CPJE LAW REVIEW TIPS ANSWERS AND QUESTIONS
SET A+
✔✔Addyi
What is the Risk? What is the REMS requirement for the med to be approved for
dispensing? - ✔✔Addyi REMS Program
Risk: Hypotension and syncope due to an interaction W/ ALCOHOL
Reuirement: No alcohol use while taking Addyi. All REMS participants must be trained
and pts must be properly counseled.
✔✔Patient counseling must include at least the following items: - ✔✔Directions for use
and storage
Importance of compliance w/ directions
Precautions and relevant warnings (common/ severe SEs and drug interactions)
✔✔If a prescription is MAILED or delivered, there must be a _____ (written/ verbal?)
notice that a pharmacist is available if the pt has any questions and a telephone # that
the pt can call. - ✔✔written
✔✔Incidental disclosures (ex: accidently overheard when counseling a patient at a
pharmacy or when discussing pt's care during medical rounds) _____ (are/ are not) a
HIPPA violation. - ✔✔are not
✔✔The Orange Book uses 2-letter code system to indicate whether or not a generic
drug is therapeutically equivalent to the branded drug.
An AB rated generic drug is _______ (therapeutically/ NOT therapeutically? ) equivalent
to the reference listed drug (RLD), which is the branded drug that the generic
manufacturer submitted to the FDA.
If the first letter is B, such as BB rated drug, the formulation is _____ (therapeutically/
NOT therapeutically) equivalent. - ✔✔AB rated: therapeutically equiv
B_ rated: NOT therapeutically equivalent
,✔✔Substitution _____ (is/ is NOT) permitted between long- acting and short-acting
forms of a medication with the same chemical ingredients (Ex: LA form of clonidine that
is indicated for ADHD (Kapvay) to be interchanged with IR clonidine)
Substitution _____ (is/ is NOT) permitted between combination drug products and
multiple single- agents (Ex: Combo drug isosorbide dinitrate/ hydralazine (BiDil) to be
interchanged with 2 indiv drugs as seperate drugs) - ✔✔Both answers: is NOT
✔✔Substitution _____ (is/ is NOT) permitted by the pahrmacist between different
formulation with same active ingredients of equivalnet strength and duration of therapy
as the prescribed drug when the change will improve patient compliance. (Ex: 1/2 tab
Bactrim DS for a child to be interchanged with 5mL/dose pediatric suspension to the
child's parents. - ✔✔is
✔✔What is a biosimilar? - ✔✔A biological product that has highly similar structure and
function to the reference product and has no significant difference in safety and
effectiveness from the reference product.
✔✔What is a biosimilar to filgrastim (Neupogen)? - ✔✔Filgrastim-sndz (Zarxio)
✔✔What is a biosimilar for infliximab (Remicade)? - ✔✔Infliximab-dyyb (Inflectra)
✔✔A biosimilar _____ (is/ is NOT) automatically interchangable with the reference
product. A biosimilar must prove that it would have the same clinical effect as the
reference product in any given patient in order to be considered interchangable. - ✔✔is
NOT
✔✔Drugs can be pre-counted or repackaged from a stock container (which is larger)
into smaller quantities suitable for dispensing. The repackaging should be done
according to the Current Good Manufacturing Practices (CGMPs), and the drugs must
be properly labeled with at least the following information: (7 things) - ✔✔Name of drug
Strength
Dosage form
Manufacturer's Name
Lot #
Expiration Date
Quantity per repackaged unit
✔✔If a MD is unable to create a written order, MD can make a verbal order instead. If a
nurse is involved, the nurse can enter the order for MD, NOTE PRESCRIBER'S NAME
AND SIGN the order. The MD then has _____ (time) to physically or electronically
COUNTERSIGN the order. - ✔✔48 hours
, ✔✔A copy of the chart order for NON-CONTROLLED substances must be kept at the
hospital for at least _____ (time). - ✔✔3 years
✔✔A copy of the chart order for CONTROLLED substances must be kept at the hospital
for at least _____ (time). - ✔✔7 years
✔✔The board has created a type of specialty license for the hospital pharmacy to
perform centralized packaging for the pharmacy's hospital & 1 or more general acute
care hospitals under COMMON OWNERSHIP & located within _____ (distance) radius
of each other - ✔✔75 mile
✔✔Hospital Dose Packaging: Label for each unit dose medication produced by a
centralized hospital packaging pharmacy must contain all of the following: (7 things) -
✔✔Name of medication
Quantity of each active ingredient
Date medication was prepared
Beyond use date
Special storage or handling requirements
Lot or control #
Name of centralized hospital packaging pharmacy
✔✔Hospital Dose Packaging: Label should include beyond use date which is no later
than either of the following: (2) - ✔✔1 year from date of the drug was repackaged
Expiration date on manufacturer's container
✔✔Drug supplies for use of medical emergencies must be immediately available at
each nursing unit or service area. The hospital drug supply must be inspected by a
pharmacist, intern, or technician at least every _____ (time). Records for inspections
must be kept for at least _____ (time). Irregularities found should be reported within
_____ (time) to the PIC and the director or chief executive officer of the healthcare
facility. - ✔✔30 days
3 years
24 hours
✔✔Dispensing Blood Clotting Products for Home Use: Each provider of blood clotting
products for home use must: - ✔✔1. Maintain 24/7 on-call service everyday of the year.
2. Have the ability to obtain all FDA-approved blood clotting products in multiple assay
ranges & vial sizes
3. Supply all necessary ancillary infusion equipment & supplies with each prescription,
as needed
Ship the prescribed blood clotting products & ancillary infusion equipment & supplies to
the pt w/in 2 business days.
