act is also called
Track and Trace Law
90
Drug Supply Chain Security Act (Track and Trace Law) requires that
pedigree/closed loop cradle-to-grave accountability for drugs
91
How many things are required for a controlled substance?
9
92
Which 9 things are required for a controlled substance?
1. Date and signature on the date issues
2. patients FULL NAME AND ADDRESS
3. Practitioners full name, address, and DEA number
4. Drug name
5. Drug strength
6. Dosage form
7. Quantity
8. Directions for use
9. number of refills
93
What is important to recognize that is NOT required on a controlled substance prescription?
phone number
94
A prescription must be written in
1. ink
2. indelible pencil
3. typewritten
95
In AL, what type of signature must be on a controlled substance prescription?
manually-signed (wet) signature ON THE DATE WRITTEN
96
Can a nurse/receptionist put information on a prescription for a practitioner to sign?
yes!
97
Who may issue a controlled Rx
1 MD
2. DO
3. DPM
4. DDS/DMD
5. DVM/VMD
Assuming they are licensed and registered with the DEA
98
Who is excluded from needing to be registered with DEA to write for controlled substances?
1. Public Health Service
2. Federal Bureau of Prisons
3. Military Practitioners
99
Which of the following require(s) an exact count when conducting a controlled substance inventory
a. CII
b CIV >1000 count
c. CIII greater tan 1000 count
d. A and B
e. A, B, C
E (A, B, and C)
100
Receipts for medication samples must contain all of the following items EXCEPT:
a. name, strength, lot number of the medication
b. date of delivery
c. expiration date of the samples
d. name and address of the requesting prescriber
c. expiration date of the samples
101
Restrictions on controlled substance prescriptions
1. must be for LEGITIMATE MEDICAL PURPOSE
2. must by within normal course of practice
102
Can CIIs be submitted electronically?
yes
103
Can CIII-CV prescriptions be submitted electronically?
yes
104
Do drivers need to be licensed to take meds from wholesaler to pharmacy?
no
105
do drivers need to be licensed to take meds from pharmacy to another pharmacy?
must be a pharmacy employee who is registered
106
What must be on a prescription label?
1. name and address of pharmacy
2. Sig
3. name of drug*
4. strength of drug*
5. Additional info (patient name, doctor name, quantity, refills, date, auxiliary labels, prescription number, RPh initials)
*can omit this if dr requests
also note that can use "prescribers mixture" if needed
107
What must be on a stock label
1. name and address of manufacturer/packager/distributor
2. active and inactive ingredients
3. statement of identity (generic, brand)
4. quantity
5. stregnth
6. Dosing info/PI
7. "Rx only" or typed out
8. Route of admin
9. lot number
10. dispensing instructions (special container)
11. expiration
108
Unit dose label requirements
1. nam eof drug
2. quanitty of active ingredient (strength)
3. expration date
4. lot number
5. name/place of business of manufacturer, packager, or distributor
6. required compendia statements
7. number of dosage units contained
(8.) "May be habit forming" if applicable
(9.) DEA schedule symbol if applicable
109
When is a boxed warning required
if a drug may lead to death or serious injury
110
Pregnancy category A
no demonstrated risk to fetus from well-controlled tudies
111
Pregnancy category B
no demonstrated risk to fetus (animal studies only)
112
Pregnancy category C
either studies in animals or studies in people demonstrated adverse effects on fetus; only give if benefits > risks
113
Pregnancy category D
positive risk to fetus
114
Pregnancy category X
Risk outweighs benefit
115
New pregnancy warnings
1. Pregnancy
2. Lactation
3. males and females of reproductive potential
116
how many digits in an NDC?
10
117
how many segments in NDC?
3
118
First segment of NDC describes
company/manufacturer (labeler)
119
Second segment of NDC describes
drug strength, dosage form, and formulation
120
third segment of NDC describes
package size
121
503a facility
traditional compounding (regular pharmacy)
122
503b facility
outsourcing facility
123
What do 503b facilities have to do that 503a facilities don't?
follow cGMP standards (expensive, strict)
124
cGMP
current good manufacturing practice
125
What are 503b facilities allowed to do that 503a facilities aren't?
compound ahead of time in large batches
126
What are current Good Manufacturing Practice regulations?
regulations that provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities
127
Who enforces cGMPs?
FDA
128
How many digits are in the first segment of an NDC?
5 (sometimes 4)
129
How many digits are in the second segment of an NDC?
3 (sometimes 4)
130
How many digits are in the third segment of an NDC?
