CPJE LAW MAIN ALL ANSWERS AND QUESTIONS
SET A+
✔✔If a non-controlled Rx has a PRN refill and is written for 90d supply, how many refills
can you give to the pt? - ✔✔3 refills (remember the 1st fill is not considered a refill)
✔✔It is allowed to dispense up change Rx to 90d supply of a NON-CONTROLLED,
NON-PSYCHIATRIC drug when the initial Rx specified a shorter time period (ex 30d
supply) as long as the following requirements are met:
1. The pt has completed an initial _____-day supply of the drug w/ no neg effects, or the
pt previously received the same medication w/ a 90d supply.
2. Total quantity dispensed (including the refills) DOES NOT EXCEED the amount
authorized on the Rx.
3. The pharmacist notifies prescriber about 90d supply change. - ✔✔30d
✔✔A pharmacist cannot dispense a greater quantity supply of drug (ex: from 30d supply
to 90d supply) if:
1. Prescriber hand written or orally indicates "_____" or words similar to that
2. Prescriber indicates that dispensing the initial amount is MEDICALLY NECESSARY -
✔✔No change to quantity
✔✔At pt's request AND with a VALID Rx that states _____-supply, the pharmacy MUST
dispense up to _____- supply of a self-administered hormonal contraceptive (ALL AT
ONE TIME) (self-admin hormonal contraceptive includes pill, patch, ring, injection) -
✔✔12 month (for both answers)
✔✔Who can be involved in an Rx transfer from one pharmacy to another? -
✔✔Pharmacists, Intern pharmacists
✔✔When a BRAND name is dispensed, the brand name should be listed on the Rx
label. Manufacturer's name _____ (is/ is not?) required because the brand name _____
(can/ cannot) be used to identify the manufacturer. - ✔✔is not
can
,✔✔When a GENERIC name is dispensed, the Rx label _____ (must/ must not?)
include:
1. The generic name
2. "GENERIC NAME FOR [insert brand name equiv] to indicate the brand name drug
equivalent to the dispensed generic drug
3. The generic drug manufacturer.
There are often multiple manufacturers of the same generic drug. - ✔✔must
✔✔Each of the following items (and onlt these 4 items) must be clustered into ONE
AREA of the label that comprises at least _____% of the label. Each item must be
printed in at least a _____ font sized sans serif typeface and listed in the FOLLOWING
ORDER: (4) - ✔✔50%
12
1. Name of pt
2. Name and strength of drug
3. Directions for use of drug
Condition or purpose of drug (if written in Rx)
✔✔Which drug classes can impair a person's ability to operate a vehicle or vessel and
the pharmacist should warn the pt about this huge side effect and be included as a
warning in the axiliary label: - ✔✔Muscle relaxants
Antipsychotic drugs w/ CNS depressant effects
Anti deppressants w/ CNS depressant effects
Antihistamines
Motion sickness agents
Antipruritics
Antinauseants
Anticonvulsants
Antihypertensive agents
Controlled substances w/ CNS depressant effects
Anticholinergic agents that may impair vision
✔✔Which drug classes pose a substantial risk of side effect(s) in combo w/ ALCOHOL
and pharmacist must then include a warning on the prescription label: - ✔✔disulfiram
(ex chlorpropamide, flagyl)
MAO inhibitors
Nitrates
Antidiabetic agents (insulin, SFU due to risk of hypoglycemia
✔✔Prospective Drug Utilization Review (DUR) vs Retrospective DUR - ✔✔Prospective
DUR: evaluating pt's med profile PRIOR to dispensing
Retrospective DUR: evaluating pt's med profile AFTER drug is dispensed
✔✔A pharmacist must keep med profiles on all pts who have Rxs filled at the pharmacy
except when pharmacist feels that the pt will NOT come back to the pharmacy. Each
, profile must be kept for at least _____ (time) from the date when the LAST Rx was filled
- ✔✔1 year
✔✔There are 3 types of written info that can be provided to the pt: - ✔✔Consumer
Medication Information (CMI) leaflets
Patient Package Inserts (PPIs)
Medication Guides (MedGuides)
✔✔When should CMI be given to pt's? - ✔✔For each new Rx
✔✔Is CMI FDA approved? - ✔✔No
✔✔When should PPI be given to pt's - ✔✔For every Rx (old and new)
✔✔In institutionalized setting (hospital/ long-term care facility), PPI must be given to
patient _____ (before/ after?) administration and every _____ (time) thereafter. -
✔✔before
30 days
✔✔Is PPI FDA approved? - ✔✔Yes
✔✔When should MedGuides be given to pts? - ✔✔Every Rx fill (old and new)
Can also be given if pt/ caregiver asks for it
✔✔Is MedGuides FDA approved? - ✔✔Yes
✔✔What does REMS mean? - ✔✔Risk Evaluation and Mitigation Strategy
It ensures that the benefits of certain drugs and biologics outweigh the risks
✔✔Thalidomide
What is the Risk? What is the REMS requirement for the med to be approved for
dispensing? - ✔✔Thalomid REMS Program (prev called STEPS program)
Risk: Severe birth defects
Requirement: Negative pregnancy test required prior to dispensing EACH prescription
✔✔Isotretinoin
What is the Risk? What is the REMS requirement for the med to be approved for
dispensing? - ✔✔iPledge Program
Risk: Severe birth defects
Requirement: Negative pregnancy test required prior to dispensing EACH prescription
✔✔Clozapine
What is the Risk? What is the REMS requirement for the med to be approved for
dispensing? - ✔✔Clozapine REMS Program
SET A+
✔✔If a non-controlled Rx has a PRN refill and is written for 90d supply, how many refills
can you give to the pt? - ✔✔3 refills (remember the 1st fill is not considered a refill)
✔✔It is allowed to dispense up change Rx to 90d supply of a NON-CONTROLLED,
NON-PSYCHIATRIC drug when the initial Rx specified a shorter time period (ex 30d
supply) as long as the following requirements are met:
1. The pt has completed an initial _____-day supply of the drug w/ no neg effects, or the
pt previously received the same medication w/ a 90d supply.
