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ALBOP FAQs > Penzak 1 > Flashcards

Penzak 1 Flashcards

1
Q

Who has legal authority to be in a pharmacy?

A
  1. Pharmacist
  2. Tech
  3. Intern/extern
  4. Pharmacist assistant
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2
Q

Intern definition

A

graduated with professional degree

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3
Q

Extern definition

A

Still in school, no professional degree

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4
Q

Pharmacist assistants ratio

A

none

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5
Q

Pharmacist assistants definition

A

someone who has practiced pharmacy under an RPh’s direct supervision for ≥15 years

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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

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7
Q

Supervising pharmacist definition

A

PIC

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8
Q

Only people ______ may practice pharmacy

A

Licensed by ALBOP

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9
Q

What constitutes “practice” of pharmacy

A
  1. interpretation and evaulation of prescription orders
  2. compounding, dispensing, administering, and labeling of drugs and devices
  3. Drug selection, therapy management
  4. Drug utilization reviews
  5. Proper and safe storage of drugs and devices
  6. Maintenance of proper records
  7. Advising of therapeutic values, content, hazards, and use of drugs and devices
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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

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11
Q

ratio of interns/externs to pharmacists

A

3:1

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12
Q

What is the application fee for techs?

A

$60

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13
Q

What is the background check fee for techs?

A

$40

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14
Q

What is the transaction fee for techs?

A

$4

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15
Q

What is th total registration fee for techs?

A

$104

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16
Q

Are techs licensed or registered?

A

registered

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17
Q

Age requirement for techs

A

17

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18
Q

Techs registration requirements

A
  1. 17 or older
  2. good moral character
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19
Q

A pharmacist whose license has been denied or revoked can/can NOT become a tech?

A

can NOT

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20
Q

All techs receiving their initial registration on or after Jan 1st, 2020 shall complete a

A

board-approved training program

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21
Q

When should techs submit evidence of completion to the board of their board-approved training program?

A

within 10 days of completion

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22
Q

How long do techs have to complete their board-approved training program?

A

6 months after registration

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23
Q

All techs MUST wear a

A

name tag while on duty

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24
Q

Al techs MUST notify ALBOP if they ________; they must do so within _____ days

A

change employment status; must notify within 10 days

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25
Q

When do techs renew their license

A

biennially on ODD years (pharmacists are EVEN years)

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26
Q

how much CE do techs need?

A

6 hours/renewal period (2 years)

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27
Q

how much CE needs to be live for techs?

A

2 hours/renewal period (2 years)

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28
Q

If no techs are certified, what is the ratio of techs to pharmacists?

A

2:1

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29
Q

if 1 tech is certified, what is the ratio of techs to pharmacists?

A

3:1

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30
Q

If 2 techs are certified, what is the ratio of techs to pharmacists?

A

4:1

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31
Q

A pharmacy tech shall/shall not counsel

A

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

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32
Q

A tech can/can NOT document receipt of controlled substances (CII-CV)

A

can NOT

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33
Q

Pharmacy techs can/can NOT accept a new prescription

A

can NOT

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34
Q

Who can call in drug orders to a pharmacy

A

basically anyone (including receptionists), but only pharmacists/interns/externs can accept

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35
Q

A tech can/can NOT prepare a copy of a prescription or read a prescription to another person

A

this is considered transferring; can NOT perform this

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36
Q

A tech can/can NOT provide a prescription or medication to a patient without a pharmacist’s verification

A

obviously, can NOT

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37
Q

Can techs perform a drug utilization review?

A

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

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38
Q

What should be available regarding techs for review by ALBOP

A

written control procedures and guidelines for supervision of techs by an RPh and for performance of tasks by techs

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39
Q

Controlled substance records must be kept for at least

A

2 years

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40
Q

Which law requires that controlled substance records be kept for at least 2 years?

A

The Controlled Substance Act

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41
Q

Controlled substance paper Rxs must be kept at

A

the pharmacy itself

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42
Q

Schedule(s) ____ records must be maintained separately from all other pharmacy records

A

I and II must be separate from CIII-CV and legends

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43
Q

Can you have a central location that is off-site from the pharmacy to store financial and shipping records?