2
131
If ordering a schedule II
use 222
132
if transferring a CII between any 2 registrants (wholesaler -> pharmacy, pharmacy -> pharmacy, pharmacy -> Dr.'s office and pharmacy, etc)
use 222
133
If transferring a schedule III, IV, or V
must maintain adequate records (invoices)
134
Invoices must be
specific (think of invoices from a wholesaler and what they contain); can use for legend drugs as well
135
Can/cannot fill an Rx for "office use"
can NOT
136
If an Rx for "office use" is given to a pharmacy, what do you do?
transfer it to the office; if it's a CII, must give form 222; otherwise invoice
137
Which of the following practitioners can legally prescribe lisinopril 10 mg?
A. MD
B. DO
C. DVM
D. DPM
E. DDS
MD, DO, DVM (if animal)
138
T/F: Prescriptions for controlled substances must be written for a legitimate medical purpose
true
139
T/F: pharmacists have a corresponding responsibility to ensure that controlled substance prescriptions are valid
true
140
T/F: prescriptions for controlled substances may not be transmitted electronically
false
141
T/F: a physician must write for prescriptions that are consistent with their "normal course of practice"
true
142
T/F: T/F: T/F:
true
143
Generally, what do you do when a drug is approved for a specific indication and the prescriber writes for it off-label?
1. use professional judgement
2. document
3. decline to fill if places patient at risk of harm
144
human products can/cannot be used for vet use
can
145
veterinary products can/cannot be used for human use
can NOT
146
drugs that have not completed the FDA approval process are called
investigational new drugs
147
what is necessary before giving an IND to a patient?
informed consent
148
how many characters are in a DEA number?
9
149
what is the 1st character of a DEA number
A, B, C, F
150
DEA number 1st character: A
retired in 1985
151
DEA number 1st character: B
doctors, clinics, hospitals
152
DEA number 1st character: C
specialists
153
DEA 2nd character
first initial of registrant's last name
154
DEA number 1st character: D
teaching institution
155
DEA number 1st character: E
manufacturer
156
DEA number 1st character: F
Distributor
157
DEA number 1st character: G
researcher
158
DEA number 1st character: M
mid-level practitioner (NP, PA)
159
DEA number 1st character: P
narcotic treatment program
160
DEA number 1st character: R
narcotic treatment program
161
DEA number 1st character: X
suboxone/subutex prescribing program
162
know how to math the DEA number
OK!
163
Exceptions for DEA registratoin
1. Military personnel
2. Public health service
3. Federal Bureau of Prisons
4. Agent/employee acting in the usual course of business (technician, cashier)
5. ultimate users
6. hospital resident (uses hospital DEA)
164
Are pharmacists allowed to dispense controlled substances
yes, just need to be licensed with ALBOP and purchase a license (or have pharmacy/facility purchase license)
165
What regulates the methadone treatment program?
SAMHSA
166
SAMHSA
Substance Abuse and Mental Health Services Administration
167
SAMHSA is regulated by the
Department of Health and Human Services (DHHS)
168
A practitioner cannot write a prescription for methadone to treat addiction unless they are
registered with the DEA as a narcotic treatment program (NTP) practitioner
169
CSAT
Center for Substance Abuse Treatment
170
DATA
Drug Addiction Treatment Act
171
DATA-waived means
the physician can prescribe suboxone/subutex
172
DATA-waived physicians get an
X at the beginning of their DEA
173
CSAT role in DATA
tells DEA that physician is DATA-waived and DEA assigns identifier
174
max number of patients for DATA-waived HCPs
30 -> 100 -> 275
275 is max
175
HCP that get a DATA waiver can initially treat
30 patients for at least the first year
176
HCPs that get a data waiver and treat 30 patients for 1 year
can increase their limit to 100
177
After 1 year at the 100-patient limit, HCPs that are data-waived can increase their patient limit to
275
178
after 1 year of treating 275 patients, data-waived hcps can increase their limit to
none; 275 is the max
179
Which type of label must include the text: Warning: may be habit forming (if applicable)
A. Stock
B. Rx label
C. Unit dose label
D. Certain OTC meds
C. A unit dose label
180
After meeting certain criteria, what is the highest number of patients that a single physician can treat with suboxone?
275
181
Can a Rx for a CS be filled/refilled by prescriber who is deceased?
yes, as long as for legitimate medical purpose by practitioner in the usual course of professional practice, for a maximum 30-day supply with no refills
182
The code of Federal Regulations states that the DEA registration of any person terminates when such a person
1. dies
2. ceases legal existence
3. DCs business
4. DCs professional practice
5. surrenders their registration
183
Can you prescribe medications from internet prescribing?
yes, but dangerous! make every reasonable effort to ensure that any order, regardless of the means of transmission, has been issued for a legitimate medical purpose by an authorized practitioner and PURSUANT TO VALID PATIENT-PRACTITIONER relationship
184
For consulting pharmacists for long-term care facilities, must take and pass certification. The initial course is
10 hours
185
for consulting pharmacists for LTCFs, how much LIVE ce is required?