2. Total quantity dispensed (including the refills) DOES NOT EXCEED the amount
authorized on the Rx.
3. The pharmacist notifies prescriber about 90d supply change. - ✔✔30d
✔✔A pharmacist cannot dispense a greater quantity supply of drug (ex: from 30d supply
to 90d supply) if:
1. Prescriber hand written or orally indicates "_____" or words similar to that
2. Prescriber indicates that dispensing the initial amount is MEDICALLY NECESSARY -
✔✔No change to quantity
✔✔At pt's request AND with a VALID Rx that states _____-supply, the pharmacy MUST
dispense up to _____- supply of a self-administered hormonal contraceptive (ALL AT
ONE TIME) (self-admin hormonal contraceptive includes pill, patch, ring, injection) -
✔✔12 month (for both answers)
✔✔Who can be involved in an Rx transfer from one pharmacy to another? -
✔✔Pharmacists, Intern pharmacists
✔✔When a BRAND name is dispensed, the brand name should be listed on the Rx
label. Manufacturer's name _____ (is/ is not?) required because the brand name _____
(can/ cannot) be used to identify the manufacturer. - ✔✔is not
can
,✔✔When a GENERIC name is dispensed, the Rx label _____ (must/ must not?)
include:
1. The generic name
2. "GENERIC NAME FOR [insert brand name equiv] to indicate the brand name drug
equivalent to the dispensed generic drug
3. The generic drug manufacturer.
There are often multiple manufacturers of the same generic drug. - ✔✔must
✔✔Each of the following items (and onlt these 4 items) must be clustered into ONE
AREA of the label that comprises at least _____% of the label. Each item must be
printed in at least a _____ font sized sans serif typeface and listed in the FOLLOWING
ORDER: (4) - ✔✔50%
12
1. Name of pt
2. Name and strength of drug
3. Directions for use of drug
Condition or purpose of drug (if written in Rx)
✔✔Which drug classes can impair a person's ability to operate a vehicle or vessel and
the pharmacist should warn the pt about this huge side effect and be included as a
warning in the axiliary label: - ✔✔Muscle relaxants
Antipsychotic drugs w/ CNS depressant effects
Anti deppressants w/ CNS depressant effects
Antihistamines
Motion sickness agents
Antipruritics
Antinauseants
Anticonvulsants
Antihypertensive agents
Controlled substances w/ CNS depressant effects
Anticholinergic agents that may impair vision
✔✔Which drug classes pose a substantial risk of side effect(s) in combo w/ ALCOHOL
and pharmacist must then include a warning on the prescription label: - ✔✔disulfiram
(ex chlorpropamide, flagyl)
MAO inhibitors
Nitrates
Antidiabetic agents (insulin, SFU due to risk of hypoglycemia
✔✔Prospective Drug Utilization Review (DUR) vs Retrospective DUR - ✔✔Prospective
DUR: evaluating pt's med profile PRIOR to dispensing
Retrospective DUR: evaluating pt's med profile AFTER drug is dispensed
✔✔A pharmacist must keep med profiles on all pts who have Rxs filled at the pharmacy
except when pharmacist feels that the pt will NOT come back to the pharmacy. Each
, profile must be kept for at least _____ (time) from the date when the LAST Rx was filled
- ✔✔1 year
✔✔There are 3 types of written info that can be provided to the pt: - ✔✔Consumer
Medication Information (CMI) leaflets
Patient Package Inserts (PPIs)
Medication Guides (MedGuides)
✔✔When should CMI be given to pt's? - ✔✔For each new Rx
✔✔Is CMI FDA approved? - ✔✔No
✔✔When should PPI be given to pt's - ✔✔For every Rx (old and new)
✔✔In institutionalized setting (hospital/ long-term care facility), PPI must be given to
patient _____ (before/ after?) administration and every _____ (time) thereafter. -
✔✔before
30 days
✔✔Is PPI FDA approved? - ✔✔Yes
✔✔When should MedGuides be given to pts? - ✔✔Every Rx fill (old and new)
Can also be given if pt/ caregiver asks for it
✔✔Is MedGuides FDA approved? - ✔✔Yes
✔✔What does REMS mean? - ✔✔Risk Evaluation and Mitigation Strategy
It ensures that the benefits of certain drugs and biologics outweigh the risks
✔✔Thalidomide
What is the Risk? What is the REMS requirement for the med to be approved for
dispensing? - ✔✔Thalomid REMS Program (prev called STEPS program)
Risk: Severe birth defects
Requirement: Negative pregnancy test required prior to dispensing EACH prescription
✔✔Isotretinoin
What is the Risk? What is the REMS requirement for the med to be approved for
dispensing? - ✔✔iPledge Program
Risk: Severe birth defects
Requirement: Negative pregnancy test required prior to dispensing EACH prescription
✔✔Clozapine
What is the Risk? What is the REMS requirement for the med to be approved for
dispensing? - ✔✔Clozapine REMS Program