A

yes, but must be able to deliver them to the registered location within 2 business days

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44
Q

If you have an off-site central location, what info can be stored there?

A

shipping and financial records only

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45
Q

If you have an off-site central location, how quickly must you be able to retrieve these records?

A

2 days

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46
Q

Is an intern/extern allowed to counsel a patient on a new medication?

A

yes, but only under the direct supervision of a pharmacist

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47
Q

T/F: Pharmacy techs must be licensed in the state of AL?

A

F

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48
Q

which ways may one dispose or destroy controlled substances?

A
  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
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49
Q

If using the assistance of a special agent in charge of the nearest DEA office to destroy a controlled substance, what is needed?

A

DEA form 41 (surrender of controlled substances)

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50
Q

What does a DEA form 41 do?

A

acknowledges surrender of controlled substances (usually for destruction)

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51
Q

Can hospitals destroy their own controlled product?

A

yes, they are given special guidelines

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52
Q

CSOS

A

Controlled substance ordering system

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53
Q

What does DEA form 222 do?

A

paper form allowing for ordering CI and CII

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54
Q

What does CSOS do?

A

allows ordering of CI, CII, CIII, CIV, and CV meds

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55
Q

to use a CSOS, what must you have?

A

power of attorney (need to apply for a digital certificate)

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56
Q

What does the digital certificate associated with the power of attorney needed to use CSOS do?

A

allows you to digitally sign for the order

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57
Q

How many copies of DEA form 222 are there?

A

3

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58
Q

Copy 1 of the DEA form 222 is

A

brown, and is kept by the wholesaler/supplier

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59
Q

Copy 2 of the DEA form 222 is

A

green, and is sent to the DEA by the wholesaler

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60
Q

Copy 3 of the DEA form 222 is

A

blue, and it is kept by the pharmacy

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61
Q

Which DEA form 222 is kept by the DEA

A

green (copy 2)

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62
Q

Which DEA form 222 is kept by the pharmacy

A

blue (copy 3)

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63
Q

Which DEA form 222 is kept by the wholesaler?

A

brown (copy 1)

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64
Q

Ordering CIII, CIV, and CV substances

A

Ordered directly from individual business (wholesaler/supplier) that is REGISTERED WITH DEA

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65
Q

Do individual pharmacists have a DEA number?

A

no, the facility/pharmacy will have a DEA number, but pharmacists do not individually

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66
Q

Who has a DEA number?

A
  1. wholesaler/supplier
  2. Pharmacy

Pharmacists do NOT, they have a controlled substance license from ALBOP (not registered with DEA)

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67
Q

Who can legally possess prescription drugs?

A
  1. Facility (pharmacy, hospital, LTCF, physician’s office, etc)
  2. End-user
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68
Q

Each pharmacy is required to have a PERMIT from

A

ALBOP

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69
Q

Before opening, each pharmacy must be

A

inspected

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70
Q

Each pharmacy must be staffed with

A

a licensed pharmacist and registered personnel

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71
Q

Pharmaceutical products may only be dispensed bia

A
  1. Prescription
  2. Drug order
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72
Q

Definition of prescription

A

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

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73
Q

A prescription is an order for medication that is

A

dispensed to or for an ultimate user; therefore, it is NOT INTENDED FOR IMMEDIATE ADMINISTRATION

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74
Q

Definition of medication order

A

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)

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75
Q

If the DEA asks for the schedule II records from your pharmacy, how long do you have to comply with their request?

A

2 business days

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76
Q

Medication SAMPLES may only be distributed to

A

licensed practitioners (or pharmacies of hospitals/health care entities)

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77
Q

Samples may/may not be sold

A

may NOT be sold

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78
Q

Starter packs left at pharmacies are/are not considered samples

A

are NOT considered samples

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79
Q

To obtain samples, prescribers must make a

A

written request

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80
Q

Drug sample receipts must contain 5 things:

A
  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
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81
Q

Drug samples are highly regulated by

A

Prescription Drug Marketing Act

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82
Q

Controlled substances must be accounted for by a ____ process

A

closed loop (“cradle to grave”)