8 hours
186
which prescriptions MUST pharmacists offer counseling?
new prescriptions and refills where appropriate
187
What is the exception to offering counseling on prescriptions?
if it is deemed inappropriate or unnecessary by the pharmacist, do not have to offer counseling
188
in which ways may a pharmacist counse
verbal, written, teleophone, or some other manner
189
who can counsel
pharmacist, intern/extern (supervised)
190
what MUST be included with every prescription
printed statement that includes the pharmacy's telephone number in case of questions
191
medication administration is/is not allowed in the practice of pharmacy
is
192
Requirements for electronically issuing and processing CS Rxs
1. prescribers must be properly registered and have the authority to dispense CS
2. prescribers must use electronic prescription application that meets all applicable requirements
3. Rxs issued must conform with the requirements of a valid electronic prescription
4. a pharmacy can process electronic prescriptions for controlled meds when using a pharmacy application that meets all requirements and conforms with the requirements of a valid electronic prescription
193
What are the software requirements for e-prescribing?
must be audited by a 3rd party and approved by the FDA
194
prescriber must digitally sign electronic Rx for CS using their cryptographic key; the pharmacy software must be able to
apply the prescriber's public key to confirm that the prescription was signed
195
the software for CS e-Rx must check to see that the prescriber's digital certificate is
still valid
196
the software for CS e-Rx must retain the
DEA# of the prescriber
197
The digitally signed Rx in the software for CS e-Rx must archive
the prescription by the softrware
198
For the CS e-Rx, the pharmacy software must limit
access by name or role
199
For the CS e-Rx, the pharmacy software must store all
Rx info
200
For the CS e-Rx, the pharmacy software must also perform automated internal
audits and provide reports of incidents to pharmacists
201
Prescriptions for controlled substances must contain
1. date of isue
2. patient name and address
3. practitioner name, address, DEA number
4. drug name
5. drug strength
6. dosage form
7. Sig
8. quantity
9. number of refills
10. MANUAL signature
202
What information 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. sig
8. cautionary statements
203
May a prescriber write multiple CII prescriptions for the same patient and same medication on the same day?
Yes, but
1. max of 90 days
2. current date must be on all prescriptions
3. prescriber typically intends for the first prescription to be filled immediately
4. on subsequent prescriptions, must indicated EARLIEST DATE ON WHICH CAN FILL
204
What canges can a pharmacist NOT make to a CII?
1. patient name
2. drug name
3. fill before date
205
Can a pharmacist inan emergecy setting give a patient a refill when there are no refills remaining?
yes, must give a one time fill for 72 hour supply (enters as NEW rx)
can NOT do this for CII or CIII!!!!
206
Which prescriptions may NOT be filled as an emergency 72 hour refill?
CII and CIII
207
If a pharmacist fills an emergency refill for a 72 hour supply of a medication, they should notify the prescriber within
72 hours
208
Can a schedule II be transmitted by fax in AL?
yes
1. writted Rx for CI can be faxed before patient arrives, however need hard copy prior to being dispensed
2. fax IS hard copy if hospice care, LTCF
209
A CII to be compounded may/may not be faxed
MAY, if given through a needle
210
3 situations in wich a CII can be faxed
1. if they're coming with a hard copy (can't dispense until hard copy)
2. if hospice/LTCF
3. if compounded and through a needle
211
Refills on CV?
no limit
212
Expiration of CV?
none
213
CII legal expiration date?
none
214
CII refills?
no
215
quantity limit on CII?
none, EXCEPT
1. 90 DS if writing multiple
2. mid-level practitioners limited to 30 DS
216
CIII and CIV refills
6 months or 5 refills, whichever comes first
217
3 specific situations in which CII substances are ok to take over the phone/orally
1. emergency situation for LTCF
2. emergency situation for hospice
3. emergency situation for home health
218
If take an oral CII Rx, quantity should be limited to
82 hour supply and must have hard copy within 7 days
219
T/F: A cashier may not ask the patient if they have any questions for the pharmacist
false
220
T/F: If a pharmacist feels that counseling is unnecessary in a particular situation, they may choose not to provide it
true
221
T/F: a supervised intern may not counsel a patient on a new prescription
false
222
T/F: a pharmacist may not offer written instructions in place of face-to-face counseling in any circumstances
false
223
Who is responsible for ensuring the validity of an electronic prescription for a controlled substance?
the pharmacy and the prescriber, NOT the DEA