SET A+
✔✔Addyi
What is the Risk? What is the REMS requirement for the med to be approved for
dispensing? - ✔✔Addyi REMS Program
Risk: Hypotension and syncope due to an interaction W/ ALCOHOL
Reuirement: No alcohol use while taking Addyi. All REMS participants must be trained
and pts must be properly counseled.
✔✔Patient counseling must include at least the following items: - ✔✔Directions for use
and storage
Importance of compliance w/ directions
Precautions and relevant warnings (common/ severe SEs and drug interactions)
✔✔If a prescription is MAILED or delivered, there must be a _____ (written/ verbal?)
notice that a pharmacist is available if the pt has any questions and a telephone # that
the pt can call. - ✔✔written
✔✔Incidental disclosures (ex: accidently overheard when counseling a patient at a
pharmacy or when discussing pt's care during medical rounds) _____ (are/ are not) a
HIPPA violation. - ✔✔are not
✔✔The Orange Book uses 2-letter code system to indicate whether or not a generic
drug is therapeutically equivalent to the branded drug.
An AB rated generic drug is _______ (therapeutically/ NOT therapeutically? ) equivalent
to the reference listed drug (RLD), which is the branded drug that the generic
manufacturer submitted to the FDA.
If the first letter is B, such as BB rated drug, the formulation is _____ (therapeutically/
NOT therapeutically) equivalent. - ✔✔AB rated: therapeutically equiv
B_ rated: NOT therapeutically equivalent
,✔✔Substitution _____ (is/ is NOT) permitted between long- acting and short-acting
forms of a medication with the same chemical ingredients (Ex: LA form of clonidine that
is indicated for ADHD (Kapvay) to be interchanged with IR clonidine)
Substitution _____ (is/ is NOT) permitted between combination drug products and
multiple single- agents (Ex: Combo drug isosorbide dinitrate/ hydralazine (BiDil) to be
interchanged with 2 indiv drugs as seperate drugs) - ✔✔Both answers: is NOT
✔✔Substitution _____ (is/ is NOT) permitted by the pahrmacist between different
formulation with same active ingredients of equivalnet strength and duration of therapy
as the prescribed drug when the change will improve patient compliance. (Ex: 1/2 tab
Bactrim DS for a child to be interchanged with 5mL/dose pediatric suspension to the
child's parents. - ✔✔is
✔✔What is a biosimilar? - ✔✔A biological product that has highly similar structure and
function to the reference product and has no significant difference in safety and
effectiveness from the reference product.
✔✔What is a biosimilar to filgrastim (Neupogen)? - ✔✔Filgrastim-sndz (Zarxio)
✔✔What is a biosimilar for infliximab (Remicade)? - ✔✔Infliximab-dyyb (Inflectra)
✔✔A biosimilar _____ (is/ is NOT) automatically interchangable with the reference
product. A biosimilar must prove that it would have the same clinical effect as the
reference product in any given patient in order to be considered interchangable. - ✔✔is
NOT
✔✔Drugs can be pre-counted or repackaged from a stock container (which is larger)
into smaller quantities suitable for dispensing. The repackaging should be done
according to the Current Good Manufacturing Practices (CGMPs), and the drugs must
be properly labeled with at least the following information: (7 things) - ✔✔Name of drug
Strength
Dosage form
Manufacturer's Name
Lot #
Expiration Date
Quantity per repackaged unit
✔✔If a MD is unable to create a written order, MD can make a verbal order instead. If a
nurse is involved, the nurse can enter the order for MD, NOTE PRESCRIBER'S NAME
AND SIGN the order. The MD then has _____ (time) to physically or electronically
COUNTERSIGN the order. - ✔✔48 hours
, ✔✔A copy of the chart order for NON-CONTROLLED substances must be kept at the
hospital for at least _____ (time). - ✔✔3 years
✔✔A copy of the chart order for CONTROLLED substances must be kept at the hospital
for at least _____ (time). - ✔✔7 years
✔✔The board has created a type of specialty license for the hospital pharmacy to
perform centralized packaging for the pharmacy's hospital & 1 or more general acute
care hospitals under COMMON OWNERSHIP & located within _____ (distance) radius
of each other - ✔✔75 mile
✔✔Hospital Dose Packaging: Label for each unit dose medication produced by a
centralized hospital packaging pharmacy must contain all of the following: (7 things) -
✔✔Name of medication
Quantity of each active ingredient
Date medication was prepared
Beyond use date
Special storage or handling requirements
Lot or control #
Name of centralized hospital packaging pharmacy
✔✔Hospital Dose Packaging: Label should include beyond use date which is no later
than either of the following: (2) - ✔✔1 year from date of the drug was repackaged
Expiration date on manufacturer's container
✔✔Drug supplies for use of medical emergencies must be immediately available at
each nursing unit or service area. The hospital drug supply must be inspected by a
pharmacist, intern, or technician at least every _____ (time). Records for inspections
must be kept for at least _____ (time). Irregularities found should be reported within
_____ (time) to the PIC and the director or chief executive officer of the healthcare
facility. - ✔✔30 days
3 years
24 hours
✔✔Dispensing Blood Clotting Products for Home Use: Each provider of blood clotting
products for home use must: - ✔✔1. Maintain 24/7 on-call service everyday of the year.
2. Have the ability to obtain all FDA-approved blood clotting products in multiple assay
ranges & vial sizes
3. Supply all necessary ancillary infusion equipment & supplies with each prescription,
as needed
Ship the prescribed blood clotting products & ancillary infusion equipment & supplies to
the pt w/in 2 business days.