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83
Q

You must maintain records of CS in which 3 ways

A
  1. inventory
  2. receipt
  3. distribution
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84
Q

inventory

A

drugs had on hand at any time

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85
Q

receipt

A

drugs coming into the pharmacy (name, strength, quantity, date)

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86
Q

Distribution

A

where the drugs go when they leave the pharmacy

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87
Q

What is a drug pedigree

A

verification process (where pharmacies get their drugs)

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88
Q

Wholesaler distributors are required to be

A

licensed

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89
Q

Drug Supply Chain Security Act is also called

A

Track and Trace Law

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90
Q

Drug Supply Chain Security Act (Track and Trace Law) requires that

A

pedigree/closed loop cradle-to-grave accountability for drugs

91
Q

How many things are required for a controlled substance?

92
Q

Which 9 things are required for a controlled substance?

A
  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
Q

What is important to recognize that is NOT required on a controlled substance prescription?

A

phone number

94
Q

A prescription must be written in

A
  1. ink
  2. indelible pencil
  3. typewritten
95
Q

In AL, what type of signature must be on a controlled substance prescription?

A

manually-signed (wet) signature ON THE DATE WRITTEN

96
Q

Can a nurse/receptionist put information on a prescription for a practitioner to sign?

97
Q

Who may issue a controlled Rx

A

1 MD
2. DO
3. DPM
4. DDS/DMD
5. DVM/VMD

Assuming they are licensed and registered with the DEA

98
Q

Who is excluded from needing to be registered with DEA to write for controlled substances?

A
  1. Public Health Service
  2. Federal Bureau of Prisons
  3. Military Practitioners
99
Q

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

A

E (A, B, and C)

100
Q

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

A

c. expiration date of the samples

101
Q

Restrictions on controlled substance prescriptions

A
  1. must be for LEGITIMATE MEDICAL PURPOSE
  2. must by within normal course of practice
102
Q

Can CIIs be submitted electronically?

103
Q

Can CIII-CV prescriptions be submitted electronically?

104
Q

Do drivers need to be licensed to take meds from wholesaler to pharmacy?

105
Q

do drivers need to be licensed to take meds from pharmacy to another pharmacy?

A

must be a pharmacy employee who is registered

106
Q

What must be on a prescription label?

A
  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
Q

What must be on a stock label

A
  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
Q

Unit dose label requirements

A
  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
Q

When is a boxed warning required

A

if a drug may lead to death or serious injury

110
Q

Pregnancy category A

A

no demonstrated risk to fetus from well-controlled tudies

111
Q

Pregnancy category B

A

no demonstrated risk to fetus (animal studies only)

112
Q

Pregnancy category C

A

either studies in animals or studies in people demonstrated adverse effects on fetus; only give if benefits > risks

113
Q

Pregnancy category D

A

positive risk to fetus

114
Q

Pregnancy category X

A

Risk outweighs benefit

115
Q

New pregnancy warnings

A
  1. Pregnancy
  2. Lactation
  3. males and females of reproductive potential
116
Q

how many digits in an NDC?

117
Q

how many segments in NDC?

118
Q

First segment of NDC describes

A

company/manufacturer (labeler)

119
Q

Second segment of NDC describes

A

drug strength, dosage form, and formulation

120
Q

third segment of NDC describes

A

package size

121
Q

503a facility

A

traditional compounding (regular pharmacy)

122
Q

503b facility

A

outsourcing facility

123
Q

What do 503b facilities have to do that 503a facilities don’t?

A

follow cGMP standards (expensive, strict)

124
Q

cGMP

A

current good manufacturing practice

125
Q

What are 503b facilities allowed to do that 503a facilities aren’t?

A

compound ahead of time in large batches

126
Q

What are current Good Manufacturing Practice regulations?

A

regulations that provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities

127
Q

Who enforces cGMPs?

128
Q

How many digits are in the first segment of an NDC?

A

5 (sometimes 4)

129
Q

How many digits are in the second segment of an NDC?

A

3 (sometimes 4)

130
Q

How many digits are in the third segment of an NDC?

131
Q

If ordering a schedule II

132
Q

if transferring a CII between any 2 registrants (wholesaler -> pharmacy, pharmacy -> pharmacy, pharmacy -> Dr.’s office and pharmacy, etc)

133
Q

If transferring a schedule III, IV, or V

A

must maintain adequate records (invoices)

134
Q

Invoices must be

A

specific (think of invoices from a wholesaler and what they contain); can use for legend drugs as well

135
Q

Can/cannot fill an Rx for “office use”

136
Q

If an Rx for “office use” is given to a pharmacy, what do you do?

A

transfer it to the office; if it’s a CII, must give form 222; otherwise invoice

137
Q

Which of the following practitioners can legally prescribe lisinopril 10 mg?
A. MD
B. DO
C. DVM
D. DPM
E. DDS

A

MD, DO, DVM (if animal)

138
Q

T/F: Prescriptions for controlled substances must be written for a legitimate medical purpose

139
Q

T/F: pharmacists have a corresponding responsibility to ensure that controlled substance prescriptions are valid

140
Q

T/F: prescriptions for controlled substances may not be transmitted electronically

141
Q

T/F: a physician must write for prescriptions that are consistent with their “normal course of practice”

142
Q

T/F: T/F: T/F:

143
Q

Generally, what do you do when a drug is approved for a specific indication and the prescriber writes for it off-label?

A
  1. use professional judgement
  2. document
  3. decline to fill if places patient at risk of harm
144
Q

human products can/cannot be used for vet use

145
Q

veterinary products can/cannot be used for human use

146
Q

drugs that have not completed the FDA approval process are called

A

investigational new drugs

147
Q

what is necessary before giving an IND to a patient?

A

informed consent

148
Q

how many characters are in a DEA number?

149
Q

what is the 1st character of a DEA number

A

A, B, C, F

150
Q

DEA number 1st character: A

A

retired in 1985

151
Q

DEA number 1st character: B

A

doctors, clinics, hospitals

152
Q

DEA number 1st character: C

A

specialists

153
Q

DEA 2nd character

A

first initial of registrant’s last name

154
Q

DEA number 1st character: D

A

teaching institution

155
Q

DEA number 1st character: E

A

manufacturer

156
Q

DEA number 1st character: F

A

Distributor

157
Q

DEA number 1st character: G

A

researcher

158
Q

DEA number 1st character: M

A

mid-level practitioner (NP, PA)

159
Q

DEA number 1st character: P

A

narcotic treatment program

160
Q

DEA number 1st character: R

A

narcotic treatment program

161
Q

DEA number 1st character: X

A

suboxone/subutex prescribing program

162
Q

know how to math the DEA number

163
Q

Exceptions for DEA registratoin

A
  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
Q

Are pharmacists allowed to dispense controlled substances

A

yes, just need to be licensed with ALBOP and purchase a license (or have pharmacy/facility purchase license)

165
Q

What regulates the methadone treatment program?

166
Q

SAMHSA

A

Substance Abuse and Mental Health Services Administration

167
Q

SAMHSA is regulated by the

A

Department of Health and Human Services (DHHS)

168
Q

A practitioner cannot write a prescription for methadone to treat addiction unless they are

A

registered with the DEA as a narcotic treatment program (NTP) practitioner

169
Q

CSAT

A

Center for Substance Abuse Treatment

170
Q

DATA

A

Drug Addiction Treatment Act

171
Q

DATA-waived means

A

the physician can prescribe suboxone/subutex

172
Q

DATA-waived physicians get an

A

X at the beginning of their DEA

173
Q

CSAT role in DATA

A

tells DEA that physician is DATA-waived and DEA assigns identifier

174
Q

max number of patients for DATA-waived HCPs

A

30 -> 100 -> 275

275 is max

175
Q

HCP that get a DATA waiver can initially treat

A

30 patients for at least the first year

176
Q

HCPs that get a data waiver and treat 30 patients for 1 year

A

can increase their limit to 100

177
Q

After 1 year at the 100-patient limit, HCPs that are data-waived can increase their patient limit to

178
Q

after 1 year of treating 275 patients, data-waived hcps can increase their limit to

A

none; 275 is the max

179
Q

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

A

C. A unit dose label

180
Q

After meeting certain criteria, what is the highest number of patients that a single physician can treat with suboxone?

181
Q

Can a Rx for a CS be filled/refilled by prescriber who is deceased?

A

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
Q

The code of Federal Regulations states that the DEA registration of any person terminates when such a person

A
  1. dies
  2. ceases legal existence
  3. DCs business
  4. DCs professional practice
  5. surrenders their registration
183
Q

Can you prescribe medications from internet prescribing?

A

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
Q

For consulting pharmacists for long-term care facilities, must take and pass certification. The initial course is

185
Q

for consulting pharmacists for LTCFs, how much LIVE ce is required?

186
Q

which prescriptions MUST pharmacists offer counseling?

A

new prescriptions and refills where appropriate

187
Q

What is the exception to offering counseling on prescriptions?

A

if it is deemed inappropriate or unnecessary by the pharmacist, do not have to offer counseling

188
Q

in which ways may a pharmacist counse

A

verbal, written, teleophone, or some other manner

189
Q

who can counsel

A

pharmacist, intern/extern (supervised)

190
Q

what MUST be included with every prescription

A

printed statement that includes the pharmacy’s telephone number in case of questions

191
Q

medication administration is/is not allowed in the practice of pharmacy

192
Q

Requirements for electronically issuing and processing CS Rxs

A
  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
Q

What are the software requirements for e-prescribing?

A

must be audited by a 3rd party and approved by the FDA

194
Q

prescriber must digitally sign electronic Rx for CS using their cryptographic key; the pharmacy software must be able to

A

apply the prescriber’s public key to confirm that the prescription was signed

195
Q

the software for CS e-Rx must check to see that the prescriber’s digital certificate is

A

still valid

196
Q

the software for CS e-Rx must retain the

A

DEA# of the prescriber

197
Q

The digitally signed Rx in the software for CS e-Rx must archive

A

the prescription by the softrware

198
Q

For the CS e-Rx, the pharmacy software must limit

A

access by name or role

199
Q

For the CS e-Rx, the pharmacy software must store all

200
Q

For the CS e-Rx, the pharmacy software must also perform automated internal

A

audits and provide reports of incidents to pharmacists

201
Q

Prescriptions for controlled substances must contain

A
  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
Q

What information is required on an Rx label?

A
  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
Q

May a prescriber write multiple CII prescriptions for the same patient and same medication on the same day?

A

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
Q

What canges can a pharmacist NOT make to a CII?

A
  1. patient name
  2. drug name
  3. fill before date
205
Q

Can a pharmacist inan emergecy setting give a patient a refill when there are no refills remaining?

A

yes, must give a one time fill for 72 hour supply (enters as NEW rx)
can NOT do this for CII or CIII!!!!

206
Q

Which prescriptions may NOT be filled as an emergency 72 hour refill?

A

CII and CIII

207
Q

If a pharmacist fills an emergency refill for a 72 hour supply of a medication, they should notify the prescriber within

208
Q

Can a schedule II be transmitted by fax in AL?

A

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
Q

A CII to be compounded may/may not be faxed

A

MAY, if given through a needle

210
Q

3 situations in wich a CII can be faxed

A
  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
Q

Refills on CV?

212
Q

Expiration of CV?

213
Q

CII legal expiration date?

214
Q

CII refills?

215
Q

quantity limit on CII?

A

none, EXCEPT
1. 90 DS if writing multiple
2. mid-level practitioners limited to 30 DS

216
Q

CIII and CIV refills

A

6 months or 5 refills, whichever comes first

217
Q

3 specific situations in which CII substances are ok to take over the phone/orally

A
  1. emergency situation for LTCF
  2. emergency situation for hospice
  3. emergency situation for home health
218
Q

If take an oral CII Rx, quantity should be limited to

A

82 hour supply and must have hard copy within 7 days

219
Q

T/F: A cashier may not ask the patient if they have any questions for the pharmacist

220
Q

T/F: If a pharmacist feels that counseling is unnecessary in a particular situation, they may choose not to provide it

221
Q

T/F: a supervised intern may not counsel a patient on a new prescription

222
Q

T/F: a pharmacist may not offer written instructions in place of face-to-face counseling in any circumstances

223
Q

Who is responsible for ensuring the validity of an electronic prescription for a controlled substance?

A

the pharmacy and the prescriber, NOT the DEA

ALBOP FAQs (29 decks)

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